Hymenoptera Venom Immunotherapy: Tolerance and Efficacy of an Ultrarush Protocol versus a Rush and a Slow Conventional Protocol

PubMed Central

Patella, Vincenzo; Florio, Giovanni; Giuliano, Ada; Oricchio, Carmine; Spadaro, Giuseppe; Marone, Gianni; Genovese, Arturo

2012-01-01

Background and Objective. Various venom immunotherapy (VIT) protocols are available for Hymenoptera allergy. Although adverse reactions (ADRs) to VIT are widely reported, controlled trials are still needed. We conducted a randomized prospective study to evaluate ADRs and the efficacy of three VIT regimens. Methods. 76 patients with Hymenoptera allergy, aged 16–76 years, were randomized to receive an ultrarush protocol (group A: 27 patients), a rush protocol (group B: 25), or a slow protocol (group C: 24). Aqueous venom extract was used in incremental phase and an adsorbed depot in maintenance phase. ADRs and accidental Hymenoptera stings during VIT were used to evaluate efficacy. Results. During incremental treatment, ADRs occurred in 1.99%, 3.7%, and 3.9% of patients in groups A, B, and C, and in 0.99%, 1.46%, and 2.7%, respectively, during maintenance. ADRs were significantly fewer in group A (incremental + maintenance phase) than in group C (1.29% versus 3.2%; P = 0.013). Reactions to accidental Hymenoptera stings did not differ among groups (1.1%, 1.2%, and 1.1%). Conclusion. Ultrarush was as effective as the rush and slow protocols and was associated with a low incidence of reactions to stings. This study indicates that ultrarush VIT is a valid therapeutic option for Hymenoptera allergy. PMID:22693521

Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

PubMed

Brehmer, Jess L; Husband, Jeffrey B

2014-10-01

There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report.

PubMed

Stevens, R Brian; Mercer, David F; Grant, Wendy J; Freifeld, Alison G; Lane, James T; Groggel, Gerald C; Rigley, Theodore H; Nielsen, Kathleen J; Henning, Megan E; Skorupa, Jill Y; Skorupa, Anna J; Christensen, Kecia A; Sandoz, John P; Kellogg, Anna M; Langnas, Alan N; Wrenshall, Lucile E

2008-05-27

The optimal dosing protocol for rabbit anti-thymocyte globulin (rATG) induction in renal transplantation has not been determined, but evidence exists that rATG infusion before renal allograft reperfusion improves early graft function. Infusing a large rATG dose over a short interval has not previously been evaluated for its effect on renal function and allograft nephropathy in a prospective, randomized comparison against conventional rATG induction. Between April 20, 2004 and December 26, 2007 we enrolled renal transplant patients into a prospective, randomized, nonblinded trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day x 4; target enrollment=160) followed after 6 months by calcineurin-inhibitor withdrawal. Primary endpoints are renal function by calculated glomerular filtration rate (GFR) and chronic allograft nephropathy at protocol biopsy. We now present the early GFR data of all 160 patients and safety and efficacy data of the first 142 patients with 6 months follow up and before calcineurin inhibitor withdrawal (average follow up=23.3+/-11.6 months). There were no differences between groups in rATG-related adverse events, patient and graft survival, acute rejection, or chronic allograft nephropathy rate at 6 months. Calculated DeltaGFR (POD 1-4) was significantly better in the single-dose group (P=0.02), with a trend toward improved renal function from months 2 to 6 in recipients of deceased donor kidneys (P=0.08). This study demonstrates that administering 6 mg/kg of rATG over 24 hr is safe and is associated with improved early renal function compared with administering rATG in alternate-day doses.

Cladribine in a weekly versus daily schedule for untreated active hairy cell leukemia: final report from the Polish Adult Leukemia Group (PALG) of a prospective, randomized, multicenter trial.

PubMed

Robak, Tadeusz; Jamroziak, Krzysztof; Gora-Tybor, Joanna; Blonski, Jerzy Z; Kasznicki, Marek; Dwilewicz-Trojaczek, Jadwiga; Wiater, Elzbieta; Zdunczyk, Andrzej; Dybowicz, Jacek; Dmoszynska, Anna; Wojtaszko, Maria; Zdziarska, Barbara; Calbecka, Malgorzata; Kostyra, Aleksandra; Hellmann, Andrzej; Lewandowski, Krzysztof; Stella-Holowiecka, Beata; Sulek, Kazimierz; Gawronski, Krzysztof; Skotnicki, Aleksander B; Nowak, Wieslaw; Zawilska, Krystyna; Molendowicz-Portala, Lucyna; Kloczko, Janusz; Sokolowski, Jaroslaw; Warzocha, Krzysztof; Seferynska, Ilona; Ceglarek, Bernardeta; Konopka, Lech

2007-05-01

Cladribine (2-chlorodeoxyadenosine, 2-CdA) treatment-associated infections may shorten potentially long-term survival in hairy cell leukemia (HCL). In search of the optimal mode of 2-CdA administration, 132 patients with untreated HCL were randomized to receive either standard 5-day 2-CdA protocol or a novel schedule of 6 weekly 2-CdA infusions suggested to be less toxic. Analysis of treatment response confirmed similar complete remission rates, overall response rates, progression-free survival, and overall survival in both 2-CdA protocols. However, we did not observe lower toxicity in the weekly schedule. Of special interest, no significant differences were found in the rate of grade 3/4 infections (18% for daily and 26% for weekly protocol, difference -8.2%; 95% confidence interval [CI] -23.2% to 6.9%; P = .28) and the rate of septic deaths (3% for daily and 2% for weekly protocol, difference 1.4%; 95% CI -4.3% to 7.0%; P = .64). In conclusion, HCL treatment with weekly 2-CdA infusions is equally effective but no safer than the standard 5-day 2-CdA protocol.

Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

2017-02-01

Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

PubMed

Zhang, Yan; Phy, Jennifer; Scott-Johnson, Chris; Garos, Sheila; Orlando, Jennie; Prien, Samuel; Huang, Jaou-Chen

2017-04-04

The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients' IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. ClinicalTrials NCT02591186 registered on October 7, 2015.

Optimizing prevention of hospital-acquired venous thromboembolism (VTE): prospective validation of a VTE risk assessment model.

PubMed

Maynard, Gregory A; Morris, Timothy A; Jenkins, Ian H; Stone, Sarah; Lee, Joshua; Renvall, Marian; Fink, Ed; Schoenhaus, Robert

2010-01-01

Hospital-acquired (HA) venous thromboembolism (VTE) is a common source of morbidity/mortality. Prophylactic measures are underutilized. Available risk assessment models/protocols are not prospectively validated. Improve VTE prophylaxis, reduce HA VTE, and prospectively validate a VTE risk-assessment model. Observational design. Academic medical center. Adult inpatients on medical/surgical services. A simple VTE risk assessment linked to a menu of preferred VTE prophylaxis methods, embedded in order sets. Education, audit/feedback, and concurrent identification of nonadherence. Randomly sampled inpatient audits determined the percent of patients with "adequate" VTE prevention. HA VTE cases were identified concurrently via digital imaging system. Interobserver agreement for VTE risk level and judgment of adequate prophylaxis were calculated from 150 random audits. Interobserver agreement with 5 observers was high (kappa score for VTE risk level = 0.81, and for judgment of "adequate" prophylaxis = 0.90). The percent of patients on adequate prophylaxis improved each of the 3 years (58%, 78%, and 93%; P < 0.001) and reached 98% in the last 6 months of 2007; 361 cases of HA VTE occurred over 3 years. Significant reductions for the risk of HA VTE (risk ratio [RR] = 0.69; 95% confidence interval [CI] = 0.47-0.79) and preventable HA VTE (RR = 0.14; 95% CI = 0.06-0.31) occurred. We detected no increase in heparin-induced thrombocytopenia (HIT) or prophylaxis-related bleeding using administrative data/chart review. We prospectively validated a VTE risk-assessment/prevention protocol by demonstrating ease of use, good interobserver agreement, and effectiveness. Improved VTE prophylaxis resulted in a substantial reduction in HA VTE. (c) 2010 Society of Hospital Medicine.

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

PubMed Central

Kim, Jinyoung; Cho, Jae-Heung

2017-01-01

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere's disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck's Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions' questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017. PMID:29387128

Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

PubMed

Berger, Marc L; Dreyer, Nancy; Anderson, Fred; Towse, Adrian; Sedrakyan, Art; Normand, Sharon-Lise

2012-01-01

In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials. This report details the recommendations of a Good Research Practice Task Force on Prospective Observational Studies for comparative effectiveness research. Key issues discussed include how to decide when to do a prospective observational study in light of its advantages and disadvantages with respect to alternatives, and the report summarizes the challenges and approaches to the appropriate design, analysis, and execution of prospective observational studies to make them most valuable and relevant to health-care decision makers. The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in prospective observational studies. The use of inception cohorts, new user designs, multiple comparator groups, matching designs, and assessment of outcomes thought not to be impacted by the therapies being compared are several strategies that should be given strong consideration recognizing that there may be feasibility constraints. The reasoning behind all study design and analytic choices should be transparent and explained in study protocol. Execution of prospective observational studies is as important as their design and analysis in ensuring that results are valuable and relevant, especially capturing the target population of interest, having reasonably complete and nondifferential follow-up. Similar to the concept of the importance of declaring a prespecified hypothesis, we believe that the credibility of many prospective observational studies would be enhanced by their registration on appropriate publicly accessible sites (e.g., clinicaltrials.gov and encepp.eu) in advance of their execution. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

PubMed Central

2012-01-01

Background The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor physical therapy alone on static and functional balance in children with CP submitted to BT-A in the lower limbs. This study describes the background, hypotheses, methodology of the procedures and measurement of the results. Trial registration RBR5qzs8h PMID:22591446

A Method of Managing Severe Traumatic Brain Injury in the Absence of Intracranial Pressure Monitoring: The Imaging and Clinical Examination Protocol.

PubMed

Chesnut, Randall M; Temkin, Nancy; Dikmen, Sureyya; Rondina, Carlos; Videtta, Walter; Petroni, Gustavo; Lujan, Silvia; Alanis, Victor; Falcao, Antonio; de la Fuenta, Gustavo; Gonzalez, Luis; Jibaja, Manuel; Lavarden, Arturo; Sandi, Freddy; Mérida, Roberto; Romero, Ricardo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Chaddock, Kelley

2018-01-01

The imaging and clinical examination (ICE) algorithm used in the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial is the only prospectively investigated clinical protocol for traumatic brain injury management without intracranial pressure (ICP) monitoring. As the default literature standard, it warrants careful evaluation. We present the ICE protocol in detail and analyze the demographics, outcome, treatment intensity, frequency of intervention usage, and related adverse events in the ICE-protocol cohort. The 167 ICE protocol patients were young (median 29 years) with a median Glasgow Coma Scale motor score of 4 but with anisocoria or abnormal pupillary reactivity in 40%. This protocol produced outcomes not significantly different from those randomized to the monitor-based protocol (favorable 6-month extended Glasgow Outcome Score in 39%; 41% mortality rate). Agents commonly employed to treat suspected intracranial hypertension included low-/moderate-dose hypertonic saline (72%) and mannitol (57%), mild hyperventilation (adjusted partial pressure of carbon dioxide 30-35 mm Hg in 73%), and pressors to maintain cerebral perfusion (62%). High-dose hyperosmotics or barbiturates were uncommonly used. Adverse event incidence was low and comparable to the BEST TRIP monitored group. Although this protocol should produce similar/acceptable results under circumstances comparable to those in the trial, influences such as longer pre-hospital times and non-specialist transport personnel, plus an intensive care unit model of aggressive physician-intensive care by small groups of neurotrauma-focused intensivists, which differs from most high-resource models, support caution in expecting the same results in dissimilar settings. Finally, this protocol's ICP-titration approach to suspected intracranial hypertension (vs. crisis management for monitored ICP) warrants further study.

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

PubMed

Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

2011-09-14

Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

Randomized trial of low versus high carbon dioxide insufflation pressures in posterior retroperitoneoscopic adrenalectomy.

PubMed

Fraser, Sheila; Norlén, Olov; Bender, Kyle; Davidson, Joanne; Bajenov, Sonya; Fahey, David; Li, Shawn; Sidhu, Stan; Sywak, Mark

2018-05-01

Posterior retroperitoneoscopic adrenalectomy has gained widespread acceptance for the removal of benign adrenal tumors. Higher insufflation pressures using carbon dioxide (CO 2 ) are required, although the ideal starting pressure is unclear. This prospective, randomized, single-blinded, study aims to compare physiologic differences with 2 different CO 2 insufflation pressures during posterior retroperitoneoscopic adrenalectomy. Participants were randomly assigned to a starting insufflation pressure of 20 mm Hg (low pressure) or 25 mm Hg (high pressure). The primary outcome measure was partial pressure of arterial CO 2 at 60 minutes. Secondary outcomes included end-tidal CO 2 , arterial pH, blood pressure, and peak airway pressure. Breaches of protocol to change insufflation pressure were permitted if required and were recorded. A prospective randomized trial including 31 patients (low pressure: n = 16; high pressure: n = 15) was undertaken. At 60 minutes, the high pressure group had greater mean partial pressure of arterial CO 2 (64 vs 50 mm Hg, P = .003) and end-tidal CO 2 (54 vs 45 mm Hg, P = .008) and a lesser pH (7.21 vs 7.29, P = .0005). There were no significant differences in base excess, peak airway pressure, operative time, or duration of hospital stay. Clinically indicated protocol breaches were more common in the low pressure than the high pressure group (8 vs 3, P = .03). In posterior retroperitoneoscopic adrenalectomy, greater insufflation pressures are associated with greater partial pressure of arterial CO 2 and end-tidal CO 2 and lesser pH at 60 minutes, be significant. Commencing with lesser CO 2 insufflation pressures decreases intraoperative acidosis. Copyright © 2017 Elsevier Inc. All rights reserved.

A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients.

PubMed

Avşar, Erol; Tiftikçi, Arzu; Poturoğlu, Sule; Erzin, Yusuf; Kocakaya, Ozan; Dinçer, Dinç; Yıldırım, Bulut; Güliter, Sefa; Türkay, Cansel; Yılmaz, Uğur; Onuk, Mehmet Derya; Bölükbaş, Cengiz; Ellidokuz, Ender; Bektaş, Ahmet; Taşan, Güralp; Aytuğ, Necip; Ateş, Yüksel; Kaymakoğlu, Sabahattin

2013-01-01

Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treatments in a prospective, multicentric, randomized study. Patients with dyspeptic complaints were recruited from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis. Two hundred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was observed during the study. Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

PubMed

Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

2016-11-01

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

PubMed

Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

2015-06-16

Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

Imposed Power of Breathing Associated With Use of an Impedance Threshold Device

DTIC Science & Technology

2007-02-01

threshold device and a sham impedance threshold device. DESIGN: Prospective randomized blinded protocol. SETTING: University medical center. PATIENTS...for males). METHODS: The volunteers completed 2 trials of breathing through a face mask fitted with an active impedance threshold device set to open...at -7cmH 2 O pressure, or with a sham impedance threshold device, which was identical to the active device except that it did not contain an

A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

PubMed

Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

2018-05-01

Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial.

PubMed

Vretzakis, George; Georgopoulou, Stavroula; Stamoulis, Konstantinos; Tassoudis, Vassilios; Mikroulis, Dimitrios; Giannoukas, Athanasios; Tsilimingas, Nikolaos; Karanikolas, Menelaos

2013-06-07

Blood transfusions are common in cardiac surgery, but have been associated with increased morbidity and long-term mortality. Efforts to reduce blood product use during cardiac surgery include fluid restriction to minimize hemodilution, and protocols to guide transfusion decisions. INVOS is a modality that monitors brain tissue oxygen saturation, and could be useful in guiding decisions to transfuse. However, the role of INVOS (brain tissue oxygen saturation) as part of an algorithm to direct blood transfusions during cardiac surgery has not been evaluated. This study was conducted to investigate the value of INVOS as part of a protocol for blood transfusions during cardiac surgery. Prospective, randomized, blinded clinical trial, on 150 (75 per group) elective cardiac surgery patients. The study was approved by the Institution Ethics committee and all patients gave written informed consent. Data were initially analyzed based on "intention to treat", but subsequently were also analyzed "per protocol". When protocol was strictly followed ("per protocol analysis"), compared to the control group, significantly fewer patients monitored with INVOS received any blood transfusions (46 of 70 patients in INVOS group vs. 55 of 67 patients in the control group, p = 0.029). Similarly, patients monitored with INVOS received significantly fewer units of red blood cell transfusions intraoperatively (0.20 ± 0.50 vs. 0.52 ± 0.88, p = 0.008) and overall during hospital stay (1.31 ± 1.20 vs. 1.82 ± 1.46, p = 0.024). When data from all patients (including patient with protocol violation) were analyzed together ("intention to treat analysis"), the observed reduction of blood transfusions in the INVOS group was still significant (51 of 75 patients transfused in the INVOS group vs. 63 of 75 patients transfused in the control group, p = 0.021), but the overall number of units transfused per patient did not differ significantly between the groups (1.55 ± 1.97 vs. 1.84 ± 1.41, p = 0.288). Our data suggest that INVOS could be a useful tool as part of an algorithm to guide decisions for blood transfusion in cardiac surgery. Additional data from rigorous, well designed studies are needed to further evaluate the role of INVOS in guiding blood transfusions in cardiac surgery, and circumvent the limitations of this study.

Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial.

PubMed

Shaefi, Shahzad; Marcantonio, Edward R; Mueller, Ariel; Banner-Goodspeed, Valerie; Robson, Simon C; Spear, Kyle; Otterbein, Leo E; O'Gara, Brian P; Talmor, Daniel S; Subramaniam, Balachundhar

2017-12-19

Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery. Studies have identified potentially injurious roles for cardiopulmonary bypass (CPB) and subsequent reperfusion injury. Cognitive dysfunction has also been linked to the deleterious effects of hyperoxia following ischemia-reperfusion injuries in several disease states, but there has been surprisingly little study into the role of hyperoxia in reperfusion injury after CPB. The potential for tightly regulated intraoperative normoxia to ameliorate the neurocognitive decline following cardiac surgery has not been investigated in a prospective manner. We hypothesize that the use of a protocolized management strategy aimed towards maintenance of an intraoperative normoxic level of oxygen, as opposed to hyperoxia, will reduce the incidence of POCD in older patients undergoing cardiac surgery. One hundred patients aged 65 years and older undergoing non-emergency coronary artery bypass grafting surgery on cardiopulmonary bypass will be enrolled in this prospective, randomized, controlled trial. Subjects will be randomized to receive a fraction of inspired oxygen of either 35% or 100% while under general anesthesia throughout the intraoperative period. The primary outcome measure will be the incidence of POCD in the acute postoperative phase and up to 6 months. The assessment of neurocognition will be undertaken by trained personnel, blinded to study group, with the telephone Montreal Cognitive Assessment (t-MoCA) tool. Secondary outcome measures will include assessment of delirium using the Confusion Assessment Method (CAM and CAM-ICU), as well as time to extubation, days of mechanical ventilation, length of ICU and hospital stay and mortality at 6 months. With the aim of later identifying mechanistic aspects of the effect of oxygen tension, blood, urine, and atrial tissue specimens will be taken at various time points during the perioperative period and later analyzed. This trial will be one of the first randomized controlled studies to prospectively assess the relationship between intraoperative oxygen levels and postoperative neurocognition in cardiac surgery. It addresses a promising biological avenue of intervention in this vulnerable aging population. ClinicalTrials.gov Identifier: NCT02591589 , registered February 13, 2015.

The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial.

PubMed

Tan, Xueli; Yowler, Charles J; Super, Dennis M; Fratianne, Richard B

2010-01-01

The purpose of this study was to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels during dressing changes in burn patients. Twenty-nine inpatients participated in this prospective, crossover randomized controlled trial. On two consecutive days, patients were randomized to receive music therapy services either on the first or second day of the study. On control days, they received no music. On music days, patients practiced music-based imagery (MBI), a form of music-assisted relaxation with patient-specific mental imagery before and after dressing changes. Also, on music days during dressing changes, the patients engaged in music alternate engagement (MAE), which consisted of active participation in music making. The dependent variables were the patients' subjective ratings of their pain and anxiety levels and the research nurse's objective ratings of their muscle tension levels. Two sets of data were collected before, three sets during, and another two sets after dressing changes. The results showed significant decrease in pain levels before (P < .025), during (P < .05), and after (P < .025) dressing changes on days the patients received music therapy in contrast to control days. Music therapy was also associated with a decrease in anxiety and muscle tension levels during the dressing changes (P < .05) followed by a reduction in muscle tension levels after dressing changes (P < .025). Music therapy significantly decreases the acute procedural pain, anxiety, and muscle tension levels associated with daily burn care.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

PubMed

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T; Farah, Bruno; Dubois, Christophe L; Feldman, Robert L; Dens, Joseph; Hagiwara, Nobuhisa; Allocco, Dominic J; Dawkins, Keith D

2011-04-19

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Electroacupuncture prevents endothelial dysfunction induced by ischemia-reperfusion injury via a cyclooxygenase-2-dependent mechanism: A randomized controlled crossover trial

PubMed Central

Park, Jimin; Woo, Jong Shin; Leem, Jungtae; Park, Jun Hyeong; Lee, Sanghoon; Chung, Hyemoon; Lee, Jung Myung; Kim, Jin-Bae; Kim, Woo-Shik; Kim, Kwon Sam; Kim, Weon

2017-01-01

Objective Exploring clinically effective methods to reduce ischemia-reperfusion (IR) injury in humans is critical. Several drugs have shown protective effects, but studies using other interventions have been rare. Electroacupuncture (EA) has induced similar protection in several animal studies but no study has investigated how the effects could be translated and reproduced in humans. This study aimed to explore the potential effect and mechanisms of EA in IR-induced endothelial dysfunction in humans. Methods This is a prospective, randomized, crossover, sham-controlled trial consisting of two protocols. Protocol 1 was a crossover study to investigate the effect of EA on IR-induced endothelial dysfunction. Twenty healthy volunteers were randomly assigned to EA or sham EA (sham). Flow mediated dilation (FMD) of the brachial artery (BA), nitroglycerin-mediated endothelial independent dilation, blood pressure before and after IR were measured. In protocol 2, seven volunteers were administered COX-2 inhibitor celecoxib (200 mg orally twice daily) for five days. After consumption, volunteers underwent FMD before and after IR identical to protocol 1. Results In protocol 1, baseline BA diameter, Pre-IR BA diameter and FMD were similar between the two groups (p = NS). After IR, sham group showed significantly blunted FMD (Pre-IR: 11.41 ± 3.10%, Post-IR: 4.49 ± 2.04%, p < 0.001). However, EA protected this blunted FMD (Pre-IR: 10.96 ± 5.30%, Post-IR: 9.47 ± 5.23%, p = NS, p < 0.05 compared with sham EA after IR). In protocol 2, this protective effect was completely abolished by pre-treatment with celecoxib (Pre-IR: 11.05 ± 3.27%; Post-IR: 4.20 ± 1.68%, p = 0.001). Conclusion EA may prevent IR-induced endothelial dysfunction via a COX-2 dependent mechanism. PMID:28591155

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

PubMed

Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

2014-04-01

Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

Optimizing Immunosuppressive Regimens Among Living-Donor Renal Transplant Recipients.

PubMed

Bakr, Mohamed Adel; Nagib, Ayman Maher; Gheith, Osama Ashry; Hamdy, Ahmed Farouk; Refaie, Ayman Fathi; Donia, Ahmed Farouk; Neamatalla, Ahmed Hassan; Eldahshan, Khaled Farouk; Denewar, Ahmed Abdelfattah; Abbas, Mohamed Hamed; Mostafa, Amany Ismail; Ghoneim, Mohamed Ahmed

2017-02-01

We review different immunosuppressant protocols used for living-donor kidney transplant recipients at our center. Many prospective randomized studies from our center have been reported between March 1976 and 2016, with more than 2700 renal transplant procedures conducted. The first study was a prospective randomized trial of azathioprine versus cyclosporine. The second study compared triple therapy (prednisolone + azathioprine + cyclosporine) versus conventional therapy (prednisolone + azathioprine). The third study was a cost-saving study, in which 100 patients received ketoconazole along with the triple regimen. Another trial demonstrated the advantages of a microemulsion form of cyclosporine. A subsequent trial compared calcineurin inhibitor minimization versus avoidance protocols. Rescue therapies were carried out to intensify immunosuppressive regimens after repeated rejection. In addition, steroid-free regimens were evaluated during both short- and long-term treatment. A recent trial reported a step-forward avoidance protocol with a calcineurin inhibitor and a steroid-free regimen, whereas another current study is the TRANSFORM one. The rationale behind antibody therapy was tho roughly evaluated among living-donor renal trans plant recipients with different agents, including basiliximab, daclizumab, antithymocyte globulin, and alemtuzumab. Earlier studies have demonstrated the efficacy of conventional regimens without induction therapy, especially in longer follow-up. The standard triple therapy has emerged with intensified immunosuppressive and lowered dose of each drug, especially cyclosporine. In minimization studies, no significant differences were encountered regarding patient and graft survival, even in the long-term. Steroid avoidance was safe and effective. Calcineurin inhibitors and steroid-free regimens have shown comparable patient and graft survival. Induction therapy has lowered the incidence and severity of acute rejection. A better 5-year graft survival and less posttransplant complications have been achieved with steroid avoidance after induction with basiliximab. Induction therapy did not affect graft and patient survival rates despite lowered incidence and severity of acute rejections.

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

PubMed

Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial.

PubMed

Kacmarek, Robert M; Villar, Jesús; Sulemanji, Demet; Montiel, Raquel; Ferrando, Carlos; Blanco, Jesús; Koh, Younsuck; Soler, Juan Alfonso; Martínez, Domingo; Hernández, Marianela; Tucci, Mauro; Borges, Joao Batista; Lubillo, Santiago; Santos, Arnoldo; Araujo, Juan B; Amato, Marcelo B P; Suárez-Sipmann, Fernando

2016-01-01

The open lung approach is a mechanical ventilation strategy involving lung recruitment and a decremental positive end-expiratory pressure trial. We compared the Acute Respiratory Distress Syndrome network protocol using low levels of positive end-expiratory pressure with open lung approach resulting in moderate to high levels of positive end-expiratory pressure for the management of established moderate/severe acute respiratory distress syndrome. A prospective, multicenter, pilot, randomized controlled trial. A network of 20 multidisciplinary ICUs. Patients meeting the American-European Consensus Conference definition for acute respiratory distress syndrome were considered for the study. At 12-36 hours after acute respiratory distress syndrome onset, patients were assessed under standardized ventilator settings (FIO2≥0.5, positive end-expiratory pressure ≥10 cm H2O). If Pao2/FIO2 ratio remained less than or equal to 200 mm Hg, patients were randomized to open lung approach or Acute Respiratory Distress Syndrome network protocol. All patients were ventilated with a tidal volume of 4 to 8 ml/kg predicted body weight. From 1,874 screened patients with acute respiratory distress syndrome, 200 were randomized: 99 to open lung approach and 101 to Acute Respiratory Distress Syndrome network protocol. Main outcome measures were 60-day and ICU mortalities, and ventilator-free days. Mortality at day-60 (29% open lung approach vs. 33% Acute Respiratory Distress Syndrome Network protocol, p = 0.18, log rank test), ICU mortality (25% open lung approach vs. 30% Acute Respiratory Distress Syndrome network protocol, p = 0.53 Fisher's exact test), and ventilator-free days (8 [0-20] open lung approach vs. 7 [0-20] d Acute Respiratory Distress Syndrome network protocol, p = 0.53 Wilcoxon rank test) were not significantly different. Airway driving pressure (plateau pressure - positive end-expiratory pressure) and PaO2/FIO2 improved significantly at 24, 48 and 72 hours in patients in open lung approach compared with patients in Acute Respiratory Distress Syndrome network protocol. Barotrauma rate was similar in both groups. In patients with established acute respiratory distress syndrome, open lung approach improved oxygenation and driving pressure, without detrimental effects on mortality, ventilator-free days, or barotrauma. This pilot study supports the need for a large, multicenter trial using recruitment maneuvers and a decremental positive end-expiratory pressure trial in persistent acute respiratory distress syndrome.

Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial.

PubMed

Eckstein, Hans-Henning; Ringleb, Peter; Allenberg, Jens-Rainer; Berger, Jürgen; Fraedrich, Gustav; Hacke, Werner; Hennerici, Michael; Stingele, Robert; Fiehler, Jens; Zeumer, Hermann; Jansen, Olav

2008-10-01

The SPACE trial is a multinational, prospective, randomised study to test the hypothesis that carotid artery stenting is not inferior to carotid endarterectomy for treating patients with severe symptomatic carotid artery stenosis. We did not prove non-inferiority of carotid artery stenting compared with carotid endarterectomy for the 30-day complication rate, and we now report the results at 2 years. Between March, 2001, and February, 2006, patients with symptomatic, severe (>or=70%) carotid artery stenosis were recruited to this non-inferiority trial and randomly assigned with a block randomisation design to have carotid artery angioplasty with stenting or carotid artery endarterectomy. 2-year endpoints include several clinical endpoints and the incidence of recurrent carotid stenosis of at least 70%. Clinical and vascular follow-up was done by a certified neurologist. Analyses were by intention to treat and per protocol. This trial is registered with ISRCTN, number 57874028.12. 1 214 patients were randomly assigned (613 were randomly assigned to carotid angioplasty with stenting and 601 were randomly assigned to carotid endarterectomy). In both the intention-to-treat and per-protocol analyses the Kaplan-Meier estimates of ipsilateral ischaemic strokes up to 2 years after the procedure and any periprocedural stroke or death do not differ between the carotid artery stenting and the carotid endarterectomy groups (intention to treat 9.5%vs 8.8%; hazard ratio (HR) 1.10, 95%CI 0.75 to 1.61; log-rank p=0.62; per protocol 9.4%vs 7.8%; HR 1.23, 95%CI 0.82 to 1.83; log-rank p=0.31). In both the intention-to-treat and per-protocol populations, recurrent stenosis of 70% or more is significantly more frequent in the carotid artery stenting group compared with the carotid endarterectomy group, with a life-table estimate of 10.7% versus 4.6% (p=0.0009) and 11.1% versus 4.6% (p=0.0007), respectively. Only two incidences of recurrent stenoses after carotid artery stenting led to neurological symptoms. After 2 years' follow-up, the rate of recurrent ipsilateral ischaemic strokes reported in the SPACE trial is similar for both treatment groups. The incidence of recurrent carotid stenosis at 2 years, as defined by ultrasound, is significantly higher after carotid artery stenting. However, it cannot be excluded that the degree of in-stent stenosis is slightly overestimated by conventional ultrasound criteria.

Quality of life and psychosocial and physical well-being among 1,023 women during their first assisted reproductive technology treatment: secondary outcome to a randomized controlled trial comparing gonadotropin-releasing hormone (GnRH) antagonist and GnRH agonist protocols.

PubMed

Toftager, Mette; Sylvest, Randi; Schmidt, Lone; Bogstad, Jeanette; Løssl, Kristine; Prætorius, Lisbeth; Zedeler, Anne; Bryndorf, Thue; Pinborg, Anja

2018-01-01

To compare self-reported quality of life, psychosocial well-being, and physical well-being during assisted reproductive technology (ART) treatment in 1,023 women allocated to either a short GnRH antagonist or long GnRH agonist protocol. Secondary outcome of a prospective phase 4, open-label, randomized controlled trial. Four times during treatment a questionnaire on self-reported physical well-being was completed. Further, a questionnaire on self-reported quality of life and psychosocial well-being was completed at the day of hCG testing. Fertility clinics at university hospitals. Women referred for their first ART treatment were randomized in a 1:1 ratio and started standardized ART protocols. Gonadotropin-releasing hormone analogue; 528 women allocated to a short GnRH antagonist protocol and 495 women allocated to a long GnRH agonist protocol. Self-reported quality of life, psychosocial well-being, and physical well-being based on questionnaires developed for women receiving ART treatment. Baseline characteristics were similar, and response rates were 79.4% and 74.3% in the GnRH antagonist and GnRH agonist groups, respectively. Self-reported quality of life during ART treatment was rated similar and slightly below normal in both groups. However, women in the GnRH antagonist group felt less emotional (adjusted odds ratio [AOR] 0.69), less limited in their everyday life (AOR 0.74), experienced less unexpected crying (AOR 0.71), and rated quality of sleep better (AOR 1.55). Further, women receiving GnRH agonist treatment felt worse physically. Women in a short GnRH antagonist protocol rated psychosocial and physical well-being during first ART treatment better than did women in a long GnRH agonist protocol. However, the one item on self-reported general quality of life was rated similarly. NCT00756028. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.

PubMed

Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R

2013-12-01

To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

Sympathetic activity and early mobilization in patients in intensive and intermediate care with severe brain injuries: a preliminary prospective randomized study.

PubMed

Rocca, A; Pignat, J-M; Berney, L; Jöhr, J; Van de Ville, D; Daniel, R T; Levivier, M; Hirt, L; Luft, A R; Grouzmann, E; Diserens, K

2016-09-13

Patients who experience severe brain injuries are at risk of secondary brain damage, because of delayed vasospasm and edema. Traditionally, many of these patients are kept on prolonged bed rest in order to maintain adequate cerebral blood flow, especially in the case of subarachnoid hemorrhage. On the other hand, prolonged bed rest carries important morbidity. There may be a clinical benefit in early mobilization and our hypothesis is that early gradual mobilization is safe in these patients. The aim of this study was to observe and quantify the changes in sympathetic activity, mainly related to stress, and blood pressure in gradual postural changes by the verticalization robot (Erigo®) and after training by a lower body ergometer (MOTOmed-letto®), after prolonged bed rest of minimum 7 days. Thirty patients with severe neurological injuries were randomized into 3 groups with different protocols of mobilization: Standard, MOTOmed-letto® or Erigo® protocol. We measured plasma catecholamines, metanephrines and blood pressure before, during and after mobilization. Blood pressure does not show any significant difference between the 3 groups. The analysis of the catecholamines suggests a significant increase in catecholamine production during Standard mobilization with physiotherapists and with MOTOmed-letto® and no changes with Erigo®. This preliminary prospective randomized study shows that the mobilization of patients with severe brain injuries by means of Erigo® does not increase the production of catecholamines. It means that Erigo® is a well-tolerated method of mobilization and can be considered a safe system of early mobilization of these patients. Further studies are required to validate our conclusions. The study was registered in the ISRCTN registry with the trial registration number ISRCTN56402432 . Date of registration: 08.03.2016. Retrospectively registered.

Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial.

PubMed

Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Guo, Xiaoling; Liu, Zhengping

2017-11-01

Uterine niche is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment for the uterine niche. This phase II clinical trial is a single-center, prospective, randomized, double-blind, placebo-controlled with 2 arms. One hundred twenty primiparous participants will be randomly (1:1 ratio) assigned to receive direct intramuscular injection of MSCs (a dose of 1*10 cells in 1 mL of 0.9% saline) (MSCs group) or an identical-appearing 1 mL of 0.9% saline (placebo-controlled group) near the uterine incision. The primary outcome of this trial is to evaluate the proportion of participants at 6 months who is found uterine niche in the uterus by transvaginal utrasonography. Adverse events will be documented in a case report form. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. This trial is the first investigation of the potential for therapeutic use of MSCs for the management of uterine niche after cesarean delivery. This protocol will help to determine the efficacy and safety of MSCs treatment in uterine niche and bridge the gap with regards to the current preclinical and clinical evidence. NCT02968459 (Clinical Trials.gov: http://clinicaltrials.gov/).

Can combined use of low-level lasers and hyaluronic acid injections prolong the longevity of degenerative knee joints?

PubMed Central

Ip, David; Fu, Nga Yue

2015-01-01

Background This study evaluated whether half-yearly hyaluronic acid injection together with low-level laser therapy in addition to standard conventional physical therapy can successfully postpone the need for joint replacement surgery in elderly patients with bilateral symptomatic tricompartmental knee arthritis. Methods In this prospective, double-blind, placebo-controlled study, 70 consecutive unselected elderly patients with bilateral tricompartmental knee arthritis were assigned at random to either one of two conservative treatment protocols to either one of the painful knees. Protocol A consisted of conventional physical therapy plus a sham light source plus saline injection, and protocol B consisted of protocol A with addition of half-yearly hyaluronic acid injection as well as low-level laser treatment instead of using saline and a sham light source. Treatment failure was defined as breakthrough pain necessitating joint replacement. Results Among the 140 painful knees treated with either protocol A or protocol B, only one of the 70 painful knees treated by protocol B required joint replacement, whereas 15 of the 70 painful knees treated by protocol A needed joint replacement surgery (P<0.05). Conclusion We conclude that half-yearly hyaluronic acid injections together with low-level laser therapy should be incorporated into the standard conservative treatment protocol for symptomatic knee arthritis, because it may prolong the longevity of the knee joint without the need for joint replacement. PMID:26346122

A nurse-guided, basal-prandial insulin treatment protocol for achieving glycaemic control of hospitalized, non-critically ill diabetes patients, is non-inferior to physician-guided therapy: A pivotal, nurse-empowerment study.

PubMed

Segal, Gad; Karniel, Eli; Mahagna, Ahmed; Kaa'dan, Fadi; Levi, Zehava; Balik, Chaya

2015-12-01

Basal-prandial insulin is established for glycaemic control for hospitalized, type 2 diabetes patients. Empowering nurses to guide such protocols could be advantageous.The study aims to comparatively assess the efficacy and safety of glycaemic control by a nurse-guided protocol with physician-guided therapy. It also aims to assess the impact of empowerment on the nurses' sense of competence. This is a prospective, controlled, randomized, single-blinded study. Validated protocol utilizing basal-prandial insulin was used. Glycaemic control was the primary efficacy outcome, whereas hypoglycaemia and laboratory parameters were followed for safety. Assessment of nurses' psychological empowerment was done. One hundred fifty-eight treatment days of 53 patients were included. Patients were randomized to either study group (n = 27) or control group (n = 26). Glycaemia deviation from liberal range (60-300 mg/dL) was 7.4% of days for nurse-guided, basal-prandial insulin treatment protocol (NGP) and 7.84% for physician-guided therapy (PGT), P = 0.901. Rate of glycaemia deviation from the strict range (100-180 mg/dL) was 49.76% for NGP and 47.38% for PGT, P = 0.703. Mean range of daily deviation was similar (77.05 mg/dL for NGP and 76.04 mg/dL for PGT, P = 0.93). There were no significant differences in safety parameters. An empowerment questionnaire showed tendency for increased nurses' sense of competence. Nurse-guided protocol is non-inferior to physician-guided treatment in efficacy and safety parameters. Nurses' sense of competence was positively influenced. © 2014 Wiley Publishing Asia Pty Ltd.

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines. In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. Methods/Design This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Discussion Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage. Trial registration www.clinicaltrials.gov Identifier: NCT01258257 PMID:21917146

Medical management of ectopic pregnancy with single-dose and 2-dose methotrexate protocols: human chorionic gonadotropin trends and patient outcomes.

PubMed

Mergenthal, Michelle C; Senapati, Suneeta; Zee, Jarcy; Allen-Taylor, Lynne; Whittaker, Paul G; Takacs, Peter; Sammel, Mary D; Barnhart, Kurt T

2016-11-01

Ectopic pregnancy, although rare, is an important cause of female morbidity and mortality and early, effective treatment is critical. Systemic methotrexate has become widely accepted as a safe and effective alternative to surgery in the stable patient. As the number and timing of methotrexate doses differ in the 3 main medical treatment regimens, one might expect trends in serum human chorionic gonadotropin and time to resolution to vary depending on protocol. Furthermore, human chorionic gonadotropin trends and time to resolution may predict ultimate treatment success. This study hypothesized that the 2-dose methotrexate protocol would be associated with a faster initial decline in serum human chorionic gonadotropin levels and a shorter time to resolution compared to the single-dose protocol. A prospective multicenter cohort study included clinical data from women who received medical management for ectopic pregnancy. Rates of human chorionic gonadotropin change and successful pregnancy resolution were assessed. Propensity score modeling addressed confounding by indication, the potential for differential assignment of patients with better prognosis to the single-dose methotrexate protocol. In all, 162 ectopic pregnancies were in the final analysis; 114 (70%) were treated with the single-dose methotrexate and 48 (30%) with the 2-dose protocol. Site, race, ethnicity, and reported pain level were associated with differential protocol allocation (P < .001, P = .011, P < .001, and P = .035, respectively). Women had similar initial human chorionic gonadotropin levels in either protocol but the mean rate of decline of human chorionic gonadotropin from day 0 (day of administration of first dose of methotrexate) to day 7 was significantly more rapid in women who received the single-dose protocol compared to those treated with the 2-dose protocol (mean change -31.3% vs -10.4%, P = .037, adjusted for propensity score and site). The 2 protocols had no significant differences in success rate or time to resolution. In a racially and geographically diverse group of women, the single- and double-dose methotrexate protocols had comparable outcomes. The more rapid human chorionic gonadotropin initial decline in the single-dose group suggested these patients were probably at lower risk for ectopic rupture than those getting the 2-dose protocol. A prospective randomized controlled design is needed to remove confounding by indication. Copyright © 2016 Elsevier Inc. All rights reserved.

Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

NASA Astrophysics Data System (ADS)

Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

2014-02-01

Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial.

PubMed

González Rueda, Vanessa; López de Celis, Carlos; Barra López, Martín Eusebio; Carrasco Uribarren, Andoni; Castillo Tomás, Sara; Hidalgo García, Cesar

2017-09-05

Mechanical neck pain is a highly prevalent problem in primary healthcare settings. Many of these patients have restricted mobility of the cervical spine. Several manual techniques have been recommended for restoring cervical mobility, but their effectiveness in these patients is unknown. The aim of the present study is to compare the effectiveness of two types of specific techniques of the upper neck region: the pressure maintained suboccipital inhibition technique (PMSIT) and the translatory dorsal glide mobilization (TDGM) C0-C1 technique, as adjuncts to a protocolized physiotherapy treatment of the neck region in subjects with chronic mechanical neck pain and rotation deficit in the upper cervical spine. A randomized, prospective, double-blind (patient and evaluator) clinical trial. The participants (n = 78) will be randomly distributed into three groups. The Control Group will receive a protocolized treatment for 3 weeks, the Mobilization Group will receive the same protocolized treatment and 6 sessions (2 per week) of the TDGM C0-C1 technique, and the Pressure Group will receive the same protocolized treatment and 6 sessions (2 per week) of the PMSIT technique. The intensity of pain (VAS), neck disability (NDI), the cervical range of motion (CROM), headache intensity (HIT-6) and the rating of clinical change (GROC scale) will be measured. The measurements will be performed at baseline, post-treatment and 3 months after the end of treatment, by the same physiotherapist blinded to the group assigned to the subject. We believe that an approach including manual treatment to upper cervical dysfunction will be more effective in these patients. Furthermore, the PMSIT technique acts mostly on the musculature, while the TDGM technique acts on the joint. We expect to clarify which component is more effective in improving the upper cervical mobility. ClinicalTrials.gov NCT02832232 . Registered on July 13th, 2016.

Incremental yield of dysplasia detection in Barrett's esophagus using volumetric laser endomicroscopy with and without laser marking compared with a standardized random biopsy protocol.

PubMed

Alshelleh, Mohammad; Inamdar, Sumant; McKinley, Matthew; Stewart, Molly; Novak, Jeffrey S; Greenberg, Ronald E; Sultan, Keith; Devito, Bethany; Cheung, Mary; Cerulli, Maurice A; Miller, Larry S; Sejpal, Divyesh V; Vegesna, Anil K; Trindade, Arvind J

2018-02-02

Volumetric laser endomicroscopy (VLE) is a new wide-field advanced imaging technology for Barrett's esophagus (BE). No data exist on incremental yield of dysplasia detection. Our aim is to report the incremental yield of dysplasia detection in BE using VLE. This is a retrospective study from a prospectively maintained database from 2011 to 2017 comparing the dysplasia yield of 4 different surveillance strategies in an academic BE tertiary care referral center. The groups were (1) random biopsies (RB), (2) Seattle protocol random biopsies (SP), (3) VLE without laser marking (VLE), and (4) VLE with laser marking (VLEL). A total of 448 consecutive patients (79 RB, 95 SP, 168 VLE, and 106 VLEL) met the inclusion criteria. After adjusting for visible lesions, the total dysplasia yield was 5.7%, 19.6%, 24.8%, and 33.7%, respectively. When compared with just the SP group, the VLEL group had statistically higher rates of overall dysplasia yield (19.6% vs 33.7%, P = .03; odds ratio, 2.1, P = .03). Both the VLEL and VLE groups had statistically significant differences in neoplasia (high-grade dysplasia and intramucosal cancer) detection compared with the SP group (14% vs 1%, P = .001 and 11% vs 1%, P = .003). A surveillance strategy involving VLEL led to a statistically significant higher yield of dysplasia and neoplasia detection compared with a standard random biopsy protocol. These results support the use of VLEL for surveillance in BE in academic centers. Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05).

PubMed

Roos, Daniel E; Davis, Sidney R; Turner, Sandra L; O'Brien, Peter C; Spry, Nigel A; Burmeister, Bryan H; Hoskin, Peter J; Ball, David L

2003-05-01

Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/-10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44). QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation.

Performance of fast-setting impression materials in the reproduction of subgingival tooth surfaces without soft tissue retraction.

PubMed

Rudolph, Heike; Röhl, Andreas; Walter, Michael H; Luthardt, Ralph G; Quaas, Sebastian

2014-01-01

Fast-setting impression materials may be prone to inaccuracies due to accidental divergence from the recommended mixing protocol. This prospective randomized clinical trial aimed to assess three-dimensional (3D) deviations in the reproduction of subgingival tooth surfaces and to determine the effect of either following or purposely diverging from the recommended mixing procedure for a fast-setting addition-curing silicone (AS) and fast-setting polyether (PE). After three impressions each were taken from 96 participants, sawcut gypsum casts were fabricated with a standardized procedure and then optically digitized. Data were assessed with a computer-aided 3D analysis. For AS impressions, multivariate analysis of variance revealed a significant influence of the individual tooth and the degree to which the recommended mixing protocol was violated. For PE impressions, the ambient air temperature and individual tooth showed significant effects, while divergence from the recommended mixing protocol was not of significance. The fast-setting PE material was not affected by changes in the recommended mixing protocol. For the two fast-setting materials examined, no divergences from the recommended mixing protocol of less than 2 minutes led to failures in the reproduction of the subgingival tooth surfaces.

Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a β-TCP-Collagen Matrix.

PubMed

Daniels, Timothy R; Younger, Alastair S E; Penner, Murray J; Wing, Kevin J; Le, Ian L D; Russell, Iain S; Lalonde, Karl-André; Evangelista, Peter T; Quiton, Jovelyn D; Glazebrook, Mark; DiGiovanni, Christopher W

2015-07-01

Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (β-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions. Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/β-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/β-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/β-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P < .001). Mean time to fusion was 14.3 ± 8.9 weeks for rhPDGF-BB/β-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/β-TCP-collagen patients and 120 of 154 (78%) autograft patients (P < .001). Safety-related outcomes were equivalent. Autograft controls had 2 bone graft harvest infections. Application of rhPDGF-BB/β-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting. Level I, prospective randomized study. © The Author(s) 2015.

A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

PubMed

Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

2016-06-01

The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

Comparison of sprinting vs non-sprinting to wean nasal continuous positive airway pressure off in very preterm infants.

PubMed

Eze, N; Murphy, D; Dhar, V; Rehan, V K

2018-02-01

Though nasal continuous positive airway pressure (NCPAP) is commonly used for non-invasive neonatal respiratory support, the optimal method of weaning NCPAP is not established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing spontaneous breathing time off NCPAP increases successful weaning from NCPAP in infants born <31 weeks gestational age. Infants were randomized to one of the two NCPAP weaning protocols, a sprinting, that is, gradually increasing spontaneous breathing time off CPAP, protocol vs a non-sprinting (weaning pressure down) protocol. Eighty-six infants were enrolled in one of the two study groups. Thirty-one infants (77%) in the sprinting group and 30 (75%) in the non-sprinting group were successfully weaned off NCPAP at the first attempt (P>0.05). It took 1.3 (1 to 1.75) (median (IQR)) attempts and 7 (7 to 7) days to wean NCPAP off in the sprinting group vs 1.3 (1 to 1.75) attempts and 7 (7 to 10) days in the non-sprinting group (P>0.05). Additionally, no differences in the secondary outcomes of bronchopulmonary dysplasia, severe retinopathy of prematurity (⩾stage 3), periventricular leukomalacia and length of stay were noted between the two groups. Weaning NCPAP via sprinting or non-sprinting protocol is comparable, not only for successful weaning but also for the occurrence of common neonatal morbidities that impact the long-term outcome in premature infants (ClinicalTrials.gov number, NCT02819050).

A systematic review of hypofractionation for primary management of prostate cancer.

PubMed

Koontz, Bridget F; Bossi, Alberto; Cozzarini, Cesare; Wiegel, Thomas; D'Amico, Anthony

2015-10-01

Technological advances in radiation therapy delivery have permitted the use of high-dose-per-fraction radiation therapy (RT) for early-stage prostate cancer (PCa). Level 1 evidence supporting the safety and efficacy of hypofractionated RT is evolving as this modality becomes more widely utilized and refined. To perform a systematic review of the current evidence on the safety and efficacy of hypofractionated RT for early-stage PCa and to provide in-context recommendations for current application of this technology. Embase, PubMed, and Scopus electronic databases were queried for English-language articles from January 1990 through June 2014. Prospective studies with a minimum of 50 patients were included. Separate consideration was made for studies involving moderate hypofractionation (doses of 2.5-4Gy per fraction) and extreme hypofractionation (5-10Gy in 4-7 fractions). Six relatively small superiority designed randomized trials of standard fractionation versus moderate hypofractionation in predominantly low- and intermediate-risk PCa have been published with follow-up ranging from 4 to 8 yr, noting similar biochemical control (5-yr freedom from biochemical failure in modern studies is >80% for low-risk and intermediate-risk patients) and late grade ≥2 genitourinary and gastrointestinal toxicities (between 2% and 20%). Noninferiority studies are pending. In prospective phase 2 studies, extreme hypofractionation has promising 2- to 5-yr biochemical control rates of >90% for low-risk patients. Results from a randomized trial are expected in 2015. Moderate hypofractionation has 5-yr data to date establishing safety compared with standard fractionation, but 10-yr outcomes and longer follow-up are needed to establish noninferiority for clinical effectiveness. Extreme hypofractionation is promising but as yet requires reporting of randomized data prior to application outside of a clinical protocol. Hypofractionation for prostate cancer delivers relatively high doses of radiation per treatment. Prospective studies support the safety of moderate hypofractionation, while extreme fractionation may have greater toxicity. Both show promising cancer control but long-term results of noninferiority studies of both methods are required before use in routine treatment outside of clinical protocols. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

PubMed

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials.gov NCT01782755 . Registered on 29 January 2013.

Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis.

PubMed

Sheth, Ujash; Simunovic, Nicole; Klein, Guy; Fu, Freddie; Einhorn, Thomas A; Schemitsch, Emil; Ayeni, Olufemi R; Bhandari, Mohit

2012-02-15

The recent emergence of autologous blood concentrates, such as platelet-rich plasma, as a treatment option for patients with orthopaedic injuries has led to an extensive debate about their clinical benefit. We conducted a systematic review and meta-analysis to determine the efficacy of autologous blood concentrates in decreasing pain and improving healing and function in patients with orthopaedic bone and soft-tissue injuries. We searched MEDLINE and Embase for randomized controlled trials or prospective cohort studies that compared autologous blood concentrates with a control therapy in patients with an orthopaedic injury. We identified additional studies by searching through the bibliographies of eligible studies as well as the archives of orthopaedic conferences and meetings. Twenty-three randomized trials and ten prospective cohort studies were identified. There was a lack of consistency in outcome measures across all studies. In six randomized controlled trials (n = 358) and three prospective cohort studies (n = 88), the authors reported visual analog scale (VAS) scores when comparing platelet-rich plasma with a control therapy across injuries to the acromion, rotator cuff, lateral humeral epicondyle, anterior cruciate ligament, patella, tibia, and spine. The use of platelet-rich plasma provided no significant benefit up to (and including) twenty-four months across the randomized trials (standardized mean difference, -0.34; 95% confidence interval [CI], -0.75 to 0.06) or the prospective cohort studies (standardized mean difference, -0.20; 95% CI, -0.64 to 0.23). Both point estimates suggested a small trend favoring platelet-rich plasma, but the associated wide confidence intervals were consistent with nonsignificant effects. The current literature is complicated by a lack of standardization of study protocols, platelet-separation techniques, and outcome measures. As a result, there is uncertainty about the evidence to support the increasing clinical use of platelet-rich plasma and autologous blood concentrates as a treatment modality for orthopaedic bone and soft-tissue injuries.

Awake craniotomy anesthetic management using dexmedetomidine, propofol, and remifentanil

PubMed Central

Prontera, Andrea; Baroni, Stefano; Marudi, Andrea; Valzania, Franco; Feletti, Alberto; Benuzzi, Francesca; Bertellini, Elisabetta; Pavesi, Giacomo

2017-01-01

Introduction Awake craniotomy allows continuous monitoring of patients’ neurological functions during open surgery. Anesthesiologists have to sedate patients in a way so that they are compliant throughout the whole surgical procedure, nevertheless maintaining adequate analgesia and anxiolysis. Currently, the use of α2-receptor agonist dexmedetomidine as the primary hypnotic–sedative medication is increasing. Methods Nine patients undergoing awake craniotomy were treated with refined monitored anesthesia care (MAC) protocol consisting of a combination of local anesthesia without scalp block, low-dose infusion of dexmedetomidine, propofol, and remifentanil, without the need of airways management. Results The anesthetic protocol applied in our study has the advantage of decreasing the dose of each drug and thus reducing the occurrence of side effects. All patients had smooth and rapid awakenings. The brain remained relaxed during the entire procedure. Conclusion In our experience, this protocol is safe and effective during awake brain surgery. Nevertheless, prospective randomized trials are necessary to confirm the optimal anesthetic technique to be used. PMID:28424537

Awake craniotomy anesthetic management using dexmedetomidine, propofol, and remifentanil.

PubMed

Prontera, Andrea; Baroni, Stefano; Marudi, Andrea; Valzania, Franco; Feletti, Alberto; Benuzzi, Francesca; Bertellini, Elisabetta; Pavesi, Giacomo

2017-01-01

Awake craniotomy allows continuous monitoring of patients' neurological functions during open surgery. Anesthesiologists have to sedate patients in a way so that they are compliant throughout the whole surgical procedure, nevertheless maintaining adequate analgesia and anxiolysis. Currently, the use of α2-receptor agonist dexmedetomidine as the primary hypnotic-sedative medication is increasing. Nine patients undergoing awake craniotomy were treated with refined monitored anesthesia care (MAC) protocol consisting of a combination of local anesthesia without scalp block, low-dose infusion of dexmedetomidine, propofol, and remifentanil, without the need of airways management. The anesthetic protocol applied in our study has the advantage of decreasing the dose of each drug and thus reducing the occurrence of side effects. All patients had smooth and rapid awakenings. The brain remained relaxed during the entire procedure. In our experience, this protocol is safe and effective during awake brain surgery. Nevertheless, prospective randomized trials are necessary to confirm the optimal anesthetic technique to be used.

A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries.

PubMed

Prado, Marcelo Pires; Mendes, Alberto Abussamra Moreira; Amodio, Daniel Tasseto; Camanho, Gilberto Luis; Smyth, Niall A; Fernandes, Tulio Diniz

2014-03-01

The objective of this study was to investigate functional results, the amount of time that patients missed from regular working activities, and the incidence of residual mechanical ankle instability following conservative treatment of a first episode of severe lateral ankle ligament sprain (with articular instability). This prospective and randomized study included 186 patients with severe lateral ankle ligament injuries, who were randomly assigned into 2 conservative treatment groups. In group A, participants were treated with a walking boot with weight-bearing allowed, pain management, ice, and elevation with restricted joint mobilization for 3 weeks. In group B, patients were treated with a functional brace for 3 weeks. After this period, patients from both groups were placed in a short, functional brace for an additional 3 weeks, during which they also started a rehabilitation program. No statistically significant difference was found in pain intensity score between the 2 groups; however, functional evaluations based on the AOFAS ankle and hindfoot score system showed a statistically significant improvement in the group treated with the functional brace. In addition, the average recovery period necessary for patients of group B to resume their duties was shorter than that for patients in group A. No significant difference was detected in residual mechanical ankle instability between the 2 groups. Patients with severe lateral ankle ligament lesions treated with a functional brace were shown to exhibit somewhat better results than those treated with a walking boot, and both methods presented a very low incidence of residual chronic instability. We found adequate conservative treatment was sufficient to reestablish ankle stability and that functional treatment had a marginally better clinical short-term outcome with a shorter average recovery period. Level I, prospective randomized study.

Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial.

PubMed

Xie, Hui; Li, Xinrong; Lai, Jiaqin; Zhou, Yanan; Wang, Caiying; Liang, Jiao

2014-10-15

Acupuncture has been used in China to treat tinnitus for a long time. There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture. However, there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus. This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective, double-blind, randomized, sham-controlled trial. This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed. The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner. Chinese Clinical Trial Registry: ChiCTR-TRC-14004720 (6 May 2014).

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

PubMed

Dalai, Shebani Sethi; Adler, Sarah; Najarian, Thomas; Safer, Debra Lynn

2018-01-01

Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. Copyright © 2017 Elsevier Inc. All rights reserved.

Ulcerative colitis patients with an inflammatory response upon mesalazine cannot be desensitized: a randomized study.

PubMed

Buurman, Dorien J; De Monchy, Jan G R; Schellekens, Reinout C A; van der Waaij, Laurens A; Kleibeuker, Jan H; Dijkstra, Gerard

2015-04-01

Mesalazine is a key drug in the treatment of ulcerative colitis (UC). Intolerance to mesalazine has been described, including fever and gastrointestinal symptoms. Several case reports reported successful desensitization of patients with mesalazine intolerance. The aim was to assess the number of UC patients who are persistently intolerant to mesalazine after single-blinded rechallenge and to test the effectiveness of a rapid desensitization protocol in UC patients demonstrated mesalazine intolerance. This is a prospective, single-blind randomized study in UC patients who discontinued mesalazine because of intolerance. Patients with severe reactions were excluded. Eligible patients underwent a skin patch test with mesalazine followed by a single-blinded randomized crossover rechallenge with 500 mg mesalazine or placebo. Patients with symptoms upon rechallenge were admitted to the hospital for 3 days oral desensitization. Nine of the 37 identified UC patients who discontinued mesalazine because of intolerance were included. All nine patients had negative patch tests, seven patients had symptoms (fever, nausea, vomiting and diarrhea) within 2 h upon rechallenge. Four of these seven patients participated in the desensitization protocol and in none a successful desensitization could be performed. All four had an inflammatory intolerance reaction with rise in C-reactive protein. There were no elevations in serum tryptase or urinary-methylhistamine levels observed and no signs of immediate type allergic reactions, like urticaria, bronchial obstruction or anaphylaxis. We recommend not to rechallenge UC patients with an inflammatory response upon mesalazine and these patients will not benefit from a rapid desensitization protocol.

Cost-effectiveness comparison between pituitary down-regulation with a gonadotropin-releasing hormone agonist short regimen on alternate days and an antagonist protocol for assisted fertilization treatments.

PubMed

Maldonado, Luiz Guilherme Louzada; Franco, José Gonçalves; Setti, Amanda Souza; Iaconelli, Assumpto; Borges, Edson

2013-05-01

To compare cost-effectiveness between pituitary down-regulation with a GnRH agonist (GnRHa) short regimen on alternate days and GnRH antagonist (GnRHant) multidose protocol on in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) outcome. Prospective, randomized. A private center. Patients were randomized into GnRHa (n = 48) and GnRHant (n = 48) groups. GnRHa stimulation protocol: administration of triptorelin on alternate days starting on the first day of the cycle, recombinant FSH (rFSH), and recombinant hCG (rhCG) microdose. GnRHant protocol: administration of a daily dose of rFSH, cetrorelix, and rhCG microdose. ICSI outcomes and treatment costs. A significantly lower number of patients underwent embryo transfer in the GnRHa group. Clinical pregnancy rate was significantly lower and miscarriage rate was significantly higher in the GnRHa group. It was observed a significant lower cost per cycle in the GnRHa group compared with the GnRHant group ($5,327.80 ± 387.30 vs. $5,900.40 ± 472.50). However, mean cost per pregnancy in the GnRHa was higher than in the GnRHant group ($19,671.80 ± 1,430.00 vs. $11,328.70 ± 907.20). Although the short controlled ovarian stimulation protocol with GnRHa on alternate days, rFSH, and rhCG microdose may lower the cost of an individual IVF cycle, it requires more cycles to achieve pregnancy. NCT01468441. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Do Bayesian adaptive trials offer advantages for comparative effectiveness research? Protocol for the RE-ADAPT study

PubMed Central

Luce, Bryan R; Broglio, Kristine R; Ishak, K Jack; Mullins, C Daniel; Vanness, David J; Fleurence, Rachael; Saunders, Elijah; Davis, Barry R

2013-01-01

Background Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. Purpose Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a ‘proof of concept’ to stimulate investment in Bayesian adaptive designs for future CER trials. Methods We will assess whether Bayesian adaptive designs offer potential efficiencies in CER by simulating a re-execution of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study using actual data from ALLHAT. Results We prospectively define seven alternate designs consisting of various combinations of arm dropping, adaptive randomization, and early stopping and describe how these designs will be compared to the original ALLHAT design. We identify the one particular design that would have been executed, which incorporates early stopping and information-based adaptive randomization. Limitations While the simulation realistically emulates patient enrollment, interim analyses, and adaptive changes to design, it cannot incorporate key features like the involvement of data monitoring committee in making decisions about adaptive changes. Conclusion This article describes our analytic approach for RE-ADAPT. The next stage of the project is to conduct the re-execution analyses using the seven prespecified designs and the original ALLHAT data. PMID:23983160

Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness.

PubMed

Mashour, George A; Tremper, Kevin K; Avidan, Michael S

2009-11-05

The incidence of intraoperative awareness with explicit recall is 1-2/1000 cases in the United States. The Bispectral Index monitor is an electroencephalographic method of assessing anesthetic depth that has been shown in one prospective study to reduce the incidence of awareness in the high-risk population. In the B-Aware trial, the number needed to treat in order to prevent one case of awareness in the high-risk population was 138. Since the number needed to treat and the associated cost of treatment would be much higher in the general population, the efficacy of the Bispectral Index monitor in preventing awareness in all anesthetized patients needs to be clearly established. This is especially true given the findings of the B-Unaware trial, which demonstrated no significant difference between protocols based on the Bispectral Index monitor or minimum alveolar concentration for the reduction of awareness in high risk patients. To evaluate efficacy in the general population, we are conducting a prospective, randomized, controlled trial comparing the Bispectral Index monitor to a non-electroencephalographic gauge of anesthetic depth. The total recruitment for the study is targeted for 30,000 patients at both low and high risk for awareness. We have developed a novel algorithm that is capable of real-time analysis of our electronic perioperative information system. In one arm of the study, anesthesia providers will receive an electronic page if the Bispectral Index value is >60. In the other arm of the study, anesthesia providers will receive a page if the age-adjusted minimum alveolar concentration is <0.5. Our minimum alveolar concentration algorithm is sensitive to both inhalational anesthetics and intravenous sedative-hypnotic agents. Awareness during general anesthesia is a persistent problem and the role of the Bispectral Index monitor in its prevention is still unclear. The Michigan Awareness Control Study is the largest prospective trial of awareness prevention ever conducted. Clinical Trial NCT00689091.

Continuous passive motion and physical therapy (CPM) versus physical therapy (PT) versus delayed physical therapy (DPT) after surgical release for elbow contractures; a study protocol for a prospective randomized controlled trial.

PubMed

Viveen, Jetske; Doornberg, Job N; Kodde, Izaak F; Goossens, Pjotr; Koenraadt, Koen L M; The, Bertram; Eygendaal, Denise

2017-11-22

The elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. Conservative treatment includes physical therapy, intra-articular injections with corticosteroids and a static progressive or dynamic splinting program. If conservative treatment fails, an operative release of the posttraumatic stiff elbow is often performed. The best Evidence-Based rehabilitation protocol for patients after an operative release is unknown to date and differs per surgeon, hospital and country. Options include early- or delayed motion supervised by a physical therapist, immediate continuous passive motion (CPM), (night) splinting and a static progressive or dynamic splinting program. The SET-Study (Stiff Elbow Trial) is a single-centre, prospective, randomized controlled trial. The primary objective of this study is to compare the active Range of Motion (ROM) (flexion arc and rotational arc) twelve months after surgery between three groups. The first group will receive in-hospital CPM in combination with early motion Physical Therapy (PT) supervised by a physical therapist, the second group will receive only in-hospital early motion PT supervised by a physical therapist and the third group will receive outpatient supervised PT from postoperative day seven till ten. Secondary outcome measures will be Patient Reported Outcome Measures (PROMs) including the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), the quick Disabilities of Arm, Shoulder and Hand (qDASH) score, Visual Analogue pain Scale in rest and activity (VAS), Pain Catastrophizing Scale (PCS), the Short Form (SF)-36, the Centre for Epidemiological Studies Depression Scale Revised (CESD-R) and the Work Rehabilitation Questionnaire (WORQ) for the upper limb. A successful completion of this trial will provide evidence on the best rehabilitation protocol in order to (re)gain optimal motion after surgical release of the stiff elbow. The trial is registered at the Dutch Trial Register: NTR6067 , 31-8-2016.

Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.

PubMed

Barbero, Cristina; Ricci, Davide; Cura Stura, Erik; Pellegrini, Augusto; Marchetto, Giovanni; ElQarra, Suad; Boffini, Massimo; Passera, Roberto; Valentini, Maria Consuelo; Rinaldi, Mauro

2017-02-21

Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.

Simplified dispatch-assisted CPR instructions outperform standard protocol.

PubMed

Dias, J A; Brown, T B; Saini, D; Shah, R C; Cofield, S S; Waterbor, J W; Funkhouser, E; Terndrup, T E

2007-01-01

Dispatch-assisted chest compressions only CPR (CC-CPR) has gained widespread acceptance, and recent research suggests that increasing the proportion of compression time during CPR may increase survival from out-of-hospital cardiac arrest. We created a simplified CC-CPR protocol to reduce time to start chest compressions and to increase the proportion of time spent delivering chest compressions. This simplified protocol was compared to a published protocol, Medical Priority Dispatch System (MPDS) Version 11.2, recommended by the National Academies of Emergency Dispatch. Subjects were randomized to the MPDS v11.2 protocol or a simplified protocol. Data was recorded from a Laerdal Resusci Anne Skillreporter manikin. A simulated emergency medical dispatcher, contacted by cell phone, delivered standardized instructions for both protocols. Outcomes included chest compression rate, depth, hand position, full release, overall proportion of compressions without error, time to start of CPR and total hands-off chest time. Proportions were analyzed by Wilcoxon's Rank Sum tests and time variables with Welch ANOVA and Wilcoxon's Rank Sum test. All tests used a two-sided alpha-level of 0.05. One hundred and seventeen subjects were randomized prospectively, 58 to the standard protocol and 59 to the simplified protocol. The average age of subjects in both groups was 25 years old. For both groups, the compression rate was equivalent (104 simplified versus 94 MPDS, p = 0.13), as was the proportion with total release (1.0 simplified versus 1.0 MPDS, p = 0.09). The proportion to the correct depth was greater in the simplified protocol (0.31 versus 0.03, p < 0.01), as was the proportion of compressions done without error (0.05 versus 0.0, p = 0.16). Time to start of chest compressions and total hands-off chest time were better in the simplified protocol (start time 60.9s versus 78.6s, p < 0.0001; hands-off chest time 69 s versus 95 s, p < 0.0001). The proportion with correct hand position, however, was worse in the simplified protocol (0.35 versus 0.84, p < 0.01). The simplified protocol was as good as, or better than the MPDS v11.2 protocol in every aspect studied except hand position, and the simplified protocol resulted in significant time savings. The protocol may need modification to ensure correct hand position. Time savings and improved quality of CPR achieved by the new set of instructions could be important in strengthening critical links in the cardiac chain of survival.

The Effect of a Connexin43-Based Peptide on the Healing of Chronic Venous Leg Ulcers: A Multicenter, Randomized Trial

PubMed Central

Ghatnekar, Gautam S; Grek, Christina L; Armstrong, David G; Desai, Sanjay C; Gourdie, Robert G

2015-01-01

The gap junction protein, connexin43 (Cx43), has critical roles in the inflammatory, edematous, and fibrotic processes following dermal injury and during wound healing, and is abnormally upregulated at the epidermal wound margins of venous leg ulcers (VLUs). Targeting Cx43 with ACT1, a peptide mimetic of the carboxyl-terminus of Cx43, accelerates fibroblast migration and proliferation, and wound reepithelialization. In a prospective, multicenter clinical trial conducted in India, adults with chronic VLUs were randomized to treatment with an ACT1 gel formulation plus conventional standard-of-care (SOC) protocols, involving maintaining wound moisture and four-layer compression bandage therapy, or SOC protocols alone. The primary end point was mean percent ulcer reepithelialization from baseline to 12 weeks. A significantly greater reduction in mean percent ulcer area from baseline to 12 weeks was associated with the incorporation of ACT1 therapy (79% (SD 50.4)) as compared with compression bandage therapy alone (36% (SD 179.8); P=0.02). Evaluation of secondary efficacy end points indicated a reduced median time to 50 and 100% ulcer reepithelialization for ACT1-treated ulcers. Incorporation of ACT1 in SOC protocols may represent a well-tolerated, highly effective therapeutic strategy that expedites chronic venous ulcer healing by treating the underlying ulcer pathophysiology through Cx43-mediated pathways. PMID:25072595

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

PubMed

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality. The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients. ClinicalTrials.gov. NCT01782755.

