The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

National German Guideline (S2k): Guideline for the Diagnosis and Treatment of Endometriosis*

PubMed Central

Ulrich, U.; Buchweitz, O.; Greb, R.; Keckstein, J.; von Leffern, I.; Oppelt, P.; Renner, S. P.; Sillem, M.; Stummvoll, W.; De Wilde, R.-L.; Schweppe, K.-W.

2014-01-01

In this guideline, recommendations and standards for optimum diagnosis and treatment of endometriosis are presented. They are based on the analysis of the available scientific evidence as published in prospective randomized and retrospective studies as well as in systematic reviews. The guideline working group consisted of experts from Austria, Germany, Switzerland, and the Czech Republic. PMID:26157194

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

Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach.

PubMed

Sarli, L; Iusco, D R; Sansebastiano, G; Costi, R

2001-08-01

No randomized trial exists that specifically addresses the issue of laparoscopic bilateral inguinal hernia repair. The purpose of the present prospective, randomized, controlled, clinical study was to assess short- and long-term results when comparing simultaneous bilateral hernia repair by an open, tension-free anterior approach with laparoscopic "bikini mesh" posterior repair. Forty-three low-risk male patients with bilateral primary inguinal hernia were randomly assigned to undergo either laparoscopic preperitoneal "bikini mesh" hernia repair (TAPP) or open Lichtenstein hernioplasty. There was no difference in operating time between the two groups. The mean cost of laparoscopic hernioplasty was higher (P < 0.001). The intensity of postoperative pain was greater in the open hernia repair group at 24 hours, 48 hours, and 7 days after surgery (P < 0.001), with a greater consumption of pain medication among these patients (P < 0.05). The median time to return to work was 30 days for the open hernia repair group and 16 days for the laparoscopic "bikini mesh" repair group (P < 0.05). Only 1 asymptomatic recurrence (4.3%) was discovered in the open group. The laparoscopic approach to bilateral hernia with "bikini mesh" appears to be preferable to the open Lichtenstein tension-free hernioplasty in terms of the postoperative quality of life and interruption of occupational activity.

The WOMEN study: what is the optimal method for ischemia evaluation in women? A multi-center, prospective, randomized study to establish the optimal method for detection of coronary artery disease (CAD) risk in women at an intermediate-high pretest likelihood of CAD: study design.

PubMed

Mieres, Jennifer H; Shaw, Leslee J; Hendel, Robert C; Heller, Gary V

2009-01-01

Coronary artery disease remains the leading cause of morbidity and mortality in women. The optimal non-invasive test for evaluation of ischemic heart disease in women is unknown. Although current guidelines support the choice of the exercise tolerance test (ETT) as a first line test for women with a normal baseline ECG and adequate exercise capabilities, supportive data for this recommendation are controversial. The what is the optimal method for ischemia evaluation in women? (WOMEN) study was designed to determine the optimal non-invasive strategy for CAD risk detection of intermediate and high risk women presenting with chest pain or equivalent symptoms suggestive of ischemic heart disease. The study will prospectively compare the 2-year event rates in women capable of performing exercise treadmill testing or Tc-99 m tetrofosmin SPECT myocardial perfusion imaging (MPI). The study will enroll women presenting for the evaluation of chest pain or anginal equivalent symptoms who are capable of performing >5 METs of exercise while at intermediate-high pretest risk for ischemic heart disease who will be randomized to either ETT testing alone or with Tc-99 m tetrofosmin SPECT MPI. The null hypothesis for this project is that the exercise ECG has the same negative predictive value for risk detection as gated myocardial perfusion SPECT in women. The primary aim is to compare 2-year cardiac event rates in women randomized to SPECT MPI to those randomized to ETT. The WOMEN study seeks to provide objective information for guidelines for the evaluation of symptomatic women with an intermediate-high likelihood for CAD.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

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

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.

Editorial Commentary: Got Evidence? What We Really Need Is an Algorithm for Treating Symptomatic Bipartite Patella.

PubMed

Fithian, Donald C

2018-05-01

Bipartite patella is an uncommon but potentially troublesome problem for young athletes. Numerous uncontrolled retrospective studies have reported good results after various treatments. What is needed are studies that will guide workup and support treatment decisions based on the condition of the cartilage surfaces of the fragment, presence of pseudoarthrosis, and size and location of the fragment. To support decisions, we need prospective comparative studies, either randomized or, at least, prospective cohort studies that identify patients at the time of presentation, document key decision points, and follow patients to successful resolution of symptoms. Copyright © 2018 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

N-terminal pro-B-type natriuretic peptide testing improves the management of patients with suspected acute heart failure: primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study.

PubMed

Moe, Gordon W; Howlett, Jonathan; Januzzi, James L; Zowall, Hanna

2007-06-19

The diagnostic utility of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in heart failure has been documented. However, most of the data were derived from countries with high healthcare resource use, and randomized evidence for utility of NT-proBNP was lacking. We tested the hypothesis that NT-proBNP testing improves the management of patients presenting with dyspnea to emergency departments in Canada by prospectively comparing the clinical and economic impact of a randomized management strategy either guided by NT-proBNP results or without knowledge of NT-proBNP concentrations. Five hundred patients presenting with dyspnea to 7 emergency departments were studied. The median NT-proBNP level among the 230 subjects with a final diagnosis of heart failure was 3697 compared with 212 pg/mL in those without heart failure (P<0.00001). Knowledge of NT-proBNP results reduced the duration of ED visit by 21% (6.3 to 5.6 hours; P=0.031), the number of patients rehospitalized over 60 days by 35% (51 to 33; P=0.046), and direct medical costs of all ED visits, hospitalizations, and subsequent outpatient services (US $6129 to US $5180 per patient; P=0.023) over 60 days from enrollment. Adding NT-proBNP to clinical judgment enhanced the accuracy of a diagnosis; the area under the receiver-operating characteristic curve increased from 0.83 to 0.90 (P<0.00001). In a universal health coverage system mandating judicious use of healthcare resources, inclusion of NT-proBNP testing improves the management of patients presenting to emergency departments with dyspnea through improved diagnosis, cost savings, and improvement in selected outcomes.

The effect of prognostic data presentation format on perceived risk among surrogate decision makers of critically ill patients: a randomized comparative trial.

PubMed

Chapman, Andy R; Litton, Edward; Chamberlain, Jenny; Ho, Kwok M

2015-04-01

The purpose of this study is to determine whether varying the format used to present prognostic data alters the perception of risk among surrogate decision makers in the intensive care unit (ICU). This was a prospective randomized comparative trial conducted in a 23-bed adult tertiary ICU. Enrolled surrogate decision makers were randomized to 1 of 2 questionnaires, which presented hypothetical ICU scenarios, identical other than the format in which prognostic data were presented (eg, frequencies vs percentages). Participants were asked to rate the risk associated with each prognostic statement. We enrolled 141 surrogate decision makers. The perception of risk varied significantly dependent on the presentation format. For "quantitative data," risks were consistently perceived as higher, when presented as frequencies (eg, 1 in 50) compared with equivalent percentages (eg, 2%). Framing "qualitative data" in terms of chance of "death" rather than "survival" led to a statistically significant increase in perceived risks. Framing "quantitative" data in this way did not significantly affect risk perception. Data format had a significant effect on how surrogate decision makers interpreted risk. Qualitative statements are interpreted widely and affected by framing. Where possible, multiple quantitative formats should be used for presenting prognostic information. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

The risk-stratified osteoporosis strategy evaluation study (ROSE): a randomized prospective population-based study. Design and baseline characteristics.

PubMed

Rubin, Katrine Hass; Holmberg, Teresa; Rothmann, Mette Juel; Høiberg, Mikkel; Barkmann, Reinhard; Gram, Jeppe; Hermann, Anne Pernille; Bech, Mickael; Rasmussen, Ole; Glüer, Claus C; Brixen, Kim

2015-02-01

The risk-stratified osteoporosis strategy evaluation study (ROSE) is a randomized prospective population-based study investigating the effectiveness of a two-step screening program for osteoporosis in women. This paper reports the study design and baseline characteristics of the study population. 35,000 women aged 65-80 years were selected at random from the population in the Region of Southern Denmark and-before inclusion-randomized to either a screening group or a control group. As first step, a self-administered questionnaire regarding risk factors for osteoporosis based on FRAX(®) was issued to both groups. As second step, subjects in the screening group with a 10-year probability of major osteoporotic fractures ≥15% were offered a DXA scan. Patients diagnosed with osteoporosis from the DXA scan were advised to see their GP and discuss pharmaceutical treatment according to Danish National guidelines. The primary outcome is incident clinical fractures as evaluated through annual follow-up using the Danish National Patient Registry. The secondary outcomes are cost-effectiveness, participation rate, and patient preferences. 20,904 (60%) women participated and included in the baseline analyses (10,411 in screening and 10,949 in control group). The mean age was 71 years. As expected by randomization, the screening and control groups had similar baseline characteristics. Screening for osteoporosis is at present not evidence based according to the WHO screening criteria. The ROSE study is expected to provide knowledge of the effectiveness of a screening strategy that may be implemented in health care systems to prevent fractures.

Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

PubMed

Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

2017-02-01

Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review.

PubMed

Shi, Guanglin; Shen, Qin; Zhang, Caixin; Ma, Jun; Mohammed, Anaz; Zhao, Huan

2018-06-19

Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

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.

Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex

DTIC Science & Technology

2012-09-01

in the formation of visible facial angiofibromas over time. The lesions appear as red or pink papules distributed over the central face...especially on the nasolabial folds, cheeks, and chin. Lesions appear in early childhood and are present in up to 80% of TSC patients. Facial angiofibromas ...facial angiofibromas without causing side effects seen with systemic administration. This project is a multi-center prospective, randomized

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…

Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

PubMed

Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

2014-12-01

To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%). Providing level 1 evidence, ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs. clinicaltrials.gov Identifier: NCT01602159.

Habitual coffee consumption and risk of cognitive decline/dementia: A systematic review and meta-analysis of prospective cohort studies.

PubMed

Liu, Qing-Ping; Wu, Yan-Feng; Cheng, Hong-Yu; Xia, Tao; Ding, Hong; Wang, Hui; Wang, Ze-Mu; Xu, Yun

2016-06-01

Findings from epidemiologic studies of coffee consumption and risk for cognitive decline or dementia are inconclusive. The aim of this study was to conduct a meta-analysis of prospective studies to assess the association between coffee consumption and the risk for cognitive decline and dementia. Relevant studies were identified by searching PubMed and Embase databases between 1966 and December 2014. Prospective cohorts that reported relative risk (RRs) and 95% confidence intervals (CIs) for the association of coffee consumption with dementia incidence or cognitive changing were eligible. Study-specific RRs were combined by using a random-effects model. Eleven prospective studies, including 29,155 participants, were included in the meta-analysis. The combined RR indicated that high coffee consumption was not associated with the different measures of cognitive decline or dementia (summary RR, 0.97; 95% CI, 0.84-1.11). Subgroup analyses suggested a significant inverse association between highest coffee consumption and the risk for Alzheimer disease (summary RR, 0.73; 95% CI, 0.55-0.97). The dose-response analysis, including eight studies, did not show an association between the increment of coffee intake and cognitive decline or dementia risk (an increment of 1 cup/d of coffee consumed; summary RR, 1.00; 95% CI, 0.98-1.02). The present study suggests that higher coffee consumption is associated with reduced risk for Alzheimer disease. Further randomized controlled trials or well-designed cohort studies are needed to determine the association between coffee consumption and cognitive decline or dementia. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Does estrogen play a role in response to adjuvant bone-targeted therapies?

PubMed Central

Russell, Kent; Amir, Eitan; Paterson, Alexander; Josse, Robert; Addison, Christina; Kuchuk, Iryna; Clemons, Mark

2013-01-01

Bone remains the most common site of breast cancer recurrence. The results of population studies, pre-clinical research and clinical studies in patients with metastatic disease provided a rationale for testing bone-targeted agents in the adjuvant setting. Despite the initial optimism, results from eight prospectively designed, randomized control studies powered to assess the value of adjuvant bone-targeted therapy in early breast cancer are conflicting. Data have shown that, where benefit exists, it tends to be in women with a “low estrogen environment”, either through menopause or suppression of ovarian function. In this manuscript, we review clinical data supporting the hypothesis that estrogen levels may play a part in explaining the response of patients to bone-targeted agents in the adjuvant setting. The results presented to date suggest that there may be data supporting a unifying role for estrogen in adjuvant trials. However, in the absence of any prospective randomized trials in which estrogen data has been systematically collected we cannot specifically answer this question. We await the results of the Oxford overview analysis of individual patient data with interest. PMID:26909288

What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

PubMed

Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

2018-02-01

There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Prospective randomized controlled trial of conventional laparoscopic versus laparoendoscopic single-site radical nephrectomy for localized renal cell carcinoma: a preliminary report regarding quality of life.

PubMed

Park, Yong Hyun; Kim, Kwang Taek; Ko, Kyungtae; Kim, Hyeon Hoe

2015-03-01

The safety and efficacy of laparoendoscopic single-site surgery (LESS) for renal cell carcinoma (RCC) have not been clearly demonstrated. We aimed to present preliminary data from a prospective randomized controlled trial of LESS versus conventional laparoscopic radical nephrectomy for localized RCC. Patients with cT1-2 RCC were randomized to LESS (n = 17) or conventional laparoscopy (n = 18) group. The short-term outcome measures assessed were perioperative morbidity, postoperative pain, and quality of recovery as determined using QoR-40. No significant differences were observed between the LESS and conventional laparoscopy groups with respect to operative time (143.5 vs. 126.1 min, p = 0.218), blood loss (143.6 vs. 118.2 ml, p = 0.121), hospital stay (3.8 vs. 3.1 day s, p = 0.170), analgesic requirements (63.2 vs. 60.0 mg, p = 0.956), and complication rates (26.7 vs. 22.2 %, p = 0.767). However, postoperative quality of recovery was better in the LESS group (176.4 vs. 152.6, p = 0.005). Furthermore, quality of recovery, as measured using the QoR-40 dimensions of emotional state (39.9 vs. 34.0, p = 0.003), physical comfort (51.9 vs. 46.7, p = 0.034), psychological support (32.2 vs. 25.8, p = 0.003), and physical independence (20.7 vs. 17.5, p = 0.047), but not pain (31.8 vs. 29.6, p = 0.259), was significantly better in the LESS group. The preliminary results from this prospective trial suggest that LESS could be a safe and effective treatment option for localized RCC with equivalent surgical outcomes and improved postoperative quality of recovery compared with conventional laparoscopic surgery.

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

Management of Hypertension in Diabetic Nephropathy: How Low Should We Go?

PubMed

Sternlicht, Hillel; Bakris, George L

2016-01-01

Hypertension is a frequent comorbidity often following the development of diabetic nephropathy among individuals with type 1 diabetes and affecting most patients with type 2 diabetes at the time of diagnosis. Multiple prospective randomized placebo-controlled trials demonstrate that tight blood pressure control among patients with diabetic nephropathy reduces the rates of macrovascular and microvascular complications. While randomized trials exist and support a blood pressure goal of <140/90 mm Hg for patients with nondiabetic kidney disease, there are no prospective data regarding a specific blood pressure goal on progression of diabetic nephropathy. Retrospective data analyses from trials show a linear relationship between either baseline or achieved study blood pressure and progression of nephropathy. Very high albuminuria is a hallmark of diabetic nephropathy with reductions by either angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blocker (ARB) monotherapy associated with slowed nephropathy progression. However, combination antihypertensive therapy, while decreasing proteinuria, augments the risk of hyperkalemia, hypotension, and kidney dysfunction. Given the lack of trial data for a BP goal among patients with diabetic nephropathy, prospective trials are needed to define the optimal blood pressure necessary to preserve kidney function. At present, guideline blood pressure goals of less than 140/90 mm Hg and the use of ACEi or ARB therapy for those with more than 300 mg of albuminuria are mandated. © 2016 S. Karger AG, Basel.

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.

Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.

PubMed

Wu, Yan-Guang; Lazzaroni-Tealdi, Emanuela; Wang, Qi; Zhang, Lin; Barad, David H; Kushnir, Vitaly A; Darmon, Sarah K; Albertini, David F; Gleicher, Norbert

2016-08-24

Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo. Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation. Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands. NCT02246309 Registered September 18, 2014.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

Inefficacy of Kinesio-Taping(®) on early postoperative pain after ACL reconstruction: Prospective comparative study.

PubMed

Laborie, M; Klouche, S; Herman, S; Gerometta, A; Lefevre, N; Bohu, Y

2015-12-01

Kinesio-Taping(®) (K-Tape) is used in sports traumatology with the aim of reducing pain and improving blood and lymph circulation. The main objective of the present study was to assess the efficacy of K-Tape on early postoperative pain after anterior cruciate ligament (ACL) reconstruction. The study hypothesis was that K-Tape significantly decreases pain. A prospective non-randomized comparative study was conducted in 2013-2014 and included all patients who underwent primary ACL reconstruction by hamstring graft. Analgesia was standardized. Two groups, "K-Tape" and "controls", were formed according to the days on which the study physiotherapist was present. The K-Tape compression/decompression assembly was applied immediately postoperatively and maintained for 3days. Patients filled out online questionnaires. The main assessment criterion was mean postoperative pain (D0-D3) on a 0-to-10 scale. Secondary criteria were analgesia intake on the three WHO levels, awakening during the night of D0 due to pain, signs of postoperative discomfort, and patient satisfaction. Sixty patients (30 per group) were included, 57 of whom could be assessed: 28 K-Tape, 29 controls; 44 male, 13 female; mean age, 30.9±8.9 years. At inclusion, the two groups were comparable. There was no significant difference in mean (D0-D3) knee pain intensity: 3.8±2.2 for K-Tape, and 3.9±2 for controls (P=0.93). Analysis of variance (ANOVA) found no significant intergroup difference in evolution of pain (P=0.34). There were no other significant differences on the other assessment criteria. K-Tape showed no efficacy on early postoperative pain following ACL reconstruction. III; prospective non-randomized comparative study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework

PubMed Central

Young, Diana L.; Goodie, Adam S.; Hall, Daniel B.

2010-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one’s knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed. PMID:21278906

Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework.

PubMed

Young, Diana L; Goodie, Adam S; Hall, Daniel B

2011-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one's knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed.

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

Comparison of Effect of Oral Premedication with Ibuprofen or Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study.

PubMed

Bidar, Maryam; Mortazavi, Soheil; Forghani, Maryam; Akhlaghi, Saeed

2017-01-01

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of preoperative oral administration of ibuprofen or dexamethasone on the success rate of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Seventy-eight patients with irreversible pulpitis were randomly divided into 3 groups (26 per group) and given one of the following at 1 hr prior to performing local anesthesia: a placebo; 400 mg ibuprofen; or 4 mg dexamethasone. Each patient recorded their pain level on a visual analog scale before taking the medication or placebo, at 15 min after completion of IANB, and during treatment if pain occurred. The success of the anesthesia was defined as no or mild pain at any stage during the endodontic procedure. The success rate of the IANB was 38.5, 73.1, and 80.8% with the placebo, ibuprofen, and dexamethasone, respectively. Both ibuprofen and dexamethasone were significantly more effective than the placebo. No significant difference was observed, however, between the two experimental medications in terms of effectiveness. The results of the present study suggest that premedication with ibuprofen or dexamethasone increases the success rate of an IANB in patients with symptomatic irreversible pulpitis in the mandibular molars.

Outcome of patients after lower limb fracture with partial weight bearing postoperatively treated with or without anti-gravity treadmill (alter G®) during six weeks of rehabilitation - a protocol of a prospective randomized trial.

PubMed

Henkelmann, Ralf; Schneider, Sebastian; Müller, Daniel; Gahr, Ralf; Josten, Christoph; Böhme, Jörg

2017-03-14

Partial or complete immobilization leads to different adjustment processes like higher risk of muscle atrophy or a decrease of general performance. The present study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau (group 1)or ankle fractures (group 2) with six weeks of partial weight bearing of 20 kg. This prospective randomized study will include a total of 60 patients for each group according to predefined inclusion and exclusion criteria. 1:1 randomization will be performed centrally via fax supported by the Clinical Trial Centre Leipzig (ZKS Leipzig). Patients in the treatment arm will be treated with an anti-gravity treadmill (alter G®) instead of physiotherapy. The protocol is designed parallel to standard physiotherapy with a frequency of two to three times of training with the treadmill per week with duration of 20 min for six weeks. Up to date no published randomized controlled trial with an anti-gravity treadmill is available. The findings of this study can help to modify rehabilitation of patients with partial weight bearing due to their injury or postoperative protocol. It will deliver interesting results if an anti-gravity treadmill is useful in rehabilitation in those patients. Further ongoing studies will identify different indications for an anti-gravity treadmill. Thus, in connection with those studies, a more valid statement regarding safety and efficacy is possible. NCT02790229 registered on May 29, 2016.

The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial.

PubMed

Agarwal, Jayant P; Mendenhall, Shaun D; Anderson, Layla A; Ying, Jian; Boucher, Kenneth M; Liu, Ting; Neumayer, Leigh A

2015-01-01

Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction. Many of the reported data are from low level-of-evidence studies, leaving many questions incompletely answered. The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix. A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of body mass index, smoking, diabetes, mastectomy type, radiation therapy, and chemotherapy on outcomes was analyzed. Acellular dermal matrix biointegration was analyzed clinically and histologically. Patient satisfaction was assessed by means of preoperative and postoperative surveys. Logistic regression models were used to identify predictors of complications. This article reports on the study design, surgical technique, patient characteristics, and preoperative survey results, with outcomes data in a separate report. After 2.5 years, we successfully enrolled and randomized 128 patients (199 breasts). The majority of patients were healthy nonsmokers, with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy. Half of the mastectomies were prophylactic, with nipple-sparing mastectomy common in both cancer and prophylactic cases. Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education. Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction. Therapeutic, II.

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

Polypropylene-based composite mesh versus standard polypropylene mesh in the reconstruction of complicated large abdominal wall hernias: a prospective randomized study.

PubMed

Kassem, M I; El-Haddad, H M

2016-10-01

To compare polypropylene mesh positioned onlay supported by omentum and/or peritoneum versus inlay implantation of polypropylene-based composite mesh in patients with complicated wide-defect ventral hernias. This was a prospective randomized study carried out on 60 patients presenting with complicated large ventral hernia in the period from January 2012 to January 2016 in the department of Gastrointestinal Surgery unit and Surgical Emergency of the Main Alexandria University Hospital, Egypt. Large hernia had an abdominal wall defect that could not be closed. Patients were divided into two groups of 30 patients according to the type of mesh used to deal with the large abdominal wall defect. The study included 38 women (63.3 %) and 22 men (37.7 %); their mean age was 46.5 years (range, 25-70). Complicated incisional hernia was the commonest presentation (56.7 %).The operative and mesh fixation times were longer in the polypropylene group. Seven wound infections and two recurrences were encountered in the propylene group. Mean follow-up was 28.7 months (2-48 months). Composite mesh provided, in one session, satisfactory results in patients with complicated large ventral hernia. The procedure is safe and effective in lowering operative time with a trend of low wound complication and recurrence rates.

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

ERIC Educational Resources Information Center

Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

2017-01-01

Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

An evaluation of biodegradable synthetic polyurethane foam in patients following septoplasty: a prospective randomized trial.

PubMed

Yilmaz, Mahmut Sinan; Guven, Mehmet; Elicora, Sultan Sevik; Kaymaz, Recep

2013-01-01

The purpose of this study is to examine the usability of biodegradable synthetic polyurethane foam (BSPF) after septoplasty by comparing it with Merocel and silicone intranasal splints as packing materials in terms of patient comfort and efficiency. A prospective, unmasked, randomized trial. A tertiary referral center. This study was designed to be a prospective, randomized clinical trial. Sixty-eight patients who underwent septoplasty were included in this study. The patients were randomized to receive Merocel, silicone intranasal septal splint (INS), or BSPF after septoplasty. Clinical efficacy on bleeding, pain, and subjective symptoms related to packing materials was evaluated. There was a statistically significant difference between the Merocel group and the other 2 groups in terms of bleeding and adhesion. The average score on the pain scale was 2.47 ± 1.01 for BSPF, 3.68 ± 1.27 for INS, and 6 ± 2.21 for Merocel. Scores on general satisfaction scales were 6.95 ± 1.42 for Merocel, 8.44 ± 2.12 for INS, and 8.28 ± 1.88 for BSPF. The efficacy of BSPF was comparable with that of Merocel and INS. Biodegradable synthetic polyurethane foam significantly reduced pain and patient discomfort during packing and removal, followed by INS, compared with Merocel.

Is The Convergence Insufficiency Symptom Survey Specific for Convergence Insufficiency? A Prospective, Randomized Study.

PubMed

Horan, Lindsay A; Ticho, Benjamin H; Khammar, Alexander J; Allen, Megan S; Shah, Birva A

2015-01-01

The Convergence Insufficiency Symptom Survey (CISS) is a questionnaire used as an outcome measure in treatment of convergence insufficiency. The current prospective randomized trial evaluates the diagnostic specificity of the CISS. Surveys were completed by 118 adolescent patients who presented for routine eye examinations. Scores were compared between patients who could be classified as having convergence insufficiency (CI) or normal binocular vision (NBV). In addition, a comparison was done between self-and practitioner-administered CISS scores within these groups. The mean CISS score did not differ significantly between NBV patients (14.1±11.3, range of 0 to 43) and CI patients (12.3±6.7, range of 3 to 28); P=0.32. Mean CISS scores were lower when physician-administered (11.4±7.9) than when self-administered (16.3±11.4); P=0.007. CISS scores tend to be higher when self-vs. practitioner-administered. This study suggests that the CISS questionnaire is not specific for convergence insufficiency. © 2015 Board of regents of the University of Wisconsin System, American Orthoptic Journal, Volume 65, 2015, ISSN 0065-955X, E-ISSN 1553-4448.

Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial.

PubMed

Palacio, Evandro Pereira; Schiavetti, Rafael Ramos; Kanematsu, Maiara; Ikeda, Tiago Moreno; Mizobuchi, Roberto Ryuiti; Galbiatti, José Antônio

2016-01-01

To evaluate the effects of platelet-rich plasma (PRP) infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaires. Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62). There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires.

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

PubMed Central

2012-01-01

This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.

PubMed

Albert, A; Altabre, C; Baró, F; Buendía, E; Cabero, A; Cancelo, M J; Castelo-Branco, C; Chantre, P; Duran, M; Haya, J; Imbert, P; Julía, D; Lanchares, J L; Llaneza, P; Manubens, M; Miñano, A; Quereda, F; Ribes, C; Vázquez, F

2002-03-01

A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.

Experimental Effects of Acute Exercise on Prospective Memory and False Memory.

PubMed

Green, David; Loprinzi, Paul D

2018-01-01

Research demonstrates that acute exercise can enhance retrospective episodic memory performance. However, limited research has examined the effects of acute exercise on prospective memory, and no studies have examined the effects of exercise on false memory performance. This study examined the potential effects of acute exercise on prospective memory and false memory performance. A between-group randomized controlled trial was employed, with participants (college students; M age  = 20 years) randomized into an exercise group (15-minute acute bout of treadmill walking; N = 25) or a control group (15 minutes of sitting; N = 26). Prospective memory was assessed from two laboratory and two naturalistic assessments outside the lab. False memory was assessed using a word-list trial. There were no statistically significant differences in prospective memory based on group allocation (F Group×Time  = 1.17; P = 0.32; η 2  = 0.06). However, the control group recalled more false words and had a higher rate of false memory recognition (F Group×Time  = 3.15; P = 0.01; η 2  = 0.26). These findings indicate that acute moderate-intensity aerobic exercise is not associated with prospective memory performance but provides some suggestive evidence that acute exercise may reduce the rate of false memories.

China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China

PubMed Central

Gao, Peng; Zhao, Zhenwei; Wang, Daming; Wu, Jian; Cai, Yiling; Li, Tianxiao; Wu, Wei; Shi, Huaizhang; He, Weiwen; Zhu, Fengshui; Ling, Feng

2015-01-01

Background Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. Methods The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%–99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. Conclusion In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers. PMID:25934656

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

PubMed

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

PubMed Central

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction. PMID:11806769

A random urine test can identify patients at risk of mesalamine non-adherence: a prospective study.

PubMed

Gifford, Anne E; Berg, Anders H; Lahiff, Conor; Cheifetz, Adam S; Horowitz, Gary; Moss, Alan C

2013-02-01

Mesalamine non-adherence is common among patients with ulcerative colitis (UC), and can be difficult to identify in practice. We sought to determine whether a random urine test for salicylates could be used as a marker of 5-aminosalicylic acid (5-ASA) ingestion and identify patients at risk of non-adherence. Our aim is to determine whether measurement of salicylates in a random urine sample correlates with 5-ASA levels, and predicts an individual's risk of mesalamine non-adherence. Prospective observational study. Urinary salicylates (by colorimetry) and 5-ASA (by liquid chromatography and tandem-mass spectrometry) were measured in a random urine sample at baseline in patients and controls. Mesalamine adherence was quantified by patient self-reports at enrollment and pharmacy refills of mesalamine over 6 months. A total of 93 patients with UC taking mesalamine maintenance therapy were prospectively enrolled from the clinic. Random urine salicylate levels (by colorimetry) were highly correlated with urine 5-ASA metabolite levels (by mass spectrometry; R2=0.9). A random urine salicylate level above 15 mg/dl distinguished patients who had recently taken mesalamine from controls (area under the curve value 0.9, sensitivity 95%, specificity 77%). A significant proportion of patients (27%) who self-identified as "high adherers" by an adherence questionnaire (Morisky Medication Adherence Scale-8) had random levels of urine salicylate below this threshold. These patients were at higher risk of objectively measured non-adherence to mesalamine over the subsequent 6 months (RR: 2.7, 95% CI: 1.1-7.0). A random urine salicylate level measured in the clinic can identify patients who have not recently taken mesalamine, and who are at higher risk of longitudinal non-adherence. This test could be used to screen patients who may warrant interventions to improve adherence and prevent disease relapse.

Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial.

PubMed

Aigner, F; Kronberger, I; Oberwalder, M; Loizides, A; Ulmer, H; Gruber, L; Pratschke, J; Peer, S; Gruber, H

2016-07-01

Novel minimally invasive techniques aimed to reposition the haemorrhoidal zone have been established for prolapsing haemorrhoids. We present a prospective randomized controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries (DG-HAL) in patients with symptomatic Grade III haemorrhoids. The trial was registered as ClinicalTrials.gov identifier NCT02372981. All consecutive patients with symptomatic Grade III haemorrhoids were randomly allocated to one of the two study arms: (i) Group A, DG-HAL with mucopexy or (ii) Group B, mucopexy alone. End-points were postoperative pain, faecal incontinence, bleeding, residual prolapse and alterations of the vascularization of the anorectal vascular plexus. Vascularization of the anorectal vascular plexus was assessed by transperineal contrast enhanced ultrasound. Patients recorded their symptoms in a diary maintained for a month. Forty patients were recruited and randomized to the two study groups. Patients in Group A had less pain in the first two postoperative weeks. At the 12-month follow-up, two patients in Group A (10%) and one in Group B (5%) showed recurrent Grade III haemorrhoids (P = 0.274). No significant morphological changes were observed in the transperineal ultrasound findings between the preoperative assessment and the assessment at 1 and 6 months in either group (P > 0.05). Mucopexy techniques for treating prolapsing haemorrhoids are effective, but DG-HAL does not add significantly to the results achieved by mucopexy. Repositioning the haemorrhoidal zone is the key to success, and mucopexy should be placed at the sites of the largest visible prolapse. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

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.

Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

PubMed

Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

2017-10-01

This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p < 0.001) and higher IgA (p < 0.001) levels immediately after aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p < 0.001) weeks gestational age (GA) were significantly higher than the pretest IgA at 16 weeks GA (baseline). This study presented evidence that aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

Long-term outcomes and recurrence patterns of standard versus extended pancreatectomy for pancreatic head cancer: a multicenter prospective randomized controlled study.

PubMed

Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe

2017-07-01

Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses.

PubMed

Khankari, Nikhil K; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I; Easton, Douglas; Eeles, Rosalind A; Gruber, Stephen B; Haiman, Christopher A; Hunter, David J; Chanock, Stephen J; Pierce, Brandon L; Zheng, Wei

2016-09-01

Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers.

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.

Postoperative long-term evaluation of interposition reconstruction compared with Roux-en-Y after total gastrectomy in gastric cancer: prospective randomized controlled trial.

PubMed

Ishigami, Sumiya; Natsugoe, Shoji; Hokita, Shuichi; Aoki, Teruaki; Kashiwagi, Hideyuki; Hirakawa, Kosei; Sawada, Tetsuji; Yamamura, Yoshitaka; Itoh, Seiji; Hirata, Koichi; Ohta, Keiichiro; Mafune, Kenichi; Nakane, Yasushi; Kanda, Tatsuo; Furukawa, Hiroshi; Sasaki, Iwao; Kubota, Tetsuro; Kitajima, Masaki; Aikou, Takashi

2011-09-01

The postoperative clinical superiority of the interposition of jejunum reconstruction (INT) to Roux-en-Y reconstruction (RY) after total gastrectomy has not been clarified. Postoperative quality of life (QOL) was evaluated between the 2 methods by a multi-institutional prospective randomized trial. A total of 103 patients with gastric cancer were prospectively randomly divided into groups for RY (n = 51) or INT reconstruction (n = 52) after total gastrectomy. They were stratified by sex, age, institute, histology, and degree of lymph node dissection. Postoperatively, body mass index (BMI) and nutritional conditions were measured serially, and QOL and postoperative squalor scores were evaluated at 3, 12, and 60 months and compared between the 2 groups. After removing patients who did not complete the follow-up survey or censured cases, 24 patients in the RY group and 18 patients in the INT group were clinically available and their postoperative status was assessed. QOL scores were increased and complication scores were improved in the postoperative periods (P < .01). Postoperative BMI significantly deteriorated compared with preoperative BMI in each group. The postoperative QOL and complication scores at 60 months after surgery were significantly better than those at 3 months after surgery in each group (P < .01). However, there was no significant difference of QOL scores and postoperative complication scores between the 2 reconstruction groups. The nutritional condition in the INT group was nearly the same as that in the RY group. Although our patient sample was small and patients who did not complete the follow-up survey were present, we could not identify any clinical difference between INT and RY after total gastrectomy 60 months after surgery. The safer and simpler RY method may be a more suitable reconstruction method than INT after total gastrectomy. Copyright © 2011. Published by Elsevier Inc.

Association between prospective registration and overall reporting and methodological quality of systematic reviews: a meta-epidemiological study.

PubMed

Ge, Long; Tian, Jin-Hui; Li, Ya-Nan; Pan, Jia-Xue; Li, Ge; Wei, Dang; Xing, Xin; Pan, Bei; Chen, Yao-Long; Song, Fu-Jian; Yang, Ke-Hu

2018-01-01

The aim of this study was to investigate the differences in main characteristics, reporting and methodological quality between prospectively registered and nonregistered systematic reviews. PubMed was searched to identify systematic reviews of randomized controlled trials published in 2015 in English. After title and abstract screening, potentially relevant reviews were divided into three groups: registered non-Cochrane reviews, Cochrane reviews, and nonregistered reviews. For each group, random number tables were generated in Microsoft Excel, and the first 50 eligible studies from each group were randomly selected. Data of interest from systematic reviews were extracted. Regression analyses were conducted to explore the association between total Revised Assessment of Multiple Systematic Review (R-AMSTAR) or Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) scores and the selected characteristics of systematic reviews. The conducting and reporting of literature search in registered reviews were superior to nonregistered reviews. Differences in 9 of the 11 R-AMSTAR items were statistically significant between registered and nonregistered reviews. The total R-AMSTAR score of registered reviews was higher than nonregistered reviews [mean difference (MD) = 4.82, 95% confidence interval (CI): 3.70, 5.94]. Sensitivity analysis by excluding the registration-related item presented similar result (MD = 4.34, 95% CI: 3.28, 5.40). Total PRISMA scores of registered reviews were significantly higher than nonregistered reviews (all reviews: MD = 1.47, 95% CI: 0.64-2.30; non-Cochrane reviews: MD = 1.49, 95% CI: 0.56-2.42). However, the difference in the total PRISMA score was no longer statistically significant after excluding the item related to registration (item 5). Regression analyses showed similar results. Prospective registration may at least indirectly improve the overall methodological quality of systematic reviews, although its impact on the overall reporting quality was not significant. Copyright © 2017 Elsevier Inc. All rights reserved.

Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

PubMed

Lee, Joo Myung; Cho, Deok-Kyu; Hahn, Joo-Yong; Song, Young Bin; Park, Taek Kyu; Oh, Ju-Hyeon; Lee, Jin Bae; Doh, Joon-Hyung; Kim, Sang-Hyun; Yang, Jeong Hoon; Choi, Jin-Ho; Choi, Seung-Hyuck; Lee, Sang Hoon; Gwon, Hyeon-Cheol

2016-12-01

Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

Applications of Data Mining Methods in the Integrative Medical Studies of Coronary Heart Disease: Progress and Prospect

PubMed Central

Wang, Yixin; Guo, Fang

2014-01-01

A large amount of studies show that real-world study has strong external validity than the traditional randomized controlled trials and can evaluate the effect of interventions in a real clinical setting, which open up a new path for researches of integrative medicine in coronary heart disease. However, clinical data of integrative medicine in coronary heart disease are large in amount and complex in data types, making exploring the appropriate methodology a hot topic. Data mining techniques are to analyze and dig out useful information and knowledge from the mass data to guide people's practices. The present review provides insights for the main features of data mining and their applications of integrative medical studies in coronary heart disease, aiming to analyze the progress and prospect in this field. PMID:25544853

Robot-assisted remote echocardiographic examination and teleconsultation: a randomized comparison of time to diagnosis with standard of care referral approach.

PubMed

Boman, Kurt; Olofsson, Mona; Berggren, Peter; Sengupta, Partho P; Narula, Jagat

2014-08-01

The strategy using cardiological consultation in addition to the robot-assisted remote echocardiography at a distance was tested in a prospective, randomized open-label trial to evaluate its feasibility and to define its clinical value in a rural area. The present study involved 1 primary healthcare center in the north of Sweden, 135 miles from the hospital where the echocardiograms and the cardiology teleconsultation were performed long distance in real time. Nineteen patients were randomized to remote consultation and imaging, and 19 to the standard of care consultation. The total process time was significantly reduced in the former arm (median 114 days vs. 26.5 days; p < 0.001). The time from randomization until attaining a specialist consultation was also significantly reduced (p < 0.001). The patients' satisfaction was reassuring; they considered that the remote consultation strategy offered an increased rapidity of diagnosis and the likelihood of receiving faster management compared with the standard of care at the primary healthcare center. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Prospective randomized study of chevron osteotomy versus Mitchell's osteotomy in hallux valgus.

PubMed

Buciuto, Robert

2014-12-01

We conducted a prospective randomized trial to compare the most popular osteotomy types of operative treatment of hallux valgus (HV) used in Norway, Mitchell's osteotomy (MO) and chevron osteotomy (CO). One hundred twenty adult female patients were prospectively randomized to treatment with either MO or CO. All operative procedures were performed with ankle block and with tourniquet applied. None of the patients received any antibiotic or antithrombotic prophylaxis. The follow-up period was 3 years. Clinical results were rated according to the American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System (CRS). HV in the MO group was reduced from 30 (range, 20 to 44) to 15 (range, 8 to 24) degrees and IM angle from 11 (range, 6 to 14) to 7 (range, 4 to 11) degrees. HV in the CO group was reduced from 31 (range, 22 to 42) to 16 (range, 6 to 24) degrees and IM angle from 14 (range, 8 to 20) to 6 (range, 2 to 10) degrees. Transfer metatarsalgia occurred in 36 (60%) patients and hammertoe in 6 (10%) patients in the MO group. In the CO group, metatarsalgia occurred in 5 patients. The median loss of postoperative HV correction was 4 (range, 2 to 10) degrees in mild deformity and 6 (6 to 10) degrees in moderate deformity. Patients treated with CO had significantly better results for AOFAS CRS, number of postoperative complications, patient satisfaction, and length of sick leave for the employed patients. Based on our results, we consider that in female patients CO should be regarded as the first-line procedure for treatment of mild and moderate HV. Level I, prospective randomized study. © The Author(s) 2014.

Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

PubMed

Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

1992-03-01

To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

Social adjustment and competence 35 years after onset of childhood epilepsy: a prospective controlled study.

PubMed

Jalava, M; Sillanpää, M; Camfield, C; Camfield, P

1997-06-01

To study the effect of childhood-onset epilepsy without other neurologic deficit on adult social adjustment and competence. Social competence was studied in a prospective, population-based cohort of childhood-onset epilepsy after a mean follow-up of 35 years. One hundred patients (60% of the total cohort) had no other neurologic problems ("epilepsy only"), and for each patient, two matched controls, a "random" control and an "employee" control were chosen. Good social outcome was significantly reduced in the "epilepsy only" cohort compared with random controls: education [cumulative odds ratio (COR), 2.4; 95% confidence interval (CI), 1.4-4.1]; employability (COR, 7.3; 95% CI, 2.7-20.0); and marriage rate (COR, 3.7; 95% CI, 1.9-7.3). The patients with epilepsy rated their own ability to control their lives as "poor or missing" four times more frequently than the employee controls. Patients receiving antiepileptic polytherapy, but not monotherapy, were significantly less satisfied with their present life (OR, 6.7; 95% CI, 1.9-24.1) and felt their general health was significantly poorer (OR, 5.1; 95% CI, 1.2-21.3) than did the employee controls. Furthermore, patients with continuing seizures were significantly less satisfied with their present life (OR, 4.1; 95% CI, 1.1-15.1) than were employee controls. Many patients with "epilepsy only" beginning in childhood have persistent and significant social-adjustment and competence problems in adulthood.

A randomized prospective study of oral levofloxacin vs intravenous flomoxef prophylaxis in postoperative infection after endoscopic sinus surgery.

PubMed

Inoshita, Ayako; Yokoi, Hidenori; Matsumoto, Fumihiko; Yao, Toru; Kawano, Kenji; Furukawa, Masayuki; Ikeda, Katsuhisa

2010-01-01

The clinical efficacy and cost effectiveness of oral antimicrobial prophylaxis with levofloxacin (LVFX) on endoscopic sinus surgery (ESS) was evaluated. Ninety-three patients undergoing ESS were prospectively enrolled in the present study. The patients were randomly divided into 2 groups, LVFX and flomoxef (FMOX). Two hundred milligrams of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days. There were no statistically significant differences between 2 groups in terms of age, sex, systemic complications, surgical procedures, the duration of the operation, the length of hospitalization, the amount of blood loss, body temperature, or the number of white blood cells or C-reactive protein. Although no statistical significance was observed in the bacterial resistance between the two antibiotics, LVFX seems to show a low rate of resistance pattern change as compared to FMOX. The present study demonstrated that no patients treated with LVFX or FMOX were afflicted with postsurgical infection. Oral administration of LVFX is a simple, cost-effective and safe alternative to intravenous prophylaxis in ESS based on clinical efficacy and bacteriological study. Copyright 2010 Elsevier Inc. All rights reserved.

Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

PubMed

Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

2012-06-01

The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P < .001). However, total hospital charges did not differ. There are no differences in outcomes between topical SSD or CO in the management of childhood burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study.

PubMed

Fekaj, Enver; Gjata, Arben; Maxhuni, Mehmet

2013-09-22

In patients with obstructive jaundice, multi-organ dysfunction may develop. This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention. This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

DTIC Science & Technology

2014-10-01

SCI. In this prospective randomized controlled trial, we will objectively measure sleep disordered breathing ( SDB ) in chronic SCI patients using...portable sleep studies, and systematically evaluate the association between SDB , cognitive performance, mood, pain, and CV measures. We will randomize...randomized shortly. 15. SUBJECT TERMS SDB , SCI, PAP, CV 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a

A multi-center randomized trial of two different intravenous fluids during labor

PubMed Central

DAPUZZO-ARGIRIOU, Lisa M.; SMULIAN, John C.; ROCHON, Meredith L.; GALDI, Luisa; KISSLING, Jessika M.; SCHNATZ, Peter F.; RIOS, Angel GONZALEZ; AIROLDI, James; CARRILLO, Mary Anne; MAINES, Jaimie; KUNSELMAN, Allen R.; REPKE, John; LEGRO, Richard S.