The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

PubMed Central

2013-01-01

Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

PubMed

Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

2013-07-29

In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

The use of a weaning and extubation protocol to facilitate effective weaning and extubation from mechanical ventilation in patients suffering from traumatic injuries: a non-randomized experimental trial comparing a prospective to retrospective cohort.

PubMed

Plani, Natascha; Becker, Piet; van Aswegen, Helena

2013-04-01

Many patients who have suffered traumatic injuries require mechanical ventilation (MV). Weaning is the transition from ventilatory support to spontaneous breathing. The purpose of this study was to determine whether the use of a nurse and a physiotherapist-driven protocol to wean and extubate patients from MV resulted in decreased MV days and intensive care unit (ICU) length of stay (LOS). A prospective cohort of 28 patients (Phase I), weaned according to the protocol developed for the Union Hospital Trauma Unit, was matched retrospectively with a historical cohort of 28 patients (Phase II), weaned according to physician preference. Pairs in the two groups were matched for gender, age, type, and severity of injury. For mean MV days, the groups did not differ statistically significantly (p 0.3; 14.4 days vs. 16.3 days), although the reduction in MV is clinically significant in view of the complications of additional MV days. The difference of 0.2 days for ICU LOS was not statistically significant (p = 0.9; 20.8 days vs. 21.0 days) demonstrating that the reduction in MV days may not result in the reduction of ICU LOS. The rate of re-intubation was similar between the groups (Phase I = 3/28 vs. Phase II = 4/24). The use of a weaning and extubation protocol led by nursing staff and physiotherapists resulted in a clinically significant reduction in MV time, reducing risk of ventilator-associated complications. The role of physiotherapists and nursing staff in weaning and extubation from MV could be greatly expanded in South African ICUs.

Protocol for evaluating the effects of a therapeutic foot exercise program on injury incidence, foot functionality and biomechanics in long-distance runners: a randomized controlled trial.

PubMed

Matias, Alessandra B; Taddei, Ulisses T; Duarte, Marcos; Sacco, Isabel C N

2016-04-14

Overall performance, particularly in a very popular sports activity such as running, is typically influenced by the status of the musculoskeletal system and the level of training and conditioning of the biological structures. Any change in the musculoskeletal system's biomechanics, especially in the feet and ankles, will strongly influence the biomechanics of runners, possibly predisposing them to injuries. A thorough understanding of the effects of a therapeutic approach focused on feet biomechanics, on strength and functionality of lower limb muscles will contribute to the adoption of more effective therapeutic and preventive strategies for runners. A randomized, prospective controlled and parallel trial with blind assessment is designed to study the effects of a "ground-up" therapeutic approach focused on the foot-ankle complex as it relates to the incidence of running-related injuries in the lower limbs. One hundred and eleven (111) healthy long-distance runners will be randomly assigned to either a control (CG) or intervention (IG) group. IG runners will participate in a therapeutic exercise protocol for the foot-ankle for 8 weeks, with 1 directly supervised session and 3 remotely supervised sessions per week. After the 8-week period, IG runners will keep exercising for the remaining 10 months of the study, supervised only by web-enabled software three times a week. At baseline, 2 months, 4 months and 12 months, all runners will be assessed for running-related injuries (primary outcome), time for the occurrence of the first injury, foot health and functionality, muscle trophism, intrinsic foot muscle strength, dynamic foot arch strain and lower-limb biomechanics during walking and running (secondary outcomes). This is the first randomized clinical trial protocol to assess the effect of an exercise protocol that was designed specifically for the foot-and-ankle complex on running-related injuries to the lower limbs of long-distance runners. We intend to show that the proposed protocol is an innovative and effective approach to decreasing the incidence of injuries. We also expect a lengthening in the time of occurrence of the first injury, an improvement in foot function, an increase in foot muscle mass and strength and beneficial biomechanical changes while running and walking after a year of exercising. Clinicaltrials.gov Identifier NCT02306148 (November 28, 2014) under the name "Effects of Foot Strengthening on the Prevalence of Injuries in Long Distance Runners". Committee of Ethics in Research of the School of Medicine of the University of Sao Paulo (18/03/2015, Protocol # 031/15).

Effects of fixed orthodontic treatment and two new mouth rinses on gingival health: A prospective cohort followed by a single-blind placebo-controlled randomized clinical trial.

PubMed

Sobouti, Farhad; Rakhshan, Vahid; Heydari, Mohaddeseh; Keikavusi, Shohreh; Dadgar, Sepideh; Shariati, Mahsa

2018-03-01

Routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. Antimicrobial mouth rinses are favorable in this regard. This two-phase study evaluated the effects of orthodontic treatment and the application of two mouthwashes not studied before on oral health indices. In this two-phase study (a prospective cohort followed by a parallel randomized controlled trial), plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and pocket probing depth (PPD) were measured in 54 orthodontic patients before orthodontic treatment and 4 months later. Then patients were randomized into three groups of mouthrinses: Persica (herbal), Ortho-Kin (containing diluted chlorhexidine), and Placebo (n=18×3). The effects of orthodontic treatment and mouthrinses were analyzed statistically (α=0.05). All the 4 indices increased between the baseline and 4th month of treatment (P values<0.01, paired t-test). They decreased back to baseline levels or below them, after one month of mouthwash application (P values<0.002). Both mouthwashes showed therapeutic effects compared to placebo in terms of PI and GBI. In the case of GI, only Persica showed significantly better results compared to placebo. Regarding PPD, only Ortho-Kin acted better than placebo (P values≤0.05, Tukey). Lack of positive control (regular chlorhexidine mouth rinse) and negative control (a group with no mouthwashes, even without the placebo). Lack of sample size predetermination based on a priori power calculations. The difference between the regime of Persica with that of Ortho-Kin and placebo (which had similar application protocols) disallowed perfectly effective blinding of the patients (hence, single-blind). Fixed orthodontic treatment might disrupt gingival health. Antimicrobial mouthwashes might reverse this. Both evaluated mouthwashes might have therapeutic effects. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

The efficacy of hypotonic and near-isotonic saline for parenteral fluid therapy given at low maintenance rate in preventing significant change in plasma sodium in post-operative pediatric patients: protocol for a prospective randomized non-blinded study

PubMed Central

2011-01-01

Background Hyponatremia is the most frequent electrolyte abnormality observed in post-operative pediatric patients receiving intravenous maintenance fluid therapy. If plasma sodium concentration (p-Na+) declines to levels below 125 mmol/L in < 48 h, transient or permanent brain damage may occur. There is an intense debate as to whether the administered volume (full rate vs. restricted rate of infusion) and the composition of solutions used for parenteral maintenance fluid therapy (hypotonic vs. isotonic solutions) contribute to the development of hyponatremia. So far, there is no definitive pediatric data to support a particular choice of parenteral fluid for maintenance therapy in post-surgical patients. Methods/Design Our prospective randomized non-blinded study will be conducted in healthy children and adolescents aged 1 to 14 years who have been operated for acute appendicitis. Patients will be randomized either to intravenous hypotonic (0.23% or 0.40% sodium chloride in glucose, respectively) or near-isotonic (0.81% sodium chloride in glucose) solution given at approximately three-fourths of the average maintenance rate. The main outcome of interest from this study is to evaluate 24 h post-operatively whether differences in p-Na+ between treatment groups are large enough to be of clinical relevance. In addition, water and electrolyte balance as well as regulatory hormones will be measured. Discussion This study will provide valuable information on the efficacy of hypotonic and near-isotonic fluid therapy in preventing a significant decrease in p-Na+. Finally, by means of careful electrolyte and water balance and by measuring regulatory hormones our results will also contribute to a better understanding of the physiopathology of post-operative changes in p-Na+ in a population at risk for hyponatremia. Trial registration The protocol for this study is registered with the current controlled trials registry; registry number: ISRCTN43896775. PMID:21729308

Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial.

PubMed

Chen, Lifang; Fang, Jianqiao; Ma, Ruijie; Froym, Ronen; Gu, Xudong; Li, Jianhua; Chen, Lina; Xu, Shouyu; Ji, Conghua

2014-06-08

Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Chinese Clinical Trial Registry ChiCTR-TRC-12001971.

Details of a prospective protocol for a collaborative meta-analysis of individual participant data from all randomized trials of intravenous rt-PA vs. control: statistical analysis plan for the Stroke Thrombolysis Trialists' Collaborative meta-analysis.

PubMed

2013-06-01

Thrombolysis with intravenous alteplase is both effective and safe when administered to particular types of patient within 4·5 hours of having an ischemic stroke. However, the extent to which effects might vary in different types of patient is uncertain. We describe the protocol for an updated individual patient data meta-analysis of trials of intravenous alteplase, including results from the recently reported third International Stroke Trial, in which a wide range of patients enrolled up to six-hours after stroke onset were randomized to alteplase vs. control. This protocol will specify the primary outcome for efficacy, specified prior to knowledge of the results from the third International Stroke Trial, as the proportion of patients having a 'favorable' stroke outcome, defined by modified Rankin Score 0-1 at final follow-up at three- to six-months. The primary analysis will be to estimate the extent to which the known benefit of alteplase on modified Rankin Score 0-1 diminishes with treatment delay, and the extent to which it is independently modified by age and stroke severity. Key secondary outcomes include effect of alteplase on death within 90 days; analyses of modified Rankin Score using ordinal, rather than dichotomous, methods; and effects of alteplase on symptomatic intracranial hemorrhage, fatal intracranial hemorrhage, symptomatic ischemic brain edema and early edema, effacement and/or midline shift. This collaborative meta-analysis of individual participant data from all randomized trials of intravenous alteplase vs. control will demonstrate how the known benefits of alteplase on ischemic stroke outcome vary across different types of patient. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Feasibility and radiation dose of high-pitch acquisition protocols in patients undergoing dual-source cardiac CT.

PubMed

Sommer, Wieland H; Albrecht, Edda; Bamberg, Fabian; Schenzle, Jan C; Johnson, Thorsten R; Neumaier, Klement; Reiser, Maximilian F; Nikolaou, Konstatin

2010-12-01

The objective of this study was to compare image quality and radiation dose between high-pitch and established retrospectively and prospectively gated cardiac CT protocols using an Alderson-Rando phantom and a set of patients. An anthropomorphic Alderson-Rando phantom equipped with thermoluminiscent detectors and a set of clinical patients underwent the following cardiac CT protocols: high-pitch acquisition (pitch 3.4), prospectively triggered acquisition, and retrospectively gated acquisition (pitch 0.2). For patients with sinus rhythm below 65 beats per minute (bpm), high-pitch protocol was used, whereas for patients in sinus rhythm between 65 and 100 bpm, prospective triggering was used. Patients with irregular heart rates or heart rates of ≥ 100 bpm, were examined using retrospectively gated acquisition. Evaluability of coronary artery segments was determined, and effective radiation dose was derived from the phantom study. In the phantom study, the effective radiation dose as determined with thermoluminescent detector (TLD) measurements was lowest in the high-pitch acquisition (1.21, 3.12, and 11.81 mSv, for the high-pitch, the prospectively triggered, and the retrospectively gated acquisition, respectively). There was a significant difference with respect to the percentage of motion-free coronary artery segments (99%, 87%, and 92% for high-pitch, prospectively triggered, and retrospectively gated, respectively (p < 0.001), whereas image noise was lowest for the high-pitch protocol (p < 0.05). High-pitch scans have the potential to reduce radiation dose up to 61.2% and 89.8% compared with prospectively triggered and retrospectively gated scans. High-pitch protocols lead to excellent image quality when used in patients with stable heart rates below 65 bpm.

Practical State Machine Replication with Confidentiality

DOE Office of Scientific and Technical Information (OSTI.GOV)

Duan, Sisi; Zhang, Haibin

2016-01-01

We study how to enable arbitrary randomized algorithms in Byzantine fault-tolerant (BFT) settings. We formalize a randomized BFT protocol and provide a simple and efficient construction that can be built on any existing BFT protocols while adding practically no overhead. We go one step further to revisit a confidential BFT protocol (Yin et al., SOSP '03). We show that their scheme is potentially susceptible to safety and confidentiality attacks. We then present a new protocol that is secure in the stronger model we formalize, by extending the idea of a randomized BFT protocol. Our protocol uses only efficient symmetric cryptography,more » while Yin et al.'s uses costly threshold signatures. We implemented and evaluated our protocols on microbenchmarks and real-world use cases. We show that our randomized BFT protocol is as efficient as conventional BFT protocols, and our confidential BFT protocol is two to three orders of magnitude faster than Yin et al.'s, which is less secure than ours.« less

Randomized trial for answers to clinical questions: evaluating a pre-appraised versus a MEDLINE search protocol.

PubMed

Patel, Manesh R; Schardt, Connie M; Sanders, Linda L; Keitz, Sheri A

2006-10-01

The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. A randomized trial involving medicine residents was performed. An inpatient general medicine rotation was used. Thirty-two internal medicine residents were block randomized into four groups of eight. Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as "fast" (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer.

Recreational music-making: a cost-effective group interdisciplinary strategy for reducing burnout and improving mood states in long-term care workers.

PubMed

Bittman, Barry; Bruhn, Karl T; Stevens, Christine; Westengard, James; Umbach, Paul O

2003-01-01

This controlled, prospective, randomized study examined the clinical and potential economic impact of a 6-session Recreational Music-making (RMM) protocol on burnout and mood dimensions, as well as on Total Mood Disturbance (TMD) in an interdisciplinary group of long-term care workers. A total of 112 employees participated in a 6-session RMM protocol focusing on building support, communication, and interdisciplinary respect utilizing group drumming and keyboard accompaniment. Changes in burnout and mood dimensions were assessed with the Maslach Burnout Inventory and the Profile of Mood States respectively. Cost savings were projected by an independent consulting firm, which developed an economic impact model. Statistically-significant reductions of multiple burnout and mood dimensions, as well as TMD scores, were noted. Economic-impact analysis projected cost savings of $89,100 for a single typical 100-bed facility, with total annual potential savings to the long-term care industry of $1.46 billion. A cost-effective, 6-session RMM protocol reduces burnout and mood dimensions, as well as TMD, in long-term care workers.

The effect of adding active flexion to modified Kleinert regime on outcomes for zone 1 to 3 flexor tendon repairs. A prospective randomized trial.

PubMed

Rigó, István Zoltán; Haugstvedt, Jan-Ragnar; Røkkum, Magne

2017-11-01

In a prospective randomized study, we studied whether adding active flexion to a modified Kleinert regime changed outcomes of flexor tendon repairs in zone 1, 2 and 3 in 73 fingers (53 patients). Evaluation included active range of finger motion, grip and pinch strengths. Twelve months after surgery, the increase in range of active finger motion after adding active flexion was insignificant compared with that with the modified Kleinert regime. According to the Strickland criteria, 20 out of 29 fingers had excellent or good recovery after adding active flexion, as did 28 out of 34 fingers with the modified Kleinert regime; we could not detect significant improvement of the good and excellent rate. At 6 months, the pinch strength was significantly higher with the addition of active flexion. We failed to find that adding active finger flexion to the modified Kleinert regime improves the overall long-term results of repairs in zone 1 to 3, though recovery appeared faster, and the good and excellent recovery of zone 2 repairs was 17% greater with the active flexion protocol. I.

CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: a prospective randomized controlled study.

PubMed

Caraco, Y; Blotnick, S; Muszkat, M

2008-03-01

Warfarin anticoagulation effect is characterized by marked variability, some of which has been attributed to CYP2C9 polymorphisms. This study prospectively examines whether a priori knowledge of CYP2C9 genotype may improve warfarin therapy. Patients were randomly assigned to receive warfarin by a validated algorithm ("control", 96 patients) or CYP2C9 genotype-adjusted algorithms ("study", 95 patients). The first therapeutic international normalized ratio and stable anticoagulation were reached 2.73 and 18.1 days earlier in the study group, respectively (P<0.001). The faster rate of initial anticoagulation was driven by a 28% higher daily dose in the study group (P<0.001). Study group patients spent more time within the therapeutic range (80.4 vs 63.4%, respectively, P<0.001) and experienced less minor bleeding (3.2 vs 12.5%, P<0.02, respectively). In conclusion, CYP2C9 genotype-guided warfarin therapy is more efficient and safer than the "average-dose" protocol. Future research should focus on construction of algorithms that incorporate other polymorphisms (VKORC1), host factors, and environmental influences.

Critical review of immediate implant loading.

PubMed

Gapski, Ricardo; Wang, Hom-Lay; Mascarenhas, Paulo; Lang, Niklaus P

2003-10-01

Implant dentistry has become successful with the discovery of the biological properties of titanium. In the original protocol, studies have advocated a 2-stage surgical protocol for load-free and submerged healing to ensure predictable osseointegration. However, the discomfort, inconvenience, and anxiety associated with waiting period remains a challenge to both patients and clinicians. Hence, loading implant right after placement was attempted and has gained popularity among clinicians. Issues/questions related to this approach remain unanswered. Therefore, it is the purpose of this review article to (1). review and analyze critically the current available literature in the field of immediate implant loading and (2). discuss, based on scientific evidence, factors that may influence this treatment modality. Literature published over the past 20 years was selected and reviewed. Findings from these studies were discussed and summarized in the tables. The advantages and disadvantages associated with immediate implant loading were analyzed. Factors that may influence the success of immediate implant loading, including patient selection, type of bone quality, required implant length, micro- and macrostructure of the implant, surgical skill, need for achieving primary stability/control of occlusal force, and prosthesis guidelines, were thoroughly reviewed and discussed. Various studies have demonstrated the feasibility and predictability of this technique. However, most of these articles are based on retrospective data or uncontrolled cases. Randomized, prospective, parallel-armed longitudinal human trials are primarily based on short-term results and long-term follow-ups are still scarce in this field. Nonetheless, from available literature, it may be concluded that anatomic locations, implant designs, and restricted prosthetic guidelines are key to ensure successful outcomes. Future studies, preferably randomized, prospective longitudinal studies, are certainly needed before this approach can be widely used.

Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study.

PubMed

Anastasiadis, Kyriakos; Asteriou, Christos; Antonitsis, Polychronis; Argiriadou, Helena; Grosomanidis, Vassilios; Kyparissa, Magdalena; Deliopoulos, Apostolos; Konstantinou, Dimitrios; Tossios, Paschalis

2013-10-01

A minimal extracorporeal circulation (MECC) circuit integrates the advances in cardiopulmonary bypass (CPB) technology into a single circuit and is associated with improved short-term outcome. The aim of this study was to prospectively evaluate MECC compared with conventional CPB in facilitating fast-track recovery after elective coronary revascularization procedures. Prospective randomized study. All patients scheduled for elective coronary artery surgery were evaluated, excluding those considered particularly high risk for fast-track failure. The fast-track protocol included careful preoperative patient selection, a fast-track anesthetic technique based on minimal administration of fentanyl, surgery at normothermia, early postoperative extubation in the cardiac recovery unit, and admission to the cardiothoracic ward within the first 24 hours postoperatively. One hundred twenty patients were assigned randomly into 2 groups (60 in each group). Group A included patients who were operated on using the MECC circuit, whereas patients in Group B underwent surgery on conventional CPB. Incidence of fast-track recovery was significantly higher in patients undergoing MECC (25% v 6.7%, p = 0.006). MECC also was recognized as a strong independent predictor of early recovery, with an odds ratio of 3.8 (p = 0.011). Duration of mechanical ventilation and cardiac recovery unit stay were significantly lower in patients undergoing MECC together with the need for blood transfusion, duration of inotropic support, need for an intra-aortic balloon pump, and development of postoperative atrial fibrillation and renal failure. MECC promotes successful early recovery after elective coronary revascularization procedures, even in a nondedicated cardiac intensive care unit setting. Copyright © 2013 Elsevier Inc. All rights reserved.

Preservation of nutritional-status in patients with refractory ascites due to hepatic cirrhosis who are undergoing repeated paracentesis.

PubMed

Sorrentino, Paolo; Castaldo, Giuseppe; Tarantino, Luciano; Bracigliano, Alessandra; Perrella, Alessandro; Perrella, Oreste; Fiorentino, Francesco; Vecchione, Raffaela; D' Angelo, Salvatore

2012-04-01

Refractory ascites in liver-cirrhosis is associated with a poor prognosis. We performed a prospective study to investigate whether aggressive nutritional-support could improve outcomes in cirrhotic patients. Cirrhotic patients undergoing serial large-volume paracentesis for refractory-ascites were enrolled and randomized into three groups. Group A received post-paracentesis intravenous nutritional-support in addition to a balanced oral diet and a late-evening protein snack, group B received the same oral nutritional-protocol as the first group but without parenteral support, and group C (the control group) received a low-sodium or sodium-free diet. Clinical, anthropometric and laboratory nutritional parameters and biochemical tests of liver and renal function were reported for 12 months of follow-up. We enrolled 120 patients, who were randomized into three groups of equal size. Patients on the nutritional-protocol showed better preservation of clinical, anthropometric and laboratory nutritional parameters that were associated with decreased deterioration of liver function compared with patients on the low-sodium or sodium-free diet (group C). Groups A and B had lower morbidity and mortality rates than the control group (C). Mortality rates were significantly better in patients who were treated with parenteral-nutritional-support than for the other two groups. In patients who were on the nutritional-protocol, there was a reduction in the requirement of taps for the treatment of refractory ascites. Post-paracentesis parenteral-nutritional-support with a balanced oral diet and an evening protein snack appears to be the best care protocol for patients with liver-cirrhosis that has been complicated by refractory-ascites. © 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.

Efficacy and safety of imidacloprid/moxidectin spot-on solution and fenbendazole in the treatment of dogs naturally infected with Angiostrongylus vasorum (Baillet, 1866).

PubMed

Willesen, J L; Kristensen, A T; Jensen, A L; Heine, J; Koch, J

2007-07-20

A randomized, blinded, controlled multicentre field trial study was conducted to evaluate the efficacy and safety of imidacloprid 10%/moxidectin 2.5% spot-on solution and fenbendazole in treating dogs naturally infected with Angiostrongylus vasorum. Dogs were randomly treated either with a single dose of 0.1 ml/kg bodyweight of imidacloprid 10%/moxidectin 2.5% spot-on solution or with 25 mg/kg bodyweight fenbendazole per os for 20 days. The study period was 42 days with dogs being examined on days 0, 7 and 42. The primary efficacy parameter was the presence of L1 larvae in faecal samples evaluated by a Baermann test from three consecutive days. Thoracic radiographs performed on each visit were being taken as a paraclinical parameter to support the results of the Baermann test. Twenty-seven dogs in the imidacloprid/moxidectin group and 23 dogs in the fenbendazole group completed the study according to protocol. The efficacies of the two treatment protocols were 85.2% (imidacloprid/moxidectin) and 91.3% (fenbendazole) with no significant difference between treatment groups. On radiographic evaluation pulmonary parenchyma showed similar improvement in each group. No serious adverse effects to treatment were recorded: most of the minor adverse effects were gastrointestinal such as diarrhea (nine dogs), vomitus (eight dogs) and salivation (three dogs). In general, these adverse effects were of short duration (1-2 days) within the first few days after treatment start and required little or no treatment. This prospective study demonstrates that both treatment protocols used are efficacious under field conditions, that treatment of mildly to moderately infected dogs with either of these protocols is safe and yields an excellent prognosis for recovering from the infection.

Prospective randomized study of arthroscopic rotator cuff repair using an early versus delayed postoperative physical therapy protocol.

PubMed

Cuff, Derek J; Pupello, Derek R

2012-11-01

This study evaluated patient outcomes and rotator cuff healing after arthroscopic rotator cuff repair using a postoperative physical therapy protocol with early passive motion compared with a delayed protocol that limited early passive motion. The study enrolled 68 patients (average age, 63.2 years) who met inclusion criteria. All patients had a full-thickness crescent-shaped tear of the supraspinatus that was repaired using a transosseous equivalent suture-bridge technique along with subacromial decompression. In the early group, 33 patients were randomized to passive elevation and rotation that began at postoperative day 2. In the delayed group, 35 patients began the same protocol at 6 weeks. Patients were monitored clinically for a minimum of 12 months, and rotator cuff healing was assessed using ultrasound imaging. Both groups had similar improvements in preoperative to postoperative American Shoulder and Elbow Surgeons scores (early group: 43.9 to 91.9, P < .0001; delayed group: 41.0 to 92.8, P < .0001) and Simple Shoulder Test scores (early group: 5.5 to 11.1, P < .0001; delayed group: 5.1 to 11.1, P < .0001). There were no significant differences in patient satisfaction, rotator cuff healing, or range of motion between the early and delayed groups. Patients in the early group and delayed group both demonstrated very similar outcomes and range of motion at 1 year. There was a slightly higher rotator cuff healing rate in the delayed passive range of motion group compared with the early passive range of motion group (91% vs 85%). Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

PubMed

Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan

2016-10-01

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

ANDRO-IVF: a novel protocol for poor responders to IVF controlled ovarian stimulation

PubMed Central

Bercaire, Ludmila; Nogueira, Sara MB; Lima, Priscila CM; Alves, Vanessa R; Donadio, Nilka; Dzik, Artur; Cavagna, Mario; Fanchin, Renato

2018-01-01

Objective This study aimed to assess a novel protocol designed to improve poor ovarian response through intra-ovarian androgenization. The endpoints were: number of oocytes and mature oocytes retrieved, fertilization, cancellation and pregnancy rates. Methods This prospective crossover study enrolled poor responders from previous ovarian stimulation cycles submitted to a novel protocol called ANDRO-IVF. The protocol included pretreatment with transdermal AndroGel(r) (Besins) 25 mg, oral letrozole 2.5 mg and subcutaneous hCG 2500 IU; cycle control was performed with estradiol valerate and micronized progesterone; ovarian stimulation was attained with gonadotropins FSH/LH 450 IU, GnRH antagonist and hCG 5000 IU. Results Fourteen poor responders were enrolled. One patient did not meet the inclusion criteria. Thirteen patients previously summited to the standard protocol were offered the ANDRO-IVF Protocol.-Standard Protocol: Mean age: 35.30 years; cancellation rate: 61.53%; mean number of MII oocytes retrieved per patient: 1.8; fertilization rate: 33.33%. Only two patients had embryo transfers, and none got pregnant.-ANDRO-IVF Protocol: Mean age: 35.83 years; cancellation rate: 7.69%; mean number of oocytes retrieved per patient: 5.58, MII oocytes: 3.91. ICSI was performed in 84.61% of the patients and a mean of 1.5 embryos were transferred per patient. Fertilization rate: 62.5%; cumulative pregnancy rate: 16.66%; mean duration of stimulation: 9.77 days. Conclusion ANDRO-IVF allows intra-ovarian androgenization by increasing serum and intra-follicular androgen levels and preventing androgen aromatization. This protocol apparently improved clinical outcomes of poor responders in parameters such as number of oocytes retrieved and clinical pregnancy rates. Further randomized controlled trials are needed to confirm these findings. PMID:29303236

Supervised versus unsupervised technology-based levodopa monitoring in Parkinson's disease: an intrasubject comparison.

PubMed

Lopane, Giovanna; Mellone, Sabato; Corzani, Mattia; Chiari, Lorenzo; Cortelli, Pietro; Calandra-Buonaura, Giovanna; Contin, Manuela

2018-06-01

We aimed to assess the intrasubject reproducibility of a technology-based levodopa (LD) therapeutic monitoring protocol administered in supervised versus unsupervised conditions in patients with Parkinson's disease (PD). The study design was pilot, intrasubject, single center, open and prospective. Twenty patients were recruited. Patients performed a standardized monitoring protocol instrumented by an ad hoc embedded platform after their usual first morning LD dose in two different randomized ambulatory sessions: one under a physician's supervision, the other self-administered. The protocol is made up of serial motor and non-motor tests, including alternate finger tapping, Timed Up and Go test, and measurement of blood pressure. Primary motor outcomes included comparisons of intrasubject LD subacute motor response patterns over the 3-h test in the two experimental conditions. Secondary outcomes were the number of intrasession serial test repetitions due to technical or handling errors and patients' satisfaction with the unsupervised LD monitoring protocol. Intrasubject LD motor response patterns were concordant between the two study sessions in all patients but one. Platform handling problems averaged 4% of total planned serial tests for both sessions. Ninety-five percent of patients were satisfied with the self-administered LD monitoring protocol. To our knowledge, this study is the first to explore the potential of unsupervised technology-based objective motor and non-motor tasks to monitor subacute LD dosing effects in PD patients. The results are promising for future telemedicine applications.

Microdose gonadotropin-releasing hormone agonist flare-up protocol versus multiple dose gonadotropin-releasing hormone antagonist protocol in poor responders undergoing intracytoplasmic sperm injection-embryo transfer cycle.

PubMed

Kahraman, Korhan; Berker, Bulent; Atabekoglu, Cem Somer; Sonmezer, Murat; Cetinkaya, Esra; Aytac, Rusen; Satiroglu, Hakan

2009-06-01

To compare the efficacy of microdose GnRH agonist (GnRH-a) flare-up and multiple dose GnRH antagonist protocols in patients who have a poor response to a long luteal GnRH-a protocol. Prospective, randomized, clinical study. University hospital. Forty-two poor responder patients undergoing intracytoplasmic sperm injection (ICSI)-embryo transfer cycle. Twenty-one patients received microdose leuprolide acetate (LA) (50 microg twice daily) starting on the second day of withdrawal bleeding. The other 21 patients received 0.25 mg of cetrorelix daily when the leading follicle reached 14 mm in diameter. Serum E(2) levels, number of growing follicles and mature oocytes, embryo quality, dose of gonadotropin used, cancellation, fertilization, implantation rate and pregnancy rate (PR). The mean serum E(2) concentration on the day of hCG administration was significantly higher in the microdose GnRH-a group than in the GnRH antagonist group (1,904 vs. 1,362 pg/mL). The clinical PRs per started cycle of microdose GnRH-a and GnRH antagonist groups were 14.2% and 9.5%, respectively. There were no statistically significant differences in the other ovulation induction characteristics, fertilization and implantation rates. Microdose GnRH-a flare-up protocol and multiple dose GnRH antagonist protocol seem to have similar efficacy in improving treatment outcomes of poor responder patients.

The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial.

PubMed

Lu, Jun-Yang; Xu, Lai; Xue, Hua-Dan; Zhou, Wei-Xun; Xu, Tao; Qiu, Hui-Zhong; Wu, Bin; Lin, Guo-Le; Xiao, Yi

2016-12-08

The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy. The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes). The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety. ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.

The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

PubMed

Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

2013-11-01

In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial.

PubMed

Sommer, Anders; Kronborg, Mads Brix; Poulsen, Steen Hvitfeldt; Böttcher, Morten; Nørgaard, Bjarne Linde; Bouchelouche, Kirsten; Mortensen, Peter Thomas; Gerdes, Christian; Nielsen, Jens Cosedis

2013-04-26

Cardiac resynchronization therapy (CRT) is an established treatment in heart failure patients. However, a large proportion of patients remain nonresponsive to this pacing strategy. Left ventricular (LV) lead position is one of the main determinants of response to CRT. This study aims to clarify whether multimodality imaging guided LV lead placement improves clinical outcome after CRT. The ImagingCRT study is a prospective, randomized, patient- and assessor-blinded, two-armed trial. The study is designed to investigate the effect of imaging guided left ventricular lead positioning on a clinical composite primary endpoint comprising all-cause mortality, hospitalization for heart failure, or unchanged or worsened functional capacity (no improvement in New York Heart Association class and <10% improvement in six-minute-walk test). Imaging guided LV lead positioning is targeted to the latest activated non-scarred myocardial region by speckle tracking echocardiography, single-photon emission computed tomography, and cardiac computed tomography. Secondary endpoints include changes in LV dimensions, ejection fraction and dyssynchrony. A total of 192 patients are included in the study. Despite tremendous advances in knowledge with CRT, the proportion of patients not responding to this treatment has remained stable since the introduction of CRT. ImagingCRT is a prospective, randomized study assessing the clinical and echocardiographic effect of multimodality imaging guided LV lead placement in CRT. The results are expected to make an important contribution in the pursuit of increasing response rate to CRT. Clinicaltrials.gov identifier NCT01323686. The trial was registered March 25, 2011 and the first study subject was randomized April 11, 2011.

Lipidomic Components Alterations of Human Follicular Fluid Reveal the Relevance of Improving Clinical Outcomes in Women Using Progestin-Primed Ovarian Stimulation Compared to Short-Term Protocol.

PubMed

Wen, Xiaowei; Kuang, Yanping; Zhou, Lixia; Yu, Baofeng; Chen, Qiuju; Fu, Yonglun; Yan, Zheng; Guo, Haiyan; Lyu, Qifeng; Xie, Jun; Chai, Weiran

2018-05-21

BACKGROUND Increasing the success rate of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) is a duty of clinicians that has made many seek a variety of protocols. This study was undertaken to use a liquid chromatography-mass spectrometry (LC-MS) to define the alterations of follicular fluid (FF) lipid metabolites in patients undergoing progestin-primed ovarian stimulation (PPOS) compared with short-term protocol, revealing potential correlations between the differentially expressed lipids and ameliorative clinical outcomes. MATERIAL AND METHODS Ninety-three infertile women undergoing IVF/ICSI treatment with PPOS (n=62) or a short-term protocol (n=31) were prospectively enrolled in a randomized controlled trial. FF samples were obtained from dominant follicles at the time of oocyte retrieval. Lipid metabolism profiles were analyzed using LC-MS. RESULTS Twelve lipids were found to be higher in patients treated with the PPOS protocol than in those receiving the short-term protocol, including triacylglycerols (TAG-34: 1+NH4, TAG-58: 0+NH4, TAG-64: 3+NH4, and TAG-64: 8+NH4), diacylglycerol DAG-38: 6+NH4, phosphatidylglycerols (PG-26: 0, PG-30: 2, and PG-40: 5), phosphatidylethanolamine PE-32: 2, lysophosphatidylethanolamine LPE-14: 1, lysophosphatidylinositol LPI-12: 0, and lysophosphatidylcholine LPC-16: 0. CONCLUSIONS Our data demonstrate that the PPOS protocol increases the levels of 12 lipids in FF, which reveals a strong association between the differentially elevated lipids and better IVF/ICSI outcomes.

Evaluation of an outpatient protocol in the treatment of canine parvoviral enteritis.

PubMed

Venn, Emilee C; Preisner, Karolina; Boscan, Pedro L; Twedt, David C; Sullivan, Lauren A

2017-01-01

To compare 2 treatment protocols (standard in-hospital versus modified outpatient) in affecting the duration of treatment or survival of dogs with parvoviral enteritis. Prospective, randomized study. University teaching hospital. Client-owned dogs with naturally acquired parvovirus were randomized to receive either an inpatient (n = 20) or outpatient (n = 20) treatment protocol. Both groups received intravenous (IV) fluid resuscitation and correction of hypoglycemia at hospital admission. Following stabilization, basic inpatient interventions included administration of IV fluids, administration of cefoxitin (22 mg/kg IV q 8 h), and maropitant (1 mg/kg IV q 24 h). Basic outpatient interventions (provided in-hospital) included administration of subcutaneous (SC) fluid (30 mL/kg q 6 h), administration of maropitant (1 mg/kg SC q 24 h) and cefovecin (8 mg/kg SC once). Using daily electrolyte and glucose evaluations, dextrose and potassium supplementation was provided intravenously (inpatients) or orally (outpatients) as indicated. Rescue criteria were used in both groups for analgesia and nausea. All dogs were syringe fed a commercial canine convalescence diet (1 mL/kg PO q 6 h) until voluntary appetite returned. Protocol success, defined as survival to hospital discharge, was 90% (18/20) for the inpatient group compared to 80% (16/20) for the outpatient group (P = 0.66). There was no difference detected in duration of hospitalization for inpatient dogs (4.6 ± 2 days) versus outpatient dogs (3.8 ± 1.8 days, P = 0.20). Metabolic disturbances were frequent in the outpatient group, with 50% of dogs requiring dextrose supplementation and 60% of dogs requiring potassium supplementation. An outpatient protocol may be a reasonable alternative for dogs that cannot receive standard in-hospital treatment for parvoviral enteritis. Diligent supportive care and monitoring are still required to optimize treatment of dogs with parvoviral enteritis in an outpatient setting. © Veterinary Emergency and Critical Care Society 2016.

The effects of baseline heart rate recovery normality and exercise training protocol on heart rate recovery in patients with heart failure.

PubMed

Yaylalı, Yalın Tolga; Fındıkoğlu, Gülin; Yurtdaş, Mustafa; Konukçu, Sibel; Şenol, Hande

2015-09-01

It is unclear which exercise training protocol yields superior heart rate recovery (HRR) improvement in heart failure (HF) patients. Whether baseline HRR normality plays a role in the improvement is unknown. We hypothesized that an exercise training protocol and baseline HRR normality would be factors in altering HRR in HF patients. In this prospective, randomized, controlled and 3 group parallel study, 41 stable HF patients were randomly assigned to 3-times-weekly training sessions for 12 weeks, consisting of i) 30 minutes of interval training (IT) (n=17, 63.7±8.8 years old) versus ii) 30 minutes of continuous training (CT) (n=13, 59.6±6.8 years old) versus iii) no training (CON) (n=11, 60.6±9.9 years old). Each patient had cardiopulmonary exercise testing before and after the training program. Maximum heart rates attained during the test and heart rates at 1 and 2 min (HRR1 and HRR2) during the recovery phase were recorded. Paired samples t-test or Wilcoxon signed-rank test was used for comparisons before and after training. One-way ANOVA or Kruskal-Wallis variance analysis was used for comparisons among groups. HRR1 was unchanged after training. HRR2 improved in the IT group after training, and post-training HRR2 values were significantly faster in the IT group than in controls. Both HRR1 and HRR2 was significantly faster, irrespective of exercise protocol in patients with abnormal baseline values after training. HRR1 did not improve after training. HRR2 improved only in the IT group. Both HRRs in patients with abnormal baseline values improved after both exercise protocols. IT might be superior to CT in improving HRR2. Baseline HRR might play a role in its response to exercise.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

Purified umbilical cord derived mesenchymal stem cell treatment in a case of systemic lupus erythematosus.

PubMed

Phillips, Christopher D; Wongsaisri, Pornpatcharin; Htut, Thein; Grossman, Terry

2017-12-01

Systemic lupus erythematosus (SLE) is a multiple organ system autoimmune disorder for which there is no known cure. We report a case of a young adult lady with SLE and Sjogren's with diagnostic and clinical resolution following purified umbilical cord derived mesenchymal stem cell (MSC) and globulin component protein macrophage activating factor (GcMAF) therapy in a combined multidisciplinary integrative medicine protocol. Our patient had complete reversal of all clinical and laboratory markers. We recommend a prospective randomized double blind study to assess the sustained efficacy of MSC and GcMAF in the treatment of autoimmune connective tissue diseases such as systemic lupus erythematosus.

Coronary CT angiography with single-source and dual-source CT: comparison of image quality and radiation dose between prospective ECG-triggered and retrospective ECG-gated protocols.

PubMed

Sabarudin, Akmal; Sun, Zhonghua; Yusof, Ahmad Khairuddin Md

2013-09-30

This study is conducted to investigate and compare image quality and radiation dose between prospective ECG-triggered and retrospective ECG-gated coronary CT angiography (CCTA) with the use of single-source CT (SSCT) and dual-source CT (DSCT). A total of 209 patients who underwent CCTA with suspected coronary artery disease scanned with SSCT (n=95) and DSCT (n=114) scanners using prospective ECG-triggered and retrospective ECG-gated protocols were recruited from two institutions. The image was assessed by two experienced observers, while quantitative assessment was performed by measuring the image noise, the signal-to-noise ratio (SNR) and the contrast-to-noise ratio (CNR). Effective dose was calculated using the latest published conversion coefficient factor. A total of 2087 out of 2880 coronary artery segments were assessable, with 98.0% classified as of sufficient and 2.0% as of insufficient image quality for clinical diagnosis. There was no significant difference in overall image quality between prospective ECG-triggered and retrospective gated protocols, whether it was performed with DSCT or SSCT scanners. Prospective ECG-triggered protocol was compared in terms of radiation dose calculation between DSCT (6.5 ± 2.9 mSv) and SSCT (6.2 ± 1.0 mSv) scanners and no significant difference was noted (p=0.99). However, the effective dose was significantly lower with DSCT (18.2 ± 8.3 mSv) than with SSCT (28.3 ± 7.0 mSv) in the retrospective gated protocol. Prospective ECG-triggered CCTA reduces radiation dose significantly compared to retrospective ECG-gated CCTA, while maintaining good image quality. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures

PubMed Central

2014-01-01

Background Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). Methods/Design CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. Discussion CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. Trial registration number ClinicalTrials.gov: NCT01828905 PMID:24606670

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Protocol: Testing the Relevance of Acupuncture Theory in the Treatment of Myofascial Pain in the Upper Trapezius Muscle.

PubMed

Elsdon, Dale S; Spanswick, Selina; Zaslawski, Chris; Meier, Peter C

2017-01-01

A protocol for a prospective single-blind parallel four-arm randomized placebo-controlled trial with repeated measures was designed to test the effects of various acupuncture methods compared with sham. Eighty self-selected participants with myofascial pain in the upper trapezius muscle were randomized into four groups. Group 1 received acupuncture to a myofascial trigger point (MTrP) in the upper trapezius. Group 2 received acupuncture to the MTrP in addition to relevant distal points. Group 3 received acupuncture to the relevant distal points only. Group 4 received a sham treatment to both the MTrP and distal points using a deactivated acupuncture laser device. Treatment was applied four times within 2 weeks with outcomes measured throughout the trial and at 2 weeks and 4 weeks posttreatment. Outcome measurements were a 100-mm visual analog pain scale, SF-36, pressure pain threshold, Neck Disability Index, the Upper Extremity Functional Index, lateral flexion in the neck, McGill Pain Questionnaire, Massachusetts General Hospital Acupuncture Sensation Scale, Working Alliance Inventory (short form), and the Credibility Expectance Questionnaire. Two-way analysis of variance (ANOVA) with repeated measures were used to assess the differences between groups. Copyright © 2017 Medical Association of Pharmacopuncture Institute. Published by Elsevier B.V. All rights reserved.

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

PubMed

Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

2013-01-05

Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people. ClinicalTrials.gov Identifier NCT00671099.

Evaluation of the impact of preoperative education in ambulatory laparoscopic cholecystectomy. A prospective, double-blind randomized trial.

PubMed

Subirana Magdaleno, Helena; Caro Tarragó, Aleidis; Olona Casas, Carles; Díaz Padillo, Alba; Franco Chacón, Mario; Vadillo Bargalló, Jordi; Saludes Serra, Judit; Jorba Martín, Rosa

2018-02-01

Outpatient laparoscopic cholecystectomy is a safe procedure and provides a better use of health resources and perceived satisfaction without affecting quality of care. Preoperative education has shown less postoperative stress, pain and nausea in some interventions. The principal objective of this study is to assess the impact of preoperative education on postoperative pain in patients undergoing ambulatory laparoscopic cholecystectomy. Secondary objectives were: to evaluate presence of nausea, morbidity, hospital admissions, readmissions rate, quality of life and satisfaction. Prospective, randomized, and double blind study. Between April 2014 and May 2016, 62 patients underwent outpatient laparoscopic cholecystectomy. ASA I-II, age 18-75, outpatient surgery criteria, abdominal ultrasonography with cholelithiasis. Patient randomization in two groups, group A: intensified preoperative education and group B: control. Sixty-two patients included, 44 women (71%), 18 men (29%), mean age 46,8 years (20-69). Mean BMI 27,5. Outpatient rate 92%. Five cases required admission, two due to nausea. Pain scores obtained using a VAS was at 24-hour, 2,9 in group A and 2,7 in group B. There were no severe complications or readmissions. Results of satisfaction and quality of life scores were similar for both groups. We did not find differences due to intensive preoperative education. However, we think that a correct information protocol should be integrated into the patient's preoperative preparation. Registered in ISRCTN number ISRCTN83787412. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Protection of xenon against postoperative oxygen impairment in adults undergoing Stanford Type-A acute aortic dissection surgery: Study protocol for a prospective, randomized controlled clinical trial.

PubMed

Jin, Mu; Cheng, Yi; Yang, Yanwei; Pan, Xudong; Lu, Jiakai; Cheng, Weiping

2017-08-01

The available evidence shows that hypoxemia after Stanford Type-A acute aortic dissection (AAD) surgery is a frequent cause of several adverse consequences. The pathogenesis of postoperative hypoxemia after AAD surgery is complex, and ischemia/reperfusion and inflammation are likely to be underlying risk factors. Xenon, recognized as an ideal anesthetic and anti-inflammatory treatment, might be a possible treatment for these adverse effects. The trial is a prospective, double-blind, 4-group, parallel, randomized controlled, a signal-center clinical trial. We will recruit 160 adult patients undergoing Stanford type-A AAD surgery. Patients will be allocated a study number and will be randomized on a 1:1:1:1 basis to receive 1 of the 3 treatment options (pulmonary inflated with 50% xenon, 75% xenon, or 100% xenon) or no treatment (control group, pulmonary inflated with 50% nitrogen). The aims of this study are to clarify the lung protection capability of xenon and its possible mechanisms in patients undergoing the Stanford type-A AAD surgery. This trial uses an innovative design to account for the xenon effects of postoperative oxygen impairment, and it also delineates the mechanism for any benefit from xenon. The investigational xenon group is considered a treatment intervention, as it includes 3 groups of pulmonary static inflation with 50%, 75%, and 100% xenon. It is suggested that future trials might define an appropriate concentration of xenon for the best practice intervention.

[Efficiency of a postoperative treatment after rotator cuff repair with a continuous passive motion device (CPM)].

PubMed

Michael, J W-P; König, D P; Imhoff, A B; Martinek, V; Braun, S; Hübscher, M; Koch, C; Dreithaler, B; Bernholt, J; Preis, S; Loew, M; Rickert, M; Speck, M; Bös, L; Bidner, A; Eysel, P

2005-01-01

The main objective of this study was to prove that a postoperative combined continuous passive motion (CPM) and physiotherapy treatment protocol (CPM group) can achieve 90 degrees active abduction in the shoulder joint earlier than physiotherapy alone (PT group). The indication was a complete tear of the rotator cuff. The study was conducted under in-patient and out-patient conditions. 55 patients were included in this study. The prospective, randomized multicenter study design complies with DIN EN 540. The primary endpoint was the time span until 90 degrees active abduction was achieved by the patients. Patients in the CPM group reached the primary endpoint on average 12 days earlier than the control group. This difference was statistically significant (p = 0.0292). Analyzing the secondary endpoints, e. g., pain and disablement, the results in the CPM group showed again advantages of the combined treatment protocol (CPM + physiotherapy). The postoperative treatment of a total tear of the rotator cuff with a combined continuous passive motion and physiotherapy protocol provided a significantly earlier range of motion in the shoulder joint than physiotherapy alone. There was no report of CPM-related adverse effects.

Evaluation of platelet adhesion and activation on polymers: Round-robin study to assess inter-center variability.

PubMed

Braune, S; Sperling, C; Maitz, M F; Steinseifer, U; Clauser, J; Hiebl, B; Krajewski, S; Wendel, H P; Jung, F

2017-10-01

The regulatory agencies provide recommendations rather than protocols or standard operation procedures for the hemocompatibility evaluation of novel materials e.g. for cardiovascular applications. Thus, there is a lack of specifications with regard to test setups and procedures. As a consequence, laboratories worldwide perform in vitro assays under substantially different test conditions, so that inter-laboratory and inter-study comparisons are impossible. Here, we report about a prospective, randomized and double-blind multicenter trial which demonstrates that standardization of in vitro test protocols allows a reproducible assessment of platelet adhesion and activation from fresh human platelet rich plasma as possible indicators of the thrombogenicity of cardiovascular implants. Standardization of the reported static in vitro setup resulted in a laboratory independent scoring of the following materials: poly(dimethyl siloxane) (PDMS), poly(ethylene terephthalate) (PET) and poly(tetrafluoro ethylene) (PTFE). The results of this in vitro study provide evidence that inter-laboratory and inter-study comparisons can be achieved for the evaluation of the adhesion and activation of platelets on blood-contacting biomaterials by stringent standardization of test protocols. Copyright © 2017 Elsevier B.V. All rights reserved.

Two medical abortion regimens for late first-trimester termination of pregnancy: a prospective randomized trial.

PubMed

Dalenda, Chelly; Ines, Najar; Fathia, Boudaya; Malika, Affes; Bechir, Zouaoui; Ezzeddine, Sfar; Hela, Chelly; Badis, Channoufi Mohamed

2010-04-01

Medical abortion regimens based on the use of either misoprostol alone or in association with mifepristone have shown high efficacy and excellent safety profile in early pregnancy abortion. However, no clear recommendation is available for late first-trimester termination of pregnancy. A prospective randomized controlled trial included 122 women seeking medical abortion at 9 to 12 weeks of gestation. Seventy-three patients were given a fixed protocol of 200 mg of mifepristone followed 48 h later by 400 mcg oral misoprostol (Group 1). The second group of 49 patients was administered 800-mcg intravaginal single-dose misoprostol (Group 2). This study sought to compare safety, efficacy and acceptability of these two nonsurgical abortion regimens. Fifty-nine (80.8%) women in Group 1 had complete abortion vs. 38 (77.4%) women in Group 2 (p=.66). Abdominal pain was observed significantly more often in Group 2 (35/49 (71.4%) vs. 32/73 (43.8%) in Group 1, p<.0001. Medical abortion was equally acceptable among the two groups [37/49 (75.5%) and 55/73 (75.7%), p=.89]. For late first-trimester termination, a single 800-mcg vaginal dose of misoprostol seems to be as effective as the mifepristone+misoprostol regimen, with acceptable side effects. Copyright 2010 Elsevier Inc. All rights reserved.

Three months of simvastatin therapy vs. placebo for severe portal hypertension in cirrhosis: A randomized controlled trial.

PubMed

Pollo-Flores, Priscila; Soldan, Mônica; Santos, Ubiratan Cassano; Kunz, Danielle Gobbi; Mattos, Denise Espindola; da Silva, Alexandre Cerqueira; Marchiori, Roberta Cabral; Rezende, Guilherme Ferreira da Motta

2015-11-01

Pleiotropic effects of statins decrease intrahepatic resistance and portal hypertension. We evaluated the effects of simvastatin on hepatic venous pressure gradient (HVPG) and azygos vein blood flow in cirrhotic patients. A 3-month prospective, randomized, triple-blind trial with simvastatin (40 mg/day) vs. placebo was conducted in patients with cirrhotic portal hypertension. HVPG and azygos blood flow, measured by colour Doppler endoscopic ultrasound, were assessed before and after treatment. The primary endpoint was a decrease in the HVPG of at least 20% from baseline or to ≤12 mmHg after the treatment. 34 patients were prospectively enrolled, and 24 completed the protocol. In the simvastatin group 6/11 patients (55%) presented a clinically relevant decrease in the HVPG; no decrease was observed in the placebo group (p=0.036). Patients with medium/large oesophageal varices and previous variceal bleeding had a higher response rate to simvastatin. HVPG and azygos blood flow values were not correlated. No significant adverse events occurred. Simvastatin lowers portal pressure and may even improve liver function. The haemodynamic effect appears to be more evident in patients with severe portal hypertension. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial.

PubMed

Wang, Xue-Qiang; Pi, Yan-Lin; Chen, Pei-Jie; Chen, Bin-Lin; Liang, Lei-Chao; Li, Xin; Wang, Xiao; Zhang, Juan

2014-04-02

Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Chinese Clinical Trial Registry: ChiCTR-TRC-13003708.

The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial.

PubMed

Kim, Eugene; Yang, Seong Mi; Yoon, So Jeong; Bahk, Jae-Hyon; Seo, Jeong-Hwa

2016-11-25

Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes. This is a prospective, double-blind, single-center, parallel-arm, noninferiority, randomized controlled trial to be conducted in participants aged 20-80 years who are undergoing elective surgery under general anesthesia with orotracheal intubation. Participants are randomly assigned into one of two groups depending on whether intubation is performed using a tracheal tube lubricated with water (n = 150) or without any pretreatment (n = 150). The primary outcome is the incidence of sore throat at 0, 2, 4, and 24 h after surgery, which is analyzed with a noninferiority test. The secondary outcomes are the incidence and severity of postoperative hoarseness, oropharyngeal injuries, and respiratory infections. Because we hypothesized that lubricating tracheal tubes using water has no advantage in reducing airway injuries associated with intubation, we will compare the incidence of sore throat, which is the most common complaint after intubation, in a noninferiority manner. This is the first randomized controlled trial to investigate the possibly beneficial or harmful effects of lubricating tracheal tubes using water before intubation. We expect that this trial will provide useful evidence to formulate a protocol for preparing tracheal tubes before intubation. This trial is registered at ClinicalTrials.gov on 1 July 2015 ( NCT02492646 ).

Comparison of intratesticular lidocaine, sacrococcygeal epidural lidocaine and intravenous methadone in cats undergoing castration: a prospective, randomized, investigator-blind clinical trial.

PubMed

Fernandez-Parra, Rocio; Zilberstein, Luca; Fontaine, Cyril; Adami, Chiara

2017-03-01

The objective of this study was to compare three analgesic protocols for feline castration. Prospective, randomized clinical study. Forty-nine client-owned cats. Cats were injected with intramuscular (IM) dexmedetomidine (15 μg kg -1 ) and alfaxalone (3 mg kg -1 ) and assigned randomly to one of three treatment groups. Group ITL (n = 15) were administered intratesticular 2% lidocaine (0.05 mL each testicle), group SCL (n = 15) a sacrococcygeal epidural injection of 2% lidocaine (0.1 mL kg -1 ) and group IVM (n = 19) intravenous (IV) methadone (0.3 mg kg -1 ), before surgery. Cardiorespiratory variables were recorded. In case of autonomic nociceptive response, IV fentanyl (2 μg kg -1 ) was administered. During recovery, time from IM atipamezole (75 μg kg -1 , administered at the end of surgery) to sternal recumbency and to active interaction was recorded. Quality of recovery was assessed using a simple descriptive scale. Postoperative analgesia was evaluated using a visual analogue scale and the UNESP-Botucatu multidimensional composite pain scale (MCPS) at return of active interaction and then 1, 2 and 3 hours later. The three analgesic protocols were comparable in terms of intraoperative fentanyl and propofol requirement. Cardiorespiratory variables stayed within normal ranges in the majority of the cases, although group IVM had the lowest intraoperative respiratory rate (p = 0.0009). No differences were detected between groups in UNESP-Botucatu MCPS scores (p = 0.21). However, group ITL showed higher visual analogue scale score than group IVM (p = 0.001). Four cats enrolled in group ITL, as well as three of group SCL and one of group IVM, required rescue analgesics before the completion of pain assessment. Intratesticular and sacrococcygeal epidural lidocaine injections could be regarded as good alternatives to systemic opioids in cats undergoing castration, although the benefits of these techniques seem to be of shorter duration than IV methadone. Copyright © 2017 Association of Veterinary Anaesthetists and American College of Veterinary Anesthesia and Analgesia. All rights reserved.

Comparison of intravenous ethanol versus diazepam for alcohol withdrawal prophylaxis in the trauma ICU: results of a randomized trial.

PubMed

Weinberg, Jordan A; Magnotti, Louis J; Fischer, Peter E; Edwards, Norma M; Schroeppel, Thomas; Fabian, Timothy C; Croce, Martin A

2008-01-01

Although benzodiazepines are the recommended first-line therapy for the prevention of alcohol withdrawal syndrome (AWS), the administration of intravenous ethanol as an alternative prophylactic agent persists in many surgical ICUs. Advocates of this therapy argue that ethanol provides effective prophylaxis against AWS without the excessive sedation observed with benzodiazepine therapy. No study to date, however, has compared the two therapies with regard to their sedative effects. The purpose of this study was to prospectively evaluate the efficacy of intravenous ethanol compared with benzodiazepines for the prevention of AWS with particular emphasis on the sedative effects of each therapy. During a 15-month period, trauma patients admitted to the ICU with a history of chronic daily alcohol consumption greater than or equal to five beverage equivalents per day were prospectively randomized to one of two 4-day prophylactic regimens: intravenous ethanol infusion (EtOH) versus scheduled-dose diazepam (BENZO). Patients were evaluated with the Riker sedation-agitation scale, a 7-point instrument for the subjective assessment of both sedation (1 = unarousable) and agitation (7 = dangerous agitation). According to protocol, regimens were titrated to achieve and maintain a Riker score of 4 (calm and cooperative). Deviation from a score of 4 during the course of treatment was compared between groups. Fifty patients met study criteria and were randomized after obtainment of informed consent (EtOH, n = 26; BENZO, n = 24). Overall, the EtOH group had a significantly greater proportion of patients who deviated from a score of 4 during the course of treatment (p = 0.020). In both groups, the majority of deviation from a score of 4 reflected periods of under-sedation rather than over-sedation. One patient in the EtOH group failed treatment, requiring diazepam and haloperidol for control of AWS symptoms as per protocol, whereas no patient in the BENZO group failed treatment (p = NS). Concerning the prophylaxis of AWS, intravenous ethanol offers no advantage over diazepam with respect to efficacy or adverse sedative effects. The purported benefit of intravenous ethanol as a prophylactic agent against AWS was not evident.

Reduction in Wound Complications After Total Ankle Arthroplasty Using a Compression Wrap Protocol.

PubMed

Schipper, Oliver N; Hsu, Andrew R; Haddad, Steven L

2015-12-01

The purpose of this study was to evaluate the clinical differences in wound complications after total ankle arthroplasty (TAA) between a cohort of patients that received a compression wrap protocol and a historical control group treated with cast immobilization. Patient charts and postoperative wound pictures were reviewed for 42 patients who underwent a compression wrap protocol and 50 patients who underwent circumferential casting after primary TAA from 2008 to 2013. A blinded reviewer graded each wound using a novel postoperative wound classification system, and recorded whether the wound was completely healed by or after 3 months. A second blinded review was performed to determine intraobserver reliability. Mean patient age was 55 years (range, 24-80) and all patients had at least 6-month follow-up. There were significantly more total wound complications (P = .02) and mild wound complications (P = .02) in the casted group compared to the compression wrap group. There were no significant differences in the number of moderate and severe complications between each group. A significantly higher proportion of TAA incisions took longer than 3 months to heal in the casted group (P = .02). Based on our clinical experience with postoperative wound care after TAA, use of a compression wrap protocol was safe and effective at reducing wound-related complications, and well tolerated by patients. Further prospective, randomized clinical trials are warranted to evaluate the utility and cost-effectiveness of a compression wrap protocol after TAA. © The Author(s) 2015.

Private randomness expansion with untrusted devices

NASA Astrophysics Data System (ADS)

Colbeck, Roger; Kent, Adrian

2011-03-01

Randomness is an important resource for many applications, from gambling to secure communication. However, guaranteeing that the output from a candidate random source could not have been predicted by an outside party is a challenging task, and many supposedly random sources used today provide no such guarantee. Quantum solutions to this problem exist, for example a device which internally sends a photon through a beamsplitter and observes on which side it emerges, but, presently, such solutions require the user to trust the internal workings of the device. Here, we seek to go beyond this limitation by asking whether randomness can be generated using untrusted devices—even ones created by an adversarial agent—while providing a guarantee that no outside party (including the agent) can predict it. Since this is easily seen to be impossible unless the user has an initially private random string, the task we investigate here is private randomness expansion. We introduce a protocol for private randomness expansion with untrusted devices which is designed to take as input an initially private random string and produce as output a longer private random string. We point out that private randomness expansion protocols are generally vulnerable to attacks that can render the initial string partially insecure, even though that string is used only inside a secure laboratory; our protocol is designed to remove this previously unconsidered vulnerability by privacy amplification. We also discuss extensions of our protocol designed to generate an arbitrarily long random string from a finite initially private random string. The security of these protocols against the most general attacks is left as an open question.

Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial.

PubMed

Rühle, Annika; Oehme, Florian; Börnert, Katja; Fourie, Lana; Babst, Reto; Link, Björn-Christian; Metzger, Jürg; Beeres, Frank Jp

2017-05-01

Skin abscesses are a frequent encountered health care problem and lead to a significant source of morbidity. They consequently have an essential impact on the quality of life and work. To date, the type of aftercare for surgically drained abscesses remains under debate. This leads to undesirable practice variations. Many clinical standard protocols include sterile wound dressings twice a day by a home-care service to reduce the chance of a recurrent wound infection. It is unknown, however, whether reinfection rates are comparable to adequate wound irrigation with a nonsterile solution performed by the patient. Our hypothesis is that simple wound irrigation with nonsterile water for postoperative wound care after an abscess is surgically drained is feasible. We assume that in terms of reinfection and reintervention rates unsterile wound irrigation is equal to sterile wound irrigation. The primary aim of this study is therefore to investigate if there is a need for sterile wound irrigation after surgically drained spontaneous skin abscesses. In a prospective, randomized controlled, single-blinded, single-center trial based on a noninferiority design, we will enroll 128 patients randomized to either the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a sterile wound irrigation performed by a home-care service twice a day. Patients randomized to the intervention group will be treated with a nonsterile wound irrigation (shower) twice a day. All patients will have a routine clinical control visit after 1, 3, 6, and 12 weeks in the outpatient clinic. Primary outcome is the reinfection and reoperation rate due to insufficient wound healing diagnosed either at the outpatient control visit or during general practitioner visits. Secondary outcome measures include a Short Form Health Survey, Visual Analog Scale, Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the EurolQol 5-Dimension Questionnaire. Those questionnaires will be completed at the outpatient control visits. The trial was started in June 2016 and enrolled 50 patients by article publication. Regarding the adherence to our protocol, we found 10% of loss to follow-up until now. Only 2 patients needed reoperation and only 1 patient needed a change of treatment (antiseptic therapy). Most patients are happy with their randomized treatment but as expected some patients in the sterile group complained about timing problems with their working hours and home-care service appointments. Most patients in the nonsterile group are satisfied being able to take care of their wounds independently although some patients still depend on the home-care service for the wound dressing. We are hoping to have enrolled enough patients by summer 2017. The follow-up will take until autumn 2017, and study results are expected to be published by the end of 2017. This trial is solely supported by the cantonal hospital of Lucerne. Nonsterile wound irrigation is more likely to be carried out independently by the patient than sterile wound irrigation. Therefore, if nonsterile wound care shows comparable results in terms of reinfection and reintervention rates, patient independence in the aftercare of surgically drained abscesses will increase, patients can return to work earlier, and health care costs can be reduced. In a preliminary, conservative estimation of health care costs, an annual savings of 300,000 CHF will be achieved in our hospital. German Clinical Trials Register DRKS00010418; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010418 (Archived by WebCite at http://www.webcitation.org/6q0AXp5EX). ©Annika Rühle, Florian Oehme, Katja Börnert, Lana Fourie, Reto Babst, Björn-Christian Link, Jürg Metzger, Frank JP Beeres. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.05.2017.

Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial.

PubMed

Morin, Charles M; Edinger, Jack D; Krystal, Andrew D; Buysse, Daniel J; Beaulieu-Bonneau, Simon; Ivers, Hans

2016-03-03

Chronic insomnia is a prevalent disorder associated with significant psychosocial, health, and economic impacts. Cognitive behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported therapeutic approaches for insomnia management. However, few investigations have directly compared their relative and combined benefits, and even fewer have tested the benefits of sequential treatment for those who do not respond to initial insomnia therapy. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose, and fixed-agent pharmacotherapy strategies that do not represent usual clinical practices. This study will address these limitations. This is a two-site randomized controlled trial, which will enroll 224 adults who meet the criteria for a chronic insomnia disorder with or without comorbid psychiatric disorders. Prospective participants will complete clinical assessments and polysomnography and then will be randomly assigned to first-stage therapy involving either behavioral therapy (BT) or zolpidem. Treatment outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered randomization to a second, 6-week treatment, again involving either pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy (CT)). All participants will be re-evaluated 12 weeks after the protocol initiation and at 3-, 6-, 9-, and 12-month follow-ups. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, a patient-reported outcome, will serve as the primary endpoint for treatment comparisons. Secondary outcomes will include sleep parameters derived from daily sleep diaries and from polysomnography, subjective measures of fatigue, mood, quality of life, and functional impairments; and measures of adverse events; dropout rates; and treatment acceptability. Centrally trained therapists will administer therapies according to manualized, albeit flexible, treatment algorithms. This clinical trial will provide new information about optimal treatment sequencing and will have direct implication for the development of clinical guidelines for managing chronic insomnia with and without comorbid psychiatric conditions. ClinicalTrials.gov Identifier: NCT01651442 , Protocol version 4, 20 April 2011, registered 26 June 2012.

Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial.

PubMed

Stevanovic, Ana; Rossaint, Rolf; Keszei, András P; Fritz, Harald; Fröba, Gebhard; Pühringer, Friedrich; Coburn, Mark

2015-07-26

The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol. A total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale. Despite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery. EudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.

Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients.

PubMed

Chang, Andrew K; Bijur, Polly E; Davitt, Michelle; Gallagher, E John

2013-09-01

Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain. This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, 'Do you want more pain medication?' Patients in the hydromorphone titration group who answered 'yes' received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered 'yes' had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome. 83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ≤ 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone. Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.

Western Trauma Association Critical Decisions in Trauma: Management of rib fractures.

PubMed

Brasel, Karen J; Moore, Ernest E; Albrecht, Roxie A; deMoya, Marc; Schreiber, Martin; Karmy-Jones, Riyad; Rowell, Susan; Namias, Nicholas; Cohen, Mitchell; Shatz, David V; Biffl, Walter L

2017-01-01

This is a recommended management algorithm from the Western Trauma Association addressing the management of adult patients with rib fractures. Because there is a paucity of published prospective randomized clinical trials that have generated Class I data, these recommendations are based primarily on published observational studies and expert opinion of Western Trauma Association members. The algorithm and accompanying comments represent a safe and sensible approach that can be followed at most trauma centers. We recognize that there will be patient, personnel, institutional, and situational factors that may warrant or require deviation from the recommended algorithm. We encourage institutions to use this as a guideline to develop their own local protocols.

Intrapartum amnioinfusion for meconium-stained fluid: meta-analysis of prospective clinical trials.

PubMed

Pierce, J; Gaudier, F L; Sanchez-Ramos, L

2000-06-01

To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0. 46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.

A Prospective Randomized Controlled Trial of Nonpharmacological Pain Management During Intravenous Cannulation in a Pediatric Emergency Department.

PubMed

Miller, Kate; Tan, Xianghong; Hobson, Andrew Dillon; Khan, Asaduzzaman; Ziviani, Jenny; OʼBrien, Eavan; Barua, Kim; McBride, Craig A; Kimble, Roy M

2016-07-01

Intravenous (IV) cannulation is commonly performed in pediatric emergency departments (EDs). The busy ED environment is often not conducive to conventional nonpharmacological pain management. This study assessed the use of Ditto (Diversionary Therapy Technologies, Brisbane, Australia), a handheld electronic device which provides procedural preparation and distraction, as a means of managing pain and distress during IV cannulation performed in the pediatric ED. A randomized controlled trial with 98 participants, aged 3 to 12 years, was conducted in a pediatric ED. Participants were recruited and randomized into 5 intervention groups as follows: (1) Standard Distraction, (2) PlayStation Portable Distraction, (3) Ditto Distraction, (4) Ditto Procedural Preparation, and (5) Ditto Preparation and Distraction. Children's pain and distress levels were assessed via self-reports and observational reports by caregivers and nursing staff across the following 3 time points: (1) before, (2) during, and (3) after IV cannulation. Caregivers and nursing staff reported significantly reduced pain and distress levels in children accessing the combined preparation and distraction Ditto protocol, as compared to standard distraction (P ≤ 0.01). This intervention also saw the greatest reduction in pain and distress as reported by the child. Caregiver reports indicate that using the combined Ditto protocol was most effective in reducing children's pain experiences while undergoing IV cannulation in the ED. The use of Ditto offers a promising opportunity to negotiate barriers to the provision of nonpharmacological approaches encountered in the busy ED environment, and provide nonpharmacological pain-management interventions in pediatric EDs.

Detecting Random, Partially Random, and Nonrandom Minnesota Multiphasic Personality Inventory-2 Protocols

ERIC Educational Resources Information Center

Pinsoneault, Terry B.

2007-01-01

The ability of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2; J. N. Butcher et al., 2001) validity scales to detect random, partially random, and nonrandom MMPI-2 protocols was investigated. Investigations included the Variable Response Inconsistency scale (VRIN), F, several potentially useful new F and VRIN subscales, and F-sub(b) - F…

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

Megahertz-Rate Semi-Device-Independent Quantum Random Number Generators Based on Unambiguous State Discrimination

NASA Astrophysics Data System (ADS)

Brask, Jonatan Bohr; Martin, Anthony; Esposito, William; Houlmann, Raphael; Bowles, Joseph; Zbinden, Hugo; Brunner, Nicolas

2017-05-01

An approach to quantum random number generation based on unambiguous quantum state discrimination is developed. We consider a prepare-and-measure protocol, where two nonorthogonal quantum states can be prepared, and a measurement device aims at unambiguously discriminating between them. Because the states are nonorthogonal, this necessarily leads to a minimal rate of inconclusive events whose occurrence must be genuinely random and which provide the randomness source that we exploit. Our protocol is semi-device-independent in the sense that the output entropy can be lower bounded based on experimental data and a few general assumptions about the setup alone. It is also practically relevant, which we demonstrate by realizing a simple optical implementation, achieving rates of 16.5 Mbits /s . Combining ease of implementation, a high rate, and a real-time entropy estimation, our protocol represents a promising approach intermediate between fully device-independent protocols and commercial quantum random number generators.

Importance of Standardized DXA Protocol for Assessing Physique Changes in Athletes.

PubMed

Nana, Alisa; Slater, Gary J; Hopkins, Will G; Halson, Shona L; Martin, David T; West, Nicholas P; Burke, Louise M

2016-06-01

The implications of undertaking DXA scans using best practice protocols (subjects fasted and rested) or a less precise but more practical protocol in assessing chronic changes in body composition following training and a specialized recovery technique were investigated. Twenty-one male cyclists completed an overload training program, in which they were randomized to four sessions per week of either cold water immersion therapy or control groups. Whole-body DXA scans were undertaken with best practice protocol (Best) or random activity protocol (Random) at baseline, after 3 weeks of overload training, and after a 2-week taper. Magnitudes of changes in total, lean and fat mass from baseline-overload, overload-taper and baseline-taper were assessed by standardization (Δmean/SD). The standard deviations of change scores for total and fat-free soft tissue mass (FFST) from Random scans (2-3%) were approximately double those observed in the Best (1-2%), owing to extra random errors associated with Random scans at baseline. There was little difference in change scores for fat mass. The effect of cold water immersion therapy on baseline-taper changes in FFST was possibly harmful (-0.7%; 90% confidence limits ±1.2%) with Best scans but unclear with Random scans (0.9%; ±2.0%). Both protocols gave similar possibly harmful effects of cold water immersion therapy on changes in fat mass (6.9%; ±13.5% and 5.5%; ±14.3%, respectively). An interesting effect of cold water immersion therapy on training-induced changes in body composition might have been missed with a less precise scanning protocol. DXA scans should be undertaken with Best.

An eCK-Secure Authenticated Key Exchange Protocol without Random Oracles

NASA Astrophysics Data System (ADS)

Moriyama, Daisuke; Okamoto, Tatsuaki

This paper presents a (PKI-based) two-pass authenticated key exchange (AKE) protocol that is secure in the extended Canetti-Krawczyk (eCK) security model. The security of the proposed protocol is proven without random oracles (under three assumptions), and relies on no implementation techniques such as a trick by LaMacchia, Lauter and Mityagin (so-called the NAXOS trick). Since an AKE protocol that is eCK-secure under a NAXOS-like implementation trick will be no more eCK-secure if some realistic information leakage occurs through side-channel attacks, it has been an important open problem how to realize an eCK-secure AKE protocol without using the NAXOS tricks (and without random oracles).

MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial.

PubMed

Hanser, Thomas; Doliveux, Romain

The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible. Using a randomized protocol, bone blocks were harvested with the MicroSaw and Piezosurgery either from the right or the left side. Clinical outcome parameters were the comparison of osteotomy time; volume of block graft; and clinical determination of intraoperative complications such as hemorrhage, nerve injury, pain, swelling, and healing of the donor site. The mean osteotomy time for harvesting including luxating a bone block was 5.63 (± 1.37) minutes using the MicroSaw and 16.47 (± 2.74) minutes using Piezosurgery (P < .05). A mean graft volume of 1.62 (± 0.27) cm 3 was measured with the MicroSaw and 1.26 (± 0.27) cm 3 with the piezoelectric surgical device (P < .05). No heavy bleeding at the donor site occurred in any of the cases. Complications due to injury of adjacent teeth or nerve lesion of the mandibular nerve were not observed in any cases. According to a scale, there was little postoperative pain with both instruments, and it decreased within 14 days postoperatively (P > .05). Swelling did not appear significantly different either (P > .05), and none of the donor sites showed primary healing complications. The data described in this randomized prospective split-mouth clinical trial indicate that the MicroSaw and Piezosurgery allowed efficient and safe bone block harvesting from the external oblique ridge. Clinically, concerning harvesting time and volume of the grafts, the MicroSaw performed significantly better, whereas pain, swelling, and healing did not appear to be considerably different. Given the improved visibility, precise cut geometries, and the margin of safety afforded by the MicroSaw and Piezosurgery, they are both instruments of choice when harvesting bone from the retromolar area.

Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

PubMed

Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

2016-03-01

Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P < 0.0001). No significant difference in striae width was observed between the treated or control quadrants. Global assessment by the physician who performed the treatment and by the patient both showed greater improved with the combination treatment compared to control areas (P = 0.004 and P = 0.01, respectively). A more homogeneous interlacing pattern and thicker collagen fibers with a decreased proportion of elastic fibers was observed after treatment. Fractional bipolar radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and mature striae of the abdomen. © 2016 Wiley Periodicals, Inc.

Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

PubMed Central

Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

2015-01-01

Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of Adaptation and Study Protocol

PubMed Central

Lee, Christina S.; Colby, Suzanne M.; Magill, Molly; Almeida, Joanna; Tavares, Tonya; Rohsenow, Damaris J.

2016-01-01

Background The NIH Strategic Plan prioritizes health disparities research for socially disadvantaged Hispanics, to reduce the disproportionate burden of alcohol-related negative consequences compared to other racial/ethnic groups. Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the lack of rigorous clinical trials designed to test the efficacy and theoretical underpinnings of cultural adaptation has made proof of concept difficult. Objective The CAMI2 (Culturally Adapted Motivational Interviewing) study design and its theoretical model, is described to illustrate how MI adapted to social and cultural factors (CAMI) can be discriminated against non-adapted MI. Methods and Design CAMI2, a large, 12 month randomized prospective trial, examines the efficacy of CAMI and MI among heavy drinking Hispanics recruited from the community (n=257). Outcomes are reductions in heavy drinking days (Time Line Follow-Back) and negative consequences of drinking among Hispanics (Drinkers Inventory of Consequences). A second aim examines perceived acculturation stress as a moderator of treatment outcomes in the CAMI condition. Summary The CAMI2 study design protocol is presented and the theory of adaptation is presented. Findings from the trial described may yield important recommendations on the science of cultural adaptation and improve MI dissemination to Hispanics with alcohol risk. PMID:27565832

Realistic noise-tolerant randomness amplification using finite number of devices.

PubMed

Brandão, Fernando G S L; Ramanathan, Ravishankar; Grudka, Andrzej; Horodecki, Karol; Horodecki, Michał; Horodecki, Paweł; Szarek, Tomasz; Wojewódka, Hanna

2016-04-21

Randomness is a fundamental concept, with implications from security of modern data systems, to fundamental laws of nature and even the philosophy of science. Randomness is called certified if it describes events that cannot be pre-determined by an external adversary. It is known that weak certified randomness can be amplified to nearly ideal randomness using quantum-mechanical systems. However, so far, it was unclear whether randomness amplification is a realistic task, as the existing proposals either do not tolerate noise or require an unbounded number of different devices. Here we provide an error-tolerant protocol using a finite number of devices for amplifying arbitrary weak randomness into nearly perfect random bits, which are secure against a no-signalling adversary. The correctness of the protocol is assessed by violating a Bell inequality, with the degree of violation determining the noise tolerance threshold. An experimental realization of the protocol is within reach of current technology.

Realistic noise-tolerant randomness amplification using finite number of devices

NASA Astrophysics Data System (ADS)

Brandão, Fernando G. S. L.; Ramanathan, Ravishankar; Grudka, Andrzej; Horodecki, Karol; Horodecki, Michał; Horodecki, Paweł; Szarek, Tomasz; Wojewódka, Hanna

2016-04-01

Randomness is a fundamental concept, with implications from security of modern data systems, to fundamental laws of nature and even the philosophy of science. Randomness is called certified if it describes events that cannot be pre-determined by an external adversary. It is known that weak certified randomness can be amplified to nearly ideal randomness using quantum-mechanical systems. However, so far, it was unclear whether randomness amplification is a realistic task, as the existing proposals either do not tolerate noise or require an unbounded number of different devices. Here we provide an error-tolerant protocol using a finite number of devices for amplifying arbitrary weak randomness into nearly perfect random bits, which are secure against a no-signalling adversary. The correctness of the protocol is assessed by violating a Bell inequality, with the degree of violation determining the noise tolerance threshold. An experimental realization of the protocol is within reach of current technology.

Realistic noise-tolerant randomness amplification using finite number of devices

PubMed Central

Brandão, Fernando G. S. L.; Ramanathan, Ravishankar; Grudka, Andrzej; Horodecki, Karol; Horodecki, Michał; Horodecki, Paweł; Szarek, Tomasz; Wojewódka, Hanna

2016-01-01

Randomness is a fundamental concept, with implications from security of modern data systems, to fundamental laws of nature and even the philosophy of science. Randomness is called certified if it describes events that cannot be pre-determined by an external adversary. It is known that weak certified randomness can be amplified to nearly ideal randomness using quantum-mechanical systems. However, so far, it was unclear whether randomness amplification is a realistic task, as the existing proposals either do not tolerate noise or require an unbounded number of different devices. Here we provide an error-tolerant protocol using a finite number of devices for amplifying arbitrary weak randomness into nearly perfect random bits, which are secure against a no-signalling adversary. The correctness of the protocol is assessed by violating a Bell inequality, with the degree of violation determining the noise tolerance threshold. An experimental realization of the protocol is within reach of current technology. PMID:27098302

Process and Outcome of Fecal Microbiota Transplants in Patients With Recurrent Clostridium difficile Infection: A Prospective Study.

PubMed

Walton, Janice; Burns, Denise; Gaehle, Kay E

The incidence of Clostridium difficile infection is on the rise worldwide, causing high mortality rates and costing patients, hospitals, and insurance companies millions of dollars annually. Fecal microbiota transplants successfully treat recurrent C. difficile infections unresponsive to standard pharmacologic treatment such as flagyl, vancomycin, or rifaximin. Evidence in the literature provided the foundation for the development and refinement of this fecal microbiota transplant protocol. During the initial phase of the project, the protocol included patient selection criteria, donor screening/selection, infection control, fecal processing and delivery, and patient pre and postprocedure education. This article highlights the second phase of prospective testing of a nurse-driven protocol to implement fecal microbiota transplantation in patients with recurrent C. difficile infection. All stages of the protocol are explained as well as rationale for component parts to achieve successful patient outcomes when the protocol is carefully followed.

Open versus percutaneous repair in the treatment of acute Achilles tendon rupture: a randomized prospective study.

PubMed

Gigante, A; Moschini, A; Verdenelli, A; Del Torto, M; Ulisse, S; de Palma, L

2008-02-01

There is no agreement on the ideal type of surgical management for Achilles tendon rupture. The present randomized prospective study was performed to compare outcome data of open and percutaneous repair in the treatment of Achilles tendon rupture. Forty consecutive patients with acute rupture of Achilles tendon were recruited. Patients were randomized to receive open (group A) or percutaneous repair with Tenolig (group B). All patients followed the same rehabilitation protocol except for slight differences in the duration of immobilization. Follow-up included objective evaluation (at 4 and 12 months), subjective evaluation using the SF-12 questionnaire (at 24 months), and bilateral ultrasound scanning and isokinetic testing (at 12 months). The differences in the parameters evaluated clinically were not significant except for ankle circumference, which was significantly greater in group B. There were two minor complications in the open repair group and one case of failed repair in the percutaneous group. SF-12 questionnaire, ultrasound and isokinetic test data did not show significant differences between the groups. The present study demonstrates that the open and the percutaneous technique are both safe and effective in repairing the ruptured Achilles tendon and that both afford the same degree of restoration of clinical, ultrasound and isokinetic patterns. Medium-term results were substantially comparable. Percutaneous repair is performed on a day-surgery basis, it reduces cutaneous complications and operation times, and enables faster recovery, enhancing overall patient compliance. To us, these characteristics make it preferable to open repair in managing subcutaneous ruptures of Achilles tendon in non-professional sports practicing adults.

Role of patient information handouts following operative treatment of ankle fractures: a prospective randomized study.

PubMed

Mayich, D Joshua; Tieszer, Christina; Lawendy, Abdel; McCormick, William; Sanders, David

2013-01-01

Widespread evidence exists for directed patient information interventions (eg, pamphlets) in the setting of several orthopaedic conditions and interventions. Up until now, no study had assessed the role of these interventions in the management of patients following ankle fractures. Between 2005 and 2007, 40 patients who suffered an operative ankle fracture were randomized to either a standard treatment group for an ankle fracture or an enhanced information group who received an American Academy of Orthopaedic Surgeons ankle fracture information pamphlet that explained postoperative routine at our institution and a physiotherapy handout depicting a standard protocol. Study participants were followed for 3 months clinically and radiographically. At the 6-week and 3-month intervals, study participants completed the Olerud-Molander Questionnaire and 2 questions regarding their level of satisfaction. The primary outcome measure was the Likert-scale-based survey question determining the level of satisfaction with the treating staff. Participants in the enhanced information group were more satisfied with treatment at 3 months (9.2 vs 6.3; P < .001). There were significant improvements in work/activity ability at 6 weeks (P = .01), but this advantage disappeared at 3 months (P = .24). No differences in postoperative complication rates were noted. Information enhancement in the form of pamphlets can be helpful in providing patients with accessible information in the postoperative period. While they do not seem to have a sustained impact on postoperative outcomes, handouts may enhance the interaction between staff and patient at postoperative visits, improving patient satisfaction. Level I, appropriately powered randomized prospective cohort study.

Reperfusion injury protection during Basic Life Support improves circulation and survival outcomes in a porcine model of prolonged cardiac arrest.

PubMed

Debaty, Guillaume; Lurie, Keith; Metzger, Anja; Lick, Michael; Bartos, Jason A; Rees, Jennifer N; McKnite, Scott; Puertas, Laura; Pepe, Paul; Fowler, Raymond; Yannopoulos, Demetris

2016-08-01

Ischemic postconditioning (PC) using three intentional pauses at the start of cardiopulmonary resuscitation (CPR) improves outcomes after cardiac arrest in pigs when epinephrine (epi) is used before defibrillation. We hypothesized PC, performed during basic life support (BLS) in the absence of epinephrine, would reduce reperfusion injury and enhance 24h functional recovery. Prospective animal investigation. Animal laboratory Female farm pigs (n=46, 39±1kg). Protocol A: After 12min of ventricular fibrillation (VF), 28 pigs were randomized to four groups: (A) Standard CPR (SCPR), (B) active compression-decompression CPR with an impedance threshold device (ACD-ITD), (C) SCPR+PC (SCPR+PC) and (D) ACD-ITD CPR+PC. Protocol B: After 15min of VF, 18 pigs were randomized to ACD-ITD CPR or ACD-ITD+PC. The BLS duration was 2.75min in Protocol A and 5min in Protocol B. Following BLS, up to three shocks were delivered. Without return of spontaneous circulation (ROSC), CPR was resumed and epi (0.5mg) and defibrillation delivered. The primary end point was survival without major adverse events. Hemodynamic parameters and left ventricular ejection fraction (LVEF) were also measured. Data are presented as mean±SEM. Protocol A: ACD-ITD+PC (group D) improved coronary perfusion pressure after 3min of BLS versus the three other groups (28±6, 35±7, 23±5 and 47±7 for groups A, B, C, D respectively, p=0.05). There were no significant differences in 24h survival between groups. LVEF 4h post ROSC was significantly higher with ACD-ITD+PC vs ACD-ITD alone (52.5±3% vs. 37.5±6.6%, p=0.045). Survival rates were significantly higher with ACD-ITD+PC vs. ACD-ITD alone (p=0.027). BLS using ACD-ITD+PC reduced post resuscitation cardiac dysfunction and improved functional recovery after prolonged untreated VF in pigs. 12-11. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Might digital drains speed up the time to thoracic drain removal?

PubMed

Afoke, Jonathan; Tan, Carol; Hunt, Ian; Zakkar, Mustafa

2014-07-01

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was: might digital drains speed up the time to thoracic drain removal in terms of time till chest drain removal, hospital stay and overall cost? A total of 296 papers were identified as a result of the search as described below. Of these, five papers provided the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of the papers are tabulated. A literature search revealed that several single-centre prospective randomized studies have shown significantly earlier removal of chest drains with digital drains ranging between 0.8 and 2.1 days sooner. However, there was heterogeneity in studies in the management protocol of chest drains in terms of the use of suction, number of drains and assessment for drain removal. Some protocols such as routinely keeping drains irrespective of the presence of air leak or drain output may have skewed results. Differences in exclusion criteria and protocols for discharging home with portable devices may have biased results. Due to heterogeneity in the management protocol of chest drains, there is conflicting evidence regarding hospital stay. The limited data on cost suggest that there may be significantly lower postoperative costs in the digital drain group. All the studies were single-centre series generally including patients with good preoperative lung function tests. Further larger studies with more robust chest drain management protocols are required especially to assess length of hospital stay, cost and whether the results are applicable to a larger patient population. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Automatic control of pressure support for ventilator weaning in surgical intensive care patients.

PubMed

Schädler, Dirk; Engel, Christoph; Elke, Gunnar; Pulletz, Sven; Haake, Nils; Frerichs, Inéz; Zick, Günther; Scholz, Jens; Weiler, Norbert

2012-03-15

Despite its ability to reduce overall ventilation time, protocol-guided weaning from mechanical ventilation is not routinely used in daily clinical practice. Clinical implementation of weaning protocols could be facilitated by integration of knowledge-based, closed-loop controlled protocols into respirators. To determine whether automated weaning decreases overall ventilation time compared with weaning based on a standardized written protocol in an unselected surgical patient population. In this prospective controlled trial patients ventilated for longer than 9 hours were randomly allocated to receive either weaning with automatic control of pressure support ventilation (automated-weaning group) or weaning based on a standardized written protocol (control group) using the same ventilation mode. The primary end point of the study was overall ventilation time. Overall ventilation time (median [25th and 75th percentile]) did not significantly differ between the automated-weaning (31 [19-101] h; n = 150) and control groups (39 [20-118] h; n = 150; P = 0.178). Patients who underwent cardiac surgery (n = 132) exhibited significantly shorter overall ventilation times in the automated-weaning (24 [18-57] h) than in the control group (35 [20-93] h; P = 0.035). The automated-weaning group exhibited shorter ventilation times until the first spontaneous breathing trial (1 [0-15] vs. 9 [1-51] h; P = 0.001) and a trend toward fewer tracheostomies (17 vs. 28; P = 0.075). Overall ventilation times did not significantly differ between weaning using automatic control of pressure support ventilation and weaning based on a standardized written protocol. Patients after cardiac surgery may benefit from automated weaning. Implementation of additional control variables besides the level of pressure support may further improve automated-weaning systems. Clinical trial registered with www.clinicaltrials.gov (NCT 00445289).

Interrater reliability among epilepsy centers: multicenter study of epilepsy surgery.

PubMed

Haut, Sheryl R; Berg, Anne T; Shinnar, Shlomo; Cohen, Hillel W; Bazil, Carl W; Sperling, Michael R; Langfitt, John T; Pacia, Steven V; Walczak, Thaddeus S; Spencer, Susan S

2002-11-01

To measure the interrater reliability of presurgical testing and surgical decisions among epilepsy centers. Seven centers participating in an ongoing, prospective multicenter study of resective epilepsy surgery agreed to conform to a detailed protocol regarding presurgical evaluation and surgery. To assess quality assurance, each center independently reviewed 21 randomly selected surgical cases for preoperative study lateralization and localization, and surgical decisions. Interrater reliability was assessed by using intraclass correlation coefficients (ICCs), validated for use with multiple raters, and calculated in a two-way random model based on absolute agreement. Agreement for ICC values: > or = 0.75, excellent; 0.60-0.74, good; 0.40-0.59, fair; < or = 0.39, poor. One center was excluded for missing data. Agreement was excellent for extracranial EEG lateralization (0.8039), magnetic resonance imaging (MRI) lateralization (0.9521) and localization (0.9130), Wada lateralization (0.9453), and intracranial EEG localization (0.7905). Agreement was good for extracranial EEG localization (0.7384) and neuropsychological testing lateralization (0.7178) and localization (0.6891). Consensus about the decision to perform intracranial monitoring was fair (0.5397), in part reflecting one center's tendency toward intracranial monitoring. Overall agreements on whether to perform surgery (0.8311) and specific surgery recommended (0.8164) were excellent. High interrater reliability among six epilepsy centers was present for interpretation of most components of presurgical testing. Although consensus for the decision to perform intracranial monitoring was only fair, agreements for the ultimate decision about resective surgery and specific choice of resection were excellent. We believe that this study demonstrates the feasibility of implementing multicenter protocols for neurologic management, especially those involving localization, as well as protocols combining study results with clinical decision making.

Evaluation of the Efficacy and Safety of High Dose Short Duration Enrofloxacin Treatment Regimen for Uncomplicated Urinary Tract Infections in Dogs

PubMed Central

Westropp, JL; Sykes, JE; Irom, S; Daniels, JB; Smith, A; Keil, D; Settje, T; Wang, Y; Chew, DJ

2012-01-01

Background Uncomplicated urinary tract infections (UTI) in dogs usually are treated with antimicrobial drugs for 10–14 days. Shorter duration antimicrobial regimens have been evaluated in human patients. Hypothesis A high dose short duration (HDSD) enrofloxacin protocol administered to dogs with uncomplicated UTI will not be inferior to a 14-day treatment regimen with amoxicillin-clavulanic acid. Animals Client-owned adult, otherwise healthy dogs with aerobic bacterial urine culture yielding ≥103 CFU/mL of bacteria after cystocentesis. Methods Prospective, multicenter, controlled, randomized blinded clinical trial. Enrolled dogs were randomized to group 1 (enrofloxacin 18–20 mg/kg PO q24h for 3 days) or group 2 (amoxicillin-clavulanic acid 13.75–25 mg/kg PO q12h for 14 days). Urine cultures were obtained at days 0, 10, and 21. Microbiologic and clinical cure rates were evaluated 7 days after antimicrobial treatment was discontinued. Lower urinary tract signs and adverse events also were recorded. Results There were 35 dogs in group 1 and 33 in group 2. The microbiologic cure rate was 77.1 and 81.2% for groups 1 and 2, respectively. The clinical cure rate was 88.6 and 87.9% for groups 1 and 2, respectively. Cure rates between groups did not differ according to the selected margin of noninferiority. Conclusions and Clinical Importance HDSD enrofloxacin treatment was not inferior to a conventional amoxicillin-clavulanic acid protocol for the treatment of uncomplicated bacterial UTI in dogs. Further research is warranted to determine if this protocol will positively impact owner compliance and decrease the emergence of antimicrobial resistance. PMID:22486931

Scoring System for the Management of Acute Gallstone Pancreatitis: Cost Analysis of a Prospective Study.

PubMed

Prigoff, Jake G; Swain, Gary W; Divino, Celia M

2016-05-01

Predicting the presence of a persistent common bile duct (CBD) stone is a difficult and expensive task. The aim of this study is to determine if a previously described protocol-based scoring system is a cost-effective strategy. The protocol includes all patients with gallstone pancreatitis and stratifies them based on laboratory values and imaging to high, medium, and low likelihood of persistent stones. The patient's stratification then dictates the next course of management. A decision analytic model was developed to compare the costs for patients who followed the protocol versus those that did not. Clinical data model inputs were obtained from a prospective study conducted at The Mount Sinai Medical Center to validate the protocol from Oct 2009 to May 2013. The study included all patients presenting with gallstone pancreatitis regardless of disease severity. Seventy-three patients followed the proposed protocol and 32 did not. The protocol group cost an average of $14,962/patient and the non-protocol group cost $17,138/patient for procedural costs. Mean length of stay for protocol and non-protocol patients was 5.6 and 7.7 days, respectively. The proposed protocol is a cost-effective way to determine the course for patients with gallstone pancreatitis, reducing total procedural costs over 12 %.

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

PubMed Central

LOCHER, JULIE L.; BALES, CONNIE W.; ELLIS, AMY C.; LAWRENCE, JEANNINE C.; NEWTON, LAURA; RITCHIE, CHRISTINE S.; ROTH, DAVID L.; BUYS, DAVID L.; VICKERS, KRISTIN S.

2012-01-01

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article. PMID:22098180

Maximizing shoulder function after accessory nerve injury and neck dissection surgery: A multicenter randomized controlled trial.

PubMed

McGarvey, Aoife C; Hoffman, Gary R; Osmotherly, Peter G; Chiarelli, Pauline E

2015-07-01

Shoulder pain and dysfunction after neck dissection may result from injury to the accessory nerve. The effect of early physical therapy in the form of intensive scapular strengthening exercises is unknown. A total of 59 neck dissection participants were prospectively recruited for this study. Participants were randomly assigned to either the intervention group (n = 32), consisting of progressive scapular strengthening exercises for 12 weeks, or the control group (n = 29). Blinded assessment occurred at baseline, and at 3, 6, and 12 months. Three-month data were collected on 52 participants/53 shoulders. Per-protocol analysis demonstrated that the intervention group had statistically significantly higher active shoulder abduction at 3 months compared to the control group (+26.6°; 95% confidence interval [CI] 7.28-45.95; p = .007). The intervention is a favorable treatment for maximizing shoulder abduction in the short term. The effect of the intervention compared to usual care is uncertain in the longer term. © 2014 Wiley Periodicals, Inc.

Low tube voltage computed tomography urography using low-concentration contrast media: Comparison of image quality in conventional computed tomography urography.

PubMed

Hwang, Inpyeong; Cho, Jeong Yeon; Kim, Sang Youn; Oh, Seung-June; Ku, Ja Hyeon; Lee, Joongyup; Kim, Seung Hyup

2015-12-01

The aim of the present study was to investigate the feasibility and image quality of excretory CT urography performed using low iodine-concentration contrast media and low tube voltage. This prospective study enrolled 63 patients who undergoing CT urography. The subjects were randomized into two groups of an excretory phase CT urography protocol and received either 240 mg I/mL of contrast media and 80 kVp of tube voltage (low-concentration protocol, n=32) or 350 mg I/mL and 120 kVp (conventional protocol, n=31). Two readers qualitatively evaluated images for sharpness of the urinary tract, image noise, streak artifact and overall diagnostic acceptability. The mean attenuation, signal-to-noise ratio, contrast-to-noise ratio and figure of merit were measured in the urinary tract. The non-inferiority test assessed the diagnostic acceptability between the two protocol groups. The low-concentration protocol showed a significantly lower effective radiation dose (3.44 vs. 5.70 mSv, P<.001). The diagnostic acceptability was significantly lower in the low-concentration protocol with iterative reconstruction algorithm than in the conventional protocol (4.06±0.45 vs. 4.50±0.37, P<.001), however, all subjects showed at least more than standard diagnostic acceptability and the difference resided in the predefined non-inferiority margin. The signal-to-noise ratio, contrast-to-noise ratio and figure of merit were significantly higher in the low-concentration protocol along the entire urinary tract (P<.001). CT urography using 240 mg I/mL iodine contrast media, 80 kVp tube voltage and an iterative reconstruction algorithm is beneficial to reduce radiation dose and iodine load, and its objective image quality and subjective diagnostic acceptability is not inferior to that of conventional CT urography. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339.

PubMed

Schapowal, Andreas

2005-06-01

Intermittent allergic rhinitis (IAR) causes patients distress and impairs their work performance and quality of life. A variety of medicines are used by sufferers whose anguish frequently leads to trying new treatments, increasingly from herbal sources. Prospective, randomized, double-blind, parallel group comparison study of Butterbur extract (Ze 339; 8 mg total petasine; one tablet thrice-daily), fexofenadine (Telfast 180, one tablet once-daily) and placebo in 330 patients. Protocol and analysis were according to the latest guidelines on new treatments for allergic rhinitis. The primary efficacy variable was a change in symptoms from baseline to endpoint during daytime. The secondary efficacy variables were: (a) as per primary variable (evening/night); (b) Physician's global assessment; (c) Responder rates. Safety was closely monitored. Both active treatments were individually significantly superior to placebo (p<0.001) in improving symptoms of IAR, while there were no differences between the two active treatments (p=0.37). Superiority to placebo was similarly shown during the evening/night (p<0.001), by physicians' own assessment and by responder rates. Both treatments were well tolerated. Butterbur Ze 339 and Fexofenadine are comparably efficacious relative to placebo. Despite being a herbal drug, Butterbur Ze 339 has now been subject to a series of well controlled trials and should be considered as an alternative treatment for IAR. Copyright (c) 2005 John Wiley & Sons, Ltd.

Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support—Results of a Prospective, Randomized, Comparative Study

PubMed Central

Pirard, Céline; Loumaye, Ernest; Wyns, Christine

2015-01-01

Background. The aim of this pilot study was to evaluate intranasal buserelin for luteal phase support and compare its efficacy with standard vaginal progesterone in IVF/ICSI antagonist cycles. Methods. This is a prospective, randomized, open, parallel group study. Forty patients underwent ovarian hyperstimulation with human menopausal gonadotropin under pituitary inhibition with gonadotropin-releasing hormone antagonist, while ovulation trigger and luteal support were achieved using intranasal GnRH agonist (group A). Twenty patients had their cycle downregulated with buserelin and stimulated with hMG, while ovulation trigger was achieved using 10,000 IU human chorionic gonadotropin with luteal support by intravaginal progesterone (group B). Results. No difference was observed in estradiol levels. Progesterone levels on day 5 were significantly lower in group A. However, significantly higher levels of luteinizing hormone were observed in group A during the entire luteal phase. Pregnancy rates (31.4% versus 22.2%), implantation rates (22% versus 15.4%), and clinical pregnancy rates (25.7% versus 16.7%) were not statistically different between groups, although a trend towards higher rates was observed in group A. No luteal phase lasting less than 10 days was recorded in either group. Conclusion. Intranasal administration of buserelin is effective for providing luteal phase support in IVF/ICSI antagonist protocols. PMID:25945092

Embracing the heart: perioperative management of patients undergoing off-pump coronary artery bypass grafting using the octopus tissue stabilizer.

PubMed

Nierich, A P; Diephuis, J; Jansen, E W; van Dijk, D; Lahpor, J R; Borst, C; Knape, J T

1999-04-01

To describe hemodynamic alterations during coronary artery bypass grafting (CABG) without extracorporeal circulation using the Octopus Tissue Stabilizer, and to describe the two anesthetic management protocols based on either general anesthesia with opioids (34 patients) or general anesthesia with high thoracic epidural anesthesia (TEA; 66 patients). A prospective observational report. An academic university heart center. First 100 patients undergoing CABG using the Octopus Tissue Stabilizer. None. Current management provided satisfactory results in preventing hypoperfusion of the heart and inadequate systemic circulation without the use of major pharmacologic interventions. Movement of the heart to reach the target site of anastomosis caused hemodynamic alterations. These could easily be corrected by anesthetic interventions, such as fluid load and low doses of inotropes. High TEA allows earlier extubation compared with the opioid anesthesia technique (0.9 v 4.5 hours). Perioperative management and the incidence of postoperative complications did not differ between anesthetic techniques. Major complications, such as death, intraoperative myocardial infarction, and stroke, did not occur. Both anesthetic protocols are safe and effective in handling these patients. Off-pump CABG surgery requires anesthetic interventions because hemodynamic alterations are caused by the presentation of the heart to the surgeon. The complication rate is low but needs to be evaluated, compared with conventional CABG, in a prospective randomized study. High thoracic epidural anesthesia allows early recovery, but improved outcome could not be proved in this patient group.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

PubMed

Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

2003-12-01

The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P < 0.0001), and heterogeneous staining (P = 0.137) or no staining (P = 0.005) were associated with dysplasia and/or carcinoma detection. The MBDB technique prolonged the endoscopy examination by an average of 6 min. The diagnostic accuracy of the MBDB technique was superior to that of the random biopsy technique for identifying specialized intestinal metaplasia, but not dysplasia or carcinoma. The intensity of methylene blue staining has an influence on the detection of specialized intestinal metaplasia and dysplasia or carcinoma, which may help in targeting the biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

P-value interpretation and alpha allocation in clinical trials.

PubMed

Moyé, L A

1998-08-01

Although much value has been placed on type I error event probabilities in clinical trials, interpretive difficulties often arise that are directly related to clinical trial complexity. Deviations of the trial execution from its protocol, the presence of multiple treatment arms, and the inclusion of multiple end points complicate the interpretation of an experiment's reported alpha level. The purpose of this manuscript is to formulate the discussion of P values (and power for studies showing no significant differences) on the basis of the event whose relative frequency they represent. Experimental discordance (discrepancies between the protocol's directives and the experiment's execution) is linked to difficulty in alpha and beta interpretation. Mild experimental discordance leads to an acceptable adjustment for alpha or beta, while severe discordance results in their corruption. Finally, guidelines are provided for allocating type I error among a collection of end points in a prospectively designed, randomized controlled clinical trial. When considering secondary end point inclusion in clinical trials, investigators should increase the sample size to preserve the type I error rates at acceptable levels.

Efficacy of Distortion Product Oto-Acoustic Emission (OAE)/Auditory Brainstem Evoked Response (ABR) Protocols in Universal Neonatal Hearing Screening and Detecting Hearing Loss in Children <2 Years of Age.

PubMed

Mishra, Girish; Sharma, Yojana; Mehta, Kanishk; Patel, Gunjan

2013-04-01

Deafness is commonest curable childhood handicap. Most remedies and programmes don't address this issue at childhood level leading to detrimental impact on development of newborns. Aims and objectives are (A) screen all newborns for deafness and detect prevalence of deafness in children less than 2 years of age. and (B) assess efficacy of multi-staged OAE/ABR protocol for hearing screening. Non-randomized, prospective study from August 2008 to August 2011. All infants underwent a series of oto-acoustic emission (OAE) and final confirmatory auditory brainstem evoked response (ABR) audiometry. Finally, out of 1,101 children, 1,069 children passed the test while 12 children had impaired hearing after final testing, confirmed by ABR. Positive predictive value of OAE after multiple test increased to 100 %. OAE-ABR test series is effective in screening neonates and multiple tests reduce economic burden. High risk screening will miss nearly 50 % deaf children, thus universal screening is indispensable in picking early deafness.

Can Radiation Dose Be Reduced and Image Quality Improved With 80-kV and Dual-Phase Scanning of the Lower Extremities With 64-Slice Computed Tomography Angiography?

PubMed

Zhou, Yunfeng; Wang, Juan; Dassarath, Meera; Wang, Minhong; Zhang, Qiang; Xiong, Yuwei; Yuan, Quan

2015-01-01

To prospectively compare the new computed tomographic angiography (CTA) protocol (NCP) using 80-kV and dual-phase scanning with the routine CTA protocol (RCP) using 120-kV and single-phase scanning in patients with peripheral arterial disease. A total of 60 patients were randomized to undergo the NCP (30 patients) or RCP (30 patients) scan. We compared the arterial attenuation values, overriding of the contrast bolus, signal-to-noise ratio, and radiation dose between 2 groups. The occurrence rate of contrast bolus overriding was not statistically significant (P = 0.69). The average arterial attenuation value in the NCP group was significantly higher (P < 0.05) than that in the RCP group. The radiation dose in the RCP group was significantly higher (P < 0.001) than that in the NCP group. The mean signal-to-noise ratio in the NCP group was significantly lower (P < 0.001). Sixty-four-slice CTA with the NCP can significantly reduce the radiation dose and improve the arterial enhancement and calf arteries imaging.

GnRHa to trigger final oocyte maturation: a time to reconsider.

PubMed

Humaidan, P; Papanikolaou, E G; Tarlatzis, B C

2009-10-01

Recently GnRH antagonist protocols for the prevention of a premature LH surge were introduced, allowing final oocyte maturation to be triggered with a single bolus of a GnRH agonist (GnRHa). GnRHa is as effective as hCG for the induction of ovulation, and apart from the LH surge a FSH surge is also induced. Until recently, prospective randomized studies reported a poor clinical outcome when GnRHa was used to trigger final oocyte maturation in IVF/ICSI antagonist protocols, presumably due to a luteal phase deficiency, despite standard luteal phase supplementation with progesterone and estradiol. As GnRHa triggering of final oocyte maturation could possess advantages over hCG triggering in terms of a reduced if not eliminated risk of ovarian hyperstimulation syndrome (OHSS) and the retrieval of more mature oocytes, the challenge has been to rescue the luteal phase. In the literature now several studies report a luteal phase rescue with a reproductive outcome comparable to that of hCG induced final oocyte maturation. Although more research is needed, GnRHa triggering is now a valid alternative with potential benefits.

[Vitamin C+sodium bicarbonate versus sodium bicarbonate alone in preventing contrast-induced nephropathy].

PubMed

Laroussi, L; Triki, M; Ibn Elhaj, Z; Ben Halima, A; Boukhris, M; Ben Amara, W; Keskes, H; Kraiem, S; Lahidheb, D; Marrakchi, S; Kammoun, I; Addad, F; Kachboura, S

2017-09-01

Contrast-induced nephropathy (CIN) is a common and severe complication in interventional cardiology. The aim of our study was to compare the incidence of contrast-induced nephropathy in two accelerated hydration protocols: the first one by the serum bicarbonate and the second combining the serum bicarbonate and oral vitamin C. This is a multicenter prospective, randomized study conducted between October 2012 and May 2013, including 160 patients. The mean age of our study population was 60.8±9.3 years (36-83 years). The two study groups were comparable in terms of cardiovascular risk factors, concomitant medication, and baseline serum creatinine. The CIN incidence was 6.3% in the vitamin C group and 10% in the control group (P=0.38). No significant difference was observed in terms of CIN incidence between the different subgroups analyzed. According to our study, ascorbic acid administered orally as part of an accelerated hydration protocol does not reduce the incidence of CIN. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders.

PubMed

DiLuigi, Andrea J; Engmann, Lawrence; Schmidt, David W; Benadiva, Claudio A; Nulsen, John C

2011-06-30

We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle. Cancellation rates, number of oocytes retrieved, clinical pregnancy rates (PR), and ongoing PRs were similar between the two groups. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

PubMed

Stephenson, Rob; Bonar, Erin E; Carrico, Adam; Hunter, Alexis; Connochie, Daniel; Himmelstein, Rebecca; Bauermeister, Jose

2018-04-30

Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people. This prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing-based substance use brief intervention (SUBI) on participants' substance use and engagement in HIV prevention. The research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR. Project Swerve was launched in April 2017 and enrollment is ongoing. Incorporating a SUBI that utilizes the principles of motivational interviewing into HIV CTR provides an opportunity to tailor counseling services for YMSM and transgender people to address additional client barriers to HIV and STI testing. ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 (Archived by WebCite at http://www.webcitation.org/6yFyOK57w). ©Rob Stephenson, Erin E Bonar, Adam Carrico, Alexis Hunter, Daniel Connochie, Rebecca Himmelstein, Jose Bauermeister. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.04.2018.

Interdisciplinary development and implementation of communication checklist for postoperative management of pediatric airway patients.

PubMed

Kim, Sang W; Maturo, Stephen; Dwyer, Danielle; Monash, Bradley; Yager, Phoebe H; Zanger, Kerstin; Hartnick, Christopher J

2012-01-01

The authors describe their multidisciplinary experience in applying the Institute of Health Improvement methodology to develop a protocol and checklist to reduce communication error during transfer of care for postoperative pediatric surgical airway patients. Preliminary outcome data following implementation of the protocol and checklist are also presented. Prospective study from July 1, 2009, to February 1, 2011. Tertiary care center. Subjects. One hundred twenty-six pediatric airway patients who required coordinated care between Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital. Two sentinel events involving airway emergencies demonstrated a critical need for a standardized, comprehensive instrument that would ensure safe transfer of care. After development and implementation of the protocol and checklist, an initial pilot period on the first set of 9 pediatric airway patients was reassessed. Subsequent prospective 11-month follow-up data of 93 pediatric airway patients were collected and analyzed. A multidisciplinary pediatric team developed and implemented a formalized, postoperative checklist and transfer protocol. After implementation of the checklist and transfer protocol, prospective analysis showed no adverse events from miscommunication during transfer of care over the subsequent 11-month period involving 93 pediatric airway patients. There has been very little written in the quality and safety patient literature about coordinating effective transfer of care between the pediatric surgical and medical subspecialty realms. After design and implementation of a simple, electronically based transfer-of-care checklist and protocol, the number of postsurgical pediatric airway information transfer and communication errors decreased significantly.

Quantum enigma cipher as a generalization of the quantum stream cipher

NASA Astrophysics Data System (ADS)

Kato, Kentaro

2016-09-01

Various types of randomizations for the quantum stream cipher by Y00 protocol have been developed so far. In particular, it must be noted that the analysis of immunity against correlation attacks with a new type of randomization by Hirota and Kurosawa prompted a new look at the quantum stream cipher by Y00 protocol (Quant. Inform. Process. 6(2) 2007). From the preceding study on the quantum stream cipher, we recognized that the quantum stream cipher by Y00 protocol would be able to be generalized to a new type of physical cipher that has potential to exceed the Shannon limit by installing additional randomization mechanisms, in accordance with the law of quantum mechanics. We call this new type of physical random cipher the quantum enigma cipher. In this article, we introduce the recent developments for the quantum stream cipher by Y00 protocol and future plans toward the quantum enigma cipher.

Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome.

PubMed

de Paula Guedes Neto, Ernesto; Savaris, Ricardo Francalacci; von Eye Corleta, Helena; de Moraes, Gisele Silva; do Amaral Cristovam, Rafael; Lessey, Bruce A

2011-09-01

To compare the ovulation rate between raloxifene and clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS). Double-blind, randomized, superiority clinical trial. Tertiary university hospital. Women with ovulatory dysfunction and PCOS based on the Rotterdam criteria. One of two oral treatments: 5 days of 100 mg/day of CC or R. Ovulation, based on follicle collapse on serial ultrasound and midsecretory serum progesterone concentration (≥3 ng/dL). The women with PCOS (n = 82) were randomized to receive CC (n = 40) or raloxifene (n = 42). From these, 68 patients finished the trial according to the protocol (CC: n = 37; raloxifene: n = 31). There were no statistically significant differences between the groups in ovulation rates per an intention-to-treat analysis based on ultrasound alone (CC: 21 of 40 vs. raloxifene: 17 of 42) or on progesterone levels (CC: 16 of 40 vs. raloxifene: 11 of 42). No serious adverse events were observed in either group. No statistically significant difference in ovulation was observed between raloxifene and clomiphene citrate in patients with PCOS with ovulatory dysfunction. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

PubMed

Kim, Gangmi

2015-10-14

Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486 ) on 14 May 2015.

Study Protocol for a Randomized Clinical Trial of a Fatherhood Intervention for African American Non-resident Fathers: Can we Improve Father and Child Outcomes?

PubMed Central

Julion, Wrenetha A.; Sumo, Jen’nea; Bounds, Dawn T.; Breitenstein, Susan M.; Schoeny, Michael; Gross, Deborah; Fogg, Louis

2016-01-01

Purpose African American (AA) fathers who live apart from their children face multiple obstacles to consistent and positive involvement with their children. Consequently, significant numbers of children are bereft of their father’s positive involvement. Intervention research that is explicitly focused on promoting the positive involvement of non-resident AA fathers with their young children is limited. The purpose of this article is to describe the study protocol of a randomized trial (RCT) designed to test the Building Bridges to Fatherhood program against a financial literacy comparison condition; and discuss early implementation challenges. Methods Fathers (n = 180) are recruited to attend 10 group meetings, reimbursed for transportation, given dinner and activity vouchers for spending time with their child, and incentivized with a $40 gift card at each data collection time point. Mothers are incentivized ($40 gift card) at data collection and must be amenable to father child interaction. Intervention targets include father psychological well-being, parenting competence, communication, problem-solving ability; father-mother relationship quality; and child behavioral and emotional/social development. Results To date, 57 fathers have been randomized to study condition. Recruitment has been influenced by father and mother hesitancy and the logistics of reaching and maintaining contact with participants. Strategies to surmount challenges to father and mother recruitment and engagement have been developed. Conclusions The prospective benefits of positive father involvement to children, fathers and families outweigh the challenges associated with community-based intervention research. The findings from this RCT can inform the body of knowledge on engaging AA non-resident fathers in culturally relevant fatherhood programming. PMID:27241687

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

PubMed

Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

2014-09-01

To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

Beyond the hype: deep neural networks outperform established methods using a ChEMBL bioactivity benchmark set.

PubMed

Lenselink, Eelke B; Ten Dijke, Niels; Bongers, Brandon; Papadatos, George; van Vlijmen, Herman W T; Kowalczyk, Wojtek; IJzerman, Adriaan P; van Westen, Gerard J P

2017-08-14

The increase of publicly available bioactivity data in recent years has fueled and catalyzed research in chemogenomics, data mining, and modeling approaches. As a direct result, over the past few years a multitude of different methods have been reported and evaluated, such as target fishing, nearest neighbor similarity-based methods, and Quantitative Structure Activity Relationship (QSAR)-based protocols. However, such studies are typically conducted on different datasets, using different validation strategies, and different metrics. In this study, different methods were compared using one single standardized dataset obtained from ChEMBL, which is made available to the public, using standardized metrics (BEDROC and Matthews Correlation Coefficient). Specifically, the performance of Naïve Bayes, Random Forests, Support Vector Machines, Logistic Regression, and Deep Neural Networks was assessed using QSAR and proteochemometric (PCM) methods. All methods were validated using both a random split validation and a temporal validation, with the latter being a more realistic benchmark of expected prospective execution. Deep Neural Networks are the top performing classifiers, highlighting the added value of Deep Neural Networks over other more conventional methods. Moreover, the best method ('DNN_PCM') performed significantly better at almost one standard deviation higher than the mean performance. Furthermore, Multi-task and PCM implementations were shown to improve performance over single task Deep Neural Networks. Conversely, target prediction performed almost two standard deviations under the mean performance. Random Forests, Support Vector Machines, and Logistic Regression performed around mean performance. Finally, using an ensemble of DNNs, alongside additional tuning, enhanced the relative performance by another 27% (compared with unoptimized 'DNN_PCM'). Here, a standardized set to test and evaluate different machine learning algorithms in the context of multi-task learning is offered by providing the data and the protocols. Graphical Abstract .

Study protocol for a randomized clinical trial of a fatherhood intervention for African American non-resident fathers: Can we improve father and child outcomes?

PubMed

Julion, Wrenetha A; Sumo, Jen'nea; Bounds, Dawn T; Breitenstein, Susan M; Schoeny, Michael; Gross, Deborah; Fogg, Louis

2016-07-01

African American (AA) fathers who live apart from their children face multiple obstacles to consistent and positive involvement with their children. Consequently, significant numbers of children are bereft of their father's positive involvement. Intervention research that is explicitly focused on promoting the positive involvement of non-resident AA fathers with their young children is limited. The purpose of this article is to describe the study protocol of a randomized trial (RCT) designed to test the Building Bridges to Fatherhood program against a financial literacy comparison condition; and discuss early implementation challenges. Fathers (n=180) are recruited to attend 10 group meetings, reimbursed for transportation, given dinner and activity vouchers for spending time with their child, and incentivized with a $40 gift card at each data collection time point. Mothers are incentivized ($40 gift card) at data collection and must be amenable to father child interaction. Intervention targets include father psychological well-being, parenting competence, communication, problem-solving ability; father-mother relationship quality; and child behavioral and emotional/social development. To date, 57 fathers have been randomized to study condition. Recruitment has been influenced by father and mother hesitancy and the logistics of reaching and maintaining contact with participants. Strategies to surmount challenges to father and mother recruitment and engagement have been developed. The prospective benefits of positive father involvement to children, fathers and families outweigh the challenges associated with community-based intervention research. The findings from this RCT can inform the body of knowledge on engaging AA non-resident fathers in culturally relevant fatherhood programming. Copyright © 2016 Elsevier Inc. All rights reserved.

Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols

PubMed Central

2012-01-01

Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home. With funding from the Canadian Partnership Against Cancer, a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocols using a rigorous methodology (CAN-IMPLEMENT©). Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines. Protocols were validated by cancer nurses from across Canada. The aim of this study is to build an effective and sustainable approach for implementing evidence-informed protocols for nurses to use when providing remote symptom assessment, triage, and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments. Methods A prospective mixed-methods study design will be used. Guided by the Knowledge to Action Framework, the study will involve (a) establishing an advisory knowledge user team in each of three targeted settings; (b) assessing factors influencing nurses’ use of protocols using interviews/focus groups and a standardized survey instrument; (c) adapting protocols for local use, ensuring fidelity of the content; (d) selecting intervention strategies to overcome known barriers and implementing the protocols; (e) conducting think-aloud usability testing; (f) evaluating protocol use and outcomes by conducting an audit of 100 randomly selected charts at each of the three settings; and (g) assessing satisfaction with remote support using symptom protocols and change in nurses’ barriers to use using survey instruments. The primary outcome is sustained use of the protocols, defined as use in 75% of the calls. Descriptive analysis will be conducted for the barriers, use of protocols, and chart audit outcomes. Content analysis will be conducted on interviews/focus groups and usability testing with comparisons across settings. Discussion Given the importance of patient safety, patient-centered care, and delivery of quality services, learning how to effectively implement evidence-informed symptom protocols in oncology healthcare services is essential for ensuring safe, consistent, and effective care for individuals with cancer. This study is likely to have a significant contribution to the delivery of remote oncology services, as well as influence symptom management by patients at home. PMID:23164244

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.

PubMed

Fleming, Jennifer; Ownsworth, Tamara; Doig, Emmah; Hutton, Lauren; Griffin, Janelle; Kendall, Melissa; Shum, David H K

2017-01-05

Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies. New Zealand Clinical Trials Registry, ACTRN12615000996561 . Registered on 23 September 2015; retrospectively registered 2 months after commencement.

Partial breast radiation for early-stage breast cancer.

PubMed

McCormick, Beryl

2012-02-01

This review is to provide an update on the current status of partial breast irradiation (PBI) for women presenting with early-stage breast cancer, as an alternate radiation technique to fractionated, whole breast radiation, following conservation surgery. As more women are asking for and receiving this treatment, both on and off protocols, understanding recent additions to the literature is important to physicians caring for this patient population. Newly published retrospective studies, with follow-up times out to 10 years and the status of both recently completed and still open large prospective phase III trials will be covered, with emphasis on unexpected side effects reported, and some hypothesis-generating radiobiology observations. A recent consensus treatment guideline for PBI use is also discussed. Selected retrospective studies continue to report outcomes matching those achieved with whole breast radiation; however, results from large prospective randomized trials comparing PBI to whole breast radiation have been reported only with short follow-up times, or in two studies, are still pending. A recent consensus guideline is useful at present in selecting patients for discussion of this treatment.

Milder is better? advantages and disadvantages of "mild" ovarian stimulation for human in vitro fertilization

PubMed Central

2011-01-01

In the last decades, several steps have been made aiming at rendering human IVF more successful on one side, more tolerable on the other side. The "mild" ovarian stimulation approach, in which a lower-than-average dose of exogenous gonadotropins is given and gonadotropin treatment is started from day 2 to 7 of the cycle, represents a significant step toward a more patient's friendly IVF. However, a clear view of its virtues and defects is still lacking, because only a few prospective randomized trials comparing "mild" vs. conventional stimulation exist, and they do not consider some important aspects, such as, e.g., thawing cycles. This review gives a complete panorama of the "mild" stimulation philosophy, showing its advantages vs. conventional ovarian stimulation, but also discussing its disadvantages. Both patients with a normal ovarian responsiveness to exogenous gonadotropins and women with a poor ovarian reserve are considered. Overall, we conclude that the level of evidence supporting the use of "mild" stimulation protocols is still rather poor, and further, properly powered prospective studies about "mild" treatment regimens are required. PMID:21324155

Effects of repetitive or intensified instructions in telephone assisted, bystander cardiopulmonary resuscitation: an investigator-blinded, 4-armed, randomized, factorial simulation trial.

PubMed

van Tulder, R; Roth, D; Krammel, M; Laggner, R; Heidinger, B; Kienbacher, C; Novosad, H; Chwojka, C; Havel, C; Sterz, F; Schreiber, W; Herkner, H

2014-01-01

Compression depth is frequently suboptimal in cardiopulmonary resuscitation (CPR). We investigated effects of intensified wording and/or repetitive target depth instructions on compression depth in telephone-assisted, protocol driven, bystander CPR on a simulation manikin. Thirty-two volunteers performed 10 min of compression only-CPR in a prospective, investigator-blinded, 4-armed, factorial setting. Participants were randomized either to standard wording ("push down firmly 5 cm"), intensified wording ("it is very important to push down 5 cm every time") or standard or intensified wording repeated every 20s. Three dispatchers were randomized to give these instructions. Primary outcome was relative compression depth (absolute compression depth minus leaning depth). Secondary outcomes were absolute distance, hands-off times as well as BORG-scale and nine-hole peg test (NHPT), pulse rate and blood pressure to reflect physical exertion. We applied a random effects linear regression model. Relative compression depth was 35 ± 10 mm (standard) versus 31 ± 11 mm (intensified wording) versus 25 ± 8 mm (repeated standard) and 31 ± 14 mm (repeated intensified wording). Adjusted for design, body mass index and female sex, intensified wording and repetition led to decreased compression depth of 13 (95%CI -25 to -1) mm (p=0.04) and 9 (95%CI -21 to 3) mm (p=0.13), respectively. Secondary outcomes regarding intensified wording showed significant differences for absolute distance (43 ± 2 versus 20 (95%CI 3-37) mm; p=0.01) and hands-off times (60 ± 40 versus 157 (95%CI 63-251) s; p=0.04). In protocol driven, telephone-assisted, bystander CPR, intensified wording and/or repetitive target depth instruction will not improve compression depth compared to the standard instruction. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study.

PubMed

Gysan, Detlef Bernd; Millentrup, Stefanie; Albus, Christian; Bjarnason-Wehrens, Birna; Latsch, Joachim; Gohlke, Helmut; Herold, Gerd; Wegscheider, Karl; Heming, Christian; Seyfarth, Melchior; Predel, Hans-Georg

2017-09-01

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees ( n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

PubMed

Ali, Ather; Kahn, Janet; Rosenberger, Lisa; Perlman, Adam I

2012-10-04

Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Clinicaltrials.gov NCT00970008 (18 August 2009).

A multicentre evaluation of two intensive care unit triage protocols for use in an influenza pandemic.

PubMed

Cheung, Winston K; Myburgh, John; Seppelt, Ian M; Parr, Michael J; Blackwell, Nikki; Demonte, Shannon; Gandhi, Kalpesh; Hoyling, Larissa; Nair, Priya; Passer, Melissa; Reynolds, Claire; Saunders, Nicholas M; Saxena, Manoj K; Thanakrishnan, Govindasamy

2012-08-06

To determine the increase in intensive care unit (ICU) bed availability that would result from the use of the New South Wales and Ontario Health Plan for an Influenza Pandemic (OHPIP) triage protocols. Prospective evaluation study conducted in eight Australian, adult, general ICUs, between September 2009 and May 2010. All patients who were admitted to the ICU, excluding those who had elective surgery, were prospectively evaluated using the two triage protocols, simulating a pandemic situation. Both protocols were originally developed to determine which patients should be excluded from accessing ICU resources during an influenza pandemic. Increase in ICU bed availability. At admission, the increases in ICU bed availability using Tiers 1, 2 and 3 of the NSW triage protocol were 3.5%, 14.7% and 22.7%, respectively, and 52.8% using the OHPIP triage protocol (P < 0.001). Re-evaluation of patients at 12 hours after admission using Tiers 1, 2 and 3 of the NSW triage protocol incrementally increased ICU bed availability by 19.2%, 16.1% and 14.1%, respectively (P < 0.001). The maximal cumulative increases in ICU bed availability using Tiers 1, 2 and 3 of the NSW triage protocol were 23.7%, 31.6% and 37.5%, respectively, at 72 hours (P < 0.001), and 65.0% using the OHPIP triage protocol, at 120 hours (P < 0.001). Both triage protocols resulted in increases in ICU bed availability, but the OHPIP protocol provided the greatest increase overall. With the NSW triage protocol, ICU bed availability increased as the protocol was escalated.

Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

PubMed

Boussi-Gross, Rahav; Golan, Haim; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: a randomized, open-blinded, prospective study.

PubMed

Guerra, Federico; Pavoni, Ilaria; Romandini, Andrea; Baldetti, Luca; Matassini, Maria Vittoria; Brambatti, Michela; Luzi, Mario; Pupita, Giuseppe; Capucci, Alessandro

2014-10-20

Sedation with propofol should be administered by personnel trained in advanced airway management. To overcome this limitation, the use of short acting benzodiazepines by cardiologists spread widely, causing concerns about the safety of this procedure in the absence of anesthesiology assistance. The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion (DCC) of persistent atrial fibrillation (AF). This prospective, open-blinded, randomized study included 204 patients, which were admitted for scheduled cardioversion of persistent AF, and randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the propofol group underwent DCC with anesthesiologist assistance, while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC. Twenty-three adverse events occurred: 13 in the propofol group and 10 in the midazolam group (p=NS). Most of them were related to bradyarrhythmias and respiratory depressions. There was no need of intubation or other advanced resuscitation techniques in any of these patients. No differences were found regarding procedure tolerability and safety endpoints between the two groups. DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs. Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance. Adverse events were few in both groups and easily handled by the cardiologist alone. A cardiologist-only approach to sedation provides less procedural delay, thus being easier to schedule and correlated with fewer costs. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Intravenous parecoxib and continuous femoral block for postoperative analgesia after total knee arthroplasty. A randomized, double-blind, prospective trial.

PubMed

Sarridou, Despoina G; Chalmouki, Georgia; Braoudaki, Maria; Koutsoupaki, Anna; Mela, Argiro; Vadalouka, Athina

2015-01-01

Up until now, the optimal strategy for postoperative pain management after total knee arthroplasty (TKA) remains to be elucidated. The current investigation aimed to examine the analgesic efficacy and the opioid sparing effects of intravenous parecoxib in combination with continuous femoral blockade. Randomized, double-blind, prospective trial. University hospital in the United Kingdom. In total, 90 patients underwent TKA under subarachnoid anesthesia and received continuous femoral block initially as a bolus with 20 mL of ropivacaine 0.75%. Infusion of 0.2% on 10 mL/h followed. Patients were randomized into 2 groups. Group D and Group P received parecoxib and placebo, respectively at 12 hour time intervals. Visual analog scale (VAS) pain scores were obtained at different time intervals including 4, 8, 12, 24 and 36 hours. The pain scores were measured with patients in a resting position. Morphine could also be administered with a patient controlled analgesia (PCA) pump if the specified analgesia was deemed inadequate (VAS > 5). None of the patients were withdrawn from the study. Parecoxib provided greater relief than placebo following TKA. The VAS pain scores measured at rest were statistically significantly lower in parecoxib-treated patients compared to the placebo group (P = 0.007) at 4 (P = 0.044), 12 (P = 0.001), and 24 hours (P = 0.012), postoperatively. Patients receiving parecoxib consumed less morphine at all time intervals than patients receiving placebo, with borderline statistical significance (P = 0.054). In each time period, all patients receiving continuous femoral block irrespectively of the treatment group, required low morphine doses. Current protocol did not answer question as to functional recovery. According to our findings intravenous parecoxib in combination with continuous femoral block provided superior analgesic efficacy and opioid sparing effects in patients undergoing TKA.

Diagnostic accuracy of 256-row multidetector CT coronary angiography with prospective ECG-gating combined with fourth-generation iterative reconstruction algorithm in the assessment of coronary artery bypass: evaluation of dose reduction and image quality.

PubMed

Ippolito, Davide; Fior, Davide; Franzesi, Cammillo Talei; Riva, Luca; Casiraghi, Alessandra; Sironi, Sandro

2017-12-01

Effective radiation dose in coronary CT angiography (CTCA) for coronary artery bypass graft (CABG) evaluation is remarkably high because of long scan lengths. Prospective electrocardiographic gating with iterative reconstruction can reduce effective radiation dose. To evaluate the diagnostic performance of low-kV CT angiography protocol with prospective ecg-gating technique and iterative reconstruction (IR) algorithm in follow-up of CABG patients compared with standard retrospective protocol. Seventy-four non-obese patients with known coronary disease treated with artery bypass grafting were prospectively enrolled. All the patients underwent 256 MDCT (Brilliance iCT, Philips) CTCA using low-dose protocol (100 kV; 800 mAs; rotation time: 0.275 s) combined with prospective ECG-triggering acquisition and fourth-generation IR technique (iDose 4 ; Philips); all the lengths of the bypass graft were included in the evaluation. A control group of 42 similar patients was evaluated with a standard retrospective ECG-gated CTCA (100 kV; 800 mAs).On both CT examinations, ROIs were placed to calculate standard deviation of pixel values and intra-vessel density. Diagnostic quality was also evaluated using a 4-point quality scale. Despite the statistically significant reduction of radiation dose evaluated with DLP (study group mean DLP: 274 mGy cm; control group mean DLP: 1224 mGy cm; P value < 0.001). No statistical differences were found between PGA group and RGH group regarding intra-vessel density absolute values and SNR. Qualitative analysis, evaluated by two radiologists in "double blind", did not reveal any significant difference in diagnostic quality of the two groups. The development of high-speed MDCT scans combined with modern IR allows an accurate evaluation of CABG with prospective ECG-gating protocols in a single breath hold, obtaining a significant reduction in radiation dose.

A prospective gating method to acquire a diverse set of free-breathing CT images for model-based 4DCT

NASA Astrophysics Data System (ADS)

O'Connell, D.; Ruan, D.; Thomas, D. H.; Dou, T. H.; Lewis, J. H.; Santhanam, A.; Lee, P.; Low, D. A.

2018-02-01

Breathing motion modeling requires observation of tissues at sufficiently distinct respiratory states for proper 4D characterization. This work proposes a method to improve sampling of the breathing cycle with limited imaging dose. We designed and tested a prospective free-breathing acquisition protocol with a simulation using datasets from five patients imaged with a model-based 4DCT technique. Each dataset contained 25 free-breathing fast helical CT scans with simultaneous breathing surrogate measurements. Tissue displacements were measured using deformable image registration. A correspondence model related tissue displacement to the surrogate. Model residual was computed by comparing predicted displacements to image registration results. To determine a stopping criteria for the prospective protocol, i.e. when the breathing cycle had been sufficiently sampled, subsets of N scans where 5  ⩽  N  ⩽  9 were used to fit reduced models for each patient. A previously published metric was employed to describe the phase coverage, or ‘spread’, of the respiratory trajectories of each subset. Minimum phase coverage necessary to achieve mean model residual within 0.5 mm of the full 25-scan model was determined and used as the stopping criteria. Using the patient breathing traces, a prospective acquisition protocol was simulated. In all patients, phase coverage greater than the threshold necessary for model accuracy within 0.5 mm of the 25 scan model was achieved in six or fewer scans. The prospectively selected respiratory trajectories ranked in the (97.5  ±  4.2)th percentile among subsets of the originally sampled scans on average. Simulation results suggest that the proposed prospective method provides an effective means to sample the breathing cycle with limited free-breathing scans. One application of the method is to reduce the imaging dose of a previously published model-based 4DCT protocol to 25% of its original value while achieving mean model residual within 0.5 mm.

Comparison of ozone gas and sodium hypochlorite/chlorhexidine two-visit disinfection protocols in treating apical periodontitis: a randomized controlled clinical trial.

PubMed

Kist, Stefan; Kollmuss, Maximilian; Jung, Jette; Schubert, Sören; Hickel, Reinhard; Huth, Karin Christine

2017-05-01

In this single-blinded, prospective, randomized, controlled clinical trial, the effectiveness of an ozone gas or NaOCl/CHX disinfection protocol was compared within the root canal treatment of apical periodontitis. Sixty permanent teeth were randomly allocated to one technique. The clinical/radiographic assessment criteria included clinical symptoms, periapical index (PAI), and size of the apical lesion. In both groups, the root canal was mechanically cleaned and irrigated with NaCl and EDTA. Ozone gas (32 g m -3 ) or NaOCl (3 %) was applied followed by a 1-week inter-appointment dressing (Ca(OH) 2 ). As final disinfection, ozone gas (ozone group) or CHX 2 % (NaOCl group) was applied. Microbial samples were taken after preparing the access cavity, after chemo-mechanical treatment and after inter-appointment dressing by sterile paper points. Microbial identification was performed by mass spectroscopy (MALDI-TOF-MS) and 16S-rRNA gene sequencing. The treated teeth were blindly re-evaluated after 6/12 months. Success rates, the decrease in PAI, the size of apical lesions and bacterial reduction were compared between groups (Fischer's exact test, Mann-Whitney U test). There were no significant differences between the success rates (ozone group: 96.2/95.5 % after 6/12 months; NaOCl group: 95.5/95.2 % after 6/12 months). The differences in the decreases in PAI values and apical lesion sizes were also insignificant after 6 and 12 months. The bacterial reduction showed no significant differences between groups after chemo-mechanical treatment and after inter-appointment dressing. The most commonly found bacterial genera were Streptococcus spp., Parvimonas spp. and Prevotella spp. The here used ozone gas and NaOCl/CHX protocols showed no difference in bacterial reduction in the sampled areas of the root canals. Within the limitations of the study, ozone gas seems to be a possible alternative disinfection agent within the root canal treatment of apical periodontitis.

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de). PMID:24884848

First intention IVF protocol for polycystic ovaries: does oral contraceptive pill pretreatment influence COH outcome?

PubMed

Decanter, Christine; Robin, Geoffroy; Thomas, Patricia; Leroy, Maryse; Lefebvre, Catherine; Soudan, Benoit; Lefebvre-Khalil, Valerie; Leroy-Martin, Brigitte; Dewailly, Didier

2013-06-19

Morphological aspect of polycystic ovaries (PCO) is a very common finding in an IVF center population: this includes PCOS patients identified in 18-25% of the couples presenting with infertility and so called "sonographic PCO only" the prevalence of which has been estimated as high as 33% in asymptomatic patients. Finding the optimal first intention IVF protocol for polycystic ovaries patients is still challenging in order to improve the controlled ovarian hyperstimulation (COH) outcome while avoiding ovarian hyperstimulation syndrome (OHSS). It has been suggested that women with PCO would benefit from a longer period of pituitary down-regulation. The purpose of this study was to compare an extended duration of OCP pretreatment with a classic GnRH agonist protocol. A single center prospective non-randomized study was performed from January 2009 to December 2010 in the Lille University Hospital including 113 women diagnosed with PCO(S) according to the Rotterdam ultrasonographic criteria and undergoing their first IVF attempt. Comprehensive hormonal and ultra-sonographic assessments were collected during COH in these patients. LH and androgen suppression and dynamics of follicular growth were compared between the two protocols as well as the COH outcome in terms of oocyte/embryo number and quality, implantation and pregnancy rates. No significant difference was observed between the two groups concerning dynamics of follicular growth and hormonal values. Clinical and ongoing pregnancy rates were significantly lower in the OCP group despite same oocyte and embryo quality. Nevertheless, the cumulative pregnancy rate did not differ between the two groups. The incidence of OHSS was not statistically significant. Extended duration of OCP pretreatment, as a first intention IVF protocol for PCO patients, does not improve the pattern of follicular growth nor the oocyte and embryo quality.

Short-Term Health-Related Quality of Life of Critically Ill Children Following Daily Sedation Interruption.

PubMed

Vet, Nienke J; de Wildt, Saskia N; Verlaat, Carin W M; Mooij, Miriam G; Tibboel, Dick; de Hoog, Matthijs; Buysse, Corinne M P

2016-11-01

Our earlier pediatric daily sedation interruption trial showed that daily sedation interruption in addition to protocolized sedation in critically ill children does not reduce duration of mechanical ventilation, length of stay, or amounts of sedative drugs administered when compared with protocolized sedation only, but undersedation was more frequent in the daily sedation interruption + protocolized sedation group. We now report the preplanned analysis comparing short-term health-related quality of life and posttraumatic stress symptoms between the two groups. Preplanned prospective part of a randomized controlled trial. Two tertiary medical-surgical PICUs in the Netherlands. Critically ill children requiring mechanical ventilation. None. Eight weeks after a child's discharge from the PICU, health-related quality of life was assessed with the validated Child Health Questionnaire and, only for children above 4 years old, posttraumatic stress was assessed with the Dutch Children's Responses to Trauma Inventory. Additionally, health-related quality of life of all study patients was compared with Dutch normative data. Of the 113 patients from two participating centers in the original study, 96 patients were eligible for follow-up and 64 patients were included (response rate, 67%). No difference was found with respect to health-related quality of life between the two study groups. None of the eight children more than 4 years old showed posttraumatic stress symptoms. Daily sedation interruption in addition to protocolized sedation for critically ill children did not seem to have an effect on short-term health-related quality of life. Also in view of the earlier found absence of effect on clinical outcome, we cannot recommend the use of daily sedation interruption + protocolized sedation.