2017-01-01

Objective To determine if the intrapartum use of a 5% glucose-containing intravenous solution decreases the chance of a cesarean delivery for women presenting in active labor. Methods This was a multi-center, prospective, single (patient) blind, randomized study design implemented at 4 obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6cm were randomized to lactated Ringer's with or without 5% glucose (LR versus D5LR) as their maintenance intravenous fluid. The primary outcome was the cesarean birth rate. Secondary outcomes included labor characteristics, as well as maternal or neonatal complications. Results There were 309 women analyzed. Demographic variables and admitting cervical dilation were similar among study groups. There was no significant difference in the cesarean delivery rate for the D5LR group (23/153 or 15.0%) versus the LR arm (18/156 or 11.5%), [RR (95%CI) of 1.32 (0.75, 2.35), P=0.34]. There were no differences in augmentation rates or intrapartum complications. Conclusions The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor. PMID:25758624

Remission in Depressed Geriatric Primary Care Patients: A Report From the PROSPECT Study

PubMed Central

Alexopoulos, George S.; Katz, Ira R.; Bruce, Martha L.; Heo, Moonseong; Have, Thomas Ten; Raue, Patrick; Bogner, Hillary R.; Schulberg, Herbert C.; Mulsant, Benoit H.; Reynolds, Charles F.

2009-01-01

Objective This study compared time to first remission for elderly depressed patients in primary care for practices that implemented a care management model versus those providing usual care. In addition, it sought to identify risk factors for nonremission that could guide treatment planning and referral to care managers or specialists. Method Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) data were analyzed. Participants were older patients (≥60 years) selected following screening of 9,072 randomly identified primary care patients. The present analysis examined patients with major depression and a 24-item Hamilton Depression Rating Scale score of 18 or greater who were followed for at least 4 months (N=215). Primary care practices were randomly assigned to offer the PROSPECT intervention or usual care. The intervention consisted of services of trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 18 months. Results First remission occurred earlier and was more common among patients receiving the intervention than among those receiving usual care. For all patients, limitations in physical and emotional functions predicted poor remission rate. Patients experiencing hopelessness were more likely to achieve remission if treated in intervention practices. Similarly, the intervention was more effective in patients with low baseline anxiety. Conclusions Longitudinal assessment of depression, hopelessness, anxiety, and physical and emotional functional limitations in depressed older primary care patients is critical. Patients with prominent symptoms or impairment in these areas may be candidates for care management or mental health care, since they are at risk for remaining depressed and disabled. PMID:15800144

Intrathecal Drug Delivery and Spinal Cord Stimulation for the Treatment of Cancer Pain.

PubMed

Xing, Fangfang; Yong, R Jason; Kaye, Alan David; Urman, Richard D

2018-02-05

The purpose of the present investigation is to summarize the body and quality of evidence including the most recent studies in support of intrathecal drug delivery systems and spinal cord stimulation for the treatment of cancer-related pain. In the past 3 years, a number of prospective studies have been published supporting intrathecal drug delivery systems for cancer pain. Additional investigation with adjuvants to morphine-based analgesia including dexmedetomidine and ziconotide support drug-induced benefits of patient-controlled intrathecal analgesia. A study has also been recently published regarding cost-savings for intrathecal drug delivery system compared to pharmacologic management, but an analysis in the Ontario, Canada healthcare system projects additional financial costs. Finally, the Polyanalgesic Consensus Committee has updated its recommendations regarding clinical guidelines for intrathecal drug delivery systems to include new information on dosing, trialing, safety, and systemic opioid reduction. There is still a paucity of clinical evidence for spinal cord stimulation in the treatment of cancer pain. There are new intrathecal drugs under investigation including various conopeptides and AYX1. Large, prospective, modern, randomized controlled studies are still needed to support the use of both intrathecal drug delivery systems as well as spinal cord stimulation for cancer pain populations. There are multiple prospective and small randomized controlled studies that highlight a potential promising future for these interventional modalities. Related to the challenge and urgency of cancer pain, the pain practitioner community is moving toward a multimodal approach that includes discussions regarding the role of intrathecal therapies and spinal cord stimulation to the individualized treatment of patients.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Postoperative therapy with infliximab for Crohn's disease: a 2-year prospective randomized multicenter study in Japan.

PubMed

Fukushima, Kouhei; Sugita, Akira; Futami, Kitaro; Takahashi, Ken-Ichi; Motoya, Satoshi; Kimura, Hideaki; Yoshikawa, Shusaku; Kinouchi, Yoshitaka; Iijima, Hideki; Endo, Katsuya; Hibi, Toshihumi; Watanabe, Mamoru; Sasaki, Iwao; Suzuki, Yasuo

2018-06-01

The prevention of postoperative recurrence is a critical issue in surgery for Crohn's disease. Prospective randomized trials in Western countries have shown that the postoperative use of anti-tumor necrosis factor α-antibodies was effective in reducing the recurrence rate. We investigated the efficacy of infliximab (IFX) for the prevention of postoperative Crohn's disease recurrence. We performed a prospective randomized multicenter study. Patients who underwent intestinal resection were assigned to groups treated with or without IFX. Immediately after surgery, patients in the IFX group received IFX at 5 mg/kg at 0, 2, and 6 weeks, followed by every 8 weeks for 2 years. The primary study outcome was the proportion of patients with endoscopic and/or clinical recurrence at 2 years after surgery. Thirty-eight eligible patients participated in this study: 19 in the IFX group and 19 in the non-IFX group. The disease recurrence rate in the IFX group was 52.6% (10/19), which was significantly lower than that in the non-IFX group (94.7% [18/19]). The postoperative use of IFX is effective in preventing Crohn's disease recurrence for 2 years.

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

PubMed

Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

2014-05-01

To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

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.

Randomized controlled trial of benzocaine versus placebo spray for pain relief at hysterosalpingogram.

PubMed

Bachman, E A; Senapati, S; Sammel, M D; Kalra, S K

2014-06-01

Many women experience pain during hysterosalpingogram (HSG). This prospective, randomized, double-blinded, placebo-controlled study assessed whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, parity, pre-procedure oral analgesic use and history of dysmenorrhoea and/or chronic pelvic pain. Median change in pain score from baseline to procedure was 50.6mm (-7.4 to 98.8mm) in the benzocaine group and 70.4mm (19.8 to 100mm) in the placebo group. There was no difference between groups after adjusting for history of dysmenorrhoea. There was no difference in resolution of pain in benzocaine versus placebo groups at 5 min post procedure--median pain score difference -11.1 (-90.1 to 18.5) versus -37.0 (-100 to 1.2)--or at 30 min post procedure. Satisfaction scores did not differ by treatment and did not correlate with pain score during the procedure (rho=0.005). The use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. Many women experience pain during hysterosalpingogram (HSG), which is a test used to evaluate the uterine cavity and fallopian tube. We conducted a prospective, randomized, double-blinded, placebo-controlled study to assess whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, previous pregnancies, pre-procedure oral analgesic use and history of dysmenorrhoea (painful periods) and/or chronic pelvic pain. There was no difference in pain scores or resolution of pain between the two groups. Satisfaction scores did not differ by treatment group and did not correlate with the pain score during the procedure. We conclude that the use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

PubMed

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

Circular vs. three-quadrant hemorrhoidectomy for end-stage hemorrhoids: short- and long-term outcomes of a prospective randomized trial.

PubMed

Qarabaki, Maia A; Mukhashavria, Gela A; Mukhashavria, Gia G; Giorgadze, Nodari G

2014-04-01

Circumferential excisional hemorrhoidectomy (CEH) enables the surgeon to remove the encircling hemorrhoids completely. The purpose of this study is to compare the efficacy of CEH with that of Ferguson hemorrhoidectomy (FH) for end-stage hemorrhoids. Between February 1998 and December 2011, a prospective randomized trial was conducted with 688 patients who presented with end-stage hemorrhoids and underwent FH or CEH at our center. The patient demographics, mean operative times, lengths of hospital stay, and cumulative rates of postoperative complications were similar in the study groups. Significant differences were revealed in the incidence of postoperative hemorrhage (9 vs. 0 patients in the FH and CEH groups, respectively; p = 0.002) and in the tendency to form anal stricture (15 vs. 32 patients in the FH and CEH groups, respectively; p = 0.02). However, all cases of anal strictures were easily managed by digital dilatations. At a mean follow-up of 7.4 (range, 1-14) years, accessible patients from the CEH group remained symptom free, whereas 126 of 308 patients in the FH group indicated that they had recurrent hemorrhoidal symptoms. Without increasing postoperative complications, CEH demonstrates an advantage compared with FH, with regard to reducing the rate of recurrence to 0 through complete hemorrhoid removal.

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.

Mechanical Thrombectomy-Ready Comprehensive Stroke Center Requirements and Endovascular Stroke Systems of Care: Recommendations from the Endovascular Stroke Standards Committee of the Society of Vascular and Interventional Neurology (SVIN)

PubMed Central

English, Joey D.; Yavagal, Dileep R.; Gupta, Rishi; Janardhan, Vallabh; Zaidat, Osama O.; Xavier, Andrew R.; Nogueira, Raul G.; Kirmani, Jawad F.; Jovin, Tudor G.

2016-01-01

Five landmark multicenter, prospective, randomized, open-label, blinded end point clinical trials have recently demonstrated significant clinical benefit of endovascular therapy with mechanical thrombectomy in acute ischemic stroke (AIS) patients presenting with proximal intracranial large vessel occlusions. The Society of Vascular and Interventional Neurology (SVIN) appointed an expert writing committee to summarize this new evidence and make recommendations on how these data should guide emergency endovascular therapy for AIS patients. PMID:27051410

Fruit and Vegetable Consumption and Changes in Anthropometric Variables in Adult Populations: A Systematic Review and Meta-Analysis of Prospective Cohort Studies

PubMed Central

Schwingshackl, Lukas; Hoffmann, Georg; Kalle-Uhlmann, Tamara; Arregui, Maria; Buijsse, Brian; Boeing, Heiner

2015-01-01

Background Randomized controlled trials provide conflicting results on the effects of increased fruit and vegetable consumption on changes in body weight. We aimed to perform a systematic review and meta-analysis of prospective cohort studies on fruit and vegetable consumption in relation to changes in anthropometric measures. Methods PubMed and EMBASE were searched up to July 2015 for prospective studies reporting on habitual fruit and/or vegetable consumption in relation to changes in body weight or waist circumference or to risk of weight gain/overweight/obesity in adults. Random-effects meta-analysis was applied to pool results across studies. Findings Seventeen cohort studies (from 20 reports) including 563,277 participants met our inclusion criteria. Higher intake of fruits was inversely associated with weight change (decrease) (beta-coefficient per 100-g increment, -13.68 g/year; 95% CI, -22.97 to -4.40). No significant changes could be observed for combined fruit and vegetable consumption or vegetable consumption. Increased intake of fruits was inversely associated with changes (decrease) in waist circumference (beta: -0.04 cm/year; 95% CI, -0.05 to -0.02). Comparing the highest combined fruit & vegetable, fruit, and vegetable intake categories were associated with a 9%, 17%, and 17% reduced risk of adiposity (odds ratio [OR]: 0.91, 95% CI, 0.84 to 0.99), (OR: 0.83, 95% CI, 0.71 to 0.99), and (OR: 0.83, 95% CI, 0.70 to 0.99), respectively. Conclusion This meta-analysis showed several inverse associations between fruit and vegetable intake and prospective improvements in anthropometric parameters, and risk of adiposity. The present meta-analysis seems to be limited by low study quality. Nevertheless, when combined with evolutionary nutrition and epidemiological modeling studies, these findings have public health relevance and support all initiatives to increase fruit and vegetable intake. PMID:26474158

The Relationship between Emotional Intelligence and Problem Solving Skills in Prospective Teachers

ERIC Educational Resources Information Center

Deniz, Sabahattin

2013-01-01

This study aims to investigate the relationship between emotional intelligence and problem solving. The sample set of the research was taken from the Faculty of Education of Mugla University by the random sampling method. The participants were 386 students--prospective teachers--(224 females; 182 males) who took part in the study voluntarily.…

Investigating Teacher Candidates' Beliefs about Standardized Testing

ERIC Educational Resources Information Center

Kinay, Ismail; Ardiç, Tuncay

2017-01-01

The purpose of this study is to examine the beliefs of prospective teachers' about standardized testing in terms of some variables. This piece of research is in survey model. The study is carried out with 442 randomly selected prospective teachers registered in different departments at Dicle University in Turkey during the 2015-2016 academic year.…

The Tension of Elite "vs". Massified Higher Education Systems: How Prospective Students Perceive Public and Private Universities in Kenya

ERIC Educational Resources Information Center

Oketch, Moses O.

2009-01-01

This article examines how recent changes, leading to a diversified supply in Kenya's university education system, is reflected in prospective students' aspirations, perceptions and preferences to undertake university education. The results, based on a combination of a convenience and snowball sampling of settings, within which random samples of…

Epidemiological study on long-term effects of pesticides on human health*

PubMed Central

Paccagnella, B.; Ghezzo, F.; Prati, L.; Fedrazzoni, U.; Belloni, G.

1971-01-01

Two rural areas in Italy with different rates of pesticide usage were subjected to a cross-sectional investigation, based on the identification of organochlorine compounds in the environment and in human fatty tissues and on the determination of their concentration and a prospective investigation, based on the collection of data of past and present pathology and symptomatology from two stratified random groups of inhabitants of both areas. The cross-sectional investigation showed only small differences in environmental pollution and no differences in the storage of organochlorine compounds in fatty tissues in the two areas. The prospective investigation showed a higher prevalence of pathology and symptomatology in the population of the area where pesticides were used in larger quantities. Several haematochemical tests were used in an attempt to differentiate between populations at different levels of risk of toxic damage, but without success. PMID:5316616

High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study.

PubMed

Osunkwo, Ifeyinwa; Ziegler, Thomas R; Alvarez, Jessica; McCracken, Courtney; Cherry, Korin; Osunkwo, Chinyere E; Ofori-Acquah, Solomon F; Ghosh, Samit; Ogunbobode, Adeolu; Rhodes, Jim; Eckman, James R; Dampier, Carlton; Tangpricha, Vin

2012-10-01

We report results of a pilot study of high-dose vitamin D in sickle cell disease (SCD). Subjects were given a 6-week course of oral high-dose cholecalciferol (4000-100 000 IU per week) or placebo and monitored prospectively for a period of six months. Vitamin D insufficiency and deficiency was present at baseline in 82·5% and 52·5% of subjects, respectively. Subjects who received high-dose vitamin D achieved higher serum 25-hydroxyvitamin D, experienced fewer pain days per week, and had higher physical activity quality-of-life scores. These findings suggest a potential benefit of vitamin D in reducing the number of pain days in SCD. Larger prospective studies with longer duration are needed to confirm these effects. © 2012 Blackwell Publishing Ltd.

Protective environment for marrow transplant recipients. A prospective study

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

Buckner, C.D.; Clift, R.A.; Sanders, J.E.

1978-12-01

Laminar air flow isolation and decontamination procedures were evaluated in a prospective randomized study in patients with aplastic anemia or acute leukemia undergoing marrow transplantation from HLA-matched siblings. Patients transplanted in the laminar air flow group had significantly less septicemia and major local infections than did patients in the control group. Nineteen of 46 laminar air flow patients and six of 44 control patients are alive at present. In patients with aplastic anemia the survival was 13 of 17 in the laminar air flow group compared with four of 17 in the control group. In patients with acute leukemia themore » survival was six of 29 in the laminar air flow group versus two of 27 in the control group. These differences were not statistically significant. Death in both the laminar air flow and control groups was predominantly due to interstitial pneumonitis or recurrent leukemia, which were unaffected by isolation and decontamination.« less

Risk attitude in small timesaving decisions.

PubMed

Munichor, Nira; Erev, Ido; Lotem, Arnon

2006-09-01

Four experiments are presented that explore situations in which a decision maker has to rely on personal experience in an attempt to minimize delays. Experiment 1 shows that risk-attitude in these timesaving decisions is similar to risk-attitude in money-related decisions from experience: A risky prospect is more attractive than a safer prospect with the same expected value only when it leads to a better outcome most of the time. Experiment 2 highlights a boundary condition: It suggests that a difficulty in ranking the relevant delays moves behavior toward random choice. Experiments 3 and 4 show that when actions must be taken during the delay (thereby helping compare delays), this increases the similarity of timesaving decisions to money-related decisions. In these settings the results reflect an increase in risk aversion with experience. The relationship of the results to the study of non-human time-related decisions, human money-related decisions and human time perception is discussed.

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

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.

The training intensity distribution among well-trained and elite endurance athletes

PubMed Central

Stöggl, Thomas L.; Sperlich, Billy

2015-01-01

Researchers have retrospectively analyzed the training intensity distribution (TID) of nationally and internationally competitive athletes in different endurance disciplines to determine the optimal volume and intensity for maximal adaptation. The majority of studies present a “pyramidal” TID with a high proportion of high volume, low intensity training (HVLIT). Some world-class athletes appear to adopt a so-called “polarized” TID (i.e., significant % of HVLIT and high-intensity training) during certain phases of the season. However, emerging prospective randomized controlled studies have demonstrated superior responses of variables related to endurance when applying a polarized TID in well-trained and recreational individuals when compared with a TID that emphasizes HVLIT or threshold training. The aims of the present review are to: (1) summarize the main responses of retrospective and prospective studies exploring TID; (2) provide a systematic overview on TIDs during preparation, pre-competition, and competition phases in different endurance disciplines and performance levels; (3) address whether one TID has demonstrated greater efficacy than another; and (4) highlight research gaps in an effort to direct future scientific studies. PMID:26578968

The training intensity distribution among well-trained and elite endurance athletes.

PubMed

Stöggl, Thomas L; Sperlich, Billy

2015-01-01

Researchers have retrospectively analyzed the training intensity distribution (TID) of nationally and internationally competitive athletes in different endurance disciplines to determine the optimal volume and intensity for maximal adaptation. The majority of studies present a "pyramidal" TID with a high proportion of high volume, low intensity training (HVLIT). Some world-class athletes appear to adopt a so-called "polarized" TID (i.e., significant % of HVLIT and high-intensity training) during certain phases of the season. However, emerging prospective randomized controlled studies have demonstrated superior responses of variables related to endurance when applying a polarized TID in well-trained and recreational individuals when compared with a TID that emphasizes HVLIT or threshold training. The aims of the present review are to: (1) summarize the main responses of retrospective and prospective studies exploring TID; (2) provide a systematic overview on TIDs during preparation, pre-competition, and competition phases in different endurance disciplines and performance levels; (3) address whether one TID has demonstrated greater efficacy than another; and (4) highlight research gaps in an effort to direct future scientific studies.

Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

PubMed

Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

2017-11-01

Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison. Copyright © 2017 Elsevier Inc. All rights reserved.

Single daily dosing ceftriaxone and metronidazole vs standard triple antibiotic regimen for perforated appendicitis in children: a prospective randomized trial.

PubMed

St Peter, Shawn D; Tsao, Kuojen; Spilde, Troy L; Holcomb, George W; Sharp, Susan W; Murphy, J Patrick; Snyder, Charles L; Sharp, Ronald J; Andrews, Walter S; Ostlie, Daniel J

2008-06-01

Appendicitis is the most common emergency condition in children. Historically, a 3-drug regimen consisting of ampicillin, gentamicin, and clindamycin (AGC) has been used postoperatively for perforated appendicitis. A retrospective review at our institution has found single day dosing of ceftriaxone and metronidazole (CM) to be a more simple and cost-effective antibiotic strategy. Therefore, we performed a prospective, randomized trial to compare efficacy and cost-effectiveness of these 2 regimens. After internal review board approval (IRB no. 04 12-149), children found to have perforated appendicitis at appendectomy were randomized to either once daily dosing of CM (2 total doses per day) or standard dosing of AGC (11 total doses per day). Perforation was defined as an identifiable hole in the appendix. The operative approach (laparoscopic), length of antibiotic use, and criteria for discharge were standardized for the groups. Based on our retrospective analysis using length of postoperative hospitalization as a primary end point, a sample size of 100 patients was calculated for an alpha of .5 and a power of 0.82. One hundred patients underwent laparoscopic appendectomy for perforated appendicitis. On presentation, there were no differences in sex distribution, days of symptoms, temperature, or leukocyte count. There was no difference in abscess rate or wound infections between groups. The CM group resulted in significantly less antibiotic charges then the AGC group. Once daily dosing with the 2-drug regimen (CM) offers a more efficient, cost-effective antibiotic management in children with perforated appendicitis without compromising infection control when compared to a traditional 3-drug regimen.

Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

PubMed

Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

2012-12-01

Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

A prospective randomized trial comparing silver sulfadiazine cream with a water-soluble polyantimicrobial gel in partial-thickness burn wounds.

PubMed

Black, Jonathan S; Drake, David B

2015-01-01

The lipid base of silver sulfadiazine (SSD) makes removal of the product painful for the patient and difficult for the physician to accurately assess particularly in partial-thickness burn injuries. As an alternative, a water-soluble antimicrobial gel is used at the University of Virginia. We present a prospective, randomized comparison of these two therapies using pain with dressing changes and time to perform dressing changes as our primary endpoints. Adult inpatients with partial-thickness burn wounds were randomized to begin therapy with either SSD cream or the water-soluble burn wound gel (BWG), and then therapies were alternated daily. Pain assessments, time to complete dressing care, total narcotic medication administered, and the number of personnel required for dressing changes were recorded. Eight patients were enrolled resulting in 13 pairs (26 points) of data comparison between the two therapies. Four of the eight enrolled patients (50%) refused to continue receiving SSD because of pain associated with dressing changes and voluntarily withdrew from the study. The amount of time to perform dressing changes was an average of 79 nurse-minutes longer for SSD. A 6.08 greater morphine equivalent was delivered to those having BWG removed.A water-soluble polyantimicrobial gel was superior to SSD in the parameters measured as exhibited by our patient dropout rate and differential time to perform dressing care. Limiting the time to perform dressing care will reduce the cumulative pain experience, improve patient satisfaction, and reduce the resources to deliver care.

Nonsurgical treatment of peri-implantitis using an air-abrasive device or mechanical debridement and local application of chlorhexidine. Twelve-month follow-up of a prospective, randomized, controlled clinical study.

PubMed

John, Gordon; Sahm, Narja; Becker, Jürgen; Schwarz, Frank

2015-11-01

The purpose of this prospective, parallel group-designed, randomized controlled clinical study was the evaluation of the effectiveness of an air-abrasive device (AAD) for nonsurgical treatment of peri-implantitis. Twenty five patients, showing at least one implant with initial to moderate peri-implantitis, underwent an oral hygiene programme and were randomly treated using either (1) AAD (amino acid glycine powder) or (2) mechanical debridement using carbon curettes and antiseptic therapy with chlorhexidine digluconate (mechanical debridement (MDA)). Clinical parameters were measured at baseline and 12 months after treatment (e.g. bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)). At 12 months, the AAD group revealed significantly higher (p < 0.05; unpaired t test) decrease in mean BOP scores when compared with MDA-treated sites (41.2 ± 29.5 vs. 16.6 ± 33.4%). Both groups exhibited comparable PD reductions (AAD = 0.5 ± 0.9 mm vs. MDA = 0.4 ± 0.9 mm) and CAL gains (AAD = 0.6 ± 1.3 mm vs. MDA = 0.5 ± 1.1 mm) (p > 0.05; Mann-Whitney test, respectively). Within its limitations, the present study has indicated that both treatment procedures resulted in comparable but limited CAL gains at 12 months. Furthermore, it could be detected that AAD was associated with significantly higher BOP decrease than MDA. The present results have indicated that nonsurgical therapy of peri-implantitis using both AAD and MDA resulted in comparable PD reductions and CAL gains after 12 months of healing. The BOP reductions were significantly higher in the AAD in comparison to the MDA group. So, AAD may be more effective for nonsurgical therapy of peri-implantitis than MDA.

Comparison of the Efficacy and Safety of Aripiprazole Versus Bupropion Augmentation in Patients With Major Depressive Disorder Unresponsive to Selective Serotonin Reuptake Inhibitors: A Randomized, Prospective, Open-Label Study.

PubMed

Cheon, Eun-Jin; Lee, Kwang-Hun; Park, Young-Woo; Lee, Jong-Hun; Koo, Bon-Hoon; Lee, Seung-Jae; Sung, Hyung-Mo

2017-04-01

The purpose of this study was to compare the efficacy and safety of aripiprazole versus bupropion augmentation in patients with major depressive disorder (MDD) unresponsive to selective serotonin reuptake inhibitors (SSRIs). This is the first randomized, prospective, open-label, direct comparison study between aripiprazole and bupropion augmentation. Participants had at least moderately severe depressive symptoms after 4 weeks or more of SSRI treatment. A total of 103 patients were randomized to either aripiprazole (n = 56) or bupropion (n = 47) augmentation for 6 weeks. Concomitant use of psychotropic agents was prohibited. Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale, Iowa Fatigue Scale, Drug-Induced Extrapyramidal Symptoms Scale, Psychotropic-Related Sexual Dysfunction Questionnaire scores were obtained at baseline and after 1, 2, 4, and 6 weeks of treatment. Overall, both treatments significantly improved depressive symptoms without causing serious adverse events. There were no significant differences in the Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale, and Iowa Fatigue Scale scores, and response rates. However, significant differences in remission rates between the 2 groups were evident at week 6 (55.4% vs 34.0%, respectively; P = 0.031), favoring aripiprazole over bupropion. There were no significant differences in adverse sexual events, extrapyramidal symptoms, or akathisia between the 2 groups. The present study suggests that aripiprazole augmentation is at least comparable to bupropion augmentation in combination with SSRI in terms of efficacy and tolerability in patients with MDD. Both aripiprazole and bupropion could help reduce sexual dysfunction and fatigue in patients with MDD. Aripiprazole and bupropion may offer effective and safe augmentation strategies in patients with MDD who are unresponsive to SSRIs. Double-blinded trials are warranted to confirm the present findings.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

PubMed Central

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies. PMID:28584874

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

2011-07-01

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001). In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial.

PubMed

Weiniger, Carolyn F; Ginosar, Yehuda; Elchalal, Uriel; Sharon, Einav; Nokrian, Malka; Ezra, Yossef

2007-12-01

To compare the success of external cephalic version using spinal analgesia with no analgesia among nulliparas. A prospective randomized controlled trial was performed in a tertiary referral center delivery suite. Nulliparous women at term requesting external cephalic version for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia before the external cephalic version. An experienced obstetrician performed the external cephalic version. Primary outcome was successful conversion to vertex presentation. Seventy-four women were enrolled, and 70 analyzed (36 spinal, 34 no analgesia). Successful external cephalic version occurred among 24 of 36 (66.7%) women randomized to receive spinal analgesia compared with 11 of 34 (32.4%) without, P=.004 (95% confidence interval [CI] of the difference: 0.0954-0.5513). External cephalic version with spinal analgesia resulted in a lower visual analog pain score, 1.76+/-2.74 compared with 6.84+/-3.08 without, P<.001. A secondary analysis logistic regression model demonstrated that the odds of external cephalic version success was 4.0-fold higher when performed with spinal analgesia P=.02 (95% CI, odds ratio [OR] 1.2-12.9). Complete breech presentation before attempting external cephalic version increased the odds of success 8.2-fold, P=.001 (95% CI, OR 2.2-30.3). Placental position, estimated fetal weight, and maternal weight did not contribute to the success rate when spinal analgesia was used. There were no cases of placental abruption or fetal distress. Administration of spinal analgesia significantly increases the success rate of external cephalic version among nulliparous women at term, which allows possible normal vaginal delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00119184 I.

[Administration of idarucizumab in spontaneous intracerebral hemorrhage under dabigatran-therapy].

PubMed

Bereczki, Dániel; Szilágyi, Géza; Kakuk, Ilona; Szakács, Zoltán; May, Zsolt

2017-09-30

Introduction - Among antidotes in development for reversal of novel oral anticoagulants, dabigatran-specific idarucizumab was the first one to reach the market. Case presentation - We present the first Hungarian case of intracerebral hemorrhage under treatment with dabigatran, where idarucizumab was administered to suspend anticoagulation. Discussion - Our report is concordant with prior publications, confirming the efficacy of the antidote in reversing the effect of dabigatran, and thus, preventing intracerebral hematoma progression in the acute phase. Conclusion - Since there is no proven alternative to idarucizumab, conducting randomized clinical trials would be unethical. Therefore, besides case reports, positive results of prospective studies could help us revise therapeutic guidelines, and thus, improve the prognosis of dabigatran-associated intracerebral hemorrhages.

Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study

PubMed Central

Chen, Ming; Bao, Yong; Ma, Hong-Lian; Wang, Jin; Wang, Yan; Peng, Fang; Zhou, Qi-Chao; Xie, Cong-Hua

2013-01-01

This prospective randomized study is to evaluate the locoregional failure and its impact on survival by comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) in combination with concurrent chemotherapy for locally advanced non-small cell lung cancer. It appears that higher dose could be delivered in IFRT arm than that in ENI arm, and IFRT did not increase the risk of initially uninvolved or isolated nodal failures. Both a tendency of improved locoregional progression-free survival and a significant increased overall survival rate are in favor of IFRT arm in this study. PMID:23762840

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

PubMed Central

Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

2016-01-01

Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers. PMID:27598322

Prospective memory: effects of divided attention on spontaneous retrieval.

PubMed

Harrison, Tyler L; Mullet, Hillary G; Whiffen, Katie N; Ousterhout, Hunter; Einstein, Gilles O

2014-02-01

We examined the effects of divided attention on the spontaneous retrieval of a prospective memory intention. Participants performed an ongoing lexical decision task with an embedded prospective memory demand, and also performed a divided-attention task during some segments of lexical decision trials. In all experiments, monitoring was highly discouraged, and we observed no evidence that participants engaged monitoring processes. In Experiment 1, performing a moderately demanding divided-attention task (a digit detection task) did not affect prospective memory performance. In Experiment 2, performing a more challenging divided-attention task (random number generation) impaired prospective memory. Experiment 3 showed that this impairment was eliminated when the prospective memory cue was perceptually salient. Taken together, the results indicate that spontaneous retrieval is not automatic and that challenging divided-attention tasks interfere with spontaneous retrieval and not with the execution of a retrieved intention.

Nutrition Education among Low-Income Older Adults: A Randomized Intervention Trial in Congregate Nutrition Sites

ERIC Educational Resources Information Center

Mitchell, Roger E.; Ash, Sarah L.; McClelland, Jacquelyn W.

2006-01-01

Nutritional well-being among older adults is critical for maintaining health, increasing longevity, and decreasing the impact of chronic illness. However, few well-controlled studies have examined nutritional behavior change among low-income older adults. A prospective, controlled, randomized design examined a five session nutrition education…

Nutrition Education Brings Behavior and Knowledge Change in Limited-Resource Older Adults

ERIC Educational Resources Information Center

McClelland, Jacquelyn W.; Jayaratne, K.S.U.; Bird, Carolyn L.

2013-01-01

A prospective, controlled, randomized, crossover design was used to examine a nutrition education curriculum's effects on knowledge and behavior of 463 limited-resource older adults in 13 counties. Counties were randomized to begin with the treatment or control curriculum and then the remaining curriculum. Participants completed a pre-test…

Improving Diabetes Care and Health Measures among Hispanics Using Community Health Workers: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Babamoto, Kenneth S.; Sey, Kwa A.; Camilleri, Angela J.; Karlan, Vicki J.; Catalasan, Joana; Morisky, Donald E.

2009-01-01

The increasing prevalence of diabetes and obesity, growing health disparities, and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers (CHWs) to provide economically sustainable and culturally relevant services. This prospective randomized design evaluated the relative…

Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

ERIC Educational Resources Information Center

Royston, Natalie Steele; Springer, D. Gregory

2015-01-01

The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

Effectiveness of skin protection measures in prevention of occupational hand eczema: results of a prospective randomized controlled trial over a follow-up period of 1 year.

PubMed

Kütting, B; Baumeister, T; Weistenhöfer, W; Pfahlberg, A; Uter, W; Drexler, H

2010-02-01

We recently found a very low adherence to a generally recommended skin protection regimen in a sample of 1355 metalworkers. The present study assessed the effectiveness of skin protection as presently recommended, especially the differential contribution of skin care and skin protection, to the prevention of occupational hand eczema. Methods Of 1355 metalworkers screened, 1020 male volunteers, all fit for work, were recruited for a prospective intervention study with four arms (skin care, skin protection, both combined, and control group, i.e. no recommendation). The study was performed from winter 2006/2007 to spring 2008, following each subject for up for 12 months. Both hands were examined using a quantitative skin score, and a standardized personal interview was performed three times. The change of the objective skin score from baseline to 12 months was used as primary outcome measure. After 12 months 800 subjects were included (78.4% of those recruited). The compliance to follow the randomized measure depended on the recommended measure and ranged from 73.7% to 88.7%. While in the control group a significant deterioration was found, the largest and significant improvement was noted in the group following the generally recommended skin protection programme (skin care + skin protection) followed by skin protection alone as second best. The generally recommended skin protection regimen seems to provide effective prevention of occupational skin disease. Therefore, the compliance to follow the skin protection regimen, especially the use of skin protection, should be enhanced.

Log-gamma linear-mixed effects models for multiple outcomes with application to a longitudinal glaucoma study

PubMed Central

Zhang, Peng; Luo, Dandan; Li, Pengfei; Sharpsten, Lucie; Medeiros, Felipe A.

2015-01-01

Glaucoma is a progressive disease due to damage in the optic nerve with associated functional losses. Although the relationship between structural and functional progression in glaucoma is well established, there is disagreement on how this association evolves over time. In addressing this issue, we propose a new class of non-Gaussian linear-mixed models to estimate the correlations among subject-specific effects in multivariate longitudinal studies with a skewed distribution of random effects, to be used in a study of glaucoma. This class provides an efficient estimation of subject-specific effects by modeling the skewed random effects through the log-gamma distribution. It also provides more reliable estimates of the correlations between the random effects. To validate the log-gamma assumption against the usual normality assumption of the random effects, we propose a lack-of-fit test using the profile likelihood function of the shape parameter. We apply this method to data from a prospective observation study, the Diagnostic Innovations in Glaucoma Study, to present a statistically significant association between structural and functional change rates that leads to a better understanding of the progression of glaucoma over time. PMID:26075565

The efficacy of surgical drainage in cervicofacial rhytidectomy: a prospective, randomized, controlled trial.

PubMed

Jones, Barry M; Grover, Rajiv; Hamilton, Stephen

2007-07-01

Postoperative drainage is often used instinctively in face lifting on the assumption that it may reduce the likelihood of complications. This potential benefit should be balanced against cost, discomfort, and the possibility of provoking bleeding and hematoma on removal. Evidence-based decisions on drainage are problematic, since no prospective studies have examined its role. This study was designed to address this issue directly. Fifty consecutive patients undergoing face lift over a 3-month period were randomized to drainage of one side of the face only, with the contralateral side serving as a paired control. Bruising, swelling, and hematoma or seroma were assessed objectively, independently of the operating surgeon and subjectively by the patients. Postoperative hematoma and edema were not influenced by the use of drains (p > 0.5). Patients reported no difference between the two sides with respect to swelling (p = 0.6) or discomfort (p = 0.5). However, drains produced a statistically significant reduction in postoperative bruising both on clinical assessment (p = 0.005) and patient assessment (p = 0.002). This article represents the first prospective, randomized, controlled trial assessing the use of postoperative drainage in facial rejuvenation surgery. Surgical drains do not influence postoperative complications, but they do significantly reduce bruising and so may facilitate the patient's return to normal activity.

A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

PubMed

Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

2014-01-01

Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

Arthroscopic Debridement Versus Platelet-Rich Plasma Injection: A Prospective, Randomized, Comparative Study of Chronic Lateral Epicondylitis With a Nearly 2-Year Follow-Up.

PubMed

Merolla, Giovanni; Dellabiancia, Fabio; Ricci, Annamaria; Mussoni, Maria Pia; Nucci, Simonetta; Zanoli, Gustavo; Paladini, Paolo; Porcellini, Giuseppe

2017-07-01

The purpose of this prospective, randomized study was to compare the efficacy of autologous platelet-rich plasma (PRP) injections and arthroscopic lateral release in treating chronic lateral epicondylitis (LE). Patients who had a clinical diagnosis of LE confirmed by ultrasound (US) were included in this study. A total of 101 patients received arthroscopic release (n = 50) or US-guided PRP injections (n = 51). Outcomes were assessed using a visual analog scale for pain, the Patient-Rated Tennis Elbow Evaluation (PRTEE), and a calibrated hand dynamometer for grip strength. Both patient groups experienced significant improvement in all measures. Between-group comparisons showed a significantly higher value in the PRP group only for grip strength at week 8 (P = .0073); all other significant differences were in favor of arthroscopy: overall pain (P = .0021), night pain (P = .0013), and PRTEE score (P = .0013) at week 104 and grip strength at weeks 24, 52, and 104 (all P < .0001). Consumption of rescue pain medication was not significantly different between the groups. The present findings suggest that (1) PRP injections and arthroscopic extensor carpi radialis brevis release are both effective in the short and medium term; (2) PRP patients experienced a significant worsening of pain at 2 years; (3) arthroscopic release ensured better long-term outcomes in terms of pain relief and grip strength recovery; and (4) both procedures were safe and well accepted by patients. LEVEL OF EVIDENCE: Level II, prospective comparative study. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer.

PubMed

Agarwal, Gaurav; Rajan, Sendhil; Mayilvaganan, Sabaretnam; Mishra, Anjali; Krishnani, Narendra; Gambhir, Sanjay

2018-05-01

The current standard-of-care for surgical staging of the axilla in clinically node-negative (N0) early breast cancers is sentinel lymph node biopsy (SLNB), which requires expensive radiopharmaceuticals for efficacious results. In-house produced low-cost radiopharmaceuticals may be the solution and have shown efficacy in earlier observational/pilot studies. We compared SLNB using in-house prepared radiopharmaceutical ( 99m Tc-Antimony-colloid) versus commercially marketed radiopharmaceutical ( 99m Tc-Sulphur-colloid) in this prospective randomized study. 78 clinically N0 early breast cancer patients (T1/2, N0 stages), undergoing primary surgery were prospectively randomized 1:1 into two groups; to receive SLNB using methylene blue, and either 99m Tc-Antimony colloid (Group-1) or   99m Tc-Sulphur colloid (Group-2). Completion axillary dissection was done in all (validation SLNB). SLNB indices were compared between the groups. The groups were comparable with regard to age, stage, tumour size, hormone receptors and HER2neu status. Cost of the in-house prepared 99m Tc-antimony colloid was 16-times lesser compared to 99m Tc-sulphur colloid. SLN identification rates (IR) in Groups 1 and 2 were 100 and 97.4% respectively, (p > 0.05). False negative rates (FNR) in Group 1 and 2 were 6.3% (1/16 patients) and 7.7% (1/13 patients), respectively, (p > 0.05). There were no major allergic reactions in either group. In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, 99m Tc-antimony colloid and commercially marketed 99m Tc-sulphur colloid as radiopharmaceutical, while 99m Tc-antimony colloid was much cheaper than 99m Tc-sulphur colloid.

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.

10-year results of a new low-monomer cement: follow-up of a randomized RSA study.

PubMed

Söderlund, Per; Dahl, Jon; Röhrl, Stephan; Nivbrant, Bo; Nilsson, Kjell G

2012-12-01

The properties and performance of a new low-monomer cement were examined in this prospective randomized, controlled RSA study. 5-year data have already been published, showing no statistically significant differences compared to controls. In the present paper we present the 10-year results. 44 patients were originally randomized to receive total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with control bone cement, Palacos R. Patients were examined using RSA, Harris hip score, and conventional radiographs. At 10 years, 33 hips could be evaluated clinically and 30 hips could be evaluated with RSA (16 Cemex and 14 Palacos). 9 patients had died and 4 patients were too old or infirm to be investigated. Except for 1 hip that was revised for infection after less than 5 years, no further hips were revised before the 10-year follow-up. There were no statistically significant clinical differences between the groups. The Cemex cement had magnitudes of migration similar to or sometimes lower than those of Palacos cement. In both groups, most hips showed extensive radiolucent lines, probably due to the use of titanium alloy stems. At 10 years, the Cemex bone cement tested performed just as well as the control (Palacos bone cement).

Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic

PubMed Central

Schmidt, Norman B.; Raines, Amanda M.; Allan, Nicholas P.; Zvolensky, Michael J.

2016-01-01

Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. PMID:26752327

Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic.

PubMed

Schmidt, Norman B; Raines, Amanda M; Allan, Nicholas P; Zvolensky, Michael J

2016-02-01

Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. Copyright © 2015 Elsevier Ltd. All rights reserved.

ALIF and total disc replacement versus 2-level circumferential fusion with TLIF: a prospective, randomized, clinical and radiological trial.

PubMed

Hoff, Eike K; Strube, Patrick; Pumberger, Matthias; Zahn, Robert K; Putzier, Michael

2016-05-01

Prospective, randomized trial. The treatment of degenerative disc disease (DDD) with two-level fusion has been associated with a reasonable rate of complications. The aim of the present study was to compare (Hybrid) stand-alone anterior lumbar interbody fusion (ALIF) at L5/S1 with total disc replacement at L4/5 (TDR) as an alternative surgical strategy to (Fusion) 2-level circumferential fusion employing transforaminal lumbar interbody fusion (TLIF) with transpedicular stabilization at L4-S1. A total of 62 patients with symptomatic DDD of segments L5/S1 (Modic ≥2°) and L4/5 (Modic ≤2°; positive discography) were enrolled; 31 were treated with Hybrid and 31 with Fusion. Preoperatively, at 0, 12, and a mean follow-up of 37 months, clinical (ODI, VAS) and radiological evaluations (plain/extension-flexion radiographs evaluated for implant failure, fusion, global and segmental lordosis, and ROM) were performed. In 26 of 31 Hybrid and 24 of 31 Fusion patients available at the final follow-up, we found a significant clinical improvement compared to preoperatively. Hybrid patients had significantly lower VAS scores immediately postoperatively and at follow-up compared to Fusion patients. The complication rates were low and similar between the groups. Lumbar lordosis increased in both groups. The increase was mainly located at L4-S1 in the Hybrid group and at L1-L4 in the Fusion group. Hybrid patients presented with increased ROM at L4/5 and L3/4, and Fusion patients presented with increased ROM at L3/4, with significantly greater ROM at L3/4 compared to Hybrid patients at follow-up. Hybrid surgery is a viable surgical alternative for the presented indication. Approach-related inferior trauma and the balanced restoration of lumbar lordosis resulted in superior clinical outcomes compared to two-level circumferential fusion with TLIF.

Factors Associated with Use of Automated Smoking Cessation Interventions: Findings from the eQuit Study

ERIC Educational Resources Information Center

Balmford, James; Borland, Ron; Benda, Peter; Howard, Steve

2013-01-01

The aim was to better understand structural factors associated with uptake of automated tailored interventions for smoking cessation. In a prospective randomized controlled trial with interventions only offered, not mandated, participants were randomized based on the following: web-based expert system (QuitCoach); text messaging program (onQ);…

Eliciting and Developing Teachers' Conceptions of Random Processes in a Probability and Statistics Course

ERIC Educational Resources Information Center

Smith, Toni M.; Hjalmarson, Margret A.

2013-01-01

The purpose of this study is to examine prospective mathematics specialists' engagement in an instructional sequence designed to elicit and develop their understandings of random processes. The study was conducted with two different sections of a probability and statistics course for K-8 teachers. Thirty-two teachers participated. Video analyses…

Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

The effect of Mediterranean diet on the development of type 2 diabetes mellitus: a meta-analysis of 10 prospective studies and 136,846 participants.

PubMed

Koloverou, Efi; Esposito, Katherine; Giugliano, Dario; Panagiotakos, Demosthenes

2014-07-01

The purpose of this work was to meta-analyze prospective studies that have evaluated the effect of a Mediterranean diet on the development of type 2 diabetes. PubMed, Embase and the Cochrane Central Register of Controlled Trials databases were searched up to 20 November 2013. English language publications were allocated; 17 original research studies (1 clinical trial, 9 prospective and 7 cross-sectional) were identified. Primary analyses were limited to prospective studies and clinical trials, yielding to a sample of 136,846 participants. A systematic review and a random effects meta-analysis were conducted. Higher adherence to the Mediterranean diet was associated with 23% reduced risk of developing type 2 diabetes (combined relative risk for upper versus lowest available centile: 0.77; 95% CI: 0.66, 0.89). Subgroup analyses based on region, health status of participants and number of confounders controlling for, showed similar results. Limitations include variations in Mediterranean diet adherence assessment tools, confounders' adjustment, duration of follow up and number of events with diabetes. The presented results are of major public health importance, since no consensus exists concerning the best anti-diabetic diet. Mediterranean diet could, if appropriately adjusted to reflect local food availability and individual's needs, constitute a beneficial nutritional choice for the primary prevention of diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

High Mortality without ESCAPE: The Registry of Heart Failure Patients Receiving Pulmonary Artery Catheters without Randomization

PubMed Central

Allen, Larry A.; Rogers, Joseph G.; Warnica, J. Wayne; DiSalvo, Thomas G.; Tasissa, Gudaye; Binanay, Cynthia; O’Connor, Christopher M.; Califf, Robert M.; Leier, Carl V.; Shah, Monica R.; Stevenson, Lynne W.

2008-01-01

Background In ESCAPE, there was no difference in days alive and out of the hospital for patients with decompensated heart failure (HF) randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes as compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial, while measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs. 6 days, p <0.001) and higher 6-month mortality (34% vs. 20%, p < 0.001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials. PMID:18926438

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.

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

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.

A Review of Clinical Trials in Spinal Cord Injury including Biomarkers.

PubMed

Badhiwala, Jetan H; Wilson, Jefferson R; Kwon, Brian K; Casha, Steve; Fehlings, Michael G

2018-06-11

Acute traumatic spinal cord injury (SCI) entered the arena of prospective randomized clinical trials almost 40 years ago, with the undertaking of the National Acute Spinal Cord Study (NASCIS) I trial. Since then, a number of clinical trials have been conducted in the field, spurred by the devastating physical, social, and economic consequences of acute SCI for patients, families, and society at large. Many of these have been controversial and attracted criticism. The current review provides a critical summary of select past and current clinical trials in SCI, focusing in particular on the findings of prospective randomized controlled trials (RCTs), the challenges and barriers encountered, and the valuable lessons learned that can be applied to future trials.

Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

PubMed Central

Nafisi, Shahram

2006-01-01

Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate. PMID:17176461

A randomized trial of the topical effect of antifibrinolytic epsilon aminocaproic Acid on coronary artery bypass surgery without cardiopulmonary bypass.

PubMed

Gurian, Danilo Bortolotto; Meneghini, Adriano; Abreu, Luiz Carlos de; Murad, Neif; Matos, Leandro Luongo de; Pires, Adilson Casemiro; Valenti, Vitor E; Breda, João Roberto

2014-09-01

We assessed the effect of the topical application of epsilon-aminocaproic antifibrinolytic acid (EACA) on the pericardium of patients submitted to coronary artery bypass graft (CABG) without the use of cardiopulmonary bypass (CPB). This is a prospective, randomized, and double-blind study. We evaluated 26 patients with chronic coronary heart disease indicated for CABG without CPB (EACA and placebo groups). The analysis of the postoperative hematological results showed no difference between groups in hemoglobin and hematocrit. There was no difference between the groups regarding the postoperative bleeding through the drains in the first 24 hours, 48 hours, and accumulated loss until removal of drains. The use of EACA in patients undergoing CABG without CPB presented no difference in the reduction of the amount of bleeding and the need for blood transfusions. © The Author(s) 2013.

Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.

PubMed

Kwak, Jung; Anderson, Keith; O'Connell Valuch, Katharine

2018-06-01

Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.

A randomized trial of three copper IUDs (MLCu250, MLCu375 and Nova-T).

PubMed

Bratt, H; Skjeldestad, F E; Cullberg Valentin, K

1988-01-01

A randomized prospective trial of three copper IUDs, Nova-T, MLCu375 and MLCu250, including 200 of each, is presented. Insertion was done at the hospital outpatient clinic on normally menstruating women and on women in puerperio. Follow-up was scheduled after 12, 24 and 36 months. Pregnancy rates were low for all 3 models. Pearl indices after 3 years were 0.5, 0.9 and 0.8 for Nova-T, MLCu375 and MLCu250 respectively (NS). Abnormal bleeding and/or pain was the most frequent termination cause. Minor differences in the termination rates because of abnormal bleeding and/or pain were found and are discussed. The continuation rates based on all medically relevant IUD removals were 74%, 73% and 81% after 3 years for Nova-T, MLCu375 and MLCu250 respectively. No important difference in clinical performance between the three copper IUDs could be demonstrated.

Estrogen and cognitive functioning in men with mild cognitive impairment.

PubMed

Sherwin, Barbara B

2002-01-01

Although men do not experience an abrupt cessation of gonadal hormone production at midlife as do women, levels of testosterone (T) decrease gradually with aging. Because estradiol (E2) arises mainly from the conversion of T in men, the availability of E2 also decreases with increasing age. In randomized clinical trials, E2 replacement therapy has been shown to maintain aspects of cognition in postmenopausal women, specifically with regard to verbal memory. The present prospective, randomized, cross-over trial is being undertaken in order to determine whether E2 will enhance verbal memory in men with Mild Cognitive Impairment (MCI). Men with MCI will randomly receive E2 or placebo for the first 3 mo of treatment and will then be crossed-over to the other treatment for an additional 3 mo. A battery of neuropsychological tests will be administered at pretreatment and, again, following each 3-mo treatment phase. It is hypothesized that elderly men with MCI will perform better on tests of explicit memory when they are being treated with E2 compared to their performance under placebo conditions.

Prospective randomized comparison of rotational angiography with three-dimensional reconstruction and computed tomography merged with electro-anatomical mapping: a two center atrial fibrillation ablation study.

PubMed

Anand, Rishi; Gorev, Maxim V; Poghosyan, Hermine; Pothier, Lindsay; Matkins, John; Kotler, Gregory; Moroz, Sarah; Armstrong, James; Nemtsov, Sergei V; Orlov, Michael V

2016-08-01

To compare the efficacy and accuracy of rotational angiography with three-dimensional reconstruction (3DATG) image merged with electro-anatomical mapping (EAM) vs. CT-EAM. A prospective, randomized, parallel, two-center study conducted in 36 patients (25 men, age 65 ± 10 years) undergoing AF ablation (33 % paroxysmal, 67 % persistent) guided by 3DATG (group 1) vs. CT (group 2) image fusion with EAM. 3DATG was performed on the Philips Allura Xper FD 10 system. Procedural characteristics including time, radiation exposure, outcome, and navigation accuracy were compared between two groups. There was no significant difference between the groups in total procedure duration or time spent for various procedural steps. Minor differences in procedural characteristics were present between two centers. Segmentation and fusion time for 3DATG or CT-EAM was short and similar between both centers. Accuracy of navigation guided by either method was high and did not depend on left atrial size. Maintenance of sinus rhythm between the two groups was no different up to 24 months of follow-up. This study did not find superiority of 3DATG-EAM image merge to guide AF ablation when compared to CT-EAM fusion. Both merging techniques result in similar navigation accuracy.

Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.

PubMed

Vihervaara, Hanna; Grönroos, Juha M; Hurme, Saija; Gullichsen, Risto; Salminen, Paulina

2017-01-01

Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction. All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement. At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns. According to these results, the use of this ARS is not recommended.

A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

PubMed

Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

2011-01-01

A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

PubMed

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

Comparison of anastomotic leakage and stricture formation following layered and stapler oesophagogastric anastomosis for cancer: a prospective randomized controlled trial.

PubMed

Zhang, Y S; Gao, B R; Wang, H J; Su, Y F; Yang, Y Z; Zhang, J H; Wang, C

2010-01-01

The objective of this prospective, randomized, controlled trial, conducted from May 2002 to December 2007, was to compare post-operative anastomotic leakage and stricture formation following layered manual versus stapler oesophagogastric anastomosis in patients who underwent resection of oesophageal or gastric cardia carcinoma. Patients (n = 516) were randomized to receive either layered manual or circular stapled oesophagogastric anastomosis. Mean follow-up time was > 12 months. Anastomotic leakage occurred in one (0.4%) patient in the layered group and six (2.2%) in the stapler group; no statistically significant between-group difference. After operation, two (0.8%) patients in the layered group and 13 (5.0%) in the stapler group developed a benign oesophageal stricture; the difference between the groups was statistically significant. Compared with stapler anastomosis, layered manual anastomosis may significantly reduce the incidence of anastomotic strictures. This method is easy to apply and could be used as an alternative procedure for oesophagogastric anastomosis after resection for oesophageal or cardia carcinoma.

Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

PubMed

Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

2015-09-01

To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

Effect of a Combination of Intranasal Ketorolac and Nitrous Oxide on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.

PubMed

Stentz, Daniel; Drum, Melissa; Reader, Al; Nusstein, John; Fowler, Sara; Beck, Mike

2018-01-01

Previous studies in patients with irreversible pulpitis have reported increased success of the inferior alveolar nerve block (IANB) using premedication with ketorolac. Preemptive nitrous oxide administration has also shown an increase in the success of the IANB. Recently, ketorolac has been made available for intranasal delivery. Perhaps combining ketorolac and nitrous oxide would increase success. Therefore, the purpose of this prospective, randomized, double-blind study was to determine the effect of a combination of intranasal ketorolac and nitrous oxide/oxygen on the anesthetic success of the IANB in patients presenting with symptomatic irreversible pulpitis. One hundred two patients experiencing spontaneous moderate to severe pain with symptomatic irreversible pulpitis in a mandibular posterior tooth participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac or intranasal saline placebo 20 minutes before the administration of nitrous oxide/oxygen. Ten minutes after the administration of nitrous oxide/oxygen, the IANB was given. After profound lip numbness, endodontic treatment was performed. Success was defined as the ability to perform endodontic access and instrumentation with no pain or mild pain. The odds of success for the IANB was 1.631 in the intranasal saline/nitrous oxide group versus the intranasal ketorolac/nitrous oxide group with no significant difference between the groups (P = .2523). Premedication with intranasal ketorolac did not significantly increase the odds of success for the IANB over the use of nitrous oxide/oxygen alone. Supplemental anesthesia will still be needed to achieve adequate anesthesia. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Does acetaminophen/hydrocodone affect cold pulpal testing in patients with symptomatic irreversible pulpitis? A prospective, randomized, double-blind, placebo-controlled study.

PubMed

Fowler, Sara; Fullmer, Spencer; Drum, Melissa; Reader, Al

2014-12-01

The purpose of this prospective randomized, double-blind, placebo-controlled study was to determine the effects of a combination dose of 1000 mg acetaminophen/10 mg hydrocodone on cold pulpal testing in patients experiencing symptomatic irreversible pulpitis. One hundred emergency patients in moderate to severe pain diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received, in a double-blind manner, identical capsules of either a combination of 1000 mg acetaminophen/10 hydrocodone or placebo. Cold testing with Endo-Ice (1,1,1,2 tetrafluoroethane; Hygenic Corp, Akron, OH) was performed at baseline and every 10 minutes for 60 minutes. Pain to cold testing was recorded by the patient using a Heft-Parker visual analog scale. Patients' reaction to the cold application was also rated. Cold testing at baseline and at 10 minutes resulted in severe pain for both the acetaminophen/hydrocodone and placebo groups. Although pain ratings decreased from 20-60 minutes, the ratings still resulted in moderate pain. Patient reaction to cold testing showed that 56%-62% had a severe reaction. Although the reactions decreased in severity over the 60 minutes, 20%-34% still had severe reactions at 60 minutes. Regarding pain and patients' reactions to cold testing, there were no significant differences between the combination acetaminophen/hydrocodone and placebo groups at any time period. A combination dose of 1000 mg of acetaminophen/10 mg of hydrocodone did not statistically affect cold pulpal testing in patients presenting with symptomatic irreversible pulpitis. Patients experienced moderate to severe pain and reactions to cold testing. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Post-operative bracing after ACL reconstruction has no effect on knee joint effusion. A prospective, randomized study.

PubMed

Lindström, Maria; Wredmark, Torsten; Wretling, Marie-Louise; Henriksson, Marketta; Felländer-Tsai, Li

2015-12-01

It is unclear what factors contribute to knee joint effusion after anterior cruciate ligament (ACL) injury and reconstruction. Knee homeostasis after injury and surgery is crucial for rehabilitation and knee well-being. We examined if effusion was affected by post-operative bracing, and if patients with effusion fit into a common profile. Patients were randomized to wearing or not wearing a post-operative brace for three weeks after ACL reconstruction with semitendinosus-gracilis tendons. Knee joint effusion was detected by computed tomography in 60 patients (22 women), before and three and 12 months after surgery. Joint effusion, clinical and subjective tests were analyzed. This is the first prospective, randomized study on post-operative bracing for patients with a semitendinosus-gracilis graft showed that bracing had no effect on three-months presence of joint effusion. Excessive joint effusion was present in 68% of the patients three months after surgery and was associated to prior meniscus injury (p=0.05) and higher prior Tegner activity level (p=0.006). We found a positive association between longer time from injury to surgery and joint effusion three months post-operatively (rho=0.29, p<0.05). Twelve months post-operatively, joint effusion had diminished to baseline levels. Subjective scores and activity levels were lower for women. Three-months joint effusion predicted lower final outcome scores in women. Prior meniscus injury and pre-injury Tegner activity levels are predictive significant variables for excessive knee joint effusion after ACL reconstruction. Post-operative bracing had no effect. A larger clinical cohort is needed to confirm findings of this logistic regression. Copyright © 2015 Elsevier B.V. All rights reserved.

A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis.

PubMed

Leong, Quan Wai; Shen, Mira L; Au, Kim W; Luo, Derek; Lau, James Y; Wu, Justin C; Chan, Francis K; Sung, Joseph J

2016-02-01

There is as yet no ideal design of a plastic biliary stent with the longest patency period. To study the safety and effective patency period of a new plastic antireflux biliary stent in the clinical setting. We conducted a prospective, randomized trial to compare the patency of 2 similar plastic biliary stents, one of which has an antiduodenobiliary reflux property. The study was conducted at 2 separate tertiary centers in 2 countries. Patients with inoperable distal malignant biliary obstruction were recruited. One of the 2 types of plastic stents under study was randomly chosen and inserted in the common bile duct of the study subjects. The subjects were followed until the end of study or occlusion occurrence. Our primary endpoint was the time to stent occlusion in days, with stent-related adverse events and all-cause mortality the secondary endpoints. A total of 16 subjects were recruited for the study; 7 were allocated to group A (ordinary Tannenbaum stent) and 9 to group B (antireflux biliary stent). Five of 7 subjects (71%) in group B had stent occlusion within 8 days, and the primary end point was reached in all 7 subjects within 30 days, whereas the primary endpoint was not reached within 30 days in any of the subjects in group A. Our data showed a significantly shorter stent patency period in group B compared with group A (P < .003). Small sample size. Routine use of antireflux plastic biliary stents in the palliative management of malignant biliary obstructions cannot be recommended at present. (Clinical trial registration number: NCT01142921.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

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.

Scissor-type knife significantly improves self-completion rate of colorectal endoscopic submucosal dissection: Single-center prospective randomized trial.

PubMed

Yamashina, Takeshi; Takeuchi, Yoji; Nagai, Kengo; Matsuura, Noriko; Ito, Takashi; Fujii, Mototsugu; Hanaoka, Noboru; Higashino, Koji; Uedo, Noriya; Ishihara, Ryu; Iishi, Hiroyasu

2017-05-01

Colorectal endoscopic submucosal dissection (C-ESD) is recognized as a difficult procedure. Recently, scissors-type knives were launched to reduce the difficulty of C-ESD. The aim of this study was to evaluate the efficacy and safety of the combined use of a scissors-type knife and a needle-type knife with a water-jet function (WJ needle-knife) for C-ESD compared with using the WJ needle-knife alone. This was a prospective randomized controlled trial in a referral center. Eighty-five patients with superficial colorectal neoplasms were enrolled and randomly assigned to undergo C-ESD using a WJ needle-knife alone (Flush group) or a scissor-type knife-supported WJ needle-knife (SB Jr group). Procedures were conducted by two supervised residents. Primary endpoint was self-completion rate by the residents. Self-completion rate was 67% in the SB Jr group, which was significantly higher than that in the Flush group (39%, P = 0.01). Even after exclusion of four patients in the SB Jr group in whom C-ESD was completed using the WJ needle-knife alone, the self-completion rate was significantly higher (63% vs 39%; P = 0.03). Median procedure time among the self-completion cases did not differ significantly between the two groups (59 vs 51 min; P = 0.14). No fatal adverse events were observed in either group. In this single-center phase II trial, scissor-type knife significantly improved residents' self-completion rate for C-ESD, with no increase in procedure time or adverse events. A multicenter trial would be warranted to confirm the validity of the present study. © 2016 Japan Gastroenterological Endoscopy Society.

Adrenaline injection plus argon plasma coagulation versus adrenaline injection plus hemoclips for treating high-risk bleeding peptic ulcers: A prospective, randomized trial

PubMed Central

Taghavi, Seyed Alireza; Soleimani, Seyed Mohammad; Hosseini-Asl, Seyed Mohammad Kazem; Eshraghian, Ahad; Eghbali, Hajar; Dehghani, Seyed Mohsen; Ahmadpour, Bita; Saberifiroozi, Mehdi

2009-01-01

BACKGROUND/OBJECTIVE: Several combination endoscopic therapies are currently in use. The present study aimed to compare argon plasma coagulation (APC) + adrenaline injection (AI) with hemoclips + AI for the treatment of high-risk bleeding peptic ulcers. METHODS: In a prospective randomized trial, 172 patients with major stigmata of peptic ulcer bleeding were randomly assigned to receive APC + AI (n=89) or hemoclips + AI (n=83). In the event of rebleeding, the initial modality was used again. Patients in whom treatment or retreatment was unsuccessful underwent emergency surgery. The primary end point of rebleeding rate and secondary end points of initial and definitive hemostasis need for surgery and mortality were compared between the two groups. RESULTS: The two groups were similar in all background variables. Definitive hemostasis was achieved in 85 of 89 (95.5%) of the APC + AI and 82 of 83 (98.8%) of the hemoclips + AI group (P=0.206). The mean volume of adrenaline injected in the two groups was equal (20.7 mL; P=0.996). There was no significant difference in terms of initial hemostasis (96.6% versus 98.8%; P=0.337), rate of rebleeding (11.2% versus 4.8%; P=0.124), need for surgery (4.5% versus 1.2%; P=0.266) and mortality (2.2% versus 1.2%; P=0.526). When compared for the combined end point of mortality plus rebleeding and the need for surgery, there was an advantage for the hemoclip group (6% versus 15.7%, P=0.042). CONCLUSION: Hemoclips + AI has no superiority over APC + AI in treating patients with high-risk bleeding peptic ulcers. Hemoclips + AI may be superior when a combination of all negative outcomes is considered. PMID:19826646

[A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

PubMed

Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg -1 , Group C getting clonidine 1mcg.kg -1 and Group D patients receiving dexmedetomidine 0.5mcg.kg -1 . The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

A Prospective Randomized Comparison Between Laparoscopic Ureterolithotomy and Semirigid Ureteroscopy for Upper Ureteral Stones >2 cm: A Single-Center Experience.

PubMed

Kumar, Anup; Vasudeva, Pawan; Nanda, Biswajit; Kumar, Niraj; Jha, Sanjeev Kumar; Singh, Harbinder

2015-11-01

The optimal management method of upper ureteral stones >2 cm is still a challenge. We performed a prospective randomized comparison between laparoscopic ureterolithotomy (LU) and ureteroscopic lithotripsy for upper ureteral calculus >2 cm to evaluate safety and efficacy of both procedures. Between January 2010 and May 2012, 110 patients with a single radiopaque upper ureteral calculus >2 cm were included in the present study. Randomization was done in two groups-group A: LU was performed and group B: Ureteroscopy (URS) was performed using a 6/7.5F semirigid ureteroscope (Richard Wolf) with holmium laser intracorporeal lithotripsy. Statistical analysis was performed regarding demographic profile, success, retreatment, auxiliary procedure rates, and also complications. Out of the total 110 patients, 54 patients were enrolled in group A and 56 patients were enrolled in group B. Mean stone size was 2.3±0.2 cm in group A versus 2.2±0.1 cm in group B (p=0.52). The overall 3-month stone-free rate was (50/50) 100% for group A versus (38/50) 76% for group B (p=0.02). The retreatment rate was significantly greater in group B than group A (8% vs. 0%, respectively; (p=0.01). Auxiliary procedure rate was higher in group B than in group A (26% vs. 0% respectively; p=0.001). The complication rate was 12% in group A versus 26% in group B (p=0.001). For upper ureteral stones of size greater than 2 cm, LU has a greater stone clearance rate, comparable operating time, lesser need for auxiliary procedure, and complication rate as compared to URS.

Real-time ultrasound-guided PCNL using a novel SonixGPS needle tracking system.

PubMed

Li, Xiang; Long, Qingzhi; Chen, Xingfa; He, Dalin; Dalin, He; He, Hui

2014-08-01

SonixGPS is a successful ultrasound guidance position system. It helps to improve accuracy in performing complex puncture operations. This study firstly used SonixGPS to perform kidney calyx access in PCNL to investigate its effectiveness and safety. This was a prospectively randomized controlled study performed from September 2011 to October 2012. A total of 97 patients were prospectively randomized into two groups using random number generated from SAS software. 47 Patients were enrolled in conventional ultrasound-guided (US-guided) group and 50 patients were classified into SonixGPS-guided group. Nine patients were lost during follow-up. Hence, a total of 88 patients were qualified and analyzed. Preoperative examinations included urine analysis, urine culture, kidney function, coagulation profile and routine analysis of blood. Ultrasonography was used to evaluate the degree of hydronephrosis. The intraoperative findings, including blood loss, operating time, time to successful puncture, the number of attempts for successful puncture and hospital stay were recorded. The stone clearance rate and complications were analyzed. The present study showed no significant difference between the two groups in terms of demographic data, preoperative markers, stone clearance rate and the stone composition. However, the time to successful puncture, the number of trials for successful puncture, operating time and hospital length of stay were significantly decreased in the SonixGPS-guided group. Furthermore, the hemoglobin decrease was also obviously lower in the SonixGPS group than that in conventional US-guided group. SonixGPS needle tacking system guided PCNL is safe and effective in treating upper urinary tract stones. This novel technology makes puncturing more accuracy and can significantly decrease the incidence of relative hemorrhage and accelerate recovery.

Modest blood pressure reduction with valsartan in acute ischemic stroke: a prospective, randomized, open-label, blinded-end-point trial.

PubMed

Oh, Mi Sun; Yu, Kyung-Ho; Hong, Keun-Sik; Kang, Dong-Wha; Park, Jong-Moo; Bae, Hee-Joon; Koo, Jaseong; Lee, Juneyoung; Lee, Byung-Chul

2015-07-01

To assess the efficacy and safety of modest blood pressure (BP) reduction with valsartan within 48 h after symptom onset in patients with acute ischemic stroke and high BP. This was a multicenter, prospective, randomized, open-label, blinded-end-point trial. A total of 393 subjects were recruited at 28 centers and then randomly assigned in a 1:1 ratio to receive valsartan (n = 195) or no treatment (n = 198) for seven-days after presentation. The primary outcome was death or dependency, defined as a score of 3-6 on the modified Rankin Scale (mRS) at 90 days after symptom onset. Early neurological deterioration (END) within seven-days and 90-day major vascular events were also assessed. There were 372 patients who completed the 90-day follow-up. The valsartan group had 46 of 187 patients (24·6%) with a 90-day mRS 3-6, compared with 42 of 185 patients (22·6%) in the control group (odds ratio [OR], 1·11; 95% confidence interval [CI], 0·69-1·79; P = 0·667). The rate of major vascular events did not differ between groups (OR, 1·41; 95% CI, 0·44-4·49; P = 0·771). There was a significant increase of END in the valsartan group (OR, 2·43; 95% CI, 1·25-4·73; P = 0·008). Early reduction of BP with valsartan did not reduce death or dependency and major vascular events at 90 days, but increased the risk of END. © 2015 World Stroke Organization.

Impact of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Prasugrel-Inhibited Platelets: Results of a Prospective, Randomized, Crossover Study (the ECCLIPSE Trial).

PubMed

Vivas, David; Martín, Agustín; Bernardo, Esther; Ortega-Pozzi, María Aranzazu; Tirado, Gabriela; Fernández, Cristina; Vilacosta, Isidre; Núñez-Gil, Iván; Macaya, Carlos; Fernández-Ortiz, Antonio

2015-05-01

Prasugrel and ticagrelor, new P2Y12-adenosine diphosphate receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events compared with clopidogrel in patients with an acute coronary syndrome. However, evidence is lacking about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared with oral aspirin on prasugrel-inhibited platelets. This was a prospective, randomized, single-center, open, 2-period crossover platelet function study conducted in 30 healthy volunteers. Subjects were randomly assigned to receive a loading dose of intravenous LA 450 mg plus oral prasugrel 60 mg or loading dose of aspirin 300 mg plus prasugrel 60 mg orally in a crossover fashion after a 2-week washout period between treatments. Platelet function was evaluated at baseline, 30 minutes, 1 h, 4 h, and 24 h using light transmission aggregometry and vasodilator-stimulated phosphoprotein phosphorylation. The primary end point of the study, inhibition of platelet aggregation after arachidonic acid 1.5 mmol/L at 30 minutes, was significantly higher in subjects treated with LA compared with aspirin: 85.3% versus 44.3%, respectively, P=0.003. This differential effect was observed at 1 hour (P=0.002) and 4 hours (P=0.048), but not at 24 hours. Subjects treated with LA presented less variability and faster and greater inhibition of platelet aggregation with arachidonic acid compared with aspirin. The administration of intravenous LA resulted in a significant reduction of platelet reactivity compared with oral aspirin on prasugrel-inhibited platelets. Loading dose of LA achieves an earlier platelet inhibition and with less variability than aspirin. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02243137. © 2015 American Heart Association, Inc.

Efficacy of a Buffered 4% Lidocaine Formulation for Incision and Drainage: A Prospective, Randomized, Double-blind Study.

PubMed

Harreld, Taryn Kratz; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

2015-10-01

Incision and drainage of symptomatic emergency patients with facial swelling is painful even after local anesthetics are administered. The purpose of this prospective, randomized, double-blind study was to compare the pain of infiltration and the pain of an incision and drainage procedure of a buffered versus a nonbuffered 4% lidocaine formulation in symptomatic emergency patients presenting with a diagnosis of pulpal necrosis, associated periapical area, and an acute clinical swelling. Eighty-eight emergency patients were randomly divided into 2 groups to receive 2 intraoral infiltration injections (mesial and distal to the swelling) of either 4% lidocaine with 1:100,000 epinephrine buffered with 0.18 mL 8.4% sodium bicarbonate using the Onpharma (Los Gatos, CA) buffering system or 4% lidocaine with 1:100,000 epinephrine. Subjects rated the pain of needle insertion, needle placement, and solution deposition for each injection using a 170-mm visual analog scale. An incision and drainage procedure was performed, and subjects rated the pain of incision, drainage, and dissection on a 170-mm visual analog scale. No significant differences between the buffered and nonbuffered 4% lidocaine formulations were found for needle insertion, placement, and solution deposition of the infiltration injections or for the treatment phases of incision, drainage, and dissection. Buffering a 4% lidocaine formulation did not significantly decrease the pain of infiltrations or significantly decrease the pain of the incision and drainage procedure when compared with a nonbuffered 4% lidocaine formulation in symptomatic patients with a diagnosis of pulpal necrosis and associated acute swelling. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Rotigotine and specific non-motor symptoms of Parkinson's disease: post hoc analysis of RECOVER.

PubMed

Ray Chaudhuri, K; Martinez-Martin, Pablo; Antonini, Angelo; Brown, Richard G; Friedman, Joseph H; Onofrj, Marco; Surmann, Erwin; Ghys, Liesbet; Trenkwalder, Claudia

2013-07-01

Non-motor symptoms of Parkinson's disease (PD) represent major causes of morbidity. RECOVER, a randomized controlled trial of rotigotine transdermal system, was the first prospective controlled trial to use the Non-Motor Symptoms Scale (NMSS) as an exploratory outcome for assessment of treatment effects on non-motor symptoms in PD. Rotigotine improved NMSS total score compared with placebo, and the "Sleep/fatigue" and "Mood/apathy" domains. This post hoc analysis further characterizes the effects of rotigotine on sleep/fatigue and mood/apathy. Patients with PD and unsatisfactory early-morning motor impairment were randomized to transdermal patches of rotigotine (2-16 mg/24 h) or placebo. Treatment was titrated to optimal dose over 1-8 weeks, maintained for 4 weeks. The NMSS was assessed at baseline and end of treatment. Post hoc analyses are presented for individual items of the "Sleep/fatigue" and "Mood/apathy" domains. The interpretation of p-values is considered exploratory in nature. Of 287 patients randomized, NMSS data were available for 267 patients (178 rotigotine, 89 placebo). Within the "Sleep/fatigue" domain there was a significant difference, in favor of rotigotine, in change from baseline score in 1 of 5 items: "fatigue (tiredness) or lack of energy" (ANCOVA, p < 0.0001). Within the "Mood/apathy" domain, there were significant differences in favor of rotigotine in 4 of 7 items: "lost interest in surroundings" (p < 0.0001), "lost interest in doing things" (p < 0.0001), "seems sad or depressed" (p < 0.01), and "difficulty experiencing pleasure" (p < 0.05). Rotigotine transdermal system may improve non-motor symptoms such as fatigue, symptoms of depression, anhedonia, and apathy in patients with PD; further prospective controlled studies are required to confirm this post hoc analysis. Copyright © 2013 Elsevier Ltd. All rights reserved.

Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

PubMed

Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

2013-12-15

Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

[Disease management programs: Difficulties in the analysis of benefit].

PubMed

Linder, Roland; Horenkamp-Sonntag, D; Bestmann, B; Battmer, U; Heilmann, T; Verheyen, F

2015-04-01

After an introduction to the theme with an overview of the implementation of the Disease Management Programs (DMP), accompanying documentation, present utilization and costs of the programs, the present article is primarily devoted to the issue of the analysis of the benefits of DMP. Following an assessment of the legally specified evaluation requirements, in the absence of a prospective, randomized, controlled trial (RCT), the results of three studies are first summarized, which, with the application of propensity score matching, utilize the routine data of the statutory health insurance schemes to form a control group. The overview concludes with a look at the planned changes in evaluation and the intended expansion of the DMP to programs for other chronic illnesses.

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.

Randomized Trial of Treatment for Children with Sexual Behavior Problems: Ten-Year Follow-Up

ERIC Educational Resources Information Center

Carpentier, Melissa Y.; Silovsky, Jane F.; Chaffin, Mark

2006-01-01

This study prospectively follows 135 children 5-12 years of age with sexual behavior problems from a randomized trial comparing a 12-session group cognitive-behavioral therapy (CBT) with group play therapy and follows 156 general clinic children with nonsexual behavior problems. Ten-year follow-up data on future juvenile and adult arrests and…

Evaluating the Effectiveness of Developmental Mathematics by Embedding a Randomized Experiment within a Regression Discontinuity Design

ERIC Educational Resources Information Center

Moss, Brian G.; Yeaton, William H.; Lloyd, Jane E.

2014-01-01

Using a novel design approach, a randomized experiment (RE) was embedded within a regression discontinuity (RD) design (R-RE-D) to evaluate the impact of developmental mathematics at a large midwestern college ("n" = 2,122). Within a region of uncertainty near the cut-score, estimates of benefit from a prospective RE were closely…

[Rethinking clinical research in surgical oncology. From comic opera to quality control].

PubMed

Evrard, Serge

2016-01-01

The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation. Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

ERIC Educational Resources Information Center

Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

2012-01-01

Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

PubMed

Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

2017-11-01

The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

Influence of intestinal bacterial decontamination using metronidazole and ciprofloxacin or ciprofloxacin alone on the development of acute graft-versus-host disease after marrow transplantation in patients with hematologic malignancies: final results and long-term follow-up of an open-label prospective randomized trial.

PubMed

Beelen, D W; Elmaagacli, A; Müller, K D; Hirche, H; Schaefer, U W

1999-05-15

In a single-center open-label prospective study, a total of 134 marrow transplant recipients with hematologic malignancies were randomly assigned to a bacterial decontamination medication using metronidazole and ciprofloxacin (n = 68) or ciprofloxacin alone (n = 66) during 5 weeks posttransplant. The development of grades II to IV acute graft-versus-host disease (GVHD) was defined as the primary study endpoint. According to the intention-to-treat, 17 patients (25%) randomized to the combined decontamination medication and 33 patients (50%) randomized to ciprofloxacin alone developed grades II to IV GVHD (P <.002). The higher frequency of grades II to IV acute GVHD in patients randomized to ciprofloxacin alone resulted from a more than twofold increased number of patients developing liver or intestinal involvement with acute GVHD compared with patients randomized to the combined decontamination medication (P <.003). The influence of the study medication on grades II to IV acute GVHD was significant only in recipients of transplants from genotypically HLA-identical sibling donors (n = 80), whereas in recipients of transplants from donors other than HLA-identical siblings (n = 54), grades II to IV acute GVHD frequencies between the study arms were not significantly different. The combined decontamination was associated with a significant reduction of culture growth of intestinal anaerobic bacteria during 5 weeks posttransplant (P <. 00001). In addition, the number of cultures with growth of anaerobic bacteria (P <.005) as well as the median concentrations of anaerobic bacteria in the posttransplant period (P <.0001) were higher in patients contracting grades II to IV acute GVHD. Neither chronic GVHD nor overall survival was significantly different between the two study arms. In patients with HLA-identical sibling donors who were treated in early disease stages, the 5-year survival estimate was slightly, but not significant, higher after the combined decontamination medication (60% +/- 11%) compared with ciprofloxacin alone (46% +/- 9%). In conclusion, the present study provides evidence that antimicrobial chemotherapy targeted to intestinal anaerobic bacteria in marrow transplant recipients significantly reduces the severity of acute GVHD and supports the theory that the intestinal anaerobic bacterial microflora plays a role in the pathogenesis of acute GVHD after human marrow transplantation.

Prospective Randomized Controlled Study on the Efficacy of Multimedia Informed Consent for Patients Scheduled to Undergo Green-Light High-Performance System Photoselective Vaporization of the Prostate

PubMed Central

Ham, Dong Yeub; Choi, Woo Suk; Song, Sang Hoon; Ahn, Young-Joon; Park, Hyoung Keun; Kim, Hyeong Gon

2016-01-01

Purpose The aim of this study was to evaluate the efficacy of a multimedia informed consent (IC) presentation on the understanding and satisfaction of patients who were scheduled to receive 120-W green-light high-performance system photoselective vaporization of the prostate (HPS-PVP). Materials and Methods A multimedia IC (M-IC) presentation for HPS-PVP was developed. Forty men with benign prostatic hyperplasia who were scheduled to undergo HPS-PVP were prospectively randomized to a conventional written IC group (W-IC group, n=20) or the M-IC group (n=20). The allocated IC was obtained by one certified urologist, followed by a 15-question test (maximum score, 15) to evaluate objective understanding, and questionnaires on subjective understanding (range, 0~10) and satisfaction (range, 0~10) using a visual analogue scale. Results Demographic characteristics, including age and the highest level of education, did not significantly differ between the two groups. No significant differences were found in scores reflecting the objective understanding of HPS-PVP (9.9±2.3 vs. 10.6±2.8, p=0.332) or in subjective understanding scores (7.5±2.1 vs. 8.6±1.7, p=0.122); however, the M-IC group showed higher satisfaction scores than the W-IC group (7.4±1.7 vs. 8.4±1.5, p=0.033). After adjusting for age and educational level, the M-IC group still had significantly higher satisfaction scores. Conclusions M-IC did not enhance the objective knowledge of patients regarding this surgical procedure. However, it improved the satisfaction of patients with the IC process itself. PMID:27169129

A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

PubMed

McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

2001-05-01

Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically significant. In addition, there were more unscheduled visits to the urology clinic, emergency room or primary physician office by boys with than without a dressing. Furthermore, 29% of the parents were not psychologically prepared to remove the dressing and 12% were so reluctant that the dressing was removed at the urology outpatient clinic. The surgical outcome and rate of adverse events or complications were not compromised without a postoperative dressing. An absent dressing simplified postoperative ambulatory parent delivered home care. We recommend that dressings should be omitted from routine use after hypospadias repair.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

PubMed Central

Zigler, Jack E.; Jackson, Robert; Nunley, Pierce D.; Bae, Hyun W.; Kim, Kee D.; Ohnmeiss, Donna D.

2016-01-01

Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease. Clinical Relevance This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients. Level of Evidence This is a Level I study. PMID:27162712

Prospective study of the effects of ventilation tubes on hearing after radiotherapy for carcinoma of nasopharynx

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

Chowdhury, C.R.; Ho, J.H.; Wright, A.

1988-03-01

In patients with nasopharyngeal carcinoma, deafness sometimes occurs following radiotherapy. It is usually conductive, but may be sensorineural. Tinnitus is present frequently and usually is distressing. The role of ventilation tubes (grommets) in relieving these problems was assessed in a prospective randomized controlled trial of 115 patients. In the group with grommets, there was an improvement in hearing, with a reduction of the averaged air-bone gap (p less than .01). This was not found in the control group without ventilation tubes, who developed a larger conductive loss (p less than .01) and, in addition, a slight deterioration of the averagedmore » bone conduction threshold (p less than .01). Surprisingly, the group with grommets did not develop this sensorineural loss (p less than .01). In addition, tinnitus was improved significantly by the insertion of ventilation tubes (p less than .01). Neither necrosis nor stenosis of the external auditory meatus was found in either group.« less

Prospective study of the effects of ventilation tubes on hearing after radiotherapy for carcinoma of nasopharynx

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

Chowdhury, C.R.; Ho, J.H.; Wright, A.

In patients with nasopharyngeal carcinoma, deafness sometimes occurs following radiotherapy. It is usually conductive, but may be sensorineural. Tinnitus is present frequently and usually is distressing. The role of ventilation tubes (grommets) in relieving these problems was assessed in a prospective randomized controlled trial of 115 patients. In the group with grommets, there was an improvement in hearing, with a reduction of the averaged air-bone gap (p less than .01). This was not found in the control group without ventilation tubes, who developed a larger conductive loss (p less than .01) and, in addition, a slight deterioration of the averagedmore » bone conduction threshold (p less than .01). Surprisingly, the group with grommets did not develop this sensorineural loss (p less than .01). In addition, tinnitus was improved significantly by the insertion of ventilation tubes (p less than .01). Neither necrosis nor stenosis of the external auditory meatus was found in either group.« less

Rethinking Risk: Prospect Theory Application in Health Message Framing Research.

PubMed

Harrington, Nancy Grant; Kerr, Anna M

2017-02-01

Although prospect theory conceptualizes risk as uncertainty, health message framing research based on the theory typically conceptualizes risk as severity. This study reports the results of two experiments designed to explore these alternative conceptualizations of risk and their effect on health decision making. Participants (N 1  = 768, N 2  = 532) were randomly assigned to one of four conditions that presented a hypothetical scenario of a sexually transmitted disease (STD) outbreak. The conditions were defined by message prompt (deadly vs. easily curable STD) and response option frame (gain vs. loss). Participants selected which of two programs (certain outcome vs. uncertain outcome) they would prefer to combat the outbreak. Across both experiments, participants expressed strong preferences for certain (low risk) outcomes in the gain-framed conditions and no preferences in the loss-framed conditions. These differences held regardless of the consequence severity of the scenario. We discuss the theoretical and practical implications of these results and offer directions for future research.

Project Whitefeather

NASA Astrophysics Data System (ADS)

Four primary tasks have been carried out in this program. Upon request of LANL, the Eloranta paper was reviewed. It was determined that the correlation solution presented was too computationally complex to execute in the allocated 1 second update time. An alternative algorithm approach was under taken using a simulation baseline. A simulation was developed and applied to generate synthetic LIDAR data from randomized aerosol patches drifting with the wind. Algorithms have been designed and implemented in the simulation to reduce the data and apply it to obtain wind estimates. A substantial effort was completed in reverse engineering the EVIEW data format structure of the supplied data. Finally the collected, LIDAR data has been examined to obtain an assessment of the prospects for successful wind estimation. Unfortunately, the data examination has not shown good prospects for a successful outcome. It is recommended that future data be taken with the procedure previously outlined. Hercules believes that if lidar data is collected using this procedure that wind information will be as successful using the collected data as it was in simulation.

Can Predictive Modeling Identify Head and Neck Oncology Patients at Risk for Readmission?

PubMed

Manning, Amy M; Casper, Keith A; Peter, Kay St; Wilson, Keith M; Mark, Jonathan R; Collar, Ryan M

2018-05-01

Objective Unplanned readmission within 30 days is a contributor to health care costs in the United States. The use of predictive modeling during hospitalization to identify patients at risk for readmission offers a novel approach to quality improvement and cost reduction. Study Design Two-phase study including retrospective analysis of prospectively collected data followed by prospective longitudinal study. Setting Tertiary academic medical center. Subjects and Methods Prospectively collected data for patients undergoing surgical treatment for head and neck cancer from January 2013 to January 2015 were used to build predictive models for readmission within 30 days of discharge using logistic regression, classification and regression tree (CART) analysis, and random forests. One model (logistic regression) was then placed prospectively into the discharge workflow from March 2016 to May 2016 to determine the model's ability to predict which patients would be readmitted within 30 days. Results In total, 174 admissions had descriptive data. Thirty-two were excluded due to incomplete data. Logistic regression, CART, and random forest predictive models were constructed using the remaining 142 admissions. When applied to 106 consecutive prospective head and neck oncology patients at the time of discharge, the logistic regression model predicted readmissions with a specificity of 94%, a sensitivity of 47%, a negative predictive value of 90%, and a positive predictive value of 62% (odds ratio, 14.9; 95% confidence interval, 4.02-55.45). Conclusion Prospectively collected head and neck cancer databases can be used to develop predictive models that can accurately predict which patients will be readmitted. This offers valuable support for quality improvement initiatives and readmission-related cost reduction in head and neck cancer care.

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias.

PubMed

Ielpo, Benedetto; Duran, Hipolito; Diaz, Eduardo; Fabra, Isabel; Caruso, Riccardo; Malavé, Luis; Ferri, Valentina; Lazzaro, Sara; Kalivaci, Denis; Quijano, Yolanda; Vicente, Emilio

2017-07-19

In literature, only a few studies have prospectively compared the results of laparoscopic with open inguinal hernia repair yet none have compared bilateral inguinal hernia repair. The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia. Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters included hospital stay, operation time, postoperative complications, immediate postoperative pain and chronic pain, recurrence and quality of life. Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-operative pain up to 7 days from surgery (p = 0.003), a shorter length of hospital stay (p = 0.001), less postoperative complications (p = 0.012) and less chronic pain (0.04) when compared with the OLR approach. TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay and postoperative complications. Copyright © 2017 Elsevier Inc. All rights reserved.

Predictors for contrast media-induced nephropathy and long-term survival: Prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial

PubMed Central

Hölscher, Birgit; Heitmeyer, Christine; Fobker, Manfred; Breithardt, Günter; Schaefer, Roland M; Reinecke, Holger

2008-01-01

BACKGROUND: Among the numerous studies concerning contrast media-induced nephropathy (CIN), there was no prospective trial that provided data on the long-term outcomes. OBJECTIVES: To prospectively assess predictors of CIN and long-term outcomes of affected patients. METHODS: Four hundred twelve consecutive patients with serum creatinine levels of 115 μmol/L to 309 μmol/L (1.3 mg/dL to 3.5 mg/dL) undergoing elective coronary angiography were included. Patients were randomly assigned to periprocedural hydration alone, hydration plus onetime hemodialysis or hydration plus N-acetylcysteine. RESULTS: Multivariate logistic regression identified the following as predictors of CIN within 72 h (equivalent to an increase in creatinine 44.2 μmol/L [0.5 mg/dL] or more) : prophylactic postprocedural hemodialysis (OR 2.86, 95% CI 1.07 to 7.69), use of angiotensin-converting enzyme inhibitors (OR 6.16, 95% CI 2.01 to 18.93), baseline glomerular filtration rate (OR 0.94, 95% CI 0.90 to 0.98) and the amount of contrast media given (OR 1.01, 95% CI 1.00 to 1.01). With regard to long-term outcome (mean follow-up 649 days), multivariate Cox regression models found elevated creatinine levels at 30 days (hazard rate ratio [HRR] 5.48, 95% CI 2.85 to 10.53), but not CIN within 72 h (HRR 1.12, 95% CI 0.63 to 2.02), to be associated with increased mortality. In addition, independent predictors for death during follow-up included left ventricular ejection fraction lower than 35% (HRR 4.01, 95% CI 2.22 to 7.26), serum phosphate (HRR 1.64, 95% CI 1.10 to 2.43) and hemoglobin (HRR 0.80, 95% CI 0.67 to 0.96). CONCLUSION: From the present prospective trial, performance of post-procedural hemodialysis, use of angiotensin-converting enzyme inhibitors, reduced baseline glomerular filtration rate and amount of contrast media were independent predictors of CIN within 72 h after catheterization. Assessing renal function after 30 days, rather than within 72 h, seemed to be more predictive for patients’ long-term survival. PMID:18987758

Progressive loss of pancreatic function in chronic pancreatitis is delayed by main pancreatic duct decompression. A longitudinal prospective analysis of the modified puestow procedure.