Nonsurgical Strategies in Patients With NET Liver Metastases: A Protocol of Four Systematic Reviews.

PubMed

Limani, Perparim; Tschuor, Christoph; Gort, Laura; Balmer, Bettina; Gu, Alexander; Ceresa, Christos; Raptis, Dimitri Aristotle; Lesurtel, Mickael; Puhan, Milo; Breitenstein, Stefan

2014-03-07

Patients diagnosed with neuroendocrine tumors (NETs) with hepatic metastases generally have a worse prognosis as compared with patients with nonmetastasized NETs. Due to tumor location and distant metastases, a surgical approach is often not possible and nonsurgical therapeutic strategies may apply. The aim of these systematic reviews is to evaluate the role of nonsurgical therapy options for patients with nonresectable liver metastases of NETs. An objective group of librarians will provide an electronic search strategy to examine the MEDLINE, EMBASE, and The Cochrane Library (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials [CENTRAL]) databases. There will be no restriction concerning language and publication date. The qualitative and quantitative synthesis of the systematic review will be conducted with randomized controlled trials (RCT), prospective, and retrospective comparative cohort, and case-control studies. Case series will be collected in a separate database and only used for descriptive purposes. This study is ongoing and presents a protocol of four systematic reviews to assess the role of nonsurgical treatment options in patients with neuroendocrine liver metastases. These systematic reviews, performed according to this protocol, will assess the value of noninvasive therapy options for patients with nonresectable liver metastases of NETs in combination with invasive techniques, such as percutaneous liver-directed techniques and local ablation techniques. International Prospective Register of Systematic Reviews (PROSPERO): CRD42012002657; http://www.metaxis.com/PROSPERO/full_doc.asp?RecordID=2657 (Archived by WebCite at http://www.webcitation.org/6NDlYi37O); CRD42012002658; http://www.metaxis.com/PROSPERO/full_doc.asp?RecordID=2658 (Archived by WebCite at http://www.webcitation.org/6NDlfWSuD); CRD42012002659; www.metaxis.com/PROSPERO/full_doc.asp?RecordID=2659 (Arichived by Webcite at http://www.webcitation.org/6NDlmWAFM); and CRD42012002660; http://www.metaxis.com/PROSPERO/full_doc.asp?RecordID=2660 (Archived by WebCite at http://www.webcitation.org/6NDmnylzp).

A police education programme to integrate occupational safety and HIV prevention: protocol for a modified stepped-wedge study design with parallel prospective cohorts to assess behavioural outcomes

PubMed Central

Strathdee, Steffanie A; Arredondo, Jaime; Rocha, Teresita; Abramovitz, Daniela; Rolon, Maria Luisa; Patiño Mandujano, Efrain; Rangel, Maria Gudelia; Olivarria, Horcasitas Omar; Gaines, Tommi; Patterson, Thomas L; Beletsky, Leo

2015-01-01

Introduction Policing practices are key drivers of HIV among people who inject drugs (PWID). This paper describes the protocol for the first study to prospectively examine the impact of a police education programme (PEP) to align law enforcement and HIV prevention. PEPs incorporating HIV prevention (including harm reduction programmes like syringe exchange) have been successfully piloted in several countries but were limited to brief pre–post assessments; the impact of PEPs on policing behaviours and occupational safety is unknown. Objectives Proyecto ESCUDO (SHIELD) aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID, adverse behaviours that interfere with HIV prevention and protective behaviours (secondary outcomes). Methods/analysis ESCUDO is a hybrid type I design that simultaneously tests an intervention and an implementation strategy. Using a modified stepped-wedge design involving all active duty street-level police officers in Tijuana (N=∼1200), we will administer one 3 h PEP course to groups of 20–50 officers until the entire force is trained. NSI incidence and geocoded arrest data will be assessed from department-wide de-identified data. Of the consenting police officers, a subcohort (N=500) will be randomly sampled from each class to undergo pre-PEP and post-PEP surveys with a semiannual follow-up for 2 years to assess self-reported NSIs, attitudes and behaviour changes. The impact on PWIDs will be externally validated through a parallel cohort of Tijuana PWIDs. Ethics/dissemination Research ethics approval was obtained from the USA and Mexico. Findings will be disseminated through open access to protocol materials through the Law Enforcement and HIV Network. Trial registration number NCT02444403. PMID:26260350

Multi-institutional, prospective, observational study comparing the Gastrografin challenge versus standard treatment in adhesive small bowel obstruction.

PubMed

Zielinski, Martin D; Haddad, Nadeem N; Cullinane, Daniel C; Inaba, Kenji; Yeh, Dante D; Wydo, Salina; Turay, David; Pakula, Andrea; Duane, Therese M; Watras, Jill; Widom, Kenneth A; Cull, John; Rodriguez, Carlos J; Toschlog, Eric A; Sams, Valerie G; Hazelton, Joshua P; Graybill, John Christopher; Skinner, Ruby; Yune, Ji-Ming

2017-07-01

Existing trials studying the use of Gastrografin for management of adhesive small bowel obstruction (SBO) are limited by methodological flaws and small sample sizes. We compared institutional protocols with and without Gastrografin (GG), hypothesizing that a SBO management protocol utilizing GG is associated with lesser rates of exploration, shorter length of stay, and fewer complications. A multi-institutional, prospective, observational study was performed on patients appropriate for GG with adhesive SBO. Exclusion criteria were internal/external hernia, signs of strangulation, history of abdominal/pelvic malignancy, or exploration within the past 6 weeks. Patients receiving GG were compared to patients receiving standard care without GG. Overall, 316 patients were included (58 ± 18 years; 53% male). There were 173 (55%) patients in the GG group (of whom 118 [75%] successfully passed) and 143 patients in the non-GG group. There were no differences in duration of obstipation (1.6 vs. 1.9 days, p = 0.77) or small bowel feces sign (32.9% vs. 25.0%, p = 0.14). Fewer patients in the GG protocol cohort had mesenteric edema on CT (16.3% vs. 29.9%; p = 0.009). There was a lower rate of bowel resection (6.9% vs. 21.0%, p < 0.001) and exploration rate in the GG group (20.8% vs. 44.1%, p < 0.0001). GG patients had a shorter duration of hospital stay (4 IQR 2-7 vs. 5 days IQR 2-12; p = 0.036) and a similar rate of complications (12.5% vs. 17.9%; p = 0.20). Multivariable analysis revealed that GG was independently associated with successful nonoperative management. Patients receiving Gastrografin for adhesive SBO had lower rates of exploration and shorter hospital length of stay compared to patients who did not receive GG. Adequately powered and well-designed randomized trials are required to confirm these findings and establish causality. Therapeutic, level III.

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

PubMed Central

2013-01-01

Background Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. Methods/Design This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. Discussion This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. Trial registration NCT01695850 PMID:24180235

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial.

PubMed

Zhong, Linda L D; Cheng, Chung Wah; Chan, Yawen; Chan, King Hong; Lam, Ting Wa; Chen, Xiao Rui; Wong, Chi Tak; Wu, Justin C Y; Bian, Zhao Xiang

2013-11-04

Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. NCT01695850.

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

Random placenta margin incision for control hemorrhage during cesarean delivery complicated by complete placenta previa: a prospective cohort study.

PubMed

Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Wang, Lijuan; Fu, Yao; Zeng, Meng; Liu, Yan; Guo, Xiaoling; Liu, Zhengping

2018-04-03

Complete placenta previa (CPP) is one of the most problematic types of abnormal placenta, which is further complicated by placenta accreta or percreta that can unexpectedly lead to catastrophic blood loss, infection, multiple complications, emergency hysterectomy, and even death. The present study aimed to assess the efficacy of random placenta margin incision in controlling intraoperative and total blood loss during cesarean section for CPP women. A prospective cohort study, including a total of 100 consecutive pregnant women with CPP, was performed at a tertiary university-affiliated medical center between March 2016 and July 2017. All of them underwent random placenta margin incision, and intraoperative and total blood loss were analyzed. Through antenatal diagnosis using color Doppler, women were further divided into abnormally invasive placenta (AIP) and non-AIP groups, and anterior and posterior placenta groups. The protocol was registered with the Clinical Trial Registry under registration number NCT02695069. Mean maternal age and gestational age at delivery were 32.26 ± 5.03 years old and 36.21 ± 2.07 weeks, respectively. Total duration of the surgical procedure time was 52.50 (42.43-64.00) min. Median estimated intraoperation blood loss was 746.43 (544.44-1092.86) ml. Total blood loss was 875.00 (604.50-1196.67) ml, and 38 (38.0%) had post-partum hemorrhage. The change from baseline in the median hemoglobin level was -0.33 (6.00-13.20). No women underwent hysterectomy due to massive hemorrhage during the study period. No women had an intraoperative urinary bladder injury, postoperative wound infection, and required relaparotomy, owing to intra-abdominal bleeding. The median hospitalization time was 5.41 (4.18-7.58) d. The random placenta margin incision may be a potentially valuable surgical procedure to control the volumes of intraoperative and postoperative blood loss and reduce the incidence of postpartum hemorrhage among women with complete placenta previa.

Low-Contrast and Low-Radiation Dose Protocol in Cardiac Computed Tomography: Usefulness of Low Tube Voltage and Knowledge-Based Iterative Model Reconstruction Algorithm.

PubMed

Iyama, Yuji; Nakaura, Takeshi; Yokoyama, Koichi; Kidoh, Masafumi; Harada, Kazunori; Oda, Seitaro; Tokuyasu, Shinichi; Yamashita, Yasuyuki

This study aimed to evaluate the feasibility of a low contrast, low-radiation dose protocol of 80-peak kilovoltage (kVp) with prospective electrocardiography-gated cardiac computed tomography (CT) using knowledge-based iterative model reconstruction (IMR). Thirty patients underwent an 80-kVp prospective electrocardiography-gated cardiac CT with low-contrast agent (222-mg iodine per kilogram of body weight) dose. We also enrolled 30 consecutive patients who were scanned with a 120-kVp cardiac CT with filtered back projection using the standard contrast agent dose (370-mg iodine per kilogram of body weight) as a historical control group. We evaluated the radiation dose for the 2 groups. The 80-kVp images were reconstructed with filtered back projection (protocol A), hybrid iterative reconstruction (HIR, protocol B), and IMR (protocol C). We compared CT numbers, image noise, and contrast-to-noise ratio among 120-kVp protocol, protocol A, protocol B, and protocol C. In addition, we compared the noise reduction rate between HIR and IMR. Two independent readers compared image contrast, image noise, image sharpness, unfamiliar image texture, and overall image quality among the 4 protocols. The estimated effective dose (ED) of the 80-kVp protocol was 74% lower than that of the 120-kVp protocol (1.4 vs 5.4 mSv). The contrast-to-noise ratio of protocol C was significantly higher than that of protocol A. The noise reduction rate of IMR was significantly higher than that of HIR (P < 0.01). There was no significant difference in almost all qualitative image quality between 120-kVp protocol and protocol C except for image contrast. A 80-kVp protocol with IMR yields higher image quality with 74% decreased radiation dose and 40% decreased contrast agent dose as compared with a 120-kVp protocol, while decreasing more image noise compared with the 80-kVp protocol with HIR.

The UAE healthy future study: a pilot for a prospective cohort study of 20,000 United Arab Emirates nationals.

PubMed

Abdulle, Abdishakur; Alnaeemi, Abdullah; Aljunaibi, Abdullah; Al Ali, Abdulrahman; Al Saedi, Khaled; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Loney, Tom; El-Sadig, Mohamed; Oulhaj, Abderrahim; Wareth, Leila Abdel; Al Mahmeed, Wael; Alsafar, Habiba; Hirsch, Benjamin; Al Anouti, Fatme; Yaaqoub, Jamila; Inman, Claire K; Al Hamiz, Aisha; Al Hosani, Ayesha; Haji, Muna; Alsharid, Teeb; Al Zaabi, Thekra; Al Maisary, Fatima; Galani, Divya; Sprosen, Tim; El Shahawy, Omar; Ahn, Jiyoung; Kirchhoff, Tomas; Ramasamy, Ravichandran; Schmidt, Ann Marie; Hayes, Richard; Sherman, Scott; Ali, Raghib

2018-01-05

The United Arab Emirates (UAE) is faced with a rapidly increasing burden of non-communicable diseases including obesity, diabetes, and cardiovascular disease. The UAE Healthy Future study is a prospective cohort designed to identify associations between risk factors and these diseases amongst Emiratis. The study will enroll 20,000 UAE nationals aged ≥18 years. Environmental and genetic risk factors will be characterized and participants will be followed for future disease events. As this was the first time a prospective cohort study was being planned in the UAE, a pilot study was conducted in 2015 with the primary aim of establishing the feasibility of conducting the study. Other objectives were to evaluate the implementation of the main study protocols, and to build adequate capacity to conduct advanced clinical laboratory analyses. Seven hundred sixty nine UAE nationals aged ≥18 years were invited to participate voluntarily in the pilot study. Participants signed an informed consent, completed a detailed questionnaire, provided random blood, urine, and mouthwash samples and were assessed for a series of clinical measures. All specimens were transported to the New York University Abu Dhabi laboratories where samples were processed and analyzed for routine chemistry and hematology. Plasma, serum, and a small whole blood sample for DNA extraction were aliquoted and stored at -80 °C for future analyses. Overall, 517 Emirati men and women agreed to participate (68% response rate). Of the total participants, 495 (95.0%), 430 (82.2%), and 492 (94.4%), completed the questionnaire, physical measurements, and provided biological samples, respectively. The pilot study demonstrated the feasibility of recruitment and completion of the study protocols for the first large-scale cohort study designed to identify emerging risk factors for the major non-communicable diseases in the region.

Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

PubMed

Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

2017-07-01

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and European Academy of Andrology.

Prevention of sternal wound complications after sternotomy: results of a large prospective randomized multicentre trial†

PubMed Central

Gorlitzer, Michael; Wagner, Florian; Pfeiffer, Steffen; Folkmann, Sandra; Meinhart, Johann; Fischlein, Theodor; Reichenspurner, Hermann; Grabenwoeger, Martin

2013-01-01

OBJECTIVES A prospective randomized multicentre trial was performed to analyse the efficacy of a vest (Posthorax support vest®) to prevent sternal wound infection after cardiac surgery, and to identify risk factors. METHODS From September 2007 to March 2010, 2539 patients undergoing cardiac surgery via median sternotomy were prospectively randomized into those who received a Posthorax® vest and those who did not. Patients were instructed to wear the vest postoperatively for 24 h a day for at least 6 weeks; the duration of follow-up was 90 days. Patients who did not use the vest within a period of 72 h postoperatively were regarded as study dropouts. Statistical calculations were based on an intention-to-treat (ITT) analysis. Further evaluations comprised all subgroups of patients. RESULTS Complete data were available for 2539 patients (age 67 ± 11years, 45% female). Of these, 1351 were randomized to receive a vest, while 1188 received no vest. No significant differences were observed between groups regarding age, gender, diabetes, body mass index, chronic obstructive pulmonary disease (COPD), renal failure, the logistic EuroSCORE and the indication for surgery. The frequency of deep wound complications (dWC: mediastinitis and sternal dehiscence) was significantly lower in vest (n = 14; 1.04%) vs non-vest (n = 27; 2.27%) patients (ITT, P < 0.01), but superficial complications did not differ between groups. Subanalysis of vest patients revealed that only 933 (Group A) wore the vest according to the protocol, while 202 (Group BR) refused to wear the vest (non-compliance) and 216 (Group BN) did not use the vest for other reasons. All dWC occurred in Groups BR (n = 7) and BN (n = 7), although these groups had the same preoperative risk profile as Group A. Postoperatively, Group BN had a prolonged intubation time, a longer stay in the intensive care unit, greater use of intra-aortic balloon pump, higher frequency of COPD and a larger percentage of patients who required prolonged surgery. CONCLUSIONS Consistent use of the Posthorax® vest prevented deep sternal wounds. The anticipated risk factors for wound complications did not prove to be relevant, whereas intra- and postoperative complications appear to be very significant. PMID:23760221

Effect of joint mobilization techniques for primary total knee arthroplasty: Study protocol for a randomized controlled trial.

PubMed

Xu, Jiao; Zhang, Juan; Wang, Xue-Qiang; Wang, Xuan-Lin; Wu, Ya; Chen, Chan-Cheng; Zhang, Han-Yu; Zhang, Zhi-Wan; Fan, Kai-Yi; Zhu, Qiang; Deng, Zhi-Wei

2017-12-01

Total knee arthroplasty (TKA) has become the most preferred procedure by patients for the relief of pain caused by knee osteoarthritis. TKA patients aim a speedy recovery after the surgery. Joint mobilization techniques for rehabilitation have been widely used to relieve pain and improve joint mobility. However, relevant randomized controlled trials showing the curative effect of these techniques remain lacking to date. Accordingly, this study aims to investigate whether joint mobilization techniques are valid for primary TKA. We will manage a single-blind, prospective, randomized, controlled trial of 120 patients with unilateral TKA. Patients will be randomized into an intervention group, a physical modality therapy group, and a usual care group. The intervention group will undergo joint mobilization manipulation treatment once a day and regular training twice a day for a month. The physical modality therapy group will undergo physical therapy once a day and regular training twice a day for a month. The usual care group will perform regular training twice a day for a month. Primary outcome measures will be based on the visual analog scale, the knee joint Hospital for Special Surgery score, range of motion, surrounded degree, and adverse effect. Secondary indicators will include manual muscle testing, 36-Item Short Form Health Survey, Berg Balance Scale function evaluation, Pittsburgh Sleep Quality Index, proprioception, and muscle morphology. We will direct intention-to-treat analysis if a subject withdraws from the trial. The important features of this trial for joint mobilization techniques in primary TKA are randomization procedures, single-blind, large sample size, and standardized protocol. This study aims to investigate whether joint mobilization techniques are effective for early TKA patients. The result of this study may serve as a guide for TKA patients, medical personnel, and healthcare decision makers. It has been registered at http://www.chictr.org.cn/showproj.aspx?proj=15262 (Identifier:ChiCTR-IOR-16009192), Registered 11 September 2016. We also could provide the correct URL of the online registry in the WHO Trial Registration. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IOR-16009192.

MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

PubMed

Benyamin, Ramsin M; Staats, Peter S

2015-01-01

Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients.

Comparison of two melphalan protocols and evaluation of outcome and prognostic factors in multiple myeloma in dogs

PubMed Central

Fernández, Ricardo

2018-01-01

Background Multiple myeloma (MM) in dogs typically is treated with melphalan. A daily melphalan dosing schedule reportedly is well tolerated and associated with favorable outcome. Although anecdotally a pulse dose regimen has resulted in successful responses, little long‐term outcome and safety data is available regarding this dosing regimen for dogs with MM. Hypothesis/objectives (1) To compare outcome and adverse event profiles between pulse dose and daily dose melphalan schedules and (2) to report prognostic factors in dogs with MM treated with melphalan. We hypothesized that both protocols would have similar outcomes and tolerability. Animals Thirty‐eight client‐owned dogs diagnosed with MM receiving pulse dose (n = 17) or daily dose (n = 21) melphalan. Methods Retrospective cohort study assessing outcome and adverse events in dogs receiving either protocol. Risk factors were evaluated for their prognostic relevance. Results Both regimens were well tolerated and similarly effective, with an overall median survival time of 930 days. Renal disease and neutrophil‐to‐lymphocyte ratio (NLR) were negative prognostic factors, whereas hypercalcemia and osteolytic lesions were not prognostic factors in this study population. Conclusions and Clinical Importance Positive results support the use of either dosing regimen for the treatment of dogs with MM, and renal disease and NLR were negative prognostic factors. Prospective, controlled, and randomized studies are warranted to confirm these findings. PMID:29566439

Fast track in colo-rectal surgery. Preliminary experience in a rural hospital

PubMed Central

FRONTERA, D.; ARENA, L.; CORSALE, I.; FRANCIOLI, N.; MAMMOLITI, F.; BUCCIANELLI, E.

2014-01-01

Background “Fast Track surgery” is a therapeutic program of large application, despite some doubts about its applicability and real validity. Literature review shows that this approach to colo-rectal surgery, particularly video-assisted, can allow a rapid recovery, better performance and a faster postoperative functional autonomy of the work, which can be discharged without cause additional welfare costs; in addition it can be reproducible in different health reality. Purpose To analyze the possibility to apply the Fast Truck protocol in patients undergoing colorectal surgery in a rural hospital and non specialistic Unit of Surgery. Patients and methods We have conducted a prospective, randomized study on 80 patients subjected to colorectal surgery in the last year. Results The protocol was observed in 95% of cases, compliance with the Fast Track was high and general morbidity was limited (7.8%). Conclusion This “aggressive” approach, which has fundamentally altered the usual surgical behavior, seems to allow a mean length of stay significantly lower than in controls (p < 0.05) with positive implications for patients and containment of health care costs, even after discharge (no need for home care in 92% of cases, no early re-admittance to the hospital). Homogeneous protocols are desirable, as well as an increased enrollment, to consolidate these rehabilitation programs in order to provide a reference for all hospitals. PMID:25644732

Biomechanical adaptations of mice cortical bone submitted to three different exercise modalities

PubMed Central

Frajacomo, Fernando Tadeu Trevisan; Falcai, Maurício José; Fernandes, Cleverson Rodrigues; Shimano, Antonio Carlos; Garcia, Sérgio Britto

2013-01-01

Objective To compare the adaptive effects of three non-weight bearing exercise on bone mechanical properties. Methods 24 male Balb/c mice (22-25g), were randomly divided into four groups (n=6): sedentary group (S); swimming group (N) which performed sessions five times per week for 60 min progressively; resistance group (R), which performed climbing exercise with progressive load, three times per week; and combined group (C), which performed the same protocols aforementioned being three times a week according to N protocol and two times a week the R protocol during eight weeks. Biomechanical tests, load until failure and stiffness evaluation of shinbone was performed after animals have been sacrificed. Results Stiffness values were statistically higher only in the isolated modalities groups (N and R, 41.68 ± 10.43 and 41.21 ± 11.38 N/mm, respectively) compared with the S group (28.48 ± 7.34 N/mm). However, taking into consideration the final body mass, relative values, there was no difference in the biomechanical tests among the groups. Conclusion Data from the present investigation demonstrated a favorable influence of muscle contraction in lower impact isolated exercise modalities on absolute stiffness values, i.e.groups N and R, whereas the combined group (C) did not present any statistical significant difference compared to sedentary group. Level of Evidence II, Prospective Comparative Study. PMID:24453691

Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study

PubMed Central

Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

2017-01-01

Introduction The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. Methods and analysis This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support–experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). Ethics and dissemination The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. PMID:28647721

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Reduction of the estimated radiation dose and associated patient risk with prospective ECG-gated 256-slice CT coronary angiography

NASA Astrophysics Data System (ADS)

Efstathopoulos, E. P.; Kelekis, N. L.; Pantos, I.; Brountzos, E.; Argentos, S.; Grebáč, J.; Ziaka, D.; Katritsis, D. G.; Seimenis, I.

2009-09-01

Computed tomography (CT) coronary angiography has been widely used since the introduction of 64-slice scanners and dual-source CT technology, but high radiation doses have been reported. Prospective ECG-gating using a 'step-and-shoot' axial scanning protocol has been shown to reduce radiation exposure effectively while maintaining diagnostic accuracy. 256-slice scanners with 80 mm detector coverage have been currently introduced into practice, but their impact on radiation exposure has not been adequately studied. The aim of this study was to assess radiation doses associated with CT coronary angiography using a 256-slice CT scanner. Radiation doses were estimated for 25 patients scanned with either prospective or retrospective ECG-gating. Image quality was assessed objectively in terms of mean CT attenuation at selected regions of interest on axial coronary images and subjectively by coronary segment quality scoring. It was found that radiation doses associated with prospective ECG-gating were significantly lower than retrospective ECG-gating (3.2 ± 0.6 mSv versus 13.4 ± 2.7 mSv). Consequently, the radiogenic fatal cancer risk for the patient is much lower with prospective gating (0.0176% versus 0.0737%). No statistically significant differences in image quality were observed between the two scanning protocols for both objective and subjective quality assessments. Therefore, prospective ECG-gating using a 'step-and-shoot' protocol that covers the cardiac anatomy in two axial acquisitions effectively reduces radiation doses in 256-slice CT coronary angiography without compromising image quality.

Transitions: A Classroom Management Concept Related to Effective Teaching. Student Guide. Utah Protocol Materials Project.

ERIC Educational Resources Information Center

Utah State Univ., Logan. Utah Protocol Materials Project.

This student guide is part of a protocol learning module designed to teach the prospective teacher to make smooth transitions from one activity to another, in order to deter disruptive behavior in the course of the transition. The entire module consists of this guide, a protocol film, and testing materials. The student guide contains: (a)…

Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger.

PubMed

Scherer, Andrea G; White, Ian K; Shaikh, Kashif A; Smith, Jodi L; Ackerman, Laurie L; Fulkerson, Daniel H

2017-07-01

OBJECTIVE The risk of venous thromboembolism (VTE) from deep venous thrombosis (DVT) is significant in neurosurgical patients. VTE is considered a leading cause of preventable hospital deaths and preventing DVT is a closely monitored quality metric, often tied to accreditation, hospital ratings, and reimbursement. Adult protocols include prophylaxis with anticoagulant medications. Children's hospitals may adopt adult protocols, although the incidence of DVT and the risk or efficacy of treatment is not well defined. The incidence of DVT in children is likely less than in adults, although there is very little prospectively collected information. Most consider the risk of DVT to be extremely low in children 12 years of age or younger. However, this consideration is based on tradition and retrospective reviews of trauma databases. In this study, the authors prospectively evaluated pediatric patients undergoing a variety of elective neurosurgical procedures and performed Doppler ultrasound studies before and after surgery. METHODS A total of 100 patients were prospectively enrolled in this study. All of the patients were between the ages of 1 month and 12 years and were undergoing elective neurosurgical procedures. The 91 patients who completed the protocol received a bilateral lower-extremity Doppler ultrasound examination within 48 hours prior to surgery. Patients did not receive either medical or mechanical DVT prophylaxis during or after surgery. The ultrasound examination was repeated within 72 hours after surgery. An independent, board-certified radiologist evaluated all sonograms. We prospectively collected data, including potential risk factors, details of surgery, and details of the clinical course. All patients were followed clinically for at least 1 year. RESULTS There was no clinical or ultrasound evidence of DVT or VTE in any of the 91 patients. There was no clinical evidence of VTE in the 9 patients who did not complete the protocol. CONCLUSIONS In this prospective study, no DVTs were found in 91 patients evaluated by ultrasound and 9 patients followed clinically. While the study is underpowered to give a definitive incidence, the data suggest that the risk of DVT and VTE is very low in children undergoing elective neurosurgical procedures. Prophylactic protocols designed for adults may not apply to pediatric patients. Clinical trial registration no.: NCT02037607 (clinicaltrials.gov).

Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

PubMed

Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

2012-01-01

The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) (p = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

Survival times for canine intranasal sarcomas treated with radiation therapy: 86 cases (1996-2011).

PubMed

Sones, Evan; Smith, Annette; Schleis, Stephanie; Brawner, William; Almond, Gregory; Taylor, Kathryn; Haney, Siobhan; Wypij, Jackie; Keyerleber, Michele; Arthur, Jennifer; Hamilton, Terrance; Lawrence, Jessica; Gieger, Tracy; Sellon, Rance; Wright, Zack

2013-01-01

Sarcomas comprise approximately one-third of canine intranasal tumors, however few veterinary studies have described survival times of dogs with histologic subtypes of sarcomas separately from other intranasal tumors. One objective of this study was to describe median survival times for dogs treated with radiation therapy for intranasal sarcomas. A second objective was to compare survival times for dogs treated with three radiation therapy protocols: daily-fractionated radiation therapy; Monday, Wednesday, and Friday fractionated radiation therapy; and palliative radiation therapy. Medical records were retrospectively reviewed for dogs that had been treated with radiation therapy for confirmed intranasal sarcoma. A total of 86 dogs met inclusion criteria. Overall median survival time for included dogs was 444 days. Median survival time for dogs with chondrosarcoma (n = 42) was 463 days, fibrosarcoma (n = 12) 379 days, osteosarcoma (n = 6) 624 days, and undifferentiated sarcoma (n = 22) 344 days. Dogs treated with daily-fractionated radiation therapy protocols; Monday, Wednesday and Friday fractionated radiation therapy protocols; and palliative radiation therapy protocols had median survival times of 641, 347, and 305 days, respectively. A significant difference in survival time was found for dogs receiving curative intent radiation therapy vs. palliative radiation therapy (P = 0.032). A significant difference in survival time was also found for dogs receiving daily-fractionated radiation therapy vs. Monday, Wednesday and Friday fractionated radiation therapy (P = 0.0134). Findings from this study support the use of curative intent radiation therapy for dogs with intranasal sarcoma. Future prospective, randomized trials are needed for confirmation of treatment benefits. © 2012 Veterinary Radiology & Ultrasound.

Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR)

PubMed Central

Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

2018-01-01

Introduction Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. Methods and analysis This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). Ethics and dissemination Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. Trial registration number NCT02632500. PMID:29674365

Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

PubMed

McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

2018-03-08

We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

Direct costs of osteoporosis and hip fracture: an analysis for the Mexican Social Insurance Health Care System.

PubMed

Carlos, Fernando; Clark, Patricia; Maciel, Humberto; Tamayo, Juan A

2009-01-01

To compare costs of diagnosis and annual treatment of osteoporosis and hip fracture between the Instituto Nacional de Rehabilitación (INR) and the protocol used by the Seguro Popular de Salud (SPSS). Direct costs gathered in a prospective study with real cases at the INR are presented, and then this data is re-analyzed with the methodology and protocol for the SPSS to estimate the costs of those cases if treated with the SPSS protocol. Important differences were found in the cost of hip fracture: the SPSS estimates ($37,363.73 MXN) almost double the INR cost ($20,286.86 MXN ). This discrepancy was caused by the different types of surgeries the INR and SPSS protocols call for (the SPSS assumes that all hip fractures will necessitate a hip replacement) and the cost of subsequent hospitalization. A prospective study at the SPSS is needed to validate these results. Important differences were found between treatment of the same osteoporosis related problems at the INR and SPSS. We recommend revising the SPSS protocol to include less costly surgical treatments.

Randomness Amplification under Minimal Fundamental Assumptions on the Devices

NASA Astrophysics Data System (ADS)

Ramanathan, Ravishankar; Brandão, Fernando G. S. L.; Horodecki, Karol; Horodecki, Michał; Horodecki, Paweł; Wojewódka, Hanna

2016-12-01

Recently, the physically realistic protocol amplifying the randomness of Santha-Vazirani sources producing cryptographically secure random bits was proposed; however, for reasons of practical relevance, the crucial question remained open regarding whether this can be accomplished under the minimal conditions necessary for the task. Namely, is it possible to achieve randomness amplification using only two no-signaling components and in a situation where the violation of a Bell inequality only guarantees that some outcomes of the device for specific inputs exhibit randomness? Here, we solve this question and present a device-independent protocol for randomness amplification of Santha-Vazirani sources using a device consisting of two nonsignaling components. We show that the protocol can amplify any such source that is not fully deterministic into a fully random source while tolerating a constant noise rate and prove the composable security of the protocol against general no-signaling adversaries. Our main innovation is the proof that even the partial randomness certified by the two-party Bell test [a single input-output pair (u* , x* ) for which the conditional probability P (x*|u*) is bounded away from 1 for all no-signaling strategies that optimally violate the Bell inequality] can be used for amplification. We introduce the methodology of a partial tomographic procedure on the empirical statistics obtained in the Bell test that ensures that the outputs constitute a linear min-entropy source of randomness. As a technical novelty that may be of independent interest, we prove that the Santha-Vazirani source satisfies an exponential concentration property given by a recently discovered generalized Chernoff bound.

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

PubMed

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial.

PubMed

dos Reis Santos, Israel; Danaga, Aline Roberta; de Carvalho Aguiar, Isabella; Oliveira, Ezequiel Fernandes; Dias, Ismael Souza; Urbano, Jessica Julioti; Martins, Aline Almeida; Ferraz, Leonardo Macario; Fonsêca, Nina Teixeira; Fernandes, Virgilio; Fernandes, Vinicius Alves Thomaz; Lopes, Viviane Cristina Delgado; Leitão Filho, Fernando Sérgio Studart; Nacif, Sérgio Roberto; de Carvalho, Paulo de Tarso Camillo; Sampaio, Luciana Maria Malosá; Giannasi, Lílian Christiane; Romano, Salvatore; Insalaco, Giuseppe; Araujo, Ana Karina Fachini; Dellê, Humberto; Souza, Nadia Karina Guimarães; Giannella-Neto, Daniel; Oliveira, Luis Vicente Franco

2013-10-08

Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life. A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height(2); circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life. CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients. The protocol for this study is registered with the Brazilian Registry of Clinical Trials (ReBEC RBR-7yhr4w and World Health Organization under Universal Trial Number UTN: U1111-1127-9390 [http://www.ensaiosclinicos.gov.br/rg/RBR-7yhr4w/]).

Exponential gain of randomness certified by quantum contextuality

NASA Astrophysics Data System (ADS)

Um, Mark; Zhang, Junhua; Wang, Ye; Wang, Pengfei; Kim, Kihwan

2017-04-01

We demonstrate the protocol of exponential gain of randomness certified by quantum contextuality in a trapped ion system. The genuine randomness can be produced by quantum principle and certified by quantum inequalities. Recently, randomness expansion protocols based on inequality of Bell-text and Kochen-Specker (KS) theorem, have been demonstrated. These schemes have been theoretically innovated to exponentially expand the randomness and amplify the randomness from weak initial random seed. Here, we report the experimental evidence of such exponential expansion of randomness. In the experiment, we use three states of a 138Ba + ion between a ground state and two quadrupole states. In the 138Ba + ion system, we do not have detection loophole and we apply a methods to rule out certain hidden variable models that obey a kind of extended noncontextuality.

A Randomized 2x2 Factorial Clinical Trial of Renal Transplantation: Steroid-Free Maintenance Immunosuppression with Calcineurin Inhibitor Withdrawal after Six Months Associates with Improved Renal Function and Reduced Chronic Histopathology.

PubMed

Stevens, R Brian; Foster, Kirk W; Miles, Clifford D; Kalil, Andre C; Florescu, Diana F; Sandoz, John P; Rigley, Theodore H; Malik, Tamer; Wrenshall, Lucile E

2015-01-01

The two most significant impediments to renal allograft survival are rejection and the direct nephrotoxicity of the immunosuppressant drugs required to prevent it. Calcineurin inhibitors (CNI), a mainstay of most immunosuppression regimens, are particularly nephrotoxic. Until less toxic antirejection agents become available, the only option is to optimize our use of those at hand. To determine whether intensive rabbit anti-thymocyte globulin (rATG) induction followed by CNI withdrawal would individually or combined improve graft function and reduce graft chronic histopathology-surrogates for graft and, therefore, patient survival. As previously reported, a single large rATG dose over 24 hours was well-tolerated and associated with better renal function, fewer infections, and improved patient survival. Here we report testing whether complete CNI discontinuation would improve renal function and decrease graft pathology. Between April 20, 2004 and 4-14-2009 we conducted a prospective, randomized, non-blinded renal transplantation trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day x 4; target enrollment = 180). Subsequent maintenance immunosuppression consisted of tacrolimus, a CNI, and sirolimus, a mammalian target of rapamycin inhibitor. We report here the outcome of converting patients after six months either to minimized tacrolimus/sirolimus or mycophenolate mofetil/sirolimus. Primary endpoints were graft function and chronic histopathology from protocol kidney biopsies at 12 and 24 months. CNI withdrawal (on-treatment analysis) associated with better graft function (p <0.001) and lower chronic histopathology composite scores in protocol biopsies at 12 (p = 0.003) and 24 (p = 0.013) months, without affecting patient (p = 0.81) or graft (p = 0.93) survival, or rejection rate (p = 0.17). CNI (tacrolimus) withdrawal at six months may provide a strategy for decreased nephrotoxicity and improved long-term function in steroid-free low immunological risk renal transplant patients. ClinicalTrials.gov NCT00556933.

International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol.

PubMed

Williams, Leanne M; Rush, A John; Koslow, Stephen H; Wisniewski, Stephen R; Cooper, Nicholas J; Nemeroff, Charles B; Schatzberg, Alan F; Gordon, Evian

2011-01-05

Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. The International Study to Predict Optimized Treatment - in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65) from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls). Study-eligible patients are antidepressant medication (ADM) naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary). Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. International Study to Predict Optimised Treatment - in Depression (iSPOT-D) ClinicalTrials.gov Identifier: NCT00693849. URL: http://clinicaltrials.gov/ct2/show/NCT00693849?term=International+Study+to+Predict+Optimized+Treatment+for+Depression&rank=1

Impact of trauma system structure on injury outcomes: a systematic review protocol.

PubMed

Moore, Lynne; Champion, Howard; O'Reilly, Gerard; Leppaniemi, Ari; Cameron, Peter; Palmer, Cameron; Abu-Zidan, Fikri M; Gabbe, Belinda; Gaarder, Christine; Yanchar, Natalie; Stelfox, Henry Thomas; Coimbra, Raul; Kortbeek, John; Noonan, Vanessa; Gunning, Amy; Leenan, Luke; Gordon, Malcolm; Khajanchi, Monty; Shemilt, Michèle; Porgo, Valérie; Turgeon, Alexis F

2017-01-21

Injury represents one of the greatest public health challenges of our time with over 5 million deaths and 100 million people temporarily or permanently disabled every year worldwide. The effectiveness of trauma systems in decreasing injury mortality and morbidity has been well demonstrated. However, the organisation of trauma care varies significantly across trauma systems and we know little about which components of trauma systems contribute to their effectiveness. The objective of the study described in this protocol is to systematically review evidence of the impact of trauma system components on clinically significant outcomes including mortality, function and disability, quality of life, and resource utilization. We will perform a systematic review of studies evaluating the association between at least one trauma system component (e.g. accreditation by a central agency, interfacility transfer agreements) and at least one injury outcome (e.g. mortality, disability, resource use). We will search MEDLINE, EMBASE, COCHRANE central, and BIOSIS/Web of Knowledge databases, thesis holdings, key injury organisation websites and conference proceedings for eligible studies. Pairs of independent reviewers will evaluate studies for eligibility and extract data from included articles. Methodological quality will be evaluated using elements of the ROBINS-I tool and the Cochrane risk of bias tool for non-randomized and randomized studies, respectively. Strength of evidence will be evaluated using the GRADE tool. We expect to advance knowledge on the components of trauma systems that contribute to their effectiveness. This may lead to recommendations on trauma system structure that will help policy-makers make informed decisions as to where resources should be focused. The review may also lead to specific recommendations for future research efforts. This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 28-06-2016. PROSPERO 2016:CRD42016041336 Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016041336 .

Meta-analysis of dietary essential fatty acids and long-chain polyunsaturated fatty acids as they relate to visual resolution acuity in healthy preterm infants.

PubMed

SanGiovanni, J P; Parra-Cabrera, S; Colditz, G A; Berkey, C S; Dwyer, J T

2000-06-01

To derive combined estimates of visual resolution acuity differences between healthy preterm infants consuming different compositions and ratios of essential fatty acids (EFAs) and docosahexaenoic acid (DHA), an omega-3 (n-3) long-chain polyunsaturated fatty acid (LCPUFA). Electronic biomedical reference database (Medline and Health Star from 1965 to July 1999) searches with index terms omega-3, n-3, infant, vision, acuity, and human. Current review article, monograph, and book chapter bibliography/reference section hand searches. A total of 5 original articles and 4 review chapters were reviewed for details on study design, conduct, and outcome. Four prospective trials of EFA/LCPUFA supplementation were included in these analyses. For behaviorally based outcomes, there were 2 randomized comparisons each at

A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease.

PubMed

Green, Robert C; Christensen, Kurt D; Cupples, L Adrienne; Relkin, Norman R; Whitehouse, Peter J; Royal, Charmaine D M; Obisesan, Thomas O; Cook-Deegan, Robert; Linnenbringer, Erin; Butson, Melissa Barber; Fasaye, Grace-Ann; Levinson, Elana; Roberts, J Scott

2015-10-01

Conventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD. A randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Three hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans. These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Strengthening of the Hip and Core Versus Knee Muscles for the Treatment of Patellofemoral Pain: A Multicenter Randomized Controlled Trial

PubMed Central

Ferber, Reed; Bolgla, Lori; Earl-Boehm, Jennifer E.; Emery, Carolyn; Hamstra-Wright, Karrie

2015-01-01

Context: Patellofemoral pain (PFP) is the most common injury in running and jumping athletes. Randomized controlled trials suggest that incorporating hip and core strengthening (HIP) with knee-focused rehabilitation (KNEE) improves PFP outcomes. However, no randomized controlled trials have, to our knowledge, directly compared HIP and KNEE programs. Objective: To compare PFP pain, function, hip- and knee-muscle strength, and core endurance between KNEE and HIP protocols after 6 weeks of rehabilitation. We hypothesized greater improvements in (1) pain and function, (2) hip strength and core endurance for patients with PFP involved in the HIP protocol, and (3) knee strength for patients involved in the KNEE protocol. Design: Randomized controlled clinical trial. Setting: Four clinical research laboratories in Calgary, Alberta; Chicago, Illinois; Milwaukee, Wisconsin; and Augusta, Georgia. Patients or Other Participants: Of 721 patients with PFP screened, 199 (27.6%) met the inclusion criteria (66 men [31.2%], 133 women [66.8%], age = 29.0 ± 7.1 years, height = 170.4 ± 9.4 cm, weight = 67.6 ± 13.5 kg). Intervention(s): Patients with PFP were randomly assigned to a 6-week KNEE or HIP protocol. Main Outcome Measure(s): Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures, which were conducted weekly. Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks. Results: Compared with baseline, both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols (P < .001), but the visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group. Both groups increased in strength (P < .001), but those in the HIP protocol gained more in hip-abductor (P = .01) and -extensor (P = .01) strength and posterior core endurance (P = .05) compared with the KNEE group. Conclusions: Both the HIP and KNEE rehabilitation protocols produced improvements in PFP, function, and strength over 6 weeks. Although outcomes were similar, the HIP protocol resulted in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol. PMID:25365133

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic

PubMed Central

Ehrlich, Shelley; Smith, Kristen; Williams, Paige L.; Chavarro, Jorge E.; Batsis, Maria; Toth, Thomas L.; Hauser, Russ

2015-01-01

Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62 ppm, range: 0.03-5.66 ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

Controlled breathing protocols probe human autonomic cardiovascular rhythms

NASA Technical Reports Server (NTRS)

Cooke, W. H.; Cox, J. F.; Diedrich, A. M.; Taylor, J. A.; Beightol, L. A.; Ames, J. E. 4th; Hoag, J. B.; Seidel, H.; Eckberg, D. L.

1998-01-01

The purpose of this study was to determine how breathing protocols requiring varying degrees of control affect cardiovascular dynamics. We measured inspiratory volume, end-tidal CO2, R-R interval, and arterial pressure spectral power in 10 volunteers who followed the following 5 breathing protocols: 1) uncontrolled breathing for 5 min; 2) stepwise frequency breathing (at 0.3, 0.25, 0.2, 0.15, 0.1, and 0.05 Hz for 2 min each); 3) stepwise frequency breathing as above, but with prescribed tidal volumes; 4) random-frequency breathing (approximately 0.5-0.05 Hz) for 6 min; and 5) fixed-frequency breathing (0.25 Hz) for 5 min. During stepwise breathing, R-R interval and arterial pressure spectral power increased as breathing frequency decreased. Control of inspired volume reduced R-R interval spectral power during 0.1 Hz breathing (P < 0.05). Stepwise and random-breathing protocols yielded comparable coherence and transfer functions between respiration and R-R intervals and systolic pressure and R-R intervals. Random- and fixed-frequency breathing reduced end-tidal CO2 modestly (P < 0.05). Our data suggest that stringent tidal volume control attenuates low-frequency R-R interval oscillations and that fixed- and random-rate breathing may decrease CO2 chemoreceptor stimulation. We conclude that autonomic rhythms measured during different breathing protocols have much in common but that a stepwise protocol without stringent control of inspired volume may allow for the most efficient assessment of short-term respiratory-mediated autonomic oscillations.

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

PubMed

Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

2018-02-02

The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

PubMed

Williams, N S; Johnston, D

1980-07-12

Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complications. The mean time spent managing the stoma was 45 +/- SEM 9 min/24 hours during spontaneous action and 53 +/- 9 min/24 hours during irrigation. This difference was not significant. The numbers of bowel actions weekly were 13 +/ SEM 2 during spontaneous action and 6 +/- 1 during irrigation (p < 0.01). Irrigation reduced odour and flatus in 20 patients and enabled 12 out of 18 to stop using drugs and seven to discard their appliance. Irrigation also improved the social life of 18 patients and the working conditions of eight out of 14. These finding show that some patients may not be suitable for irrigation but that for many it is better than the conventional British method of colostomy management. With modern apparatus the technique is safe.

Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

PubMed Central

Williams, N S; Johnston, D

1980-01-01

Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complications. The mean time spent managing the stoma was 45 +/- SEM 9 min/24 hours during spontaneous action and 53 +/- 9 min/24 hours during irrigation. This difference was not significant. The numbers of bowel actions weekly were 13 +/ SEM 2 during spontaneous action and 6 +/- 1 during irrigation (p < 0.01). Irrigation reduced odour and flatus in 20 patients and enabled 12 out of 18 to stop using drugs and seven to discard their appliance. Irrigation also improved the social life of 18 patients and the working conditions of eight out of 14. These finding show that some patients may not be suitable for irrigation but that for many it is better than the conventional British method of colostomy management. With modern apparatus the technique is safe. PMID:7000249

Emergency abdominal aortic aneurysm repair with a preferential endovascular strategy: mortality and cost-effectiveness analysis.

PubMed

Kapma, Marten R; Groen, Henk; Oranen, Bjorn I; van der Hilst, Christian S; Tielliu, Ignace F; Zeebregts, Clark J; Prins, Ted R; van den Dungen, Jan J; Verhoeven, Eric L

2007-12-01

To assess mortality and treatment costs of a new management protocol with preferential use of emergency endovascular aneurysm repair (eEVAR) for acute abdominal aortic aneurysm (AAA). From September 2003 until February 2005, 49 consecutive patients (45 men; mean age 71 years) with acute AAA were entered into a prospective study of a new management protocol that featured preferential use of eEVAR (n=18); patients with unsuitable anatomy or who were hemodynamically unstable underwent open repair (n=31). Mortality data and costs of treatment were compared in this mixed prospective group to a historical control group consisting of 147 patients (128 men; mean age 71 years) who underwent open repair from January 1998 to December 2001. All direct medical costs were included from the moment of admission until discharge from the hospital. Mortality in the mixed prospective group (18%) was lower than in the historical control group (31%), but the difference did not reach statistical significance (p=0.099). The mean total cost in the mixed prospective group was 17,164 euro compared to 21,084 euro in the historical open repair group (p=0.255). A preferential eEVAR protocol for acute AAA can decrease mortality and does not increase overall costs during initial treatment, but larger studies are needed to determine if these trends are statistically significant.

Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study.

PubMed

Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

2017-06-24

The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support-experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies.

PubMed

Azad, Meghan B; Abou-Setta, Ahmed M; Chauhan, Bhupendrasinh F; Rabbani, Rasheda; Lys, Justin; Copstein, Leslie; Mann, Amrinder; Jeyaraman, Maya M; Reid, Ashleigh E; Fiander, Michelle; MacKay, Dylan S; McGavock, Jon; Wicklow, Brandy; Zarychanski, Ryan

2017-07-17

Nonnutritive sweeteners, such as aspartame, sucralose and stevioside, are widely consumed, yet their long-term health impact is uncertain. We synthesized evidence from prospective studies to determine whether routine consumption of non-nutritive sweeteners was associated with long-term adverse cardiometabolic effects. We searched MEDLINE, Embase and Cochrane Library (inception to January 2016) for randomized controlled trials (RCTs) that evaluated interventions for nonnutritive sweeteners and prospective cohort studies that reported on consumption of non-nutritive sweeteners among adults and adolescents. The primary outcome was body mass index (BMI). Secondary outcomes included weight, obesity and other cardiometabolic end points. From 11 774 citations, we included 7 trials (1003 participants; median follow-up 6 mo) and 30 cohort studies (405 907 participants; median follow-up 10 yr). In the included RCTs, nonnutritive sweeteners had no significant effect on BMI (mean difference -0.37 kg/m 2 ; 95% confidence interval [CI] -1.10 to 0.36; I 2 9%; 242 participants). In the included cohort studies, consumption of nonnutritive sweeteners was associated with a modest increase in BMI (mean correlation 0.05, 95% CI 0.03 to 0.06; I 2 0%; 21 256 participants). Data from RCTs showed no consistent effects of nonnutritive sweeteners on other measures of body composition and reported no further secondary outcomes. In the cohort studies, consumption of nonnutritive sweeteners was associated with increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events. Publication bias was indicated for studies with diabetes as an outcome. Evidence from RCTs does not clearly support the intended benefits of nonnutritive sweeteners for weight management, and observational data suggest that routine intake of nonnutritive sweeteners may be associated with increased BMI and cardiometabolic risk. Further research is needed to fully characterize the long-term risks and benefits of nonnutritive sweeteners. Protocol registration: PROSPERO-CRD42015019749. © 2017 Canadian Medical Association or its licensors.

Long-term Outcome of Irish Wolfhound Dogs with Preclinical Cardiomyopathy, Atrial Fibrillation, or Both Treated with Pimobendan, Benazepril Hydrochloride, or Methyldigoxin Monotherapy.

PubMed

Vollmar, A C; Fox, P R

2016-01-01

Dilated cardiomyopathy (DCM) is a common cause of morbidity and mortality in the Irish Wolfhound (IW). However, the benefit of medical treatment in IW dogs with preclinical DCM, atrial fibrillation (AF), or both has not been demonstrated. Compare the time to develop congestive heart failure (CHF) or sudden death in IW dogs with preclinical DCM, AF, or both receiving monotherapy with pimobendan, methyldigoxin, or benazepril hydrochloride. Seventy-five client-owned IW dogs. Irish Wolfhound dogs were prospectively randomized to receive pimobendan (Vetmedin®), benazepril HCl (Fortekor®), or methyldigoxin (Lanitop®) monotherapy in a 1:1:1 ratio in a blinded clinical trial. The prospectively defined composite primary endpoint was onset of CHF or sudden death. To assure stringent evaluation of treatment effect, data from dogs complying with the study protocol were analyzed. Sixty-six IW fulfilling the study protocol included 39 males, 27 females; median (interquartile range) age, 4.0 years (3.0-5.0 years) and weight, 70.0 kg (63.0-75.0 kg). Primary endpoint was reached in 5 of 23 (21.7%) IW receiving pimobendan, 11 of 22 (50.0%) receiving benazepril HCl, and 9 of 21 (42.9%) receiving methyldigoxin. Median time to primary endpoint was significantly longer for pimobendan (1,991 days; 65.4 months) compared to methyldigoxin (1,263 days; 41.5 months; P = .031) or benazepril HCl-(997 days; 32.8 months; P = .008) treated dogs. In IW dogs with preclinical DCM, AF or both, pimobendan monotherapy significantly prolonged time to onset of CHF or sudden death than did monotherapy with benazepril HCl or methyldigoxin. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Species Distribution 2.0: An Accurate Time- and Cost-Effective Method of Prospection Using Street View Imagery

PubMed Central

Schwoertzig, Eugénie; Millon, Alexandre

2016-01-01

Species occurrence data provide crucial information for biodiversity studies in the current context of global environmental changes. Such studies often rely on a limited number of occurrence data collected in the field and on pseudo-absences arbitrarily chosen within the study area, which reduces the value of these studies. To overcome this issue, we propose an alternative method of prospection using geo-located street view imagery (SVI). Following a standardised protocol of virtual prospection using both vertical (aerial photographs) and horizontal (SVI) perceptions, we have surveyed 1097 randomly selected cells across Spain (0.1x0.1 degree, i.e. 20% of Spain) for the presence of Arundo donax L. (Poaceae). In total we have detected A. donax in 345 cells, thus substantially expanding beyond the now two-centuries-old field-derived record, which described A. donax only 216 cells. Among the field occurrence cells, 81.1% were confirmed by SVI prospection to be consistent with species presence. In addition, we recorded, by SVI prospection, 752 absences, i.e. cells where A. donax was considered absent. We have also compared the outcomes of climatic niche modeling based on SVI data against those based on field data. Using generalized linear models fitted with bioclimatic predictors, we have found SVI data to provide far more compelling results in terms of niche modeling than does field data as classically used in SDM. This original, cost- and time-effective method provides the means to accurately locate highly visible taxa, reinforce absence data, and predict species distribution without long and expensive in situ prospection. At this time, the majority of available SVI data is restricted to human-disturbed environments that have road networks. However, SVI is becoming increasingly available in natural areas, which means the technique has considerable potential to become an important factor in future biodiversity studies. PMID:26751565

A systematic review on the relations between pasta consumption and cardio-metabolic risk factors.

PubMed

Huang, M; Li, J; Ha, M-A; Riccardi, G; Liu, S

2017-11-01

The traditional Italian dish pasta is a major food source of starch with low glycemic index (GI) and an important low-GI component of the Mediterranean diet. This systematic review aimed at assessing comprehensively and in-depth the potential benefit of pasta on cardio-metabolic disease risk factors. Following a standard protocol, we conducted a systematic literature search of PubMed, CINAHL, and Cochrane Central Register of Controlled Trials for prospective cohort studies and randomized controlled dietary intervention trials that examined pasta and pasta-related fiber and grain intake in relation to cardio-metabolic risk factors of interest. Studies comparing postprandial glucose response to pasta with that to bread or potato were quantitatively summarized using meta-analysis of standardized mean difference. Evidence from studies with pasta as part of low-GI dietary intervention and studies investigating different types of pasta were qualitatively summarized. Pasta meals have significantly lower postprandial glucose response than bread or potato meals, but evidence was lacking in terms of how the intake of pasta can influence cardio-metabolic disease risk. More long-term randomized controlled trials are needed where investigators directly contrast the cardio-metabolic effects of pasta and bread or potato. Long-term prospective cohort studies with required data available should also be analyzed regarding the effect of pasta intake on disease endpoints. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

A Cycle Ergometer Exercise Program Improves Exercise Capacity and Inspiratory Muscle Function in Hospitalized Patients Awaiting Heart Transplantation: a Pilot Study

PubMed Central

Forestieri, Patrícia; Guizilini, Solange; Peres, Monique; Bublitz, Caroline; Bolzan, Douglas W.; Rocco, Isadora S.; Santos, Vinícius B.; Moreira, Rita Simone L.; Breda, João R.; de Almeida, Dirceu R.; Carvalho, Antonio Carlos de C.; Arena, Ross; Gomes, Walter J.

2016-01-01

Objective The purpose of this study was to evaluate the effect of a cycle ergometer exercise program on exercise capacity and inspiratory muscle function in hospitalized patients with heart failure awaiting heart transplantation with intravenous inotropic support. Methods Patients awaiting heart transplantation were randomized and allocated prospectively into two groups: 1) Control Group (n=11) - conventional protocol; and 2) Intervention Group (n=7) - stationary cycle ergometer exercise training. Functional capacity was measured by the six-minute walk test and inspiratory muscle strength assessed by manovacuometry before and after the exercise protocols. Results Both groups demonstrated an increase in six-minute walk test distance after the experimental procedure compared to baseline; however, only the intervention group had a significant increase (P=0.08 and P=0.001 for the control and intervention groups, respectively). Intergroup comparison revealed a greater increase in the intervention group compared to the control (P<0.001). Regarding the inspiratory muscle strength evaluation, the intragroup analysis demonstrated increased strength after the protocols compared to baseline for both groups; statistical significance was only demonstrated for the intervention group, though (P=0.22 and P<0.01, respectively). Intergroup comparison showed a significant increase in the intervention group compared to the control (P<0.01). Conclusion Stationary cycle ergometer exercise training shows positive results on exercise capacity and inspiratory muscle strength in patients with heart failure awaiting cardiac transplantation while on intravenous inotropic support. PMID:27982348

Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

PubMed

Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

2018-04-19

Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The AN69 ST haemodialysis membrane under conditions of two different extracorporeal circuit rinse protocols a comparison of thrombogenicity parameters.

PubMed

Richtrova, Pavlina; Opatrny, Karel; Vit, Ladislav; Sefrna, Frantisek; Perlik, Radek

2007-10-01

Thrombogenicity is an important parameter of haemodialysis (HD) membrane biocompatibility. The surface of the polyacrylonitrile AN69 ST membrane is coated with a polyethylenimine. This modification allows heparin adsorption. The binding of heparin to the membrane surface occurs during priming of the extracorporeal circuit (ECC) by rinsing it with saline and heparin. Our aims were to assess and compare the thrombogenicity of the AN69 ST membrane under conditions of two extracorporeal circuit (ECC) rinse protocols-with and without unfractionated heparin (UFH). In a prospective, crossover and randomized study, we examined 10 patients during HD after ECC preparation with either rinse protocols. Prior to HD and at 15, 60 and 240 min, we determined plasma levels of the thrombin-antithrombin complexes (TAT), platelet factor 4 (PF4), heparin concentration (antiXa) and thrombocyte count. Systemic anticoagulation was performed using UFH. During HD after ECC rinse without UFH, there was a significantly earlier and more marked increase in TAT compared with UFH-containing rinse (P <0.05). Using Spearman coefficient, we demonstrated a significant correlation between TAT and antiXa at 60 min (r = -0.534) and 240 min (r = -0.538). A comparison of the TAT/antiXa ratios between rinses at 60 min revealed a significantly higher increase in TAT following UFH-free rinse (P <0.05). There was no difference in PF4 between the rinses. Platelet count did not change significantly during HD using either rinse protocol. Based on plasma TAT levels, ECC priming with an UFH-containing solution reduces the thrombogenicity of the AN69 ST membrane. There is no significant difference between both types of priming concerning PF4 and thrombocyte count.

Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: A systematic review.

PubMed

Lin, Kuan-Yin; Granger, Catherine L; Denehy, Linda; Frawley, Helena C

2015-11-01

To identify, evaluate and synthesize the evidence examining the effectiveness of pelvic floor muscle training (PFMT) on bowel dysfunction in patients who have undergone colorectal cancer surgery. Eight electronic databases (MEDLINE 1950-2014; CINAHL 1982-2014; EMBASE 1980-2014; Scopus 1823-2014; PsycINFO 1806-2014; Web of Science 1970-2014; Cochrane Library 2014; PEDro 1999-2014) were systematically searched in March 2014. Reference lists of identified articles were cross referenced and hand searched. Randomized controlled trials, cohort studies and case series were included if they investigated the effects of conservative treatments, including PFMT on bowel function in patients with colorectal cancer following surgery. Two reviewers independently assessed the risk of bias of studies using the Newcastle-Ottawa Scale (NOS). Six prospective non-randomized studies and two retrospective studies were included. The mean (SD) NOS risk of bias score was 4.9 (1.2) out of 9; studies were limited by a lack of non-exposed cohort, lack of independent blinded assessment, heterogeneous treatment protocols, and lack of long-term follow-up. The majority of studies reported significant improvements in stool frequency, incontinence episodes, severity of fecal incontinence, and health-related quality of life (HRQoL) after PFMT. Meta-analysis was not possible due to lack of randomized controlled trials. Pelvic floor muscle training for patients following surgery for colorectal cancer appears to be associated with improvements in bowel function and HRQoL. Results from non-randomized studies are promising but randomized controlled trials with sufficient power are needed to confirm the effectiveness of PFMT in this population. © 2014 Wiley Periodicals, Inc.

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

The effect of myofascial release and microwave diathermy combined with acupuncture versus acupuncture therapy in tension-type headache patients: A pragmatic randomized controlled trial.

PubMed

Georgoudis, George; Felah, Bledjana; Nikolaidis, Pantelis; Damigos, Dimitrios

2018-04-01

Nonpharmacological therapies for tension-type headache (TTH) and cervicogenic cephalalgia are often a treatment choice, despite the weak to moderate evidence. The aim of this study was to compare the effectiveness of an acupuncture/stretching protocol versus acupuncture/stretching plus physiotherapy techniques, in patients with TTH cephalalgia. A single-blind, prospective, multicentre, randomized controlled trial was designed considering the pragmatic situation of administering such protocols and treating the 44 headache patients participating in this study. The patients were randomly assigned in 2 treatment groups (control group, n = 20, acupuncture/stretching; experimental group, n = 24, acupuncture/stretching plus physiotherapy) and completed 10 treatment sessions within 4 weeks with measurements taking place before treatment, after the fifth treatment and after the 10th treatment. The mechanical pressure pain threshold (PPT) was considered as the main outcome measure, using a mechanical algometer to measure 7 bilateral somatic points. Acupuncture in both groups included 17-20 acupuncture points, whereas stretching was initially taught and subsequently self-administered (self-stretches), following a standardized set of movements of the cervical spine. Physiotherapy consisted of microwave diathermy and myofascial release with hands-on techniques. An improvement was noted in both groups/treatments regarding the main outcome measure PPT, all the way from the first to fifth and the 10th treatment, at all measuring sites and at all measurements in both groups (p < .001). When comparing the 2 groups, differences were noted after the 10th treatment (p < .05). In conclusion, patients with TTH headache were benefited from acupuncture and stretching but further PPT improvements were evidenced when physiotherapy hands-on techniques were added. In clinical terms, the combination of physiotherapy in the form of myofascial release and microwave diathermy with acupuncture and stretching in order to improve the analgesic effect (PPT) is strongly recommended. Copyright © 2017 John Wiley & Sons, Ltd.

Effect of high-intensity home-based respiratory muscle training on strength of respiratory muscles following a stroke: a protocol for a randomized controlled trial.

PubMed

Menezes, Kênia Kiefer Parreiras De; Nascimento, Lucas Rodrigues; Polese, Janaine Cunha; Ada, Louise; Teixeira-Salmela, Luci Fuscaldi

Respiratory muscle training has shown to increase strength of the respiratory muscles following a stroke. However, low duration and/or intensity of training may be responsible for the small effect size seen and/or absence of carry-over effects to an activity, e.g., walking. Therefore, an investigation of the effects of long-duration, high-intensity respiratory muscle training is warranted. This proposed protocol for a randomized clinical trial will examine the efficacy of high-intensity respiratory muscle training to increase strength and improve activity following a stroke. This study will be a two-arm, prospectively registered, randomized controlled trial, with blinded assessors. Thirty-eight individuals who have suffered a stroke will participate. The experimental group will undertake a 40-min of respiratory muscle training program, seven days/week, for eight weeks in their homes. Training loads will be increased weekly. The control group will undertake a sham respiratory muscle training program with equivalent duration and scheduling of training. The primary outcome will be the strength of the inspiratory muscles, measured as maximal inspiratory pressure. Secondary outcomes will include expiratory muscle strength, inspiratory muscle endurance, dyspnea, respiratory complications, and walking capacity. Outcomes will be collected by a researcher blinded to group allocation at baseline (Week 0), after intervention (Week 8), and one month beyond intervention (Week 12). High-intensity respiratory muscle training may have the potential to optimize the strength of the respiratory muscles following a stroke. If benefits are carried over to activity, the findings may have broader implications, since walking capacity has been shown to predict physical activity and community participation on this population. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial.

PubMed

Caponnetto, Pasquale; Polosa, Riccardo; Auditore, Roberta; Minutolo, Giuseppe; Signorelli, Maria; Maglia, Marilena; Alamo, Angela; Palermo, Filippo; Aguglia, Eugenio

2014-03-22

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders". The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia. ClinicalTrials.gov, NCT01979796.

Protocol of randomized control trial for effectiveness of angiotensin receptor blockers on blood pressure control among euvolemic hypertensive hemodialysis patients

PubMed Central

Aftab, Raja Ahsan; Khan, Amer Hayat; Syed Sulaiman, Syed Azhar; Khan, Tahir Mehmood; Adnan, Azreen Syazril

2017-01-01

Abstract Introduction: Volume overload and the renin–aldosterone–angiotensin system (RAAS) are 2 major factors contributing to hypertension (HTN) among hemodialysis (HD) patients. Although volume-dependent components of HTN can be corrected by appropriate volume removal, a proportion of HD patients experience elevated blood pressure (BP) despite achieving euvolemic and ideal dry weight. Method and analysis: A single center, prospective, randomized, parallel design, single-blind trial will be conducted in the Malaysian state of Kelantan among postdialysis euvolemic hypertensive patients that are on regular dialysis at least 3 times a week. The primary outcome of the trial will be to note the effectiveness of losartan (RAAS inhibitor) in reducing systolic BP < 140 mm Hg compared to standard non-RAAS-inhibitor antihypertensive therapy. The secondary outcome will be to look at all causes of mortality. A body composition monitor (BCM) will be used to assess postdialysis volume and dry weight. Postdialysis euvolemic patients that have systolic BP > 140 mm Hg will be randomized using Covariate Adaptive Randomization to standard or treatment arm. Participants in the treatment arm will be given 50 mg of losartan once daily except on dialysis days, whereas the standard arm patients will be prescribed non-RAAS antihypertensive agents. The study participants will be followed for a period of 12 months. A Wilcoxon statistical test will be performed to note the difference in BP from baseline up to 12 months using Statistical Package for the Social Sciences (SPSS) 20. Ethical and trial registration: The study protocols are approved from the Ethical and Research Committee of the Universiti Sains Malaysia (USM/JEPeM/15050173). The trial is registered under the Australia New Zealand Clinical Trial Registry (ACTRN12615001322527). The trial was registered on 2/12/2015 and the 1st patient was enrolled on 10/12/2015. The trial was formally initiated on 16/02/2016. Conclusion: Management of HTN among HD patients requires understanding the primary cause of HTN and treating accordingly. The current trial is an attempt to reduce BP among postdialysis euvolemic but hypertensive patients. PMID:28383400

Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial.

PubMed

You, Jie-Shu; Chen, Jian-Ping; Chan, Jessie S M; Lee, Ho-Fun; Wong, Mei-Kuen; Yeung, Wing-Fai; Lao, Li-Xing

2016-07-26

The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ceases. YH0618, a prescription, has showed efficacy in reducing chemotherapy-induced toxicity through long clinical practice. However, there is no scientific research exploring the effects of YH0618 in patients with cancer. Therefore, using a randomized controlled trial, this study will explore the efficacy of YH0618 on ameliorating chemotherapy-induced toxicity including dermatologic toxicity, myelosuppression, hepatotoxicity and nephrotoxicity and improving fatigue in cancer patients who have completed chemotherapy. This is a prospective assessor-blinded, parallel, randomized controlled trial. Patients with cancer at any stage who have completed chemotherapy within two weeks will be randomly divided into group A (YH0618) and group B (wait-list) using a 1:1 allocation ratio. The chemotherapeutic agents include taxanes or anthracyclines. Subjects assigned to group A will receive YH0618 soup 6 days a week for 6 weeks and uncontrolled follow-up for 6 weeks, while group B are required to wait for 6 weeks before receiving YH0618 intervention. The primary outcome of this study is the incidence of protocol-specified grade ≥2 dermatologic toxicities graded by NCI CTCAE Chinese version 4.0 and changes of fingernail color, face skin color and tongue color evaluated by the L*a*b system within 6 weeks. There are some secondary outcomes associated with dermatologic toxicity including fatigue and clinical objective examination. There are few scientific and safe methods in ameliorating chemotherapy-induced toxicity. The proposed study may provide direct and convincing evidence to support YH0618 as an adjuvant treatment for reducing chemotherapy-induced toxicity, which could be introduced into clinical settings. Chinese Clinical Trial Registry: ChiCTR-IOR-15006486 . Registered on 21 May 2015.

Early cessation of triptorelin in in vitro fertilization: a double-blind, randomized study.

PubMed

Simons, Arnold H M; Roelofs, Henny J M; Schmoutziguer, Alex P E; Roozenburg, Brigitte J; van't Hof-van den Brink, Eefje P; Schoonderwoerd, Simon A

2005-04-01

To compare the efficacy of two early cessation protocols of triptorelin treatment in controlled ovarian hyperstimulation with the conventional long protocol in in vitro fertilization/intracytoplasmic sperm injection. A double-blind, randomized, multicenter study. Three Dutch hospitals. One hundred seventy-eight women randomized to one of three treatment groups at the start of stimulation. Midluteally started triptorelin administration was continued until the first day of hMG treatment (group S), or up to and including the fourth day of hMG treatment (group M) or the day of hCG injection (group L). Occurrence of a premature LH surge. One premature LH surge was observed in group M but not in groups S and L. Both early cessation protocols (S and M) are at least as effective as the long protocol (L) with regard to the number of oocytes (11.1 and 10.3 vs. 9.3), number of embryos (7.3 and 6.5 vs. 5.5), and ongoing pregnancy rate (28% and 24% vs. 21%). Early cessation of triptorelin on day 1 of hMG treatment in a midluteally started IVF protocol is as effective as the traditional long protocol in preventing a premature LH surge and results in similar fertility effects.

Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: Protocol for a randomized, placebo-controlled trial.

PubMed

Sprigg, Nikola; Robson, Katie; Bath, Philip; Dineen, Robert; Roberts, Ian; Robinson, Tom; Roffe, Christine; Werring, David; Al-Shahi Salman, Rustam; Pocock, Stuart; Duley, Lelia; England, Tim; Whynes, David; Ciccone, Alfonso; Laska, Ann Charlotte; Christensen, Hanne; Ozturk, Serefnur; Collins, Ronan; Bereczki, Daniel; Egea-Guerrero, Juan Jose; Law, Zhe Kang; Czlonkowska, Anna; Seiffge, David; Beredzie, Maia

2016-08-01

Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions. This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency. Phase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo. A trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79. The primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization. This pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214. © 2016 World Stroke Organization.

Randomized Controlled Trial Comparing Transepithelial Corneal Cross-linking Using Iontophoresis with the Dresden Protocol in Progressive Keratoconus.

PubMed

Lombardo, Marco; Giannini, Daniela; Lombardo, Giuseppe; Serrao, Sebastiano

2017-06-01

To compare clinical outcomes of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) and standard corneal cross-linking (standard CL) for the treatment of progressive keratoconus 12 months after the operation. Prospective randomized controlled clinical trial. Thirty-four eyes of 25 participants with progressive keratoconus were randomized into T-ionto CL (22 eyes) or standard CL (12 eyes). T-ionto CL was performed using an iontophoresis device with dextran-free 0.1% riboflavin-5-phosphate solution with enhancers and by irradiating the cornea with a 10 mW/cm 2 ultraviolet A device for 9 minutes. Standard CL was performed according to the Dresden protocol. The primary outcome measure was stabilization of keratoconus after 12 months through analysis of maximum simulated keratometry readings (K max , diopters). Other outcome measures were corrected distance visual acuity (CDVA, logarithm of the minimum angle of resolution [logMAR]), manifest spherical equivalent refraction (D), central corneal thickness (CCT, micrometers) and endothelial cell density (ECD). Follow-up examinations were arranged at 3 and 7 days and 1, 3, 6, and 12 months. Twelve months after T-ionto CL and standard CL, K max on average flattened by -0.52±1.30 D (P = 0.06) and -0.82±1.20 D (P = 0.04), respectively. The mean change in CDVA was -0.10±0.12 logMAR (P = 0.003) and -0.03±0.06 logMAR (P = 0.10) after T-ionto CL and standard CL, respectively. The manifest spherical equivalent refraction changed on average by +0.71±1.44 D (P = 0.03) and +0.21±0.76 D (P = 0.38), respectively. The CCT and ECD measures did not change significantly in any group at 12 months. Significant differences in the outcome measures between treatments were found in the first week postoperatively. No complications occurred in the T-ionto CL group; 1 eye (8%) had sterile corneal infiltrates, which did not affect the final visual acuity, in the standard CL group. Significant visual and refractive improvements were found 12 months after T-ionto CL, though the average improvement in corneal topography readings was slightly lower than the Dresden protocol in the same period. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Computed tomographic venography for varicose veins of the lower extremities: prospective comparison of 80-kVp and conventional 120-kVp protocols.

PubMed

Cho, Eun-Suk; Kim, Joo Hee; Kim, Sungjun; Yu, Jeong-Sik; Chung, Jae-Joon; Yoon, Choon-Sik; Lee, Hyeon-Kyeong; Lee, Kyung Hee

2012-01-01

To prospectively investigate the feasibility of an 80-kilovolt (peak) (kVp) protocol in computed tomographic venography for varicose veins of the lower extremities by comparison with conventional 120-kVp protocol. Attenuation values and signal-to-noise ratio of iodine contrast medium (CM) were determined in a water phantom for 2 tube voltages (80 kVp and 120 kVp). Among 100 patients, 50 patients were scanned with 120 kVp and 150 effective milliampere second (mAs(eff)), and the other 50 patients were scanned with 80 kVp and 390 mAs(eff) after the administration of 1.7-mL/kg CM (370 mg of iodine per milliliter). The 2 groups were compared for venous attenuation, contrast-to-noise ratio, and subjective degree of venous enhancement, image noise, and overall diagnostic image quality. In the phantom, the attenuation value and signal-to-noise ratio value for iodine CM at 80 kVp were 63.8% and 33.0% higher, respectively, than those obtained at 120 kVp. The mean attenuation of the measured veins of the lower extremities was 148.3 Hounsfield units (HU) for the 80-kVp protocol and 94.8 HU for the 120-kVp protocol. Contrast-to-noise ratio was also significantly higher with the 80-kVp protocol. The overall diagnostic image quality of the 3-dimensional volume-rendered images was good with both protocols. The subjective score for venous enhancement was higher at the 80-kVp protocol. The mean volume computed tomography dose index of the 80-kVp (5.6 mGy) protocol was 23.3% lower than that of the 120-kVp (7.3 mGy) protocol. The use of the 80-kVp protocol improved overall venous attenuation, especially in perforating vein, and provided similarly high diagnostic image quality with a lower radiation dose when compared to the conventional 120-kVp protocol.

Moving the Learning of Teaching Closer to Practice: Teacher Education Implications of School-Based Inquiry Teams

ERIC Educational Resources Information Center

Gallimore, Ronald; Ermeling, Bradley A.; Saunders, William M.; Goldenberg, Claude

2009-01-01

A 5-year prospective, quasi-experimental investigation demonstrated that grade-level teams in 9 Title 1 schools using an inquiry-focused protocol to solve instructional problems significantly increased achievement. Teachers applying the inquiry protocol shifted attribution of improved student performance to their teaching rather than external…

Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

PubMed

Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.

Analysis of 213 currently used rehabilitation protocols in foot and ankle fractures.

PubMed

Pfeifer, Christian G; Grechenig, Stephan; Frankewycz, Borys; Ernstberger, Antonio; Nerlich, Michael; Krutsch, Werner

2015-10-01

Fractures of the ankle, hind- and midfoot are amongst the five most common fractures. Besides initial operative or non-operative treatment, rehabilitation of the patients plays a crucial role for fracture union and long term functional outcome. Limited evidence is available with regard to what a rehabilitation regimen should include and what guidelines should be in place for the initial clinical course of these patients. This study therefore investigated the current rehabilitation concepts after fractures of the ankle, hind- and midfoot. Written rehabilitation protocols provided by orthopedic and trauma surgery institutions in terms of recommendations for weight bearing, range of motion (ROM), physiotherapy and choice of orthosis were screened and analysed. All protocols for lateral ankle fractures type AO 44A1, AO 44B1 and AO 44C1, for calcaneal fractures and fractures of the metatarsal as well as other not specific were included. Descriptive analysis was carried out and statistical analysis applied where appropriate. 209 rehabilitation protocols for ankle fractures type AO 44B1 and AO 44C1, 98 for AO 44A1, 193 for metatarsal fractures, 142 for calcaneal fractures, 107 for 5(th) metatarsal base fractures and 70 for 5(th) metatarsal Jones fractures were evaluated. The mean time recommended for orthosis treatment was 6.04 (SD 0.04) weeks. While the majority of protocols showed a trend towards increased weight bearing and increased ROM over time, the best consensus was noted for weight bearing recommendations. Our study shows that there exists a huge variability in rehabilitation of fractures of the ankle-, hind- and midfoot. This may be contributed to a lack of consensus (e.g. missing publication of guidelines), individualized patient care (e.g. in fragility fractures) or lack of specialization. This study might serve as basis for prospective randomized controlled trials in order to optimize rehabilitation for these common fractures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Prospective Evaluation of a Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry System in a Hospital Clinical Microbiology Laboratory for Identification of Bacteria and Yeasts: a Bench-by-Bench Study for Assessing the Impact on Time to Identification and Cost-Effectiveness

PubMed Central

Tan, K. E.; Ellis, B. C.; Lee, R.; Stamper, P. D.; Zhang, S. X.

2012-01-01

Matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) has been found to be an accurate, rapid, and inexpensive method for the identification of bacteria and yeasts. Previous evaluations have compared the accuracy, time to identification, and costs of the MALDI-TOF MS method against standard identification systems or commercial panels. In this prospective study, we compared a protocol incorporating MALDI-TOF MS (MALDI protocol) with the current standard identification protocols (standard protocol) to determine the performance in actual practice using a specimen-based, bench-by-bench approach. The potential impact on time to identification (TTI) and costs had MALDI-TOF MS been the first-line identification method was quantitated. The MALDI protocol includes supplementary tests, notably for Streptococcus pneumoniae and Shigella, and indications for repeat MALDI-TOF MS attempts, often not measured in previous studies. A total of 952 isolates (824 bacterial isolates and 128 yeast isolates) recovered from 2,214 specimens were assessed using the MALDI protocol. Compared with standard protocols, the MALDI protocol provided identifications 1.45 days earlier on average (P < 0.001). In our laboratory, we anticipate that the incorporation of the MALDI protocol can reduce reagent and labor costs of identification by $102,424 or 56.9% within 12 months. The model included the fixed annual costs of the MALDI-TOF MS, such as the cost of protein standards and instrument maintenance, and the annual prevalence of organisms encountered in our laboratory. This comprehensive cost analysis model can be generalized to other moderate- to high-volume laboratories. PMID:22855510

Prospective evaluation of a matrix-assisted laser desorption ionization-time of flight mass spectrometry system in a hospital clinical microbiology laboratory for identification of bacteria and yeasts: a bench-by-bench study for assessing the impact on time to identification and cost-effectiveness.

PubMed

Tan, K E; Ellis, B C; Lee, R; Stamper, P D; Zhang, S X; Carroll, K C

2012-10-01

Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has been found to be an accurate, rapid, and inexpensive method for the identification of bacteria and yeasts. Previous evaluations have compared the accuracy, time to identification, and costs of the MALDI-TOF MS method against standard identification systems or commercial panels. In this prospective study, we compared a protocol incorporating MALDI-TOF MS (MALDI protocol) with the current standard identification protocols (standard protocol) to determine the performance in actual practice using a specimen-based, bench-by-bench approach. The potential impact on time to identification (TTI) and costs had MALDI-TOF MS been the first-line identification method was quantitated. The MALDI protocol includes supplementary tests, notably for Streptococcus pneumoniae and Shigella, and indications for repeat MALDI-TOF MS attempts, often not measured in previous studies. A total of 952 isolates (824 bacterial isolates and 128 yeast isolates) recovered from 2,214 specimens were assessed using the MALDI protocol. Compared with standard protocols, the MALDI protocol provided identifications 1.45 days earlier on average (P < 0.001). In our laboratory, we anticipate that the incorporation of the MALDI protocol can reduce reagent and labor costs of identification by $102,424 or 56.9% within 12 months. The model included the fixed annual costs of the MALDI-TOF MS, such as the cost of protein standards and instrument maintenance, and the annual prevalence of organisms encountered in our laboratory. This comprehensive cost analysis model can be generalized to other moderate- to high-volume laboratories.

Heating and humidifying of carbon dioxide during pneumoperitoneum is not indicated: a prospective randomized trial.

PubMed

Davis, S S; Mikami, D J; Newlin, M; Needleman, B J; Barrett, M S; Fries, R; Larson, T; Dundon, J; Goldblatt, M I; Melvin, W S

2006-01-01

Carbon dioxide (CO2) pneumoperitoneum usually is created by a compressed gas source. This exposes the patient to cool dry gas delivered at room temperature (21 degrees C) with 0% relative humidity. Various delivery methods are available for humidifying and heating CO2 gas. This study was designed to determine the effects of heating and humidifying gas for the intraabdominal environment. For this study, 44 patients undergoing laparoscopic Roux-en-Y gastric bypass were randomly assigned to one of four arms in a prospective, randomized, single-blinded fashion: raw CO2 (group 1), heated CO2 (group 2), humidified CO2 (group 3), and heated and humidified CO2 (group 4). A commercially available CO2 heater-humidifier was used. Core temperatures, intraabdominal humidity, perioperative data, and postoperative outcomes were monitored. Peritoneal biopsies were taken in each group at the beginning and end of the case. Biopsies were subjected staining protocols designed to identify structural damage and macrophage activity. Postoperative narcotic use, pain scale scores, recovery room time, and length of hospital stay were recorded. One-way analysis of variance (ANOVA) and the nonparametric Kruskal-Wallis test were used to compare the groups. Demographics, volume of CO2 used, intraabdominal humidity, bladder temperatures, lens fogging, and operative times were not significantly different between the groups. Core temperatures were stable, and intraabdominal humidity measurements approached 100% for all the patients over the entire procedure. Total narcotic dosage and pain scale scores were not statistically different. Recovery room times and length of hospital stay were similar in all the groups. Only one biopsy in the heated-humidified group showed an increase in macrophage activity. The intraabdominal environment in terms of temperature and humidity was similar in all the groups. There was no significant difference in the intraoperative body temperatures or the postoperative variable measured. No histologic changes were identified. Heating or humidifying of CO2 is not justified for patients undergoing laparoscopic bariatric surgery.

The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology.

PubMed

Salvadori, Emilia; Poggesi, Anna; Valenti, Raffaella; Della Rocca, Eleonora; Diciotti, Stefano; Mascalchi, Mario; Inzitari, Domenico; Pantoni, Leonardo

2016-10-01

Cerebral small vessel disease (SVD) may cause attentional and executive cognitive deficits. No drug is currently available to improve cognitive performance or to prevent dementia in SVD patients, and cognitive rehabilitation could be a promising approach. We aimed to investigate: (1) the effectiveness of the Attention Process Training-II program in the rehabilitation of patients with mild cognitive impairment (MCI) and SVD; (2) the impact of the induced cognitive improvement on functionality and quality of life; (3) the effect of training on brain activity at rest and the possibility of a training-induced plasticity effect. The RehAtt study is designed as a 3-year prospective, single-blinded, randomized clinical trial. Inclusion criteria were: (1) MCI defined according to Winblad et al. criteria; (2) evidence of impairment across attention neuropsychological tests; (3) evidence on MRI of moderate/severe white matter hyperintensities. All enrolled patients are evaluated at baseline, and after 6 and 12 months, according to an extensive clinical, functional, MRI and neuropsychological protocol. The baseline RehAtt cohort includes 44 patients (66 % males, mean ± SD age and years of education 75.3 ± 6.8 and 8.3 ± 4.3, respectively). After baseline assessment, patients have been randomly assigned to 'attention training' or 'standard care'. Treatments and follow-up visits at 6 months are completed, while follow-up visits at 12 months are ongoing. This study is the first attempt to reduce attention deficits in patients affected by MCI with SVD. The results of this pilot experience will represent an essential background for designing larger multicenter, prospective, double-blinded, randomized and controlled clinical trials. NCT02033850 (ClinicalTrials.gov Identifier).

Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

PubMed

Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

2016-09-01

Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).

Hyperbaric Oxygen Therapy Can Improve Post Concussion Syndrome Years after Mild Traumatic Brain Injury - Randomized Prospective Trial

PubMed Central

Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Background Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. Methods and Findings The trial population included 56 mTBI patients 1–5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. “Mindstreams” was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. Conclusions HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. Trial Registration ClinicalTrials.gov NCT00715052 PMID:24260334

Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia.

PubMed

Morin, Mélanie; Carroll, Marie-Soleil; Bergeron, Sophie

2017-07-01

Pelvic floor muscle physical therapy is recommended in clinical guidelines for women with provoked vestibulodynia (PVD). Including isolated or combined treatment modalities, physical therapy is viewed as an effective first-line intervention, yet no systematic review concerning the effectiveness of physical therapy has been conducted. To systematically appraise the current literature on the effectiveness of physical therapy modalities for decreasing pain during intercourse and improving sexual function in women with PVD. A systematic literature search using PubMed, Scopus, CINHAL, and PEDro was conducted until October 2016. Moreover, a manual search from reference lists of included articles was performed. Ongoing trials also were reviewed using clinicaltrial.gov and ISRCTNregistry. Randomized controlled trials, prospective and retrospective cohorts, and case reports evaluating the effect of isolated or combined physical therapy modalities in women with PVD were included in the review. Main outcome measures were pain during intercourse, sexual function, and patient's perceived improvement. The literature search resulted in 43 eligible studies including 7 randomized controlled trials, 20 prospective studies, 5 retrospective studies, 6 case reports, and 6 study protocols. Most studies had a high risk of bias mainly associated with the lack of a comparison group. Another common bias was related to insufficient sample size, non-validated outcomes, non-standardized intervention, and use of other ongoing treatment. The vast majority of studies showed that physical therapy modalities such as biofeedback, dilators, electrical stimulation, education, multimodal physical therapy, and multidisciplinary approaches were effective for decreasing pain during intercourse and improving sexual function. The positive findings for the effectiveness of physical therapy modalities in women with PVD should be investigated further in robust and well-designed randomized controlled trials. Morin M, Carroll M-S, Bergeron S. Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. Sex Med Rev 2017;5:295-322. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.

PubMed

Brunori, Giuliano; Viola, Battista F; Parrinello, Giovanni; De Biase, Vincenzo; Como, Giovanna; Franco, Vincenzo; Garibotto, Giacomo; Zubani, Roberto; Cancarini, Giovanni C

2007-05-01

A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Mortality, hospitalization, and metabolic markers. 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections.

PubMed

Gyssens, Inge C; Dryden, Matthew; Kujath, Peter; Nathwani, Dilip; Schaper, Nicolaas; Hampel, Barbara; Reimnitz, Peter; Alder, Jeff; Arvis, Pierre

2011-11-01

The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7-21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP-AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP-AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP-AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs.

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0.007). Furthermore, a significant decline in death rate was noted in case group as compared to control group ( P = 0.03). Goal-directed optimized patients with perforation peritonitis were discharged early as compared to control group with significantly lesser mortality as compared with randomly optimized patients in the perioperative period.

A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections

PubMed Central

Gyssens, Inge C.; Dryden, Matthew; Kujath, Peter; Nathwani, Dilip; Schaper, Nicolaas; Hampel, Barbara; Reimnitz, Peter; Alder, Jeff; Arvis, Pierre

2011-01-01

Objectives The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). Patients and methods The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7–21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. Results A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP–AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP–AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP–AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP–AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Conclusions Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs. PMID:21896561

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial.

PubMed

Lee, Ju-Hee; Kim, Sang-Hyun; Choi, Dong-Ju; Tahk, Seung-Jea; Yoon, Jung-Han; Choi, Si Wan; Hong, Taek-Jong; Kim, Hyo-Soo

2017-01-01

This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva ® ) and the reference formulation (Lipitor ® ) of atorvastatin, both at a dosage of 20 mg once daily. This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (-43.9%±15.3% in the generic group, -43.3%±17.0% in the reference group, P =0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P =0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P =0.804). The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia.

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial

PubMed Central

Lee, Ju-Hee; Kim, Sang-Hyun; Choi, Dong-Ju; Tahk, Seung-Jea; Yoon, Jung-Han; Choi, Si Wan; Hong, Taek-Jong; Kim, Hyo-Soo

2017-01-01

Purpose This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva®) and the reference formulation (Lipitor®) of atorvastatin, both at a dosage of 20 mg once daily. Methods This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. Results Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (−43.9%±15.3% in the generic group, −43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P=0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0.804). Conclusion The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia. PMID:28814835

Partial-mouth periodontal examination protocols for the determination of the prevalence and extent of gingival bleeding in adolescents.

PubMed

Machado, Michely Ediani; Tomazoni, Fernanda; Casarin, Maísa; Ardenghi, Thiago M; Zanatta, Fabricio Batistin

2017-10-01

To compare the performance of partial-mouth periodontal examination (PMPE) protocols with different cut-off points to the full-mouth examination (FME) in the assessment of the prevalence and extent of gingival bleeding in adolescents. A cross-sectional study was conducted involving 12-year-old adolescents. Following a systematic two-stage cluster sampling process, 1134 individuals were evaluated. Different PMPE protocols were compared to the FME with six sites per tooth. Sensitivity, specificity, area under the ROC curve (AUC), intraclass correlation coefficient (ICC), relative and absolute biases and the inflation factor were assessed for each PMPE protocol with different cut-off points for the severity of gingival bleeding. The highest AUC values were found for the six-site two-diagonal quadrant (2-4) (0.97), six-site random half-mouth (0.95) and Community Periodontal Index (0.95) protocols. The assessment of three sites [mesiobuccal (MB), buccal (B) and distolingual (DL)] in two diagonal quadrants and the random half-mouth protocol had higher sensitivity and lower specificity than the same protocols with distobuccal (DB) sites. However, the use of DB sites led to better specificity and improved the balance between sensitivity and specificity, except for the two-diagonal quadrant (1-3) protocol. The ≥1 cut-off point led to the most discrepant results from the FME. Six-site two-diagonal quadrant (2-4) and random half-mouth assessments perform better in the evaluation of gingival bleeding in adolescents. However, when a faster protocol is needed, a two-diagonal quadrant assessment using only MB, B and DL sites can be used with no important loss of information. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

PubMed

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-03-01

Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial

PubMed Central

Kurebayashi, Leonice Fumiko Sato; da Silva, Maria Júlia Paes

2014-01-01

Objective this randomized single blind clinical study aimed to evaluate the efficacy of auriculotherapy with and without a protocol for reducing stress levels among nursing staff. Method a total of 175 nursing professionals with medium and high scores according to Vasconcelos' Stress Symptoms List were divided into 3 groups: Control (58), Group with protocol (58), Group with no protocol (59). They were assessed at the baseline, after 12 sessions, and at the follow-up (30 days). Results in the analysis of variance, statistically significant differences between the Control and Intervention groups were found in the two evaluations (p<0.05) with greater size of effect indices (Cohen) for the No protocol group. The Yang Liver 1 and 2, Kidney, Brain Stem and Shen Men were the points most used. Conclusion individualized auriculotherapy, with no protocol, could expand the scope of the technique for stress reduction compared with auriculotherapy with a protocol. NCT: 01420835 PMID:25029046

Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic.

PubMed

Wright, Diane L; Afeiche, Myriam C; Ehrlich, Shelley; Smith, Kristen; Williams, Paige L; Chavarro, Jorge E; Batsis, Maria; Toth, Thomas L; Hauser, Russ

2015-01-01

Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62ppm, range: 0.03-5.66ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. Copyright © 2015 Elsevier Inc. All rights reserved.

A Nurse-Initiated Perioperative Pressure Injury Risk Assessment and Prevention Protocol.

PubMed

Meehan, Anita J; Beinlich, Nancy R; Hammonds, Tracy L

2016-12-01

Pressure injuries negatively affect patients physically, emotionally, and economically. Studies report that pressure injuries occur in 69% of inpatients who have undergone a surgical procedure while hospitalized. In 2012, we created a nurse-initiated, perioperative pressure injury risk assessment measure for our midwestern, urban, adult teaching hospital. We retrospectively applied the risk assessment to a random sample of 350 surgical patients which validated the measure. The prospective use of the risk assessment and prevention measures in 350 surgical patients resulted in a 60% reduction in pressure injuries compared with the retrospective group. Our findings support the use of a multipronged approach for the prevention of health care-associated pressure injuries in the surgical population, which includes assessment of risk, implementation of evidence-based prevention interventions for at-risk patients, and continuation of prevention beyond the perioperative setting to the nursing care unit. Copyright © 2016 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Automated Weaning from Mechanical Ventilation after Off-Pump Coronary Artery Bypass Grafting.

PubMed

Fot, Evgenia V; Izotova, Natalia N; Yudina, Angelika S; Smetkin, Aleksei A; Kuzkov, Vsevolod V; Kirov, Mikhail Y

2017-01-01

The discontinuation of mechanical ventilation after coronary surgery may prolong and significantly increase the load on intensive care unit personnel. We hypothesized that automated mode using INTELLiVENT-ASV can decrease duration of postoperative mechanical ventilation, reduce workload on medical staff, and provide safe ventilation after off-pump coronary artery bypass grafting (OPCAB). The primary endpoint of our study was to assess the duration of postoperative mechanical ventilation during different modes of weaning from respiratory support (RS) after OPCAB. The secondary endpoint was to assess safety of the automated weaning mode and the number of manual interventions to the ventilator settings during the weaning process in comparison with the protocolized weaning mode. Forty adult patients undergoing elective OPCAB were enrolled into a prospective single-center study. Patients were randomized into two groups: automated weaning ( n  = 20) using INTELLiVENT-ASV mode with quick-wean option; and protocolized weaning ( n  = 20), using conventional synchronized intermittent mandatory ventilation (SIMV) + pressure support (PS) mode. We assessed the duration of postoperative ventilation, incidence and duration of unacceptable RS, and the load on medical staff. We also performed the retrospective analysis of 102 patients (standard weaning) who were weaned from ventilator with SIMV + PS mode based on physician's experience without prearranged algorithm. Realization of the automated weaning protocol required change in respiratory settings in 2 patients vs. 7 (5-9) adjustments per patient in the protocolized weaning group. Both incidence and duration of unacceptable RS were reduced significantly by means of the automated weaning approach. The FiO 2 during spontaneous breathing trials was significantly lower in the automated weaning group: 30 (30-35) vs. 40 (40-45) % in the protocolized weaning group ( p  < 0.01). The average time until tracheal extubation did not differ in the automated weaning and the protocolized weaning groups: 193 (115-309) and 197 (158-253) min, respectively, but increased to 290 (210-411) min in the standard weaning group. The automated weaning system after off-pump coronary surgery might provide postoperative ventilation in a more protective way, reduces the workload on medical staff, and does not prolong the duration of weaning from ventilator. The use of automated or protocolized weaning can reduce the duration of postoperative mechanical ventilation in comparison with non-protocolized weaning based on the physician's decision.

The Role of Predictability in Saccadic Eye Responses in the Suppression Head Impulse Test of Horizontal Semicircular Canal Function.

PubMed

Rey-Martinez, Jorge; Yanes, Joaquin; Esteban, Jonathan; Sanz, Ricardo; Martin-Sanz, Eduardo

2017-01-01

In the suppression head impulse paradigm (SHIMP) vHIT protocol, the participant is instructed to follow with his gaze a mobile target generated by a laser placed on the participant's head. Recent studies have reported that the refixation saccade latencies are in relation with the time evolution of the vestibular dysfunction in both (standard and SHIMP) procedures. We hypothesized that some central mechanisms like head impulse prediction could be one of the causes for the differences in the saccadic eye responses. A prospective cohort non-randomized study was designed. For the SHIMP protocol, recorded with the ICS Impulse ver. 4.0 ® (Otometrics A/S, Taastrup, Denmark) vHIT device, three different algorithms were performed: "predictable," "less predictable," and "unpredictable" depending on the target's predictability. A mathematical method was developed to analyze the SHIMP responses. The method was implemented as an additional tool to the MATLAB open source script for the extended analysis of the vHIT responses named HITCal. In cohort 1, 52 participants were included in "predictable" SHIMP protocol. In cohort 2, 60 patients were included for the "less predictable" and 35 patients for the "unpredictable" SHIMP protocol. The participants made more early saccades when instructed to perform the "predictable" paradigm compared with the "less predictable" paradigm ( p  < 0.001). The less predictable protocol did not reveal any significant difference when compared with the unpredictable protocol ( p  = 0.189). For the latency of the first saccade, there was statistical difference between the "unpredictable" and "predictable" protocols ( p  < 0.001) and between the "less predictable" and "predictable" protocols ( p  < 0.001). Finally, we did not find any relationship between the horizontal vestibulo-ocular reflex (hVOR) gain and the latency of the saccades. We developed a specific method to analyze and detect early SHIMP saccades. Our findings offer evidence regarding the influence of predictability on the latency of the SHIMP saccadic responses, suggesting that early saccades are probably caused by a conditioned response of the participant. The lack of relationship between the hVOR gain and the latency of the saccades suggests that the predictive behavior that caused the early eye saccades are independent of the vestibular function.

Comparison of visual evoked potential monitoring during spine surgeries under total intravenous anesthesia versus balanced general anesthesia.

PubMed

Uribe, Alberto A; Mendel, Ehud; Peters, Zoe A; Shneker, Bassel F; Abdel-Rasoul, Mahmoud; Bergese, Sergio D

2017-10-01

To determine the comparison of its clinical utility and safety profile for visual evoked potential (VEP) monitoring during prone spine surgeries under total intravenous anesthesia (TIVA) versus balanced general anesthesia using the SightSaver™ visual stimulator. The protocol was designed asa pilot, single center, prospective, randomized, and double-arm study. Subjects were randomized to receive either TIVA or balanced general anesthesia. Following induction and intubation, 8 electrodes were placed subcutaneously to collect VEP recordings. The SightSaver™ visual stimulator was placed on the subject's scalp before prone positioning. VEP waveforms were recorded every 30min and assessed by a neurophysiologist throughout the length of surgery. A total of 19 subjects were evaluated and VEP waveforms were successfully collected. TIVA group showed higher amplitude and lower latency than balanced anesthesia. Our data suggested that TIVA is associated with higher VEP amplitude and shorter latencies than balanced general anesthesia; therefore, TIVA could be the most efficient anesthesia regimen for VEP monitoring. The findings help to better understand the effect of different anesthesia regimens on intra-operative VEP monitoring. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients.

PubMed

Pacheco, Larissa Sgaria; Garcia, Valter Duro; Prá, Ronivan Luis Dal; Cardoso, Bruna Doleys; Rodrigues, Mariana Ferras; Zanetti, Helen Kris; Meinerz, Gisele; Neumann, Jorge; Gnatta, Diego; Keitel, Elizete

2018-05-14

Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients. This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV-positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors. Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between group (p-value G=0.286). Group 1 showed a higher incidence of dyslipidemia (p=0.03) and proteinuria events (p=0.01), while no difference was observed in the incidence of anemia (p=0.17), new onset of post-transplant diabetes mellitus (p=1.00) or urinary tract infection (p=0.60). The mean eGFR was similar in both groups. Our study did not show viral load decrease after conversion to EVR with maintenance of antiproliferative therapy.

Efficacy of two different dosages of levofloxacin in curing Helicobacter pylori infection: A Prospective, Single-Center, randomized clinical trial.

PubMed

Gan, Huo-Ye; Peng, Tie-Li; Huang, You-Ming; Su, Kai-Hua; Zhao, Lin-Li; Yao, Li-Ya; Yang, Rong-Jiao

2018-06-13

Bismuth + proton pump inhibitor (PPI) + amoxicillin + levofloxacin is one of the bismuth quadruple therapy regimens widely used for the eradication of H. pylori infection. The recommended dosage of levofloxacin is 500 mg once daily or 200 mg twice daily to eradicate H. pylori infection. The aim of the present open-label, randomized control trial was to compare the effectiveness, safety, and compliance of different dosages of levofloxacin used to cure Helicobacter pylori infection. Eligible patients were randomly assigned to receive esomeprazole, amoxicillin, colloidal bismuth pectin and levofloxacin 500 mg once/day (group A) or levofloxacin 200 mg twice/day (group B) for 14 days. The primary outcome was the eradication rates in the intention-to-treat (ITT) and per protocol (PP) analyses. Overall, 400 patients were enrolled. The eradication rates in group A and group B were 77.5% and 79.5% respectively, in the ITT analysis, and 82.9% and 86.4%, respectively, in the PP analysis. No significant differences were found between two groups in terms of eradication rate, adverse effects or compliance. Oral levofloxacin 200 mg twice daily was similar in efficacy for eradicating H. pylori infection to oral levofloxacin 500 mg once daily but with lower mean total costs.

Mandibular single-implant overdentures: a review with surgical and prosthodontic perspectives of a novel approach.

PubMed

Alsabeeha, Nabeel; Payne, Alan G T; De Silva, Rohana K; Swain, Michael V

2009-04-01

To review the literature on mandibular single-implant overdentures (opposing complete maxillary dentures), and present surgical and prosthodontic perspectives of a novel approach for this treatment option. An electronic search through the databases of Pubmed, Embase and Medline using the linked key words 'mandibular single implant overdentures' was performed. The search was limited to English language articles published up to August 2008. Hand searches through articles retrieved from the electronic search, peer-reviewed journals and recent conference proceedings were also conducted. A limited number of reports were identified on mandibular single-implant overdentures (opposing maxillary complete dentures). They comprised of case-series reports, short-term prospective trials and current randomized-controlled clinical trials. Different loading protocols with different implant systems have been used, but always with regular diameter implants. Specific anatomical and vascular dangers of the mandibular midline symphysis are identified including a novel surgical approach using a currently available short, wide diameter tapered implant. In addition, the prosthodontic rationale for using a larger attachment system (incorporating a platform switch) for mandibular single-implant overdentures is described. The review reveals that there is a lack of published randomized clinical trials using mandibular single-implant overdentures, opposing maxillary complete dentures. Without the evidence from randomized clinical trials, routine use of this novel approach cannot be recommended, compared with using regular diameter implants and matching attachment systems.

A randomized controlled comparison of flushing protocols in home care patients with peripherally inserted central catheters.

PubMed

Lyons, Margaret G; Phalen, Ann G

2014-01-01

Research has failed to demonstrate an optimal flushing solution or frequency for central catheters. In a 2002 study of 50 000 home care patients, catheter dysfunction with loss of patency was the most common complication and occurred in 29% of the peripherally inserted central catheters (PICCs) tracked. With the advent of the Affordable Care Act and the promise of expanded home care services, this study offers evidence as to a preferred flushing protocol to prevent catheter patency complications for home infusion patients with PICCs. This prospective, randomized, 1-way, single-blinded posttest with control group study was performed to compare 3 commonly used flushing protocols in home infusion patients with PICCs. The independent variable was the flushing protocol, and dependent variables included the development of patency-related complications and other significant issues such as sluggishness, occlusion, missed medication doses, catheter replacement, additional nursing visits, and the use of alteplase (Cathflo Activase). Each of the study groups had patients who experienced 1 or more patency-related complications. Additional factors that may affect catheter function, including patient age, gender, diagnosis, therapy type, frequency of catheter use, catheter brand/size/number of lumens, concomitant use of anticoagulant medications, and whether PICCs were used for routine lab testing, were analyzed, and no statistical significance was determined. Catheter dwell time (catheter days) was statistically significant (p = .003, confidence interval = 95%; assuming equal variance) and confirmed the assumption that the longer a home care patient's catheter was in place, the more complications occurred. There were no cases of heparin allergy, heparin-induced thrombocytopenia, or line infection. The data provide some evidence to support the elimination of heparin flushing in home care patients with PICCs, although data in the saline-only group that related to additional registered nurse visits to assess PICC patency and the use of alteplase (Cathflo Activase) were trending toward significance because this group experienced a higher incidence of these complications than both the heparin groups. These findings should not be translated to home care patients with cancer or pregnancy diagnoses because these populations were excluded from this study. More studies of this topic area should be initiated. Please see video abstract, Supplemental Digital Content 1, for more information (http://links.lww.com/JIN/A3).

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

Representing the work of medical protocols for organizational simulation.

PubMed Central

Fridsma, D. B.

1998-01-01

Developing and implementing patient care protocols within a specific organizational setting requires knowledge of the protocol, the organization, and the way in which the organization does its work. Computer-based simulation tools have been used in many industries to provide managers with prospective insight into problems of work process and organization design mismatch. Many of these simulation tools are designed for well-understood routine work processes in which there are few contingent tasks. In this paper, we describe theoretic that make it possible to simulate medical protocols using an information-processing theory framework. These simulations will allow medical administrators to test different protocol and organizational designs before actually using them within a particular clinical setting. PMID:9929231

The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication.

PubMed

Hong, Haeyeon; Mackey, William C

2014-08-01

Despite numerous efforts to develop effective medications for the treatment of intermittent claudication (IC) over the past 4 decades, a gold standard medical management option has yet to be defined. Although not life-threatening, IC interferes with mobility and activities of daily living, significantly impairing quality of life and potentially causing depression. Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in PubMed. The majority of included clinical trials were initially identified through the most recent Cochrane review articles as well as the FDA's approval packet for cilostazol. The technology appraisal guidance of the National Institute for Health and Care Excellence of the United Kingdom and the manufacturer's response to this guidance document were located via an online search engine. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect difficult. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted. The history of the evaluation, approval, and marketing of these drugs illustrates the limitations of data in the regulatory approval and marketing of agents whose benefit is subjective and difficult to quantify. Implementation of a standardized protocol with strict eligibility criteria, objective quantifiable measurement of drug effect, and validated endpoints will eventually allow development of an ideal pharmacotherapy for IC. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial.

PubMed

Tejera-Falcón, Emma; Toledo-Martel, Nuria Del Carmen; Sosa-Medina, Francisco Manuel; Santana-González, Fátima; Quintana-de la Fe, Miriam Del Pino; Gallego-Izquierdo, Tomás; Pecos-Martín, Daniel

2017-09-18

Shoulder pain of musculoskeletal origin is the main cause of upper limb pain of non-traumatic origin. Despite being one of the most common reasons for consultation, there is no established protocol for treatment due to the complexity of its etiology. However, it has been shown that the presence of myofascial trigger points on the shoulder muscles is a common condition associated with patients suffering from shoulder pain. This protocol has been created which describes the design of a randomized controlled trial to evaluate the effectiveness of the inclusion of dry needling (DN) within a protocol of manual physiotherapy and therapeutic exercise in the treatment of chronic shoulder pain of unspecific origin. Thirty-six participants aged 18-65 years will be recruited having mechanical chronic shoulder pain on unspecific origin and meeting the inclusion criteria. These will be randomized to one of two interventions, (i) DN, manual physiotherapy and therapeutic exercise or (ii) sham DN, manual physiotherapy and therapeutic exercise. The protocol will cover 6 weeks of treatment, with a 6-month follow-up. Our main outcome measure will be the Visual Analogue Scale for pain. This is the first study to combine the use of DN, manual physiotherapy and an exercise program with a 6-month follow-up, thus becoming a new contribution to the treatment of chronic shoulder pain, while new lines of research may be established to help determine the effects of DN on chronic shoulder pain and the frequency and proper dosage. International Standard Randomized Controlled Trial Number Register: ISRCTN30604244 ( http://www.controlled-trials.com ) 29 June 2016.

[The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

PubMed

Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

2017-01-01

In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

Improving the quality of colonoscopy bowel preparation using a smart phone application: a randomized trial.

PubMed

Lorenzo-Zúñiga, Vicente; Moreno de Vega, Vicente; Marín, Ingrid; Barberá, Marta; Boix, Jaume

2015-07-01

Getting ready for a colonoscopy is difficult and involves many steps. Information given to patients is very important for adherence to treatment. We created a novel smart phone application (SPA) aimed to increase bowel preparation quality and patient satisfaction. We carried out a prospective, endoscopist-blinded, randomized, controlled trial. We enrolled 260 outpatient (58% female, age range 21-75 years) owners of a smartphone. Patients were allocated to two different protocols: instructions provided by SPA (SPA group; n = 108) or written instructions with visual aids (control group; n = 152). All procedures were carried out in the afternoon and patients received the same purgative regimen (2 L polyethylene glycol (PEG) solution plus ascorbic acid), in a full-dose same-day regimen. The study was designed to detect an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS) scale. Effect of protocol on patient satisfaction was assessed with a specific questionnaire at the time of colonoscopy. Proportion of patients who obtained successful bowel preparation for colonoscopy (HCS A or B) was significantly higher in the SPA group than in the control group (100% vs 96.1%, respectively; P = 0.037). Mean global HCS scores were similar in both groups. Patient-reported tolerability and overall experience with the prescribed bowel preparation were significantly higher for the SPA group than for the control group. Successful cleansing and patient acceptability with the use of SPA were superior to written instructions in outpatients submitted for colonoscopy using 2 L PEG solution plus ascorbic acid. © 2015 The Authors. Digestive Endoscopy © 2015 Japan Gastroenterological Endoscopy Society.

Use of a GnRH antagonist in controlled ovarian hyperstimulation for assisted conception in women with polycystic ovary disease: a randomized, prospective, pilot study.

PubMed

Bahçeci, Mustafa; Ulug, Ulun; Ben-Shlomo, Izhar; Erden, Halit Firat; Akman, Mehmet Ali

2005-02-01

To compare the outcome of using gonadotropin-releasing hormone (GnRH) antagonists versus agonists in women with polycystic ovary disease (PCOD) who underwent controlled ovarian hyperstimulation (COH) for assisted reproductive techniques (ART). A total of 129 patients with PCOD were randomly allocated to undergo COH with a GnRH antagonist (59 patients) and GnRH agonist (leuprolide acetate) (70 patients) to prevent a premature luteinizing hormone (LH) surge. Assisted fertilization following oocyte retrieval and embryo transfer was performed. None of the cycles were cancelled due to a premature LH surge. There was no significant difference between the antagonist and agonist arms in the number of gonadotropin ampules consumed per cycle. However, in the antagonist arm a shorter duration of ovarian stimulation was recorded as compared to the agonist arm. Although similar numbers of oocytes was retrieved from both groups of patients, the quality of the oocytes, as measured by metaphase 2/total oocyte ratio, was lower in the antagonist arm as compared to the agonist arm. Pregnancy rates were 57.6% and 58.5% in the antagonist and agonist arms, respectively (p > 0.05). Implantation rates were not different (34.0% and 34.6%, respectively). The frequency of ovarian hyperstimulation syndrome also did not differ between the treatment groups (5% and 7.1%, respectively). The size of our study, on a specific subgroup of patients, does not allow a reliable conclusion regarding ART outcomefollowing the use of a GnRH antagonist versus agonist. Nevertheless, the protocol with the antagonist gave results that were as good as those of the protocol with the agonist in this PCOD patient population.

The impact of duty cycle workflow on sign-out practices: a qualitative study of an internal medicine residency program in Maryland, USA

PubMed Central

Lee, Soo-Hoon; Desai, Sanjay V

2017-01-01

Objectives Although JCAHO requires a standardised approach to handoffs, and while many standardised protocols have been tested, sign-out practices continue to vary. We believe this is due to the variability in workflow during inpatient duty cycle. We investigate the impact of such workflows on intern sign-out practices. Design We employed a prospective, grounded theory mixed-method design. Setting The study was conducted at a residency programme in the mid-Atlantic USA. Two observers randomly evaluated three types of daily sign-outs for 1 week every 3 months from September 2013 to March 2014. The compliance of each observed behaviour to JCAHO’s Handoff Communication Checklist was recorded. Participants Thirty one interns conducting 134 patient sign-outs were observed randomly among the 52 in the programme. Results In the 06:00 to 07:00 sign-back, the night-cover focused on providing information on overnight events to the day interns. In the 11:00 to 12:00 sign-out, the night-cover focused on transferring task accountability to a day-cover intern before departure. In the 20:00 to 21:00 sign-out, the day interns focused on transferring responsibility of their patients to a night-cover. Conclusion Different sign-out periods had different emphases regarding information exchange, personal responsibility and task accountability. Sign-outs are context-specific, implying that across-the-board standardised sign-out protocols are likely to have limited efficacy and compliance. Standardisation may need to be relative to the specific type and purpose of each sign-out to be supported by interns. PMID:28487461

Protocol for a prospective collaborative systematic review and meta-analysis of individual patient data from randomized controlled trials of vasoactive drugs in acute stroke: The Blood pressure in Acute Stroke Collaboration, stage-3.

PubMed

Sandset, Else Charlotte; Sanossian, Nerses; Woodhouse, Lisa J; Anderson, Craig; Berge, Eivind; Lees, Kennedy R; Potter, John F; Robinson, Thompson G; Sprigg, Nikola; Wardlaw, Joanna M; Bath, Philip M

2018-01-01

Rationale Despite several large clinical trials assessing blood pressure lowering in acute stroke, equipoise remains particularly for ischemic stroke. The "Blood pressure in Acute Stroke Collaboration" commenced in the mid-1990s focussing on systematic reviews and meta-analysis of blood pressure lowering in acute stroke. From the start, Blood pressure in Acute Stroke Collaboration planned to assess safety and efficacy of blood pressure lowering in acute stroke using individual patient data. Aims To determine the optimal management of blood pressure in patients with acute stroke, including both intracerebral hemorrhage and ischemic stroke. Secondary aims are to assess which clinical and therapeutic factors may alter the optimal management of high blood pressure in patients with acute stroke and to assess the effect of vasoactive treatments on hemodynamic variables. Methods and design Individual patient data from randomized controlled trials of blood pressure management in participants with ischemic stroke and/or intracerebral hemorrhage enrolled during the ultra-acute (pre-hospital), hyper-acute (<6 h), acute (<48 h), and sub-acute (<168 h) phases of stroke. Study outcomes The primary effect variable will be functional outcome defined by the ordinal distribution of the modified Rankin Scale; analyses will also be carried out in pre-specified subgroups to assess the modifying effects of stroke-related and pre-stroke patient characteristics. Key secondary variables will include clinical, hemodynamic and neuroradiological variables; safety variables will comprise death and serious adverse events. Discussion Study questions will be addressed in stages, according to the protocol, before integrating these into a final overreaching analysis. We invite eligible trials to join the collaboration.

Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

PubMed

Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

2016-03-01

Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

PubMed

Gerber, David E; Hamann, Heidi A; Santini, Noel O; Abbara, Suhny; Chiu, Hsienchang; McGuire, Molly; Quirk, Lisa; Zhu, Hong; Lee, Simon J Craddock

2017-09-01

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016. Copyright © 2017 Elsevier Inc. All rights reserved.

The influence of social networking sites on health behavior change: a systematic review and meta-analysis

PubMed Central

Laranjo, Liliana; Arguel, Amaël; Neves, Ana L; Gallagher, Aideen M; Kaplan, Ruth; Mortimer, Nathan; Mendes, Guilherme A; Lau, Annie Y S

2015-01-01

Objective Our aim was to evaluate the use and effectiveness of interventions using social networking sites (SNSs) to change health behaviors. Materials and methods Five databases were scanned using a predefined search strategy. Studies were included if they focused on patients/consumers, involved an SNS intervention, had an outcome related to health behavior change, and were prospective. Studies were screened by independent investigators, and assessed using Cochrane's ‘risk of bias’ tool. Randomized controlled trials were pooled in a meta-analysis. Results The database search retrieved 4656 citations; 12 studies (7411 participants) met the inclusion criteria. Facebook was the most utilized SNS, followed by health-specific SNSs, and Twitter. Eight randomized controlled trials were combined in a meta-analysis. A positive effect of SNS interventions on health behavior outcomes was found (Hedges’ g 0.24; 95% CI 0.04 to 0.43). There was considerable heterogeneity (I2 = 84.0%; T2 = 0.058) and no evidence of publication bias. Discussion To the best of our knowledge, this is the first meta-analysis evaluating the effectiveness of SNS interventions in changing health-related behaviors. Most studies evaluated multi-component interventions, posing problems in isolating the specific effect of the SNS. Health behavior change theories were seldom mentioned in the included articles, but two particularly innovative studies used ‘network alteration’, showing a positive effect. Overall, SNS interventions appeared to be effective in promoting changes in health-related behaviors, and further research regarding the application of these promising tools is warranted. Conclusions Our study showed a positive effect of SNS interventions on health behavior-related outcomes, but there was considerable heterogeneity. Protocol registration The protocol for this systematic review is registered at http://www.crd.york.ac.uk/PROSPERO with the number CRD42013004140. PMID:25005606

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial.

PubMed

Günter, Christina Irene; Bader, Augustinus; Dornseifer, Ulf; Egert, Silvia; Dunda, Sebastian; Grieb, Gerrit; Wolter, Thomas; Pallua, Norbert; von Wild, Tobias; Siemers, Frank; Mailänder, Peter; Thamm, Oliver; Ernert, Carsten; Steen, Michael; Sievers, Reiner; Reichert, Bert; Rahmanian-Schwarz, Afshin; Schaller, Hans; Hartmann, Bernd; Otte, Max; Kehl, Victoria; Ohmann, Christian; Jelkmann, Wolfgang; Machens, Hans-Günther

2013-05-03

Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage. This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences. We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries. EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.

Optimal duration of fasting period after endoscopic submucosal dissection for gastric epithelial neoplasia: A prospective evaluation.

PubMed

Oh, Kwang Hoon; Lee, Sang Jin; Park, Jong Kyu

2017-08-01

There are currently no standardized guidelines for adequately determining the fasting period following gastric endoscopic submucosal dissection (ESD). The aim of this study was to determine the appropriate fasting period. The enrolled patients were randomized into a short and a long-fasting group. In the short-fasting group, patients had fasted until the day after the ESD. In the long-fasting group, patients had fasted until 2 days after the ESD. A second-look endoscopy was performed immediately prior to starting to eat meals. The primary end-point was the measurement of discomfort-related ESD after starting meals such as epigastric pain, heartburn, regurgitation, nausea and vomiting. Secondary end-points included the bleeding rate after starting meals, hospital stay, patient satisfaction and hemostasis upon second-look endoscopy. We analyzed data from 101 of 110 randomized patients. Both groups demonstrated similar baseline characteristics. There were no significant differences in reports of epigastric pain, heartburn, regurgitation, nausea and vomiting after starting meals. Both groups demonstrated similar hemostasis rates upon second-look endoscopy (26% vs 31.4%, P = 0.551) and bleeding rate (4% vs 0%, P = 0.149). The duration of hospital stay was significantly shorter in the short-fasting group (4.3 days vs 5.1 days, P < 0.001), and patient satisfaction was greater (P = 0.003) than in the long-fasting group. A short fasting protocol does not cause discomfort related to ESD or influence post-ESD bleeding. Moreover, the short fasting protocol results in shorter hospital stays and greater patient satisfaction. © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Comparison between two physiotherapy protocols for patients with chronic kidney disease on dialysis

PubMed Central

Neto, José Roberto Sostena; Figueiredo e Castro, Letícia Magalhães; Santos de Oliveira, Fernanda; Silva, Andréia Maria; Maria dos Reis, Luciana; Quirino, Ana Paula Assunção; Dragosavac, Desanka; Kosour, Carolina

2016-01-01

[Purpose] To compare the effects of two physiotherapy protocols for chronic kidney disease patients on dialysis. [Subjects and Methods] This is a prospective, randomized study, in chronic kidney disease patients 18 years of age or older on dialysis. Sessions for each group (were conducted three times per week for a total of 10 sessions), during hemodialysis. Respiratory muscle strength (maximal inspiratory and expiratory pressure), peak expiratory flow, and peripheral muscle strength were evaluated. The study group received motor and respiratory physiotherapy, and the control group received motor physiotherapy alone. [Results] We observed a significant increase in the maximal inspiratory pressure in the study group in the 5th and 10th sessions and in the maximal expiratory pressure in the 1st session, peak flow in the 1st and 10th sessions, and dynamometry in the 10th session. In the control group, there was a significant decrease in maximal inspiratory pressure in the 5th and 10th sessions, and in maximal expiratory pressure in the 10th session, peak flow in the 5th and 10th sessions, and dynamometry in the 5th session. [Conclusion] Implementation of motor physiotherapy combined with respiratory physiotherapy may have contributed to the improvement of the variables analyzed in the study group. PMID:27313390

Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial.

PubMed

Dedering, Åsa; Halvorsen, Marie; Cleland, Joshua; Svensson, Mikael; Peolsson, Anneli

2014-08-12

Patients with cervical radiculopathy often have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods. The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity. The current protocol is a two armed intervention randomised clinical trial comparing the outcomes of patients receiving neck specific training or prescribed physical activity. A total of 144 patients with cervical radiculopathy will be randomly allocated to either of the two interventions. The interventions will be delivered by experienced physiotherapists and last 14 weeks. The primary outcome variable is neck- and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at 3, 6, 12 and 24 months after base-line assessment. We anticipate that the results of this study will provide evidence to support recommendations as to the effectiveness of conservative interventions for patients with cervical radiculopathy. ClinicalTrials.gov identifier: NCT01831271.

Factors influencing early rehabilitation after THA: a systematic review.

PubMed

Sharma, Vivek; Morgan, Patrick M; Cheng, Edward Y

2009-06-01

A wide variation exists in rehabilitation after total hip arthroplasty (THA) in part due to a paucity of evidence-based literature. We asked whether a minimally invasive surgical approach, a multimodal approach to pain control with revised anesthesia protocols, hip restrictions, or preoperative physiotherapy achieved a faster rehabilitation and improved immediate short-term outcome. We conducted a systematic review of 16 level I and II studies after a strategy-based search of English literature on OVID Medline, PubMed, CINAHL, Cochrane, and EMBASE databases. We defined the endpoint of assessment as independent ambulation and ability to perform activities of daily living. Literature supports the use of a multimodal pain control to improve patient compliance in accelerated rehabilitation. Multimodal pain control with revised anesthesia protocols and accelerated rehabilitation speeds recovery after minimally invasive THA compared to the standard approach THA, but a smaller incision length or minimally invasive approach does not demonstrably improve the short-term outcome. Available studies justify no hip restrictions following an anterolateral approach but none have examined the question for a posterior approach. Preoperative physiotherapy may facilitate faster postoperative functional recovery but multicenter and well-designed prospective randomized studies with outcome measures are necessary to confirm its efficacy. Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Comparison of pain perception during miniscrew placement in orthodontic patients with a visual analog scale survey between compound topical and needle-injected anesthetics: A crossover, prospective, randomized clinical trial.

PubMed

Lamberton, Jordan A; Oesterle, Larry J; Shellhart, W Craig; Newman, Sheldon M; Harrell, Ricky E; Tilliss, Terri; Singh, Neha; Carey, Clifton M

2016-01-01

The use of a compound topical anesthetic (CTA) instead of an injection of a local anesthetic for placing miniscrew implants offers advantages to both the clinician and the patient. The purpose of this crossover, prospective, randomized clinical trial was to compare the clinical effectiveness of a CTA with that of a needle injection of local anesthetic for miniscrew placement. Twenty-four orthodontic patients in a university clinic were recruited; they required bilateral buccal miniscrews for orthodontic anchorage. Eligibility criteria included healthy patients with no special needs; over 8 years of age and 25 pounds; not taking sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines; and not allergic to ester-type local anesthetics or any of the other materials used in the study. A computer generated a randomization list. The allocation was randomized by anesthetic protocol and side of the mouth, and was restricted to achieve balance by treatment and side of the mouth. No allocation concealment was applied. Associated with each randomized number was the subjects' assignment into 1 of 4 groups divided by the side of first miniscrew placement and the type of anesthetic. Blinding was done only for data analysis because of clinical limitations. Each patient received a CTA on one side and an injection of anesthetic on the other before miniscrew placement in a crossover study design. The outcome was assessed by measuring pain levels with a 100-mm visual analog scale at 5 time points. Anesthetic failures occurred when the miniscrew could not be fully comfortably placed with a given anesthetic. Data were organized by visual analog scale time points, and descriptive statistics were calculated. A factorial repeated-measures analysis of variance was used to determine any differences. Twenty-seven patients were assessed for eligibility, and 24 agreed to participate in the study. Patients did not distinguish any differences in pain between the application of the CTA and the injection before or during anesthetic placement, but they experienced more pain with the CTA during miniscrew placement. The mean difference for the entire procedure between the 2 anesthesia types was 24.6 units, and the 95% confidence interval was 18.8 to 30.4, a statistically significant finding (P = 0.0002). The CTA was still viewed as more painful 1 month after the procedures. Significantly more anesthetic failures occurred with the CTA (41.6%) than with the injection (0%). No serious harm was observed in any patient; when significant pain was observed with the CTA, a needle injection of local anesthetic was administered. CTAs provided less predictable, often inadequate, and less comfortable anesthesia than an injection of a local anesthetic for managing patient discomfort during miniscrew placement in buccal sites. This trial was not registered. The protocol was determined and approved by the research committee and institutional review board before the trial. No external funding was used other than the donation of the miniscrews from Rocky Mountain Orthodontics, and no conflict of interest was declared. Copyright © 2016. Published by Elsevier Inc.

A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

PubMed

Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

2017-01-01

Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, p<0.001. The novel protocol resulted in deeper chest compressions (mean (SD): 58 (12)mm vs. 52 (13)mm, p=0.02) and improved rate of correct hand position (61% vs. 36%, p=0.01) compared with the standard protocol. In both protocols hands-off time was short. The novel protocol improved motivation among rescuers compared with the standard protocol (p=0.002). Participants guided with a standard dispatch protocol performed high quality CPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Prospective Intervention of a Novel Levothyroxine Dosing Protocol Based on Body Mass Index after Thyroidectomy.

PubMed

Elfenbein, Dawn M; Schaefer, Sarah; Shumway, Cynthia; Chen, Herbert; Sippel, Rebecca S; Schneider, David F

2016-01-01

Weight-based postoperative levothyroxine (LT4) dosing often fails to appropriately dose overweight and underweight patients. Previously, we created an LT4-dosing algorithm based on BMI. We hypothesize that more patients will achieve euthyroidism at their postoperative visit with the use of the protocol. A prospective evaluation was performed of our previously published BMI-based LT4 dosing. All adults who underwent thyroidectomy for benign disease between January 1, 2011 and December 31, 2013 were included; the new protocol was implemented in October 2012. Serum TSH was measured for all patients 6 to 8 weeks postoperatively, and adjustments were based on TSH. Three hundred and thirty patients were included, with 54% undergoing thyroidectomy after institution of the protocol. The groups were well matched. Before protocol implementation, LT4 was dosed solely by weight and 25% of patients were euthyroid at initial follow-up. After the protocol, 39% of patients were euthyroid (p = 0.01). The percentage of patients who were given too high a dose of LT4 remained the same (46% vs 42%), and there was a significant reduction in the number of patients who were given too little (29% vs 19%; p = 0.05). The effect was most profound in patients with low and normal BMI, and there were slight differences between sexes. Although correct initial dosing of LT4 remains challenging, this dosing protocol that we developed and implemented has improved patient care by increasing the number of patients who achieve euthyroidism at the first postoperative visit. We have made a change to our original protocol to incorporate sex differences into the calculation. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.

PubMed

Donovan, Jenny L; Young, Grace J; Walsh, Eleanor I; Metcalfe, Chris; Lane, J Athene; Martin, Richard M; Tazewell, Marta K; Davis, Michael; Peters, Tim J; Turner, Emma L; Mills, Nicola; Khazragui, Hanan; Khera, Tarnjit K; Neal, David E; Hamdy, Freddie C

2018-04-01

Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. Population-based cluster randomization created a prospective study of prostate-specific antigen (PSA) testing and a comprehensive-cohort study including groups choosing treatment or excluded from the RCT, as well as those randomized. Baseline information assessed selection and response during RCT conduct. The prospective study (82,430 PSA-tested men) represented healthy men likely to respond to a screening invitation. The extended comprehensive cohort comprised 1,643 randomized, 997 choosing treatment, and 557 excluded with advanced cancer/comorbidities. Men choosing treatment were very similar to randomized men except for having more professional/managerial occupations. Excluded men were similar to the randomized socio-demographically but different clinically, representing less healthy men with more advanced PCa. The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Evaluation of a High Concentrated Contrast Media Injection Protocol in Combination with Low Tube Current for Dose Reduction in Coronary Computed Tomography Angiography: A Randomized, Two-center Prospective Study.

PubMed

Sun, Yibo; Hua, Yanqing; Wang, Mingpeng; Mao, Dingbiao; Jin, Xiu; Li, Cheng; Shi, Kailei; Xu, Jianrong

2017-12-01

The study aimed to prospectively evaluate the radiation dose reduction potential and image quality (IQ) of a high-concentration contrast media (HCCM) injection protocol in combination with a low tube current (mAs) in coronary computed tomography angiography. Eighty-one consecutive patients (mean age: 62 years; 34 females; body mass index: 18-31) were included and randomized-assigned into two groups. All computed tomography (CT) examinations were performed in two groups with the same tube voltage (100 kV), flow rate of contrast medium (5.0 mL/s), and iodine dose (22.8 g). An automatic mAs and low concentration contrast medium (300 mgI/mL) were used in group A, whereas effective mAs was reduced by a factor 0.6 along with HCCM (400 mgI/mL) in group B. Radiation dose was assessed (CT dose index [CTDI vol ] and dose length product), and vessel-based objective IQ for various regions of interest (enhancement, noise, signal-to-noise ratio, and contrast-to-noise ratio), subjective IQ, noise, and motion artifacts were analyzed overall and vessel-based with a 5-point Likert scale. The CT attenuation of coronary arteries and image noise in group B were significantly higher than those in group A (ranges: 507.5-548.1 Hounsfield units vs 407.5-444.5 Hounsfield units; and 20.3 ± 8.6 vs 17.7 ± 8.0) (P ≤ 0.0166). There was no significant difference between the two groups in signal-to-noise ratio, contrast-to-noise ratio, and subjective IQ of coronary arteries (29.4-31.7, 30.0-37.0, and medium score of 5 in group A vs 29.4-32.4, 27.7-36.3, and medium score of 5 in group B, respectively, P ≥ 0.1859). Both mean CTDI vol and dose length product in group B were 58% of those of group A. HCCM combined with low tube current allows dose reduction in coronary computed tomography angiography and does not compromise IQ. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Comparative Efficacy and Durability of Continuation Phase Cognitive Therapy for Preventing Recurrent Depression: Design of a Double-Blinded, Fluoxetine- and Pill-Placebo–Controlled, Randomized Trial with 2-Year Follow-up

PubMed Central

Thase, Michael E.

2010-01-01

Background Major depressive disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower versus higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24-months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12–14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression ≤ 12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete (N=523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide. PMID:20451668

Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design.

PubMed

Rush, A John; Fava, Maurizio; Wisniewski, Stephen R; Lavori, Philip W; Trivedi, Madhukar H; Sackeim, Harold A; Thase, Michael E; Nierenberg, Andrew A; Quitkin, Frederic M; Kashner, T Michael; Kupfer, David J; Rosenbaum, Jerrold F; Alpert, Jonathan; Stewart, Jonathan W; McGrath, Patrick J; Biggs, Melanie M; Shores-Wilson, Kathy; Lebowitz, Barry D; Ritz, Louise; Niederehe, George

2004-02-01

STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.

The Hypertension Optimal Treatment (HOT) Study--patient characteristics: randomization, risk profiles, and early blood pressure results.

PubMed

Hansson, L; Zanchetti, A

1994-09-01

The Hypertension Optimal Treatment (HOT) Study is a prospective, randomized, multicenter trial being conducted in 26 countries. Its main aim is to evaluate the relationship between three levels of target diastolic blood pressure (< or = 90, < or = 85 or < or = 80 mmHg) and cardiovascular morbidity and mortality in hypertensive patients. In addition, the study will examine the effects on morbidity and mortality of a low dose, 75 mg daily, of acetylsalicylic acid (ASA, aspirin) or placebo. In the HOT Study, basic antihypertensive treatment is initiated with the calcium antagonist felodipine at a dose of 5 mg daily. If target blood pressure is not reached, additional antihypertensive therapy with either an angiotensin converting enzyme (ACE) inhibitor or a beta-adrenoceptor blocking agent is given. Further dosage adjustments are made in accordance with a set protocol. As a fifth and final step, a diuretic may be added. Inclusion of patients was stopped on April 30, 1994. At that time 19,196 patients had been randomized. There were 9,055 (47%) women and 10,141 (53%) men with an average age of 61.5 +/- 7.5 (SD) years. At enrollment, 52% of patients were receiving antihypertensive treatment. These patients entered a wash-out period of at least 2 weeks before randomization. The average randomization blood pressure in untreated patients was 169 +/- 14/106 +/- 3 mmHg and in the treated patients 170 +/- 14/105 +/- 3 mmHg. On August 15, 1994, blood pressure data were available for 14,710 and 10,275 patients, who had completed 3 and 6 months treatment, respectively. The average reduction in diastolic blood pressure was 22 mmHg after 6 months.(ABSTRACT TRUNCATED AT 250 WORDS)

Improving prospective memory in persons with Parkinson disease: A randomized controlled trial

PubMed Central

Foster, Erin R.; McDaniel, Mark A.; Rendell, Peter G.

2017-01-01

Background Prospective memory is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause prospective memory deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions is an encoding strategy that may improve prospective memory in this population. Objective To determine the effect of implementation intentions on prospective memory performance in PD. Methods This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (N = 62) performed a computerized prospective memory test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either implementation intentions or a rehearsal encoding strategy. Results Prospective memory performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared to time-based cues. In addition, implementation intentions resulted in a larger effect than rehearsal for the non-repeated tasks. Conclusions Strategies that support full encoding of prospective memory cues and actions can improve prospective memory performance among people with PD, particularly for tasks with cues that are readily available in the environment. Implementation intentions may be more effective than rehearsal for non-repeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage prospective memory impairment could improve function and quality of life and significantly impact clinical care for people with PD. (NCT01469741) PMID:28176547

Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE).

PubMed

de Parisot, Audrey; Kodjikian, Laurent; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Broussolle, Christiane; Decullier, Evelyne; Sève, Pascal

2017-06-01

To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis. Noninferiority, prospective, multicenter, clustered randomized controlled trial. Consecutive patients with uveitis, who visited 1 of the participating departments of ophthalmology, were included. In the standardized group, all patients had a minimal evaluation regardless of the type of uveitis (complete blood count, erythrocyte sedimentation rate, C-reactive protein, tuberculin skin test, syphilis serology, and chest radiograph) followed by more complex investigations according to ophthalmologic findings. In the open group, the ophthalmologist could order any type of investigation. Main outcome was the percentage of etiologic diagnoses at 6 months. Nine hundred and three patients with uveitis were included from January 2010 to May 2013 and the per-protocol population comprised 676 patients (open 373; standardized 303). Mean age at diagnosis was 46 years. Anatomic distribution of uveitis was as follows: anterior (60.8% and 72.3%, P = .0017), intermediate (11.7% and 12.3%, P = .8028), posterior (17.8% and 8.2%, P = .0004), and panuveitis (15.3% and 15.2%, P = .9596). An etiologic diagnosis was established in 54.4% of cases in the open group and 49.5% in the standardized group (P = .2029). The difference between both strategies (standardized minus open) was -4.9% (95% CI [-12.5%; 2.6%]). There were more investigations in the open group than in the standardized group (5371 vs 3759, P < .0001). The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved. Copyright © 2017 Elsevier Inc. All rights reserved.

Role of antibiotic prophylaxis in antenatal hydronephrosis: A systematic review from the European Association of Urology/European Society for Paediatric Urology Guidelines Panel.

PubMed

Silay, Mesrur Selcuk; Undre, Shabnam; Nambiar, Arjun K; Dogan, Hasan Serkan; Kocvara, Radim; Nijman, Rien J M; Stein, Raimund; Tekgul, Serdar; Radmayr, Christian

2017-06-01

The benefits and harms of continuous antibiotic prophylaxis (CAP) versus observation in patients with antenatal hydronephrosis (ANH) are controversial. The aim was to determine the effectiveness of CAP for ANH, and if beneficial to determine the best type and regimen of antibiotic and the most harmful to provide guidance for clinical practice. A systematic literature search was performed in databases including Medline, Embase, and Cochrane in June 2015. The protocol was prospectively registered to PROSPERO (CRD42015024775). The search started from 1980, when maternal ultrasound was first introduced into clinical practice. Eligible studies were critically evaluated for risk of bias using Revman software. The outcomes included reduction in urinary tract infections (UTI), drug-related adverse events and kidney functions. Of 797 articles identified, 57 full text articles and six abstracts were eligible for inclusion (2 randomized controlled trials, 11 non-randomized comparative studies, and 50 case series). It remains unclear whether CAP is superior to observation in decreasing UTIs. No conclusion could be drawn for drug-related adverse events and kidney function because of lack of data. Children who were not circumcised, with ureteral dilatation, and high-grade hydronephrosis may be more likely to develop UTI, and CAP may be warranted for these subgroups of patients. A majority of the studies had low-to-moderate quality of evidence and with high risk of bias. The benefits of CAP in a heterogeneous group of children with ANH involving different etiologies remains unproven. However, the evidence in the form of prospective and retrospective observational studies has shown that it reduces febrile UTI in particular subgroups. Copyright © 2017 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

The 2012 Chitranjan Ranawat award: intraarticular analgesia after TKA reduces pain: a randomized, double-blinded, placebo-controlled, prospective study.

PubMed

Goyal, Nitin; McKenzie, James; Sharkey, Peter F; Parvizi, Javad; Hozack, William J; Austin, Matthew S

2013-01-01

Postoperative pain after total knee arthroplasty remains one of the most important challenges facing patients undergoing this surgery. Providing a balance of adequate analgesia while limiting the functional impact of regional anesthesia and minimizing opioid side effects is critical to minimize adverse events and improve patient satisfaction. We asked whether bupivacaine delivered through an elastomeric device decreases the (1) patients' perception of pain after TKA; (2) narcotic consumption; and (3) narcotic-related side effects as compared with a placebo. In this prospective, double-blind, placebo-controlled study, all patients received standardized regional anesthesia, a preemptive and multimodal analgesic protocol, and a continuous intraarticular infusion at 5 mL/hour through an elastomeric infusion pump. The patients were randomized to receive either an infusion pump filled with (1) 300 mL of 0.5% bupivacaine, the experimental group (n = 75); or (2) 300 mL of 0.9% normal saline solution, the control group (n = 75). Data concerning postoperative pain levels through a visual analog scale, postoperative opioid consumption, opioid-related side effects, and complications were collected and analyzed. Patients in the experimental group receiving the bupivacaine reported a reduction in pain levels in highest, lowest, and current visual analog scale scores compared with the placebo group on the first postoperative day and highest visual analog scale score on postoperative Day 2 along with a 33% reduction in opioid consumption on postoperative Day 2 and a 54% reduction on postoperative Day 3. In patients undergoing TKA, continuous intraarticular analgesia provided an effective adjunct for pain relief in the immediate postoperative period without the disadvantages encountered with other analgesic methods.

Transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: a protocol for a network meta-analysis.

PubMed

You, Tao; Yi, Kang; Ding, Zhao-Hong; Hou, Xiao-Dong; Liu, Xing-Guang; Wang, Xin-Kuan; Ge, Long; Tian, Jin-Hui

2017-06-21

Both transcatheter device closure and surgical repair are effective treatments with excellent midterm outcomes for perimembranous ventricular septal defects (pmVSDs) in children. The mini-invasive periventricular device occlusion technique has become prevalent in research and application, but evidence is limited for the assessment of transcatheter closure, mini-invasive closure and open-heart surgical repair. This study comprehensively compares the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of pmVSDs in children using Bayesian network meta-analysis. A systematic search will be performed using Chinese Biomedical Literature Database, China National Knowledge Infrastructure, PubMed, EMBASE.com and the Cochrane Central Register of Controlled Trials to include random controlled trials, prospective or retrospective cohort studies comparing the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair. The risk of bias for the included prospective or retrospective cohort studies will be evaluated according to the risk of bias in non-randomised studies of interventions (ROBINS-I). For random controlled trials, we will use risk of bias tool from Cochrane Handbook version 5.1.0. A Bayesian network meta-analysis will be conducted using R-3.3.2 software. Ethical approval and patient consent are not required since this study is a network meta-analysis based on published trials. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication. CRD42016053352. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double-blind, placebo-controlled trial.

PubMed

Serón, Daniel; Oppenheimer, Federico; Pallardó, Luis M; Lauzurica, Ricardo; Errasti, Pedro; Gomez-Huertas, Ernesto; Bosmans, Jean Louis; Sanchez-Plumed, Jaime; Romero, Rafael; Marques, María; Fulladosa, Xavier; Moreso, Francesc

2008-07-15

Statins prevent the progression of transplant vasculopathy in heart transplants, but its beneficial effect on the transplanted kidney is controversial. The aim is to evaluate the utility of fluvastatin 80 mg/day to reduce the progression of 6-month renal transplant vasculopathy in a multicenter, prospective, randomized, placebo-controlled trial stratified according to donor age. All patients received cyclosporine, mycophenolate mofetil, and prednisone. The progression of transplant vasculopathy was evaluated in paired donor and 6-month protocol biopsies. The primary efficacy variable was the progression of mean arterial intimal volume fraction (deltaVvintima/artery) evaluated with histomorphometry. The minimum sample size to detect a 50% reduction in the progression of deltaVvintima/artery was 62 patients per group. The secondary efficacy variable included the incidence of transplant vasculopathy evaluated according to Banff criteria. A total of 89 patients were included, 74 completed the 6-month study and 57 have paired biopsies with sufficient tissue for histological evaluation. The deltaVvintima/artery was not different between treatment and placebo groups (6.9+/-8.2% vs. 6.9+/-7.4%, P=ns), whereas the incidence of transplant vasculopathy was lower in the fluvastatin group (7% vs. 33%; P=0.02). Because there was a discrepancy between the primary and secondary efficacy variables, post hoc analysis was performed to evaluate the reproducibility of both variables in a subset of 50 biopsies. The reproducibility of transplant vasculopathy was higher than the reproducibility of Vvintima/artery (kappa 0.86 vs. 0.33). In summary, there were no differences in deltaVvintima/artery between groups, but fluvastatin treatment was associated with a reduced incidence of transplant vasculopathy.

Lung donor treatment protocol in brain dead-donors: A multicenter study.

PubMed

Miñambres, Eduardo; Pérez-Villares, Jose Miguel; Chico-Fernández, Mario; Zabalegui, Arturo; Dueñas-Jurado, Jose María; Misis, Maite; Mosteiro, Fernando; Rodriguez-Caravaca, Gil; Coll, Elisabeth

2015-06-01

The shortage of lung donors for transplantation is the main limitation among patients awaiting this type of surgery. We previously demonstrated that an intensive lung donor-treatment protocol succeeded in increasing the lung procurement rate. We aimed to validate our protocol for centers with or without lung transplant programs. A quasi-experimental study was performed to compare lung donor rate before (historical group, 2010 to 2012) and after (prospective group, 2013) the application of a lung management protocol for donors after brain death (DBDs) in six Spanish hospitals. Lung donor selection criteria remained unchanged in both periods. Outcome measures for lung recipients were early survival and primary graft dysfunction (PGD) rates. A total of 618 DBDs were included: 453 in the control period and 165 in the protocol period. Donor baseline characteristics were similar in both periods. Lung donation rate in the prospective group was 27.3%, more than twice that of the historical group (13%; p < 0.001). The number of lungs retrieved, grafts transplanted, and transplants performed more than doubled over the study period. No differences in early recipients' survival between groups were observed (87.6% vs. 84.5%; p = 0.733) nor in the rate of PGD. Implementing our intensive lung donor-treatment protocol increases lung procurement rates. This allows more lung transplants to be performed without detriment to either early survival or PGD rate. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Evaluation of a Sexual Assault Risk Reduction and Self-Defense Program: A Prospective Analysis of a Revised Protocol

ERIC Educational Resources Information Center

Orchowski, Lindsay M.; Gidycz, Christine A.; Raffle, Holly

2008-01-01

The current study extends the development and evaluation of an existing and previously evaluated sexual assault risk reduction program with a self-defense component for college women (N = 300). The program protocol was revised to address psychological barriers to responding assertively to risky dating situations, and a placebo-control group was…

Implementing clinical protocols in oncology: quality gaps and the learning curve phenomenon.

PubMed

Kedikoglou, Simos; Syrigos, Konstantinos; Skalkidis, Yannis; Ploiarchopoulou, Fani; Dessypris, Nick; Petridou, Eleni

2005-08-01

The quality improvement effort in clinical practice has focused mostly on 'performance quality', i.e. on the development of comprehensive, evidence-based guidelines. This study aimed to assess the 'conformance quality', i.e. the extent to which guidelines once developed are correctly and consistently applied. It also aimed to assess the existence of quality gaps in the treatment of certain patient segments as defined by age or gender and to investigate methods to improve overall conformance quality. A retrospective audit of clinical practice in a well-defined oncology setting was undertaken and the results compared to those obtained from prospectively applying an internally developed clinical protocol in the same setting and using specific tools to increase conformance quality. All indicators showed improvement after the implementation of the protocol that in many cases reached statistical significance, while in the entire cohort advanced age was associated (although not significantly) with sub-optimal delivery of care. A 'learning curve' phenomenon in the implementation of quality initiatives was detected, with all indicators improving substantially in the second part of the prospective study. Clinicians should pay separate attention to the implementation of chosen protocols and employ specific tools to increase conformance quality in patient care.

Quantum random oracle model for quantum digital signature

NASA Astrophysics Data System (ADS)

Shang, Tao; Lei, Qi; Liu, Jianwei

2016-10-01

The goal of this work is to provide a general security analysis tool, namely, the quantum random oracle (QRO), for facilitating the security analysis of quantum cryptographic protocols, especially protocols based on quantum one-way function. QRO is used to model quantum one-way function and different queries to QRO are used to model quantum attacks. A typical application of quantum one-way function is the quantum digital signature, whose progress has been hampered by the slow pace of the experimental realization. Alternatively, we use the QRO model to analyze the provable security of a quantum digital signature scheme and elaborate the analysis procedure. The QRO model differs from the prior quantum-accessible random oracle in that it can output quantum states as public keys and give responses to different queries. This tool can be a test bed for the cryptanalysis of more quantum cryptographic protocols based on the quantum one-way function.

Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.

PubMed

Jüttler, Eric; Schwab, Stefan; Schmiedek, Peter; Unterberg, Andreas; Hennerici, Michael; Woitzik, Johannes; Witte, Steffen; Jenetzky, Ekkehart; Hacke, Werner

2007-09-01

Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached, patient enrollment was interrupted as per protocol until recalculation of the projected sample size was performed on the basis of the 6-month outcome (primary end point=modified Rankin Scale score, dichotomized to 0 to 3 versus 4 to 6). All analyses were based on intention to treat. A statistically significant reduction in mortality was reached after 32 patients had been included: 15 of 17 (88%) patients randomized to hemicraniectomy versus 7 of 15 (47%) patients randomized to conservative therapy survived after 30 days (P=0.02). After 6 and 12 months, 47% of patients in the surgical arm versus 27% of patients in the conservative treatment arm had a modified Rankin Scale score of 0 to 3 (P=0.23). DESTINY showed that hemicraniectomy reduces mortality in large hemispheric stroke. With 32 patients included, the primary end point failed to demonstrate statistical superiority of hemicraniectomy, and the projected sample size was calculated to 188 patients. Despite this failure to meet the primary end point, the steering committee decided to terminate the trial in light of the results of the joint analysis of the 3 European hemicraniectomy trials.

Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

PubMed Central

Dubbert, Patricia M.

2017-01-01

Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7) years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS)) and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life) were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9) compared to the control group (0.5; 95% CI, −0.3–1.3) at 8 weeks (average intergroup difference (95% CI), 5.5 (4.3–6.7), p < 0.001) after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045. PMID:28261500

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

PubMed

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial): assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial.

PubMed

Rafiq, Sulman; Johansson, Pär Ingemar; Zacho, Mette; Stissing, Trine; Kofoed, Klaus; Lilleør, Nikolaj Bang; Steinbrüchel, Daniel Andreas

2012-04-27

Hypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively. This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg) together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT) at three months after surgery. The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy. Clinicaltrials.gov Identifier NCT01046942.

An empirical evaluation of lightweight random walk based routing protocol in duty cycle aware wireless sensor networks.

PubMed

Mian, Adnan Noor; Fatima, Mehwish; Khan, Raees; Prakash, Ravi

2014-01-01

Energy efficiency is an important design paradigm in Wireless Sensor Networks (WSNs) and its consumption in dynamic environment is even more critical. Duty cycling of sensor nodes is used to address the energy consumption problem. However, along with advantages, duty cycle aware networks introduce some complexities like synchronization and latency. Due to their inherent characteristics, many traditional routing protocols show low performance in densely deployed WSNs with duty cycle awareness, when sensor nodes are supposed to have high mobility. In this paper we first present a three messages exchange Lightweight Random Walk Routing (LRWR) protocol and then evaluate its performance in WSNs for routing low data rate packets. Through NS-2 based simulations, we examine the LRWR protocol by comparing it with DYMO, a widely used WSN protocol, in both static and dynamic environments with varying duty cycles, assuming the standard IEEE 802.15.4 in lower layers. Results for the three metrics, that is, reliability, end-to-end delay, and energy consumption, show that LRWR protocol outperforms DYMO in scalability, mobility, and robustness, showing this protocol as a suitable choice in low duty cycle and dense WSNs.

A Randomized 2x2 Factorial Clinical Trial of Renal Transplantation: Steroid-Free Maintenance Immunosuppression with Calcineurin Inhibitor Withdrawal after Six Months Associates with Improved Renal Function and Reduced Chronic Histopathology

PubMed Central

Stevens, R. Brian; Foster, Kirk W.; Miles, Clifford D.; Kalil, Andre C.; Florescu, Diana F.; Sandoz, John P.; Rigley, Theodore H.; Malik, Tamer; Wrenshall, Lucile E.

2015-01-01

Introduction The two most significant impediments to renal allograft survival are rejection and the direct nephrotoxicity of the immunosuppressant drugs required to prevent it. Calcineurin inhibitors (CNI), a mainstay of most immunosuppression regimens, are particularly nephrotoxic. Until less toxic antirejection agents become available, the only option is to optimize our use of those at hand. Aim To determine whether intensive rabbit anti-thymocyte globulin (rATG) induction followed by CNI withdrawal would individually or combined improve graft function and reduce graft chronic histopathology–surrogates for graft and, therefore, patient survival. As previously reported, a single large rATG dose over 24 hours was well-tolerated and associated with better renal function, fewer infections, and improved patient survival. Here we report testing whether complete CNI discontinuation would improve renal function and decrease graft pathology. Methods Between April 20, 2004 and 4-14-2009 we conducted a prospective, randomized, non-blinded renal transplantation trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day x 4; target enrollment = 180). Subsequent maintenance immunosuppression consisted of tacrolimus, a CNI, and sirolimus, a mammalian target of rapamycin inhibitor. We report here the outcome of converting patients after six months either to minimized tacrolimus/sirolimus or mycophenolate mofetil/sirolimus. Primary endpoints were graft function and chronic histopathology from protocol kidney biopsies at 12 and 24 months Results CNI withdrawal (on-treatment analysis) associated with better graft function (p <0.001) and lower chronic histopathology composite scores in protocol biopsies at 12 (p = 0.003) and 24 (p = 0.013) months, without affecting patient (p = 0.81) or graft (p = 0.93) survival, or rejection rate (p = 0.17). Conclusion CNI (tacrolimus) withdrawal at six months may provide a strategy for decreased nephrotoxicity and improved long-term function in steroid-free low immunological risk renal transplant patients. Trial Registration ClinicalTrials.gov NCT00556933 PMID:26465152

Password-only authenticated three-party key exchange with provable security in the standard model.

PubMed

Nam, Junghyun; Choo, Kim-Kwang Raymond; Kim, Junghwan; Kang, Hyun-Kyu; Kim, Jinsoo; Paik, Juryon; Won, Dongho

2014-01-01

Protocols for password-only authenticated key exchange (PAKE) in the three-party setting allow two clients registered with the same authentication server to derive a common secret key from their individual password shared with the server. Existing three-party PAKE protocols were proven secure under the assumption of the existence of random oracles or in a model that does not consider insider attacks. Therefore, these protocols may turn out to be insecure when the random oracle is instantiated with a particular hash function or an insider attack is mounted against the partner client. The contribution of this paper is to present the first three-party PAKE protocol whose security is proven without any idealized assumptions in a model that captures insider attacks. The proof model we use is a variant of the indistinguishability-based model of Bellare, Pointcheval, and Rogaway (2000), which is one of the most widely accepted models for security analysis of password-based key exchange protocols. We demonstrated that our protocol achieves not only the typical indistinguishability-based security of session keys but also the password security against undetectable online dictionary attacks.

Randomness determines practical security of BB84 quantum key distribution.

PubMed

Li, Hong-Wei; Yin, Zhen-Qiang; Wang, Shuang; Qian, Yong-Jun; Chen, Wei; Guo, Guang-Can; Han, Zheng-Fu

2015-11-10

Unconditional security of the BB84 quantum key distribution protocol has been proved by exploiting the fundamental laws of quantum mechanics, but the practical quantum key distribution system maybe hacked by considering the imperfect state preparation and measurement respectively. Until now, different attacking schemes have been proposed by utilizing imperfect devices, but the general security analysis model against all of the practical attacking schemes has not been proposed. Here, we demonstrate that the general practical attacking schemes can be divided into the Trojan horse attack, strong randomness attack and weak randomness attack respectively. We prove security of BB84 protocol under randomness attacking models, and these results can be applied to guarantee the security of the practical quantum key distribution system.

Randomness determines practical security of BB84 quantum key distribution

PubMed Central

Li, Hong-Wei; Yin, Zhen-Qiang; Wang, Shuang; Qian, Yong-Jun; Chen, Wei; Guo, Guang-Can; Han, Zheng-Fu

2015-01-01

Unconditional security of the BB84 quantum key distribution protocol has been proved by exploiting the fundamental laws of quantum mechanics, but the practical quantum key distribution system maybe hacked by considering the imperfect state preparation and measurement respectively. Until now, different attacking schemes have been proposed by utilizing imperfect devices, but the general security analysis model against all of the practical attacking schemes has not been proposed. Here, we demonstrate that the general practical attacking schemes can be divided into the Trojan horse attack, strong randomness attack and weak randomness attack respectively. We prove security of BB84 protocol under randomness attacking models, and these results can be applied to guarantee the security of the practical quantum key distribution system. PMID:26552359

Randomness determines practical security of BB84 quantum key distribution

NASA Astrophysics Data System (ADS)

Li, Hong-Wei; Yin, Zhen-Qiang; Wang, Shuang; Qian, Yong-Jun; Chen, Wei; Guo, Guang-Can; Han, Zheng-Fu

2015-11-01

Unconditional security of the BB84 quantum key distribution protocol has been proved by exploiting the fundamental laws of quantum mechanics, but the practical quantum key distribution system maybe hacked by considering the imperfect state preparation and measurement respectively. Until now, different attacking schemes have been proposed by utilizing imperfect devices, but the general security analysis model against all of the practical attacking schemes has not been proposed. Here, we demonstrate that the general practical attacking schemes can be divided into the Trojan horse attack, strong randomness attack and weak randomness attack respectively. We prove security of BB84 protocol under randomness attacking models, and these results can be applied to guarantee the security of the practical quantum key distribution system.

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

PubMed

Wetzel, F Todd; McNally, Thomas A; Phillips, Frank M

2002-11-15

Retrospective literature review. To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.

Integration and Analysis of Neighbor Discovery and Link Quality Estimation in Wireless Sensor Networks

PubMed Central

Radi, Marjan; Dezfouli, Behnam; Abu Bakar, Kamalrulnizam; Abd Razak, Shukor

2014-01-01

Network connectivity and link quality information are the fundamental requirements of wireless sensor network protocols to perform their desired functionality. Most of the existing discovery protocols have only focused on the neighbor discovery problem, while a few number of them provide an integrated neighbor search and link estimation. As these protocols require a careful parameter adjustment before network deployment, they cannot provide scalable and accurate network initialization in large-scale dense wireless sensor networks with random topology. Furthermore, performance of these protocols has not entirely been evaluated yet. In this paper, we perform a comprehensive simulation study on the efficiency of employing adaptive protocols compared to the existing nonadaptive protocols for initializing sensor networks with random topology. In this regard, we propose adaptive network initialization protocols which integrate the initial neighbor discovery with link quality estimation process to initialize large-scale dense wireless sensor networks without requiring any parameter adjustment before network deployment. To the best of our knowledge, this work is the first attempt to provide a detailed simulation study on the performance of integrated neighbor discovery and link quality estimation protocols for initializing sensor networks. This study can help system designers to determine the most appropriate approach for different applications. PMID:24678277

Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial

PubMed Central

Dieterle, Thomas; Dürr, Selina; Arnet, Isabelle; Hersberger, Kurt E; Leuppi, Jörg D

2017-01-01

Background Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among patients with asthma and chronic obstructive pulmonary disease (COPD) is high and patients are frequently hospitalized due to exacerbations. Reasons for uncontrolled diseases are manifold, but are often associated with poor inhalation technique and non-adherence to the prescribed treatment plan. This causes substantial mortality, morbidity, and costs to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase and maintain treatment adherence in chronic diseases is of major clinical importance. Objective The primary objective of this study is to investigate the impact of using specific, validated electronic devices on adherence to inhaled medication in patients with chronic obstructive lung diseases such as asthma and COPD. Furthermore, it aims to assess the impact of a reminder and close supervision of the course of disease and quality of life. Methods In this ongoing prospective, single-blind, randomized controlled study, adherence to inhaled medication is analyzed over a 6-month period in at least 154 in- and outpatients with asthma or COPD who have experienced at least 1 exacerbation during the last year. Adherence is measured using electronic data capture devices, which save the date and time of each inhalative device actuation and transfer these data daily via a wireless connection to a Web-based database. Patients are randomly assigned to either the intervention or the control group. The clinical intervention consists of an automated and personal reminder. The intervention group receives an audio reminder and support calls in case medication has not been taken as prescribed or if rescue medication is used more frequently than pre-specified in the study protocol. During the study, participants are assessed every 2 months in the form of clinical visits. Results Recruitment started in January 2014. To date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017. Conclusions Few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With this prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of healthcare in chronically ill patients suffering from asthma or COPD. Trial Registration ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (Archived by WebCite at http://www.webcitation.org/6oJq1fel0) PMID:29061556

Semi-quantum Dialogue Based on Single Photons

NASA Astrophysics Data System (ADS)

Ye, Tian-Yu; Ye, Chong-Qiang

2018-02-01

In this paper, we propose two semi-quantum dialogue (SQD) protocols by using single photons as the quantum carriers, where one requires the classical party to possess the measurement capability and the other does not have this requirement. The security toward active attacks from an outside Eve in the first SQD protocol is guaranteed by the complete robustness of present semi-quantum key distribution (SQKD) protocols, the classical one-time pad encryption, the classical party's randomization operation and the decoy photon technology. The information leakage problem of the first SQD protocol is overcome by the classical party' classical basis measurements on the single photons carrying messages which makes him share their initial states with the quantum party. The security toward active attacks from Eve in the second SQD protocol is guaranteed by the classical party's randomization operation, the complete robustness of present SQKD protocol and the classical one-time pad encryption. The information leakage problem of the second SQD protocol is overcome by the quantum party' classical basis measurements on each two adjacent single photons carrying messages which makes her share their initial states with the classical party. Compared with the traditional information leakage resistant QD protocols, the advantage of the proposed SQD protocols lies in that they only require one party to have quantum capabilities. Compared with the existing SQD protocol, the advantage of the proposed SQD protocols lies in that they only employ single photons rather than two-photon entangled states as the quantum carriers. The proposed SQD protocols can be implemented with present quantum technologies.

Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial.

PubMed

Li, Juan; Ng, Ernest Hung Yu; Stener-Victorin, Elisabet; Hu, Zhenxing; Shao, Xiaoguang; Wang, Haiyan; Li, Meifang; Lai, Maohua; Xie, Changcai; Su, Nianjun; Yu, Chuyi; Liu, Jia; Wu, Taixiang; Ma, Hongxia

2017-03-09

Our prospective pilot study of acupuncture affecting insulin sensitivity on polycystic ovary syndrome (PCOS) combined with insulin resistance (IR) showed that acupuncture had a significant effect on improving the insulin sensitivity of PCOS. But there is still no randomized controlled trial to determine the effect of acupuncture on the insulin sensitivity in women with PCOS and IR. In this article, we present the protocol of a randomized controlled trial to compare the effect of true acupuncture on the insulin sensitivity of these patients compared with metformin and sham acupuncture. Acupuncture may be an effective therapeutic alternative that is superior to metformin and sham acupuncture in improving the insulin sensitivity of PCOS combined with IR. This study is a multi-center, controlled, double-blind, and randomized clinical trial aiming to evaluate the effect of acupuncture on the insulin sensitivity in PCOS combined with IR. In total 342 patients diagnosed with PCOS and IR will be enrolled. Participants will be randomized to one of the three groups: (1) true acupuncture + metformin placebo; (2) sham acupuncture + metformin, and (3) sham acupuncture + metformin placebo. Participants and assessors will be blinded. The acupuncture intervention will be given 3 days per week for a total of 48 treatment sessions during 4 months. Metformin (0.5 g per pill) or placebo will be given, three times per day, and for 4 months. Primary outcome measures are changes in homeostasis model assessment of insulin resistance (HOMA-IR) and improvement rate of HOMA-IR by oral glucose tolerance test (OGTT) and insulin releasing test (Ins). Secondary outcome measures are homeostasis model assessment-β (HOMA-β), area under the curve for glucose and insulin, frequency of regular menstrual cycles and ovulation, body composition, metabolic profile, hormonal profile, questionnaires, side effect profile, and expectation and credibility of treatment. Outcome measures are collected at baseline, at the end of treatments, and 3 months after the last acupuncture treatment. On completion of the screening visit, randomization will be conducted using a central randomization system. This study will investigate the effects of acupuncture on the insulin sensitivity of PCOS and IR women compared with metformin and sham acupuncture. We will test whether true acupuncture with needles placed in skeletal muscles and stimulated manually and by electrical stimulation is more effective than metformin and sham acupuncture with superficial needle placement with no manual or electrical stimulation in improving the insulin sensitivity in PCOS women with IR. ClinicalTrials.gov, NCT02491333 ; Chinese Clinical Trial Registry, ChiCTR-ICR-15006639. Registered on 24 June 2015.

Single-photon continuous-variable quantum key distribution based on the energy-time uncertainty relation.

PubMed

Qi, Bing

2006-09-15

We propose a new quantum key distribution protocol in which information is encoded on continuous variables of a single photon. In this protocol, Alice randomly encodes her information on either the central frequency of a narrowband single-photon pulse or the time delay of a broadband single-photon pulse, while Bob randomly chooses to do either frequency measurement or time measurement. The security of this protocol rests on the energy-time uncertainty relation, which prevents Eve from simultaneously determining both frequency and time information with arbitrarily high resolution. Since no interferometer is employed in this scheme, it is more robust against various channel noises, such as polarization and phase fluctuations.

A rapid infusion protocol is safe for total dose iron polymaltose: time for change.

PubMed

Garg, M; Morrison, G; Friedman, A; Lau, A; Lau, D; Gibson, P R

2011-07-01

Intravenous correction of iron deficiency by total dose iron polymaltose is inexpensive and safe, but current protocols entail prolonged administration over more than 4 h. This results in reduced patient acceptance, and hospital resource strain. We aimed to assess prospectively the safety of a rapid intravenous protocol and compare this with historical controls. Consecutive patients in whom intravenous iron replacement was indicated were invited to have up to 1.5 g iron polymaltose by a 58-min infusion protocol after an initial 15-min test dose without pre-medication. Infusion-related adverse events (AE) and delayed AE over the ensuing 5 days were also prospectively documented and graded as mild, moderate or severe. One hundred patients, 63 female, mean age 54 (range 18-85) years were studied. Thirty-four infusion-related AE to iron polymaltose occurred in a total of 24 patients--25 mild, 8 moderate and 1 severe; higher than previously reported for a slow protocol iron infusion. Thirty-one delayed AE occurred in 26 patients--26 mild, 3 moderate and 2 severe; similar to previously reported. All but five patients reported they would prefer iron replacement through the rapid protocol again. The presence of inflammatory bowel disease (IBD) predicted infusion-related reactions (54% vs 14% without IBD, P < 0.001) and the serum C-reactive protein was higher in those with reactions (P = 0.043). Iron polymaltose can be successfully administered using a rapid total dose infusion protocol and was well accepted by patients. It offers significant cost, resource utilization and time benefits for the patient and hospital system. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.

PubMed

Maduell, Francisco; Moreso, Francesc; Pons, Mercedes; Ramos, Rosa; Mora-Macià, Josep; Foraster, Andreu; Soler, Jordi; Galceran, Josep M; Martinez-Castelao, Alberto

2011-01-01

Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials. A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%. From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period. The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

Community Pharmacists Assisting in Total Cardiovascular Health (CPATCH): A Cluster-Randomized, Controlled Trial Testing a Focused Adherence Strategy Involving Community Pharmacies.

PubMed

Blackburn, David F; Evans, Charity D; Eurich, Dean T; Mansell, Kerry D; Jorgenson, Derek J; Taylor, Jeff G; Semchuk, William M; Shevchuk, Yvonne M; Remillard, Alfred J; Tran, David A; Champagne, Anne P

2016-10-01

To test a brief intervention for preventing statin nonadherence among community pharmacy patrons. Prospective, cluster-randomized, controlled trial (the Community Pharmacists Assisting in Total Cardiovascular Health [CPATCH] trial). Thirty community pharmacies in Saskatchewan, Canada. Participating pharmacies were randomized to 15 intervention pharmacies where a brief statin adherence intervention was delivered by pharmacists (intervention group [907 patients]) or 15 usual care pharmacies where no statin adherence intervention was delivered (usual care group [999 patients]) to new users of statins (defined as less than 1 yr of statin therapy). Staff (pharmacy managers, staff pharmacists, and technicians) from intervention pharmacies attended a 2.5-hour workshop on the CPATCH program that prepared pharmacists to deal with the adherence barriers most likely associated with statin use (e.g., safety, cost, patient-provider relationship, and tolerability). Intervention pharmacists screened for new statin users and assessed these adherence barriers. Pharmacists were then instructed to tailor their follow-up plan based on the individual patient's situation. Investigators contacted the intervention pharmacies monthly to assess their compliance with the protocol and to offer additional support to motivate ongoing participation. The primary outcome was mean difference in statin adherence between the intervention and usual care groups. Adherence was measured by the proportion of days covered (PDC) between 6 and 12 months following the original prescription fill date. General estimating equations were used to evaluate the difference in mean adherence between groups. Secondary outcomes included the percentage of new statin users exhibiting optimal adherence (defined as PDC of 80% or higher) and the percentage exhibiting nonpersistence (defined as the cessation of all statin dispensations within 3 mo of the first dispensation). Among 1906 eligible patients, no significant differences in mean adherence were observed between those receiving the intervention and those receiving usual care (71.6% vs 70.9%, p=0.64), the percentage of patients achieving optimal adherence (57.3% vs 55.9%, p=0.51), or the percentage exhibiting nonpersistence (9.4% vs 8.3%, p=0.41). However, compliance to the study protocol was extremely low in several intervention pharmacies. In a post hoc analysis, a higher level of protocol compliance among intervention pharmacies was significantly associated with higher adherence (p<0.01 for trend). Pharmacies falling in the highest tertile of compliance to the study protocol exhibited higher mean adherence among their patients compared with those in the usual care group (β = 0.056, 95% confidence interval [CI] 0.010-0.101, p=0.01), and a significantly higher percentage of patients achieving optimal adherence (odds ratio 1.32, 95% CI 1.08-1.61; p<0.01); however, nonpersistence did not significantly differ between the two groups (5.5% vs 8.3%, p=0.27). The CPATCH intervention was ineffective for improving patient adherence to statin therapy in community pharmacies. However, poor effectiveness may have resulted from a failure to deliver the protocol consistently in several intervention pharmacies. © 2016 Pharmacotherapy Publications, Inc.

Pulmonary Venous Anatomy Imaging with Low-Dose, Prospectively ECG-Triggered, High-Pitch 128-Slice Dual Source Computed Tomography

PubMed Central

Thai, Wai-ee; Wai, Bryan; Lin, Kaity; Cheng, Teresa; Heist, E. Kevin; Hoffmann, Udo; Singh, Jagmeet; Truong, Quynh A.

2012-01-01

Background Efforts to reduce radiation from cardiac computed tomography (CT) are essential. Using a prospectively triggered, high-pitch dual source CT (DSCT) protocol, we aim to determine the radiation dose and image quality (IQ) in patients undergoing pulmonary vein (PV) imaging. Methods and Results In 94 patients (61±9 years, 71% male) who underwent 128-slice DSCT (pitch 3.4), radiation dose and IQ were assessed and compared between 69 patients in sinus rhythm (SR) and 25 in atrial fibrillation (AF). Radiation dose was compared in a subset of 19 patients with prior retrospective or prospectively triggered CT PV scans without high-pitch. In a subset of 18 patients with prior magnetic resonance imaging (MRI) for PV assessment, PV anatomy and scan duration were compared to high-pitch CT. Using the high-pitch protocol, total effective radiation dose was 1.4 [1.3, 1.9] mSv, with no difference between SR and AF (1.4 vs 1.5 mSv, p=0.22). No high-pitch CT scans were non-diagnostic or had poor IQ. Radiation dose was reduced with high-pitch (1.6 mSv) compared to standard protocols (19.3 mSv, p<0.0001). This radiation dose reduction was seen with SR (1.5 vs 16.7 mSv, p<0.0001) but was more profound with AF (1.9 vs 27.7 mSv, p=0.039). There was excellent agreement of PV anatomy (kappa 0.84, p<0.0001), and a shorter CT scan duration (6 minutes) compared to MRI (41 minutes, p<0.0001). Conclusions Using a high-pitch DSCT protocol, PV imaging can be performed with minimal radiation dose, short scan acquisition, and excellent IQ in patients with SR or AF. This protocol highlights the success of new cardiac CT technology to minimize radiation exposure, giving clinicians a new low-dose imaging alternative to assess PV anatomy. PMID:22586259

A distance limited method for sampling downed coarse woody debris

Treesearch

Jeffrey H. Gove; Mark J. Ducey; Harry T. Valentine; Michael S. Williams

2012-01-01

A new sampling method for down coarse woody debris is proposed based on limiting the perpendicular distance from individual pieces to a randomly chosen sample point. Two approaches are presented that allow different protocols to be used to determine field measurements; estimators for each protocol are also developed. Both protocols are compared via simulation against...

Quantum cryptography without switching.

PubMed

Weedbrook, Christian; Lance, Andrew M; Bowen, Warwick P; Symul, Thomas; Ralph, Timothy C; Lam, Ping Koy

2004-10-22

We propose a new coherent state quantum key distribution protocol that eliminates the need to randomly switch between measurement bases. This protocol provides significantly higher secret key rates with increased bandwidths than previous schemes that only make single quadrature measurements. It also offers the further advantage of simplicity compared to all previous protocols which, to date, have relied on switching.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

PubMed

Kasenda, Benjamin; von Elm, Erik; You, John J; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2016-06-01

Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.

Physical key-protected one-time pad

PubMed Central

Horstmeyer, Roarke; Judkewitz, Benjamin; Vellekoop, Ivo M.; Assawaworrarit, Sid; Yang, Changhuei

2013-01-01

We describe an encrypted communication principle that forms a secure link between two parties without electronically saving either of their keys. Instead, random cryptographic bits are kept safe within the unique mesoscopic randomness of two volumetric scattering materials. We demonstrate how a shared set of patterned optical probes can generate 10 gigabits of statistically verified randomness between a pair of unique 2 mm3 scattering objects. This shared randomness is used to facilitate information-theoretically secure communication following a modified one-time pad protocol. Benefits of volumetric physical storage over electronic memory include the inability to probe, duplicate or selectively reset any bits without fundamentally altering the entire key space. Our ability to securely couple the randomness contained within two unique physical objects can extend to strengthen hardware required by a variety of cryptographic protocols, which is currently a critically weak link in the security pipeline of our increasingly mobile communication culture. PMID:24345925

Sheehan Suicidality Tracking Scale (Sheehan-STS)

PubMed Central

2009-01-01

Objective: Accurate and prospective assessments of treatment-emergent suicidal thoughts and behaviors are essential to both clinical care and randomized clinical trials. The Sheehan Suicidality Tracking Scale is a prospective, patient self-report or clinician-administered rating scale that tracks both treatment-emergent suicidal ideation and behaviors. The Sheehan Suicidality Tracking Scale was incorporated into a multicenter, randomized, double-blind, placebo-controlled, and active comparator study examining the efficacy of an experimental corticotropin-releasing factor antagonist (BMS-562086) for the treatment of generalized anxiety disorder. Method: The Sheehan Suicidality Tracking Scale was administered to subjects at baseline, Week 2, Week 4, and Week 8 or early termination. Subjects completed theSheehan Suicidality Tracking Scale by self report. The Sheehan Suicidality Tracking Scale was designated as an exploratory outcome measure in the study protocol, and post-hoc analyses were performed to examine the performance of the Sheehan Suicidality Tracking Scale. Results: A total of 82 subjects completed the Sheehan Suicidality Tracking Scale during the course of the study. Altogether, these subjects provided 297 completed Sheehan Suicidality Tracking Scale ratings across the study time points. Sixty-one subjects (n=25 placebo, n=24 BMS-562086, and n=12 escitalopram) had a baseline and at least one post-baseline Sheehan Suicidality Tracking Scale measurement. The mean change from baseline at Week 8 in the Sheehan Suicidality Tracking Scale total score was -0.10, -0.02, and -0.06 for escitalopram, placebo, and BMS-562086 groups, respectively. The sensitivity of the Sheehan Suicidality Tracking Scale and HAM-D Item #3 (suicide) for identifying subjects with suicidal thoughts or behaviors was 100 percent and 63 percent, respectively. Conclusions: The Sheehan Suicidality Tracking Scale may be a sensitive psychometric tool to prospectively assess for treatment-emergent suicidal thoughts and behaviors. Despite the small sample size and low occurrence of suicidal ideation during the course of this clinical trial, the self-reported Sheehan Suicidality Tracking Scale demonstrated increased sensitivity over the rater administered HAM-D Item #3 in identifying suicide related ideations and behaviors. Further research in larger study samples as well as in other psychiatric disorders are needed. PMID:19724740

Associations between sleep bruxism and (peri-) implant complications: a prospective cohort study

PubMed Central

Thymi, Magdalini; Visscher, Corine M; Yoshida-Kohno, Eiko; Crielaard, Wim; Wismeijer, Daniel; Lobbezoo, Frank

2017-01-01

Objectives/Aims: To describe the protocol of a prospective cohort study designed to answer the question: ‘Is sleep bruxism a risk factor for (peri-)implant complications?’. Materials and Methods: Our study is a single-centre, double-blind, prospective cohort study with a follow-up time of 2 years. Ninety-eight participants fulfilling inclusion criteria (planned treatment with implant-supported fixed suprastructure(s) and age 18 years or older) will be included. Sleep bruxism will be monitored at several time points as masticatory muscle activity during sleep by means of a portable single-channel electromyographic device. Our main outcomes are biological complications (i.e., related to peri-implant bleeding, probing depth, marginal bone height, quality of submucosal biofilm and loss of osseointegration) and technical complications (i.e., suprastructure, abutment, implant body or other). Results: The study is currently ongoing, and data are being gathered. Discussion: The results of this prospective cohort study will provide important information for clinicians treating bruxing patients with dental implants. Furthermore, it will contribute to the body of evidence related to the behaviour of dental implants and their complications under conditions of high mechanical loadings that result from sleep bruxism activity. Conclusion: The protocol of a prospective cohort study designed to investigate possible associations between sleep bruxism and (peri-) implant complications was presented. PMID:29607076

Implementation of Injury and Illness Surveillance Protocols in Varsity Athletes.

PubMed

Gamble, Alexander Shand Davis; Mountjoy, Margo Lynn; Bigg, Jessica Lynne; Spriet, Lawrence Leon

2018-05-02

To develop and implement a prospective varsity athlete surveillance system to identify injury and illness trends in a multisport varsity-level university setting. Longitudinal prospective surveillance study. Varsity-level sport program at the University of Guelph, Guelph, ON, Canada. Athletic therapists (ATs) (n = 35) from 17 varsity sports provided injury and illness information on 624 varsity-level athletes (381 men and 243 women) during the 2016/2017 competitive season. Team ATs reported athlete health complaints weekly. Athletes reported additional details on the injury or illness that was reported. The outcome measurements included when the injury or illness occurred, anatomical location, diagnosis, cause, perceived severity, treatment, estimated athlete exposure (AE) to training and competition, and time loss from sport. Measures were recorded from the teams' first competition through to end their season and/or playoffs. Twenty-nine of 30 varsity sports teams participated in this injury and illness surveillance protocol. The compliance of team ATs and varsity athletes was 89% (men: 94%, women: 82%). The overall injury and illness rates were 5.5 injuries and 1.7 illnesses per 1000 AEs, respectively. Men's injury rates were greater than women's, and injury rates of contact sports were greater than noncontact sports. The utilization of a prospective injury and illness surveillance protocol in the Canadian University sport system is feasible with good athlete, AT, and coach acceptance. The surveillance data should inform future injury and illness prevention strategies.

Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France. Method and design A prospective randomized trial was designed to assess the impact of a Housing First intervention on health outcomes and costs over a period of 24 months on homeless people with severe mental illness, compared to Treatment-As-Usual. The study is being conducted in four cities in France: Lille, Marseille, Paris and Toulouse. The inclusion criteria are as follows: over 18 years of age, absolutely homeless or in precarious housing, and possessing a ‘high’ level of need: diagnosis of schizophrenia or bipolar disorder and moderate to severe disability according to the Multnomah Community Ability Scale (score ≤ 62) and at least one of the following three criteria: 1) having been hospitalized for mental illness two or more times in any one year during the preceding five years; 2) co-morbid alcohol or substance use; and 3) having been recently arrested or incarcerated. Participants will be randomized to receiving the Housing First intervention or Treatment-As-Usual. The Housing First intervention provides immediate access to independent housing and community care. The primary outcome criterion is the use of high-cost health services (that is,, number of hospital admissions and number of emergency department visits) during the 24-month follow-up period. Secondary outcome measures include health outcomes, social functioning, housing stability and contact with police services. An evaluation of the cost-effectiveness and cost-utility of Housing First will also be conducted. A total of 300 individuals per group will be included. Discussion This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context. Trial registration The current clinical trial number is NCT01570712 PMID:24063556

Effectiveness and cost-effectiveness of a blended exercise intervention for patients with hip and/or knee osteoarthritis: study protocol of a randomized controlled trial.

PubMed

Kloek, Corelien J J; Bossen, Daniël; Veenhof, Cindy; van Dongen, Johanna M; Dekker, Joost; de Bakker, Dinny H

2014-08-08

Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain, increasing physical activity and physical functioning, but costly and a burden for the health care budget. A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility. However, the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates. In order to combine the best of two worlds, we have developed the intervention e-Exercise. In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention. The aim of this study is to investigate the short- (3 months) and long-term (12 months) (cost)-effectiveness of e-Exercise compared to usual care physical therapy. Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care. This paper presents the protocol of a prospective, single-blinded, multicenter cluster randomized controlled trial. In total, 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care (physical therapy). E-Exercise is a 12-week intervention, consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program. The web-based program contains assignments to gradually increase patients' physical activity, strength and stability exercises and information about OA related topics. Primary outcomes are physical activity and physical functioning. Secondary outcomes are health related quality of life, self-perceived effect, pain, tiredness and self-efficacy. All measurements will be performed at baseline, 3 and 12 months after inclusion. Retrospective cost questionnaires will be sent at 3, 6, 9 and 12 months and used for the cost-effectiveness and cost-utility analysis. This study is the first randomized controlled trial in the (cost)-effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee. The findings will help to improve the treatment of patients with osteoarthritis. NTR4224.

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible effects of creative music therapy on short- and long-term brain development in preterm infants. This project lies at the interface of music therapy, neuroscience, and medical imaging. New insights into the potential role and impact of music on brain function and development may be elucidated. If such a low-cost, low-risk intervention is demonstrated in a future multi-center trial to be effective in supporting brain development in preterm neonates, findings could have broad clinical implications for this vulnerable patient population. ClinicalTrials.gov, NCT02434224.

Smoking Cessation and Reduction in Schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial

PubMed Central

2014-01-01

Background It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. Methods/Design Intervention: We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants’ perception and satisfaction of the product. Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit (“reducers”). Abstinence from smoking will be calculated at each study visit (“quitters”). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of “reducers” and “quitters” will be defined “non responders”. Statistical analysis: The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. Discussion The main strengths of the SCARIS study are the following: it’s the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks). The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia. Trial registration ClinicalTrials.gov, NCT01979796. PMID:24655473

Electroencephalography for children with autistic spectrum disorder: a sedation protocol.

PubMed

Keidan, Ilan; Ben-Menachem, Erez; Tzadok, Michal; Ben-Zeev, Bruria; Berkenstadt, Haim

2015-02-01

To report the effectiveness and efficiency of a predetermined sedation protocol for providing sedation for electroencephalograph (EEG) studies in children with autism. Sleep EEG has been advocated for the majority of children with autism spectrum disorder. In most cases, sedation is required to allow adequate studies. Most sedation drugs have negative effects on the EEG pattern. The sedation protocol we adopted included chloral hydrate, dexmedetomidine, and ketamine and was evaluated prospectively for 2 years. One hundred and eighty-three children with autistic spectrum disorder were sedated with the described drug protocol that was efficient, provided adequate EEG readings, and was not associated with serious adverse events. Our protocol kept costs to a minimum but provided appropriate escalation in care when required. © 2014 John Wiley & Sons Ltd.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

A 1-year randomized controlled trial of deferasirox vs deferoxamine for myocardial iron removal in β-thalassemia major (CORDELIA)

PubMed Central

Porter, John B.; Piga, Antonio; Lai, Yongrong; El-Beshlawy, Amal; Belhoul, Khawla M.; Elalfy, Mohsen; Yesilipek, Akif; Kilinç, Yurdanur; Lawniczek, Tomasz; Habr, Dany; Weisskopf, Marianne; Zhang, Yiyun; Aydinok, Yesim

2014-01-01

Randomized comparison data on the efficacy and safety of deferasirox for myocardial iron removal in transfusion dependent patients are lacking. CORDELIA was a prospective, randomized comparison of deferasirox (target dose 40 mg/kg per day) vs subcutaneous deferoxamine (50-60 mg/kg per day for 5-7 days/week) for myocardial iron removal in 197 β-thalassemia major patients with myocardial siderosis (T2* 6-20 milliseconds) and no signs of cardiac dysfunction (mean age, 19.8 years). Primary objective was to demonstrate noninferiority of deferasirox for myocardial iron removal, assessed by changes in myocardial T2* after 1 year using a per-protocol analysis. Geometric mean (Gmean) myocardial T2* improved with deferasirox from 11.2 milliseconds at baseline to 12.6 milliseconds at 1 year (Gmeans ratio, 1.12) and with deferoxamine (11.6 milliseconds to 12.3 milliseconds; Gmeans ratio, 1.07). The between-arm Gmeans ratio was 1.056 (95% confidence interval [CI], 0.998, 1.133). The lower 95% CI boundary was greater than the prespecified margin of 0.9, establishing noninferiority of deferasirox vs deferoxamine (P = .057 for superiority of deferasirox). Left ventricular ejection fraction remained stable in both arms. Frequency of drug-related adverse events was comparable between deferasirox (35.4%) and deferoxamine (30.8%). CORDELIA demonstrated the noninferiority of deferasirox compared with deferoxamine for myocardial iron removal. This trial is registered at www.clinicaltrials.gov as #NCT00600938. PMID:24385534

Surface electrical stimulation in dysphagic Parkinson patients: a randomized clinical trial.

PubMed

Baijens, Laura W J; Speyer, Renée; Passos, Valéria Lima; Pilz, Walmari; van der Kruis, Jolien; Haarmans, Saskia; Desjardins-Rombouts, Christel

2013-11-01

A new treatment for oropharyngeal dysphagia in Parkinson's disease was evaluated in the present study. Prospective randomized controlled trial. The study describes the effects of surface electrical stimulation (SES) of the neck (submental region) in dysphagic Parkinson patients using different intensities of electrical current. Quasi-random allocation was performed when assigning patients to treatment groups. Three groups consisting of dysphagic patients with idiopathic Parkinson's disease (N = 90) received daily treatment for 15 days with periods of no treatment during the weekend. All three received traditional logopedic dysphagia treatment. In addition, two groups received SES, either motor-level or sensory-level stimulation. A standardized measurement protocol, including fiber optic endoscopic evaluation of swallowing (FEES) and videofluoroscopy of swallowing (VFS), was performed before and after therapy. A team of experienced raters was blinded to the treatment group and to the moment of measurement. Intrarater and interrater reliability were calculated. Using proportional odds models (POMs), some of the visuoperceptual ordinal outcome variables showed significant improvement in all groups following treatment. Following 15 days of SES of the submental region, few significant effects were found, suggesting a therapy effect of traditional logopedic dysphagia treatment without any additional influence of SES. On the grounds of this study, it is concluded that further research is needed on the exact mechanism of SES and its effects on the neural pathways involved in swallowing. Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Chronic Achilles tendinopathy: a prospective randomized study comparing the therapeutic effect of eccentric training, the AirHeel brace, and a combination of both.

PubMed

Petersen, Wolf; Welp, Robert; Rosenbaum, Dieter

2007-10-01

Previous studies have shown that eccentric training has a positive effect on chronic Achilles tendinopathy. A new strategy for the treatment of chronic Achilles tendinopathy is the AirHeel brace. AirHeel brace treatment improves the clinical outcome of patients with chronic Achilles tendinopathy. The combination of the AirHeel brace and an eccentric training program has a synergistic effect. Randomized controlled clinical trial; Level of evidence, 1. One hundred patients were randomly assigned to 1 of 3 treatment groups: (1) eccentric training, (2) AirHeel brace, and (3) combination of eccentric training and AirHeel brace. Patients were evaluated at 6, 12, and 54 weeks after the beginning of the treatment protocol with ultrasonography, visual analog scale (VAS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) ankle score, and Short Form-36 (SF-36). The VAS score for pain, AOFAS score, and SF-36 improved significantly in all 3 groups at all 3 follow-up examinations. At the 3 time points (6 weeks, 12 weeks, and 54 weeks) of follow-up, there was no significant difference between all 3 treatment groups. In all 3 groups, there was no significant difference in tendon thickness after treatment. The AirHeel brace is as effective as eccentric training in the treatment of chronic Achilles tendinopathy. There is no synergistic effect when both treatment strategies are combined. The AirHeel brace is an alternative treatment option for chronic Achilles tendinopathy.

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

PubMed

Ferrando, Carlos; Soro, Marina; Canet, Jaume; Unzueta, Ma Carmen; Suárez, Fernando; Librero, Julián; Peiró, Salvador; Llombart, Alicia; Delgado, Carlos; León, Irene; Rovira, Lucas; Ramasco, Fernando; Granell, Manuel; Aldecoa, César; Diaz, Oscar; Balust, Jaume; Garutti, Ignacio; de la Matta, Manuel; Pensado, Alberto; Gonzalez, Rafael; Durán, M Eugenia; Gallego, Lucia; Del Valle, Santiago García; Redondo, Francisco J; Diaz, Pedro; Pestaña, David; Rodríguez, Aurelio; Aguirre, Javier; García, Jose M; García, Javier; Espinosa, Elena; Charco, Pedro; Navarro, Jose; Rodríguez, Clara; Tusman, Gerardo; Belda, Francisco Javier

2015-04-27

Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications. Registered on 5 June 2014 with identification no. NCT02158923 .

Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background One of the major risk variables for surgical site infection is wound management. Understanding infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes. The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization. Patients’ perception at self-assessment will also be analyzed. Methods/Design This is a two-arm randomized controlled trial. Two hundred breast cancer patients undergoing immediate or delayed breast reconstruction will be prospectively enrolled. Patients will be randomly allocated to group I (dressing removed on postoperative day one) or group II (dressing removed on postoperative day six). Surgical site infections will be defined by standard criteria from the Centers for Disease Control and Prevention (CDC). Skin colonization will be assessed by culture of samples collected at predefined time points. Patients will score dressing wear time with regard to safety, comfort and convenience. Discussion The evidence to support dressing standards for breast surgery wounds is empiric and scarce. CDC recommends protecting, with a sterile dressing for 24 to 48 hours postoperatively, a primarily closed incision, but there is no recommendation to cover this kind of incision beyond 48 hours, or on the appropriate time to shower or bathe with an uncovered incision. The results of the ongoing trial may support standard recommendations regarding dressing wear time after breast reconstruction. Trial registration ClinicalTrials.gov identifier: http://NCT01148823. PMID:23432779

Frequency and management of breakthrough bleeding with continuous use of the transvaginal contraceptive ring: a randomized controlled trial.

PubMed

Sulak, Patricia J; Smith, Virginia; Coffee, Andrea; Witt, Iris; Kuehl, Alicia L; Kuehl, Thomas J

2008-09-01

To assess bleeding patterns with continuous use of the transvaginal contraceptive ring. We did a prospective analysis of daily menstrual flow during a 21/7 cycle followed by 6 months of continuous use and institution of a randomized protocol to manage breakthrough bleeding/spotting. Seventy-four women completed the baseline 21/7 phase and were randomized equally into two groups during the continuous phase. Group 1 was instructed to replace the ring monthly on the same calendar day with no ring-free days. Group 2 was instructed to use the same process, but if breakthrough bleeding/spotting occurred for 5 days or more, they were to remove the ring for 4 days, store it, and then reinsert that ring. Sixty-five women completed the continuous phase with reduced average flow scores in the continuous phase compared with the 21/7 phase (P<.02). Most patients had no to minimal bleeding during continuous use, with group 2 experiencing a statistically greater percentage of days without breakthrough bleeding or spotting (95%) compared with group 1 (89%) (P=.016). Instituting a 4-day hormone-free interval was more (P<.001) effective in resolving breakthrough bleeding/spotting than continuing ring use. A reduction in bleeding occurred during continuous use with replacement of the transvaginal ring compared with baseline 21/7 use. Continuous vaginal ring use resulted in an acceptable bleeding profile in most patients, reduction in flow, reduction in pelvic pain, and a high continuation rate.

Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4–5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition. Methods/design Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH = day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality. Discussion This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002917 PMID:23957458

Is caffeine intake a risk factor leading to infertility? A protocol of an epidemiological systematic review of controlled clinical studies.

PubMed

Cao, Huijuan; Ren, Jun; Feng, Xue; Yang, Guoyan; Liu, Jianping

2016-03-15

Previous studies showed that high dose of caffeine intake may induce some specific human reproductive system diseases, even lead to infertility. In consideration of the high consumption of caffeine according to the latest population-based survey, this review is aimed to systematically review the evidence from all controlled clinical studies of caffeine intake for infertility. Relevant randomized/quasi-randomized controlled trials, non-randomized clinical studies, cohort studies, and case-control studies will be included in this review. Participants will be either those without a history of infertility who are willing to have a baby (for prospective studies) or infertile patients with confirmed diagnosis (for retrospective studies). Caffeine or caffeine-containing beverage will be observed as the exposure factor. The key outcome will be the diagnosis of infertility in participants. All relevant published/unpublished or ongoing studies will be searched from seven databases and four online systems until December 2015. Two authors will screen the literatures and extract the data independently. Methodological quality of the included studies will be assessed by two authors according to either Risk of Bias Assessment or Newcastle-Ottawa Scale. We will use R software to analyze the data. Dose of caffeine will be quantified on a daily basis, and relative risk with their 95 % confidence interval will be measured. If data permit, meta-analysis and dose-response analysis will be conducted. Summary of findings tables will be generated using Guideline Development Tool online. PROSPERO CRD42015015714.

Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria.

PubMed

Akinyotu, Oriyomi; Bello, Folasade; Abdus-Salam, Rukiyat; Arowojolu, Ayodele

2018-05-02

To compare the effectiveness of mefloquine and sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria among pregnant women with HIV. The present randomized, controlled, prospective, open-label study enrolled women with HIV who had reached at least 16 weeks of pregnancy attending prenatal clinics at secondary and tertiary health facilities in South West Nigeria between January 1 and August 31, 2016. Block randomization was used to assign patients to treatment with mefloquine or sulphadoxine-pyrimethamine for malaria prophylaxis. The primary outcome was malaria parasitemia at delivery. Data were compared with the χ 2 and t tests on a per-protocol basis. Of 142 women enrolled and randomized equally to each group, 131 (92.3%) completed the study (64 in the mefloquine group and 67 in the sulphadoxine-pyrimethamine group). Blood-sample malaria parasites were isolated from 6 (9%) and 5 (7%) patients in the mefloquine and sulphadoxine-pyrimethamine groups, respectively, at enrolment, and 6 (9%) and 9 (13%) patients in the mefloquine and sulphadoxine-pyrimethamine groups, respectively, at delivery; the differences between the groups was not significant at enrolment (P=0.693) or delivery (P=0.466). Outcomes following prophylactic use of mefloquine for intermittent preventive therapy for malaria among pregnant women with HIV were comparable to sulphadoxine-pyrimethamine treatment; mefloquine is a feasible alternative therapy. ClinicalTrials.gov: NCT02524444. © 2018 International Federation of Gynecology and Obstetrics.

The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

PubMed

Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

2016-01-01

Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period of time. The results will eventually contribute to the development of evidence-based preventive measures specifically adapted to Paralympic sport in order to provide safe and healthy sport participation. Thereby, the project will be of relevance for Paralympic athletes at all levels and to the Paralympic Movement. The study is registered at ClinicalTrials.gov (Identifier: NCT02788500; Registration date: 22 May 2016).

Effectiveness of multi-drug regimen chemotherapy treatment in osteosarcoma patients: a network meta-analysis of randomized controlled trials.

PubMed

Wang, Xiaojie; Zheng, Hong; Shou, Tao; Tang, Chunming; Miao, Kun; Wang, Ping

2017-03-29

Osteosarcoma is the most common malignant bone tumour. Due to the high metastasis rate and drug resistance of this disease, multi-drug regimens are necessary to control tumour cells at various stages of the cell cycle, eliminate local or distant micrometastases, and reduce the emergence of drug-resistant cells. Many adjuvant chemotherapy protocols have shown different efficacies and controversial results. Therefore, we classified the types of drugs used for adjuvant chemotherapy and evaluated the differences between single- and multi-drug chemotherapy regimens using network meta-analysis. We searched electronic databases, including PubMed (MEDLINE), EmBase, and the Cochrane Library, through November 2016 using the keywords "osteosarcoma", "osteogenic sarcoma", "chemotherapy", and "random*" without language restrictions. The major outcome in the present analysis was progression-free survival (PFS), and the secondary outcome was overall survival (OS). We used a random effect network meta-analysis for mixed multiple treatment comparisons. We included 23 articles assessing a total of 5742 patients in the present systematic review. The analysis of PFS indicated that the T12 protocol (including adriamycin, bleomycin, cyclophosphamide, dactinomycin, methotrexate, cisplatin) plays a more critical role in osteosarcoma treatment (surface under the cumulative ranking (SUCRA) probability 76.9%), with a better effect on prolonging the PFS of patients when combined with ifosfamide (94.1%) or vincristine (81.9%). For the analysis of OS, we separated the regimens to two groups, reflecting the disconnection. The T12 protocol plus vincristine (94.7%) or the removal of cisplatinum (89.4%) is most likely the best regimen. We concluded that multi-drug regimens have a better effect on prolonging the PFS and OS of osteosarcoma patients, and the T12 protocol has a better effect on prolonging the PFS of osteosarcoma patients, particularly in combination with ifosfamide or vincristine. The OS analysis showed that the T12 protocol plus vincristine or the T12 protocol with the removal of cisplatinum might be a better regimen for improving the OS of patients. However, well-designed randomized controlled trials of chemotherapeutic protocols are still necessary.

Counterfactual Quantum Deterministic Key Distribution

NASA Astrophysics Data System (ADS)

Zhang, Sheng; Wang, Jian; Tang, Chao-Jing

2013-01-01

We propose a new counterfactual quantum cryptography protocol concerning about distributing a deterministic key. By adding a controlled blocking operation module to the original protocol [T.G. Noh, Phys. Rev. Lett. 103 (2009) 230501], the correlation between the polarizations of the two parties, Alice and Bob, is extended, therefore, one can distribute both deterministic keys and random ones using our protocol. We have also given a simple proof of the security of our protocol using the technique we ever applied to the original protocol. Most importantly, our analysis produces a bound tighter than the existing ones.

Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

PubMed

Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; Van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

2015-09-04

Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previous research originating in the fields of sports medicine and physical rehabilitation shows that the degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat, it remains to be proven whether the same concepts will apply. This ongoing randomized controlled trial in chemoradiotherapy-treated patients with head and neck cancer investigates the effect of three tongue strengthening exercise protocols, with different degrees of exercise load, on tongue strength and swallowing. At enrollment, 51 patients whose dysphagia is primarily related to reduced tongue strength are randomly assigned to a training schedule of 60, 80, or 100% of their maximal tongue strength. Patients are treated three times a week for 8 weeks, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every 2 weeks. Patients are evaluated before, during and after treatment by means of tongue strength measurements, fiber-optic endoscopic evaluation of swallowing and quality-of-life questionnaires. This randomized controlled trial is the first to systematically investigate the effect of different exercise loads in tongue strengthening exercise protocols. The results will allow the development of more efficacious protocols. Current Controlled Trials ISRCTN14447678.

Biofeedback treatment of constipation: a critical review.

PubMed

Heymen, Steve; Jones, Kenneth R; Scarlett, Yolanda; Whitehead, William E

2003-09-01

This review was designed to 1) critically examine the research design used in investigations of biofeedback for pelvic floor dyssynergia, 2) compare the various biofeedback treatment protocols for pelvic floor dyssynergia-type constipation used in this research, 3) identify factors that influence treatment outcome, and 4) identify goals for future biofeedback research for pelvic floor dyssynergia. A comprehensive review of both the pediatric and adult research from 1970 to 2002 on "biofeedback for constipation" was conducted using a Medline search in all languages. Only prospective studies including five or more subjects that described the treatment protocol were included. In addition, a meta-analysis of these studies was performed to compare the outcome of different biofeedback protocols for treating constipation. Thirty-eight studies were reviewed, and sample size, treatment protocol, outcome rates, number of sessions, and etiology are shown in a table. Ten studies using a parallel treatment design were reviewed in detail, including seven that randomized subjects to treatment groups. A meta-analysis (weighted by subjects) was performed to compare the results of two treatment protocols prevalent in the literature. The mean success rate of studies using pressure biofeedback (78 percent) was superior (P = 0.018) to the mean success rate for studies using electromyography biofeedback (70 percent). However, the mean success rates comparing studies using intra-anal electromyography sensors to studies using perianal electromyography sensors were 69 and 72 percent, respectively, indicating no advantages for one type of electromyography protocol over the other (P = 0.428). In addition to the varied protocols and instrumentation used, there also are inconsistencies in the literature regarding the severity and etiology of symptoms, patient selection criteria, and the definition of a successful outcome. Finally, no anatomic, physiologic, or demographic variables were identified that would assist in predicting successful outcome. Having significant psychological symptoms was identified as a factor that may influence treatment outcome, but this requires further study. Although most studies report positive results using biofeedback to treat constipation, quality research is lacking. Specific recommendations are made for future investigations to 1) improve experimental design, 2) clearly define outcome measures, 3) identify the etiology and severity of symptoms, 4) determine which treatment protocol and which component of treatment is most effective for different types of subjects, 5) systematically explore the role of psychopathology in this population, 6) use an adequate sample size that allows for meaningful analysis, and 7) include long-term follow-up data.

Device-independent randomness generation from several Bell estimators

NASA Astrophysics Data System (ADS)

Nieto-Silleras, Olmo; Bamps, Cédric; Silman, Jonathan; Pironio, Stefano

2018-02-01

Device-independent randomness generation and quantum key distribution protocols rely on a fundamental relation between the non-locality of quantum theory and its random character. This relation is usually expressed in terms of a trade-off between the probability of guessing correctly the outcomes of measurements performed on quantum systems and the amount of violation of a given Bell inequality. However, a more accurate assessment of the randomness produced in Bell experiments can be obtained if the value of several Bell expressions is simultaneously taken into account, or if the full set of probabilities characterizing the behavior of the device is considered. We introduce protocols for device-independent randomness generation secure against classical side information, that rely on the estimation of an arbitrary number of Bell expressions or even directly on the experimental frequencies of measurement outcomes. Asymptotically, this results in an optimal generation of randomness from experimental data (as measured by the min-entropy), without having to assume beforehand that the devices violate a specific Bell inequality.

Prospective Randomized Trial of the Military Anti-Shock Garment

DTIC Science & Technology

1987-12-20

No prospective, controlled, randomized studies of !.’AST use were available in the scientific literature. Numerous --ports of MAST use were available...in the scientific literature. ,umerous reports of MAST causing compartment syndromes and amputations did appear in the literature. Beginning in 1983...research funding, computerization of these work sheets became possible, making analysis possible. In that no definitive or scientific clinically controlled

Minimal stimulation protocol using letrozole versus microdose flare up GnRH agonist protocol in women with poor ovarian response undergoing ICSI.

PubMed

Mohsen, Iman Abdel; El Din, Rasha Ezz

2013-02-01

To compare the IVF outcomes of letrozole/antagonist and microdose GnRH agonist flare up protocols in poor ovarian responders undergoing intracytoplasmic sperm injection. A randomized controlled trial was performed in patients with one or more previous failed IVF cycles in which four or less oocytes were retrieved when the gonadotrophin starting dose was at least 300 IU/day. Sixty patients were randomized by computer-generated list to receive either letrozole/antagonist (mild stimulation) n = 30 or GnRH-a protocol (microdose flare) n = 30. Both groups were similar with respect to background and hormonal characteristics (age, duration of infertility, BMI, FSH, LH and E2). The clinical pregnancy rate per cycle was similar in both groups (13.3 vs. 16.6%; OR = 0.769; 95% CI = 0.185, 3.198). The doses of used gonadotropins and the number of stimulation days were significantly lower in the letrozole/antagonist protocol. The peak E2 level on the day of hCG, the endometrial thickness, the retrieved oocytes, the number of fertilized oocytes, the number of transferred embryos and the cancellation rate were statistically similar in both groups. The letrozole/antagonist protocol is a cost-effective and patient-friendly protocol that may be used in poor ovarian responders for IVF/ICSI.

Online attention modification for social anxiety disorder: replication of a randomized controlled trial.

PubMed

Carleton, R Nicholas; Teale Sapach, Michelle J N; Oriet, Chris; LeBouthillier, Daniel M

2017-01-01

Social anxiety disorder (SAD) models posit vigilance for external social threat cues and exacerbated self-focused attention as key in disorder development and maintenance. Evidence indicates a modified dot-probe protocol may reduce symptoms of SAD; however, the efficacy when compared to a standard protocol and long-term maintenance of treatment gains remains unclear. Furthermore, the efficacy of such protocols on SAD-related constructs remains relatively unknown. The current investigation clarified these associations using a randomized control trial replicating and extending previous research. Participants with SAD (n = 113; 71% women) were randomized to complete a standard (i.e. control) or modified (i.e. active) dot-probe protocol consisting of 15-min sessions twice weekly for four weeks. Self-reported symptoms were measured at baseline, post-treatment, and 4-month and 8-month follow-ups. Hierarchical linear modeling indicated significant self-reported reductions in symptoms of social anxiety, fear of negative evaluation, trait anxiety, and depression, but no such reductions in fear of positive evaluation. Symptom changes did not differ based on condition and were maintained at 8-month follow-up. Attentional biases during the dot-probe task were not related to symptom change. Overall, our results replicate support for the efficacy of both protocols in reducing symptoms of SAD and specific related constructs, and suggest a role of exposure, expectancy, or practice effects, rather than attention modification, in effecting such reductions. The current results also support distinct relationships between fears of negative and positive evaluation and social anxiety. Further research focused on identifying the mechanisms of change in attention modification protocols appears warranted.

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock: Study protocol for a randomized cross-over design.

PubMed

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-02-01

Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders. Methods/design Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate. Discussion This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies. Systematic review registration PROSPERO CRD42014009506 PMID:25312992

Prophylactic ampicillin versus cefazolin for the prevention of post-cesarean infectious morbidity in Rwanda.

PubMed

Mivumbi, Victor N; Little, Sarah E; Rulisa, Stephen; Greenberg, James A

2014-03-01

To evaluate the efficacy of ampicillin versus cefazolin as prophylactic antibiotics prior to cesarean delivery in Rwanda. In a prospective, randomized, open-label, single-site study conducted between March and May 2012, the effects of prophylactic ampicillin versus cefazolin were compared among women undergoing cesarean delivery at the Centre Hospitalier Universitaire de Kigali, Rwanda. Postoperatively, participants were evaluated daily for infectious morbidity while in the hospital. Follow-up was done by phone and by appointment at the hospital within 2 weeks of delivery. During the study period, there were 578 total deliveries and 234 cesarean deliveries (40.4%). Overall, 132 women were enrolled in the study and randomized to receive either ampicillin (n=66) or cefazolin (n=66). No women were lost to follow-up. The overall infection rate was 15.9% (21/132). The infection rate in the ampicillin group and the cefazolin group was 25.8% (17/66) and 6.1% (4/66), respectively. Implementing a universal protocol in Rwanda of prophylactic cefazolin prior to cesarean delivery might reduce postoperative febrile morbidity, use of postoperative antibiotics, and number of postoperative days in hospital. Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

"FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

PubMed

Bird, M L; Cannell, J; Callisaya, M L; Moles, E; Rathjen, A; Lane, K; Tyson, A; Smith, S

2016-04-16

Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation. A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested. Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility. ACTRN12614000427673 . Prospectively registered 17 April 2014.

Radial hemostasis is facilitated with a potassium ferrate hemostatic patch: the Statseal with TR band assessment trial (STAT).

PubMed

Seto, Arnold H; Rollefson, William; Patel, Mitul P; Suh, William M; Tehrani, David M; Nguyen, Jacqueline A; Amador, Daniel G; Behnamfar, Omid; Garg, Vinisha; Cohen, Mauricio G

2018-05-15

Hemostasis is a limiting factor for discharge after uncomplicated transradial procedures. The potassium ferrate hemostatic patch (PFHP) may serve as an adjunct to the air-bladder TR band (TRB) and allow expedited deflation of the TRB. Prospective multicenter randomized controlled trial comparing radial hemostatic protocols. Deflation of the TRB was attempted at 40 minutes with PFHP and at 120 minutes without the PFHP. The primary outcome was time to full deflation of the TRB with hemostasis. At four U.S. sites, 180 patients were enrolled after receiving a minimum of 5,000 units of unfractionated heparin or bivalirudin. Interventions comprised 30% of procedures. Successful TRB deflation occurred at 43 ± 14 minutes with PFHP and 160 ± 43 minutes without PFHP (p<0.001). Minor hematomas occurred in 9 (10.3%) of TRB patients and 16 (17.2%) of PFHP patients (p=0.20). Radial artery occlusion occurred in 2% of patients in the PFHP group (p=NS). Outpatients randomized to PFHP were discharged 51 ± 83.5 minutes earlier than control. The PFHP hemostatic patch facilitated early deflation of the TRB with a nonsignificant increase in forearm hematomas. Use of the PFHP may improve patient throughput and allow for earlier discharge following transradial procedures.