PubMed

Nealon, W H; Thompson, J C

1993-05-01

This study evaluated the effect of operative drainage of the main pancreatic duct (MPD) on functional derangements associated with chronic pancreatitis (CP). The author previously reported delayed functional impairment in an evaluation of the impact of operative drainage in patients with CP. The author now reports on a prospective study of 143 patients with this diagnosis. Each patient underwent 1) ERCP, 2) the Bentiromide PABA, 3) 72-hour fecal fat test, 4) oral glucose tolerance test (OGTT) and 5) fat meal (LIPOMUL)--stimulated pancreatic polypeptide release (PP). All patients were stratified as mild/moderate (M/M) or severe CP on the basis of a 5-point system that was developed by the author. Patients were studied at 16-month intervals. All 143 patients underwent initial and follow-up evaluations in a mean follow-up of 47.3 months; 83 of 143 patients had M/M grade at initial evaluation. Eighty-seven patients underwent (MPD) decompression to relieve abdominal pain. In a separate prospective 17 patients with a diagnosis of CP, a grade of M/M and non-disabling abdominal pain were randomized to operative or non-operative treatment; 9 of these randomized patients were operated upon and 8 were not. No patient improved their grade during follow-up; 47 of 83 M/M patients had operative drainage and 36 did not. This grade was preserved in 41 of 47 (87%) operated patients but in only 8 of the 36 non-operated patients (22%). In the randomized trial, seven of nine operated patients retained their functional status in follow-up, whereas only two of eight patients (25%) randomized to non-operation preserved their functional grade. These data in this large study as well as among a previous randomized sample, support a policy of early operative drainage before the development of irreversible functional impairment in patients with chronic pancreatitis and associated dilation of the main pancreatic duct.

Primary repair of penetrating colon injuries: a systematic review.

PubMed

Singer, Marc A; Nelson, Richard L

2002-12-01

Primary repair of penetrating colon injuries is an appealing management option; however, uncertainty about its safety persists. This study was conducted to compare the morbidity and mortality of primary repair with fecal diversion in the management of penetrating colon injuries by use of a meta-analysis of randomized, prospective trials. We searched for prospective, randomized trials in MEDLINE (1966 to November 2001), the Cochrane Library, and EMBase using the terms colon, penetrating, injury, colostomy, prospective, and randomized. Studies were included if they were randomized, controlled trials that compared the outcomes of primary repair with fecal diversion in the management of penetrating colon injuries. Five studies were included. Reviewers performed data extraction independently. Outcomes evaluated from each trial included mortality, total complications, infectious complications, intra-abdominal infections, wound complications, penetrating abdominal trauma index, and length of stay. Peto odds ratios for combined effect were calculated with a 95 percent confidence interval for each outcome. Heterogeneity was also assessed for each outcome. The penetrating abdominal trauma index of included subjects did not differ significantly between studies. Mortality was not significantly different between groups (odds ratio, 1.70; 95 percent confidence interval, 0.51-5.66). However, total complications (odds ratio, 0.28; 95 percent confidence interval, 0.18-0.42), total infectious complications (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.63), abdominal infections including dehiscence (odds ratio, 0.59; 95 percent confidence interval, 0.38-0.94), abdominal infections excluding dehiscence (odds ratio, 0.52; 95 percent confidence interval, 0.31-0.86), wound complications including dehiscence (odds ratio, 0.55; 95 percent confidence interval, 0.34-0.89), and wound complications excluding dehiscence (odds ratio, 0.43; 95 percent confidence interval, 0.25-0.76) all significantly favored primary repair. Meta-analysis of currently published randomized, controlled trials favors primary repair over fecal diversion for penetrating colon injuries.

Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.

PubMed

Zelen, Charles M; Poka, Attila; Andrews, James

2013-10-01

Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis. An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being. Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM. In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings. Level I, prospective randomized study.

Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem-Cell Transplantation for Patients With Myelodysplastic Syndrome: A Prospective Randomized Phase III Study of the EBMT (RICMAC Trial).

PubMed

Kröger, Nicolaus; Iacobelli, Simona; Franke, Georg-Nikolaus; Platzbecker, Uwe; Uddin, Ruzena; Hübel, Kai; Scheid, Christof; Weber, Thomas; Robin, Marie; Stelljes, Matthias; Afanasyev, Boris; Heim, Dominik; Deliliers, Giorgio Lambertenghi; Onida, Francesco; Dreger, Peter; Pini, Massimo; Guidi, Stefano; Volin, Liisa; Günther, Andreas; Bethge, Wolfgang; Poiré, Xavier; Kobbe, Guido; van Os, Marleen; Brand, Ronald; de Witte, Theo

2017-07-01

Purpose To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.

Clinical study on the therapeutic role of midodrine in non azotemic cirrhotic patients with tense ascites: a double-blind, placebo-controlled, randomized trial.

PubMed

Ali, Ahmed; Farid, Samar; Amin, Mona; Kassem, Mohamed; Al-Garem, Nouman

2014-10-01

Midodrine is an α-agonist prodrug of desglymidodrine used for the management of hypotension. Midodrine has demonstrated usefulness in hepatorenal syndrome. The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites. This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites (52 men and 15 women; age range, 45-72). One patient declined to participate in the study, 33 patients were randomly assigned to take midodrine hydrochloride, and 33 patients were randomly assigned to take placebo. Out of 67 enrolled patients, 60 patients (30: in midodrine group; 30: in placebo group) completed the study and 6 patients lost to follow up. Patients were assessed for patients’ characteristics, history of tapping their ascetic fluid, laboratory values, and Doppler parameters before and after the study. Average 24-h urine volume was assessed before and after the start of the study. significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy. Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites.

Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

PubMed

Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

2012-10-01

Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

Does press-fit technique reduce tunnel volume enlargement after anterior cruciate ligament reconstruction with autologous hamstring tendons? A prospective randomized computed tomography study.

PubMed

Hwang, Dae-Hee; Shetty, Gautam M; Kim, Jong In; Kwon, Jae Ho; Song, Jae-Kwang; Muñoz, Michael; Lee, Jun Seop; Nha, Kyung-Wook

2013-01-01

The purpose of this prospective, randomized, computed tomography-based study was to investigate whether the press-fit technique reduces tunnel volume enlargement (TVE) and improves the clinical outcome after anterior cruciate ligament reconstruction at a minimum follow-up of 1 year compared with conventional technique. Sixty-nine patients undergoing primary ACL reconstruction using hamstring autografts were randomly allocated to either the press-fit technique group (group A) or conventional technique group (group B). All patients were evaluated for TVE and tunnel widening using computed tomography scanning, for functional outcome using International Knee Documentation Committee and Lysholm scores, for rotational stability using the pivot-shift test, and for anterior laxity using the KT-2000 arthrometer at a minimum of 1-year follow-up. There were no significant differences in TVE between the 2 groups. In group A, in which the press-fit technique was used, mean volume enlargement in the femoral tunnel was 65% compared with 71.5% in group B (P = .84). In group A, 57% (20 of 35) of patients developed femoral TVE compared with 67% (23 of 34) of patients in group B (P = .27). Both groups showed no significant difference for functional outcome (mean Lysholm score P = .73, International Knee Documentation Committee score P = .15), or knee laxity (anterior P = .78, rotational P = .22) at a minimum follow-up of 1 year. In a comparison of press-fit and conventional techniques, there were no significant differences in TVE and clinical outcome at short-term follow-up. Level II, therapeutic study, prospective randomized clinical trial. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Unilateral versus bilateral neck exploration for primary hyperparathyroidism: a prospective randomized controlled trial.

PubMed

Bergenfelz, Anders; Lindblom, Pia; Tibblin, Sten; Westerdahl, Johan

2002-11-01

To compare unilateral and bilateral neck exploration for primary hyperparathyroidism in a prospective randomized controlled trial. Based on the assumption that unilateral neck exploration for a solitary parathyroid adenoma should reduce operating time and morbidity, a variety of minimally invasive procedures have challenged the idea that bilateral neck exploration is the gold standard for the surgical treatment of primary hyperparathyroidism. However, to date, no open prospective randomized trial has been published comparing unilateral and bilateral neck exploration. Ninety-one patients with the preoperative diagnosis of primary hyperparathyroidism were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. The primary end-point was the use of postoperative medication for hypocalcemic symptoms. Eighty-eight patients (97%) were cured. Histology and cure rate did not differ between the two groups. Patients in the bilateral group consumed more oral calcium, had lower serum calcium values on postoperative days 1 to 4, and had a higher incidence of early severe symptomatic hypocalcemia compared with patients in the unilateral group. In addition, for patients undergoing surgery for a solitary parathyroid adenoma, unilateral exploration was associated with a shorter operative time. The cost for the two procedures did not differ. Patients undergoing a unilateral procedure had a lower incidence of biochemical and severe symptomatic hypocalcemia in the early postoperative period compared with patients undergoing bilateral exploration. Unilateral neck exploration with intraoperative parathyroid hormone assessment is a valid surgical strategy in patients with primary hyperparathyroidism with distinct advantages, especially for patients with solitary parathyroid adenoma.

Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

PubMed

Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

2006-01-01

To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (< 30 days) was 1.5% for the MECC group and 2.5% for the CPB group (P = NS). Low-cardiac-output syndrome occurred in 0.66% and 4% for the CPB group (P < .001.). The inflammatory response was significantly reduced with the MECC. Likewise, C-reactive protein release was significantly higher in group B at 24 hours (69.6 +/- 38.5 vs 40.8 +/- 21.8 mg/L for the group A, P < .01) and at 48 hours (116.7 +/- 47.0 vs 65.4 +/- 39.5 mg/L, P < .05) postoperatively. In the CPB group, there was a significantly higher decrease of hematocrit and hemoglobin rate. So, the intraoperative transfusion rate amounted to 6% for the MECC group and 12.8% for the CPB group (P < .001). Patients in the CPB group had significantly higher levels of postoperative blood creatinine and urea. The MECC system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

Stand-alone anchored cage versus cage with plating for single-level anterior cervical discectomy and fusion: a prospective, randomized, controlled study with a 2-year follow-up.

PubMed

Nemoto, Osamu; Kitada, Akira; Naitou, Satoko; Tachibana, Atsuko; Ito, Yuya; Fujikawa, Akira

2015-07-01

To avoid complications associated with plating in anterior cervical discectomy and fusion (ACDF), stand-alone anchored PEEK cage was developed and favourable outcomes with a low rate of dysphasia have been described. The objective of this study was to compare the clinical and radiological outcomes of ACDF using a standalone anchored PEEK cage (PREVAIL; Medtronic Sofamor Danek, Memphis, TN) with those of a PEEK cage with plating in a prospective randomized manner. Fifty patients with single-level cervical radiculopathy were randomly assigned to a PREVAIL or a PEEK cage with plating. Following 3, 6, 12, and 24 months, clinical and radiological outcomes were assessed. The mean surgical time for the patients with a PREVAIL was significantly shorter than that for those with a PEEK cage with plating. The clinical outcomes evaluated by visual analogue scale for pain and the Odom's criteria were comparable between both the groups. Both the groups demonstrated the high fusion rate (92% in PREVAIL; 96% in PEEK cage with plating). The subsidence rate and the improvement of cervical alignment were comparable between both the groups. The incidence of adjacent-level ossification was significantly lower for patients with a PREVAIL than that for those with a PEEK cage with plating. The rate of dysphasia graded by the method of Bazaz and measurement of prevertebral soft tissue swelling indicated no significant differences between both the groups. Our prospective randomized study confirmed that stand-alone anchored PEEK cage is a valid alternative to plating in ACDF with a low rate of adjacent-level ossification. However, the potential to reduce the incidence of dysphasia was not confirmed.

Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

PubMed

da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

2017-06-01

The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p < 0.001) improvement in post-test evaluation (average grade 73.9 %). The correct pre-test (p = 0.556) and post-test (p = 0.729) evaluation and the retention of information (p = 0.408) were not different between the two groups. The course in PHO allowed significant acquisition of knowledge to undergraduate students, but the level of information retention was statistically similar between the traditional classroom form and the e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

PubMed

Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

2013-02-15

Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.

PubMed

Jin, Cai De; Kim, Moo Hyun; Bang, Junghee; Serebruany, Victor

The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017. © 2017 S. Karger AG, Basel.

Critical thinking and reflection exercises in a biochemistry course to improve prospective health professions students' attitudes toward physician-pharmacist collaboration.

PubMed

Van Winkle, Lon J; Cornell, Susan; Fjortoft, Nancy; Bjork, Bryan C; Chandar, Nalini; Green, Jacalyn M; La Salle, Sophie; Viselli, Susan M; Burdick, Paulette; Lynch, Sean M

2013-10-14

To determine the impact of performing critical-thinking and reflection assignments within interdisciplinary learning teams in a biochemistry course on pharmacy students' and prospective health professions students' collaboration scores. Pharmacy students and prospective medical, dental, and other health professions students enrolled in a sequence of 2 required biochemistry courses. They were randomly assigned to interdisciplinary learning teams in which they were required to complete case assignments, thinking and reflection exercises, and a team service-learning project. Students were asked to complete the Scale of Attitudes Toward Physician-Pharmacist Collaboration prior to the first course, following the first course, and following the second course. The physician-pharmacist collaboration scores of prospective health professions students increased significantly (p<0.001). Having prospective health professions students work in teams with pharmacy students to think and reflect in and outside the classroom improves their attitudes toward physician-pharmacist collaboration.

Update on the Methodological Quality of Research Published in The American Journal of Sports Medicine: Comparing 2011-2013 to 10 and 20 Years Prior.

PubMed

Brophy, Robert H; Kluck, Dylan; Marx, Robert G

2016-05-01

In recent years, the number of articles in The American Journal of Sports Medicine (AJSM) has risen dramatically, with an increasing emphasis on evidence-based medicine in orthopaedics and sports medicine. Despite the increase in the number of articles published in AJSM over the past decade, the methodological quality of articles in 2011-2013 has improved relative to those in 2001-2003 and 1991-1993. Meta-analysis. All articles published in AJSM during 2011-2013 were reviewed and classified by study design. For each article, the use of pertinent methodologies, such as prospective data collection, randomization, control groups, and blinding, was recorded. The frequency of each article type and the use of evidence-based techniques were compared relative to 1991-1993 and 2001-2003 by use of Pearson χ(2) testing. The number of research articles published in AJSM more than doubled from 402 in 1991-1993 and 423 in 2001-2003 to 953 in 2011-2013. Case reports decreased from 15.2% to 10.6% to 2.1% of articles published over the study period (P < .001). Cadaveric/human studies and meta-analysis/literature review studies increased from 5.7% to 7.1% to 12.4% (P < .001) and from 0.2% to 0.9% to 2.3% (P = .01), respectively. Randomized, prospective clinical trials increased from 2.7% to 5.9% to 7.4% (P = .007). Fewer studies used retrospective compared with prospective data collection (P < .001). More studies tested an explicit hypothesis (P < .001) and used controls (P < .001), randomization (P < .001), and blinding of those assessing outcomes (P < .001). Multi-investigator trials increased (P < .001), as did the proportion of articles citing a funding source (P < .001). Despite a dramatic increase in the number of published articles, the research published in AJSM shifted toward more prospective, randomized, controlled, and blinded designs during 2011-2013 compared with 2001-2003 and 1991-1993, demonstrating a continued improvement in methodological quality. © 2015 The Author(s).

Angina on the Palm: randomized controlled pilot trial of Palm PDA software for referrals for cardiac testing.

PubMed

Greiver, Michelle; Drummond, Neil; White, David; Weshler, Jason; Moineddin, Rahim

2005-03-01

Personal digital assistants (PDAs) are popular with physicians: in 2003, 33% of Canadian doctors reported using them in their practices. We do not know, however, whether using a PDA changes the behaviour of practising physicians. We studied the effectiveness of a PDA software application to help family physicians diagnose angina among patients with chest pain. Prospective randomized controlled pilot trial using a cluster design. Primary care practices in the Toronto area. Eighteen family physicians belonging to the North Toronto Primary Care Research Network (Nortren) or recruited from a local hospital. We randomized physicians to receive a Palm PDA (which included the angina diagnosis software) or to continue conventional care. Physicians prospectively recorded the process of care for patients aged 30 to 75 presenting with suspected angina, over 7 months. Did the process of care for patients with suspected angina improve when their physicians had PDAs and software? The primary outcomes we looked at were frequency of cardiac stress test orders for suspected angina, and the appropriateness of referral for cardiac stress testing at presentation and for nuclear cardiology testing after cardiac stress testing. Secondary outcome was referrals to cardiologists. The software led to more overall use of cardiac stress testing (81% vs 50%). The absolute increase was 31% (P = .007, 95% confidence interval [CI] 8% to 58%). There was a trend toward more appropriate use of stress testing (48.6% with the PDA vs 28.6% control), an increase of 20% (P = .284, 95% CI -11.54% to 51.4%). There was also a trend toward more appropriate use of nuclear cardiology following cardiac stress testing (63.0% vs 45.5%), an absolute increase of 17.5% (P =.400, 95% CI -13.9% to 48.9%). Referrals to cardiologists did not increase (38.2% with the PDA vs 40.9%, P =.869). A PDA-based software application can lead to improved care for patients with suspected angina seen in family practices; this finding requires confirmation in a larger study.

Advances in surgical management of lumbar degenerative disease.

PubMed

Silber, Jeff S; Anderson, D Greg; Hayes, Victor M; Vaccaro, Alexander R

2002-07-01

The past several years have seen many advances in spine technology. Some of these advances have improved the quality of life of patients suffering from disabling low back pain from degenerative disk disease. Traditional fusion procedures are trending toward less invasive approaches with less iatrogenic soft-tissue morbidity. The diversity of bone graft substitutes is increasing with the potential for significant improvements in fusion success with the future introduction of several well tested bone morphogenic proteins to the spinal market. Biologic solutions to modify the natural history of disk degeneration are being investigated. Recently, electrothermal modulation of the posterior annulus fibrosis has been published as a semi-invasive technique to relieve low back pain generated by fissures in the outer annulus and ingrowing nociceptors (intradiskal electrothermal therapy, and intradiskal electrothermal annuloplasty). Initial results are promising, however, prospective randomized studies comparing this technique with conservative therapy are still lacking. The same is true for artificial nucleus pulposus replacement using hydrogel cushions implanted in the intervertebral space after removal of the nucleus pulposus posterior or through an anterior approach. Intervertebral disk prostheses are presently being studied in small prospective patient cohorts. As with all new developments, careful prospective, long-term trials are needed to fully define the role of these technologies in the management of symptomatic lumbar degenerative disk disease.

Refining Preoperative Therapy for Locally Advanced Rectal Cancer

Cancer.gov

In the PROSPECT trial, patients with locally advanced, resectable rectal cancer will be randomly assigned to receive either standard neoadjuvant chemoradiation therapy or neoadjuvant FOLFOX chemotherapy, with chemoradiation reserved for nonresponders.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

PubMed

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. Level I, prospective randomized study. © The Author(s) 2016.

Is instillation of anesthetic gel necessary in flexible cystoscopic examination? A prospective randomized study.

PubMed

Kobayashi, Takashi; Nishizawa, Koji; Ogura, Keiji

2003-01-01

To determine whether urethral injection of anesthetic and lubricating agent before outpatient flexible cystoscopic examination is worthwhile regarding patient tolerance of pain. A randomized prospective study was conducted. A total of 133 consecutive men scheduled to undergo flexible cystoscopy were randomized to receive 11 mL of 0.2% oxybuprocaine hydrochloride gel (group 1), 11 mL of plain lubricating gel (group 2), or no gel injection (group 3). In every group, 2% lidocaine gel was applied to the fiberscope. Patients recorded the level of pain during gel instillation, scope insertion, and intravesical observation separately on a 100-mm visual analog self-assessment scale. Pain scores for gel instillation were approximately two thirds those for scope insertion and intravesical observation in groups 1 and 2. No significant difference was noted in the pain score of each group during either scope insertion or intravesical observation. Pain during intraurethral gel instillation is significant. Anesthetic gel instillation has no advantage compared with no-gel injection in men when lubricating gel is applied to a flexible fiberscope.

Clinical and electrophysiologic results after intracameral lidocaine 1% anesthesia: a prospective randomized study.

PubMed

Anders, N; Heuermann, T; Rüther, K; Hartmann, C

1999-10-01

To evaluate the efficacy and safety of intracameral lidocaine in cataract surgery compared to peribulbar anesthesia. A prospective, randomized, controlled study. A total of 200 consecutive cataract patients (200 eyes) participated. Eyes were randomly assigned to two groups: one group received 0.15 ml intracameral 1% unpreserved lidocaine combined with topical anesthesia (oxybuprocaine); the other group received 6 ml prilocaine peribulbar before phacoemulsification with sclerocorneal tunnel incision. Duration of surgery was measured; implicit time and amplitudes of the b-waves of the photopic electroretinogram (ERG) potentials (single-flash ERG and the 30-Hz flicker ERG) were recorded; frequencies of intraoperative problems, complications, intraoperative, and postoperative pain were evaluated. After lidocaine anesthesia combined with topical anesthesia, similar complications were found, longer operation time (P < 0.001), and significantly better visual acuity immediately after surgery (P < 0.001). The ERG amplitudes were not significantly reduced after 0.15-ml intracameral lidocaine half an hour after surgery (P > 0.05). Intracameral lidocaine 1% combined with topical anesthesia can be recommended as an alternative procedure to peribulbar anesthesia in cataract surgery with corneoscleral tunnel incision.

Randomized prospective trial of ganciclovir maintenance therapy for cytomegalovirus retinitis.

PubMed

Jacobson, M A; O'Donnell, J J; Brodie, H R; Wofsy, C; Mills, J

1988-07-01

We report the first randomized prospective comparative study of long-term maintenance ganciclovir (9-[2-hydroxy-1-(hydroxymethyl)ethoxymethyl]guanine, BW759U, DHPG) therapy for cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome (AIDS). Eleven retinitis patients who received a 10-day course of ganciclovir induction therapy and then were randomized to receive either immediate daily ganciclovir maintenance therapy or deferred maintenance (eight deferred maintenance, three immediate maintenance) were evaluated for drug efficacy. Median time to retinitis progression was 42 days for the immediate maintenance group compared with 16 days for the deferred maintenance group, (P = 0.07). After crossing over to maintenance therapy, patients in the deferred group had a median time to retinitis progression of 58 days compared to 16 days while not on maintenance therapy (P = 0.13). Only 9% of cultures obtained while patients received maintenance therapy were positive for cytomegalovirus, vs 40% of those obtained off maintenance (P less than 0.001). We can state then that maintenance therapy with ganciclovir delays, but does not halt, progression of cytomegalovirus retinitis and suppresses, but does not eradicate, cytomegalovirus shedding in patients with AIDS.

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

PubMed

Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

2010-01-01

To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

PubMed

Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

2018-06-01

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

Journal of Special Operations Medicine. Volume 4, Edition 1, Winter 2004

DTIC Science & Technology

2004-01-01

an ophthalmologist. He has been instrumental in PRK initiatives, has been a very productive mem- ber of the BISC, knows the risks of our missions...results to SOF mission commanders in a format suit- able for training at the unit level. 1999-3 PROSPECTIVE EVALUATION OF WAVE- FRONT-GUIDED PRK (Year...1 of 3) Conduct a prospective, randomized clinical trial to compare PRK for the treatment of naturally occurring myopia and astigmatism using

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

PubMed

Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung-Hwan; Yoon, Hong Jin; Lee, Dong Ki

2017-07-15

A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic ® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

COMPUTERIZED EXPERT SYSTEM FOR EVALUATION OF AUTOMATED VISUAL FIELDS FROM THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL: METHODS, BASELINE FIELDS, AND SIX-MONTH LONGITUDINAL FOLLOW-UP

PubMed Central

Feldon, Steven E

2004-01-01

ABSTRACT Purpose To validate a computerized expert system evaluating visual fields in a prospective clinical trial, the Ischemic Optic Neuropathy Decompression Trial (IONDT). To identify the pattern and within-pattern severity of field defects for study eyes at baseline and 6-month follow-up. Design Humphrey visual field (HVF) change was used as the outcome measure for a prospective, randomized, multi-center trial to test the null hypothesis that optic nerve sheath decompression was ineffective in treating nonarteritic anterior ischemic optic neuropathy and to ascertain the natural history of the disease. Methods An expert panel established criteria for the type and severity of visual field defects. Using these criteria, a rule-based computerized expert system interpreted HVF from baseline and 6-month visits for patients randomized to surgery or careful follow-up and for patients who were not randomized. Results A computerized expert system was devised and validated. The system was then used to analyze HVFs. The pattern of defects found at baseline for patients randomized to surgery did not differ from that of patients randomized to careful follow-up. The most common pattern of defect was a superior and inferior arcuate with central scotoma for randomized eyes (19.2%) and a superior and inferior arcuate for nonrandomized eyes (30.6%). Field patterns at 6 months and baseline were not different. For randomized study eyes, the superior altitudinal defects improved (P = .03), as did the inferior altitudinal defects (P = .01). For nonrandomized study eyes, only the inferior altitudinal defects improved (P = .02). No treatment effect was noted. Conclusions A novel rule-based expert system successfully interpreted visual field defects at baseline of eyes enrolled in the IONDT. PMID:15747764

WWC Quick Review of the Article "Outcomes of a Prospective Trial of Student-Athlete Drug Testing: The Student Athlete Testing Using Random Notification ('SATURN') Study"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2008

2008-01-01

This study examines whether the Student Athlete Testing Using Random Notification ("SATURN") program affects illicit drug and alcohol use among student athletes. The study experienced high rates of sample attrition. Seven of the 18 study schools (39%) left the study and were not included in the analysis. Some students at the remaining…

Differences in highly cross-linked polyethylene wear between zirconia and cobalt-chromium femoral heads in Japanese patients: a prospective, randomized study.

PubMed

Kawate, Kenji; Ohmura, Tetsuji; Kawahara, Ikuo; Tamai, Katsuya; Ueha, Tomoyuki; Takemura, Kazuo

2009-12-01

The purpose of this study was to compare highly cross-linked polyethylene wear between the zirconia head and the cobalt-chromium head in Japanese patients. A prospective, randomized study was performed to evaluate the outcomes in 32 hips that had zirconia heads and in 30 hips that had cobalt-chromium heads. The mean follow-up periods of both groups were same (5 years). There were no significant differences between the zirconia head and the cobalt-chromium head in the mean polyethylene linear wear per year and the mean volumetric polyethylene wear per year in the steady phase. This study indicates that zirconia head offers no benefits over metal head in terms of wear reduction at 5 years in Japanese patients who have lightweight and thin polyethylene liners.

Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

PubMed

Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

2015-12-01

There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

Carvedilol prospective randomized cumulative survival (COPERNICUS) trial: carvedilol in severe heart failure.

PubMed

Fowler, Michael B

2004-05-06

The impact of carvedilol on the survival of patients with severe heart failure was examined in the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial. The trial recruited 2,289 patients with symptoms at rest or on minimal exertion despite therapy with angiotensin-converting enzyme inhibitors and a left ventricular ejection fraction of < or = 0.25. After an average follow-up period of 10.4 months, mortality was reduced by 34% in the carvedilol group. Carvedilol also reduced the number of days spent in the hospital for any cause by 27% and the number of days spent in the hospital for heart failure by 40%. Patients in the carvedilol group felt better and were less likely to have a serious adverse event. The benefits of carvedilol appeared early and were detected during the up-titration period.

Magnesium Sulfate Reduced Opioid Consumption in Obese Patients Undergoing Sleeve Gastrectomy: a Prospective, Randomized Clinical Trial.

PubMed

Kizilcik, Nurcan; Koner, Ozge

2018-05-12

The purpose of the study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation. A prospective, randomized, placebo-controlled clinical study. University hospital. Eighty patients undergoing sleeve gastrectomy. Visual analog scale for the evaluation of pain, sedation score, mean arterial pressure, heart rate, and total analgesic consumption was recorded. Serum magnesium levels were determined before the operation, at the end of the operation, and at 24 h. There were no significant differences between the groups with respect to demographics, and sedation scores. Cumulative morphine consumption and pain scores were found to be higher in the control group than the magnesium group. Perioperative use of magnesium sulfate reduced postoperative pain and opioid consumption in obese patients undergoing sleeve gastrectomy operations.

Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

PubMed

Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

2016-12-01

The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

Endoscopic versus traditional saphenous vein harvesting: a prospective, randomized trial.

PubMed

Allen, K B; Griffith, G L; Heimansohn, D A; Robison, R J; Matheny, R G; Schier, J J; Fitzgerald, E B; Shaar, C J

1998-07-01

Saphenous vein harvested with a traditional longitudinal technique often results in leg wound complications. An alternative endoscopic harvest technique may decrease these complications. One hundred twelve patients scheduled for elective coronary artery bypass grafting were prospectively randomized to have vein harvested using either an endoscopic (group A, n = 54) or traditional technique (group B, n = 58). Groups A and B, respectively, were similar with regard to length of vein harvested (41 +/- 8 cm versus 40 +/- 14 cm), bypasses done (4.1 +/- 1.1 versus 4.2 +/- 1.4), age, preoperative risk stratification, and risks for wound complication (diabetes, sex, obesity, preoperative anemia, hypoalbuminemia, and peripheral vascular disease). Leg wound complications were significantly (p < or = 0.02) reduced in group A (4% [2 of 51] versus 19% [11 of 58]). Univariate analysis identified traditional incision (p < or = 0.02) and diabetes (p < or = 0.05) as wound complication risk factors. Multiple logistic regression analysis identified only the traditional harvest technique as a risk factor for leg wound complications with no significant interaction between harvest technique and any preoperative risk factor (p < or = 0.03). Harvest rate (0.9 +/- 0.4 cm/min versus 1.2 +/- 0.5 cm/min) was slower for group A (p < or = 0.02) and conversion from endoscopic to a traditional harvest occurred in 5.6% (3 of 54) of patients. In a prospective, randomized trial, saphenous vein harvested endoscopically was associated with fewer wound complications than the traditional longitudinal method.

Prospective randomized trial: outcomes of SF₆ versus C₃F₈ in macular hole surgery.

PubMed

Briand, Sophie; Chalifoux, Emmanuelle; Tourville, Eric; Bourgault, Serge; Caissie, Mathieu; Tardif, Yvon; Giasson, Marcelle; Boivin, Jocelyne; Blanchette, Caty; Cinq-Mars, Benoit

2015-04-01

To compare macular hole (MH) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade. The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications. Prospective, randomized study. Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group. Preoperative data included MH minimum diameter, Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA), cataract staging, and intraocular pressure (IOP) measurement. Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year, and ETDRS BCVA and cataract development/extraction, both 1 year after the MH surgery. Primary MH closure was achieved in 93.3% in the SF6 group and 92.9% in the C3F8 group. Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group. The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant. Regardless of the dye used, similar results were achieved. Finally, the proportion of adverse events was similar in both groups. MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement, MH closure, cataract development/extraction, and adverse events. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

PubMed

Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

2015-12-01

To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Clinical effect of intratympanic dexamethasone injection in acute unilateral tinnitus: A prospective, placebo-controlled, multicenter study.

PubMed

Lee, Hyun-Jin; Kim, Min-Beom; Yoo, Shin-Young; Park, Shi Nae; Nam, Eui-Cheol; Moon, In Seok; Lee, Ho-Ki

2018-01-01

The purpose of this study was to investigate the effectiveness of intratympanic dexamethasone injection (ITDI) in acute tinnitus of presumed cochlear origin. A prospective, randomized, placebo-controlled, double-blinded, multicenter study. Between August 2013 and December 2015, 54 patients with unilateral tinnitus were enrolled at four different centers. Patients were assigned either to an ITDI (n = 27) or an intratympanic normal saline injection (ITNI; n = 27) group through block randomization. Intratympanic injections were administered four times over 2 weeks. At 4 weeks after initial injection, we analyzed the improvement rates of tinnitus using the tinnitus handicap Inventory (THI) and visual analogue scale (VAS) for loudness, awareness, and annoyance. We defined improvement as the reduction of more than 7 points or of more than 20% in the final THI score compared to the initial THI score. The initial mean hearing thresholds and VAS and THI scores of the two groups did not differ significantly. At 4 weeks after initial injection, the mean VAS and THI scores of both groups had significantly reduced. However, the improvement rate did not differ significantly between the groups (ITDI, 51.9%; ITNI, 59.3%). The results indicate that ITDI might not be more effective than ITNI for the treatment of acute unilateral tinnitus. Therefore, ITDI should not be considered as the main treatment for patients presenting with acute tinnitus as the primary symptom. 1b. Laryngoscope, 128:184-188, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Applicability of action planning and coping planning to dental flossing among Norwegian adults: a confirmatory factor analysis approach.

PubMed

Astrøm, Anne Nordrehaug

2008-06-01

Using a prospective design and a representative sample of 25-yr-old Norwegians, this study hypothesized that action planning and coping planning will add to the prediction of flossing at 4 wk of follow-up over and above the effect of intention and previous flossing. This study tested the validity of a proposed 3-factor structure of the measurement model of intention, action planning, and coping planning and for its invariance across gender. A survey was conducted in three Norwegian counties, and 1,509 out of 8,000 randomly selected individuals completed questionnaires assessing the constructs of action planning and coping planning related to daily flossing. A random subsample of 500 participants was followed up at 4 wk with a telephone interview to assess flossing. Confirmatory factor analysis (CFA) confirmed the proposed 3-factor model after respecification. Although the chi-square test was statistically significant [chi(2) = 58.501, degrees of freedom (d.f.) = 17), complementary fit indices were satisfactory [goodness-of-fit index (GFI) = 0.99, root mean squared error of approximation (RMSEA) = 0.04]. Multigroup CFA provided evidence of complete invariance of the measurement model across gender. After controlling for previous flossing, intention (beta = 0.08) and action planning (beta = 0.11) emerged as independent predictors of subsequent flossing, accounting for 2.3% of its variance. Factorial validity of intention, action planning and coping planning, and the validity of action planning in predicting flossing prospectively, was confirmed by the present study.

Surgical treatment of hepatocellular carcinoma: evidence-based outcomes.

PubMed

Yamazaki, Shintaro; Takayama, Tadatoshi

2008-02-07

Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy.

Surgical treatment of hepatocellular carcinoma: Evidence-based outcomes

PubMed Central

Yamazaki, Shintaro; Takayama, Tadatoshi

2008-01-01

Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy. PMID:18205256

Health status, resource consumption, and costs of dysthymia. A multi-center two-year longitudinal study.

PubMed

Barbui, Corrado; Motterlini, Nicola; Garattini, Livio

2006-02-01

In this study we estimated the health status, resource consumption and costs of a large cohort of patients with early and late-onset dysthymia. The DYSCO (DYSthymia COsts) project is a multi-center observational study which prospectively followed for two years a randomly chosen sample of patients with dysthymia in the Italian primary health care system. A total of 501 patients were followed for two years; 81% had early-onset dysthymic disorder. During the study, improvement was seen in most domains of the 36-Item Short Form Health Survey (SF-36) questionnaire. Comparison of the SF-36 scores for the two groups showed that only the physical health index significantly differed during the two years. The use of outpatient consultations, laboratory tests and diagnostic procedures was similar in the two groups, but patients with early-onset dysthymia were admitted significantly more than late-onset cases. Hospital admissions were almost entirely responsible for the higher total cost per patient per year of early-onset dysthymia. A first limitation of this study is that general practitioners were selected on the basis of their willingness to participate, not at random; secondly, no information was collected on concomitant psychiatric comorbidities. The present study provides the first prospective, long-term data on service use and costs in patients with dysthymia. Differently from patients with early-onset dysthymia, patients with late-onset dysthymia were admitted less and cost less.

Outcomes of the modified Brostrom procedure using suture anchors for chronic lateral ankle instability--a prospective, randomized comparison between single and double suture anchors.

PubMed

Cho, Byung-Ki; Kim, Yong-Min; Kim, Dong-Soo; Choi, Eui-Sung; Shon, Hyun-Chul; Park, Kyoung-Jin

2013-01-01

The present prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using single and double suture anchors for chronic lateral ankle instability. A total of 50 patients were followed up for more than 2 years after undergoing the modified Brostrom procedure. Of the 50 procedures, 25 each were performed using single and double suture anchors by 1 surgeon. The Karlsson scale had improved significantly to 89.8 points and 90.6 points in the single and double anchor groups, respectively. Using the Sefton grading system, 23 cases (92%) in the single anchor group and 22 (88%) in the double anchor group achieved satisfactory results. The talar tilt angle and anterior talar translation on stress radiographs using the Telos device had improved significantly to an average of 5.7° and 4.6 mm in the single anchor group and 4.5° and 4.3 mm in the double anchor group, respectively. The double anchor technique was superior with respect to the postoperative talar tilt. The single and double suture anchor techniques produced similar clinical and functional outcomes, with the exception of talar tilt as a reference of mechanical stability. The modified Brostrom procedure using both single and double suture anchors appears to be an effective treatment method for chronic lateral ankle instability. Copyright © 2013 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma.

PubMed

Kaminski, Rafal; Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

PubMed Central

Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K.; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

Objective The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome. PMID:29713647

Maternal and neonatal individual risks and benefits associated with caesarean delivery: multicentre prospective study

PubMed Central

Carroli, Guillermo; Zavaleta, Nelly; Donner, Allan; Wojdyla, Daniel; Faundes, Anibal; Velazco, Alejandro; Bataglia, Vicente; Langer, Ana; Narváez, Alberto; Valladares, Eliette; Shah, Archana; Campodónico, Liana; Romero, Mariana; Reynoso, Sofia; de Pádua, Karla Simônia; Giordano, Daniel; Kublickas, Marius; Acosta, Arnaldo

2007-01-01

Objective To assess the risks and benefits associated with caesarean delivery compared with vaginal delivery. Design Prospective cohort study within the 2005 WHO global survey on maternal and perinatal health. Setting 410 health facilities in 24 areas in eight randomly selected Latin American countries; 123 were randomly selected and 120 participated and provided data Participants 106 546 deliveries reported during the three month study period, with data available for 97 095 (91% coverage). Main outcome measures Maternal, fetal, and neonatal morbidity and mortality associated with intrapartum or elective caesarean delivery, adjusted for clinical, demographic, pregnancy, and institutional characteristics. Results Women undergoing caesarean delivery had an increased risk of severe maternal morbidity compared with women undergoing vaginal delivery (odds ratio 2.0 (95% confidence interval 1.6 to 2.5) for intrapartum caesarean and 2.3 (1.7 to 3.1) for elective caesarean). The risk of antibiotic treatment after delivery for women having either type of caesarean was five times that of women having vaginal deliveries. With cephalic presentation, there was a trend towards a reduced odds ratio for fetal death with elective caesarean, after adjustment for possible confounding variables and gestational age (0.7, 0.4 to 1.0). With breech presentation, caesarean delivery had a large protective effect for fetal death. With cephalic presentation, however, independent of possible confounding variables and gestational age, intrapartum and elective caesarean increased the risk for a stay of seven or more days in neonatal intensive care (2.1 (1.8 to 2.6) and 1.9 (1.6 to 2.3), respectively) and the risk of neonatal mortality up to hospital discharge (1.7 (1.3 to 2.2) and 1.9 (1.5 to 2.6), respectively), which remained higher even after exclusion of all caesarean deliveries for fetal distress. Such increased risk was not seen for breech presentation. Lack of labour was a risk factor for a stay of seven or more days in neonatal intensive care and neonatal mortality up to hospital discharge for babies delivered by elective caesarean delivery, but rupturing of membranes may be protective. Conclusions Caesarean delivery independently reduces overall risk in breech presentations and risk of intrapartum fetal death in cephalic presentations but increases the risk of severe maternal and neonatal morbidity and mortality in cephalic presentations. PMID:17977819

Relapse of Graves' disease after successful outcome of antithyroid drug therapy: results of a prospective randomized study on the use of levothyroxine.

PubMed

Hoermann, Rudolf; Quadbeck, Beate; Roggenbuck, Ulla; Szabolcs, István; Pfeilschifter, Johannes; Meng, Wieland; Reschke, Kirsten; Hackenberg, Klaus; Dettmann, Juergen; Prehn, Brigitte; Hirche, Herbert; Mann, Klaus

2002-12-01

Antithyroid drugs are effective in restoring euthyroidism in Graves' disease, but many patients experience relapse after withdrawal. Prevention of recurrence would therefore be a desirable goal. In a prospective study, patients with successful outcome of 12 to 15 months antithyroid drug therapy were stratified for risk factors and randomly assigned to receive levothyroxine in a variable thyrotropin (TSH)-suppressive dose for 2 years or no treatment. The levothyroxine group was randomized to continue or discontinue levothyroxine after 1 year. End points included relapse of overt hyperthyroidism. Of 346 patients with Graves' disease enrolled 225 were euthyroid 4 weeks after antithyroid drug withdrawal and were randomly assigned to receive levothyroxine (114 patients) or no treatment (controls, 111 patients). Of those not randomized, 39 patients showed early relapse within 4 weeks, 61 endogenous TSH suppression, 7 TSH elevation, and 14 had to be excluded. Dropout rate during the study were 13.3%. Kaplan-Meier analyses showed relapse rates to be similar in the levothyroxine group (20% after 1 year, 32% after 2 years) and the randomized controls (18%, 24%), whereas relapses were significantly more frequent in the follow-up group of patients with endogenously suppressed TSH (33%, 49%). Levothyroxine therapy did not influence TSH-receptor antibody, nor did it reduce goiter size. The best prognostic marker available was basal TSH determined 4 weeks after withdrawal of antithyroid drugs (posttreatment TSH). The study demonstrates that levothyroxine does not prevent relapse of hyperthyroidism after successful restoration of euthyroid function by antithyroid drugs and characterizes posttreatment TSH as a main prognostic marker.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

PubMed

Rasgon, Natalie L; Geist, Cheri L; Kenna, Heather A; Wroolie, Tonita E; Williams, Katherine E; Silverman, Daniel H S

2014-01-01

The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT-) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET). Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE)-based HT, as well as women who continued conjugated equine estrogen (CEE)-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC) area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE). Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease. ClinicalTrials.gov NCT00097058.

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

PubMed

Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain.

PubMed

Sherry, E; Kitchener, P; Smart, R

2001-10-01

Low back pain is one of the most significant medical and socioeconomic problems in modern society. International guidelines call for evidence-based management for the pain and disability associated with musculoskeletal disorders. The purpose of this randomized controlled trial is to address the question of efficacy and appropriateness of vertebral axial decompression (VAX-D) therapy, a new technology that has been shown in clinical research to create negative intradiscal pressures, and has been shown to be effective in treating patients presenting with chronic low back pain (> 3 months duration) with associated leg pain. Successful outcome was defined as a 50% reduction in pain utilizing a 10 cm Visual Analog Pain Scale and an improvement in the level of functioning as measured by patient-nominated disability ratings. Patients were randomly assigned to VAX-D or to TENS which was used as a control treatment or placebo. The TENS treatment demonstrated a success rate of 0%, while VAX-D demonstrated a success rate of 68.4% (p < 0.001). A statistically significant reduction in pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D.

The effect of endometrial scratch on natural-cycle cryopreserved embryo transfer outcomes: a randomized controlled study.

PubMed

Mak, Jennifer Sze Man; Chung, Cathy Hoi Sze; Chung, Jacqueline Pui Wah; Kong, Grace Wing Shan; Saravelos, Sotirios H; Cheung, Lai Ping; Li, Tin-Chiu

2017-07-01

The benefit of endometrial scratch (ES) prior to embryo transfer is controversial. Systemic analysis has confirmed its potential benefit, especially in women with repeated IVF failures, yet most studies have focused on fresh embryo transfer, and its effect on vitrified-warmed embryo transfer (FET) cycles is yet to be explored. We hereby present our prospective, double-blind, randomized controlled study on the evaluation of the implantation and pregnancy rate after ES prior to natural-cycle FET. A total of 299 patients underwent natural-cycle FET and were randomized to receive ES (n = 115) or endocervical manipulation as control (n = 114) prior to FET cycle, and a total of 196 patients had embryo transfer (93 patients in each group). Our study showed no significant difference in the implantation and pregnancy rate, as well as the clinical and ongoing pregnancy or live birth rates between the two groups. It appears that ES does not have any beneficial effect on an unselected group of women undergoing FET in natural cycles. Further studies on its effect in women with recurrent implantation failure after IVF are warranted. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

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

Strength Training Using Elastic Bands: Improvement of Muscle Power and Throwing Performance in Young Female Handball Players.

PubMed

Mascarin, Naryana Cristina; de Lira, Claudio Andre Barbosa; Vancini, Rodrigo Luiz; de Castro Pochini, Alberto; da Silva, Antonio Carlos; Dos Santos Andrade, Marilia

2017-05-01

Imbalance in shoulder-rotator muscles has been considered a risk factor for injuries in handball. Strength training programs (STPs) may play an important preventive role. To verify the effects of an STP using elastic bands on shoulder muscles and ball-throwing speed. Randomized and prospective controlled trial. Exercise physiology laboratory. Thirty-nine female handball players were randomly assigned to an experimental (EG, n = 21, 15.3 ± 1.1 y) or a control (CG, n = 18, 15.0 ± 0.8 y) group. The EG performed the STP with elastic-band progressive exercises for 6 wk before regular handball training, and the CG underwent only their regular training. Before and after the STP, both groups underwent a ball-throwing-speed test and isokinetic test to assess shoulder internal- (IR) and external-rotator muscle performance. Average power values for IR muscles presented a significant group-vs-time interaction effect (F = 3.9, P = .05); EG presented significantly higher values after the STP (P = .03). Ball speed presented higher values in EG after the STP in standing (P = .04) and jumping (P = .03) throws. IR peak-torque values and balance in shoulder-rotator muscles presented no group-vs-time interaction effect. STP using elastic bands performed for 6 wk was effective to improve muscle power and ball speed for young female handball players.

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

A review of escitalopram and citalopram in child and adolescent depression.

PubMed

Carandang, Carlo; Jabbal, Rekha; Macbride, Angela; Elbe, Dean

2011-11-01

To review the basic pharmacology and published literature regarding escitalopram and citalopram in child and adolescent depression. A LITERATURE REVIEW WAS CONDUCTED USING THE SEARCH TERMS: 'escitalopram', 'citalopram', 'depression', 'randomized controlled trial', 'open label trial' and limits set to: Human trials, English Language and All Child (Age 0-18). Additional articles were identified from reference information and poster presentation data. Three prospective, randomized controlled trials (RCT) were found for escitalopram in pediatric depression, and two RCTs were found for citalopram. One RCT each for escitalopram and citalopram showed superiority over placebo on the primary out come measure. Adverse effects in escitalopram and citalopram trials were generally mild to moderate. Suicidality was not assessed systematically in all RCTs reviewed, but did not appear to be elevated over placebo in escitalopram RCTs. One trial reported numerically higher suicide related events for citalopram compared to placebo (14 vs. 5, p=0.06). At present, escitalopram and citalopram should be considered a second-line option for adolescent depression. The US Food and Drug Administration approval of escitalopram for treatment of adolescent depression was based on a single positive RCT. This is less evidence than typically required for approval of a drug for a new indication.

Stressful life events and cancer risk

PubMed Central

Bergelt, C; Prescott, E; Grønbæk, M; Koch, U; Johansen, C

2006-01-01

In a prospective cohort study in Denmark of 8736 randomly selected people, no evidence was found among 1011 subjects who developed cancer that self-reported stressful major life events had increased their risk for cancer. PMID:17106440

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.

Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

PubMed

Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

2009-11-01

This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

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

Anesthetic efficacy of a repeated intraosseous injection following a primary intraosseous injection.

PubMed

Jensen, Joanne; Nusstein, John; Drum, Melissa; Reader, Al; Beck, Mike

2008-02-01

The purpose of this prospective, randomized, single-blinded study was to determine the anesthetic efficacy of a repeated intraosseous injection given 30 minutes after a primary intraosseous injection. Using a crossover design, 55 subjects randomly received a primary X-tip intraosseous injection (Dentsply Inc, York, PA) of 1.4 mL of 2% lidocaine with epinephrine (using the Wand; Milestone Scientific, Deerfield, IL) and a repeated intraosseous or mock injection at 30 minutes in two appointments. The first molar and adjacent teeth were pulp tested every 2 minutes for a total of 120 minutes. Success was defined as obtaining two consecutive 80 readings with the electric pulp tester. Success of the initial intraosseous injection was 100% for the first molar. The repeated intraosseous injection mimicked the initial intraosseous injection in terms of pulpal anesthesia and statistically provided another 15 minutes of pulpal anesthesia. In conclusion, using the methodology presented, repeating the intraosseous injection 30 minutes after an initial intraosseous injection will provide an additional 15 minutes of pulpal anesthesia.

ORGANIC INFLAMMATORY RESPONSE TO REDUCED PREOPERATIVE FASTING TIME, WITH A CARBOHYDRATE AND PROTEIN ENRICHED SOLUTION; A RANDOMIZED TRIAL.

PubMed

de Andrade Gagheggi Ravanini, Guilherme; Portari Filho, Pedro Eder; Abrantes Luna, Renato; Almeida de Oliveira, Vinicius

2015-08-01

this study aims to assess the organic inflammatory response of the video laparoscopic cholecystectomy, with abbreviation of the preoperative fasting to 2h using a carbohydrate and protein enriched solution. this is a randomized, prospective study with patients divided into the following 2 groups: group A, conventional fasting and group B, 2h abbreviated fasting with oral ingestion of a carbohydrate and protein solution. Serum glucose, insulin, interleukin 1, and TNF-α were mesasured before ingestion of the solution, during induction of anesthesia, and 4 h after the end of surgery. thirty-eight patients completed the study without presenting pulmonary complications associated with bronchoaspiration. The postoperative HOMA-IR variance was greater in group A (p = 0.001). the abbreviation of preoperative fasting for 2 h, using carbohydrate and protein enriched solutions, is safe, reduces insulin resistance, and does not increase the risk of bronchoaspiration. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix.

PubMed

El Khouly, Nabih I

2017-04-01

The purpose of this study was to evaluate the effectiveness and safety of transcervical Foley catheter with and without oxytocin versus oxytocin alone for labour induction with unfavourable cervix. This trial enrolled 108 women with singleton pregnancies presented for labour induction with unfavourable cervix. Patients were randomly assigned to receive Foley catheter alone (I), Foley catheter plus oxytocin (II) or oxytocin alone (III). Outcomes were analysed in terms of success of induction, induction delivery interval, route of delivery, dose and duration of oxytocin, and complications. Successful normal vaginal delivery was more common in group I (p = .02) compared to group III. Induction delivery time was statistically shorter in group II and group III (p < .001). Patients in group I required significantly less oxytocin dose and duration (p < .001). This led to our conclusion that induction of labour with Foley catheter without oxytocin increases success rate of normal vaginal delivery; however, it has a longer induction delivery interval with similar complications.

Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial

PubMed Central

2011-01-01

Introduction Succinylcholine and rocuronium are widely used to facilitate rapid sequence induction (RSI) intubation in intensive care. Concerns relate to the side effects of succinylcholine and to slower onset and inferior intubation conditions associated with rocuronium. So far, succinylcholine and rocuronium have not been compared in an adequately powered randomized trial in intensive care. Accordingly, the aim of the present study was to compare the incidence of hypoxemia after rocuronium or succinylcholine in critically ill patients requiring an emergent RSI. Methods This was a prospective randomized controlled single-blind trial conducted from 2006 to 2010 at the University Hospital of Basel. Participants were 401 critically ill patients requiring emergent RSI. Patients were randomized to receive 1 mg/kg succinylcholine or 0.6 mg/kg rocuronium for neuromuscular blockade. The primary outcome was the incidence of oxygen desaturations defined as a decrease in oxygen saturation ≥ 5%, assessed by continuous pulse oxymetry, at any time between the start of the induction sequence and two minutes after the completion of the intubation. A severe oxygen desaturation was defined as a decrease in oxygen saturation ≥ 5% leading to a saturation value of ≤ 80%. Results There was no difference between succinylcholine and rocuronium regarding oxygen desaturations (succinylcholine 73/196; rocuronium 66/195; P = 0.67); severe oxygen desaturations (succinylcholine 20/196; rocuronium 20/195; P = 1.0); and extent of oxygen desaturations (succinylcholine -14 ± 12%; rocuronium -16 ± 13%; P = 0.77). The duration of the intubation sequence was shorter after succinycholine than after rocuronium (81 ± 38 sec versus 95 ± 48 sec; P = 0.002). Intubation conditions (succinylcholine 8.3 ± 0.8; rocuronium 8.2 ± 0.9; P = 0.7) and failed first intubation attempts (succinylcholine 32/200; rocuronium 36/201; P = 1.0) did not differ between the groups. Conclusions In critically ill patients undergoing emergent RSI, incidence and severity of oxygen desaturations, the quality of intubation conditions, and incidence of failed intubation attempts did not differ between succinylcholine and rocuronium. Trial Registration ClinicalTrials.gov, number NCT00355368. PMID:21846380

Minimally Displaced, Isolated Radial Head and Neck Fractures Do Not Require Formal Physical Therapy: Results of a Prospective Randomized Trial.

PubMed

Egol, Kenneth A; Haglin, Jack M; Lott, Ariana; Fisher, Nina; Konda, Sanjit R

2018-04-18

Nondisplaced and minimally displaced fractures of the radial head and neck are common injuries, yet the role of physical therapy (PT) in their treatment is unclear. The aim of this trial was to assess the need for formal PT following a simple fracture of the radial head or neck. Patients who had a nondisplaced or minimally displaced fracture of the radial head or neck and presented to 1 of 2 providers were enrolled prospectively between January 2014 and August 2016. Patients were randomized to receive outpatient PT or perform self-directed home exercise. The follow-up intervals were 6 weeks, 3 months, 6 months, and at least 1 year. The outcome measures were Disabilities of the Arm, Shoulder and Hand (DASH) scores; pain; time to clinical healing; and range of motion. Demographic data were analyzed using the Mann-Whitney U test and Fisher exact test. Independent-samples t tests were utilized to compare outcome measures. Fifty-one patients were enrolled in the study. The average follow-up was 16.6 months. Twenty-five patients were randomized to a home-exercise cohort, and 26 patients were randomized to a formal-outpatient-PT cohort. There were no significant differences in demographics between cohorts. At 6 weeks, the home-exercise cohort had better function as indicated by a significantly lower mean DASH score compared with the PT cohort (p = 0.021). At 3 months, 6 months, and final follow-up, there were no significant differences between cohorts for any outcome measure. Patients who performed home exercises after sustaining a nondisplaced or minimally displaced fracture of the radial head or neck demonstrated better early function at 6 weeks compared with patients who received formal PT. After 6 weeks, there were no significant differences in outcomes. These data suggest that prescribing PT for patients who have an isolated nondisplaced or minimally displaced fracture of the radial head or neck is not cost-effective and that instructing the patient to perform self-directed exercises will be followed by a similar outcome. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Transfusion of cell saver salvaged blood in neonates and infants undergoing open heart surgery significantly reduces RBC and coagulant product transfusions and donor exposures: results of a prospective, randomized, clinical trial.

PubMed

Cholette, Jill M; Powers, Karen S; Alfieris, George M; Angona, Ronald; Henrichs, Kelly F; Masel, Debra; Swartz, Michael F; Daugherty, L Eugene; Belmont, Kevin; Blumberg, Neil

2013-02-01

To evaluate whether transfusion of cell saver salvaged, stored at the bedside for up to 24 hrs, would decrease the number of postoperative allogeneic RBC transfusions and donor exposures, and possibly improve clinical outcomes. Prospective, randomized, controlled, clinical trial. Pediatric cardiac intensive care unit. Infants weighing less than 20 kg (n = 106) presenting for cardiac surgery with cardiopulmonary bypass. Subjects were randomized to a cell saver transfusion group where cell saver blood was available for transfusion up to 24 hrs after collection, or to a control group. Cell saver subjects received cell saver blood for volume replacement and/or RBC transfusions. Control subjects received crystalloid or albumin for volume replacement and RBCs for anemia. Blood product transfusions, donor exposures, and clinical outcomes were compared between groups. Children randomized to the cell saver group had significantly fewer RBC transfusions (cell saver: 0.19 ± 0.44 vs. control: 0.75 ± 1.2; p = 0.003) and coagulant product transfusions in the first 48 hrs post-op (cell saver: 0.09 ± 0.45 vs. control: 0.62 ± 1.4; p = 0.013), and significantly fewer donor exposures (cell saver: 0.60 ± 1.4 vs. control: 2.3 ± 4.8; p = 0.019). This difference persisted over the first week post-op, but did not reach statistical significance (cell saver: 0.64 ± 1.24 vs. control: 1.1 ± 1.4; p = 0.07). There were no significant clinical outcome differences. Cell saver blood can be safely stored at the bedside for immediate transfusion for 24 hrs after collection. Administration of cell saver blood significantly reduces the number of RBC and coagulant product transfusions and donor exposures in the immediate postoperative period. Reduction of blood product transfusions has the potential to reduce transfusion-associated complications and decrease postoperative morbidity. Larger studies are needed to determine whether this transfusion strategy will improve clinical outcomes.

Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

DTIC Science & Technology

2014-09-26

SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

Late results of the Royal Free Hospital prospective controlled trial of prednisolone therapy in hepatitis B surface antigen negative chronic active hepatitis.

PubMed Central

Kirk, A P; Jain, S; Pocock, S; Thomas, H C; Sherlock, S

1980-01-01

A long-term follow-up of at least 10 years or until death of 44 patients taking part in a controlled prospective trial of prednisolone therapy in hepatitis B antigen negative chronic active hepatitis (lupoid hepatitis) has been performed at the Royal Free Hospital, London. Patients presenting between 1963 and 1967 were randomly allocated into control and treatment groups. Ten year life table survival curves showed a significantly improved survival in the treatment group where 63% of patients were alive at 10 years compared with only 27% in the control group (log rank test, P = 0.03). The median survival in the treatment group was 12.2 years compared with 3.3 years in the control group. The mean duration of treatment was 4.5 years. Age, presence of antinuclear factor, cirrhosis, or level of serum transaminases at presentation did not appear to affect survival. Male patients if untreated had a poorer prognosis than females (P = 0.02). The natural history of chronic active hepatitis appeared from clinical, biochemical, and histological findings to be from an active hepatitis or cirrhosis to inactive macronodular cirrhosis. Prednisolone therapy significantly improved survival by reducing mortality in the early active phase of the disease. PMID:6988304

A Meta-Analysis of Randomized Controlled Trials and Prospective Cohort Studies of Eicosapentaenoic and Docosahexaenoic Long-Chain Omega-3 Fatty Acids and Coronary Heart Disease Risk.

PubMed

Alexander, Dominik D; Miller, Paige E; Van Elswyk, Mary E; Kuratko, Connye N; Bylsma, Lauren C

2017-01-01

To conduct meta-analyses of randomized controlled trials (RCTs) to estimate the effect of eicosapentaenoic and docosahexaenoic acid (EPA+DHA) on coronary heart disease (CHD), and to conduct meta-analyses of prospective cohort studies to estimate the association between EPA+DHA intake and CHD risk. A systematic literature search of Ovid/Medline, PubMed, Embase, and the Cochrane Library from January 1, 1947, to November 2, 2015, was conducted; 18 RCTs and 16 prospective cohort studies examining EPA+DHA from foods or supplements and CHD, including myocardial infarction, sudden cardiac death, coronary death, and angina, were identified. Random-effects meta-analysis models were used to generate summary relative risk estimates (SRREs) and 95% CIs. Heterogeneity was examined in subgroup and sensitivity analyses and by meta-regression. Dose-response was evaluated in stratified dose or intake analyses. Publication bias assessments were performed. Among RCTs, there was a nonstatistically significant reduction in CHD risk with EPA+DHA provision (SRRE=0.94; 95% CI, 0.85-1.05). Subgroup analyses of data from RCTs indicated a statistically significant CHD risk reduction with EPA+DHA provision among higher-risk populations, including participants with elevated triglyceride levels (SRRE=0.84; 95% CI, 0.72-0.98) and elevated low-density lipoprotein cholesterol (SRRE=0.86; 95% CI, 0.76-0.98). Meta-analysis of data from prospective cohort studies resulted in a statistically significant SRRE of 0.82 (95% CI, 0.74-0.92) for higher intakes of EPA+DHA and risk of any CHD event. Results indicate that EPA+DHA may be associated with reducing CHD risk, with a greater benefit observed among higher-risk populations in RCTs. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

[Prospective economic evaluation of image-guided radiation therapy for prostate cancer in the framework of the national programme for innovative and costly therapies assessment].

PubMed

Pommier, P; Morelle, M; Perrier, L; de Crevoisier, R; Laplanche, A; Dudouet, P; Mahé, M-A; Chauvet, B; Nguyen, T-D; Créhange, G; Zawadi, A; Chapet, O; Latorzeff, I; Bossi, A; Beckendorf, V; Touboul, E; Muracciole, X; Bachaud, J-M; Supiot, S; Lagrange, J-L

2012-09-01

The main objective of the economical study was to prospectively and randomly assess the additional costs of daily versus weekly patient positioning quality control in image-guided radiotherapy (IGRT), taking into account the modalities of the 3D-imaging: tomography (CBCT) or gold seeds implants. A secondary objective was to prospectively assess the additional costs of 3D versus 2D imaging with portal imaging for patient positioning controls. Economics data are issued from a multicenter randomized medico-economics trial comparing the two frequencies of patient positioning control during prostate IGRT. A prospective cohort with patient positioning control with PI (control group) was constituted for the cost comparison between 3D (IGRT) versus 2D imaging. The economical evaluation was focused to the radiotherapy direct costs, adopting the hospital's point of view and using a microcosting method applied to the parameters that may lead to cost differences between evaluated strategies. The economical analysis included a total of 241 patients enrolled between 2007 and 2011 in seven centres, 183 in the randomized study (128 with CBCT and 55 with fiducial markers) and 58 in the control group. Compared to weekly controls, the average additional cost per patient of daily controls was €847 (CBCT) and €179 (markers). Compared to PI, the average additional cost per patient was €1392 (CBCT) and €997 (fiducial markers) for daily controls; €545 (CBCT) and €818 (markers) in case of weekly controls. A daily frequency for image control in IGRT and 3D images patient positioning control (IGRT) for prostate cancer lead to significant additional cost compared to weekly control and 2D imaging (PI). Long-term clinical assessment will permit to assess the medico-economical ratio of these innovative radiotherapy modalities. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

PubMed

Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

2015-12-01

To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

Air bubble migration is a random event post embryo transfer.

PubMed

Confino, E; Zhang, J; Risquez, F

2007-06-01

Air bubble location following embryo transfer (ET) is the presumable placement spot of embryos. The purpose of this study was to document endometrial air bubble position and migration following embryo transfer. Multicenter prospective case study. Eighty-eight embryo transfers were performed under abdominal ultrasound guidance in two countries by two authors. A single or double air bubble was loaded with the embryos using a soft, coaxial, end opened catheters. The embryos were slowly injected 10-20 mm from the fundus. Air bubble position was recorded immediately, 30 minutes later and when the patient stood up. Bubble marker location analysis revealed a random distribution without visible gravity effect when the patients stood up. The bubble markers demonstrated splitting, moving in all directions and dispersion. Air bubbles move and split frequently post ET with the patient in the horizontal position, suggestive of active uterine contractions. Bubble migration analysis supports a rather random movement of the bubbles and possibly the embryos. Standing up changed somewhat bubble configuration and distribution in the uterine cavity. Gravity related bubble motion was uncommon, suggesting that horizontal rest post ET may not be necessary. This report challenges the common belief that a very accurate ultrasound guided embryo placement is mandatory. The very random bubble movement observed in this two-center study suggests that a large "window" of embryo placement maybe present.

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.

Critical Thinking and Reflection Exercises in a Biochemistry Course to Improve Prospective Health Professions Students’ Attitudes Toward Physician-Pharmacist Collaboration

PubMed Central

Cornell, Susan; Fjortoft, Nancy; Bjork, Bryan C.; Chandar, Nalini; Green, Jacalyn M.; La Salle, Sophie; Viselli, Susan M.; Burdick, Paulette; Lynch, Sean M.

2013-01-01

Objective. To determine the impact of performing critical-thinking and reflection assignments within interdisciplinary learning teams in a biochemistry course on pharmacy students’ and prospective health professions students’ collaboration scores. Design. Pharmacy students and prospective medical, dental, and other health professions students enrolled in a sequence of 2 required biochemistry courses. They were randomly assigned to interdisciplinary learning teams in which they were required to complete case assignments, thinking and reflection exercises, and a team service-learning project. Assessment. Students were asked to complete the Scale of Attitudes Toward Physician-Pharmacist Collaboration prior to the first course, following the first course, and following the second course. The physician-pharmacist collaboration scores of prospective health professions students increased significantly (p<0.001). Conclusions. Having prospective health professions students work in teams with pharmacy students to think and reflect in and outside the classroom improves their attitudes toward physician-pharmacist collaboration. PMID:24159210

Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial

ClinicalTrials.gov

2018-01-16

Complications Wounds; Negative Pressure Wound Therapy; Wound Healing Delayed; Incisional; Panniculectomy; Incisional Negative Pressure Wound Therapy; Incisional Vac; Wound Vac; Obese; Renal Failure; Kidney Transplant; Complications; Wound Healing Complication

Extracorporeal shock waves in the treatment of nonunions.

PubMed

Biedermann, Rainer; Martin, Arho; Handle, Gerhart; Auckenthaler, Thomas; Bach, Christian; Krismer, Martin

2003-05-01

Nonunion remains a major complication after skeletal trauma. In the last decade, extracorporeal shock wave therapy has become a common tool for the treatment of nonunions. To date, no prospective, randomized trial has been conducted to show the efficacy of this form of treatment. This study was performed to determine the value of extracorporeal shock wave therapy for nonunions. Previous published results in the literature and our own clinical results were analyzed and related to the natural history of bony union. No study has proven that extracorporeal shock wave therapy improves bone healing. Clinical studies reporting the acceleration of union after application of shock waves instead seem to misinterpret the natural history of bony union. No evidence supports the treatment of pseudarthroses with extracorporeal shock waves. A randomized, prospective, clinical trial with a control group has to be performed before a final decision can be made regarding this indication for extracorporeal shock wave therapy.

[Laservaporization of the prostate: current status of the greenlight and diode laser].

PubMed

Rieken, M; Bachmann, A; Gratzke, C

2013-03-01

In the last decade laser vaporization of the prostate has emerged as a safe and effective alternative to transurethral resection of the prostate (TURP). This was facilitated in particular by the introduction of photoselective vaporization of the prostate (PVP) with a 532 nm 80 W KTP laser in 2002. Prospective randomized trials comparing PVP and TURP with a maximum follow-up of 3 years mostly demonstrated comparable functional results. Cohort studies showed a safe application of PVP in patients under oral anticoagulation and with large prostates. Systems from various manufacturers with different maximum power output and wavelengths are now available for diode laser vaporization of the prostate. Prospective randomized trials comparing diode lasers and TURP are not yet available. In cohort studies and comparative studies PVP diode lasers are characterized by excellent hemostatic properties but functional results vary greatly with some studies reporting high reoperation rates.

Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

PubMed Central

Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

1989-01-01

In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies. PMID:2529814

Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

PubMed

Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

1989-08-01

In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

Hyperthermia and fever control in brain injury.

PubMed

Badjatia, Neeraj

2009-07-01

Fever in the neurocritical care setting is common and has a negative impact on outcome of all disease types. Meta-analyses have demonstrated that fever at onset and in the acute setting after ischemic brain injury, intracerebral hemorrhage, and cardiac arrest has a negative impact on morbidity and mortality. Data support that the impact of fever is sustained for longer durations after subarachnoid hemorrhage and traumatic brain injury. Recent advances have made eliminating fever and maintaining normothermia feasible. However, there are no prospective randomized trials demonstrating the benefit of fever control in these patient populations, and important questions regarding indications and timing remain. The purpose of this review is to analyze the data surrounding the impact of fever across a range of neurologic injuries to better understand the optimal timing and duration of fever control. Prospective randomized trials are needed to determine whether the beneficial impact of secondary injury prevention is outweighed by the potential risks of prolonged fever control.

Comparing the effects of single shot sciatic nerve block versus posterior capsule local anesthetic infiltration on analgesia and functional outcome after total knee arthroplasty: a prospective, randomized, double-blinded, controlled trial.

PubMed

Safa, Ben; Gollish, Jeffrey; Haslam, Lynn; McCartney, Colin J L

2014-06-01

Peripheral nerve blocks appear to provide effective analgesia for patients undergoing total knee arthroplasty. Although the literature supports the use of femoral nerve block, addition of sciatic nerve block is controversial. In this study we investigated the value of sciatic nerve block and an alternative technique of posterior capsule local anesthetic infiltration analgesia. 100 patients were prospectively randomized into three groups. Group 1: sciatic nerve block; Group 2: posterior local anesthetic infiltration; Group 3: control. All patients received a femoral nerve block and spinal anesthesia. There were no differences in pain scores between groups. Sciatic nerve block provided a brief clinically insignificant opioid sparing effect. We conclude that sciatic nerve block and posterior local anesthetic infiltration do not provide significant analgesic benefits. Copyright © 2014 Elsevier Inc. All rights reserved.

Electronic Cigarettes for Smoking Cessation.

PubMed

Orellana-Barrios, Menfil A; Payne, Drew; Medrano-Juarez, Rita M; Yang, Shengping; Nugent, Kenneth

2016-10-01

The use of electronic cigarettes (e-cigarettes) is increasing, but their use as a smoking-cessation aid is controversial. The reporting of e-cigarette studies on cessation is variable and inconsistent. To date, only 1 randomized clinical trial has included an arm with other cessation methods (nicotine patches). The cessation rates for available clinical trials are difficult to compare given differing follow-up periods and broad ranges (4% at 12 months with non-nicotine e-cigarettes to 68% at 4 weeks with concomitant nicotine e-cigarettes and other cessation methods). The average combined abstinence rate for included prospective studies was 29.1% (combination of 6-18 months׳ rates). There are few comparable clinical trials and prospective studies related to e-cigarettes use for smoking cessation, despite an increasing number of citations. Larger randomized clinical trials are essential to determine whether e-cigarettes are effective smoking-cessation devices. Copyright © 2016 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

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.

Progressive loss of pancreatic function in chronic pancreatitis is delayed by main pancreatic duct decompression. A longitudinal prospective analysis of the modified puestow procedure.

PubMed Central

Nealon, W H; Thompson, J C

1993-01-01

OBJECTIVE: This study evaluated the effect of operative drainage of the main pancreatic duct (MPD) on functional derangements associated with chronic pancreatitis (CP). SUMMARY BACKGROUND DATA: The author previously reported delayed functional impairment in an evaluation of the impact of operative drainage in patients with CP. The author now reports on a prospective study of 143 patients with this diagnosis. METHODS: Each patient underwent 1) ERCP, 2) the Bentiromide PABA, 3) 72-hour fecal fat test, 4) oral glucose tolerance test (OGTT) and 5) fat meal (LIPOMUL)--stimulated pancreatic polypeptide release (PP). All patients were stratified as mild/moderate (M/M) or severe CP on the basis of a 5-point system that was developed by the author. Patients were studied at 16-month intervals. RESULTS: All 143 patients underwent initial and follow-up evaluations in a mean follow-up of 47.3 months; 83 of 143 patients had M/M grade at initial evaluation. Eighty-seven patients underwent (MPD) decompression to relieve abdominal pain. In a separate prospective 17 patients with a diagnosis of CP, a grade of M/M and non-disabling abdominal pain were randomized to operative or non-operative treatment; 9 of these randomized patients were operated upon and 8 were not. No patient improved their grade during follow-up; 47 of 83 M/M patients had operative drainage and 36 did not. This grade was preserved in 41 of 47 (87%) operated patients but in only 8 of the 36 non-operated patients (22%). In the randomized trial, seven of nine operated patients retained their functional status in follow-up, whereas only two of eight patients (25%) randomized to non-operation preserved their functional grade. CONCLUSIONS: These data in this large study as well as among a previous randomized sample, support a policy of early operative drainage before the development of irreversible functional impairment in patients with chronic pancreatitis and associated dilation of the main pancreatic duct. PMID:8489308

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

Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up.

PubMed

Freitas, Maria Cristina Carvalho de Almendra; Fagundes, Ticiane Cestari; Modena, Karin Cristina da Silva; Cardia, Guilherme Saintive; Navarro, Maria Fidela de Lima

2018-01-18

This prospective, randomized, split-mouth clinical trial evaluated the clinical performance of conventional glass ionomer cement (GIC; Riva Self-Cure, SDI), supplied in capsules or in powder/liquid kits and placed in Class I cavities in permanent molars by the Atraumatic Restorative Treatment (ART) approach. A total of 80 restorations were randomly placed in 40 patients aged 11-15 years. Each patient received one restoration with each type of GIC. The restorations were evaluated after periods of 15 days (baseline), 6 months, and 1 year, according to ART criteria. Wilcoxon matched pairs, multivariate logistic regression, and Gehan-Wilcoxon tests were used for statistical analysis. Patients were evaluated after 15 days (n=40), 6 months (n=34), and 1 year (n=29). Encapsulated GICs showed significantly superior clinical performance compared with hand-mixed GICs at baseline (p=0.017), 6 months (p=0.001), and 1 year (p=0.026). For hand-mixed GIC, a statistically significant difference was only observed over the period of baseline to 1 year (p=0.001). Encapsulated GIC presented statistically significant differences for the following periods: 6 months to 1 year (p=0.028) and baseline to 1 year (p=0.002). Encapsulated GIC presented superior cumulative survival rate than hand-mixed GIC over one year. Importantly, both GICs exhibited decreased survival over time. Encapsulated GIC promoted better ART performance, with an annual failure rate of 24%; in contrast, hand-mixed GIC demonstrated a failure rate of 42%.

Phosphatidylethanol Compared with Other Blood Tests as a Biomarker of Moderate Alcohol Consumption in Healthy Volunteers: A Prospective Randomized Study.

PubMed

Kechagias, Stergios; Dernroth, Dženeta Nezirević; Blomgren, Anders; Hansson, Therese; Isaksson, Anders; Walther, Lisa; Kronstrand, Robert; Kågedal, Bertil; Nystrom, Fredrik H

2015-07-01

It is generally agreed that traditional alcohol biomarkers lack in sensitivity to detect hazardous alcohol consumption. The present study was undertaken to evaluate the ability of phosphatidylethanol (PEth) and traditional alcohol markers to detect moderate alcohol consumption and to distinguish between moderate alcohol consumption and abstinence. Forty-four subjects, 32 females and 12 males, were included in the study. They were randomized to alcohol abstention or to alcohol consumption. Female participants consumed 150 ml of red wine (equivalent to 16 g of alcohol) per 24 h and the male participants double the amount. The study lasted for 3 months. Blood samples were drawn at the start and at the end of the study period. Blood samples were analysed for PEth, carbohydrate-deficient transferrin (CDT), mean corpuscular volume (MCV), γ-glutamyltransferase (GGT), aspartate aminotransferase (AST) and alanine aminotransferase (ALT). ROC curves for the various biochemical markers were plotted in order to assess their ability to discriminate between abstention and moderate daily consumption of alcohol. PEth and CDT were the only markers with AUROCs significantly higher than 0.5, and PEth was detected in all participants randomized to alcohol consumption. PEth was the only marker that could detect moderate intake and the present results also indicate that PEth probably can distinguish moderate alcohol consumption from abstinence. © The Author 2015. Medical Council on Alcohol and Oxford University Press. All rights reserved.

Phytomedicine in Otorhinolaryngology and Pulmonology: Clinical Trials with Herbal Remedies

PubMed Central

Moghadam, Koosha Ghazi; Inançlı, Hasan Mete; Bazazy, Nazanin; Plinkert, Peter K.; Efferth, Thomas; Sertel, Serkan

2012-01-01

Phytomedicine has become an important alternative treatment option for patients in the Western world, as they seek to be treated in a holistic and natural way after an unsatisfactory response to conventional drugs. Ever since herbal remedies have been introduced in the Western world, clinicians have raised concerns over their efficacy and possible side-effects. A PubMed (Medline) search was performed covering the last five years (01/07–04/12) and including 55 prospective clinical randomized control trials in the medical specialities Otorhinolaryngology and Pulmonology. In this review, we present evidence-based clinical data with herbal remedies and try to enlighten the question of efficacy and reliability of phytomedicine. PMID:24280678

Homocysteine and cerebrovascular accidents.

PubMed

Datta, Saikat; Pal, Salil K; Mazumdar, Hirak; Bhandari, Biswanath; Bhattacherjee, Sharmistha; Pandit, Sudipta

2009-06-01

Hyperhomocysteinaemia is rapidly emerging as an important risk factor for coronary artery disease, possibly because of its propensity to accelerate atherosclerosis. Whether it is also a risk factor for cerebrovascular accidents (CVA) is a matter of debate till now, as there are conflicting results of the various prospective studies. The present study was performed to correlate the levels of plasma homocysteine levels with that of ischaemic and haemorrhagic CVA. Forty-two cases of CVA were randomly selected over a period of one year, and their risk factors were assessed. It was observed that serum homocysteine levels were significantly raised in those with intracerebral infarcts when compared to those with intracerebral haemorrhage, although homocysteine levels didn't prove to be prognostically significant.

Lymph node metastasis in melanoma: a debate on the significance of nodal metastases, conditional survival analysis and clinical trials.

PubMed

Faries, Mark B; Han, Dale; Reintgen, Michael; Kerivan, Lauren; Reintgen, Douglas; Caracò, Corrado

2018-05-18

While there is no doubt that regional lymph node metastases are an enormously important factor in melanoma staging and treatment, the biology behind this significance and its precise implications for treatment planning have been a leading controversy in melanoma and other solid tumors for over a century. Recent clinical data, including data from prospective randomized clinical trials have refined our understanding of the process of nodal metastases and the advantages and disadvantages of different clinical management strategies. This review presents two points of view in this debate and discusses the results of new data analyses as well as pivotal clinical trials informing the discussion.

Tocolysis in term breech external cephalic version.

PubMed

Nor Azlin, M I; Haliza, H; Mahdy, Z A; Anson, I; Fahya, M N; Jamil, M A

2005-01-01

To study the effect of ritodrine tocolysis on the success of external cephalic version (ECV) and to assess the role of ECV in breech presentation at our centre. A prospective randomized double-blind-controlled trial comparing ritodrine and placebo in ECV of singleton term breech pregnancy at a tertiary hospital. Among the 60 patients who were recruited, there was a success rate of 36.7%. Ritodrine tocolysis significantly improved the success rate of ECV (50% vs. 23%; P=0.032). There was a marked effect of ritodrine tocolysis on the ECV success in nulliparae (36.4% vs. 13.0%) and multiparae (87.5% vs. 57.1%). External cephalic version has shown to reduce the rate of cesarean section for breech presentation by 33.5% in our unit. External cephalic version significantly reduced the rate of cesarean section in breech presentation, and ritodrine tocolysis improved the success of ECV and should be offered to both nulliparous and parous women in the case of term breech presentation.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

PubMed

Harris, Lyndsay N; Ismaila, Nofisat; McShane, Lisa M; Andre, Fabrice; Collyar, Deborah E; Gonzalez-Angulo, Ana M; Hammond, Elizabeth H; Kuderer, Nicole M; Liu, Minetta C; Mennel, Robert G; Van Poznak, Catherine; Bast, Robert C; Hayes, Daniel F

2016-04-01

To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. © 2016 by American Society of Clinical Oncology.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

PubMed Central

Harris, Lyndsay N.; McShane, Lisa M.; Andre, Fabrice; Collyar, Deborah E.; Gonzalez-Angulo, Ana M.; Hammond, Elizabeth H.; Kuderer, Nicole M.; Liu, Minetta C.; Mennel, Robert G.; Van Poznak, Catherine; Bast, Robert C.; Hayes, Daniel F.

2016-01-01

Purpose To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. Methods A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. Results The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. Recommendations In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. PMID:26858339

Prospective randomized comparison of dacarbazine (DTIC) versus DTIC plus interferon-alpha (IFN-alpha) in metastatic melanoma.

PubMed

Young, A M; Marsden, J; Goodman, A; Burton, A; Dunn, J A

2001-01-01

Dacarbazine (DTIC) has been the mainstay of chemotherapy for metastatic melanoma for over two decades, but only 15%-20% of patients respond and benefit is usually transient. Randomized studies combining DTIC with interferon-alpha (IFN-alpha) in advanced disease have so far been inconclusive in terms of response and survival. We report a randomized prospective pilot Phase III trial of DTIC +IFN-alpha in patients with metastatic melanoma. The primary endpoint was death. A total of 61 patients were randomized between April 1995 and April 1998. Differences in survival between groups were assessed using log-rank analysis. Quality of life was measured using the European Organization for Research on Treatment of Cancer QLQ C30 (+3) questionnaire. Fifty-seven patients died during the study. The median survival for patients receiving DTIC was 7.2 months (95% confidence interval (CI) 4.4-9.0); it was 4.8 months for DTIC + IFN-alpha (95% CI 2.0-8.0). There was no significant difference in survival between the two treatment arms (chi2 unadjusted = 0.15, P = 0.70; chi2 adjusted = 0.01, P = 0.91). The 6-month survival of those patients randomized to DTIC alone was 58% compared with 40% for those patients randomized to DTIC + IFN-alpha. There were no differences in quality of life between treatment groups. This study failed to demonstrate a survival benefit for patients receiving IFN-alpha in combination with DTIC. These results are inconclusive primarily owing to the small size of the trial. A meta-analysis is required to determine whether there is a role for the addition of IFN-alpha to DTIC in the treatment of this disease.

Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study.

PubMed

Wang, Chung-Jing; Huang, Shi-Wei; Chang, Chien-Hsing

2009-06-01

The aim of our study was to evaluate the effect of tamsulosin in improving symptoms in patients with indwelling double-J ureteral stents. This prospective study lasted from April 2006 to March 2008. All the patients with symptomatic lower ureteral stones with <15 mm diameter were enrolled, and were prospectively randomized (random numbers table) into two groups. A total of 154 patients, with insertion of a double-J ureteral stent after ureteroscopic stone removal. In group 1, 75 patients were enrolled and received placebo for 2 weeks. Group 2 included 79 patients who received 0.4 mg of tamsulosin, once daily for 2 weeks. All patients completed the validated ureteral stent symptom questionnaire (USSQ) and quality of life of international prostate symptom scale (IPSS) for evaluating the symptoms of double-J stents and quality of life after double-J stent insertion and removal, respectively. The analysis of the questionnaire at W1 revealed a significant difference in the main score index of urinary symptoms, body pain and general health between groups 1 and 2. When comparing W1 evaluation with that of W4 after double-J removal, both groups showed significant worsening of urinary symptoms, body pain, general health and work performance, except sexual performance. The mean score of quality of life in IPSS was 4.21 in group 1 and 1.6 in group 2. Tamsulosin can improve a subset of stent-related urinary symptoms and quality of life effectively and may be applied in routine clinical practice.

Influence of an apical negative pressure irrigation system on bacterial elimination during endodontic therapy: a prospective randomized clinical study.

PubMed

Pawar, Rekha; Alqaied, Abdullah; Safavi, Kamran; Boyko, Jennifer; Kaufman, Blythe

2012-09-01

Recent in vitro studies that use an apical negative pressure irrigation system, EndoVac, have demonstrated promising results in the production of debris-free root canals, while also preventing potential extrusion of irrigants into the periapical region. We conducted a randomized, controlled, prospective clinical study to determine whether the use of EndoVac irrigation (EndoVac group) was more efficient compared with standard needle irrigation (control group) in obtaining canals from which microbes could not be cultivated. Routine endodontic therapy was performed in 48 patients with necrotic, single-rooted, single-canal teeth. The patients were randomly assigned to either the EndoVac group (n = 25) or control group (n = 23). Irrigation with either method was carried out with 0.5% sodium hypochlorite. After surface disinfection, before instrumentation and on completion of chemomechanical preparation, intracanal microbial samples were obtained and cultured under anaerobic conditions. The frequency of microbial cultivability by using either irrigation system was analyzed. The frequency of obtaining culture-negative root canals was 90.9% and 82.6% for the control group and EndoVac group, respectively. There was no significant difference in the antimicrobial efficacy of either control group or EndoVac group (Fisher exact test, P = .665). Furthermore, no significant association between study variables and the irrigation systems' antimicrobial efficacy was found (P > .05). The results of this prospective in vivo study demonstrate that the antimicrobial efficacy of EndoVac irrigation is comparable to that of standard irrigation. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

PubMed Central

2013-01-01

Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.

PubMed

Gujjar, Arunodaya R; Nandhagopal, Ramachandiran; Jacob, Poovathoor C; Al-Hashim, Abdulhakeem; Al-Amrani, Khalfan; Ganguly, Shyam S; Al-Asmi, Abdullah

2017-07-01

Status Epilepticus (SE) is a common medical emergency carrying a high morbidity and mortality. Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures. Few prospective studies have addressed its use in SE. We aimed to examine the efficacy of intravenous LEV in controlling SE and cluster attacks of seizures (CS), in comparison with IV phenytoin (DPH), using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine to control ongoing seizure, were randomized to receive either medication. Rates of seizure control over 24h, adverse effects and outcomes were compared. A logistic regression model was used to identify outcome predictors. 52 patients with SE and 63 with CS received either LEV or DPH. In the SE group, LEV was effective in18/22(82%) and DPH in 22/30(73.3%) patients in controlling seizures. Among patients with CS, LEV was effective in 31/38(81.6%) and DPH in 20/25(80%). With the use of LEV, DPH or both, SE and CS were controlled among 92% and 96% of patients respectively. Adverse events included hypotension (in 2 on DPH) and transient agitation (2 on LEV). IV Levetiracetam controls status epilepticus or cluster seizures with an efficacy comparable to that of phenytoin. Use of these two agents consecutively may control >90% of all such conditions without resort to anaesthetic agents. Further studies should explore its efficacy in larger cohorts of epileptic emergencies. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

PubMed

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

45 CFR 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the...

Code of Federal Regulations, 2010 CFR

2010-10-01

... presenting the prospect of direct benefit to the individual subjects. 46.405 Section 46.405 Public Welfare... risk but presenting the prospect of direct benefit to the individual subjects. HHS will conduct or fund... procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring...

A comparison of the results of prospective and retrospective cohort studies in the field of digestive surgery.

PubMed

Ukai, Tomohiko; Shikata, Satoru; Nakayama, Takeo; Takemura, Yousuke C

2017-07-01

We compared the results of prospective and retrospective cohort studies in the field of digestive surgery to clarify whether the results of prospective cohort studies were more similar to those of randomized controlled trials (RCTs). We conducted a secondary analysis of the results to compare the results of RCTs with those of cohort studies in meta-analyses of 18 digestive surgical topics. The data from the prospective and retrospective cohort studies were combined. The summary estimates of each design were compared with those of RCTs. We used the Z score to investigate discrepancies. Twenty-nine outcomes of 11 topics were investigated in 289 cohort studies (prospective, n = 69; retrospective, n = 220). These were compared with the outcomes of 123 RCTs. In comparison to retrospective studies, the summary estimates of the prospective cohort studies were more similar to those of the RCTs [19/29 (prospective) vs. 10/29 (retrospective), P = 0.035). Five of the 29 outcomes of prospective studies and 6 of 29 outcomes of retrospective studies (P = 0.99) showed significant discrepancies in comparison to RCTs. In the digestive surgical field, the results of prospective cohort studies tended to be more similar to those of RCTs than retrospective studies; however, there were no significant discrepancies between the two types of cohort study.

A randomized, prospective, double-blind study of the efficacy of dexpanthenol nasal spray on the postoperative treatment of patients with chronic rhinosinusitis after endoscopic sinus surgery.