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

PubMed

Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

2016-03-31

Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of patients needed for a confirmatory RCT. ClinicalTrials.gov: NCT02360033 ; date of registration: 21 January 2015.

Alveolar bone changes after rapid maxillary expansion with tooth-born appliances: a systematic review.

PubMed

Lo Giudice, Antonino; Barbato, Ersilia; Cosentino, Leandro; Ferraro, Claudia Maria; Leonardi, Rosalia

2017-08-10

During rapid maxillary expansion (RME), heavy forces are transmitted to the maxilla by the anchored teeth causing buccal inclination and buccal bone loss of posterior teeth. To systematically review the literature in order to investigate whether RME causes periodontal sequelae, assessed by cone-beam computed tomography (CBCT). Fifteen electronic databases and reference lists of studies were searched up to March 2017. To be included in the systematic review, articles must be human studies on growing subjects, with transversal maxillary deficiency treated with RME and with assessment of buccal bone loss by CBCT images. Only randomized and non-randomized trials were included. Two authors independently performed study selection, data extraction, and risk of bias assessment. Study characteristics (study design, sample size, age, sex, skeletal maturity, type of appliance, daily activation, evaluated linear measurements, observation period, CBCT settings), and study outcomes (loss of buccal bone thickness and marginal bone) were reported according to the PRISMA statement. On the basis of the applied inclusion criteria, only six articles, three randomized clinical trials and three controlled clinical trials were included. An individual analysis of the selected articles was undertaken. The risks of bias of the six trials were scored as medium to low. The results of the present systematic review are based on a limited number of studies and only one study included a control group. In all considered studies, significant loss of buccal bone thickness and marginal bone level were observed in anchored teeth, following RME. Further prospective studies correlating the radiological data of bone loss to the periodontal soft tissues reaction after RME are required. A preliminary evaluation of the patient-related risk factors for RR may be advisable when considering to administering RME. This systematic review was registered in the National Institute of Health Research database with an appropriate protocol number (http://www.crd.york.ac.uk/PROSPERO Protocol: CRD42017062645). The present study has not received any contributions from private or public funding agencies. © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

How to Improve the Peer Review Method: Free-Selection vs Assigned-Pair Protocol Evaluated in a Computer Networking Course

ERIC Educational Resources Information Center

Papadopoulos, Pantelis M.; Lagkas, Thomas D.; Demetriadis, Stavros N.

2012-01-01

This study provides field research evidence on the efficiency of a "free-selection" peer review assignment protocol as compared to the typically implemented "assigned-pair" protocol. The study employed 54 sophomore students who were randomly assigned into three groups: Assigned-Pair (AP) (the teacher assigns student works for review to student…

The Effects of Cognitive Jamming on Wireless Sensor Networks Used for Geolocation

DTIC Science & Technology

2012-03-01

continuously sends out random bits to the channel without following any MAC-layer etiquette [31]. Normally, the underlying MAC protocol allows...23 UDP User Datagram Protocol . . . . . . . . . . . . . . . . . . . 30 MIMO Multiple Input Multiple Output . . . . . . . . . . . . . . . 70...information is packaged and distributed on the network layer, only the physical measurements are considered. This protocol is used to detect faulty nodes

Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.

PubMed

Klein-Laansma, Christien T; Jong, Mats; von Hagens, Cornelia; Jansen, Jean Pierre C H; van Wietmarschen, Herman; Jong, Miek C

2018-03-22

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated. A multicenter, randomized, controlled pragmatic trial with parallel groups. The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany. Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized. Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences. Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03). With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

A prospective protocol for nasopharyngeal carcinoma in children and adolescents: the Italian Rare Tumors in Pediatric Age (TREP) project.

PubMed

Casanova, Michela; Bisogno, Gianni; Gandola, Lorenza; Cecchetto, Giovanni; Di Cataldo, Andrea; Basso, Eleonora; Indolfi, Paolo; D'Angelo, Paolo; Favini, Francesca; Collini, Paola; Potepan, Paolo; Ferrari, Andrea

2012-05-15

Nasopharyngeal carcinoma (NPC) is very rare in childhood. It differs from its adult counterpart in the prevalence of the nonkeratinizing, undifferentiated subtype and by an advanced clinical stage at onset and better chances of survival. The risk of long-term treatment-related toxicity also may be a more important issue in younger individuals. A prospective chemoradiotherapy protocol for pediatric NPC was started in Italy in 2000 within the framework of the Rare Tumors in Pediatric Age (TREP) project. Three courses of cisplatin/5-fluorouracil induction chemotherapy were followed by radiotherapy (doses up to 65 grays) with concomitant cisplatin. Forty-six patients (ages 9-17 years) were considered eligible for the study over a 10-year period. The ratio of observed to expected cases based on epidemiological data was approximately 1 for both children and adolescents. All but 1 patient had lymph node involvement, and 5 patients had distant metastases. The rate of response to primary chemotherapy was 90%. The 5-year overall and progression-free survival rates were 80.9% and 79.3%, respectively (median follow-up, 62 months). The only statistically significant prognostic variable was the presence or absence of distant metastases. A 65% incidence of late sequelae was reported. This study demonstrates the feasibility and efficacy of a prospective protocol even for such rare tumors as pediatric NPC. The use of lower radiotherapy doses than those used in adults did not affect locoregional failure rates. Long-term follow-up will be needed to obtain more information on both survival and treatment sequelae. The next objective will be to establish broader, international prospective cooperation schemes. Copyright © 2011 American Cancer Society.

Food groups and risk of chronic disease: a protocol for a systematic review and network meta-analysis of cohort studies.

PubMed

Schwingshackl, Lukas; Chaimani, Anna; Bechthold, Angela; Iqbal, Khalid; Stelmach-Mardas, Marta; Hoffmann, Georg; Schwedhelm, Carolina; Schlesinger, Sabrina; Boeing, Heiner

2016-07-27

There is a lack of systematic and comprehensive evaluations whether food intakes lower or increase risk of chronic diseases. In this network meta-analysis of prospective cohort studies, we aim to evaluate the effects of different foods on risk of chronic diseases. We will search PubMed and EMBASE. This will be supplemented by a hand search and author contacts. Citations, abstracts, and relevant papers will be screened for eligibility by two reviewers independently. Prospective cohort studies will be included if they meet the following criteria: (1) evaluate the association of single food or food groups with all-cause mortality, cardiovascular diseases (incidence and mortality), cancer (incidence and mortality) or risk of type 2 diabetes. The following food groups will be evaluated: whole grains, refined grains, vegetables, fruits, nuts, legumes, eggs, dairy products, fish, red meat, processed meat and sugar-sweetened beverages; (2) include participants ≥18 years of age; and (3) study population were free of outcome(s) of interest at the onset of the study. To assess study quality, we will extract the following characteristics: study size, duration of follow-up, dietary assessment method, assessment of outcome and adjustment factors. If the identified studies appear sufficiently similar within and across the different comparisons between pairs of food groups, we will estimate summary-relative effects using random effects network meta-analysis. Subgroup and meta-regression analyses will be performed stratified by different follow-up cut-points, geographical region and sex. This is a presentation of the study protocol only. Results and conclusions are pending completion of this study. Our systematic review will be of great value to national and international authorities for evidence-based nutritional recommendation/guidelines, regarding the implementation of food-based dietary guidelines for prevention of chronic diseases. Moreover, our results can be implemented to develop new diet quality indices/scores. PROSPERO CRD42016037069.

Password-Only Authenticated Three-Party Key Exchange with Provable Security in the Standard Model

PubMed Central

Nam, Junghyun; Kim, Junghwan; Kang, Hyun-Kyu; Kim, Jinsoo; Paik, Juryon

2014-01-01

Protocols for password-only authenticated key exchange (PAKE) in the three-party setting allow two clients registered with the same authentication server to derive a common secret key from their individual password shared with the server. Existing three-party PAKE protocols were proven secure under the assumption of the existence of random oracles or in a model that does not consider insider attacks. Therefore, these protocols may turn out to be insecure when the random oracle is instantiated with a particular hash function or an insider attack is mounted against the partner client. The contribution of this paper is to present the first three-party PAKE protocol whose security is proven without any idealized assumptions in a model that captures insider attacks. The proof model we use is a variant of the indistinguishability-based model of Bellare, Pointcheval, and Rogaway (2000), which is one of the most widely accepted models for security analysis of password-based key exchange protocols. We demonstrated that our protocol achieves not only the typical indistinguishability-based security of session keys but also the password security against undetectable online dictionary attacks. PMID:24977229

Improved Compressive Sensing of Natural Scenes Using Localized Random Sampling

PubMed Central

Barranca, Victor J.; Kovačič, Gregor; Zhou, Douglas; Cai, David

2016-01-01

Compressive sensing (CS) theory demonstrates that by using uniformly-random sampling, rather than uniformly-spaced sampling, higher quality image reconstructions are often achievable. Considering that the structure of sampling protocols has such a profound impact on the quality of image reconstructions, we formulate a new sampling scheme motivated by physiological receptive field structure, localized random sampling, which yields significantly improved CS image reconstructions. For each set of localized image measurements, our sampling method first randomly selects an image pixel and then measures its nearby pixels with probability depending on their distance from the initially selected pixel. We compare the uniformly-random and localized random sampling methods over a large space of sampling parameters, and show that, for the optimal parameter choices, higher quality image reconstructions can be consistently obtained by using localized random sampling. In addition, we argue that the localized random CS optimal parameter choice is stable with respect to diverse natural images, and scales with the number of samples used for reconstruction. We expect that the localized random sampling protocol helps to explain the evolutionarily advantageous nature of receptive field structure in visual systems and suggests several future research areas in CS theory and its application to brain imaging. PMID:27555464

Recall of ICU Stay in Patients Managed With a Sedation Protocol or a Sedation Protocol With Daily Interruption.

PubMed

Burry, Lisa; Cook, Deborah; Herridge, Margaret; Devlin, John W; Fergusson, Dean; Meade, Maureen; Steinberg, Marilyn; Skrobik, Yoanna; Olafson, Kendiss; Burns, Karen; Dodek, Peter; Granton, John; Ferguson, Niall; Jacka, Michael; Tanios, Maged; Fowler, Robert; Reynolds, Steven; Keenan, Sean; Mallick, Ranjeeta; Mehta, Sangeeta

2015-10-01

To 1) describe factual, emotional, and delusional memories of ICU stay for patients enrolled in the SLEAP (Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol) trial; 2) compare characteristics of patients with and without ICU recall, and patients with and without delusional memories; and 3) determine factors associated with delusional memories 28 days after ICU discharge. Prospective cohort. Sixteen North American medical and surgical ICUs. Critically ill, mechanically ventilated adults randomized in the SLEAP trial. Post-ICU interviews on days 3, 28, and 90 using the validated ICU Memory Tool. Overall, 289 of 297 ICU survivors (97%) (146 protocolized sedation and 143 protocolized sedation plus daily interruption patients) were interviewed at least once. Because there were no differences in recall status or types of memories between the two sedation groups, we present the findings for all patients rather than by study group. On days 3, 28, and 90, 28%, 26%, and 36% of patients, respectively, reported no recall of being in the ICU (overall perception, self-reported) (p = 0.75). Mean daily doses of benzodiazepines and opioids were lower in patients with no ICU recall than those with recall (p < 0.0001 for both). Despite one third of patients reporting no recall of ICU stay on day 3, 97% and 90% reported at least one factual and one emotional memory from ICU, respectively. Emotional memories declined with time after ICU discharge, particularly panic and confusion. Delusional memories 28 days after discharge were common (70%) yet unrelated to delirium (p = 0.84), recall status (p = 0.15), total dose of benzodiazepine (p = 0.78), or opioid (p = 0.21). Delusional memories were less likely with longer duration of mechanical ventilation (odds ratio, 0.955; 95% CI, 0.91-1.00; p = 0.04). Recall of ICU stay and types of memories reported were not influenced by the trial sedation strategy. Lack of ICU recall and delusional memories were common after ICU discharge despite the use of sedation strategies that promoted wakefulness.

Effect of irrigation fluid temperature on body temperature during arthroscopic elbow surgery in dogs.

PubMed

Thompson, K R; MacFarlane, P D

2013-01-01

This prospective randomised clinical trial evaluated the effect of warmed irrigation fluid on body temperature in anaesthetised dogs undergoing arthroscopic elbow surgery. Nineteen dogs undergoing elbow arthroscopy were included in the study and were randomly allocated to one of two groups. Group RT received irrigation fluid at room temperature (RT) while dogs in group W received warmed (W) irrigation fluid (36°C). A standardised patient management and anaesthetic protocol was used and body temperature was measured at four time points; (T1) pre-anaesthetic examination, (T2) arrival into theatre, (T3) end of surgery and (T4) arrival into recovery. There was no significant difference in body temperature at any time point between the groups. The mean overall decrease in body temperature between pre-anaesthetic examination (T1) and return to the recovery suite (T4) was significant in both groups, with a fall of 1.06±0.58°C (p<0.001) in group RT and 1.53±0.76°C (p<0.001) group W. There was no significant difference between the groups. At the end of surgery (T3) 4/19 (21.1%) of dogs were hypothermic (<37°C). The addition of warmed irrigation fluids to a temperature management protocol in dogs undergoing elbow arthroscopy during general anaesthesia did not lead to decreased temperature losses.

Effect of irrigation fluid temperature on body temperature during arthroscopic elbow surgery in dogs

PubMed Central

Thompson, K.R.; MacFarlane, P.D.

2013-01-01

This prospective randomised clinical trial evaluated the effect of warmed irrigation fluid on body temperature in anaesthetised dogs undergoing arthroscopic elbow surgery. Nineteen dogs undergoing elbow arthroscopy were included in the study and were randomly allocated to one of two groups. Group RT received irrigation fluid at room temperature (RT) while dogs in group W received warmed (W) irrigation fluid (36°C). A standardised patient management and anaesthetic protocol was used and body temperature was measured at four time points; (T1) pre-anaesthetic examination, (T2) arrival into theatre, (T3) end of surgery and (T4) arrival into recovery. There was no significant difference in body temperature at any time point between the groups. The mean overall decrease in body temperature between pre-anaesthetic examination (T1) and return to the recovery suite (T4) was significant in both groups, with a fall of 1.06±0.58°C (p<0.001) in group RT and 1.53±0.76°C (p<0.001) group W. There was no significant difference between the groups. At the end of surgery (T3) 4/19 (21.1%) of dogs were hypothermic (<37°C). The addition of warmed irrigation fluids to a temperature management protocol in dogs undergoing elbow arthroscopy during general anaesthesia did not lead to decreased temperature losses. PMID:26623323

SUGAR: spotting undiagnosed glucose abnormal results--a new protocol to increase postpartum testing among women with gestational diabetes mellitus.

PubMed

Carson, Michael P; Morgan, Benjamin; Gussman, Debra; Brown, Monica; Rothenberg, Karen; Wisner, Theresa A

2015-02-01

Over 70% of women with gestational diabetes mellitus (GDM) will develop diabetes mellitus (DM), but only 30% follow through with the recommended postpartum oral glucose tolerance testing (OGTT). HbA1c is approved to diagnose DM, and combined with a fasting plasma glucose it can identify 93% of patients with dysglycemia. We tested the hypothesis that a single blood draw to assess for dysglycemia at the postpartum visit could improve testing rates compared with those required to obtain an OGTT at an outside laboratory. Prospective cohort study of all women with GDM who delivered between July 2010 and December 2011. When insurance status required testing at an outside laboratory an OGTT was ordered, when insurance allowed testing at our center a random sugar and HbA1c were drawn at the postpartum visit (SUGAR Protocol). Of the 40 women, 36 attended a postpartum visit. In the SUGAR arm, 19 of 19 (100%) were tested versus 9 of 17 (53%) in the OGTT arm; relative risk of testing was 1.9 (95% confidence interval, 1.2-3.0). 36% were glucose intolerant. This pilot study found that an in-office testing model doubled the rate of postpartum testing in this clinic population, and was reasonably sensitive at detecting dysglycemia. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A meta-analysis of the effect of neuromuscular training on the prevention of the anterior cruciate ligament injury in female athletes.

PubMed

Yoo, Jae Ho; Lim, Bee Oh; Ha, Mina; Lee, Soo Won; Oh, Soo Jin; Lee, Yong Seuk; Kim, Jin Goo

2010-06-01

Female athletes are more prone to anterior cruciate ligament (ACL) injury than their male counterparts, presumably because of anatomical, hormonal, and neuromuscular differences. Of these three, only the neuromuscular component can be modified by preventive exercise. We aimed to evaluate the effect of a neuromuscular protocol on the prevention of ACL injury by performing meta-analysis, and to identify essential factors by subgroup analysis. An extensive literature review was conducted to identify relevant studies, and eventually, only seven randomized controlled trials or prospective cohort studies were included in the analysis. The odds ratios (OR) and the confidence interval (CI) for the overall effects of training and of potentially contributory factors were estimated. The OR and the 95% CI for the overall effect of the preventive training were 0.40 and [0.27, 0.60], respectively. Subgroup analysis revealed that an age under 18, soccer rather than handball, pre- and in-season training rather than either pre- or in-season training, and the plyometrics and strengthening components rather than balancing were significant. Meta-analysis showed that pre- and in-season neuromuscular training with an emphasis on plyometrics and strengthening exercises was effective at preventing ACL injury in female athletes, especially in those under 18 years of age. Further study is required to develop a relevant training program protocol of appropriate intensity.

Impact of providing psychiatry specialty pharmacist intervention on reducing drug-related problems among children with autism spectrum disorder related to disruptive behavioural symptoms: A prospective randomized open-label study.

PubMed

Wongpakaran, R; Suansanae, T; Tan-Khum, T; Kraivichian, C; Ongarjsakulman, R; Suthisisang, C

2017-06-01

Psychopharmacologic therapy has so far focused on ameliorating disruptive behaviours to improve patient's function and quality of life. Due to the complicated neurobiological aetiology of autism spectrum disorder (ASD), a traditional pharmacist intervention may be insufficient to initiate the optimal care for this vulnerable population. We evaluate the impact of providing specialty psychiatry (PS) pharmacist intervention in identifying and resolving drug-related problems (DRPs) among children with ASD associated with disruptive behaviours. An eight-week-long, prospective, randomized open-label study was conducted. Children between 2.5 and 12 years of age with ASD and showing disruptive behaviours were included. They were randomly assigned to an intervention or a control group. Patients in the intervention group received pharmacist interventions delivered by a PS pharmacist, while those in control group were cared by a hospital pharmacist. The primary outcome was the number of patients who resolved of at least one DRP by the end of the study. The secondary outcome was to compare the mean Aberrant Behavior Checklist-Irritability (ABC-I) scores between the two groups. Twenty-five patients were randomly assigned to either an intervention or control group. At week 8, the total number of patients who resolved of at least one DRP was 13 (52%) in the intervention group and 4 (16%) in the control group, respectively (P=.016). Improper drug selection, medication non-adherence and subtherapeutic dosage were the most common DRPs. Mean ABC-I scores improved in the intervention group more than in the control group (9.8±5.6 vs 17.7±7.9; P<.001). To the best of our knowledge, this is the first study which demonstrated that PS pharmacist intervention is an effective strategy to resolve DRPs in patient with ASD. The reduction in common DRPs mostly resulted from the PS pharmacist interventions, including selection of antipsychotic agent, adjustment of dosage based on ABC-I scores and provision of individualized drug counselling. Reducing DRPs led to the improvement of any disruptive behaviour. In addition, multidisciplinary team should develop drug therapy protocols to promote the role of pharmacists in this setting. © 2017 John Wiley & Sons Ltd.

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial.

PubMed

Raaben, Marco; Redzwan, Syaiful; Augustine, Robin; Blokhuis, Taco Johan

2018-04-12

Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly. This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group. The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible. TrialRegister.nl, NTR6794 . Registered on 31 October 2017.

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

PubMed

Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

2011-05-06

The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire.Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Netherlands Trial Register (NTR): NTR2064. © 2011 Hannemann et al; licensee BioMed Central Ltd.

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

PubMed Central

2011-01-01

Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire. Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Trial registration Netherlands Trial Register (NTR): NTR2064 PMID:21548951

Adaptive Peer Sampling with Newscast

NASA Astrophysics Data System (ADS)

Tölgyesi, Norbert; Jelasity, Márk

The peer sampling service is a middleware service that provides random samples from a large decentralized network to support gossip-based applications such as multicast, data aggregation and overlay topology management. Lightweight gossip-based implementations of the peer sampling service have been shown to provide good quality random sampling while also being extremely robust to many failure scenarios, including node churn and catastrophic failure. We identify two problems with these approaches. The first problem is related to message drop failures: if a node experiences a higher-than-average message drop rate then the probability of sampling this node in the network will decrease. The second problem is that the application layer at different nodes might request random samples at very different rates which can result in very poor random sampling especially at nodes with high request rates. We propose solutions for both problems. We focus on Newscast, a robust implementation of the peer sampling service. Our solution is based on simple extensions of the protocol and an adaptive self-control mechanism for its parameters, namely—without involving failure detectors—nodes passively monitor local protocol events using them as feedback for a local control loop for self-tuning the protocol parameters. The proposed solution is evaluated by simulation experiments.

Continuous infusion of low-dose unfractionated heparin after aneurysmal subarachnoid hemorrhage: a preliminary study of cognitive outcomes.

PubMed

James, Robert F; Khattar, Nicolas K; Aljuboori, Zaid S; Page, Paul S; Shao, Elaine Y; Carter, Lacey M; Meyer, Kimberly S; Daniels, Michael W; Craycroft, John; Gaughen, John R; Chaudry, M Imran; Rai, Shesh N; Everhart, D Erik; Simard, J Marc

2018-05-11

OBJECTIVE Cognitive dysfunction occurs in up to 70% of aneurysmal subarachnoid hemorrhage (aSAH) survivors. Low-dose intravenous heparin (LDIVH) infusion using the Maryland protocol was recently shown to reduce clinical vasospasm and vasospasm-related infarction. In this study, the Montreal Cognitive Assessment (MoCA) was used to evaluate cognitive changes in aSAH patients treated with the Maryland LDIVH protocol compared with controls. METHODS A retrospective analysis of all patients treated for aSAH between July 2009 and April 2014 was conducted. Beginning in 2012, aSAH patients were treated with LDIVH in the postprocedural period. The MoCA was administered to all aSAH survivors prospectively during routine follow-up visits, at least 3 months after aSAH, by trained staff blinded to treatment status. Mean MoCA scores were compared between groups, and regression analyses were performed for relevant factors. RESULTS No significant differences in baseline characteristics were observed between groups. The mean MoCA score for the LDIVH group (n = 25) was 26.4 compared with 22.7 in controls (n = 22) (p = 0.013). Serious cognitive impairment (MoCA ≤ 20) was observed in 32% of controls compared with 0% in the LDIVH group (p = 0.008). Linear regression analysis demonstrated that only LDIVH was associated with a positive influence on MoCA scores (β = 3.68, p =0.019), whereas anterior communicating artery aneurysms and fevers were negatively associated with MoCA scores. Multivariable linear regression analysis resulted in all 3 factors maintaining significance. There were no treatment complications. CONCLUSIONS This preliminary study suggests that the Maryland LDIVH protocol may improve cognitive outcomes in aSAH patients. A randomized controlled trial is needed to determine the safety and potential benefit of unfractionated heparin in aSAH patients.

Initial experience with ketamine-based analgesia in patients undergoing robotic radical cystectomy and diversion.

PubMed

Jacobsohn, Kenneth; Davis, Tanya D; El-Arabi, Ahmad M; Tlachac, Jonathan; Langenstroer, Peter; O'Connor, R Corey; Guralnick, Michael L; See, William A; Schlosser, Robert

2015-01-01

We instituted a ketamine-predominant analgesic regimen in the peri- and postoperative periods to limit the effects of narcotic analgesia on bowel function in patients undergoing radical cystectomy. The primary end points of interest were time to return of bowel function, time to discharge, and efficacy of the analgesic regimen. We performed a retrospective chart review of patients undergoing robotic-assisted laparoscopic cystectomy (RARC) with urinary diversion by a single surgeon at our institution from January 1, 2011 to June 30, 2012. Patients receiving the opioid-minimizing ketamine protocol were compared to a cohort of patients undergoing RARC with an opioid-predominant analgesic regimen. In total, 15 patients (Group A) were included in the ketamine-predominant regimen and 25 patients (Group B) in the opioid-predominant control group. Three patients (19%) in Group A discontinued the protocol due to ketamine side effects. The mean time to bowel movement and length of stay in Group A versus Group B was 3 versus 6 days (p < 0.001), and 4 versus 8 days, respectively (p < 0.001). Group A patients received an average of 13.0 mg of morphine versus 97.5 mg in Group B (p < 0.001). Patients who received our ketamine pain control regimen had a shorter time to return of bowel function and length of hospitalization after RARC. Our study has its limitations as a retrospective, single surgeon, single institution study and the non-randomization of patients. Notwithstanding these limitations, this study was not designed to show inferiority of one approach, but instead to show that our protocol is safe and efficacious, warranting further study in a prospective fashion.

Radiation dose reduction in parasinus CT by spectral shaping.

PubMed

May, Matthias S; Brand, Michael; Lell, Michael M; Sedlmair, Martin; Allmendinger, Thomas; Uder, Michael; Wuest, Wolfgang

2017-02-01

Spectral shaping aims to narrow the X-ray spectrum of clinical CT. The aim of this study was to determine the image quality and the extent of radiation dose reduction that can be achieved by tin prefiltration for parasinus CT. All scans were performed with a third generation dual-source CT scanner. A study protocol was designed using 100 kV tube voltage with tin prefiltration (200 mAs) that provides image noise levels comparable to a low-dose reference protocol using 100 kV without spectral shaping (25 mAs). One hundred consecutive patients were prospectively enrolled and randomly assigned to the study or control group. All patients signed written informed consent. The study protocol was approved by the local Institutional Review Board and applies to the HIPAA. Subjective and objective image quality (attenuation values, image noise, and contrast-to-noise ratio (CNR)) were assessed. Radiation exposure was assessed as volumetric CT dose index, and effective dose was estimated. Mann-Whitney U test was performed for radiation exposure and for image noise comparison. All scans were of diagnostic image quality. Image noise in air, in the retrobulbar fat, and in the eye globe was comparable between both groups (all p > 0.05). CNR eye globe/air did not differ significantly between both groups (p = 0.7). Radiation exposure (1.7 vs. 2.1 mGy, p < 0.01) and effective dose (0.055 vs. 0.066 mSv, p < 0.01) were significantly reduced in the study group. Radiation dose can be further reduced by 17% for low-dose parasinus CT by tin prefiltration maintaining diagnostic image quality.

Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis

PubMed Central

Sobral, Ana Paula Taboada; de Godoy, Camila Leal H; Fernandes, Kristianne P Santos; Bussadori, Sandra Kalil; Ferrari, Raquel Agnelli Mesquita; Monken, Sonia F

2018-01-01

Introduction Epidemiological data show that the signs and symptoms of temporomandibular disorder (TMD) start becoming apparent from 6 years of age, and during adolescence these signs and symptoms are similar to those of adults. The present study aims to estimate the direct costs for treatment of chronic muscle pain with photobiomodulation therapy, occlusal splint and placebo in patients with TMD; to evaluate the effectiveness of photobiomodulation therapy and occlusal splint for treatment of muscle pain in patients with TMD; to analyse the cost-effectiveness of the two proposed treatments for pain; and to describe and compare the results of the analyses of these treatments. Methods and analysis This is a prospective trial of clinical and economic analyses that will include 135 patientswith TMD aged between 15 years and 25 years, randomly assigned to a treatment group: G1 (photobiomodulation), G2 (occlusal splint) and G3 (placebo). The analyses will be based on the cost of each treatment during the 12-month period. The outcome of the analysis of effectiveness will be pain, measured periodically by means of clinical examination of Research Diagnostic Criteria for Temporomandibular Disorders. The cost-effectiveness ratio will be calculated using, as end points, pain and the ratio of the differences in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D. Ethics and dissemination This protocol has been ethically approved by the local medical ethical committee, protocol number 2.014.339. Results will be submitted to international peer-reviewed journals and presented at international conferences. Trial registration number NCT03096301. PMID:29730613

Reversal of rocuronium-induced neuromuscular blockade by sugammadex allows for optimization of neural monitoring of the recurrent laryngeal nerve.

PubMed

Lu, I-Cheng; Wu, Che-Wei; Chang, Pi-Ying; Chen, Hsiu-Ya; Tseng, Kuang-Yi; Randolph, Gregory W; Cheng, Kuang-I; Chiang, Feng-Yu

2016-04-01

The use of neuromuscular blocking agent may effect intraoperative neuromonitoring (IONM) during thyroid surgery. An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a porcine model and subsequently clinically applied during human thyroid neural monitoring surgery. Prospective animal and retrospective clinical study. In the animal experiment, 12 piglets were injected with rocuronium 0.6 mg/kg and randomly allocated to receive normal saline, sugammadex 2 mg/kg, or sugammadex 4 mg/kg to compare the recovery of laryngeal electromyography (EMG). In a subsequent clinical application study, 50 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol-rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at the operation start. The train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission. In our porcine model, it took 49 ± 15, 13.2 ± 5.6, and 4.2 ± 1.5 minutes for the 80% recovery of laryngeal EMG after injection of saline, sugammadex 2 mg/kg, and sugammadex 4 mg/kg, respectively. In subsequent clinical human application, the TOF ratio recovered from 0 to >0.9 within 5 minutes after administration of sugammadex 2 mg/kg at the operation start. All patients had positive and high EMG amplitude at the early stage of the operation, and intubation was without difficulty in 96% of patients. Both porcine modeling and clinical human application demonstrated that sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium. Implementation of this enhanced NMB recovery protocol assures optimal conditions for tracheal intubation as well as IONM in thyroid surgery. NA. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

[Results of the SHOP LNHB98 (LMB89) trial in pediatric patients with B-cell non-Hodgkin's lymphoma].

PubMed

Forns, Marga; Javier, Germán; Estella, Jesús; Fernández-Delgado, Rafael; Gallego, Soledad; García-Miguel, Purificación; Indiano, José M; Navajas, Aurora; Pardo, Nuria

2007-05-05

After the good results obtained by the Société Française d'Oncologie Pédiatrique (SFOP) regarding the pediatric B-type non-Hodgkin's (Burkitt and large B-cell) lymphoma and L3 leukemia, the Sociedad Española de Hematología y Oncología Pediátricas (SHOP) decided to use the same treatment protocol. Pediatric patients diagnosed with B-type non-Hodgkin's lymphoma without a previous history of malignant diseases were eligible for this study. They were classified in 3 groups of risk: group A (resected stage I and abdominal stage II), group B (not eligible for groups A or C), and group C (with central nervous system involvement and L3 leukemia). All received treatment according to the SFOP's LMB89 protocol. A total of 153 patients were considered in this multicenter, prospective and non-randomized trial (1997-2005). The global and event-free survival (EFS) were found to be of 88% (0.88; 95% confidence interval [CI], 0.83-0.93) and 85% (0.85; 95% CI, 0.79-0.90), respectively. The EFS was 100% for the group A (n = 16), 86% (0.86; 95% CI, 0.79-0.92) for the group B (n = 113), and 68% (0.68; 95% CI, 0.49-0.86) for the group C (n = 24). The results confirm the good efficiency of the LMB89 protocol for treating B-cell lymphoma and L3 leukemia, despite having diminished the treatment intensity in the less risk groups. The worst prognostic factor was found to be a central nervous system involvement, whereas being younger than 10 years was confirmed to be a favorable prognostic factor. In addition, no differences were evidenced between Burkitt and large B-cell lymphoma.

Digital subtraction angiography during transjugular intrahepatic portosystemic shunt creation or revision: data on radiation exposure and image quality obtained using a standard and a low-dose acquisition protocol in a flat-panel detector-based system.

PubMed

Miraglia, Roberto; Maruzzelli, Luigi; Cortis, Kelvin; Tafaro, Corrado; Gerasia, Roberta; Parisi, Carmelo; Luca, Angelo

2015-08-01

To determine whether the use of a low-dose acquisition protocol (LDP) in digital subtraction angiography during transjugular intrahepatic portosystemic shunt (TIPS) creation/revision results in significant reduction of patient radiation exposure and adequate image quality, as compared to a default reference standard-dose acquisition protocol (SDP). Two angiographic runs were performed during TIPS creation/revision: the first following catheterization of the portal venous system and the second after stent deployment/angioplasty. Constant field of view, object to image-detector distance, and source to image-receptor distance were maintained in each patient during the two angiographic runs. 17 consecutive adult patients who underwent TIPS creation (n = 11) or TIPS revision (n = 6) from December 2013 to March 2014 were considered eligible for this single centre prospective study. In each patient, the LDP and the SDP were used in a random order for the two runs, with each patient serving as his/her own control. The dose-area product (DAP) was calculated for each image and compared. Image quality was graded by two interventional radiologists other than the operator. In all runs acquired with the LDP, image quality was considered adequate for a successful procedural outcome. The DAP per image of the LDP was numerically inferior as compared to the DAP per image of the SDP in all patients. The mean reduction in DAP per image was 75.24% ± 5.7% (p < 0. 001). Radiation exposure during TIPS creation/revision was significantly reduced by selecting a LDP in our flat-panel detector-based system, while maintaining adequate image quality.

Prevalence of peritonitis and mortality in patients treated with continuous ambulatory peritoneal dialysis (CAPD) in Africa: a protocol for a systematic review and meta-analysis.

PubMed

Moloi, Mothusi Walter; Kajawo, Shepherd; Noubiap, Jean Jacques; Mbah, Ikechukwu O; Ekrikpo, Udeme; Kengne, Andre Pascal; Bello, Aminu K; Okpechi, Ikechi G

2018-05-24

Continuous ambulatory peritoneal dialysis (CAPD) is the ideal modality for renal replacement therapy in most African settings given that it is relatively cheaper than haemodialysis (HD) and does not require in-centre care. CAPD is, however, not readily utilised as it is often complicated by peritonitis leading to high rates of technique failure. The objective of this study is to assess the prevalence of CAPD-related peritonitis and all-cause mortality in patients treated with CAPD in Africa. We will search PubMed, EMBASE, SCOPUS, Africa Journal Online and Google Scholar for studies conducted in Africa from 1 January 1980 to 30 June 2017 with no language restrictions. Eligible studies will include cross-sectional, prospective observational and cohort studies of patients treated with CAPD. Two authors will independently screen, select studies, extract data and conduct risk of bias assessment. Data consistently reported across studies will be pooled using random-effects meta-analysis. Heterogeneity will be evaluated using Cochrane's Q statistic and quantified using I 2 statistics. Graphical and formal statistical tests will be used to assess for publication bias. Ethical approval will not be needed for this study as data used will be extracted from already published studies. Results of this review will be published in a peer-reviewed journal and presented at conferences. The Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015) framework guided the development of this protocol. CRD42017072966. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Quantum-key-distribution protocol with pseudorandom bases

NASA Astrophysics Data System (ADS)

Trushechkin, A. S.; Tregubov, P. A.; Kiktenko, E. O.; Kurochkin, Y. V.; Fedorov, A. K.

2018-01-01

Quantum key distribution (QKD) offers a way for establishing information-theoretical secure communications. An important part of QKD technology is a high-quality random number generator for the quantum-state preparation and for post-processing procedures. In this work, we consider a class of prepare-and-measure QKD protocols, utilizing additional pseudorandomness in the preparation of quantum states. We study one of such protocols and analyze its security against the intercept-resend attack. We demonstrate that, for single-photon sources, the considered protocol gives better secret key rates than the BB84 and the asymmetric BB84 protocols. However, the protocol strongly requires single-photon sources.

Intrathecal versus IV fentanyl in pediatric cardiac anesthesia.

PubMed

Pirat, Arash; Akpek, Elif; Arslan, Gülnaz

2002-11-01

Systemic large-dose opioids are widely used in pediatric cardiac anesthesia, but there are no randomized, prospective studies regarding the use of intrathecal (IT) opioids for these procedures. In this randomized, prospective study, we compared cardiovascular and neurohumoral responses during IT or IV fentanyl anesthesia for pediatric cardiac surgery. Thirty children aged 6 mo to 6 yr were anesthetized with an IV fentanyl bolus of 10 micro g/kg. This was followed by a fentanyl infusion of 10 micro g. kg(-1). h(-1) (Group IV; n = 10), 2 micro g/kg of IT fentanyl (Group IT; n = 10), or combined IV and IT protocols (Group IV + IT; n = 10). Heart rate, mean arterial blood pressure, additional fentanyl doses, time to first analgesic requirement, COMFORT and Children's Hospital of Eastern Ontario Pain Scale scores, and extubation time were recorded. Blood cortisol, insulin, glucose, and lactate levels were measured presurgery, poststernotomy, during the rewarming phase of cardiopulmonary bypass (CPB), and 6 and 24 h after surgery. The patients' urinary cortisol excretion rates were also measured during the first postoperative day. The findings in all three groups were statistically similar, except for higher blood glucose levels during CPB in Group IT compared with Group IV (P < 0.004). Group IV + IT was the only group in which the increases in heart rate and mean arterial blood pressure from presurgery to poststernotomy were not significant. The 24-h urinary cortisol excretion rates ( micro g. kg(-1). d(-1)) were 61.51 +/- 39, 92.54 +/- 67.55, and 40.15 +/- 29.69 for Groups IV, IT, and IV + IT, respectively (P > 0.05). A single IT injection of fentanyl 2 micro g/kg offers no advantage over systemic fentanyl (10 micro g/kg bolus and 10 micro g. kg(-1). h(-1)) with regard to hemodynamic stability or suppression of stress response. The combination of these two regimens may provide better hemodynamic stability during the pre-CPB period and may be associated with a decreased 24-h urinary cortisol excretion rate. In this prospective, randomized study, we investigated the adequacy of a single intrathecal injection of fentanyl for intraoperative analgesia, compared the effects of IT and IV fentanyl on stress response, and assessed for an additive effect of IT and IV fentanyl administration in pediatric cardiac anesthesia. The results with these three different anesthetic regimens were similar regarding anesthesia depth and level of stress response. However, the combination of IT and IV routes may provide better hemodynamic stability and a less pronounced stress response, as reflected by 24-h urinary cortisol excretion.

A Secure Authenticated Key Exchange Protocol for Credential Services

NASA Astrophysics Data System (ADS)

Shin, Seonghan; Kobara, Kazukuni; Imai, Hideki

In this paper, we propose a leakage-resilient and proactive authenticated key exchange (called LRP-AKE) protocol for credential services which provides not only a higher level of security against leakage of stored secrets but also secrecy of private key with respect to the involving server. And we show that the LRP-AKE protocol is provably secure in the random oracle model with the reduction to the computational Difie-Hellman problem. In addition, we discuss about some possible applications of the LRP-AKE protocol.

Comment on 'Two-way protocols for quantum cryptography with a nonmaximally entangled qubit pair'

DOE Office of Scientific and Technical Information (OSTI.GOV)

Qin Sujuan; Gao Fei; Wen Qiaoyan

2010-09-15

Three protocols of quantum cryptography with a nonmaximally entangled qubit pair [Phys. Rev. A 80, 022323 (2009)] were recently proposed by Shimizu, Tamaki, and Fukasaka. The security of these protocols is based on the quantum-mechanical constraint for a state transformation between nonmaximally entangled states. However, we find that the second protocol is vulnerable under the correlation-elicitation attack. An eavesdropper can obtain the encoded bit M although she has no knowledge about the random bit R.

Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial.

PubMed

Slusher, Tina M; Olusanya, Bolajoko O; Vreman, Hendrik J; Wong, Ronald J; Brearley, Ann M; Vaucher, Yvonne E; Stevenson, David K

2013-12-28

Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT. This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm²/nm. FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT. This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics. ClinicalTrials.gov Identifier: NCT01434810.

Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.

PubMed

Brouwer, Patrick A; Brand, Ronald; van den Akker-van Marle, M Elske; Jacobs, Wilco C H; Schenk, Barry; van den Berg-Huijsmans, Annette A; Koes, Bart W; van Buchem, M A; Arts, Mark P; Peul, Wilco C

2015-05-01

Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

PubMed

Sun, Fenghua; Wang, Li-Juan; Wang, Lin

2015-04-10

Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.

PubMed

Gasparini, Maurizio; Galimberti, Paola; Bragato, Renato; Ghio, Stefano; Raineri, Claudia; Landolina, Maurizio; Chieffo, Enrico; Lunati, Maurizio; Mulargia, Ederina; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Vicentini, Alessandro; Marcantoni, Lina; Zanon, Francesco; Klersy, Catherine

2016-12-03

Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

PubMed

Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

PubMed

Murphy, Patrick; Lee, Kevin; Dubois, Luc; DeRose, Guy; Forbes, Thomas; Power, Adam

2015-11-04

Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs. NCT02084017 , March 2014.

Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial.

PubMed

Villar, Jesús; Belda, Javier; Blanco, Jesús; Suarez-Sipmann, Fernando; Añón, José Manuel; Pérez-Méndez, Lina; Ferrando, Carlos; Parrilla, Dácil; Montiel, Raquel; Corpas, Ruth; González-Higueras, Elena; Pestaña, David; Martínez, Domingo; Fernández, Lorena; Soro, Marina; García-Bello, Miguel Angel; Fernández, Rosa Lidia; Kacmarek, Robert M

2016-10-13

Patient-ventilator asynchrony is a common problem in mechanically ventilated patients with acute respiratory failure. It is assumed that asynchronies worsen lung function and prolong the duration of mechanical ventilation (MV). Neurally Adjusted Ventilatory Assist (NAVA) is a novel approach to MV based on neural respiratory center output that is able to trigger, cycle, and regulate the ventilatory cycle. We hypothesized that the use of NAVA compared to conventional lung-protective MV will result in a reduction of the duration of MV. It is further hypothesized that NAVA compared to conventional lung-protective MV will result in a decrease in the length of ICU and hospital stay, and mortality. This is a prospective, multicenter, randomized controlled trial in 306 mechanically ventilated patients with acute respiratory failure from several etiologies. Only patients ventilated for less than 5 days, and who are expected to require prolonged MV for an additional 72 h or more and are able to breathe spontaneously, will be considered for enrollment. Eligible patients will be randomly allocated to two ventilatory arms: (1) conventional lung-protective MV (n = 153) and conventional lung-protective MV with NAVA (n = 153). Primary outcome is the number of ventilator-free days, defined as days alive and free from MV at day 28 after endotracheal intubation. Secondary outcomes are total length of MV, and ICU and hospital mortality. This is the first randomized clinical trial examining, on a multicenter scale, the beneficial effects of NAVA in reducing the dependency on MV of patients with acute respiratory failure. ClinicalTrials.gov website ( NCT01730794 ). Registered on 15 November 2012.

Specific music therapy techniques in the treatment of primary headache disorders in adolescents: a randomized attention-placebo-controlled trial.

PubMed

Koenig, Julian; Oelkers-Ax, Rieke; Kaess, Michael; Parzer, Peter; Lenzen, Christoph; Hillecke, Thomas Karl; Resch, Franz

2013-10-01

Migraine and tension-type headache have a high prevalence in children and adolescents. In addition to common pharmacologic and nonpharmacologic interventions, music therapy has been shown to be efficient in the prophylaxis of pediatric migraine. This study aimed to assess the efficacy of specific music therapy techniques in the treatment of adolescents with primary headache (tension-type headache and migraine). A prospective, randomized, attention-placebo-controlled parallel group trial was conducted. Following an 8-week baseline, patients were randomized to either music therapy (n = 40) or a rhythm pedagogic program (n = 38) designed as an "attention placebo" over 6 sessions within 8 weeks. Reduction of both headache frequency and intensity after treatment (8-week postline) as well as 6 months after treatment were taken as the efficacy variables. Treatments were delivered in equal dose and frequency by the same group of therapists. Data analysis of subjects completing the protocol showed that neither treatment was superior to the other at any point of measurement (posttreatment and follow-up). Intention-to-treat analysis revealed no impact of drop-out on these results. Both groups showed a moderate mean reduction of headache frequency posttreatment of about 20%, but only small numbers of responders (50% frequency reduction). Follow-up data showed no significant deteriorations or improvements. This article presents a randomized placebo-controlled trial on music therapy in the treatment of adolescents with frequent primary headache. Music therapy is not superior to an attention placebo within this study. These results draw attention to the need of providing adequate controls within therapeutic trials in the treatment of pain. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

A meta-analysis of comparative outcomes following cervical arthroplasty or anterior cervical fusion: results from 4 prospective multicenter randomized clinical trials and up to 1226 patients.

PubMed

McAfee, Paul C; Reah, Chris; Gilder, Kye; Eisermann, Lukas; Cunningham, Bryan

2012-05-15

Meta-analysis of 4 prospective randomized controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials. To maximize the information available from 4 IDE studies by analyzing the combined outcomes of cervical arthroplasty versus fusion at 24-month follow-up. To date, 4 randomized clinical trials have been completed in the United States under FDA IDE protocols to study cervical arthroplasty. Each trial reported arthroplasty to be at least as successful as fusion controls based on noninferiority trial designs. However, sample sizes in any given trial may not be sufficient to demonstrate superiority of treatment effect. Meta-analysis enables pooling of results from comparable trials, which may lead to more precise and statistically significant estimates of treatment effect. Four cervical arthroplasty randomized clinical trials with comparable enrollment criteria and outcome measures were conducted independently by 3 separate sponsors to study the following devices: Bryan, Prestige, ProDisc-C, and PCM cervical disc replacements. A total of 1608 patients were treated across 98 investigative sites. Data were available for 1352 treated patients, of which 1226 were evaluable at 24 months. Assessments included clinical success definitions based on neck disability index, maintenance or improvement of neurological status, subsequent surgery or intervention at the index level (survivorship), and a composite score comprising these as well as serious device-related adverse events. Trial endpoint comparisons were made at 24 months postoperatively. For each endpoint, a random-effects meta-analysis was performed to compare the success rates of cervical arthroplasty with anterior cervical discectomy and fusion (ACDF). Also, supportive frequentist and bayesian analyses were performed. The pooled primary overall success results indicated a statistically significant treatment effect favoring arthroplasty compared with ACDF. Overall success was achieved by 77.6% of the arthroplasty patients and by 70.8% of the ACDF patients (pooled odds ratio [OR]: 0.699, 95% confidence interval [CI]: 0.539-0.908, P = 0.007). The results of the individual subcomponent meta-analyses, all of which favored arthroplasty, were neck disability index success (OR: 0.786, 95% CI: 0.589-1.050, P = 0.103), neurological status (OR: 0.552, 95% CI: 0.364-0.835, P = 0.005), and survivorship (OR: 0.510, 95% CI: 0.275-0.946, P = 0.033). Only the survivorship endpoint suggested low heterogeneity. These findings suggest that cervical arthroplasty is superior to ACDF in overall success, neurological success, and survivorship outcomes at 24 months postoperatively.

Intraocular pressure decrease with preservative-free fixed and unfixed combination of tafluprost and timolol in pseudoexfoliative glaucoma.

PubMed

Holló, Gábor; Ropo, Auli

2015-01-01

We investigated the intraocular pressure (IOP) lowering efficacy of preservative-free fixed and non-fixed combination of tafluprost 0.0015% and timolol 0.5% in pseudoexfoliative glaucoma (XFG). A per protocol worse eye analysis was made on all XFG patients who participated in a recent 6 month, prospective, randomized, double-masked, parallel group, multicenter phase III study. The mean time-wise IOP decreased by 8.62 to 10.25 mmHg (31.8 to 36.7%) in the fixed dose combination arm (15 patients) and by 5.38 to 11.35 mmHg (21.3 to 41.2%) in the non-fixed combination arm (13 patients), respectively (p < 0.001 for all comparisons). The results show that a preservative-free fixed dose combination of tafluprost and timolol provides a clinically significant IOP reduction in XFG, and may offer an advantage for the XFG patients with dry eye, due to its preservative-free nature.

Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials

PubMed Central

2012-01-01

Background There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. Methods Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. Results Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture. PMID:22953730

Prostate biopsies assisted by comanipulated probe-holder: first in man.

PubMed

Vitrani, Marie-Aude; Baumann, Michael; Reversat, David; Morel, Guillaume; Moreau-Gaudry, Alexandre; Mozer, Pierre

2016-06-01

A comanipulator for assisting endorectal prostate biopsies is evaluated through a first-in-man clinical trial. This lightweight system, based on conventional robotic components, possesses six degrees of freedom. It uses three electric motors and three brakes. It features a free mode, where its low friction and inertia allow for natural manipulation of the probe and a locked mode, exhibiting both a very low stiffness and a high steady-state precision. Clinical trials focusing on the free mode and the locked mode of the robot are presented. The objective was to evaluate the practical usability and performance of the robot during clinical procedures. A research protocol for a prospective randomized clinical trial has been designed. Its specific goal was to compare the accuracy of biopsies performed with and without the assistance of the comanipulator. The accuracy is compared between biopsies performed with and without the assistance of the comanipulator, across the 10 first patients included in the trial. Results show a statistically significant increase in the precision.

Evidence and evidence gaps of laryngeal cancer surgery

PubMed Central

Wiegand, Susanne

2016-01-01

Surgical treatment of laryngeal cancer has been established for decades. In addition to total laryngectomy, which was first performed in 1873, a large number or organ preservation surgical techniques, like open partial laryngectomy, transoral laser microsurgery, and transoral robotic surgery have been developed. Studies on laryngeal cancer surgery are mainly retrospective case series and cohort studies. The evolution of chemoradiation protocols and their analysis in prospective randomized trials have led to an increasing acceptance of non-surgical treatment procedures. In addition to an improvement of prognosis, in recent years the preservation of function and maintenance of life quality after primary therapy of laryngeal cancer has increasingly become the focus of therapy planning. Significant late toxicity after chemoradiation has been identified as an important issue. This leads to a reassessment of surgical concepts and initiation of studies on laryngeal cancer surgery which was additionally stimulated by the advent of transoral robotic surgery in the US. Improving the evidence base of laryngeal cancer surgery by successful establishment of surgical trials should be the future goal. PMID:28025603

Effect of Acu-TENS on recovery heart rate after treadmill running exercise in subjects with normal health.

PubMed

Cheung, Leo Chin-Ting; Jones, Alice Yee-Men

2007-06-01

This study aims to investigate the effect of transcutaneous electrical nerve stimulation, applied at bilateral acupuncture points PC6 (Acu-TENS), on recovery heart rate (HR) in healthy subjects after treadmill running exercise. A single blinded, randomized controlled trial. Laboratory with healthy male subjects (n=28). Each subject participated in three separate protocols in random order. PROTOCOL A: The subject followed the Bruce protocol and ran on a treadmill until their HR reached 70% of their maximum (220-age). At this 'target' HR, the subject adopted the supine position and Acu-TENS to bilateral PC6 was commenced. PROTOCOL B: Identical to protocol A except that Acu-TENS was applied in the supine position for 45min prior to, but not after exercise. PROTOCOL C: Identical to protocol A except that placebo Acu-TENS was applied. Heart rate was recorded before and at 30s intervals after exercise until it returned to the pre-exercise baseline. The time for HR to return to baseline was compared for each protocol. Acu-TENS applied to bilateral PC6 resulted in a faster return to pre-exercise HR compared to placebo. Time required for HR to return to pre-exercise level in protocols A-C was 5.5+/-3.0; 4.8+/-3.3; 9.4+/-3.7 min, respectively (p<0.001). There was no statistical difference in HR recovery time between protocols A and B. Subjects expressed the lowest rate of perceived exertion score (RPE) at 70% maximum HR with protocol B. This study suggests that Acu-TENS applied to PC6 may facilitate HR recovery after high intensity treadmill exercise.

The Effects of Respondents' Consent to Be Recorded on Interview Length and Data Quality in a National Panel Study

ERIC Educational Resources Information Center

McGonagle, Katherine A.; Brown, Charles; Schoeni, Robert F.

2015-01-01

Recording interviews is a key feature of quality control protocols for most survey organizations. We examine the effects on interview length and data quality of a new protocol adopted by a national panel study. The protocol recorded a randomly chosen one-third of all interviews digitally, although all respondents were asked for permission to…

Propofol and non-propofol based sedation for outpatient colonoscopy-prospective comparison of depth of sedation using an EEG based SEDLine monitor.

PubMed

Goudra, Basavana; Singh, Preet Mohinder; Gouda, Gowri; Borle, Anuradha; Carlin, Augustus; Yadwad, Avantika

2016-10-01

Propofol is a popular anesthetic sedative employed in colonoscopy. It is known to increase the patient satisfaction and improve throughput. However, there are concerns among the clinicians with regard to the depth of sedation, as a deeper degree of sedation is known to increase the incidence of aspiration and other adverse events. So we planned to compare the depth of sedation between propofol and non-propofol based sedation in patients undergoing outpatient colonoscopy, as measured by an electroencephalogram (EEG) based monitor SEDLine monitor (SedlineInc., San Diego, CA). The non-randomized prospective observational study was performed in the outpatient gastroenterology suite of the Hospital of the University of Pennsylvania, Philadelphia. Patients included ASA class I-III aged more than 18 years scheduled for colonoscopy under Propofol or non-propofol based sedation. After an institutional review board approval, a written consent was obtained from prospective patients. Sedation (propofol or non-propofol based) was administered by either a certified nurse anesthetist under the supervision of an anesthesiologist (propofol) or a registered endoscopy nurse under the guidance of the endoscopist performing the procedure (non-propofol sedation). Depth of sedation was measured with an EEG based SEDLine monitor. The sedation providers were blinded to the patient state index-the indicator of depth of sedation. PSI (patient state index-SEDLine reading) was documented at colonoscope insertion, removal and at the return of verbal responsiveness after colonoscope withdrawal. Sedation spectrum was retrieved from the data stored on the SEDLine monitor. Patients sedated with propofol experience significantly deeper degrees of sedation at all times during the procedure. Additionally, during significant part of the procedure, they are at PSI levels associated with deep general anesthesia. The group that received propofol was more deeply sedated and had lower PSI values. Lighter propofol titration protocols may lead to improved patient care such as lowering risk of aspiration and hypotension. The role of processed EEG monitors such as the SEDLine monitor to improve sedation protocols remains to be determined. Trial registration We obtained an ethical clearance from the Institute. No trial registration was mandated, as no interventional drug or investigational device were used during the study.

A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

ClinicalTrials.gov

2016-07-03

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

Improving the prospects of cleavage-based nanopore sequencing engines

NASA Astrophysics Data System (ADS)

Brady, Kyle T.; Reiner, Joseph E.

2015-08-01

Recently proposed methods for DNA sequencing involve the use of cleavage-based enzymes attached to the opening of a nanopore. The idea is that DNA interacting with either an exonuclease or polymerase protein will lead to a small molecule being cleaved near the mouth of the nanopore, and subsequent entry into the pore will yield information about the DNA sequence. The prospects for this approach seem promising, but it has been shown that diffusion related effects impose a limit on the capture probability of molecules by the pore, which limits the efficacy of the technique. Here, we revisit the problem with the goal of optimizing the capture probability via a step decrease in the nucleotide diffusion coefficient between the pore and bulk solutions. It is shown through random walk simulations and a simplified analytical model that decreasing the molecule's diffusion coefficient in the bulk relative to its value in the pore increases the nucleotide capture probability. Specifically, we show that at sufficiently high applied transmembrane potentials (≥100 mV), increasing the potential by a factor f is equivalent to decreasing the diffusion coefficient ratio Dbulk/Dpore by the same factor f. This suggests a promising route toward implementation of cleavage-based sequencing protocols. We also discuss the feasibility of forming a step function in the diffusion coefficient across the pore-bulk interface.

Double-dose, new-generation proton pump inhibitors do not improve Helicobacter pylori eradication rate.

PubMed

Choi, Hyo Sun; Park, Dong Il; Hwang, Sang Jun; Park, Jung Sik; Kim, Hong Joo; Cho, Yong Kyun; Sohn, Chong Il; Jeon, Woo Kyu; Kim, Byung Ik

2007-12-01

Up to present, omeprazole plus two antibiotics are used for Helicobacter pylori eradication therapy . Few studies have compared double-dose new-generation, proton pump inhibitors (PPI) with omeprazole. Therefore, we conducted a randomized, prospective study to evaluate differences in H. pylori eradication rates by PPI type. Between January 2006 and December 2006, 576 consecutive patients with proven H. pylori infection were enrolled prospectively. Four different PPIs [omeprazole 20 mg b.i.d. (old generation), or pantoprazole 40 mg b.i.d., rabeprazole 20 mg b.i.d., or esomeprazole 40 mg b.i.d. (new generation)] were added to clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week. By intention-to-treat analysis, no difference was found between the eradication rates of these four PPIs: 64.9% (omeprazole, n = 148), 69.3% (pantoprazole, n = 140), 69.3% (rabeprazole, n = 140), and 72.9% (esomoprazole, n = 148). When eradication rates were analyzed according to whether patients had an ulcer or not on a per-protocol basis, no difference was found between the eradication rates of the four PPIs. However, side-effects were more common in the esomeprazole-based triple therapy group than in the other groups (p < .05). No convincing evidence was obtained that double-dose new-generation PPIs have better H. pylori eradication rates and tolerability than omeprazole.

Establishing security of quantum key distribution without monitoring disturbance

NASA Astrophysics Data System (ADS)

Koashi, Masato

2015-10-01

In conventional quantum key distribution (QKD) protocols, the information leak to an eavesdropper is estimated through the basic principle of quantum mechanics dictated in the original version of Heisenberg's uncertainty principle. The amount of leaked information on a shared sifted key is bounded from above essentially by using information-disturbance trade-off relations, based on the amount of signal disturbance measured via randomly sampled or inserted probe signals. Here we discuss an entirely different avenue toward the private communication, which does not rely on the information disturbance trade-off relations and hence does not require a monitoring of signal disturbance. The independence of the amount of privacy amplification from that of disturbance tends to give it a high tolerance on the channel noises. The lifting of the burden of precise statistical estimation of disturbance leads to a favorable finite-key-size effect. A protocol based on the novel principle can be implemented by only using photon detectors and classical optics tools: a laser, a phase modulator, and an interferometer. The protocol resembles the differential-phase-shift QKD protocol in that both share a simple binary phase shift keying on a coherent train of weak pulses from a laser. The difference lies in the use of a variable-delay interferometer in the new protocol, which randomly changes the combination of pulse pairs to be superposed. This extra randomness has turned out to be enough to upper-bound the information extracted by the eavesdropper, regardless of how they have disturbed the quantum signal.

A Secure and Efficient Handover Authentication Protocol for Wireless Networks

PubMed Central

Wang, Weijia; Hu, Lei

2014-01-01

Handover authentication protocol is a promising access control technology in the fields of WLANs and mobile wireless sensor networks. In this paper, we firstly review an efficient handover authentication protocol, named PairHand, and its existing security attacks and improvements. Then, we present an improved key recovery attack by using the linearly combining method and reanalyze its feasibility on the improved PairHand protocol. Finally, we present a new handover authentication protocol, which not only achieves the same desirable efficiency features of PairHand, but enjoys the provable security in the random oracle model. PMID:24971471

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

An agenda-based routing protocol in delay tolerant mobile sensor networks.

PubMed

Wang, Xiao-Min; Zhu, Jin-Qi; Liu, Ming; Gong, Hai-Gang

2010-01-01

Routing in delay tolerant mobile sensor networks (DTMSNs) is challenging due to the networks' intermittent connectivity. Most existing routing protocols for DTMSNs use simplistic random mobility models for algorithm design and performance evaluation. In the real world, however, due to the unique characteristics of human mobility, currently existing random mobility models may not work well in environments where mobile sensor units are carried (such as DTMSNs). Taking a person's social activities into consideration, in this paper, we seek to improve DTMSN routing in terms of social structure and propose an agenda based routing protocol (ARP). In ARP, humans are classified based on their agendas and data transmission is made according to sensor nodes' transmission rankings. The effectiveness of ARP is demonstrated through comprehensive simulation studies.

Efficient Measurement of Quantum Gate Error by Interleaved Randomized Benchmarking

NASA Astrophysics Data System (ADS)

Magesan, Easwar; Gambetta, Jay M.; Johnson, B. R.; Ryan, Colm A.; Chow, Jerry M.; Merkel, Seth T.; da Silva, Marcus P.; Keefe, George A.; Rothwell, Mary B.; Ohki, Thomas A.; Ketchen, Mark B.; Steffen, M.

2012-08-01

We describe a scalable experimental protocol for estimating the average error of individual quantum computational gates. This protocol consists of interleaving random Clifford gates between the gate of interest and provides an estimate as well as theoretical bounds for the average error of the gate under test, so long as the average noise variation over all Clifford gates is small. This technique takes into account both state preparation and measurement errors and is scalable in the number of qubits. We apply this protocol to a superconducting qubit system and find a bounded average error of 0.003 [0,0.016] for the single-qubit gates Xπ/2 and Yπ/2. These bounded values provide better estimates of the average error than those extracted via quantum process tomography.

Dual sensory loss: development of a dual sensory loss protocol and design of a randomized controlled trial

PubMed Central

2013-01-01

Background Dual sensory loss (DSL) has a negative impact on health and wellbeing and its prevalence is expected to increase due to demographic aging. However, specialized care or rehabilitation programs for DSL are scarce. Until now, low vision rehabilitation does not sufficiently target concurrent impairments in vision and hearing. This study aims to 1) develop a DSL protocol (for occupational therapists working in low vision rehabilitation) which focuses on optimal use of the senses and teaches DSL patients and their communication partners to use effective communication strategies, and 2) describe the multicenter parallel randomized controlled trial (RCT) designed to test the effectiveness and cost-effectiveness of the DSL protocol. Methods/design To develop a DSL protocol, literature was reviewed and content was discussed with professionals in eye/ear care (interviews/focus groups) and DSL patients (interviews). A pilot study was conducted to test and confirm the DSL protocol. In addition, a two-armed international multi-center RCT will evaluate the effectiveness and cost-effectiveness of the DSL protocol compared to waiting list controls, in 124 patients in low vision rehabilitation centers in the Netherlands and Belgium. Discussion This study provides a treatment protocol for rehabilitation of DSL within low vision rehabilitation, which aims to be a valuable addition to the general low vision rehabilitation care. Trial registration Netherlands Trial Register (NTR) identifier: NTR2843 PMID:23941667

Risk and Protective Factors for Intimate Partner Violence Against Women: Systematic Review and Meta-analyses of Prospective-Longitudinal Studies.

PubMed

Yakubovich, Alexa R; Stöckl, Heidi; Murray, Joseph; Melendez-Torres, G J; Steinert, Janina I; Glavin, Calla E Y; Humphreys, David K

2018-07-01

The estimated lifetime prevalence of physical or sexual intimate partner violence (IPV) is 30% among women worldwide. Understanding risk and protective factors is essential for designing effective prevention strategies. To quantify the associations between prospective-longitudinal risk and protective factors and IPV and identify evidence gaps. We conducted systematic searches in 16 databases including MEDLINE and PsycINFO from inception to June 2016. The study protocol is registered with PROSPERO (CRD42016039213). We included published and unpublished studies available in English that prospectively analyzed any risk or protective factor(s) for self-reported IPV victimization among women and controlled for at least 1 other variable. Three reviewers were involved in study screening. One reviewer extracted estimates of association and study characteristics from each study and 2 reviewers independently checked a random subset of extractions. We assessed study quality with the Cambridge Quality Checklists. When studies investigated the same risk or protective factor using similar measures, we computed pooled odds ratios (ORs) by using random-effects meta-analyses. We summarized heterogeneity with I 2 and τ 2 . We synthesized all estimates of association, including those not meta-analyzed, by using harvest plots to illustrate evidence gaps and trends toward negative or positive associations. Of 18 608 studies identified, 60 were included and 35 meta-analyzed. Most studies were based in the United States. The strongest evidence for modifiable risk factors for IPV against women were unplanned pregnancy (OR = 1.66; 95% confidence interval [CI] = 1.20, 1.31) and having parents with less than a high-school education (OR = 1.55; 95% CI = 1.10, 2.17). Being older (OR = 0.96; 95% CI = 0.93, 0.98) or married (OR = 0.93; 95% CI = 0.87, 0.99) were protective. To our knowledge, this is the first systematic, meta-analytic review of all risk and protective factors for IPV against women without location, time, or publication restrictions. Unplanned pregnancy and having parents with less than a high-school education, which may indicate lower socioeconomic status, were shown to be risk factors, and being older or married were protective. However, no prospective-longitudinal study investigated the associations between IPV against women and any community or structural factor outside the United States, and more studies investigated risk factors related to women as opposed to their partners. Public health implications. This review highlights that prospective evidence for perpetrator- and context-related risk and protective factors for women's experiences of IPV outside of the United States is lacking and urgently needed to inform global policy recommendations. The current evidence base of prospective studies suggests that, at least in the United States, education and sexual health interventions may be effective targets for preventing IPV against women, with young, unmarried women at greatest risk.

Adaptive consensus of scale-free multi-agent system by randomly selecting links

NASA Astrophysics Data System (ADS)

Mou, Jinping; Ge, Huafeng

2016-06-01

This paper investigates an adaptive consensus problem for distributed scale-free multi-agent systems (SFMASs) by randomly selecting links, where the degree of each node follows a power-law distribution. The randomly selecting links are based on the assumption that every agent decides to select links among its neighbours according to the received data with a certain probability. Accordingly, a novel consensus protocol with the range of the received data is developed, and each node updates its state according to the protocol. By the iterative method and Cauchy inequality, the theoretical analysis shows that all errors among agents converge to zero, and in the meanwhile, several criteria of consensus are obtained. One numerical example shows the reliability of the proposed methods.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

PubMed Central

Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

2016-01-01

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol. PMID:27352244

Reducing Office Workers' Sitting Time at Work Using Sit-Stand Protocols: Results From a Pilot Randomized Controlled Trial.

PubMed

Li, Ingrid; Mackey, Martin G; Foley, Bridget; Pappas, Evangelos; Edwards, Kate; Chau, Josephine Y; Engelen, Lina; Voukelatos, Alexander; Whelan, Anna; Bauman, Adrian; Winkler, Elisabeth; Stamatakis, Emmanuel

2017-06-01

To examine the effects of different sit-stand protocols on work-time sitting and physical activity (PA) of office workers. Participants (n = 26, 77% women, mean age 42) were randomly allocated to usual sitting (control) or one of three sit-stand protocols (intervention) facilitated by height-adjustable workstations for a 4-week period between June and August 2015. Sitting, standing, and stepping time were assessed by inclinometry (activPAL); leisure-time physical activity (LTPA) by self-report. One-way analysis of covariance (ANCOVA) and post-hoc (Bonferroni) tests explored between-group differences. Compared with baseline, intervention groups reduced work sitting time by 113 minutes/8-hour workday (95% confidence interval [CI] [-147,-79]) and increased work standing time by 96 minutes/8-hour workday (95% CI [67,125]) without significantly impacting LTPA/sleep time. Sit-stand protocols facilitated by height-adjustable workstations appear to reduce office workers' sitting time without significant adverse effects on LTPA.

An Efficient Distributed Coverage Hole Detection Protocol for Wireless Sensor Networks.

PubMed

Sahoo, Prasan Kumar; Chiang, Ming-Jer; Wu, Shih-Lin

2016-03-17

In wireless sensor networks (WSNs), certain areas of the monitoring region may have coverage holes and serious coverage overlapping due to the random deployment of sensors. The failure of electronic components, software bugs and destructive agents could lead to the random death of the nodes. Sensors may be dead due to exhaustion of battery power, which may cause the network to be uncovered and disconnected. Based on the deployment nature of the nodes in remote or hostile environments, such as a battlefield or desert, it is impossible to recharge or replace the battery. However, the data gathered by the sensors are highly essential for the analysis, and therefore, the collaborative detection of coverage holes has strategic importance in WSNs. In this paper, distributed coverage hole detection algorithms are designed, where nodes can collaborate to detect the coverage holes autonomously. The performance evaluation of our protocols suggests that our protocols outperform in terms of hole detection time, limited power consumption and control packet overhead to detect holes as compared to other similar protocols.

PRP for Degenerative Cartilage Disease: A Systematic Review of Clinical Studies

PubMed Central

Laver, Lior; Marom, Niv; Dnyanesh, Lad; Mei-Dan, Omer; Espregueira-Mendes, João; Gobbi, Alberto

2016-01-01

Objective: To explore the utilization of platelet-rich plasma (PRP) for degenerative cartilage processes and evaluate whether there is sufficient evidence to better define its potential effects. Design: Systematic literature reviews were conducted in PubMed/MEDLINE and Cochrane electronic databases till May 2015, using the keywords “platelet-rich plasma OR PRP OR autologous conditioned plasma OR ACP AND cartilage OR chondrocyte OR chondrogenesis OR osteoarthritis (OA) OR arthritis.” Results: The final result yielded 29 articles. Twenty-six studies examined PRP administration for knee OA and 3 involved PRP administration for hip OA. The results included 9 prospective randomized controlled trials (RCTs) (8 knee and 1 hip), 4 prospective comparative studies, 14 case series, and 2 retrospective comparative studies. Hyaluronic acid (HA) was used as a control in 11 studies (7 RCTs, 2 prospective comparative studies, and 2 retrospective cohort). Overall, all RCTs reported on improved symptoms compared to baseline scores. Only 2 RCTs—one for knee and one for hip—did not report significant superiority of PRP compared to the control group (HA). Nine out of 11 HA controlled studies showed significant better results in the PRP groups. A trend toward better results for PRP injections in patients with early knee OA and young age was observed; however, lack of uniformity was evident in terms of indications, inclusion criteria, and pathology definitions in the different studies. Conclusion: Current clinical evidence supports the benefit in PRP treatment for knee and hip OA, proven to temporarily relieve pain and improve function of the involved joint with superior results compared with several alternative treatments. Further research to establish the optimal preparation protocol and characteristics of PRP injections for OA is needed. PMID:28317389

The Effect of Coded Healing Abutments on Treatment Duration and Clinical Outcome: A Randomized Controlled Clinical Trial Comparing Encode and Conventional Impression Protocols.