PubMed

Tantilipikorn, Pongsakorn; Tunsuriyawong, Prayuth; Jareoncharsri, Perapun; Bedavanija, Anan; Assanasen, Paraya; Bunnag, Chaweewan; Metheetrairut, Choakchai

2012-01-01

To assess the efficacy of dexpanthenol nasal spray compared with normal saline spray in the postoperative treatment of patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS). A prospective, randomized controlled study was conducted in CRS patients who underwent ESS. The enrolled patients had never been operated intranasally. These patients received either dexpanthenol or normal saline nasal spray intranasally four times a day for six weeks post-operatively. Fifty CRS patients were recruited in the present study. Age ranged from 23 to 63 years (means 43.4 +/- 11.2 years). Forty-four percent of patients were diagnosed as CRS without nasal polyps (NP) (CRSs NP) and 56% were CRS with NP (CRSw NP). Twenty-five cases were randomly assigned to use dexpanthenol nasal spray whereas the other 25 cases used normal saline nasal spray. The preoperative severity of CRS, determined by the computerized tomography (CT) scan scoring system of Lund-McKay was 13.9 +/- 6.2 in the dexpanthenol group and 13.6 +/- 6.9 in the normal saline group, which were not statistically different (p > 0.05). The endoscopic scoring was 10.2 +/- 2 in the dexpanthenol group and 10.7 +/- 3 in the normal saline group, which were not statistically different (p > 0.05). The mucociliary transit time improvement (time difference between pre- and post-treatment by nasal spray) was 8.4 +/- 3.3 minutes in the dexpanthenol group and 1.7 +/- 1.2 minutes in the normal saline group, which were statistically different (p < 0.05). The majority of the postoperative symptom scores and all of the endoscopic scores of the dexpanthenol group were not statistically different from those of the normal saline group. However, dexpanthenol nasal spray has superior efficacy compared with normal saline nasal spray on improvement of mucociliary clearance and nasal discharge in the postoperative care of CRS patients after ESS.

Comparison of Nerve Stimulation-guided Axillary Brachial Plexus Block, Single Injection versus Four Injections: A Prospective Randomized Double-blind Study.

PubMed

Badiger, Santoshi V; Desai, Sameer N

2017-01-01

A variety of techniques have been described for the axillary block using nerve stimulator, either with single injection, two, three, or four separate injections. Identification of all the four nerves is more difficult and time-consuming than other methods. Aim of the present study is to compare success rate, onset, and duration of sensory and motor anesthesia of axillary block using nerve stimulator, either with single injection after identification of any one of the four nerves or four separate injections following identification of each of nerve. Prospective, randomized, double-blind study. Patients undergoing forearm and hand surgeries under axillary block. One hundred patients, aged 18-75 years, were randomly allocated into two groups of 50 each. Axillary block was performed under the guidance of nerve stimulator with a mixture of 18 ml of 1.5% lignocaine and 18 ml of 0.5% bupivacaine. In the first group ( n = 50), all 36 ml of local anesthetic was injected after the identification of motor response to any one of the nerves and in Group 2, all the four nerves were identified by the motor response, and 9 ml of local anesthetic was injected at each of the nerves. The success rate of the block, onset, and duration of sensory and motor block was assessed. Categorical variables were compared using the Chi-square test, and continuous variables were compared using independent t -test. The success rate of the block with four injection technique was higher compared to single-injection technique (84% vs. 56%, P = 0.02). Four injection groups had a faster onset of sensory and motor block and prolonged duration of analgesia compared to single-injection group ( P < 0.001). There were no significant differences in the incidence of accidental arterial puncture and hemodynamic parameter between the groups. Identification of all the four nerves produced higher success rate and better quality of the block when compared to single-injection technique.

A single dose of erythropoietin reduces perioperative transfusions in cardiac surgery: results of a prospective single-blind randomized controlled trial.

PubMed

Weltert, Luca; Rondinelli, Beatrice; Bello, Ricardo; Falco, Mauro; Bellisario, Alessandro; Maselli, Daniele; Turani, Franco; De Paulis, Ruggero; Pierelli, Luca

2015-07-01

We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; p<0.0005). After baseline Hb was controlled for, there was no difference in the incidence of aRBCt between HRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; p<0.0005). The distribution of number of units transfused was shifted toward fewer units in HRE (p<0.0005). The all-cause mortality at 45 days was 3.00% (HRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). In anemic patients (Hb<13 g/dL), a single high dose of HRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events. © 2015 AABB.

Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial.

PubMed

Ott, O J; Hertel, S; Gaipl, U S; Frey, B; Schmidt, M; Fietkau, R

2012-10-01

The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 ± 20.2 and 55.7 ± 18.0 (p = 0.463), 32.1 ± 24.5 and 34.4 ± 22.5 (p = 0.256), and 27.0 ± 27.7 and 23.5 ± 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 ± 2.9 and 8.1 ± 3.1 (p = 0.207), 4.5 ± 3.2 and 5.0 ± 3.4 (p = 0.507), 3.9 ± 3.6 and 2.8 ± 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy.

Conservative vs Surgical Interventions for Umbilical Pilonidal Sinus: A Multicenter, Double-Blind, Prospective, Randomized Clinical Trial.

PubMed

Kaplan, Mehmet; Ozcan, Onder; Kaplan, Fatma Cigdem; Yalcin, Huseyin Cahit; Salman, Bulent

2016-05-01

Umbilical pilonidal sinus (UPS) is one of the most neglected disorders, and there is still no clear consensus regarding optimal treatment of the disease. We therefore present our data from a prospective, randomized, controlled clinical trial comparing conservative vs surgical treatment of UPS. The study was conducted in Turkey between January 2012 and November 2015. All eligible patients with the diagnosis of UPS (n = 84) were randomized for either conservative treatment (CT, n = 42) or surgical treatment (ST, n = 42). All patients were followed up for at least 2 years; then, the results of both groups were compared. The primary outcomes were initial healing, recurrence, and the cure rate of the disease after each treatment modality. Mean (± SD) age of the patients was 20.83 ± 5.73 years old, and the majority were men (94%). Nearly 60% of the patients had a deep navel, and 55% had intense hair status. The main symptoms were drainage and wetness, pain, itching, and malodor. Overall, in 10 (27.8%) patients, relapse of the disease was observed in the CT group; it was observed in only 1 patient in the ST group (p = 0.002). Initial healing time was significantly shorter in the ST group (p = 0.001). Of the 81 patients who completed the 2-year follow-up, a cure could be obtained in only 28 of 41 patients in the CT group; it was achieved in all 40 patients in the ST group (68.3% vs 100%, respectively; p = 0.0001). This study provided evidence that surgical treatment is superior to conservative surgery regarding the primary and secondary outcomes of UPS at least 2 years after surgery. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Results of a prospective randomized control trial comparing hydrophilic to uncoated catheters in children with neurogenic bladder.

PubMed

DeFoor, William; Reddy, Pramod; Reed, Melissa; VanderBrink, Brian; Jackson, Elizabeth; Zhang, Bin; Denlinger, Julie; Noh, Paul; Minevich, Eugene; Sheldon, Curtis

2017-08-01

Children with neurogenic bladder (NGB) often require a lifetime of clean intermittent catheterization (CIC), typically using uncoated catheters (UCs). Hydrophilic catheters (HCs) have lower friction than UCs with reported less damage to the urethra. The purpose of this study is to compare outcomes between these catheters. An investigator-initiated, prospective, randomized clinical trial was conducted to compare HCs versus UCs. Children aged 2-17 years with NGB on CIC were enrolled for 1 year. Block randomization was used. Dexterity scores were obtained in those who perform self-catheterization. Outcomes were UTI, difficulty passing the catheter, urethral injury, and patient satisfaction. Demographic data is presented in the Table. Seventy-eight patients were enrolled. Age and gender were similar between the groups. Fifteen patients in each group performed CIC via an abdominal wall stoma. Eight and 15 patients withdrew from the UC and HC groups, respectively. The HC group overall had more problems with the catheter, mainly difficulty with handling. There were no differences for passing the catheter, pain, hematuria, or urethral injuries. There were two urinary tract infections (UTIs) in two HC patients and 17 UTIs in seven UC patients (p = 0.003). Patients with UTIs in the HC group went from 16% in the previous year to 5% during the study. Three children in the HC group had three or more UTIs in the year before enrollment and none during the study. The patients that completed the study with HC were overall satisfied and many requested to continue with the HC. HCs may decrease the risk of UTI in children with NGB. Urethral complications were low in both groups. Most HC patients were pleased but some found the slippery coating difficult to handle. Copyright © 2017 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial.

PubMed

Aggarwal, Vivek; Singla, Mamta; Kabi, Debipada

2010-03-01

Anesthetic efficacy of inferior alveolar nerve block decreases in patients with irreversible pulpitis. It was hypothesized that premedication with nonsteroidal anti-inflammatory drugs might improve the success rates in patients with inflamed pulps. Sixty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, double-blind study. The patients were divided into 3 groups on a random basis and were randomly given 1 of the 3 drugs including ibuprofen, ketorolac, and placebo 1 hour before anesthesia. All patients received standard inferior alveolar nerve block of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of initial inferior alveolar nerve block. Pain during treatment was recorded by using a Heft Parker visual analog scale. Success was recorded as none or mild pain. Statistical analysis with nonparametric chi2 tests showed that placebo gave 29% success rate. Premedication with ibuprofen gave 27%, and premedication with ketorolac gave 39% success rate. There was no significant difference between the 3 groups. Preoperative administration of ibuprofen or ketorolac has no significant effect on success rate of inferior alveolar nerve block in patients with irreversible pulpitis. Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

PubMed

Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

2012-05-01

Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

PubMed Central

Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

2014-01-01

Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

PubMed

Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

2016-05-01

Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

PubMed

Dippel, Eric J; Makam, Prakash; Kovach, Richard; George, Jon C; Patlola, Raghotham; Metzger, D Christopher; Mena-Hurtado, Carlos; Beasley, Robert; Soukas, Peter; Colon-Hernandez, Pedro J; Stark, Matthew A; Walker, Craig

2015-01-01

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Suprapatellar Versus Infrapatellar Tibial Nail Insertion: A Prospective Randomized Control Pilot Study.

PubMed

Chan, Daniel S; Serrano-Riera, Rafael; Griffing, Rebecca; Steverson, Barbara; Infante, Anthony; Watson, David; Sagi, H Claude; Sanders, Roy W

2016-03-01

The purpose of this OTA-approved pilot study was to compare the clinical and functional outcomes of the knee joint after infrapatellar (IP) versus suprapatellar (SP) tibial nail insertion. Prospective, randomized. Level I trauma center. After institutional review board approval, skeletally mature patients with OTA 42 tibial shaft fractures were randomized into either an IP or SP nail insertion group after informed consent was obtained. The SP also underwent prenail and postnail insertion patella-femoral (PF) joint arthroscopy. Patients underwent follow-up (6 weeks, 3, 6, and 12 months) with standard radiographs, as well as visual analog score and pain diagram documentation. At the 6-month and 12-month visits, knee function questionnaires (Lysholm knee scale and SF-36) were completed. Magnetic resonance imaging/image (MRI) of the affected knee was obtained at 12 months. Ten patients in each group were required for a power analysis for the anticipated larger randomized control trial, but enrollment in each arm was not limited because of known problems with patient follow-up over a 12-month period. A total of 41 patients/fractures were enrolled in this study. Of those, only 25 patients/fractures (14 IP, 11 SP) fully complied with and completed 12 months of follow-up. Six of 11 SP presented with articular changes (chondromalacia) in the PF joint during the preinsertion arthroscopy. Three patients displayed a change in the articular cartilage based on postnail insertion arthroscopy. At 12 months, all fractures in both groups had proceeded to union. There were no differences between the affected and unaffected knee with respect to range of motion. Functional visual analog score and Lysholm knee scores showed no significant differences between groups (P > 0.05). The SF-36v2 comparison also revealed no significant differences in the overall score, all 4 mental components, and 3/4 physical components (P > 0.05). The bodily pain component score was superior in the SP group (45 vs. 36, P = 0.035). All 11 SP patients obtained MRIs at 1 year. Five of these patients had evidence of chondromalacia on MRI. These findings did not correlate with either the prenail or postnail insertion arthroscopy. Importantly, no patient in the SP group with postnail insertion arthroscopic changes had PF joint pain at 1 year. Overall, there seemed to be no significant differences in pain, disability, or knee range of motion between these 2 tibial intramedullary nail insertion techniques after 12 months of follow-up. Based on this pilot study data, larger prospective trial with long-term follow-up is warranted. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.

PubMed

Kudo, Taiki; Kawakami, Hiroshi; Hayashi, Tsuyoshi; Yasuda, Ichiro; Mukai, Tsuyoshi; Inoue, Hiroyuki; Katanuma, Akio; Kawakubo, Kazumichi; Ishiwatari, Hirotoshi; Doi, Shinpei; Yamada, Reiko; Maguchi, Hiroyuki; Isayama, Hiroyuki; Mitsuhashi, Tomoko; Sakamoto, Naoya

2014-12-01

EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. Prospective, single-blind, randomized, controlled crossover trial. Seven tertiary referral centers. Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. EUS-FNA by using NNP and HNP. The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. This was a single-blinded, crossover study. Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. ( UMIN000005939.). Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Effect of Sleep-Disordered Breathing on Appropriate Implantable Cardioverter-defibrillator Therapy in Patients With Heart Failure

PubMed Central

Kwon, Younghoon; Koene, Ryan J.; Kwon, Osung; Kealhofer, Jessica V.; Adabag, Selcuk; Duval, Sue

2017-01-01

Background Patients with heart failure and reduced ejection fraction are at increased risk of malignant ventricular arrhythmias. Implantable cardioverter-defibrillator (ICD) is recommended to prevent sudden cardiac death in some of these patients. Sleep-disordered breathing (SDB) is highly prevalent in this population and may impact arrhythmogenicity. We performed a systematic review and meta-analysis of prospective studies that assessed the impact of SDB on ICD therapy. Methods and Results Relevant prospective studies were identified in the Ovid MEDLINE, EMBASE, and Google Scholar databases. Weighted risk ratios of the association between SDB and appropriate ICD therapies were estimated using random effects meta-analysis. Nine prospective cohort studies (n=1274) were included in this analysis. SDB was present in 52% of the participants. SDB was associated with a 55% higher risk of appropriate ICD therapies (45% versus 28%; risk ratio, 1.55; 95% confidence interval, 1.32–1.83). In a subgroup analysis based on the subtypes of SDB, the risk was higher in both central (risk ratio, 1.50; 95% confidence interval, 1.11–2.02) and obstructive (risk ratio, 1.43; 95% confidence interval, 1.01–2.03) sleep apnea. Conclusions SDB is associated with an increased risk of appropriate ICD therapy in patients with heart failure and reduced ejection fraction. PMID:28213507

[Tumor markers for bladder cancer: up-to-date study by the Kiel Tumor Bank].

PubMed

Hautmann, S; Eggers, J; Meyhoff, H; Melchior, D; Munk, A; Hamann, M; Naumann, M; Braun, P M; Jünemann, K P

2007-11-01

The number of noninvasive diagnostic tests for bladder cancer has increased tremendously over the last years with a large number of experimental and commercial tests. Comparative analyses of tests for diagnosis, follow-up, and recurrence detection of bladder cancer were performed retrospectively as well as prospectively, unicentrically, and multicentrically. An analysis of multicentric studies with large patient numbers compared with our own Kiel Tumor Bank data is presented. The Kiel Tumor Bank data looked prospectively at 106 consecutive bladder tumor patients from the year 2006. Special focus was put on urine cytology as a reference test, as well as the commercial NMP 22 Bladder Chek. The analysis of the NMP 22 Bladder Chek showed an overall sensitivity of 69% for all tumor grades and stages, with a specificity of 76%. Comparison to multicentric data with an overall sensitivity of 75% for all tumor grades and stages, with a specificity of 73%, showed results similar to those in the literature. Urine cytology showed a comparable overall sensitivity of 73% for all tumor grades and stages, with a specificity of 80%. A large number of noninvasive tests for bladder cancer follow-up with reasonable sensitivity and specificity can currently be used. Because of limited numbers of prospective randomized multicentric studies, no single particular marker for bladder cancer screening can be recommended at this point in time.

[Secondary malignancies after breast cancer surgery. Comparison of retro- and prospective findings].

PubMed

Holdener, E E; Osterwalder, J; Senn, H J; Enderlin, F; Gloor, F

1982-12-04

Second malignancies (SM) represent one of the potential hazards of modern cancer treatment and especially of radio- and chemotherapy after surgery for breast cancer. For this reason, regional tumor registry data (1960-1975) on 1985 breast cancer patients were analyzed for SM in the retrospective part of our study. These data were compared with the prospective part of the study in which 241 patients were randomly assigned to either mastectomy or mastectomy and chemoimmunotherapy (CT + IT). In the retrospective part of the study, SM were observed in 83 cases (4.2%), 49% of which were SM of the contralateral breast. Most frequent extramammary SM were of gastrointestinal (25%), gynecologic (8%) and cerebral (5%) origin. Leukemias were found in 4% of all SM. Median time interval to SM was 5 years and 1 month. Within 5, 10 and 15 years after mastectomy 60%, 85% and 95% of SM were observed respectively. Median survival of patients with SM was 6 1/2 years. In the prospective part of the study, SM were observed in 9 cases (3.7%), 4.1% in the surgical control group and 3.4% in the adjuvant CT + IT group with a median observation time of 6 years post mastectomy. These data are compared to other current adjuvant breast trials and do not indicate as of now an increase in SM under present adjuvant therapy.

Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

PubMed

Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

2016-11-03

The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

Prospective, randomized assessment of transfer of training (ToT) and transfer effectiveness ratio (TER) of virtual reality simulation training for laparoscopic skill acquisition.

PubMed

Gallagher, Anthony G; Seymour, Neal E; Jordan-Black, Julie-Anne; Bunting, Brendan P; McGlade, Kieran; Satava, Richard Martin

2013-06-01

We assessed the effectiveness of ToT from VR laparoscopic simulation training in 2 studies. In a second study, we also assessed the TER. ToT is a detectable performance improvement between equivalent groups, and TER is the observed percentage performance differences between 2 matched groups carrying out the same task but with 1 group pretrained on VR simulation. Concordance between simulated and in-vivo procedure performance was also assessed. Prospective, randomized, and blinded. In Study 1, experienced laparoscopic surgeons (n = 195) and in Study 2 laparoscopic novices (n = 30) were randomized to either train on VR simulation before completing an equivalent real-world task or complete the real-world task only. Experienced laparoscopic surgeons and novices who trained on the simulator performed significantly better than their controls, thus demonstrating ToT. Their performance showed a TER between 7% and 42% from the virtual to the real tasks. Simulation training impacted most on procedural error reduction in both studies (32-42%). The correlation observed between the VR and real-world task performance was r > 0·96 (Study 2). VR simulation training offers a powerful and effective platform for training safer skills.

Milrinone, a phosphodiesterase III inhibitor, prevents reduction of jugular bulb saturation during rewarming from hypothermic cardiopulmonary bypass.

PubMed

Iritakenishi, T; Hayashi, Y; Yamanaka, H; Kamibayashi, T; Ueda, K; Mashimo, T

2012-01-01

Inadequate cerebral oxygen balance during cardiopulmonary bypass may cause neuropsychological dysfunction. Milrinone, a phosphodiesterase III inhibitor, augments cerebral blood flow by direct vasodilatation. We conducted a prospective, randomized study in patients undergoing cardiac surgery with cardiopulmonary bypass to clarify the clinical efficacy of milrinone in the imbalance of cerebral oxygen supply and demand during the rewarming period of cardiopulmonary bypass. This is a prospective, randomized and placebo-controlled study. After anesthesia, a 5.5 F fiberoptic oximeter catheter was inserted into the right jugular bulb retrogradely for monitoring the jugular venous oxyhemoglobin saturation (SjO(2)). Patients were randomly assigned to two groups, one receiving a continuous infusion of milrinone, 0.5 µg/kg/min during hypothermic cardiopulmonary bypass, and the other receiving saline as control. Milrinone significantly prevented the reduction of the jugular venous oxyhemoglobin saturation at 10 minutes from the start of rewarming compared with the control group, but did not do so from 10 to 20 minutes after rewarming. Milrinone suppresses the reduction of SjO(2) and improves the balance of cerebral oxygen supply and demand during the early rewarming period of hypothermic cardiopulmonary bypass.

Informed consent in rhinoplasty: prospective randomized study of risk recall in patients who are given written disclosure of risks versus traditional oral discussion groups.

PubMed

Hong, Paul; Makdessian, Ara Samuel; Ellis, David A F; Taylor, S Mark

2009-06-01

To determine the effectiveness of providing written information in enhancing patient understanding and retention. A multicentre prospective randomized study was conducted in university-affiliated ambulatory surgical centres. One hundred consecutive patients seen for rhinoplasty consultation were included. Patients were randomly assigned to (1) those receiving traditional oral dialogue of the surgical risks or (2) those receiving an oral discussion and a written pamphlet outlining the risks of the procedure. Fourteen to 18 days after the consultation, each patient was contacted for an assessment of risk recall. Overall risk recall was higher in the group that received written information (2.3 vs 1.3 of 5 risks; p < .008). As well, in the group that received a pamphlet, patients with university and postgraduate levels of education had a better rate of recall (p < .05). Female patients in both groups reported higher risk recall (p < .01). Patient risk recall of rhinoplasty is improved with the addition of written information during the informed consent process. As the process of informed consent plays a very decisive role in facial plastic surgery, enhanced postoperative satisfaction may result from the use of supplemental educational materials.

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.

Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

PubMed

Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

2012-02-01

The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p < .05). The median survival time for patients in Group A and Group B were 8.9 and 6.2 months, respectively (p > .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

PubMed

Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

2012-01-01

This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

Drain placement can safely be omitted for open partial nephrectomy: Results from a prospective randomized trial.

PubMed

Kriegmair, Maximilian C; Mandel, Philipp; Krombach, Patrick; Dönmez, Hasan; John, Axel; Häcker, Axel; Michel, Maurice S

2016-05-01

To examine the benefit of drain placement during open partial nephrectomy. Overall, 106 patients treated with open partial nephrectomy were enrolled in a prospective randomized trial. Based on the randomization, a drain was placed or omitted. Complications were assessed according to the Clavien classification. Pain level and requirement for analgesics was evaluated according to a customized pattern. There was no significant difference in the two groups regarding age, body mass index, American Society of Anesthesiologists score, tumor size and nephrometry (preoperative aspects and dimensions used for an anatomical classification). In terms of overall and drain-related complications, no advantage of placing a drain could be proven (P = 0.249). Patients with a drain suffered from a significantly higher pain level (P = 0.01) and showed prolonged mobilization (P < 0.001). There was no difference in bowel movements and requirement of additional analgesics (P = 0.347 and 0.11). The results of the study suggest that drain placement during open partial nephrectomy can safely be omitted, even in cases with violation of the collecting system. © 2016 The Japanese Urological Association.

A Prospective, Randomized, Double-Blind Comparison of 2% Mepivacaine With 1 : 20,000 Levonordefrin Versus 2% Lidocaine With 1 : 100,000 Epinephrine for Maxillary Infiltrations

PubMed Central

Lawaty, Ingrid; Drum, Melissa; Reader, Al; Nusstein, John

2010-01-01

The purpose of this prospective, randomized, double-blind crossover study was to compare the anesthetic efficacy of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine in maxillary central incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary central incisor and first molar infiltrations of 1.8 mL of 2% mepivacaine with 1 : 20,000 levonordefrin and 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine at 2 separate appointments spaced at least 1 week apart. The teeth were electric pulp tested in 2-minute cycles for a total of 60 minutes. Anesthetic success (obtaining 2 consecutive 80 readings with the electric pulp tester within 10 minutes) was not significantly different between 2% mepivacaine with 1 : 20,000 levonordefrin and 2% lidocaine with 1 : 100,000 epinephrine for the central incisor and first molar. However, neither anesthetic agent provided an hour of pulpal anesthesia. PMID:21174567

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

PubMed

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

An Agent for the Prospect Presentation Problem

DTIC Science & Technology

2014-05-01

Economics, 12:133–158. [18] Daniel Kahneman . Thinking , fast and slow . Allen Lane, London, 2011. [19] Daniel Kahneman and Amos Tversky. Prospect theory...u(X) = log(X) (2) 2.2 Prospect Theory The Prospect Theory was presented by Kahneman and Tversky in [19] and later refined to the Cumulative Prospect...fully rationally, but rather use their own de- cision weights when deciding whether to reject or accept a gamble. In his book, Kahneman [18] (p.314

Psychophysiological effects of a web-based stress management system: a prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861].

PubMed

Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

2005-07-25

The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor alpha (TNFalpha) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

A prospective, randomized controlled preclinical trial to evaluate different formulations of biphasic calcium phosphate in combination with a hydroxyapatite collagen membrane to reconstruct deficient alveolar ridges.

PubMed

Nevins, Myron; Nevins, Marc L; Schupbach, Peter; Kim, Soo-Woo; Lin, Zhao; Kim, David M

2013-04-01

Many patients and clinicians would prefer a synthetic particulate bone replacement graft, but most available alloplastic biomaterials have limited osteogenic potential. An alloplast with increased regenerative capacity would be advantageous for the treatment of localized alveolar ridge defects. This prospective, randomized controlled preclinical trial utilized 6 female foxhounds to analyze the osteogenic impact of different formulations of biphasic calcium phosphate (BCP) in combination with an hydroxyapatite-collagen membrane and their ability to reconstruct deficient alveolar ridges for future implant placement. The grafted sites were allowed to heal 3 months, and then trephine biopsies were obtained to perform light microscopic and histomorphometric analyses. All treated sites healed well with no early membrane exposure or adverse soft tissue responses during the healing period. The grafted sites exhibited greater radiopacity than the surrounding native bone with BCP particles seen as radiopaque granules. The graft particles appeared to be well-integrated and no areas of loose particles were observed. Histologic evaluation demonstrated BCP particles embedded in woven bone with dense connective tissue/marrow space. New bone growth was observed around the graft particles as well as within the structure of the graft particulate. There was intimate contact between the graft particles and newly formed bone, and graft particles were bridged by the newly formed bone in all biopsies from the tested groups. The present study results support the potential of these BCP graft particulates to stimulate new bone formation. Clinical studies are recommended to confirm these preclinical findings.

Complex Atheromatosis of the Aortic Arch in Cerebral Infarction

PubMed Central

Capmany, Ramón Pujadas; Ibañez, Montserrat Oliveras; Pesquer, Xavier Jané

2010-01-01

In many stroke patients it is not possible to establish the etiology of stroke. However, in the last two decades, the use of transesophageal echocardiography in patients with stroke of uncertain etiology reveals atherosclerotic plaques in the aortic arch, which often protrude into the lumen and have mobile components in a high percentage of cases. Several autopsy series and retrospective studies of cases and controls have shown an association between aortic arch atheroma and arterial embolism, which was later confirmed by prospectively designed studies. The association with ischemic stroke was particularly strong when atheromas were located proximal to the ostium of the left subclavian artery, when the plaque was ≥ 4 mm thick and particularly when mobile components are present. In these cases, aspirin might not prevent adequately new arterial ischemic events especially stroke. Here we review the evidence of aortic arch atheroma as an independent risk factor for stroke and arterial embolism, including clinical and pathological data on atherosclerosis of the thoracic aorta as an embolic source. In addition, the impact of complex plaques (≥ 4 mm thick, or with mobile components) on increasing the risk of stroke is also reviewed. In non-randomized retrospective studies anticoagulation was superior to antiplatelet therapy in patients with stroke and aortic arch plaques with mobile components. In a retrospective case-control study, statins significantly reduced the relative risk of new vascular events. However, given the limited data available and its retrospective nature, randomized prospective studies are needed to establish the optimal secondary prevention therapeutic regimens in these high risk patients. PMID:21804777

Complex atheromatosis of the aortic arch in cerebral infarction.

PubMed

Capmany, Ramón Pujadas; Ibañez, Montserrat Oliveras; Pesquer, Xavier Jané

2010-08-01

In many stroke patients it is not possible to establish the etiology of stroke. However, in the last two decades, the use of transesophageal echocardiography in patients with stroke of uncertain etiology reveals atherosclerotic plaques in the aortic arch, which often protrude into the lumen and have mobile components in a high percentage of cases. Several autopsy series and retrospective studies of cases and controls have shown an association between aortic arch atheroma and arterial embolism, which was later confirmed by prospectively designed studies. The association with ischemic stroke was particularly strong when atheromas were located proximal to the ostium of the left subclavian artery, when the plaque was ≥ 4 mm thick and particularly when mobile components are present. In these cases, aspirin might not prevent adequately new arterial ischemic events especially stroke. Here we review the evidence of aortic arch atheroma as an independent risk factor for stroke and arterial embolism, including clinical and pathological data on atherosclerosis of the thoracic aorta as an embolic source. In addition, the impact of complex plaques (≥ 4 mm thick, or with mobile components) on increasing the risk of stroke is also reviewed. In non-randomized retrospective studies anticoagulation was superior to antiplatelet therapy in patients with stroke and aortic arch plaques with mobile components. In a retrospective case-control study, statins significantly reduced the relative risk of new vascular events. However, given the limited data available and its retrospective nature, randomized prospective studies are needed to establish the optimal secondary prevention therapeutic regimens in these high risk patients.

The efficacy of nasal tip hold-press on venous cannulation pain in children: a prospective randomize controlled study.

PubMed

Maghsoudi, Behzad; Jookar, Mehrdad; Haddad, Hosein; Zoonobi, Zahra; Rakhshan, Mahnaz

2016-12-22

Venipuncture is a common and quiet unpleasant experience for pediatric patients. The pain associated with venous cannulation disturbs the children. Different methods have been used to minimize the pain. The present study evaluated the efficacy of holding and pressing the tip of the nose on the venipuncture pain in pediatric patients. A prospective randomize controlled study carried out using the Visual analogue scale (YAS) for assessment cannulation pain and the Yale preoperative anxiety scale (YPAS) for the assessment of anxiety before cannulation. 60 patients, 6-12 years old, who needed venipuncture for general anesthesia were divided in to two groups of 30 each: the control and the study group. Nasal tip was held and pressed during venipuncture by the parents in the study group. No intervention was done in the control group. The anxiety scale (YPAS) was not different between the two groups before venous cannulation (P = 0.136). Comparing the two groups. There was no different regarding the change in HR and BP during venous cannulation. There was significantly lower cannulation pain in the study in comparison with the control group (P value = 0.010). Holding and pressing the tip of the nose during venipuncture reduce the severity of venipuncture pain in pediatric patients. This could be secondary to distraction along with the physiological effect of the valsalva maneuver on pain. Therefore, we recommend that holding and pressing the tip of the nose is a safe and effective method for reducing the severity of pain from venipuncture in pediatric patients.

In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial.

PubMed

Boehne, Martin; Jack, Thomas; Köditz, Harald; Seidemann, Kathrin; Schmidt, Florian; Abura, Michaela; Bertram, Harald; Sasse, Michael

2013-02-06

Infused particles induce thrombogenesis, impair microcirculation and modulate immune response. We have previously shown in critically ill children, that particle-retentive in-line filtration reduced the overall complication rate of severe events, length of stay and duration of mechanical ventilation. We now evaluated the influence of in-line filtration on different organ function and thereby elucidated the potential underlying pathophysiological effects of particle infusion. In this single-centre, prospective, randomized controlled trial 807 critically ill children were assigned to either control (n = 406) or filter group (n = 401), the latter receiving in-line filtration for complete infusion therapy. Both groups were compared regarding the differences of incidence rates and its 95% confidence interval (CI) of different organ dysfunction as defined by the International Pediatric Sepsis Consensus Conference 2005. The incidence rates of respiratory (-5.06%; 95% CI, -9.52 to -0.59%), renal (-3.87%; 95% CI, -7.58 to -0.15%) and hematologic (-3.89%; 95% CI, -7.26 to -0.51%) dysfunction were decreased in the filter group. No difference was demonstrated for the occurrence rates of cardiovascular, hepatic, or neurologic dysfunction between both groups. In-line filtration has beneficial effects on the preservation of hematologic, renal and respiratory function in critically ill patients. The presented clinical data further support our hypothesis regarding potential harmful effects of particles. In critically ill patients infused particles may lead to further deterioration of the microcirculation, induce a systemic hypercoagulability and inflammation with consecutive negative effects on organ function. ClinicalTrials.gov number; NCT00209768.

Novel robotic catheter manipulation system integrated with remote magnetic navigation for fully remote ablation of atrial tachyarrhythmias: a two-centre evaluation.

PubMed

Nölker, Georg; Gutleben, Klaus-Jürgen; Muntean, Bogdan; Vogt, Jürgen; Horstkotte, Dieter; Dabiri Abkenari, Lara; Akca, Ferdi; Szili-Torok, Tamas

2012-12-01

Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium. This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system. The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.

A prospective, open, comparative study of 5% potassium hydroxide solution versus cryotherapy in the treatment of genital warts in men*

PubMed Central

Camargo, Caio Lamunier de Abreu; Belda, Walter; Fagundes, Luiz Jorge; Romiti, Ricardo

2014-01-01

BACKGROUND Genital warts are caused by human papillomavirus infection and represent one of the most common sexually transmitted diseases. Many infections are transient but the virus may recur, persist, or become latent. To date, there is no effective antiviral treatment to eliminate HPV infection and most therapies are aimed at the destruction of visible lesions. Potassium hydroxide is a strong alkali that has been shown to be safe and effective for the treatment of genital warts and molluscum contagiosum. Cryotherapy is considered one of the most established treatments for genital warts. No comparative trials have been reported to date on the use of potassium hydroxide for genital warts. OBJECTIVE A prospective, open-label, randomized clinical trial was conducted to compare topical potassium hydroxide versus cryotherapy in the treatment of genital warts affecting immunocompetent, sexually active men. METHODS Over a period of 10 months, 48 patients were enrolled. They were randomly divided into two groups and selected on an alternative basis for either potassium hydroxide therapy or cryotherapy. While response to therapy did not differ substantially between both treatment modalities, side effects such as local pain and post-treatment hypopigmentation were considerably more prevalent in the groups treated using cryotherapy. RESULT In our study, potassium hydroxide therapy proved to be at least as effective as cryotherapy and offered the benefit of a better safety profile. CONCLUSION Topical 5% potassium hydroxide presents an effective, safe, and low-cost treatment modality for genital warts in men and should be included in the spectrum of therapies for genital warts. PMID:24770498

A prospective, open, comparative study of 5% potassium hydroxide solution versus cryotherapy in the treatment of genital warts in men.

PubMed

Camargo, Caio Lamunier de Abreu; Belda Junior, Walter; Fagundes, Luiz Jorge; Romiti, Ricardo

2014-01-01

Genital warts are caused by human papillomavirus infection and represent one of the most common sexually transmitted diseases. Many infections are transient but the virus may recur, persist, or become latent. To date, there is no effective antiviral treatment to eliminate HPV infection and most therapies are aimed at the destruction of visible lesions. Potassium hydroxide is a strong alkali that has been shown to be safe and effective for the treatment of genital warts and molluscum contagiosum. Cryotherapy is considered one of the most established treatments for genital warts. No comparative trials have been reported to date on the use of potassium hydroxide for genital warts. A prospective, open-label, randomized clinical trial was conducted to compare topical potassium hydroxide versus cryotherapy in the treatment of genital warts affecting immunocompetent, sexually active men. Over a period of 10 months, 48 patients were enrolled. They were randomly divided into two groups and selected on an alternative basis for either potassium hydroxide therapy or cryotherapy. While response to therapy did not differ substantially between both treatment modalities, side effects such as local pain and post-treatment hypopigmentation were considerably more prevalent in the groups treated using cryotherapy. In our study, potassium hydroxide therapy proved to be at least as effective as cryotherapy and offered the benefit of a better safety profile. Topical 5% potassium hydroxide presents an effective, safe, and low-cost treatment modality for genital warts in men and should be included in the spectrum of therapies for genital warts.

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

Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; 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

2014-09-01

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 the 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. Copyright © 2014 Elsevier Inc. All rights reserved.

Is diabetes mellitus a risk factor for venous thromboembolism? A systematic review and meta-analysis of case-control and cohort studies.

PubMed

Gariani, Karim; Mavrakanas, Thomas; Combescure, Christophe; Perrier, Arnaud; Marti, Christophe

2016-03-01

Diabetes mellitus is a well-established risk factor for atherosclerotic disease, but its role in the occurrence of venous thromboembolism (VTE) has not been elucidated. We conducted a meta-analysis of published cohort and case-control studies to assess whether diabetes mellitus is a risk factor for VTE. We systematically searched MEDLINE and EMBASE for case-control and prospective cohort studies assessing association between the risk of venous thromboembolism and diabetes. Odds ratios (OR) from case-control studies were combined while for prospective studies hazard ratios (HR) were combined. Models with random effects were used. Meta-analyses were conducted separately for raw and adjusted measures of association. 24 studies were identified including 10 cohort studies (274,501 patients) and 14 case-control studies (1,157,086 patients). Meta-analysis of the prospective cohort studies demonstrated a significant association between diabetes and VTE (HR 1.60; 95% CI 1.35 to 1.89). This association was no longer present after analysis of multi-adjusted HRs (HR 1.10; 95% CI 0.77 to 1.56). Meta-analysis of case-control studies showed a significant association between diabetes and VTE (OR 1.57; 95%CI 1.17 to 2.12), but this association was no longer present when adjusted ORs were used (OR 1.18; 95%CI 0.89 to 1.56). The increased risk of VTE associated with diabetes mainly results from confounders rather than an intrinsic effect of diabetes on venous thrombotic risk. Therefore, no specific recommendations should apply for the management of diabetic patients at risk for VTE. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Coffee intake and the incident risk of cognitive disorders: A dose-response meta-analysis of nine prospective cohort studies.

PubMed

Wu, Lei; Sun, Dali; He, Yao

2017-06-01

Previous epidemiological studies have provided inconsistent conclusions on the impact of coffee consumption in the developing of cognitive disorders. However, no previous meta-analysis has pooled the evidence from the prospective cohort studies to assess the influence of coffee drinking and its potential dose-response patterns on the risk of developing cognitive disorders specifically. Two databases (PubMed and Embase) were searched for evidence of cohort studies from inception to February 2016. We used a generic inverse-variance method with a random-effects model to pool the fully adjusted relative risks (RRs) and the corresponding 95% confidence intervals (CIs). In the dose-response analyses, a generalized least-squares trend estimation model was applied to computing the study-specific slopes. Nine prospective cohort studies involving 34,282 participants were included in our study. The duration of follow-up years ranged from 1.3 to 28. Compared with <1 cup, daily drinking of 1-2 cups of coffee was inversely linked with the occurrence of cognitive disorders (i.e., Alzheimer's disease, dementia, cognitive decline, and cognitive impairment), and the pooled RR (95% CI) was 0.82 (0.71, 0.94) with evidence of non-significant heterogeneity (I 2  = 25%). Non-significant differences were presented for the association between coffee consumption (>3 vs. <1 cup/d) and incident cognitive disorders. The dose-response analysis showed a "J-shaped" curve relationship of the risk of developing cognitive disorders with coffee consumption. A "J-shaped" association was presented between coffee intake and incident cognitive disorders, with the lowest risk of incident cognitive disorders at a daily consumption level of 1-2 cups of coffee. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Complementary treatment with oral Pidotimod plus vitamin C after laser vaporization for female genital warts: a prospective study

PubMed Central

Iatrakis, G; Peitsidou, A; Papandonopolos, L; Nikolopoulou, MK; Papadopoulos, L; Vladareanu, R

2010-01-01

This is a prospective study to assess a complementary treatment for genital warts after laser vaporization. 62 patients were enrolled in two randomized groups: A1: laser vaporization alone. A2: laser vaporization, followed with Pidotimod plus vitamin C for 2 and 1/2 months. The latter treatment shortened the time of warts remission and marginally decreased the rate of the warts' recurrence: 81% versus 67% (N.S.). Despite the non–significant difference, this complementary treatment seems to have some efficiency. PMID:20945819

[Prospect and Current Situation of Immune Checkpoint Inhibitors 
in First-line Treatment in Advanced Non-small Cell Lung Cancer Patients].

PubMed

Wang, Haiyang; Yu, Xiaoqing; Fan, Yun

2017-06-20

With the breakthroughs achieved of programmed death-1 (PD-1)/PD-L1 inhibitors monotherapy as first-line and second-line treatment in advanced non-small cell lung cancer (NSCLC), the treatment strategy is gradually evolving and optimizing. Immune combination therapy expands the benefit population and improves the curative effect. A series of randomized phase III trials are ongoing. In this review, we discuss the prospect and current situation of immune checkpoint inhibitors in first-line treatment in advanced NSCLC patients.

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

Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids?

PubMed

Manchikanti, Laxmaiah; Manchukonda, Rajeev; Pampati, Vidyasagar; Damron, Kim S; Brandon, Doris E; Cash, Kim A; McManus, Carla D

2006-04-01

Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance. To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study. A prospective, consecutive study. Interventional pain management practice setting in the United States. A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present. Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent. The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.

Migraine headache is present in the aura phase

PubMed Central

Hansen, Jakob M.; Lipton, Richard B.; Dodick, David W.; Silberstein, Stephen D.; Saper, Joel R.; Aurora, Sheena K.; Goadsby, Peter J.

2012-01-01

ABSTRACT Objectives: Migraine aura is commonly considered to be a distinct phase of a migraine attack that precedes headache. The objective of the study was to examine a large number of prospectively recorded attacks of migraine with aura and determine the timing of headache and other migraine symptoms relative to aura. Methods: As part of a clinical trial we collected prospective data on the time course of headache and other symptoms relative to the aura. Patients (n = 267) were enrolled from 16 centers, and asked to keep a headache diary for 1 month (phase I). They were asked to record headache symptoms as soon as possible after aura began and always within 1 hour of aura onset. A total of 456 attacks were reported during phase I by 201 patients. These patients were then randomized and included in phase II, during which a total of 405 attacks were reported in 164 patients. In total, we present data from 861 attacks of migraine with aura from 201 patients. Results: During the aura phase, the majority of attacks (73%) were associated with headache. Other migraine symptoms were also frequently reported during the aura: nausea (51%), photophobia (88%), and photophobia (73%). During the first 15 minutes within the onset of aura, 54% of patients reported headache fulfilling the criteria for migraine. Conclusion: Our results indicate that headaches as well as associated migraine symptoms are present early, during the aura phase of the migraine attack in the majority of patients. PMID:23115208

Internal fixation of distal tibiofibular syndesmotic injuries: a systematic review with meta-analysis.

PubMed

Wang, Chen; Ma, Xin; Wang, Xu; Huang, Jiazhang; Zhang, Chao; Chen, Li

2013-09-01

No consensus had been reached about the optimal method for syndesmotic fixation. The present study analysed syndesmotic fixation based on the highest level of clinical evidence in order to obtain more reliable results. Medline, Embase and Cochrane database were searched through the OVID retrieval engine. Manual searching was undertaken afterward to identify additional studies. Only randomized controlled trials (RCT) and prospective comparative studies were selected for final inclusion. Study screening and data extraction were completed independently by two reviewers. All study characteristics were summarized into a table. The extracted data were used for data analysis. Twelve studies were finally included: six of them were RCTs, two were quasi-randomized studies and four were prospective comparative studies. Four comparisons with traditional metallic screw were identified in terms of bioabsorbable screws, tricortical fixation method, suture-button device as well as non-fixation choice in low syndesmotic injuries. Both absorbable screws and the tricortical fixation method showed almost no better results than traditional quadricortical metallic screw (p > 0.05). Additionally, existing studies could not illustrate their efficiency of reducing hardware removal rate. The suture button technique had significantly better functional score (p = 0.003), ankle motion (p = 0.02), time to full weightbearing (p < 0.0001) and much less complications (p = 0.0008) based on short and intermediate term follow-up data. Transfixation in low syndesmotic injuries showed poorer results than the non fixed group in all outcome measurements, but didn't reach a significant level (p > 0.05). The present evidence still couldn't find superior performance of the bioabsorbable screw and tricortical fixation method. Their true effects in decreasing second operation rate need further specific studies. Better results of the suture-button made it a promising technique, but it still needs long-term testing and cost-efficiency studies. The patients with low syndemotic injuries should be well assessed before fixation determination and the indication of screw placement in such conditions needs to be further defined.

Improved Intermittent-clamped Drainage in Lower Lumbar Internal Fixation: A Randomized Prospective Study

PubMed Central

Hao, Qing-Ying; Liu, Chu-Yin; Fu, Chan-Juan; Zhang, Xiao-Hua; Tan, Ming-Sheng

2016-01-01

Background: Continuous negative pressure drainage (CNPD) is widely used after lower lumbar internal fixation; however, it may cause tremendous blood loss and lead to postoperative hemorrhagic anemia. The present study explored the efficacy and safety of improved intermittent-clamped drainage (ICD) for lower lumbar internal fixation. Methods: This was a prospective study that included 156 patients with decompression of the spinal canal and internal fixation for the first time from January 2012 to December 2014. The patients were randomly divided into ICD group and CNPD group, and each group had 78 cases. A drainage tube was placed under the deep fascia in all patients within 10 min after the commencement of wound closure. The postoperative drainage amount at different time points, the hemoglobin level, and postoperative complications were recorded and compared between the two groups. Shapiro-Wilk test, independent samples t-test, and Mann-Whitney U-test were used in this study. Results: The drainage amount was significantly reduced in the ICD group, as compared with the CNPD group (Z = 10.74, P < 0.01). The mean total drainage amount (in ml) of the single-segment and two-segment procedures was significantly greater in the CNPD group than the ICD group (Z = 10.63 and 10.75, respectively; P < 0.01). For the adverse events, there was no significant difference in postoperative temperature, wound problem, and complications between the two groups. Conclusions: The present study showed a statistically significant reduction in postoperative drainage amount between ICD and CNPD groups, and ICD is an effective, convenient, and safe method for routine use in lower lumbar surgery. It is essential to focus on the effect of clamping drainage with long-segment surgical procedure and complex lumbar disease in the further investigation, as well as the effect of clamping on long-term functional outcomes. PMID:27900992

Effective and safe mannitol administration in patients undergoing supratentorial tumor surgery: A prospective, randomized and double blind study.

PubMed

Akcil, Eren Fatma; Dilmen, Ozlem Korkmaz; Karabulut, Esra Sultan; Koksal, Serdar Selcuk; Altindas, Fatis; Tunali, Yusuf

2017-08-01

Although osmotic diuresis with mannitol is commonly used to provide brain relaxation, there is no consensus regarding its optimal dose and combination with loop diuretics. The aim of the present study is to evaluate the effects of mannitol and combination of furosemide with different doses of mannitol on brain relaxation and on blood electrolytes, lactate level, urine output, fluid balance and blood osmolarity in patients undergoing supratentorial tumor surgery. This prospective, randomized, double blind, placebo-controlled study included 51 patients (ASA I-III) scheduled for elective supratentorial craniotomy. Different doses and combinations of diuretics were administered after the bone flap removal. The Group 1 received mannitol at 0.5gkg -1 and furosemide at 0.5mgkg -1 , the Group 2 received mannitol at 1gkg -1 and furosemide at 0.5mgkg -1 , and the Group 3 received mannitol at 0.5gkg -1 and placebo. The primary end-point of the present study is to evaluate the effects of mannitol and combination of furosemide with different doses of mannitol on brain relaxation and the secondary end-points are to evaluate their effects on blood electrolytes, lactate level, urine output, fluid balance and blood osmolarity. This study shows that mannitol alone (0.5gkg -1 ), and the combinations of furosemide (0.5mgkg -1 ) with different doses of mannitol (0.5gkg -1 -1gkg -1 ) provides adequate brain relaxation. However, administration of furosemide with low or high doses of mannitol may cause reduction in the sodium and chloride levels as well as rise in the lactate level. Moreover it may cause high urine output and negative intra-operative fluid balance. Administration of 0.5gkg -1 mannitol provides adequate brain relaxation without causing systemic side effects in patients undergoing supratentorial tumor surgery. This study is registered to clinical trials (Clinical Trials.gov identifier NCT02712476). Copyright © 2017 Elsevier B.V. All rights reserved.

Buffered Lidocaine With Sodium Bicarbonate did not Increase Inferior Alveolar Nerve Block Success Rate in Patients Having Symptomatic Irreversible Pulpitis.

PubMed

Parirokh, Masoud

2016-03-01

Effect of buffered 4% lidocaine on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind study. Schellenberg J, Drum M, Reader A, Nusstein J, Fowler S, Beck M. J Endod 2015;41(6):791-6. The study was supported by Meyers/Reader Graduate Endodontic Support Fund Double blinded randomized controlled trial. Copyright © 2016 Elsevier Inc. All rights reserved.

Extraction Site Preservation Using FDBA With Bioxclude vs. FDBA With Bio-Gide: A Randomized Clinical Trial

DTIC Science & Technology

2015-06-01

neovascularization. J Surgical Res 2015; 193(2): 953-962 48. Zelen CM, Gould L, Serena TE, et al . A prospective, randomized, controlled, multi-center...tissue repair and regeneration. Tiss Eng 2002; 8(2): 295-308. 24. Niknejad H, Peirovi H, Jmjani M, et al . Properties of the amniotic membrane for...Guler R, Ercan MT, Ulutuncel M, et al . Measurement of blood flow by the 133Xe clearance technique to grafts of amnion used in vestibuloplasty. Brit J

Efficacy and mode of action of a noise-sensor light alarm to decrease noise in the pediatric intensive care unit: a prospective, randomized study.

PubMed

Jousselme, Chloé; Vialet, Renaud; Jouve, Elisabeth; Lagier, Pierre; Martin, Claude; Michel, Fabrice

2011-03-01

To determine whether a sound-activated light-alarm device could reduce the noise in the central area of our pediatric intensive care unit and to determine whether this reduction was significant enough to decrease the noise that could be perceived by a patient located in a nearby room. The secondary objective was to determine the mode of action of the device. In a 16-bed pediatric and neonatal intensive care unit, a large and clearly noticeable sound-activated light device was set in the noisiest part of the central area of our unit, and noise measurements were made in the central area and in a nearby room. In a prospective, quasi-experimental design, sound levels were compared across three different situations--no device present, device present and turned on, and device present but turned off--and noise level measurements were made over a total of 18 days. None. Setting a sound-activated light device on or off. When the device was present, the noise was about 2 dB lower in the central area and in a nearby room, but there was no difference in noise level with the device turned on vs. turned off. The noise decrease in the central area was of limited importance but was translated in a nearby room. The sound-activated light device did not directly decrease noise when turned on, but repetition of the visual signal throughout the day raised staff awareness of noise levels over time.

Compressed-Sensing Multi-Spectral Imaging of the Post-Operative Spine

PubMed Central

Worters, Pauline W.; Sung, Kyunghyun; Stevens, Kathryn J.; Koch, Kevin M.; Hargreaves, Brian A.

2012-01-01

Purpose To apply compressed sensing (CS) to in vivo multi-spectral imaging (MSI), which uses additional encoding to avoid MRI artifacts near metal, and demonstrate the feasibility of CS-MSI in post-operative spinal imaging. Materials and Methods Thirteen subjects referred for spinal MRI were examined using T2-weighted MSI. A CS undersampling factor was first determined using a structural similarity index as a metric for image quality. Next, these fully sampled datasets were retrospectively undersampled using a variable-density random sampling scheme and reconstructed using an iterative soft-thresholding method. The fully- and under-sampled images were compared by using a 5-point scale. Prospectively undersampled CS-MSI data were also acquired from two subjects to ensure that the prospective random sampling did not affect the image quality. Results A two-fold outer reduction factor was deemed feasible for the spinal datasets. CS-MSI images were shown to be equivalent or better than the original MSI images in all categories: nerve visualization: p = 0.00018; image artifact: p = 0.00031; image quality: p = 0.0030. No alteration of image quality and T2 contrast was observed from prospectively undersampled CS-MSI. Conclusion This study shows that the inherently sparse nature of MSI data allows modest undersampling followed by CS reconstruction with no loss of diagnostic quality. PMID:22791572

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis.

PubMed

Papachristou, Georgios I; Machicado, Jorge D; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C; Singh, Vikesh K; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O; Triantafyllou, Konstantinos; Barbu, Sorin T; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch; Nawaz, Haq; Park, Walter G; de-Madaria, Enrique; Lee, Peter J; Wu, Bechien U; Greer, Phil J; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

A new challenge in clinical research in childhood ALL: the prospective meta-analysis strategy for intergroup collaboration.

PubMed

Valsecchi, M G; Masera, G

1996-12-01

We consider the problems arising in clinical research on childhood acute lymphoblastic leukemia (ALL). Given the therapeutic progress achieved over the last few decades, any improvement in the outcome for the majority of children with ALL is difficult to assess with the usual size trials. Furthermore, the progress in genetics and molecular biology has now led to the identification of subgroups of children, typically with rare characteristics, for whom new treatments still await evaluation. For both these aspects of clinical research, there is an increasing need for international intergroup cooperation. After a discussion on the role of retrospective meta-analysis and randomized controlled trials in ALL research, we suggest that intergroup studies could be made more feasible, but still scientifically rigorous, by adopting a strategy of prospective meta-analysis. This strategy can be described as follows: i) different groups prospectively plan to ask the same randomized question within their protocols which may differ in other aspects, and to pool their data in order to evaluate treatment effect; ii) the management of the study can be de-centralized, by allowing each group to be responsible for conducting its own protocol. We would like to stimulate the debate on the methodological and practical aspects of research perspectives in ALL (and in pediatric oncology).

Extracorporeal shockwaves versus ultrasound-guided percutaneous lavage for the treatment of rotator cuff calcific tendinopathy: a randomized controlled trial.

PubMed

Del Castillo-González, Federico; Ramos-Alvarez, Juan J; Rodríguez-Fabián, Guillermo; González-Pérez, José; Jiménez-Herranz, Elena; Varela, Enrique

2016-04-01

Extracorporeal shockwave treatment (ESWT) and ultrasound-guided percutaneous lavage (UGPL) are two effective ways of treating rotator cuff calcific tendinopathy (RCCT). The aim of the present study was to compare the effectiveness of these techniques in the treatment of RCCT. Prospective, randomized, controlled trial. Patients treated in our sports medicine and rehabilitation center (Centro Médico Deyre, Madrid. Spain) between January 2007 and December 2013. This randomized study compares the results achieved with these techniques over one year following their use to treat the above condition. Eighty patients received ESWT and 121 received UGPL. A visual analogue scale was used to measure pain, and ultrasound to determine the extent of calcification, at 3, 6, and 12 months after treatment. Pain and the amount of calcification were significantly reduced by both techniques at 3, 6 and 12 months (P<0.001 for each), but significantly more so by UGPL (P<0.001). Both techniques are valid for the treatment of RCCT, although UGPL is associated with a greater reduction of calcification and greater reduction in pain. The results obtained applying UGPL, the low cost and the lack of complications should therefore make the treatment of choice in centers that are appropriately equipped and staffed.

Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial.

PubMed

Seino, Yoshihiko; Momomura, Shin-Ichi; Kihara, Yasuki; Adachi, Hitoshi; Yasumura, Yoshio; Yokoyama, Hiroyuki

2015-01-16

Adaptive servo-ventilation (ASV) therapy, which is a form of noninvasive positive pressure ventilation therapy and uses an innovative ventilator that has simple operability and provides good patient adherence, potentially has therapeutic benefits-suppression of the deterioration and progression of chronic heart failure (CHF) and a reduction in the number of repeated hospitalizations. Therefore, ASV therapy draws attention as a novel, noninvasive nonpharmacotherapy for patients with CHF owing to its hemodynamics-improving effect, and it is currently being accepted in real-world clinical settings in Japan. However, clinical evidence sufficient for treatment recommendation is lacking because a multicenter, randomized, controlled study of ASV therapy has never been conducted. The present study is a confirmatory, prospective, multicenter, collaborative, open-label, blinded-endpoint, parallel-group, randomized, controlled study. At 40 medical institutions in Japan, 200 Japanese outpatients with mild to severe CHF (age: ≥ 20 years; New York Heart Association classification: greater than or equal to class II) will be randomly assigned to either of the following two study groups: the ASV group, in which 100 outpatients undergo guideline-directed medical therapy and ASV therapy for 24 weeks; and the control group, in which 100 outpatients undergo only guideline-directed medical therapy for 24 weeks. The objective of the present study is to confirm whether the ASV group is superior to the control group concerning the improvement of left ventricular contractility and remodeling, both assessed by two-dimensional echocardiography. Furthermore, the present study will also secondarily examine the effects of ASV therapy on the prognosis and quality of life of patients with CHF. ASV therapy using the device has the potential to provide therapeutic benefits based on its simple operability and good patient adherence and possesses the potential to improve left ventricular contractility and remodeling. Therefore, the present study is expected to afford more solid scientific evidence regarding ASV therapy as a novel, noninvasive, nonpharmacological, in-home, long-term ventilation therapy for patients with mild to severe CHF. UMIN identifier: UMIN000006549 , registered on 17 October, 2011.

Glenohumeral corticosteroid injections in adhesive capsulitis: a systematic search and review

PubMed Central

Song, Amos; Higgins, Laurence D.; Newman, Joel; Jain, Nitin B.

2014-01-01

OBJECTIVES To assess the literature on outcomes of corticosteroid injections for adhesive capsulitis, and in particular, image-guided corticosteroid injections. TYPE Systematic search and review LITERATURE SURVEY The databases used were PubMed (1966-present), Embase (1947-present), Web of Science (1900–present), and the Cochrane Central Register of Controlled Trials. Upon reviewing full text articles of these studies, a total of 25 studies were identified for inclusion. The final yield included 7 prospective studies, 16 randomized trials, and 2 retrospective studies. METHODOLOGY This systematic review was formatted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Study criteria were limited to clinical trials, prospective studies, and retrospective studies that specifically evaluated intra-articular corticosteroid injections, both alone and in combination with other treatment modalities, for shoulder adhesive capsulitis. We included studies that were not randomized control trials because our review was not a meta-analysis. Data items extracted from each study included: study design, study population, mean patient age, duration of study, duration of symptoms, intervention, single or multiple injections, location of injections, control population, follow up duration, and outcome measurements. A percent change in outcome measures was calculated when corresponding data was available. Risk of bias in individual studies was assessed when appropriate. SYNTHESIS All studies involved at least one corticosteroid injection intended for placement in the glenohumeral joint but only eight studies used image-guidance for all injections. Seven of these studies reported statistically significant improvements in ROM at 12 weeks of follow-up or earlier. Ninety-two percent of all studies documented a greater improvement in either visual analog pain scores or range of motion after corticosteroid injections in the first 1–6 weeks as compared with the control or comparison group. CONCLUSIONS Corticosteroid injections offer rapid pain relief in the short-term (particularly in the first 6 weeks) for adhesive capsulitis. Long-term outcomes seem to be similar to other treatments including placebo. The added benefit of image-guided corticosteroid injections in improving shoulder outcomes needs further assessment. PMID:24998406

Laser absorption of carbon fiber reinforced polymer with randomly distributed carbon fibers

NASA Astrophysics Data System (ADS)

Hu, Jun; Xu, Hebing; Li, Chao

2018-03-01

Laser processing of carbon fiber reinforced polymer (CFRP) is a non-traditional machining method which has many prospective applications. The laser absorption characteristics of CFRP are analyzed in this paper. A ray tracing model describing the interaction of the laser spot with CFRP is established. The material model contains randomly distributed carbon fibers which are generated using an improved carbon fiber placement method. It was found that CFRP has good laser absorption due to multiple reflections of the light rays in the material’s microstructure. The randomly distributed carbon fibers make the absorptivity of the light rays change randomly in the laser spot. Meanwhile, the average absorptivity fluctuation is obvious during movement of the laser. The experimental measurements agree well with the values predicted by the ray tracing model.

A Review of Escitalopram and Citalopram in Child and Adolescent Depression

PubMed Central

Carandang, Carlo; Jabbal, Rekha; MacBride, Angela; Elbe, Dean

2011-01-01

Objective: To review the basic pharmacology and published literature regarding escitalopram and citalopram in child and adolescent depression. Methods: A literature review was conducted using the search terms: ‘escitalopram’, ‘citalopram’, ‘depression’, ‘randomized controlled trial’, ‘open label trial’ and limits set to: Human trials, English Language and All Child (Age 0–18). Additional articles were identified from reference information and poster presentation data. Results: Three prospective, randomized controlled trials (RCT) were found for escitalopram in pediatric depression, and two RCTs were found for citalopram. One RCT each for escitalopram and citalopram showed superiority over placebo on the primary out come measure. Adverse effects in escitalopram and citalopram trials were generally mild to moderate. Suicidality was not assessed systematically in all RCTs reviewed, but did not appear to be elevated over placebo in escitalopram RCTs. One trial reported numerically higher suicide related events for citalopram compared to placebo (14 vs. 5, p=0.06). Conclusion: At present, escitalopram and citalopram should be considered a second-line option for adolescent depression. The US Food and Drug Administration approval of escitalopram for treatment of adolescent depression was based on a single positive RCT. This is less evidence than typically required for approval of a drug for a new indication. PMID:22114615

[Considerations about the efficiency of treatment regimens with fixed Rifampicin-Isoniazid combinations in pulmonary tuberculosis].

PubMed

Munteanu, Ioana; Husar, Iulia; Didilescu, C; Stoicescu, I P

2004-01-01

Here are presented the results of a prospective, randomized study regarding the efficiency of regimens with fixed drug combination Rifampicin-Isoniazide manufactured by Antibiotics S.A. of Iasi in comparison with single drugs routinely used in treatment of patients with pulmonary tuberculosis. Newly diagnosed (confirmed by smear and culture) pulmonary tuberculosis patients were selected, and those who accepted to be included in the study, were admitted to the National Institute of Pneumology "Marius Nasta" between August 2001 and September 2002. At the time of admission, they were randomized into two groups: 20 patients received fixed drug combination RMP300 HIN150, and 18 patients received RMP and HIN in single drug tablets (2 patients were excluded). The follow-up of the patients was for one year from the date of enclosure. The smear conversion rate was 83,3% for the patients using single drug tablets, and 70% for those using fixed drug combination, motivated with some more severe TB patterns. The success rate was 100% for all TB patients. Although the present study was done for few patients, we can say that it demonstrated the same efficiency of fixed drug combination produced in Romania, with the single drug tablets, and it suggests a better compliance to treatment with a lower price.

[Total-body irradiation in non-Hodgkin's lymphomas as an alternative to chemotherapy].

PubMed

Rühl, U

1977-05-01

On the bases of previous experiences and present results it can be stated that total-body irradiation is an effective therapeutical technique for treatment of lymphocytic non-Hodkin's lymphomas including chronic lymphatic leukemia; first results from prospectively randomized studies even revealed a slight superiority of this method as compared to the scheme of combined cytostatical therapy (CVP) mostly applied at present. Particular advantages of total-body irradiation are the easy applicability, the relatively short time needed for treatment, and the lack of subjective secondary effects. Thus, ambulatory therapy can be performed without any difficulty. The only complication which may occur arises from myelotoxicity reaching its maximum not earlier than after the end of treatment. Careful follow-up of the patients, therefore, is indispensable. The indication of total-body irradiation for the treatment of non-Hodgkin's lymphomas depends on the objective findings, the stage of disease, and mainly on the histological classification.

Merkel cell carcinoma in the community setting: a case report.

PubMed

Callaghan, Cameron M; Amornmarn, Rumpa

2018-04-12

Merkel cell carcinoma (MCC) is a rare neuroendocrine tumor of the skin initially believed to arise from the Merkel cells. In the community setting a general radiation oncologist may only encounter this pathology in a handful of cases over the course of their career. Due to the low incidence of this malignancy, few prospective randomized controlled trials have ever been conducted and therefore guidelines are based on relatively lower levels of evidence upon which the clinical recommendations are made. We discuss the case of a female in her 90s presenting with a classic MCC primary lesion, as well as satellite lesions proximal to both the primary and the draining regional lymph nodes with no evidence of nodal involvement. Here we discuss the presentation, management, treatment planning, underlying pathology, results and sequelae of treatment. We also review new treatment modalities, and the most current staging systems and guidelines.

Hemostatic techniques following multilevel posterior lumbar spine surgery: a randomized control trial.

PubMed

Wu, Jian; Jin, Yongming; Zhang, Jun; Shao, Haiyu; Yang, Di; Chen, Jinping

2014-12-01

This was a prospective, randomized controlled clinical study. To determine the efficacy of absorbable gelatin sponge in reducing blood loss, as well as shortening the length of hospital stay in patients undergoing multilevel posterior lumbar spinal surgery. Absorbable gelatin sponge is reported to decrease postoperative drain output and the length of hospital stay after multilevel posterior cervical spine surgery. However, there is a dearth of literature on prospective study of the efficacy of absorbable gelatin sponge in reducing postoperative blood loss, as well as shortening the length of hospital stay in patients undergoing multilevel posterior lumbar spinal surgery. A total of 82 consecutive patients who underwent multilevel posterior lumbar fusion or posterior lumbar interbody fusion between June 2011 and June 2012 were prospectively randomized into one of the 2 groups according to whether absorbable gelatin sponge for postoperative blood management was used or not. Demographic distribution, total drain output, blood transfusion rate, the length of stay, the number of readmissions, and postoperative complications were analyzed. Total drain output averaged 173 mL in the study group and 392 mL in the control group (P=0.000). Perioperative allogeneic blood transfusion rate were lower in the Gelfoam group (34.1% vs. 58.5%, P=0.046); moreover, length of stay in patients with the use of absorbable gelatin sponge (12.58 d) was significantly shorter (P=0.009) than the patients in the control group (14.46 d). No patient developed adverse reactions attributable to the absorbable gelatin sponge. Application of absorbable gelatin sponge at the end of multilevel posterior lumbar fusion can significantly decrease postoperative drain output and length of hospital stay.

The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial.

PubMed

Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören

2014-03-01

A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

PubMed

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

2012-05-01

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

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.

Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization

PubMed Central

Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J.; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K.; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M.; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J.; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E.; Nordestgaard, Børge G.; Nielsen, Sune F.; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K.; Rookus, Matti A.; van den Hurk, Katja; de Kort, Wim L. A. M.; Couch, Fergus J.; Olson, Janet E.; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M. Pilar; Perez, Jose I. A.; Cox, Angela; Cross, Simon S.; Reed, Malcolm W. R.; Andrulis, Irene L.; Knight, Julia A.; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J.; Tomlinson, Ian; Kerin, Michael J.; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A.; Henderson, Brian E.; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J.; Martens, John W. M.; Tilanus-Linthorst, Madeleine M. A.; Collée, J. Margriet; Hopper, John L.; Southey, Melissa C.; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E.; Ambrosone, Christine B.; Yannoukakos, Drakoulis; Giles, Graham G.; Milne, Roger L.; McLean, Catriona; Fasching, Peter A.; Haeberle, Lothar; Ekici, Arif B.; Beckmann, Matthias W.; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J.; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M.; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J.; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K.; Neuhausen, Susan L.; Anton-Culver, Hoda; Kristensen, Vessela N.; Grenaker Alnæs, Grethe I.; Pierce, Brandon L.; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S.; John, Esther M.; Gammon, Marilie D.; Malone, Kathleen E.; Tessier, Daniel C.; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S.; González-Neira, Anna; Pita, Guillermo; Alonso, M. Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D. P.; Simard, Jacques; Hall, Per; Hunter, David J.; Easton, Douglas F.

2015-01-01

Background: Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. Methods: We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control subjects, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control subjects. Results: The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor–positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P < 5×10–8. Conclusions: Our study provides strong evidence that adult height is a risk factor for breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. PMID:26296642

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Immediate mobilization following fixation of mandible fractures: a prospective, randomized study.

PubMed

Kaplan, B A; Hoard, M A; Park, S S

2001-09-01

To compare outcomes of open reduction and internal fixation of displaced mandible fractures followed by either immediate mobilization or 2 weeks of mandibular-maxillary fixation. A prospective, randomized, single-blinded study was performed. The study was performed between January 1, 1997, and March 30, 2000. Inclusion criteria were displaced fractures between the mandibular angles, age greater than 16 years, and no involvement of the alveolus, ramus, condyles, or maxilla. All fractures were repaired by means of open reduction and internal fixation using 2.0-mm titanium plates secured either in transoral fashion or percutaneously. Data were collected at 6-week and 3- and 6-month postoperative examinations. Variables were assessed by a surgeon blinded to the history of immobilization and included pain, malunion or nonunion, occlusion, trismus, wound status, infection rates, dental hygiene, and weight loss. Twenty-nine consecutive patients were enrolled, 16 patients to immediate function and 13 patients to 2 weeks of mandibular-maxillary fixation. No statistically significant differences were found between groups for any of the variables. Immediate release and temporary immobilization showed mean weight loss of 10 and 8 pounds and trismus of 4.2 and 4.6 cm, respectively. One wound separation and one infection were seen in the immobilization population, and no wound separation or infection was seen in the immediate-release group. Dental hygiene was similar between the groups. No malunion or nonunion was noted in either group. In this prospective and randomized study, no significant differences were noted between the groups receiving either immediate release or 2 weeks of mandibular-maxillary fixation. The findings support the treatment of selective mandible fractures with 2.0-mm miniplates and immediate mobilization.

Effects of using intravenous antibiotic only versus local intrawound vancomycin antibiotic powder application in addition to intravenous antibiotics on postoperative infection in spine surgery in 907 patients.

PubMed

Tubaki, Vijay Ramappa; Rajasekaran, S; Shetty, Ajoy Prasad

2013-12-01

A prospective randomized controlled trial. To assess the ability of local vancomycin powder in controlling postoperative infection in spine surgery. Despite improvements through the use of prophylactic systemic antibiotics, surgical site infections remain a significant problem in spine surgical procedures. Various retrospective and prospective studies have reported the efficacy of local application of vancomycin powder in reducing the infection in animal and human studies. However, there were no randomized control trials that reported on its efficacy. Prospective randomized controls of 907 patients with various spinal pathologies were treated surgically during a period of 18 months. The control group received standard systemic prophylaxis only, whereas the treatment group received vancomycin powder in the surgical wound in addition to systemic prophylaxis. Patient demographics, comorbidities, level of spinal pathology, estimated blood loss, nutritional status, and hemoglobin were recorded. Incidence of infection was the primary outcome evaluated. There were 8 infections (1.68%) in the control group (6 instrumented and 2 noninstrumented, 6 deep and 2 superficial) with bacteria cultured in 3 (1 Escherichia coli and 2 Staphylococcus aureus). In the treatment group, 7 infections (1.61%) were observed (6 instrumented and 1 noninstrumented surgical procedures, 6 deep and 1 superficial) with bacteria cultured in 3 (1 Staphylococcus aureus and 2 Klebsiella). No adverse effects were observed from the use of vancomycin powder. Statistically no significant difference was seen in infection rate between the treatment group and control group. The local application of vancomycin powder in surgical wounds did not significantly reduce the incidence of infection in patients with surgically treated spinal pathologies. The use of vancomycin powder may not be effective when incidence of infection is low.

Prospective, randomized comparison of transperitoneal versus retroperitoneal laparoscopic adrenalectomy.

PubMed

Rubinstein, Mauricio; Gill, Inderbir S; Aron, Monish; Kilciler, Mete; Meraney, Anoop M; Finelli, Antonio; Moinzadeh, Ali; Ukimura, Osamu; Desai, Mihir M; Kaouk, Jihad; Bravo, Emmanuel

2005-08-01

We report a prospective, randomized comparison of transperitoneal laparoscopic adrenalectomy (TLA) vs retroperitoneal laparoscopic adrenalectomy (RLA) for adrenal lesions with long-term followup. Between December 1997 and November 1999, 57 consecutive eligible patients with surgical adrenal disease were prospectively randomized to undergo TLA (25) or RLA (32). Study exclusion criteria were patient age greater than 80 years, body mass index greater than 40, bilateral adrenalectomy and significant prior abdominal surgery in the quadrant of interest. Mean followup was 5.96 years in the 2 groups. The groups were matched in regard to patient age (p = 0.84), body mass index (p = 0.43), American Society of Anesthesiologists class (p = 0.81) and laterality (p = 0.12). Median adrenal mass size was 2.7 cm (range 1 to 9) in the TLA group and 2.6 cm (range 0.5 to 6) in the RLA group (p = 0.83). TLA was comparable to RLA in terms of operative time (130 vs 126.5 minutes, p = 0.64), estimated blood loss (p = 0.92), specimen weight (p = 0.81), analgesic requirements (p = 0.25), hospital stay (p = 0.56) and the complication rate (p = 0.58). One case per group was electively converted to open surgery. Pathology data on the intact extracted specimens were similar between the groups. Averaged convalescence was 4.7 weeks in the TLA group and 2.3 weeks in the RLA group (p = 0.02). During a mean followup of 6 years 2 patients in the TLA group had a late complication (port site hernia). Mortality occurred in 5 patients, including 1 with TLA and 4 with RLA, during the 6-year followup. For most benign adrenal lesions requiring surgery laparoscopic adrenalectomy can be performed safely and effectively by the transperitoneal or the retroperitoneal approach.

No relationship between circulating levels of sex steroids and mammographic breast density: the Prospect-EPIC cohort

PubMed Central

Verheus, Martijn; Peeters, Petra HM; van Noord, Paulus AH; van der Schouw, Yvonne T; Grobbee, Diederick E; van Gils, Carla H

2007-01-01

Background High breast density is associated with increased breast cancer risk. Epidemiologic studies have shown an increase in breast cancer risk in postmenopausal women with high levels of sex steroids. Hence, sex steroids may increase postmenopausal breast cancer risk via an increase of breast density. The objective of the present study was to study the relation between circulating oestrogens and androgens as well as sex hormone binding globulin (SHBG) in relation to breast density. Methods We conducted a cross-sectional study among 775 postmenopausal women, using baseline data of a random sample of the Prospect-EPIC study. Prospect-EPIC is one of two Dutch cohorts participating in the European Prospective Investigation into Cancer and Nutrition, and women were recruited via a breast cancer screening programme. At enrolment a nonfasting blood sample was taken and a mammogram was made. Oestrone, oestradiol, dehydroepiandrosterone sulfate, androstenedione, testosterone and SHBG levels were measured, using double-antibody radioimmunoassays. Concentrations of free oestradiol and free testosterone were calculated from the measured oestradiol, testosterone and SHBG levels Mammographic dense and nondense areas were measured using a semiquantitative computerized method and the percentage breast density was calculated. Mean breast measures for quintiles of hormone or SHBG levels were estimated using linear regression analyses. Results Both oestrogens and testosterone were inversely related with percent breast density, but these relationships disappeared after adjustment for BMI. None of the sex steroids or SHBG was associated with the absolute measure of breast density, the dense area. Conclusion The results of our study do not support the hypothesis that sex steroids increase postmenopausal breast cancer risk via an increase in breast density. PMID:17692133

Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia

PubMed Central

Tornheim, Jeffrey A.; Lozano Beltran, Daniel F.; Gilman, Robert H.; Castellon, Mario; Solano Mercado, Marco A.; Sullca, Walter; Torrico, Faustino; Bern, Caryn

2013-01-01

Background Chagas disease treatment is limited by drug availability, adverse side effect profiles of available medications, and poor adherence. Methods Adult Chagas disease patients initiating 60-days of benznidazole were randomized to weekly or twice-weekly evaluations of medication adherence and screening for adverse drug events (ADEs). Mid-week evaluations employed phone-based evaluations. Adherence was measured by self-report, pill counts with intentional over-distribution, and Medication Event Monitoring Systems (MEMS). Prospective data were compared to historical controls treated with benznidazole at the same hospital. Results 162 prospective patients were compared to 172 historical patients. Pill counts correlated well with MEMS data (R = 0.498 for 7-day intervals, R = 0.872 for intervals >7 days). Treatment completion rates were higher among prospective than historical patients (82.1% vs. 65.1%), primarily due to lower abandonment rates. Rates of ADEs were lower among prospective than historical patients (56.8% vs. 66.9%). Twice-weekly evaluations increased identification of mild ADEs, prompting higher suspension rates than weekly evaluations. While twice-weekly evaluations identified ADEs earlier, they did not reduce incidence of moderate or severe ADEs. Many dermatologic ADEs were moderately severe upon presentation (35.6%), were not reduced by use of antihistamines, occurred among adult patients of all ages, and occurred throughout treatment, rather than the first few weeks alone. Conclusions Intensive management improved completion and identified more ADEs, but did not reduce moderate or severe ADEs. Risk of dermatologic ADEs cannot be reduced by selecting younger adults or monitoring only during the first few weeks of treatment. Pill counts and phone-based encounters are reliable tools for treatment programming in rural Bolivia. PMID:24069472

Prospective study of polydimethylsiloxane vs dextranomer/hyaluronic acid injection for treatment of vesicoureteral reflux.

PubMed

Moore, Katherine; Bolduc, Stéphane

2014-12-01

Endoscopic injection of a bulking agent is becoming a first-line treatment for low grade vesicoureteral reflux. We prospectively compared the efficacy of 2 such products commercially available in Canada. A total of 275 patients with documented grade I to V vesicoureteral reflux were prospectively enrolled in a comparative study between April 2005 and February 2011 to be randomly treated endoscopically with either polydimethylsiloxane (Macroplastique®) or dextranomer/hyaluronic acid copolymer (Deflux®). Of the ureters 202 were treated with polydimethylsiloxane and 197 with dextranomer/hyaluronic acid copolymer. Patients were followed with voiding cystourethrography at 3 months and renal ultrasonography at 3 months and at 1 year. Median followup was 4.3 years. The primary outcome was surgical success (resolution vs nonresolution), and secondary outcomes included occurrence of adverse events. Vesicoureteral reflux was fully corrected in 182 of 202 ureters (90%) treated with polydimethylsiloxane, compared to 159 of 197 (81%) treated with dextranomer/hyaluronic acid copolymer (p <0.05). Obstruction was found in 5 ureters. Univariate and multivariate analyses did not allow identification of any characteristics that could explain the significant difference in the success rates except for the type of product used. We present the largest known prospective evaluation comparing 2 bulking agents for the treatment of vesicoureteral reflux. Endoscopic injection of polydimethylsiloxane resulted in a better success rate than dextranomer/hyaluronic acid copolymer. The rate of resolution obtained with the latter is lower than those previously published due to the inclusion of high grade reflux. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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.

Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.

PubMed

Moore, Nicholas; Verdoux, Hélène; Fantino, Bruno

2005-05-01

Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.

Do Nonsteroidal Anti-Inflammatory Drugs Affect Bone Healing? A Critical Analysis

PubMed Central

Pountos, Ippokratis; Georgouli, Theodora; Calori, Giorgio M.; Giannoudis, Peter V.

2012-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) play an essential part in our approach to control pain in the posttraumatic setting. Over the last decades, several studies suggested that NSAIDs interfere with bone healing while others contradict these findings. Although their analgesic potency is well proven, clinicians remain puzzled over the potential safety issues. We have systematically reviewed the available literature, analyzing and presenting the available in vitro animal and clinical studies on this field. Our comprehensive review reveals the great diversity of the presented data in all groups of studies. Animal and in vitro studies present so conflicting data that even studies with identical parameters have opposing results. Basic science research defining the exact mechanism with which NSAIDs could interfere with bone cells and also the conduction of well-randomized prospective clinical trials are warranted. In the absence of robust clinical or scientific evidence, clinicians should treat NSAIDs as a risk factor for bone healing impairment, and their administration should be avoided in high-risk patients. PMID:22272177

Comparison of microdose flare-up and antagonist multiple-dose protocols for poor-responder patients: a randomized study.

PubMed

Demirol, Aygul; Gurgan, Timur

2009-08-01

To compare the efficacy of the microdose flare-up and multiple-dose antagonist protocols for poor-responder patients in intracytoplasmic sperm injection-ET cycles. A randomized, prospective study. Center for assisted reproductive technology in Turkey. Ninety patients with poor ovarian response in a minimum of two previous IVF cycles. All women were prospectively randomized into two groups by computer-assisted randomization. The patients in group 1 were stimulated according to the microdose flare-up protocol (n = 45), while the patients in group 2 were stimulated according to antagonist multiple-dose protocol (n = 45). The mean number of mature oocytes retrieved was the primary outcome measure, and fertilization rate, implantation rate per embryo, and clinical pregnancy rates were secondary outcome measures. The mean age of the women, the mean duration of infertility, basal FSH level, and the number of previous IVF cycles were similar in both groups. The total gonadotropin dose used was significantly higher in group 2, while the number of oocytes retrieved was significantly greater in group 1. Although the fertilization and clinical pregnancy rates were nonsignificantly higher in group 1 compared with group 2, the implantation rate was significantly higher in the microdose flare-up group than in the multiple-dose antagonist group (22% vs. 11%). The microdose flare-up protocol seems to have a better outcome in poor-responder patients, with a significantly higher mean number of mature oocytes retrieved and higher implantation rate.

Intraoperative Sedation With Dexmedetomidine is Superior to Propofol for Elderly Patients Undergoing Hip Arthroplasty: A Prospective Randomized Controlled Study.

PubMed

Mei, Bin; Meng, Gaige; Xu, Guanghong; Cheng, Xinqi; Chen, Shishou; Zhang, Ye; Zhang, Ming; Liu, Xuesheng; Gu, Erwei

2018-03-09

Peripheral nerve block is a preferable method for elderly patients receiving hip arthroplasty. Sedation with dexmedetomidine may reduce postoperative delirium. The aim of this study was to investigate whether intraoperative sedation with dexmedetomidine, as a supplementary to peripheral nerve block for elderly patients receiving total hip arthroplasty, can decrease the prevalence of postoperative delirium. A prospective, randomized controlled study was conducted with patients 65 years of age or older who underwent total hip arthroplasty between June 2016 and June 2017. The patients were randomly assigned to receive a lumbosacral plexus plus T12 paravertebral block supplemented with propofol or dexmedetomidine for sedation. Incidence of postoperative delirium was the primary endpoint and was determined with the Confusion Assessment Method, and incidence of postoperative cognitive dysfunction was assessed with the Mini-Mental State Examination. The time of ambulation, discharge time, and complications over a 30-day post-surgery period were also recorded. 296 patients were randomly assigned to two groups. The patients sedated with dexmedetomidine had lower incidences of postoperative delirium and postoperative cognitive dysfunction and were out of bed and discharged sooner than the patients sedated with propofol. There was no difference in complications between the two groups. As a supplementary to peripheral nerve block, intraoperative sedation with dexmedetomidine could be associated with a lower incidence of POD, which may have benefits on reducing the incidence of early postoperative cognitive dysfunction and offering a better short-term recovery for elderly patients receiving hip arthroplasty.

Dual axis operation of a micromachined rate gyroscope

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

Juneau, T.; Pisano, A.P.; Smith, J.

Since micromachining technology has raised the prospect of fabricating high performance sensors without the associated high cost and large size, many researchers have investigated micromachined rate gyroscopes. The vast majority of research has focused on single input axis rate gyroscopes, but this paper presents work on a dual input axis micromachined rate gyroscope. The key to successful simultaneous dual axis operation is the quad symmetry of the circular oscillating rotor design. Untuned gyroscopes with mismatched modes yielded random walk as low as 10{degrees}/{radical}hour with cross sensitivity ranging from 6% to 16%. Mode frequency matching via electrostatic tuning allowed performance bettermore » than 2{degrees}/{radical}hour, but at the expense of excessive cross sensitivity.« less

76 FR 28788 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... studies have been quasi-experimental designs focused on short term workload assessments as outcomes. The... experimental research to define further the effectiveness and cost-benefit of MSD control interventions. A... prospective experimental design (multiple baselines across groups with randomization). These interventions...

Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias

ClinicalTrials.gov

2010-11-12

The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH); in Orifices Created by Trocars Measuring ≥10 mm in Diameter,; and to Determine Whether Closure of the External Fascial Layer Prevents; TSH and Potential Related Complications.

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

PubMed

OʼToole, Robert V; Gary, Joshua L; Reider, Lisa; Bosse, Michael J; Gordon, Wade T; Hutson, James; Quinnan, Stephen M; Castillo, Renan C; Scharfstein, Daniel O; MacKenzie, Ellen J

2017-04-01

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Self-gripping mesh versus fibrin glue fixation in laparoscopic inguinal hernia repair: a randomized prospective clinical trial in young and elderly patients

PubMed Central

Bindi, Marco; Rivelli, Matteo; Solej, Mario; Enrico, Stefano; Martino, Valter

2016-01-01

Abstract Laparoscopic transabdominal preperitoneal inguinal hernia repair is a safe and effective technique. In this study we tested the hypothesis that self-gripping mesh used with the laparoscopic approach is comparable to polypropylene mesh in terms of perioperative complications, against a lower overall cost of the procedure. We carried out a prospective randomized trial comparing a group of 30 patients who underwent laparoscopic inguinal hernia repair with self-gripping mesh versus a group of 30 patients who received polypropylene mesh with fibrin glue fixation. There were no statistically significant differences between the two groups with regard to intraoperative variables, early or late intraoperative complications, chronic pain or recurrence. Self-gripping mesh in transabdominal hernia repair was found to be a valid alternative to polypropylene mesh in terms of complications, recurrence and postoperative pain. The cost analysis and comparability of outcomes support the preferential use of self-gripping mesh. PMID:28352842

Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

PubMed

Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

2014-08-01

The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Postdural puncture headache is not an age-related symptom in children: a prospective, open-randomized, parallel group study comparing a22-gauge Quincke with a 22-gauge Whitacre needle.

PubMed

Kokki, H; Salonvaara, M; Herrgård, E; Onen, P

1999-01-01

Many reports have shown a low incidence of postdural puncture headache (PDPH) and other complaints in young children. The objective of this open-randomized, prospective, parallel group study was to compare the use of a cutting point spinal needle (22-G Quincke) with a pencil point spinal needle (22-G Whitacre) in children. We studied the puncture characteristics, success rate and incidence of postpuncture complaints in 57 children, aged 8 months to 15 years, following 98 lumbar punctures (LP). The patient/parents completed a diary at 3 and 7 days after LP. The response rate was 97%. The incidence of PDPH was similar, 15% in the Quincke group and 9% in the Whitacre group (P=0.42). The risk of developing a PDPH was not dependent on the age (r < 0.00, P=0.67). Eight of the 11 PDPHs developed in children younger than 10 years, the youngest being 23-months-old.

Postoperative treatment of metacarpal fractures-Classical physical therapy compared with a home exercise program.

PubMed

Gülke, Joachim; Leopold, Barbara; Grözinger, Daniel; Drews, Björn; Paschke, Stephan; Wachter, Nikolaus J

Prospective cohort randomized controlled trial. Is either a home exercise (HE) program or traditional physical therapy (PT) more effective in the postoperative management of metacarpal fractures? Sixty patients suffering from nonthumb metacarpal fractures who received mobilization-stable open reduction and internal fixation were included. All patients were prospectively randomized into either the PT group or the HE group. Follow-up examinations at 2, 6 and 12 weeks postoperatively. After 2 weeks, the range of motion (ROM) in both groups was still severely reduced. Twelve weeks after surgery the ROM improved to 245° (PT) and 256° (HE). Grip strength after 6 weeks was 68% (PT) and 71% (HE) when compared to the non-injured hand, improving to 91% (PT) and 93% (HE) after 12 weeks. Study results show that both HE program and traditional PT are effective in the postoperative management of metacarpal fractures. II. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

[Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

PubMed

Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

2016-02-01

Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Use of a portable voice organizer to remember therapy goals in traumatic brain injury rehabilitation: a within-subjects trial.

PubMed

Hart, Tessa; Hawkey, Karen; Whyte, John

2002-12-01

To test the efficacy of a portable voice organizer in helping people with traumatic brain injury (TBI) to recall therapy goals and plans discussed with their clinical case managers. Prospective within-subjects trial, in which individualized therapy goals were randomly assigned to intervention or no intervention. Comprehensive postacute TBI rehabilitation program. Ten people with moderate to severe TBI enrolled from 3 months to 18 years after injury. Memory for therapy goals. Clinicians generated statements describing six current therapy goals, half of which were randomly assigned to be recorded on a voice organizer during the next case management session. Participants selected three times per day to listen to the recorded goals, prompted by an alarm. One-week recall was tested using both free- and cued-recall formats. Recorded goals were recalled better than unrecorded goals and appeared to be associated with better awareness or follow-through with therapy objectives. Portable electronic devices have the potential to assist with treatment areas beyond tasks involving prospective memory.

Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

PubMed

Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

2014-12-01

To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p < 0.05) over the study period in both groups in total; changes (p < 0.05) were seen only in dimension D (group B) and E (both groups) during regular therapy. Physiotherapy may be more effective when provided regularly rather than in blocks.

A prospective single-blind randomized-controlled trial comparing two surgical techniques for the treatment of snoring: laser palatoplasty versus uvulectomy with punctate palatal diathermy.