PubMed

Abduo, Jaafar; Chen, Chen; Le Breton, Eugene; Radu, Alexandra; Szeto, Josephine; Judge, Roy; Darby, Ivan

To compare the Encode impression protocol (Biomet 3i) with the conventional impression protocol in terms of treatment duration, clinical accuracy, and outcome up to the first postplacement review of single-implant crowns. A total of 45 implants were included in this study. The implants were randomly allocated to the Encode group (23 implants) or the conventional group (22 implants). At the time of surgery, all implants received two-piece Encode healing abutments. The implants were restored 3 months after insertion. In the conventional protocol, open-tray implant-level impressions were taken and the implants were restored with prefabricated abutments and porcelain-fused-to-metal (PFM) crowns. For the implants in the Encode group, closed-tray impressions of the healing abutments were taken. The generated casts were sent to the Biomet 3i scanning/milling center for custom abutment manufacturing on which PFM crowns were fabricated. Treatment duration (laboratory and clinical), clinical accuracy of occlusal and proximal contacts, and outcome (esthetics, patient satisfaction, and crown contour) were evaluated with the aid of a series of questionnaires. The Encode protocol required significantly less laboratory time (18 minutes) than the conventional protocol for adjustment of the abutments. The impression pour time, time for the laboratory to return the crown, time for crown insertion at the final appointment, and total clinical time for crown insertion did not differ significantly between the two protocols. Likewise, clinical accuracy, esthetics, and patient satisfaction were similar for the two protocols. The two protocols were clinically comparable. The Encode protocol is advantageous in reducing the laboratory time before crown fabrication.

Improved False Discovery Rate Estimation Procedure for Shotgun Proteomics.

PubMed

Keich, Uri; Kertesz-Farkas, Attila; Noble, William Stafford

2015-08-07

Interpreting the potentially vast number of hypotheses generated by a shotgun proteomics experiment requires a valid and accurate procedure for assigning statistical confidence estimates to identified tandem mass spectra. Despite the crucial role such procedures play in most high-throughput proteomics experiments, the scientific literature has not reached a consensus about the best confidence estimation methodology. In this work, we evaluate, using theoretical and empirical analysis, four previously proposed protocols for estimating the false discovery rate (FDR) associated with a set of identified tandem mass spectra: two variants of the target-decoy competition protocol (TDC) of Elias and Gygi and two variants of the separate target-decoy search protocol of Käll et al. Our analysis reveals significant biases in the two separate target-decoy search protocols. Moreover, the one TDC protocol that provides an unbiased FDR estimate among the target PSMs does so at the cost of forfeiting a random subset of high-scoring spectrum identifications. We therefore propose the mix-max procedure to provide unbiased, accurate FDR estimates in the presence of well-calibrated scores. The method avoids biases associated with the two separate target-decoy search protocols and also avoids the propensity for target-decoy competition to discard a random subset of high-scoring target identifications.

Improved False Discovery Rate Estimation Procedure for Shotgun Proteomics

PubMed Central

2016-01-01

Interpreting the potentially vast number of hypotheses generated by a shotgun proteomics experiment requires a valid and accurate procedure for assigning statistical confidence estimates to identified tandem mass spectra. Despite the crucial role such procedures play in most high-throughput proteomics experiments, the scientific literature has not reached a consensus about the best confidence estimation methodology. In this work, we evaluate, using theoretical and empirical analysis, four previously proposed protocols for estimating the false discovery rate (FDR) associated with a set of identified tandem mass spectra: two variants of the target-decoy competition protocol (TDC) of Elias and Gygi and two variants of the separate target-decoy search protocol of Käll et al. Our analysis reveals significant biases in the two separate target-decoy search protocols. Moreover, the one TDC protocol that provides an unbiased FDR estimate among the target PSMs does so at the cost of forfeiting a random subset of high-scoring spectrum identifications. We therefore propose the mix-max procedure to provide unbiased, accurate FDR estimates in the presence of well-calibrated scores. The method avoids biases associated with the two separate target-decoy search protocols and also avoids the propensity for target-decoy competition to discard a random subset of high-scoring target identifications. PMID:26152888

Effects of Vestibular Rehabilitation on Balance Control in Older People with Chronic Dizziness: A Randomized Clinical Trial.

PubMed

Ricci, Natalia Aquaroni; Aratani, Mayra Cristina; Caovilla, Heloísa Helena; Ganança, Fernando Freitas

2016-04-01

The aim of this study was to compare the effects of vestibular rehabilitation protocols on balance control in elderly with dizziness. This is a randomized clinical trial with 3-mo follow-up period. The sample was composed of 82 older individuals with chronic dizziness from vestibular disorders. The control group was treated according to the Conventional Cawthorne & Cooksey protocol (n = 40), and the experimental group was submitted to a Multimodal Cawthorne & Cooksey protocol (n = 42). Measures included Dynamic Gait Index, fall history, hand grip strength, Time Up-and-Go Test, sit-to-stand test, multidirectional reach, and static balance tests. With the exception of history of falls, Forward Functional Reach, Unipedal Right and Left Leg Eyes Closed, and Sensorial Romberg Eyes Open, all outcomes improved after treatments. Such results persisted at follow-up period, with the exception of the Tandem Eyes Open and the Timed Up-and-Go manual. The between-group differences for Sensorial Romberg Eyes Closed (4.27 secs) and Unipedal Left Leg Eyes Open (4.08 secs) were significant after treatment, favoring the Multimodal protocol. Both protocols resulted in improvement on elderly's balance control, which was maintained during a short-term period. The multimodal protocol presented better performance on specific static balance tests.

Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999–2003)

PubMed Central

Bonfill, Xavier; Ballesteros, Mónica; Gich, Ignasi; Serrano, María Antonia; García López, Fernando; Urrútia, Gerard

2013-01-01

Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research. PMID:24236154

Prospective trial of angiography and embolization for all grade III to V blunt splenic injuries: nonoperative management success rate is significantly improved.

PubMed

Miller, Preston R; Chang, Michael C; Hoth, J Jason; Mowery, Nathan T; Hildreth, Amy N; Martin, R Shayn; Holmes, James H; Meredith, J Wayne; Requarth, Jay A

2014-04-01

Nonoperative management (NOM) of blunt splenic injury is well accepted. Substantial failure rates in higher injury grades remain common, with one large study reporting rates of 19.6%, 33.3%, and 75% for grades III, IV, and V, respectively. Retrospective data show angiography and embolization can increase salvage rates in these severe injuries. We developed a protocol requiring referral of all blunt splenic injuries, grades III to V, without indication for immediate operation for angiography and embolization. We hypothesized that angiography and embolization of high-grade blunt splenic injury would reduce NOM failure rates in this population. This was a prospective study at our Level I trauma center as part of a performance-improvement project. Demographics, injury characteristics, and outcomes were compared with historic controls. The protocol required all stable patients with grade III to V splenic injuries be referred for angiography and embolization. In historic controls, referral was based on surgeon preference. From January 1, 2010 to December 31, 2012, there were 168 patients with grades III to V spleen injuries admitted; NOM was undertaken in 113 (67%) patients. The protocol was followed in 97 patients, with a failure rate of 5%. Failure rate in the 16 protocol deviations was 25% (p = 0.02). Historic controls from January 1, 2007 to December 31, 2009 were compared with the protocol group. One hundred and fifty-three patients with grade III to V injuries were admitted during this period, 80 (52%) patients underwent attempted NOM. Failure rate was significantly higher than for the protocol group (15%, p = 0.04). Use of a protocol requiring angiography and embolization for all high-grade spleen injuries slated for NOM leads to a significantly decreased failure rate. We recommend angiography and embolization as an adjunct to NOM for all grade III to V splenic injuries. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

A Study on Chocolate Consumption in Prospective Teachers

ERIC Educational Resources Information Center

Ozgen, Leyla

2016-01-01

This study was planned and conducted to determine the chocolate consumption habits of prospective teachers. The study population was comprised of students attending the Faculty of Education at Gazi University in Ankara and the sample consisted of 251 prospective teachers selected with simple random sampling. 96.4% and 3.6% of the prospective…

The Relationship between Prospective Teachers' Critical Thinking Dispositions and Their Educational Philosophies

ERIC Educational Resources Information Center

Aybek, Birsel; Aslan, Serkan

2017-01-01

The aim of this research is to investigate the relationship between prospective teachers' critical thinking dispositions and their educational philosophies. The research used relational screening model. The study hosts a total of 429 prospective teachers selected by the simple random sampling method. Research data has been collected through…

Chemotherapy-Induced Cognitive Impairment: A Novel Prospective Study of the Cognitive Effects of Platinum Taxane-Based Chemotherapy in Ovarian Cancer Patients

DTIC Science & Technology

2017-09-01

post chemotherapy testing , completing all protocol-defined tests and procedures and are now off study. Two patients are currently undergoing treatment...and will complete post treatment testing within the upcoming weeks. The first patient enrolled onto this trial was unable to complete post treatment...completed post chemotherapy testing , completing all protocol-defined tests and procedures and are now off study. Two patients are currently

Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation.

PubMed

Manousaki, Despoina; Deladoëy, Johnny; Geoffroy, Louis; Olivier, Patricia

2017-01-01

The occurrence of hypoglycemia and hyperglycemia during the first days after transition to continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes has not been systematically studied in children. The aim of this prospective study was to demonstrate that the protocol applied in our diabetes clinic is safe at CSII initiation in children. We assessed 22 pediatric patients with type 1 diabetes, using continuous glucose monitoring (CGM) before and after CSII initiation (±3 days). After CSII initiation, there was no difference in the rates of hypoglycemic events expressed as relative rates (RRs) per person-reading (RR = 0.85, p  = 0.52, 95% CI 0.52-1.39), as well as in the number of prolonged hypoglycemic events (>1 h) per day (RR = 1.12, p  = 0.56, 95% CI 0.75-1.68). We observed only a trend toward prolonged episodes of hyperglycemia after pump initiation (RR = 1.52, p  = 0.06, 95% CI 0.97-2.35). Our study is the first to assess, through CGM and in a prospective way, the impact of a CSII initiation protocol on glycemic values. Our protocol provides a safe model to avoid hypoglycemia at CSII initiation in children. www.ClinicalTrials.gov, identifier NCT01840358.

Utility of intranasal Ketamine and Midazolam to perform gastric aspirates in children: a double-blind, placebo controlled, randomized study

PubMed Central

2014-01-01

Background We performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis. Primary outcome: evaluation of Modified Objective Pain Score (MOPS) reduction in children undergoing INKM compared to the placebo group. Secondary outcomes: evaluation of safety of INKM protocol, start time sedation effect, duration of sedation and evaluation of parents and doctors’ satisfaction about the procedure. Methods In the sedation group, 19 children, mean age 41.5 months, received intranasal Midazolam (0.5 mg/kg) and Ketamine (2 mg/kg). In the placebo group, 17 children received normal saline solution twice in each nostril. The child’s degree of sedation was scored using the MOPS. A questionnaire was designed to evaluate the parents’ and doctors’ opinions on the procedures of both groups. Results Fifty-seven gastric washings were performed in the sedation-group, while in the placebo-group we performed 51 gastric aspirates. The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs. The mean duration of sedation was 71.5 min. Mean MOPS was 3.5 (range 1-8) in the sedation-group, 7.2 (range 4-9) in the placebo-group (p <0.0001). The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group. The only side effect registered was post-sedation agitation in 6 procedures in the sedation group (10.5%). Conclusions Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children. Trial registration Unique trial Number: UMIN000010623; Receipt Number: R000012422. PMID:24598046

Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study

PubMed Central

Min, Byunghun; Hwang, Jin-Young

2018-01-01

Background The preemptive multimodal pain protocols used in total knee arthroplasty (TKA) often cause emesis postoperatively. We investigated whether palonosetron prophylaxis reduces postoperative nausea and vomiting (PONV) in high-risk patients after TKA. Methods We randomized 120 female patients undergoing TKA to receive either palonosetron (0.075 mg, intravenous) or no antiemetic prophylaxis (0.9% saline, control group). All patients were given spinal anesthesia, a continuous femoral nerve block, and fentanyl-based intravenous patient controlled analgesia. Patients undergoing staged bilateral TKA were assigned to one group for the first knee and the other group for the second knee. The overall incidence of PONV, the incidences of both nausea and vomiting, severity of nausea, complete response, requirement for rescue antiemetics, pain level, opioid consumption, and satisfaction scores were evaluated during three periods: 0–2, 2–24, and 24–48 h postoperatively. We also compared PONV and pain between the first and second TKA. Results The incidence of PONV during the first 48 h was lower in the palonosetron group compared with the controls (22 vs. 41%, p = 0.028), especially 2–24 h after surgery, as was the nausea and vomiting respectively. The severity of nausea was lower in the palonosetron group (p = 0.010). The complete response rate (93 vs. 73%, p = 0.016) and satisfaction score (84 ± 12 vs. 79 ± 15, p = 0.032) were higher in the palonosetron group during 2–24 h after surgery. Patients who underwent a second operation complained of more severe pain, and consumed more opioids than those of the first operation. There was no difference in the incidence of PONV between the first and second operations. Conclusions Palonosetron prophylaxis reduced the incidence and severity of PONV in high-risk patients managed with multimodal pain protocol for 48 h, notably 2–24 h after TKA. PMID:29758039

Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study.

PubMed

Ryu, Jung-Hee; Jeon, Young-Tae; Min, Byunghun; Hwang, Jin-Young; Sohn, Hye-Min

2018-01-01

The preemptive multimodal pain protocols used in total knee arthroplasty (TKA) often cause emesis postoperatively. We investigated whether palonosetron prophylaxis reduces postoperative nausea and vomiting (PONV) in high-risk patients after TKA. We randomized 120 female patients undergoing TKA to receive either palonosetron (0.075 mg, intravenous) or no antiemetic prophylaxis (0.9% saline, control group). All patients were given spinal anesthesia, a continuous femoral nerve block, and fentanyl-based intravenous patient controlled analgesia. Patients undergoing staged bilateral TKA were assigned to one group for the first knee and the other group for the second knee. The overall incidence of PONV, the incidences of both nausea and vomiting, severity of nausea, complete response, requirement for rescue antiemetics, pain level, opioid consumption, and satisfaction scores were evaluated during three periods: 0-2, 2-24, and 24-48 h postoperatively. We also compared PONV and pain between the first and second TKA. The incidence of PONV during the first 48 h was lower in the palonosetron group compared with the controls (22 vs. 41%, p = 0.028), especially 2-24 h after surgery, as was the nausea and vomiting respectively. The severity of nausea was lower in the palonosetron group (p = 0.010). The complete response rate (93 vs. 73%, p = 0.016) and satisfaction score (84 ± 12 vs. 79 ± 15, p = 0.032) were higher in the palonosetron group during 2-24 h after surgery. Patients who underwent a second operation complained of more severe pain, and consumed more opioids than those of the first operation. There was no difference in the incidence of PONV between the first and second operations. Palonosetron prophylaxis reduced the incidence and severity of PONV in high-risk patients managed with multimodal pain protocol for 48 h, notably 2-24 h after TKA.

Evaluating a Serious Gaming Electronic Medication Administration Record System Among Nursing Students: Protocol for a Pragmatic Randomized Controlled Trial.

PubMed

Booth, Richard; Sinclair, Barbara; McMurray, Josephine; Strudwick, Gillian; Watson, Gavan; Ladak, Hanif; Zwarenstein, Merrick; McBride, Susan; Chan, Ryan; Brennan, Laura

2018-05-28

Although electronic medication administration record systems have been implemented in settings where nurses work, nursing students commonly lack robust learning opportunities to practice the skills and workflow of digitalized medication administration during their formative education. As a result, nursing students' performance in administering medication facilitated by technology is often poor. Serious gaming has been recommended as a possible intervention to improve nursing students' performance with electronic medication administration in nursing education. The objectives of this study are to examine whether the use of a gamified electronic medication administration simulator (1) improves nursing students' attention to medication administration safety within simulated practice, (2) increases student self-efficacy and knowledge of the medication administration process, and (3) improves motivational and cognitive processing attributes related to student learning in a technology-enabled environment. This study comprised the development of a gamified electronic medication administration record simulator and its evaluation in 2 phases. Phase 1 consists of a prospective, pragmatic randomized controlled trial with second-year baccalaureate nursing students at a Canadian university. Phase 2 consists of qualitative focus group interviews with a cross-section of nursing student participants. The gamified medication administration simulator has been developed, and data collection is currently under way. If the gamified electronic medication administration simulator is found to be effective, it could be used to support other health professional simulated education and scaled more widely in nursing education programs. ClinicalTrials.gov NCT03219151; https://clinicaltrials.gov/show/NCT03219151 (Archived by WebCite at http://www.webcitation.org/6yjBROoDt). RR1-10.2196/9601. ©Richard Booth, Barbara Sinclair, Josephine McMurray, Gillian Strudwick, Gavan Watson, Hanif Ladak, Merrick Zwarenstein, Susan McBride, Ryan Chan, Laura Brennan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.05.2018.

An operations-partnered evaluation of care redesign for high-risk patients in the Veterans Health Administration (VHA): Study protocol for the PACT Intensive Management (PIM) randomized quality improvement evaluation.

PubMed

Chang, Evelyn T; Zulman, Donna M; Asch, Steven M; Stockdale, Susan E; Yoon, Jean; Ong, Michael K; Lee, Martin; Simon, Alissa; Atkins, David; Schectman, Gordon; Kirsh, Susan R; Rubenstein, Lisa V

2018-06-01

Patient-centered medical homes have made great strides providing comprehensive care for patients with chronic conditions, but may not provide sufficient support for patients at highest risk for acute care use. To address this, the Veterans Health Administration (VHA) initiated a five-site demonstration project to evaluate the effectiveness of augmenting the VA's Patient Aligned Care Team (PACT) medical home with PACT Intensive Management (PIM) teams for Veterans at highest risk for hospitalization. Researchers partnered with VHA leadership to design a mixed-methods prospective multi-site evaluation that met leadership's desire for a rigorous evaluation conducted as quality improvement rather than research. We conducted a randomized QI evaluation and assigned high-risk patients to participate in PIM and compared them with high-risk Veterans receiving usual care through PACT. The summative evaluation examines whether PIM: 1) decreases VHA emergency department and hospital use; 2) increases satisfaction with VHA care; 3) decreases provider burnout; and 4) generates positive returns on investment. The formative evaluation aims to support improved care for high-risk patients at demonstration sites and to inform future initiatives for high-risk patients. The evaluation was reviewed by representatives from the VHA Office of Research and Development and the Office of Research Oversight and met criteria for quality improvement. VHA aims to function as a learning organization by rapidly implementing and rigorously testing QI innovations prior to final program or policy development. We observed challenges and opportunities in designing an evaluation consistent with QI standards and operations priorities, while also maintaining scientific rigor. This trial was retrospectively registered at ClinicalTrials.gov on April 3, 2017: NCT03100526. Protocol v1, FY14-17. Copyright © 2018 Elsevier Inc. All rights reserved.

Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose.

PubMed

Lu, Michael T; Douglas, Pamela S; Udelson, James E; Adami, Elizabeth; Ghoshhajra, Brian B; Picard, Michael H; Roberts, Rhonda; Lee, Kerry L; Einstein, Andrew J; Mark, Daniel B; Velazquez, Eric J; Carter, William; Ridner, Michael; Al-Khalidi, Hussein R; Hoffmann, Udo

Coronary computed tomography angiography (CTA) and functional testing strategies for stable chest pain yield similar outcomes; one aspect that may guide test choice is safety. We compared test safety (test complications, incidental findings, and effective radiation dose) between CTA and functional testing as-tested in PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain). In the subgroup whose physicians intended nuclear stress over other functional tests if randomized to the functional arm, we compared radiation dose of CTA versus nuclear stress and identified characteristics associated with dose. Of 9470 patients, none had major and <1% had minor complications (CTA: 0.8% [37/4633] vs. functional: 0.6% [27/4837]). CTA identified more incidental findings (11.6% [539/4633] vs. 0.7% [34/4837], p < 0.001), most commonly pulmonary nodules (9.4%, 437/4633). CTA had similar 90-day cumulative radiation dose to functional testing. However, in the subgroup whose physicians intended nuclear stress (CTA 3147; nuclear 3203), CTA had lower median index test (8.8 vs. 12.6 mSv, p < 0.001) and 90-day cumulative (11.6 vs. 13.1 mSv, p < 0.001) dose, independent of patient characteristics. The lowest nuclear doses employed 1-day Tc-99m protocols (12.2 mSv). The lowest CTA doses were at sites performing ≥500 CTAs/year (6.9 mSv) and with advanced (latest available) CT scanners (5.5 mSv). Complications were negligibly rare for both CTA and functional testing. CTA detects more incidental findings. Compared to nuclear stress testing, CTA's lower radiation dose, independent of patient characteristics, makes it an attractive test choice. Radiation dose varies with imaging protocol, indicating opportunities to further reduce dose. (ClinicalTrials.gov number, NCT01174550). Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

PubMed

Mistiaen, Patriek; Achterberg, Wilco; Ament, Andre; Halfens, Ruud; Huizinga, Janneke; Montgomery, Ken; Post, Henri; Francke, Anneke L

2008-01-07

Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-)effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

Increasing organ donation via anticipated regret (INORDAR): protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Throughout the world there is an insufficient supply of donor organs to meet the demand for organ transplantations. This paper presents a protocol for a randomised controlled trial, testing whether a simple, theory-based anticipated regret manipulation leads to a significant increase in posthumous organ donor registrations. Methods We will use a between-groups, prospective randomised controlled design. A random sample of 14,520 members of the adult Scottish general public will be contacted via post. These participants will be randomly allocated into 1 of the 4 conditions. The no questionnaire control (NQC) group will simply receive a letter and donor registration form. The questionnaire control (QC) arm will receive a questionnaire measuring their emotions and non-cognitive affective attitudes towards organ donation. The theory of planned behavior (TPB) group will complete the emotions and affective attitudes questionnaire plus additional items assessing their cognitive attitudes towards organ donation, perceived control over registration and how they think significant others view this action. Finally, the anticipated regret (AR) group will complete the same indices as the TPB group, plus two additional anticipated regret items. These items will assess the extent to which the participant anticipates regret for not registering as an organ donor in the near future. The outcome variable will be NHS Blood and Transplant verified registrations as an organ donor within 6 months of receiving our postal intervention. Discussion This study will assess whether simply asking people to reflect on the extent to which they may anticipate regret for not registering as an organ donor increases organ donor registration 6 months later. If successful, this simple and easy to administer theory-based intervention has the potential to save lives and money for the NHS by reducing the number of people receiving treatments such as dialysis. This intervention may also be incorporated into future organ donor campaigns. Trial registration number ISRCTN: ISRCTN92204897 PMID:22401534

The influence of social networking sites on health behavior change: a systematic review and meta-analysis.

PubMed

Laranjo, Liliana; Arguel, Amaël; Neves, Ana L; Gallagher, Aideen M; Kaplan, Ruth; Mortimer, Nathan; Mendes, Guilherme A; Lau, Annie Y S

2015-01-01

Our aim was to evaluate the use and effectiveness of interventions using social networking sites (SNSs) to change health behaviors. Five databases were scanned using a predefined search strategy. Studies were included if they focused on patients/consumers, involved an SNS intervention, had an outcome related to health behavior change, and were prospective. Studies were screened by independent investigators, and assessed using Cochrane's 'risk of bias' tool. Randomized controlled trials were pooled in a meta-analysis. The database search retrieved 4656 citations; 12 studies (7411 participants) met the inclusion criteria. Facebook was the most utilized SNS, followed by health-specific SNSs, and Twitter. Eight randomized controlled trials were combined in a meta-analysis. A positive effect of SNS interventions on health behavior outcomes was found (Hedges' g 0.24; 95% CI 0.04 to 0.43). There was considerable heterogeneity (I(2) = 84.0%; T(2) = 0.058) and no evidence of publication bias. To the best of our knowledge, this is the first meta-analysis evaluating the effectiveness of SNS interventions in changing health-related behaviors. Most studies evaluated multi-component interventions, posing problems in isolating the specific effect of the SNS. Health behavior change theories were seldom mentioned in the included articles, but two particularly innovative studies used 'network alteration', showing a positive effect. Overall, SNS interventions appeared to be effective in promoting changes in health-related behaviors, and further research regarding the application of these promising tools is warranted. Our study showed a positive effect of SNS interventions on health behavior-related outcomes, but there was considerable heterogeneity. Protocol registration The protocol for this systematic review is registered at http://www.crd.york.ac.uk/PROSPERO with the number CRD42013004140. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.comFor numbered affiliations see end of article.

The effect of antenatal education in small classes on obstetric and psycho-social outcomes: a systematic review and meta-analysis protocol.

PubMed

Brixval, Carina Sjöberg; Axelsen, Solveig Forberg; Andersen, Stig Krøger; Due, Pernille; Koushede, Vibeke

2014-02-13

The aims of antenatal education contain both outcomes related to pregnancy, birth and parenthood. Both content and methods of antenatal education have changed over time without evidence of effects on relevant outcomes. The effect of antenatal education in groups, with participation of a small number of participants, may differ from the effect of other forms of antenatal education. The latest Cochrane review, assessed as up-to-date in 2007, concluded that the effect of antenatal education for childbirth or parenthood or both remains largely unknown. This systematic review and meta-analysis aims to assess the effects of antenatal education in small groups on obstetric as well as psycho-social outcomes. Eligible studies include individually randomized as well as cluster-randomized trials irrespective of language, publication year, publication type, and publication status. Only interventions carried out in the Western world will be considered in this review. We will search the databases Medline, EMBASE, CENTRAL, CINAHL, Web of Science, and PsycINFO using relevant search terms. Two independent review authors will extract data and assess risk of bias. Results will be presented as structured summaries of the included trials. A meta-analysis will be conducted. We will assess heterogeneity by using both the Chi-squared test and the I-squared statistic, and conduct subgroup analysis separately for various intervention types. In healthcare systems with limited resources evidence of the effectiveness of services provided is important for decision making, and there is a need for policy makers to implement changes in healthcare systems based on scientific evidence. The effectiveness of antenatal education in small classes is still questioned. Therefore an up-to-date systematic review is needed.This systematic review protocol was registered within the International Prospective Register of Systematic Reviews (PROSPERO) as number CRD42013004319.

Point-of-care ultrasound leads to diagnostic shifts in patients with undifferentiated hypotension.

PubMed

Shokoohi, Hamid; Boniface, Keith S; Zaragoza, Michelle; Pourmand, Ali; Earls, James P

2017-12-01

To assess the impact of an ultrasound hypotension protocol in identifying life-threatening diagnoses that were missed in the initial evaluation of patients with hypotension and shock. A subset of cases from a previously published prospective study of hypotensive patients who presented at the Emergency Department in a single, academic tertiary care hospital is described. An ultrasound-trained emergency physician performed an ultrasound on each patient using a standardized hypotension protocol. In each case, the differential diagnosis and management plan was solicited from the treating physician immediately before and after the ultrasound. This is a case series of patients with missed diagnoses in whom ultrasound led to a dramatic shift in diagnosis and management by detecting life threatening pathologies. Following a published prospective study of the effect on an ultrasound protocol in 118 hypotensive patients, we identified a series of cases that ultrasound protocol unexpectedly determined serious life threatening diagnoses such as Takotsubo cardiomyopathy, pulmonary embolism, pericardial effusion with tamponade physiology, abdominal aortic aneurysm and perforated viscus resulting in proper diagnoses and management. These hypotensive patients had completely unsuspected but critical diagnoses explaining their hypotension, who in every case had their management altered to target the newly identified life-threatening condition. A hypotension protocol is an optimal use of ultrasound that exemplifies "right time, right place", and impacts decision-making at the bedside. In cases with undifferentiated hypotension, ultrasound is often the most readily available option to ensure that the most immediate life-threatening conditions are quickly identified and addressed in the order of their risk potential. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of the TCARE® intervention on caregiver burden and depressive symptoms: preliminary findings from a randomized controlled study.

PubMed

Montgomery, Rhonda J V; Kwak, Jung; Kosloski, Karl; O'Connell Valuch, Katharine

2011-09-01

We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden-objective, relationship, and stress burdens; depression; and intention for nursing home placement. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes.

Effects of the TCARE® Intervention on Caregiver Burden and Depressive Symptoms: Preliminary Findings From a Randomized Controlled Study

PubMed Central

Kwak, Jung; Kosloski, Karl; O’Connell Valuch, Katharine

2011-01-01

Objectives. We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Methods. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden—objective, relationship, and stress burdens; depression; and intention for nursing home placement. Results. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. Discussion. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes. PMID:21840840

Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial.

PubMed

Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany; Onyoo, Pamela; Ho, Lara S; Manary, Mark; Briend, André; Opondo, Charles; Kerac, Marko

2018-04-24

Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings. This study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted. If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme. ISRCTN, ISRCTN30393230 . Registered on 16 March 2017.

Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Arruda Viani, Gustavo, E-mail: gusviani@gmail.com; Carrara Fonseca, Ellen; Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo

2012-03-01

Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment,more » both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.« less

Surgical reconstruction of ruptured anterior cruciate ligament prolongs trauma-induced increase of inflammatory cytokines in synovial fluid: an exploratory analysis in the KANON trial.

PubMed

Larsson, S; Struglics, A; Lohmander, L S; Frobell, R

2017-09-01

Prospectively monitor how treatment of acutely ruptured anterior cruciate ligament (ACL) affects biomarkers of inflammation and proteolytic degradation over 5 years. We studied 119 subjects with acute ACL injury from the randomized controlled knee anterior cruciate ligament, non-surgical versus surgical treatment (KANON)-trial (Clinical trial ISRCTN 84752559) who had synovial fluid, serum and urine samples available from at least two out of six visits over 5 years after acute ACL rupture. All subjects followed a similar rehabilitation protocol where, according to randomization, 60 also had early ACL reconstruction and 59 had the option to undergo a delayed ACL reconstruction if needed. Interleukin (IL)-6, IL-8, IL-10, interferon-gamma (IFNγ), tumor necrosis factor (TNF), amino acids alanine, arginine, glycine, serine (ARGS)-aggrecan, C-terminal crosslinking telopeptide type II collagen (CTX-II) and N-terminal crosslinking telopeptide type I collagen (NTX-I) were quantified by enzyme-linked immunosorbent assays (ELISA). Subjects randomized to early ACL reconstruction had higher cytokine concentrations in index knee synovial fluid at 4 months (IL-6, IL-8, IL-10, TNF), 8 months (IL-6 and TNF) and at 5 years (IFNγ) compared to those randomized to optional delayed reconstruction. Those that underwent delayed ACL reconstruction within 5 years (30 subjects), had higher synovial fluid concentrations of IL-6 at 5 years compared to those treated with rehabilitation alone. No differences between groups were noted for ARGS-aggrecan in synovial fluid and serum or CTX-II and NTX-I in urine over 5 years, neither as randomized nor as treated. Surgical ACL reconstruction constitutes a second trauma to the acutely injured joint resulting in a prolonged elevation of already high synovial fluid levels of inflammatory cytokines. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment.

PubMed

Wu, Jiun-Ting; Chiu, Chien-Tung; Wei, Yu-Feng; Lai, Yung-Fa

2015-06-01

Fixed-dose combination formulations, which simplify the administration of drugs and prevent the development of drug resistance, have been recommended as a standard anti-tuberculosis treatment regimen. However, the composition and dosage recommendations for fixed-dose combination formulations differ from those for separate formulations. Thus, questions about the effectiveness and side effects of combination formulations remain. The aim of this study was to compare the safety and efficacy of these two types of anti-tuberculosis regimens for pulmonary tuberculosis treatment. A prospective, randomized controlled study was conducted using the directly observed treatment short-course strategy. Patients were randomly allocated to one of two short-course regimens. One year after completing the treatment, these patients' outcomes were analyzed. ClinicalTrials.gov: NCT00979290. A total of 161 patients were enrolled, 142 of whom were evaluable for safety assessment. The two regimens had a similar incidence of adverse effects. In the per-protocol population, serum bilirubin concentrations at the peak level, at week 4, and at week 8 were significantly higher for the fixed-dose combination formulation than for the separate formulations. All patients had negative sputum cultures at the end of the treatment, and no relapse occurred after one year of follow-up. In this randomized study, transient higher serum bilirubin levels were noted for the fixed-dose combination regimen compared with the separate formulations during treatment. However, no significant difference in safety or efficacy was found between the groups when the directly observed treatment short-course strategy was used.

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

Study protocol and rationale for a prospective, randomized, double-blind, placebo-controlled study to evaluate the effects of Ashwagandha (Withania somnifera) extract on nonrestorative sleep.

PubMed

Deshpande, Abhijit; Irani, Nushafreen; Balakrishnan, Rathna

2018-06-01

Nonrestorative sleep (NRS) is one of the cardinal symptoms of insomnia and can occur independent of other components of insomnia. Among the sleep disturbances, NRS has been little studied in the general population, even though this symptom plays an important role in several medical conditions associated with chronic inflammation such as heart disease, fibromyalgia, and chronic fatigue syndrome, as well as various sleep disorders. There is paucity in the literature about effective treatments for NRS. Ashwagandha (Withania somnifera) has been demonstrated to reduce anxiety and stress, allowing the body to settle down and prepare for sleep. This study will be a double-blind, randomized, placebo-controlled interventional study in NRS population.The NRS participants are identified using Restorative Sleep Questionnaire-weekly version (RSQ-W) questionnaire. Actigraphy and polysomnography are used for the objective assessment of sleep. The other assessments used are Hamilton Anxiety Depression Scale (HADS), World Health Organization Quality of Life (WHOQOL) scales, and C-reactive protein. Routine blood and urine analyses will be conducted to assess the safety of treatment. Duration of study for each participant will be 50 days with "day one" for screening followed by randomization for the treatment. The duration for medicine/placebo intake shall be 42 days.Primary outcome will be to evaluate effect of daily supplement of ashwagandha extract compared with placebo in subjects with NRS at 6 weeks from baseline, as assessed by the total score of RSQ-W. CTRI/2017/02/007801.

Prehospital Blood Product Resuscitation for Trauma: A Systematic Review

PubMed Central

Smith, Iain M.; James, Robert H.; Dretzke, Janine; Midwinter, Mark J.

2016-01-01

ABSTRACT Introduction: Administration of high ratios of plasma to packed red blood cells is a routine practice for in-hospital trauma resuscitation. Military and civilian emergency teams are increasingly carrying prehospital blood products (PHBP) for trauma resuscitation. This study systematically reviewed the clinical literature to determine the extent to which the available evidence supports this practice. Methods: Bibliographic databases and other sources were searched to July 2015 using keywords and index terms related to the intervention, setting, and condition. Standard systematic review methodology aimed at minimizing bias was used for study selection, data extraction, and quality assessment (protocol registration PROSPERO: CRD42014013794). Synthesis was mainly narrative with random effects model meta-analysis limited to mortality outcomes. Results: No prospective comparative or randomized studies were identified. Sixteen case series and 11 comparative studies were included in the review. Seven studies included mixed populations of trauma and non-trauma patients. Twenty-five of 27 studies provided only very low quality evidence. No association between PHBP and survival was found (OR for mortality: 1.29, 95% CI: 0.84–1.96, P = 0.24). A single study showed improved survival in the first 24 h. No consistent physiological or biochemical benefit was identified, nor was there evidence of reduced in-hospital transfusion requirements. Transfusion reactions were rare, suggesting the short-term safety of PHBP administration. Conclusions: While PHBP resuscitation appears logical, the clinical literature is limited, provides only poor quality evidence, and does not demonstrate improved outcomes. No conclusions as to efficacy can be drawn. The results of randomized controlled trials are awaited. PMID:26825635

A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders

PubMed Central

Geier, David A.; Kern, Janet K.; Davis, Georgia; King, Paul G.; Adams, James B.; Young, John L.; Geier, Mark R.

2011-01-01

Summary Background L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted. Material/Methods Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing. Results Significant improvements were observed in CARS (−2.03, 95% CI=−3.7 to −0.31), CGI (−0.69, 95% CI=−1.1 to −0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given. Conclusions L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended. PMID:21629200

Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic cluster headache with verapamil

PubMed Central

2013-01-01

Background Episodic cluster headache (ECH) is a primary headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of cluster attacks in the beginning of a cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a cluster episode. Methods and design PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with episodic cluster headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German headache clinics that specialize in the treatment of ECH. Discussion PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of cluster attacks in the beginning of a cluster episode as compared to monotherapy with verapamil. Trial registration German Clinical Trials Register DRKS00004716 PMID:23889923

Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). Methods/Design The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke. Summary The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI. Trial registration The trial is registered under http://www.clinicaltrials.gov: NCT01612312. PMID:23782681

First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial.

PubMed

Grønhøj, Christian; Jensen, David H; Glovinski, Peter V; Jensen, Siri Beier; Bardow, Allan; Oliveri, Roberto S; Specht, Lena; Thomsen, Carsten; Darkner, Sune; Kiss, Katalin; Fischer-Nielsen, Anne; von Buchwald, Christian

2017-03-07

Salivary gland hypofunction and xerostomia are major complications following radiotherapy for head and neck cancer and may lead to debilitating oral disorders and impaired quality of life. Currently, only symptomatic treatment is available. However, mesenchymal stem cell (MSC) therapy has shown promising results in preclinical studies. Objectives are to assess safety and efficacy in a first-in-man trial on adipose-derived MSC therapy (ASC) for radiation-induced xerostomia. This is a single-center, phase I/II, randomized, placebo-controlled, double-blinded clinical trial. A total of 30 patients are randomized in a 1:1 ratio to receive ultrasound-guided, administered ASC or placebo to the submandibular glands. The primary outcome is change in unstimulated whole salivary flow rate. The secondary outcomes are safety, efficacy, change in quality of life, qualitative and quantitative measurements of saliva, as well as submandibular gland size, vascularization, fibrosis, and secretory tissue evaluation based on contrast-induced magnetic resonance imaging (MRI) and core-needle samples. The assessments are performed at baseline (1 month prior to treatment) and 1 and 4 months following investigational intervention. The trial is the first attempt to evaluate the safety and efficacy of adipose-derived MSCs (ASCs) in patients with radiation-induced xerostomia. The results may provide evidence for the effectiveness of ASC in patients with salivary gland hypofunction and xerostomia and deliver valuable information for the design of subsequent trials. EudraCT, Identifier: 2014-004349-29. Registered on 1 April 2015. ClinicalTrials.gov, Identifier: NCT02513238 . First received on 2 July 2015. The trial is prospectively registered.

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

PubMed Central

Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Karlson, Elizabeth W.

2014-01-01

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. PMID:25151341

Is An Ostomy Rod Useful for Bridging the Retraction During the Creation of a Loop Ileostomy? A Randomized Control Trial.

PubMed

Uchino, Motoi; Ikeuchi, Hiroki; Bando, Toshihiro; Chohno, Teruhiro; Sasaki, Hirofumi; Horio, Yuki

2017-08-01

A loop ileostomy is generally created during restorative proctocolectomy (RPC) for treating ulcerative colitis (UC), and an ostomy rod is often used to prevent stoma retraction. However, its usefulness or harmfulness has not been proven. We performed a prospective randomized control study to investigate the non-inferiority of ostomy creation without a rod to prevent stoma retraction. Patients with UC who underwent RPC were enrolled and randomly divided into groups either with or without ostomy rod use. Incidences of stoma retraction and dermatitis were compared. Of the 320 patients in the study groups, 308 qualified for the intention-to-treat (ITT) analysis, and 257 were included in the per-protocol (PP) analysis. Ostomy retraction was recognized in 6 patients, 3 with a rod and 3 without. The difference with rod use (95% confidence interval) was 0.1 (-2.9 to 3.1)% in the PP analysis and 0.0 (-2.2 to 2.2)% in the ITT analysis. There were no significant differences in stoma retraction regardless of whether an ostomy rod was used in either analysis. Dermatitis was more common in patients with rod use (84/154) than in those without (40/154) (p < 0.01). Although median body mass indices were extremely low (20 kg/m 2 ), an ostomy rod is not routinely needed as it may increase the risk of dermatitis. However, results in obese patients may differ from those shown here, which should be clarified via further studies.

Neck-Related Physical Function, Self-Efficacy, and Coping Strategies in Patients With Cervical Radiculopathy: A Randomized Clinical Trial of Postoperative Physiotherapy.

PubMed

Wibault, Johanna; Öberg, Birgitta; Dedering, Åsa; Löfgren, Håkan; Zsigmond, Peter; Persson, Liselott; Andell, Maria; R Jonsson, Margareta; Peolsson, Anneli

2017-06-01

The purpose of this study was to compare postoperative rehabilitation with structured physiotherapy to the standard approach in patients with cervical radiculopathy (CR) in a prospective randomized study at 6 months follow-up based on measures of neck-related physical function, self-efficacy, and coping strategies. Patients with persistent CR and scheduled for surgery (N = 202) were randomly assigned to structured postoperative physiotherapy or a standard postoperative approach. Structured postoperative physiotherapy combined neck-specific exercises with a behavioral approach. Baseline, 3-month, and 6-month evaluations included questionnaires and clinical examinations. Neck muscle endurance, active cervical range of motion, self-efficacy, pain catastrophizing (CSQ-CAT), perceived control over pain, and ability to decrease pain were analyzed for between-group differences using complete case and per-protocol approaches. No between-group difference was reported at the 6-month follow-up (P = .05-.99), but all outcomes had improved from baseline (P < .001). Patients undergoing structured postoperative physiotherapy with ≥50% attendance at treatment sessions had larger improvements in CSQ-CAT (P = .04) during the rehabilitation period from 3 to 6 months after surgery compared with the patients who received standard postoperative approach. No between-group difference was found at 6 months after surgery based on measures of neck-related physical function, self-efficacy, and coping strategies. However, the results confirm that neck-specific exercises are tolerated by patients with CR after surgery and may suggest a benefit from combining surgery with structured postoperative physiotherapy for patients with CR. Copyright © 2017. Published by Elsevier Inc.

Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

PubMed Central

Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

2016-01-01

Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP <150/95 mm Hg; intolerant of/at maximum RAASi dose. Protocol. 3-wk screening; Baseline randomization; Urine and blood measures at months 1, 2, 4, and Month 6 study completion. Urine interleukin-6 (IL-6) and osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr) ratio at Month 6 vs Baseline. Results 30 patients completed the study. The 15% decline in U P: Cr in minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

Effect of variation in active route timeout and my route timeout on the performance of AODV-ETX protocol in mobile adhoc network

NASA Astrophysics Data System (ADS)

Purnomo, A.; Widyawan; Najib, W.; Hartono, R.; Hartatik

2018-03-01

Mobile adhoc network (MANET) consists of nodes that are independent. A node can communicate each other without the presence of network infrastructure. A node can act as a transmitter and receiver as well as a router. This research has been variation in active route timeout and my route timeout on the performance of AODV-ETX protocol in MANET. The AODV-ETX protocol is the AODV protocol that uses the ETX metric. Performance testing is done on the static node topology with 5 m x 5 m node grid model where the distance between nodes is 100 m and node topology that consists of 25 nodes moves randomly with a moving speed of 1.38 m/s in an area of 1500 m x 300 m. From the test result, on the static node, AODV protocol-ETX shows optimal performance at a value MRT and ART of 10 s and 15 s, but showed a stable performance in the value of MRT and ART ≥60 s, while in randomly moved node topology shows stable performance in the value of MRT and ART ≥80 s.

Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial.

PubMed

Osma, Jorge; Suso-Ribera, Carlos; García-Palacios, Azucena; Crespo-Delgado, Elena; Robert-Flor, Cristina; Sánchez-Guerrero, Ana; Ferreres-Galan, Vanesa; Pérez-Ayerra, Luisa; Malea-Fernández, Amparo; Torres-Alfosea, Mª Ángeles

2018-03-12

Emotional disorders, which include both anxiety and depressive disorders, are the most prevalent psychological disorders according to recent epidemiological studies. Consequently, public costs associated with their treatment have become a matter of concern for public health systems, which face long waiting lists. Because of their high prevalence in the population, finding an effective treatment for emotional disorders has become a key goal of today's clinical psychology. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The study is a multicenter, randomized, non-inferiority controlled clinical trial. Participants will be 220 individuals with emotional disorders, who are randomized to either a treatment as usual (individual cognitive behavioral therapy) or to a Unified Protocol condition in group format. Depression, anxiety, and diagnostic criteria are the primary outcome measures. Secondary measures include the assessment of positive and negative affect, anxiety control, personality traits, overall adjustment, and quality of life. An analysis of treatment satisfaction is also conducted. Assessment points include baseline, post-treatment, and three follow-ups at 3, 6, and 12 months. To control for missing data and possible biases, intention-to-treat and per-protocol analyses will be performed. This is the first randomized, controlled clinical trial to test the effectiveness of a transdiagnostic intervention in a group format for the treatment of emotional disorders in public settings in Spain. Results obtained from this study may have important clinical, social, and economic implications for public mental health settings in Spain. Retrospectively registered at https://clinicaltrials.gov/ . Trial NCT03064477 (March 10, 2017). The trial is active and recruitment is ongoing. Recruitment is expected to finish by January 2020.

Association Between In-Office And At-Home Tooth Bleaching: A Single Blind Randomized Clinical Trial.

PubMed

Rodrigues, João Lima; Rocha, Patrícia Souza; Pardim, Silvia Letícia de Souza; Machado, Ana Cláudia Vieira; Faria-E-Silva, André Luis; Seraidarian, Paulo Isaías

2018-01-01

This controlled randomized clinical trial evaluated the effect of associating at-home and in-office bleaching procedures on tooth sensitivity (TS) and bleaching effectiveness. Forty patients subjected to on session of in-office bleaching with 38% peroxide hydrogen. Subsequently, the patients were randomly allocated to receive a second session of in-office bleaching or to use a tray containing 10% carbamide peroxide delivered during 7 consecutive days. The worst TS score reported during or after each bleaching procedure was recorded using a verbal rating scale and TS risk (score different from 0) was calculated. Color changes were measured 7 days after each in-office session (for patients receiving in-office procedures only) or after the end of at-home bleaching (for the combined protocol), and 6 months after the last procedure for both bleaching protocols. Color was assessed by a spectrophotometer and by color match with the Vita Classical and Bleach guide scales. Statistical analyses were carried out to assess possible differences between the protocols regarding the outcomes and to analyze the effect of time of assessment on color changes. The bleaching protocol did not affect the risk for and the maximum level of TS reported, irrespective of the time of assessment. In the color evaluation, the bleaching protocol also did not affect the ultimate tooth color. In conclusion, after one in-office bleaching session, there was no difference in bleaching effectiveness and TS between performing a second in-office session and associating it with 1-week at-home bleaching.

Prospective monitoring improves outcomes of primary total hip replacement: a cohort study

PubMed Central

Streubel, Philipp N; Pachón, Marcela; Kerguelén, Carlos A; Navas, José; Portocarrero, Julio; Pesantez, Rodrigo F; Zayed, Gamal; Carrillo, Germán; Llinás, Adolfo M

2009-01-01

Background Over the past decade several studies have questioned current standards of patient safety in health care delivery. In response, our institution started a clinical pathway for total hip replacement in 1996. Prospective monitoring with regular feedback sessions to the individuals involved in patient care did however not start until 2003. The present study evaluates the effect of prospective monitoring on outcomes of total hip replacement. Methods Clinical records of patients undergoing primary elective total hip replacement between 1997 and 2004 were reviewed. Data on adverse events as well as adherence to protocols for venous thromboembolism prophylaxis were extracted retrospectively for the period 1997 to 2001 and prospectively from 2003 to 2004. Results were compared and analyzed in order to establish possible improvement in outcomes. Data was analyzed with Chi-square or Fisher's Exact test for categorical variables and Student's t-test for continuous variables. Alpha was set as less than 5% and analysis was performed with Stata 9.0 for Macintosh. Results Two-hundred and eighty-three patients were included from 1997 to 2001, and 62 from 2003 to 2004. Mean age, male to female ratio and initial diagnosis were similar in both groups. At least one adverse event occurred in 45% of patients in 1997–2001 and in 21% in 2003–2004 (p < 0.001). In-hospital hip dislocations occurred in 6% and 0% (p = 0.05), oliguria in 19% and 5% (p = 0.007), SSI and VTE in 3% and 0% (p = 0.37), adverse drug reactions in 11% and 13% (p = 0.66) and non-adherence to VTE prophylaxis protocols in 15% and 2% of cases respectively (p = 0.002). Conclusion Overall rate of adverse events as well as in-hospital hip dislocations, oliguria and non-adherence to VTE prophylaxis protocols were significantly reduced during the second period. We conclude that clinical pathways alone are insufficient to improve patient safety and require prospective monitoring and continuous feedback to health care providers in order to achieve the desired effect. PMID:19366438

Behavior Intervention for Students with Externalizing Behavior Problems: Primary-Level Standard Protocol

ERIC Educational Resources Information Center

Benner, Gregory J.; Nelson, J. Ron; Sanders, Elizabeth A.; Ralston, Nicole C.

2012-01-01

This article examined the efficacy of a primary-level, standard-protocol behavior intervention for students with externalizing behavioral disorders. Elementary schools were randomly assigned to treatment (behavior intervention) or control (business as usual) conditions, and K-3 students were screened for externalizing behavior risk status. The…

A MORE COST-EFFECTIVE EMAP-ESTUARIES BENTHIC MACROFAUNAL SAMPLING PROTOCOL

EPA Science Inventory

The standard benthic macrofaunal sampling protocol in the U.S. Environmental Protection Agency's Pacific Coast Environmental Monitoring and Assessment Program (EMAP) is to collect a minimum of 30 random benthic samples per reporting unit (e.g., estuary) using a 0.1 m2 grab and to...

A MORE COST-EFFECTIVE EMAP BENTHIC MACROFAUNAL SAMPLING PROTOCOL

EPA Science Inventory

Benthic macrofaunal sampling protocols in the U.S. Environmental Protection Agency's Environmental Monitoring and Assessment Program (EMAP) are to collect 30 to 50 random benthic macrofauna [defined as animals retained on a 0.5 mm (East and Gulf Coasts, USA) or a 1.0 mm mesh siev...

Results of a Prospective Echocardiography Trial in International Space Station Crew

NASA Technical Reports Server (NTRS)

Hamilton, Douglas R.; Sargsyan, Ashot E.; Martin, David; Garcia, Kathleen M.; Melton, Shannon; Feiverson, Alan; Dulchavsky, Scott A.

2009-01-01

In the framework of an operationally oriented investigation, we conducted a prospective trial of a standard clinical echocardiography protocol in a cohort of long-duration crewmembers. The resulting primary and processed data appear to have no precedents. Our tele-echocardiography paradigm, including just-in-time e-training methods, was also assessed. A critical review of the imaging technique, equipment and setting limitations, and quality assurance is provided, as well as the analysis of "space normal" data.

Extended high dose letrozole regimen versus short low dose letrozole regimen as an adjuvant to gonadotropin releasing hormone antagonist protocol in poor responders undergoing IVF-ET.

PubMed

Fouda, Usama M; Sayed, Ahmed M

2011-12-01

To compare the efficacy and cost-effectiveness of extended high dose letrozole regimen/HPuFSH-gonadotropin releasing hormone antagonist (GnRHant) protocol with short low dose letrozole regimen/HPuFSH-GnRHant protocol in poor responders undergoing IVF-ET. In this randomized controlled trial, 136 women who responded poorly to GnRH agonist long protocol in their first IVF cycle were randomized into two equal groups using computer generated list and were treated in the second IVF cycle by either extended letrozole regimen (5 mg/day during the first 5 days of cycle and 2.5 mg/day during the subsequent 3 days) combined with HPuFSH-GnRHant protocol or short letrozole regimen (2.5 mg/day from cycle day 3-7) combined with HPuFSH-GnRHant protocol. There were no significant differences between both groups with regard to number of oocytes retrieved and clinical pregnancy rate (5.39 ± 2.08 vs. 5.20 ± 1.88 and 22.06% vs. 16.18%, respectively).The total gonadotropins dose and medications cost per cycle were significantly lower in extended letrozole group (44.87 ± 9.16 vs. 59.97 ± 14.91 ampoules and 616.52 ± 94.97 vs. 746.84 ± 149.21 US Dollars ($), respectively).The cost-effectiveness ratio was 2794 $ in extended letrozole group and 4616 $ in short letrozole group. Extended letrozole regimen/HPuFSH-GnRHant protocol was more cost-effective than short letrozole regimen/HPuFSH-GnRHant protocol in poor responders undergoing IVF-ET.

Clomiphene citrate 'stair-step' protocol vs. traditional protocol in patients with polycystic ovary syndrome: a randomized controlled trial.

PubMed

Deveci, Canan Dura; Demir, Berfu; Sengul, Ozlem; Dilbaz, Berna; Goktolga, Umit

2015-01-01

To evaluate the efficacy of the stair-step protocol using clomiphene citrate (CC) and to assess the uterine and systemic side effects in patients with polycystic ovary syndrome (PCOS). A total of 60 PCOS patients who failed to respond to 50 mg/day for 5 days of CC treatment within the cycle were randomly allocated to the control (traditional protocol) and study (stair-step protocol) groups. In the stair-step protocol,patients were treated with CC 50 mg/day for 5 days and then in nonresponsive patients, the dosage was increased to 100 mg/day for 5 days in the same cycle. Patients who failed the 50 mg/day CC treatment in the previous cycle were stimulated with 100 mg/day CC and were accepted as the control group. Ovulation and pregnancy rates, duration of treatment and uterine and systemic side effects were evaluated. Ovulation and pregnancy rates were similar between the stair-step and the control group (43.3 vs. 33.3 %, respectively) (16.7 vs. 10 %, respectively). The duration of treatment was significantly shorter in stair-step compared to traditional protocol (20.5 ± 2.0 vs. 48.6 ± 2.4 days, respectively). There were no significant differences in the systemic side effects between the groups. Uterine side effects were evaluated with endometrial thickness and uterine artery Doppler ultrasound; no significant differences were observed in stair-step compared to traditional protocol. The stair-step protocol was determined to have a significantly shorter treatment period without any detrimental effect on the ovulation and pregnancy rates.

Current trends and future prospects of biotechnological interventions through tissue culture in apple.

PubMed

Bhatti, Shammi; Jha, Gopaljee

2010-11-01

Apple (Malus domestica Borkh.), which is a widely cultivated, important economic fruit crop with nutritive and medicinal importance, has emerged as a model horticultural crop in this post-genomic era. Apple cultivation is heavily dependent on climatic condition and is susceptible to several diseases caused by fungi, bacteria, viruses, insects, etc. Extensive research work has been carried out to standardize tissue culture protocols and utilize them in apple improvement. We review the in vitro shoot multiplication, rooting, transformation and regeneration methodologies in apple and tabulate various such protocols for easy reference. The utility and limitation of transgenesis in apple improvement have also been summarized. The concepts of marker-free plants, use of non-antibiotic resistance selectable markers, and cisgenic and intragenic approaches are highlighted. Furthermore, the limitations, current trends and future prospects of tissue culture-mediated biotechnological interventions in apple improvement are discussed.

DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols.

PubMed

Neugebauer, Hermann; Heuschmann, Peter U; Jüttler, Eric

2012-10-02

Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18-60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e.g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76% mRS ≤ 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies. (ICTRP and DRKS): DRKS00000624.

Angiographic predictors of 3-year patency of bypass grafts implanted on the right coronary artery system: a prospective randomized comparison of gastroepiploic artery, saphenous vein, and right internal thoracic artery grafts.

PubMed

Glineur, David; D'hoore, William; de Kerchove, Laurent; Noirhomme, Philippe; Price, Joel; Hanet, Claude; El Khoury, Gebrine

2011-11-01

Saphenous vein, in situ right gastroepiploic artery, and right internal thoracic artery grafts are routinely used to revascularize the right coronary artery. Little is known about the predictive value of objective preoperative angiographic parameters on midterm graft patency. We prospectively enrolled 210 consecutive patients undergoing coronary revascularization. Revascularization of the right coronary artery was randomly performed with the saphenous vein grafts in 81 patients and the right gastroepiploic artery in 92 patients. During the same study period, 37 patients received right coronary artery revascularization with the right internal thoracic artery used in a Y-composite fashion. All patients underwent a protocol-driven coronary angiogram 3 years after surgery. Preoperative angiographic parameters included minimum lumen diameter percent stenosis measured by quantitative angiography. A graft was considered "not functional" with patency scores of 0 to 2 and "functional" with patency scores of 3 or 4. Angiographic follow-up was 100% complete. A significant difference in the distribution of flow patterns was observed in the 3 groups. In multivariate analysis, the use of a saphenous vein graft was associated with superior graft functionality compared with the other conduits (odds ratio, 6.1; 95% confidence interval, 2.4-15). Graft function was negatively influenced by the minimum lumen diameter (odds ratio, 0.11; confidence interval, 0.05-0.25). In the right gastroepiploic artery and right internal thoracic artery groups, the proportion of functional grafts was higher when the minimum lumen diameter was below a threshold value in the third minimum lumen diameter quartile (0.64-1.30 mm). Preoperative angiography predicts graft patency in the right gastroepiploic artery and right internal thoracic artery, whereas the flow pattern in saphenous vein grafts is significantly less influenced by quantitative angiographic parameters. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Secondary Prevention of Chronic PTSD by Early and Short-Term Administration of Escitalopram: A Prospective Randomized, Placebo-Controlled, Double-Blind Trial.

PubMed

Zohar, Joseph; Fostick, Leah; Juven-Wetzler, Alzabeta; Kaplan, Zeev; Shalev, Hadar; Schreiber, Gavriel; Miroshnik, Natalie; Shalev, Arieh Y; Stein, Dan J; Seedat, Soraya; Suliman, Sharain; Klein, Ehud

Prospective studies have not identified a viable pharmacologic strategy for secondary prevention of posttraumatic stress disorder (PTSD). The authors examined whether preventive intervention via early and short-term administration of a selective serotonin reuptake inhibitor (SSRI), within 1 month of exposure to a traumatic event (before diagnosis of PTSD could be made), may reduce the severity of PTSD symptoms according to DSM-IV at 13 months' follow-up. Over 25,000 screening calls to patients referred to an emergency department for a traumatic event performed between June 2006 and December 2008 yielded 353 participants who were recruited within the month following a traumatic event . Participants were randomly assigned in a double-blind design to escitalopram (n = 176) or placebo (n = 177). The per-protocol analysis comprised 198 participants (escitalopram, n = 102; placebo, n = 96) who received treatment for 12 to 24 weeks and were available for follow-up at week 56. The primary outcome measure, the Clinician Administered PTSD Scale (CAPS), revealed no prevention effect. However, a secondary outcome, the Pittsburgh Sleep Quality Inventory (PSQI), showed better results for the SSRI group than for the placebo group. For a subset of participants who experienced intentional trauma (missile attacks, rape, or physical assault; n = 50), the prevention effect was found on both primary and secondary measures (CAPS, PSQI and measures of depression and global illness severity). Early and short-term administration of escitalopram was not shown to prevent PTSD, although it did improve sleep quality. In a subgroup of participants who experienced intentional trauma, however, this early-treatment approach may be effective as secondary prevention. This large study is the first to investigate the preventive effect of early administration of escitalopram on PTSD. It highlights the relevance of the type of trauma (intentional vs unintentional) to the outcome. ClinicalTrials.gov identifier: NCT00300313​​. © Copyright 2018 Physicians Postgraduate Press, Inc.

Short- and long-term performance of a tripolar down-sized single lead for implantable cardioverter defibrillator treatment: a randomized prospective European multicenter study. European Endotak DSP Investigator Group.

PubMed

Sandstedt, B; Kennergren, C; Schaumann, A; Herse, B; Neuzner, J

1998-11-01

A new, thinner (10 Fr) and more flexible, single-pass transvenous endocardial ICD lead, Endotak DSP, was compared with a conventional lead, Endotak C, as a control in a prospective randomized multicenter study in combination with a nonactive can ICD. A total of 123 patients were enrolled, 55 of whom received a down-sized DSP lead. Lead-alone configuration was successfully implanted in 95% of the DSP patients vs 88% in the control group. The mean defibrillation threshold (DFT) was determined by means of a step-down protocol, and was identical in the two groups, 10.5 +/- 4.8 J in the DSP group versus 10.5 +/- 4.8 J in the control group. At implantation, the DSP mean pacing threshold was lower, 0.51 +/- 0.18 V versus 0.62 +/- 0.35 V (p < 0.05) in the control group, and the mean pacing impedance higher, 594 +/- 110 omega vs 523 +/- 135 omega (p < 0.05). During the follow-up period, the statistically significant difference in thresholds disappeared, while the difference in impedance remained. Tachyarrhythmia treatment by shock or antitachycardia pacing (ATP) was delivered in 53% and 41%, respectively, of the patients with a 100% success rate. In the DSP group, all 28 episodes of polymorphic ventricular tachycardia or ventricular fibrillation were converted by the first shock as compared to 57 of 69 episodes (83%) in the control group (p < 0.05). Monomorphic ventricular tachycardias were terminated by ATP alone in 96% versus 94%. Lead related problems were minor and observed in 5% and 7%, respectively. In summary, both leads were safe and efficacious in the detection and treatment of ventricular tachyarrhythmias. There were no differences between the DSP and control groups regarding short- or long-term lead related complications.

Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial.

PubMed

Ardehali, Abbas; Esmailian, Fardad; Deng, Mario; Soltesz, Edward; Hsich, Eileen; Naka, Yoshifumi; Mancini, Donna; Camacho, Margarita; Zucker, Mark; Leprince, Pascal; Padera, Robert; Kobashigawa, Jon

2015-06-27

The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. TransMedics. Copyright © 2015 Elsevier Ltd. All rights reserved.

Leveraging ongoing research to evaluate the health impacts of South Africa's salt reduction strategy: a prospective nested cohort within the WHO-SAGE multicountry, longitudinal study

PubMed Central

Charlton, Karen; Menyanu, Elias; Biritwum, Richard Berko; Naidoo, Nirmala; Pieterse, Chiné; Madurai, Savathree (Lorna); Baumgartner, Jeannine; Asare, George A; Thiele, Elizabeth; Schutte, Aletta E; Kowal, Paul

2016-01-01

Introduction Attempting to curb the rising epidemic of hypertension, South Africa implemented legislation in June 2016 mandating maximum sodium levels in a range of manufactured foods that contribute significantly to population salt intake. This natural experiment, comparing two African countries with and without salt legislation, will provide timely information on the impact of legislative approaches addressing the food supply to improve blood pressure in African populations. This article outlines the design of this ongoing prospective nested cohort study. Methods and analysis Baseline sodium intake was assessed in a nested cohort of the WHO Study on global AGEing and adult health (WHO-SAGE) wave 2 (2014–2015), a multinational longitudinal study on the health and well-being of adults and the ageing process. The South African cohort consisted of randomly selected households (n=4030) across the country. Spot and 24-hour urine samples are collected in a random subsample (n=1200) and sodium, potassium, creatinine and iodine analysed. Salt behaviour and sociodemographic data are captured using face-to-face interviews, alongside blood pressure and anthropometric measures. Ghana, the selected control country with no formal salt policy, provided a nested subsample (n=1200) contributing spot and 24-hour urine samples from the SAGE Ghana cohort (n=5000). Follow-up interviews and urine collection (wave 3) in both countries will take place in 2017 (postlegislation) to assess change in population-level sodium intake and blood pressure. Ethics and dissemination SAGE was approved by the WHO Ethics Review Committee (reference number RPC149) with local approval from the North-West University Human Research Ethics Committee and University of the Witwatersrand Human Research Ethics Committee (South Africa), and University of Ghana Medical School Ethics and Protocol Review Committee (Ghana). The results of the study will be published in peer-reviewed international journals, presented at national and international conferences, and summarised as research and policy briefs. PMID:27903563

Host-Associated Metagenomics: A Guide to Generating Infectious RNA Viromes

PubMed Central

Robert, Catherine; Pascalis, Hervé; Michelle, Caroline; Jardot, Priscilla; Charrel, Rémi; Raoult, Didier; Desnues, Christelle

2015-01-01

Background Metagenomic analyses have been widely used in the last decade to describe viral communities in various environments or to identify the etiology of human, animal, and plant pathologies. Here, we present a simple and standardized protocol that allows for the purification and sequencing of RNA viromes from complex biological samples with an important reduction of host DNA and RNA contaminants, while preserving the infectivity of viral particles. Principal Findings We evaluated different viral purification steps, random reverse transcriptions and sequence-independent amplifications of a pool of representative RNA viruses. Viruses remained infectious after the purification process. We then validated the protocol by sequencing the RNA virome of human body lice engorged in vitro with artificially contaminated human blood. The full genomes of the most abundant viruses absorbed by the lice during the blood meal were successfully sequenced. Interestingly, random amplifications differed in the genome coverage of segmented RNA viruses. Moreover, the majority of reads were taxonomically identified, and only 7–15% of all reads were classified as “unknown”, depending on the random amplification method. Conclusion The protocol reported here could easily be applied to generate RNA viral metagenomes from complex biological samples of different origins. Our protocol allows further virological characterizations of the described viral communities because it preserves the infectivity of viral particles and allows for the isolation of viruses. PMID:26431175

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

A Randomized Prospective Trial Comparing Paravertebral Block and General Anesthesia for Operative Treatment of Breast Cancer

DTIC Science & Technology

2001-10-01

block the anesthetic of choice for operative treatment of breast cancer. To test this hypothesis we proposed a prospective randomized clinical trial ...coordinators. Months 4-6. Status: Complete The study’s existing part-time Clinical Trial Coordinator, Mr. John Arbo, was enlisted full-time in June...of full-time Clinical Trial Coordinator for Mount Sinai. ■ Poster presentation by Mount Sinai staff of study goals and methods at a Department of

Benefits of E-Cigarettes Among Heavy Smokers Undergoing a Lung Cancer Screening Program: Randomized Controlled Trial Protocol.

PubMed

Lucchiari, Claudio; Masiero, Marianna; Veronesi, Giulia; Maisonneuve, Patrick; Spina, Stefania; Jemos, Costantino; Omodeo Salè, Emanuela; Pravettoni, Gabriella

2016-02-03

Smoking is a global public health problem. For this reason, experts have called smoking dependence a global epidemic. Over the past 5 years, sales of electronic cigarettes, or e-cigarettes, have been growing strongly in many countries. Yet there is only partial evidence that e-cigarettes are beneficial for smoking cessation. In particular, although it has been proven that nicotine replacement devices may help individuals stop smoking and tolerate withdrawal symptoms, e-cigarettes' power to increase the quitting success rate is still limited, ranging from 5% to 20% dependent on smokers' baseline conditions as shown by a recent Cochrane review. Consequently, it is urgent to know if e-cigarettes may have a higher success rate than other nicotine replacement methods and under what conditions. Furthermore, the effects of the therapeutic setting and the relationship between individual characteristics and the success rate have not been tested. This protocol is particularly innovative, because it aims to test the effectiveness of electronic devices in a screening program (the COSMOS II lung cancer prevention program at the European Institute of Oncology), where tobacco reduction is needed to lower individuals' lung cancer risks. This protocol was designed with the primary aim of investigating the role of tobacco-free cigarettes in helping smokers improve lung health and either quit smoking or reduce their tobacco consumption. In particular, we aim to investigate the impact of a 3-month e-cigarettes program to reduce smoking-related respiratory symptoms (eg, dry cough, shortness of breath, mouth irritation, and phlegm) through reduced consumption of tobacco cigarettes. Furthermore, we evaluate the behavioral and psychological (eg, well-being, mood, and quality of life) effects of the treatment. This is a prospective, randomized, placebo-controlled, double-blind, three-parallel group study. The study is organized as a nested randomized controlled study with 3 branches: a nicotine e-cigarettes group, a nicotine-free e-cigarettes group, and a control group. The study is nested in a screening program for early lung cancer detection in heavy smokers. The study is open and is still recruiting. Stopping or reducing tobacco consumption should be a main goal of any health organization. However, traditional antismoking programs are expensive and not always effective. Therefore, favoring a partial or complete shift to e-cigarettes in heavy smokers (eg, persons at high risk for a number of diseases) could be considered a moral imperative. However, before following this path, sound and reliable data on large samples and in a variety of contexts are required. Clinicaltrials.gov NCT02422914; https://clinicaltrials.gov/ct2/show/NCT02422914 (Archived by WebCite at http://www.webcitation.org/6etwz1bPL).