PubMed

Uppal, S; Nadig, S; Jones, C; Nicolaides, A R; Coatesworth, A P

2004-06-01

The aim of this study was to compare laser palatoplasty with uvulectomy with punctate palatal diathermy as treatment modalities for snoring. The study design was a prospective, single-blind, randomized-controlled trial. Eighty-three patients entered the trial. After a mean follow-up period of more than 18 months there was no statistically significant difference between the two groups regarding the patient perception of benefit from surgery or the subjective improvement in snoring. However, there was a statistically significant difference in the degree of pain in the immediate postoperative period (mean difference = 22.14, 95% CI = 7.98-36.31, P = 0.003), with the pain being worse in the laser palatoplasty group. Relative risk of complications for laser palatoplasty was 1.42 (95% CI = 0.93-2.17). The snoring scores and Glasgow Benefit Inventory scores decreased with time in both the groups but there was no statistically significant difference between the two groups.

Conventional versus computer-assisted technique for total knee arthroplasty: a minimum of 5-year follow-up of 200 patients in a prospective randomized comparative trial.

PubMed

Cip, Johannes; Widemschek, Mark; Luegmair, Matthias; Sheinkop, Mitchell B; Benesch, Thomas; Martin, Arno

2014-09-01

In the literature, studies of computer-assisted total knee arthroplasty (TKA) after mid-term period are not conclusive and long-term data are rare. In a prospective, randomized, comparative study 100 conventional TKAs (group REG) were compared with 100 computer-assisted TKAs (group NAV). Minimum follow-up was 5years. No difference in implant failure was found with 1.1% in group NAV versus 4.6% in group REG (P=0.368). Group NAV showed a significantly less mean deviation of mechanical limb axis (P=0.015), more TKAs (90% versus 81% in group REG) were within 3° varus/valgus and a higher tibial slope and lateral distal femoral angle (LDFA) accuracy was found (P≤0.034). Clinical investigational parameters showed no differences (P≥0.058). Insall and HSS score total were also higher in group NAV (P≤0.016). Copyright © 2014 Elsevier Inc. All rights reserved.

Erlotinib in African Americans with Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study with Genetic and Pharmacokinetic Analysis

PubMed Central

Phelps, Mitch A.; Stinchcombe, Thomas E.; Blachly, James S.; Zhao, Weiqiang; Schaaf, Larry J.; Starrett, Sherri L.; Wei, Lai; Poi, Ming; Wang, Danxin; Papp, Audrey; Aimiuwu, Josephine; Gao, Yue; Li, Junan; Otterson, Gregory A.; Hicks, William J.; Socinski, Mark A.; Villalona-Calero, Miguel A.

2014-01-01

Prospective studies focusing on EGFR inhibitors in African Americans with NSCLC have not been previously performed. In this phase II randomized study, 55 African Americans with NSCLC received erlotinib 150mg/day or a body weight adjusted dose with subsequent escalations to the maximum allowable, 200mg/day, to achieve rash. Erlotinib and OSI-420 exposures were lower compared to previous reports, consistent with CYP3A pharmacogenetics implying higher metabolic activity. Tumor genetics revealed only two EGFR mutations, EGFR amplification in 17/47 samples, 8 KRAS mutations and 5 EML4-ALK translocations. Although absence of rash was associated with shorter time to progression (TTP), disease control rate, TTP, and 1-year survival were not different between the two dose groups, indicating the dose-to-rash strategy failed to increase clinical benefit. Observed low incidence of toxicity and low erlotinib exposure suggest standardized and maximum allowable dosing may be suboptimal in African Americans. PMID:24781527

Transfer of training in the development of intracorporeal suturing skill in medical student novices: a prospective randomized trial.

PubMed

Muresan, Claude; Lee, Tommy H; Seagull, Jacob; Park, Adrian E

2010-10-01

To help optimize the use of limited resources in trainee education, we developed a prospective randomized trial to determine the most effective means of teaching laparoscopic suturing to novices. Forty-one medical students received rudimentary instruction in intracorporeal suturing, then were pretested on a pig enterotomy model. They then were posttested after completion of 1 of 4 training arms: laparoscopic suturing, laparoscopic drills, open suturing, and virtual reality (VR) drills. Tests were scored for speed, accuracy, knot quality, and mental workload (National Aeronautics and Space Administration [NASA] Task Load Index). Paired t tests were used. Task time was improved in all groups except the VR group. Knot quality improved only in the open or laparoscopic suturing groups. Mental workload improved only for those practicing on a physical laparoscopic trainer. For novice trainees, the efficacy of VR training is questionable. In contrast, the other training methods had benefits in terms of time, quality, and perceived workload. Copyright © 2010 Elsevier Inc. All rights reserved.

Peripheral T-cell lymphoma: the role of hematopoietic stem cell transplantation.

PubMed

Gkotzamanidou, Maria; Papadimitriou, Christos A

2014-02-01

Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphomas (NHLs). Whereas the incidence of the disease appears to increase during last decades and the prognosis remains dramatically poor, so far no standard treatment has been established. High-dose chemotherapy and autologous stem cell transplantation (HDT-ASCT) has been proven effective in relapsed PTCL, while retrospective studies have shown a survival benefit as first-line treatment in some subsets of PTCL patients. However, given disease rarity, there is a paucity of randomized trials in both upfront and relapse setting. Here, we critically evaluated eligible prospective and retrospective studies that address the role of ASCT in treatment of PTCL, with respect to quality of design and performance. Additionally, the role of allogeneic transplantation has been reviewed. The comparison of ASCT with novel agents that emerge or the combination of both, are to be ascertained via prospective randomized trials in this field. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up

PubMed Central

Freitas, Maria Cristina Carvalho de Almendra; Fagundes, Ticiane Cestari; Modena, Karin Cristina da Silva; Cardia, Guilherme Saintive; Navarro, Maria Fidela de Lima

2018-01-01

Abstract Objective This prospective, randomized, split-mouth clinical trial evaluated the clinical performance of conventional glass ionomer cement (GIC; Riva Self-Cure, SDI), supplied in capsules or in powder/liquid kits and placed in Class I cavities in permanent molars by the Atraumatic Restorative Treatment (ART) approach. Material and Methods A total of 80 restorations were randomly placed in 40 patients aged 11-15 years. Each patient received one restoration with each type of GIC. The restorations were evaluated after periods of 15 days (baseline), 6 months, and 1 year, according to ART criteria. Wilcoxon matched pairs, multivariate logistic regression, and Gehan-Wilcoxon tests were used for statistical analysis. Results Patients were evaluated after 15 days (n=40), 6 months (n=34), and 1 year (n=29). Encapsulated GICs showed significantly superior clinical performance compared with hand-mixed GICs at baseline (p=0.017), 6 months (p=0.001), and 1 year (p=0.026). For hand-mixed GIC, a statistically significant difference was only observed over the period of baseline to 1 year (p=0.001). Encapsulated GIC presented statistically significant differences for the following periods: 6 months to 1 year (p=0.028) and baseline to 1 year (p=0.002). Encapsulated GIC presented superior cumulative survival rate than hand-mixed GIC over one year. Importantly, both GICs exhibited decreased survival over time. Conclusions Encapsulated GIC promoted better ART performance, with an annual failure rate of 24%; in contrast, hand-mixed GIC demonstrated a failure rate of 42%. PMID:29364343

Effect of Prayer on Intensity of Migraine Headache: A Randomized Clinical Trial.

PubMed

Tajadini, Haleh; Zangiabadi, Nasser; Divsalar, Kouros; Safizadeh, Hossein; Esmaili, Zahra; Rafiei, Hossein

2017-01-01

Migraine is a common form of headache that affects patients quality of life negatively. In addition to pharmacologic treatment, there are a variety of nonpharmacologic treatments for migraine headache. In present study, we examined the effect of prayer on intensity of migraine pain. In a prospective, randomized, controlled trial from October 2013 to June 2014, this study has been conducted in Kerman, Iran. We randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group "A") or 40 mg of propranolol twice a day for 2 months with prayer (group "B"). At the beginning of study and 3 months after intervention, patients' pain was measured using the visual analogue scale. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001). The present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients. © The Author(s) 2016.

Treatment with a barrier-strengthening moisturizer prevents relapse of hand-eczema. An open, randomized, prospective, parallel group study.

PubMed

Lodén, Marie; Wirén, Karin; Smerud, Knut; Meland, Nils; Hønnås, Helge; Mørk, Gro; Lützow-Holm, Claus; Funk, Jörgen; Meding, Birgitta

2010-11-01

Hand eczema influences the quality of life. Management strategies include the use of moisturizers. In the present study the time to relapse of eczema during treatment with a barrier-strengthening moisturizer (5% urea) was compared with no treatment (no medical or non-medicated preparations) in 53 randomized patients with successfully treated hand eczema. The median time to relapse was 20 days in the moisturizer group compared with 2 days in the no treatment group (p = 0.04). Eczema relapsed in 90% of the patients within 26 weeks. No difference in severity was noted between the groups at relapse. Dermatology Life Quality Index (DLQI) increased significantly in both groups; from 4.7 to 7.1 in the moisturizer group and from 4.1 to 7.8 in the no treatment group (p < 0.01) at the time of relapse. Hence, the application of moisturizers seems to prolong the disease-free interval in patients with controlled hand eczema. Whether the data is applic-able to moisturizers without barrier-strengthening properties remains to be elucidated.

Probabilistic pathway construction.

PubMed

Yousofshahi, Mona; Lee, Kyongbum; Hassoun, Soha

2011-07-01

Expression of novel synthesis pathways in host organisms amenable to genetic manipulations has emerged as an attractive metabolic engineering strategy to overproduce natural products, biofuels, biopolymers and other commercially useful metabolites. We present a pathway construction algorithm for identifying viable synthesis pathways compatible with balanced cell growth. Rather than exhaustive exploration, we investigate probabilistic selection of reactions to construct the pathways. Three different selection schemes are investigated for the selection of reactions: high metabolite connectivity, low connectivity and uniformly random. For all case studies, which involved a diverse set of target metabolites, the uniformly random selection scheme resulted in the highest average maximum yield. When compared to an exhaustive search enumerating all possible reaction routes, our probabilistic algorithm returned nearly identical distributions of yields, while requiring far less computing time (minutes vs. years). The pathways identified by our algorithm have previously been confirmed in the literature as viable, high-yield synthesis routes. Prospectively, our algorithm could facilitate the design of novel, non-native synthesis routes by efficiently exploring the diversity of biochemical transformations in nature. Copyright © 2011 Elsevier Inc. All rights reserved.

Conductance Quantization in Resistive Random Access Memory

NASA Astrophysics Data System (ADS)

Li, Yang; Long, Shibing; Liu, Yang; Hu, Chen; Teng, Jiao; Liu, Qi; Lv, Hangbing; Suñé, Jordi; Liu, Ming

2015-10-01

The intrinsic scaling-down ability, simple metal-insulator-metal (MIM) sandwich structure, excellent performances, and complementary metal-oxide-semiconductor (CMOS) technology-compatible fabrication processes make resistive random access memory (RRAM) one of the most promising candidates for the next-generation memory. The RRAM device also exhibits rich electrical, thermal, magnetic, and optical effects, in close correlation with the abundant resistive switching (RS) materials, metal-oxide interface, and multiple RS mechanisms including the formation/rupture of nanoscale to atomic-sized conductive filament (CF) incorporated in RS layer. Conductance quantization effect has been observed in the atomic-sized CF in RRAM, which provides a good opportunity to deeply investigate the RS mechanism in mesoscopic dimension. In this review paper, the operating principles of RRAM are introduced first, followed by the summarization of the basic conductance quantization phenomenon in RRAM and the related RS mechanisms, device structures, and material system. Then, we discuss the theory and modeling of quantum transport in RRAM. Finally, we present the opportunities and challenges in quantized RRAM devices and our views on the future prospects.

Conductance Quantization in Resistive Random Access Memory.

PubMed

Li, Yang; Long, Shibing; Liu, Yang; Hu, Chen; Teng, Jiao; Liu, Qi; Lv, Hangbing; Suñé, Jordi; Liu, Ming

2015-12-01

The intrinsic scaling-down ability, simple metal-insulator-metal (MIM) sandwich structure, excellent performances, and complementary metal-oxide-semiconductor (CMOS) technology-compatible fabrication processes make resistive random access memory (RRAM) one of the most promising candidates for the next-generation memory. The RRAM device also exhibits rich electrical, thermal, magnetic, and optical effects, in close correlation with the abundant resistive switching (RS) materials, metal-oxide interface, and multiple RS mechanisms including the formation/rupture of nanoscale to atomic-sized conductive filament (CF) incorporated in RS layer. Conductance quantization effect has been observed in the atomic-sized CF in RRAM, which provides a good opportunity to deeply investigate the RS mechanism in mesoscopic dimension. In this review paper, the operating principles of RRAM are introduced first, followed by the summarization of the basic conductance quantization phenomenon in RRAM and the related RS mechanisms, device structures, and material system. Then, we discuss the theory and modeling of quantum transport in RRAM. Finally, we present the opportunities and challenges in quantized RRAM devices and our views on the future prospects.

Reducing Pain and Anxiety during Second Trimester Genetic Amniocentesis Using Aromatic Therapy: A Randomized Trial.

PubMed

Hanprasertpong, Tharangrut; Kor-anantakul, Ounjai; Leetanaporn, Roengsak; Suwanrath, Chitkasaem; Suntharasaj, Thitima; Pruksanusak, Ninlapa; Pranpanus, Savitree

2015-08-01

To evaluate the benefit of aromatic therapy using menthol for decrease pain perception during amniocentesis. A prospective randomized study was conducted to compare pain level between groups ofpregnant women who underwent amniocentesis with and without aromatic therapy using menthol. Visual analogue scale (VAS) was usedfor pain assessment. The participants were askedfor their anticipated pain and anxiety level and level ofpain before and immediately after the procedure. Three hundred seventeen pregnant women were recruited into the present study, 158 in the menthol group and 159 in the non-menthol group. Mean VAS score of the post-procedure pain and anxiety did not differ significantly between the two groups. Mean VAS score of the anticipated pain influenced the mean VAS score of the pre-procedure anxiety and post-procedure pain and anxiety irrespective of the group. Mean VAS score of the pre-procedure anxiety and post-procedure pain and anxiety increased about 0.3 cm for each 1 cm of increasing mean VAS score of anticipated pain. Aromatic therapy using menthol was not significantly effective in reducing pain and anxiety during second trimester genetic amniocentesis.

A randomized, prospective study comparing the use of the missile trocar and the pyramidal trocar for laparoscopy access.

PubMed

Tansatit, Tanvaa; Wisawasukmongchol, Wirach; Bunyavejchevin, Suvit

2006-07-01

The missile trocar was developed for smooth abdominal penetration of the primary port. It contains a longitudinal tunnel connecting the abdominal cavity with the outside. To evaluate the efficacy of the missile trocar compared with the traditional method using the Veress needle. The times required to enter the abdominal cavity and the difficulty of the procedure were compared with the traditional Veress needle. A blind technique was used on 100 consecutive patients in a randomized fashion. The missile trocar technique took 2.7 +/- 1.6 minutes to perform compared with 3.9 +/- 1.3 min in the Veress needle group (p = 0.001), and the difficulty of the procedure was 2.1 +/- 1.9 cm (p = 0.433) rated from 10-cm scale. No carbon dioxide leakage or serious complications occurred in any patient. The results of the present study indicate that a long-tip missile trocar technique may be used safely when the technique is fully understood. This procedure is a relatively quick alternative approach for laparoscopy.

Topical versus peribulbar anaesthesia for cataract surgery.

PubMed

Sauder, Gangolf; Jonas, Jost B

2003-12-01

To assess and compare the efficacy and safety of topical versus peribulbar anaesthesia in patients undergoing routine cataract surgery. The unicentre, prospective, randomized, clinical interventional trial included 140 consecutive patients undergoing routine cataract surgery performed by one of two surgeons. The patients were randomly distributed to either peribulbar anaesthesia or topical anaesthesia. To assess intraoperative pain, each patient was asked immediately after surgery to quantitate his/her pain using a 10-point pain rating scale. The study groups did not differ significantly in pain score (p=0.54), duration of surgery (p=0.52), anaesthesia-related intraoperative difficulties (p=0.17), postoperative visual acuity (p=0.94), overall intraoperative surgical complication rate, blood pressure rise (p=0.16) or blood oxygen saturation (p=0.74) Patient comfort and surgery-related complications did not differ between topical anaesthesia and peribulbar anaesthesia. As there are no significant differences between the two techniques in terms of subjective pain experienced by patients, intraoperative complications and postoperative visual outcome, and in view of the minimally invasive character of topical anaesthesia compared to peribulbar anaesthesia, the present study suggests the use of topical anaesthesia for routine cataract surgery.

34 CFR 97.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... presenting the prospect of direct benefit to the individual subjects. 97.405 Section 97.405 Education Office... the prospect of direct benefit to the individual subjects. ED conducts or funds research in which the... holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that...

A randomized prospective trial of radical (Halsted) mastectomy versus modified radical mastectomy in 311 breast cancer patients.

PubMed Central

Maddox, W A; Carpenter, J T; Laws, H L; Soong, S J; Cloud, G; Urist, M M; Balch, C M

1983-01-01

This study reports the results of a prospectively randomized trial for treatment of carcinoma of the breast comparing standard (Halsted) radical mastectomy to a modified radical mastectomy. Three hundred eleven patients with primary operable carcinoma of the breast were entered in a surgical and adjunctive chemotherapy trial in Alabama between 1975 and 1978. A total of 91 surgeons participated (all Diplomats of the American Board of Surgery and Members of the American College of Surgeons). All operative reports, pathology and therapy were reviewed by referees. Histologically node positive patients were randomized after operation to receive melphalan or C.M.F.(cytoxan, methotrexate, and 5-FU) for 1 year. After a median follow-up of 5.5 years, there was no significant difference in disease-free survival or in overall survival between the two groups. There was a trend toward improved 5-year survival rates in the radical mastectomy group compared to the modified radical mastectomy group (84% vs. 76%, p = 0.14). There was also an increased incidence of local wound recurrence in those patients receiving modified radical mastectomy, but the differences were not statistically significant (p = 0.09). Longer follow-up will be necessary to evaluate these results more fully. PMID:6870379

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

[Are there selection criteria between abdominal approach and vaginal route for genital prolapse surgical management?].

PubMed

Cour, F; Vidart, A

2016-07-01

The never ending debate over the surgical approach of genital prolapse repair (abdominal versus vaginal route) is as passionate as ever. The available literature may support a multidisciplinary analysis of our expert daily practice. Our purpose was to define selection criteria for surgical approach between abdominal and vaginal route in the management of genital prolapse by reviewing the literature. Systematically review of the literature concerning comparative anatomical and functionnal results of surgery of pelvic organ prolaps by vaginal or abdominal route. We were confronted to the lack of data in the literature, with few prospective randomized comparative studies. Many limitations were identified such as small populations in the studies, no description of sub-population, multiplicity of surgical procedures. Moreover, vaginal route was compared to sacral colpopexy by open abdominal approach, whereas laparoscopic sacrocolpopexy is now recommended. Only one prospective randomized comparative trial assessed laparoscopic sacrocolpopexy and vaginal approach, in which was used a mesh withdrawn from the market. The lack of available randomized trials makes it impossible to define HAS compliant guidelines on this topic. However, selection criteria for each surgical approach and technique were drawn from experts' advices. © 2016 Published by Elsevier Masson SAS. © 2016 Elsevier Masson SAS. Tous droits réservés.

Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study.

PubMed

Heikkilä, Jouni T; Kukkonen, Juha; Aho, Allan J; Moisander, Susanna; Kyyrönen, Timo; Mattila, Kimmo

2011-04-01

Purpose of this study was to compare bioactive glass and autogenous bone as a bone substitute material in tibial plateau fractures. We designed a prospective, randomized study consisting of 25 consecutive operatively treated patients with depressed unilateral tibial comminuted plateau fracture (AO classification 41 B2 and B3).14 patients (7 females, 7 males, mean age 57 years, range 25-82) were randomized in the bioglass group (BG) and 11 patients (6 females, 5 males, mean age 50 years, range 31-82) served as autogenous bone control group (AB). Clinical examination of the patients was performed at 3 and 12 months, patients' subjective and functional results were evaluated at 12 months. Radiological analysis was performed preoperatively, immediately postoperatively and at 3 and 12 months. The postoperative redepression for both studied groups was 1 mm until 3 months and remained unchanged at 12 months. No differences were identified in the subjective evaluation, functional tests and clinical examination between the two groups during 1 year follow-up. We conclude that bioactive glass granules can be clinically used as filler material instead of autogenous bone in the lateral tibial plateau compression fractures.

Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal.

PubMed

Yayla Abide, Cigdem; Ozkaya, Enis; Sanverdi, Ilhan; Bostancı Ergen, Evrim; Kurek Eken, Meryem; Devranoglu, Belgin; Bilgiç, Bulent Emre; Kilicci, Cetin; Kayatas Eser, Semra

2018-05-14

To compare embryo transfer (ET) technique based on catheter rotation during its withdrawal in cases with unexplained infertility in a prospective, randomized trial (NCT03097042). Two hundred intracytoplasmic sperm injection (ICSI) patients undergoing ET with cleaving or blastocyst-stage fresh embryos were randomized into 2 groups: cases with (n = 100), and without (n = 100) catheter rotation during its withdrawal. Groups were matched for age and some clinical parameters. A soft catheter was used to transfer a single embryo with catheter rotation during its withdrawal in the study group and without rotation in the control. The use of a stiff catheter or tenaculum was not needed in any case. Groups were compared in terms of cycle characteristics and clinical pregnancy rates. Pregnancy rate was significantly higher in the study group (41 vs. 26%, p = 0.04). Clinical pregnancy rate was also significantly higher in the study group (39 vs. 25%, OR 1.9 [1.1-3.5], p = 0.05). On the other hand, the ongoing pregnancy rate was similar between the 2 groups (33 vs. 23%, p = 0.2). Catheter rotation during its withdrawal may be associated with increased pregnancy and clinical pregnancy rates; however, the difference in ongoing pregnancy rates did not reach statistical significance. © 2018 S. Karger AG, Basel.

Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Choi, Geun Joo; Kang, Hyun; Ahn, Eun Jin; Oh, Jong In; Baek, Chong Wha; Jung, Yong Hun; Kim, Jin Yun

2016-12-01

Systemic lidocaine has analgesic and anti-inflammatory effects. The purpose of this prospective, randomized, double-blind study was to evaluate the effects of intravenous lidocaine on pain following thyroidectomy. Fifty-eight adult patients scheduled for total thyroidectomy were randomly allocated to receive a 1.5 mg/kg lidocaine bolus followed by a 2 mg/kg/h infusion during surgery, or the same volume of normal saline (control). After thyroidectomy, we evaluated postoperative pain, nausea, fentanyl consumption, frequency of pushing the button (FPB) for patient-controlled analgesia (PCA), High-sensitivity C-reactive protein (hs-CRP) in serum, and patient satisfaction scores regarding the recovery process. Postoperative pain and nausea scores were significantly lower in the lidocaine group for the first 4 h following thyroidectomy, compared to the control group. Fentanyl consumption and FPB for the PCA were also significantly reduced in the lidocaine group for 4 h following thyroidectomy, and hs-CRP was significantly less in the lidocaine group at postoperative days 1 and 3. Furthermore, satisfaction scores were significantly higher in the lidocaine group compared to the control group. Intravenous lidocaine effectively reduced postoperative pain and nausea following thyroidectomy as well as improved the quality of recovery. Clinicaltrials.gov NCT01608360.

Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blind study.

PubMed

Roje, Zeljka; Racić, Goran; Dogas, Zoran; Pisac, Valdi Pesutić; Timms, Michael

2009-03-01

The aim of this prospective randomized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation, and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity, to compare intraoperative blood loss, postoperative pain severity, time to resuming normal physical activity, and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years. 72 children aged 3-16 years scheduled for tonsillectomy randomly assigned into two groups submitted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy, with a 14-day follow up. Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue (p < 0.001), intraoperative blood loss (p < 0.004), in postoperative pain severity (p < 0.05) and in time to resuming normal physical activity between the two groups (p < 0.001). There was no case of reactionary or secondary bleeding in either group. In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage: less thermal damage is associated with less postoperative morbidity.

A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

PubMed

Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

2010-03-01

This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P < 0.02, Fisher's exact); assistance required (enema = 19; suppository = 3; P < 0.005, Fisher's exact); grade of effectiveness (enema = 83; suppository = 44; P < 0.0001, Fisher's exact), and whether patients wished to try another preparation in future (enema = 16; suppository = 24; P = 0.016, Fisher's exact). Endoscopist data available for 151 patients (enema = 76; suppository = 75) revealed: average depth of insertion (enema = 53.6 +/- 11.6 cm; suppository 46.3 +/- 13.7 cm; P < 0.001, Student's t test); acceptable (excellent + good) quality of preparation [enema = 60 (78.9%); suppository = 34 (45.3%); P < 0.0001, Fisher's exact]. Bowel preparation for flexible sigmoidoscopy using a single Fleet enema is acceptable to patients and more effective than glycerin suppositories.

Randomized prospective crossover study of biphasic intermittent positive airway pressure ventilation (BIPAP) versus pressure support ventilation (PSV) in surgical intensive care patients.

PubMed

Elrazek, E Abd

2004-10-01

The aim of this prospective, randomized and crossover study was to assess the role of a relatively new mode of mechanical ventilation, biphasic intermittent positive airway pressure (BIPAP) in comparison to another well established one, pressure-support ventilation (PSV) in surgical intensive care patients. 24 generally stable patients, breathing on their own after short-term (< 24 hours) postoperative controlled mechanical ventilation (CMV) were randomized to start on either PSV or BIPAP, and indirect calorimetry measurements were performed after 1 hour adaptation period at two time intervals; immediately after the investigated ventilatory mode was started and 1 hour later. Statistics included a two-tailed paired t-test to compare the two sets of different data, p < 0.5 was considered significant. Oxygen consumption (VO2), energy expenditure (EE), Carbon dioxide production (VCO2), and respiratory quotient (RQ) did not differ significantly between the two groups. There were also no significant differences regarding respiratory rate (RR), minute volume (MV) and arterial blood gas analysis (ABGs). Both modes of ventilation were well tolerated by all patients. PSV and BIPAP can be used for weaning patients comfortably in surgical intensive care after short-term postoperative ventilation. BIPAP may have the credit of being smoother than PSV where no patient effort is required.

An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study.

PubMed

Gupta, Devendra; Agarwal, Anil; Dhiraaj, Sanjay; Tandon, Manish; Kumar, Mukesh; Singh, Ravi Shankar; Singh, Prabhat K; Singh, Uttam

2006-05-01

Venipuncture is the most common painful event for a hospitalized child. We evaluated the efficacy of balloon inflation for attenuating venipuncture pain in children. Seventy-five pediatric patients aged 6-12 yr, ASA physical status I-II, of either sex, undergoing elective surgery were included in this prospective and randomized study. Patients were randomly divided into 3 equal groups of 25 each; Group I (control), Group II (distraction) pressed a rubber ball, and Group III (balloon) inflated a balloon. A manual venous occlusion was applied on the forearm and venipuncture was performed with a 22-gauge venous cannula. Pain was self-reported by a pain face scale with a 10-cm visual analog scale (VAS) placed at its back, where 0 = "no pain" and 10 = "worst imaginable pain." VAS scores of 1-3 were rated as mild, 4-6 as moderate, and >6 as severe. Median (interquartile range) VAS score in the balloon group was 1 (3), which was reduced as compared with 2 (2) and 4 (2) observed in the distraction and control groups, respectively (P < 0.000). Significant reduction in the incidence and severity of venipuncture pain was also observed in the balloon group compared with the other 2 groups (P < 0.05).

Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study.

PubMed

Savino, Francesco; Pelle, Emanuela; Palumeri, Elisabetta; Oggero, Roberto; Miniero, Roberto

2007-01-01

The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized study would improve symptoms of infantile colic. Ninety breastfed colicky infants were assigned randomly to receive either the probiotic L. reuteri (10(8) live bacteria per day) or simethicone (60 mg/day) each day for 28 days. The mothers avoided cow's milk in their diet. Parents monitored daily crying times and adverse effects by using a questionnaire. Eighty-three infants completed the trial: 41 in the probiotic group and 42 in the simethicone group. The infants were similar regarding gestational age, birth weight, gender, and crying time at baseline. Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day, respectively, on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day. On day 28, 39 patients (95%) were responders in the probiotic group and 3 patients (7%) were responders in the simethicone group. No adverse effects were reported. In our cohort, L. reuteri improved colicky symptoms in breastfed infants within 1 week of treatment, compared with simethicone, which suggests that probiotics may have a role in the treatment of infantile colic.

A prospective, randomized study on the efficacy of tongue protector in patients with burning mouth syndrome.

PubMed

López-Jornet, P; Camacho-Alonso, F; Andujar-Mateos, P

2011-04-01

To apply a tongue protector with habit-modifying therapy through self-control, in the patients with burning mouth syndrome (BMS). A prospective, randomized study was made of 65 consecutive patients with BMS. Fifty subjects were randomized to two groups: group A (informed) and group B (informed and the application of a tongue protector). The symptoms were evaluated by VAS, whereas the psychological profile was assessed using the HAD, with application of the quality of life questionnaires SF-36 and OHIP-49. The duration of treatment was 2 months. Fifty patients (46 females and 4 males) completed the study. The VAS scores in group B were 8.2 at baseline and 4.5 after 2 months. The respective scores in group A were 7.1 and 5.6 - the differences between the two groups being significant (P < 0.001). In group B the OHIP-49 yielded lower scores for most of the scales, with significant differences vs group A. In group B the SF 36 yielded significant differences vs group A in physical role, bodily pain, general health and emotional role. Parafunctional traumatism of the tongue should be taken into account in the pathogenesis of BMS with a view to exploring new therapeutic options. © 2010 John Wiley & Sons A/S.

Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

PubMed Central

Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

2016-01-01

Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD. PMID:27635180

Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

PubMed Central

Duara, Rajnish; Misra, Manoranjan; Bhuyan, Ritwick Raj; Sarma, P. Sankara; Jayakumar, Karunakaran

2008-01-01

Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB) circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG) and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1) cases where residual pump blood was used and (2) controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained. PMID:20041077

Microdose GnRH Agonist Flare-Up versus Ultrashort GnRH Agonist Combined with Fixed GnRH Antagonist in Poor Responders of Assisted Reproductive Techniques Cycles.

PubMed

Eftekhar, Maryam; Mohammadian, Farnaz; Yousefnejad, Fariba; Khani, Parisa

2013-01-01

This study compares the microdose flare-up protocol to the ultrashort gonadotropinreleasing hormone (GnRH) agonist flare combined with the fixed multidose GnRH antagonist protocol in poor responders undergoing ovarian stimulation. In this randomized clinical trial, 120 women who were candidates for assisted reproductive techniques (ART) and had histories of one or more failed in vitro fertilization (IVF) cycles with three or fewer retrieved oocytes were prospectively randomized into two groups. Group I (60 patients) received the microdose flare-up regimen and group II (60 patients) received the ultrashort GnRH agonist combined with fixed GnRH antagonist. There were no significant differences between the groups in the number of used gonadotropin ampoules (p=0.591), duration of stimulation (p=0.610), number of retrieved oocytes (p=0.802), fertilization rate (p=0.456), and the number of transferred embryos (p=0.954). The clinical pregnancy rates were statistically similar in group I (10%) compared with group II (13.3%, p=0.389). According to our results, there is no significant difference between these protocols for improving the ART outcome in poor responders. Additional prospective, randomized studies with more patients is necessary to determine the best protocol (Registration Number: IRCT201105096420N1).

The preference of probability over negative values in action selection.

PubMed

Neyedli, Heather F; Welsh, Timothy N

2015-01-01

It has previously been found that when participants are presented with a pair of motor prospects, they can select the prospect with the largest maximum expected gain (MEG). Many of those decisions, however, were trivial because of large differences in MEG between the prospects. The purpose of the present study was to explore participants' preferences when making non-trivial decisions between two motor prospects. Participants were presented with pairs of prospects that: 1) differed in MEG with either only the values or only the probabilities differing between the prospects; and 2) had similar MEG with one prospect having a larger probability of hitting the target and a higher penalty value and the other prospect a smaller probability of hitting the target but a lower penalty value. In different experiments, participants either had 400 ms or 2000 ms to decide between the prospects. It was found that participants chose the configuration with the larger MEG more often when the probability varied between prospects than when the value varied. In pairs with similar MEGs, participants preferred a larger probability of hitting the target over a smaller penalty value. These results indicate that participants prefer probability information over negative value information in a motor selection task.

Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial.

PubMed

Chalifoux, Laurie A; Bauchat, Jeanette R; Higgins, Nicole; Toledo, Paloma; Peralta, Feyce M; Farrer, Jason; Gerber, Susan E; McCarthy, Robert J; Sullivan, John T

2017-10-01

Breech presentation is a leading cause of cesarean delivery. The use of neuraxial anesthesia increases the success rate of external cephalic version procedures for breech presentation and reduces cesarean delivery rates for fetal malpresentation. Meta-analysis suggests that higher-dose neuraxial techniques increase external cephalic version success to a greater extent than lower-dose techniques, but no randomized study has evaluated the dose-response effect. We hypothesized that increasing the intrathecal bupivacaine dose would be associated with increased external cephalic version success. We conducted a randomized, double-blind trial to assess the effect of four intrathecal bupivacaine doses (2.5, 5.0, 7.5, 10.0 mg) combined with fentanyl 15 μg on the success rate of external cephalic version for breech presentation. Secondary outcomes included mode of delivery, indication for cesarean delivery, and length of stay. A total of 240 subjects were enrolled, and 239 received the intervention. External cephalic version was successful in 123 (51.5%) of 239 patients. Compared with bupivacaine 2.5 mg, the odds (99% CI) for a successful version were 1.0 (0.4 to 2.6), 1.0 (0.4 to 2.7), and 0.9 (0.4 to 2.4) for bupivacaine 5.0, 7.5, and 10.0 mg, respectively (P = 0.99). There were no differences in the cesarean delivery rate (P = 0.76) or indication for cesarean delivery (P = 0.82). Time to discharge was increased 60 min (16 to 116 min) with bupivacaine 7.5 mg or higher as compared with 2.5 mg (P = 0.004). A dose of intrathecal bupivacaine greater than 2.5 mg does not lead to an additional increase in external cephalic procedural success or a reduction in cesarean delivery.

International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer.

PubMed

Debourdeau, P; Farge, D; Beckers, M; Baglin, C; Bauersachs, R M; Brenner, B; Brilhante, D; Falanga, A; Gerotzafias, G T; Haim, N; Kakkar, A K; Khorana, A A; Lecumberri, R; Mandala, M; Marty, M; Monreal, M; Mousa, S A; Noble, S; Pabinger, I; Prandoni, P; Prins, M H; Qari, M H; Streiff, M B; Syrigos, K; Büller, H R; Bounameaux, H

2013-01-01

Although long-term indwelling central venous catheters (CVCs) may lead to pulmonary embolism (PE) and loss of the CVC, there is lack of consensus on management of CVC-related thrombosis (CRT) in cancer patients and heterogeneity in clinical practices worldwide. To establish common international Good Clinical Practices Guidelines (GCPG) for the management of CRT in cancer patients. An international working group of experts was set up to develop GCPG according to an evidence-based medicine approach, using the GRADE system. For the treatment of established CRT in cancer patients, we found no prospective randomized studies, two non-randomized prospective studies and one retrospective study examining the efficacy and safety of low-molecular-weight heparin (LMWH) plus vitamin K antagonists (VKAs). One retrospective study evaluated the benefit of CVC removal and two small retrospective studies were on thrombolytic drugs. For the treatment of symptomatic CRT, anticoagulant treatment (AC) is recommended for a minimum of 3 months; in this setting, LMWHs are suggested. VKAs can also be used, in the absence of direct comparisons of these two types of anticoagulants in this setting [Guidance]. The CVC can be kept in place if it is functional, well-positioned and non-infected and there is good resolution under close surveillance; whether the CVC is kept or removed, no standard approach in terms of AC duration has been established [Guidance]. For the prophylaxis of CRT in cancer patients, we found six randomized studies investigating the efficacy and safety of VKA vs. placebo or no treatment, one on the efficacy and safety of unfractionnated heparin, six on the value of LMWH, one double-blind randomized and one non randomized study on thrombolytic drugs and six meta-analyses of AC and CVC thromboprophylaxis. Type of catheter (open-ended like the Hickman(®) catheter vs. closed-ended catheter with a valve like the Groshong(®) catheter), its position (above, below or at the junction of the superior vena cava and the right atrium) and method of placement may influence the onset of CRT on the basis of six retrospective trials, four prospective non-randomized trials, three randomized trials and one meta-analysis. In light of these data: use of AC for routine prophylaxis of CRT is not recommended [1A]; a CVC should be inserted on the right side, in the jugular vein, and distal extremity of the CVC should be located at the junction of the superior vena cava and the right atrium [1A]. Dissemination and implementation of these international GCPG for the prevention and treatment of CRT in cancer patients at each national level is a major public health priority, needing worldwide collaboration. © 2012 International Society on Thrombosis and Haemostasis.

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.

Evolving with modern technology: Impact of incorporating audiovisual aids in preanesthetic checkup clinics on patient education and anxiety.

PubMed

Kaur, Haramritpal; Singh, Gurpreet; Singh, Amandeep; Sharda, Gagandeep; Aggarwal, Shobha

2016-01-01

Perioperative stress is an often ignored commonly occurring phenomenon. Little or no prior knowledge of anesthesia techniques can increase this significantly. Patients awaiting surgery may experience high level of anxiety. Preoperative visit is an ideal time to educate patients about anesthesia and address these fears. The present study evaluates two different approaches, i.e., standard interview versus informative audiovisual presentation with standard interview on information gain (IG) and its impact on patient anxiety during preoperative visit. This prospective, double-blind, randomized study was conducted in a Tertiary Care Teaching Hospital in rural India over 2 months. This prospective, double-blind, randomized study was carried out among 200 American Society of Anesthesiologist Grade I and II patients in the age group 18-65 years scheduled to undergo elective surgery under general anesthesia. Patients were allocated to either one of the two equal-sized groups, Group A and Group B. Baseline anxiety and information desire component was assessed using Amsterdam Preoperative Anxiety and Information Scale for both the groups. Group A patients received preanesthetic interview with the anesthesiologist and were reassessed. Group B patients were shown a short audiovisual presentation about operation theater and anesthesia procedure followed by preanesthetic interview and were also reassessed. In addition, patient satisfaction score (PSS) and IG was assessed at the end of preanesthetic visit using standard questionnaire. Data were expressed as mean and standard deviation. Nonparametric tests such as Kruskal-Wallis, Mann-Whitney, and Wilcoxon signed rank tests, and Student's t -test and Chi-square test were used for statistical analysis. Patient's IG was significantly more in Group B (5.43 ± 0.55) as compared to Group A (4.41 ± 0.922) ( P < 0.001). There was significant reduction in total anxiety from the baseline values in both the groups. This reduction was significantly more in Group B (8.47 ± 1.861) as compared to Group A (9.29 ± 1.616) ( P < 0.001). PSS was also more in Group B (29.27 ± 2.378) as compared to Group A (25.62 ± 1.745) ( P < 0.001). Audiovisual presentation provides unhurried, detailed, and reliable information about the perioperative environment and anesthesia procedure. This helps in significant IG and reduction of patient anxiety.

Assessing risk-adjustment approaches under non-random selection.

PubMed

Luft, Harold S; Dudley, R Adams

2004-01-01

Various approaches have been proposed to adjust for differences in enrollee risk in health plans. Because risk-selection strategies may have different effects on enrollment, we simulated three types of selection--dumping, skimming, and stinting. Concurrent diagnosis-based risk adjustment, and a hybrid using concurrent adjustment for about 8% of the cases and prospective adjustment for the rest, perform markedly better than prospective or demographic adjustments, both in terms of R2 and the extent to which plans experience unwarranted gains or losses. The simulation approach offers a valuable tool for analysts in assessing various risk-adjustment strategies under different selection situations.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

2018-05-28

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

[Eyelid hygiene for contact lens wearers with blepharitis. Comparative investigation of treatment with baby shampoo versus phospholipid solution].

PubMed

Khaireddin, R; Hueber, A

2013-02-01

Blepharitis due to Meibom gland dysfunction (MGD) is presumed to be one of the main reasons for dry eye symptoms which occur in up to 50% of contact lens users. Thus, MGD presumably plays an important role in dry eye in contact lens wearers. In the present prospective, randomized and double blind trial the efficacy of two established treatment options for MGD and blepharitis was evaluated in symptomatic contact lens wearers. In this prospective, randomized 2-centre trial 53 symptomatic contact lens wearers suffering from blepharitis were included. Patients were randomly selected for two treatment groups: group A performed lid margin hygiene using the commonly recommended mild baby shampoo (Bübchen Kinder Shampoo-extra augenmild, Bübchen Werk Ewald Hermes Pharmazeutische Fabrik GmbH, Soest, Germany) and group B performed lid margin hygiene using a phospholipid-liposome solution specially designed for lid hygiene (Blepha Cura, Optima, Moosburg/Wang, Germany), each for 4 weeks. Before as well as 4 weeks after initiation of this study the following tests were performed: standardized subjective assessment using the ocular surface disease index, non-invasive break-up time (NIBUT) and objective evaluation of lid-parallel conjunctival folds (LIPCOF) and further lid margin criteria by double blinded evaluation of slit lamp photographs. Of the 53 symptomatic contact lens wearers suffering from blepharitis 21 (39,6%) were randomly selected for treatment group A and 32 (60.4%) for group B. In both treatment groups there was objective and subjective improvement of symptoms of dry eye in contact lens wearers. Interestingly, there was a significantly greater improvement, subjective as well as objective, in treatment group B which used the phospholipidliposome solution for lid margin hygiene compared to group A using baby shampoo. Although both therapies improved symptoms of dry eye due to blepharitis in symptomatic contact lens wearers, patients using phospholipid-liposomal solution for lid margin hygiene demonstrated a significantly greater clinical benefit from the therapy. Thus, clinical practice recommending just baby shampoo for lid margin hygiene should be re-considered, as phospholipid-liposomal solution for lid margin hygiene appears to yield greater and faster clinical benefits for symptomatic contact lens wearers suffering from dry eye symptoms.

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

Pilot Feasibility Study of Therapeutic Hypothermia for Moderate to Severe Acute Respiratory Distress Syndrome.

PubMed

Slack, Donald F; Corwin, Douglas S; Shah, Nirav G; Shanholtz, Carl B; Verceles, Avelino C; Netzer, Giora; Jones, Kevin M; Brown, Clayton H; Terrin, Michael L; Hasday, Jeffrey D

2017-07-01

Prior studies suggest hypothermia may be beneficial in acute respiratory distress syndrome, but cooling causes shivering and increases metabolism. The objective of this study was to assess the feasibility of performing a randomized clinical trial of hypothermia in patients with acute respiratory distress syndrome receiving treatment with neuromuscular blockade because they cannot shiver. Retrospective study and pilot, prospective, open-label, feasibility study. Medical ICU. Retrospective review of 58 patients with acute respiratory distress syndrome based on Berlin criteria and PaO2/FIO2 less than 150 who received neuromuscular blockade. Prospective hypothermia treatment in eight acute respiratory distress syndrome patients with PaO2/FIO2 less than 150 receiving neuromuscular blockade. Cooling to 34-36°C for 48 hours. Core temperature, hemodynamics, serum glucose and electrolytes, and P/F were sequentially measured, and medians (interquartile ranges) presented, 28-day ventilator-free days, and hospital mortality were calculated in historical controls and eight cooled patients. Average patient core temperature was 36.7°C (36-37.3°C), and fever occurred during neuromuscular blockade in 30 of 58 retrospective patients. In the prospectively cooled patients, core temperature reached target range less than or equal to 4 hours of initiating cooling, remained less than 36°C for 92% of the 48 hours cooling period without adverse events, and was lower than the controls (34.35°C [34-34.8°C]; p < 0.0001). Compared with historical controls, the cooled patients tended to have lower hospital mortality (75% vs 53.4%; p = 0.26), more ventilator-free days (9 [0-21.5] vs 0 [0-12]; p = 0.16), and higher day 3 P/F (255 [160-270] vs 171 [120-214]; p = 0.024). Neuromuscular blockade alone does not cause hypothermia but allowed acute respiratory distress syndrome patients to be effectively cooled. Results support conducting a randomized clinical trial of hypothermia in acute respiratory distress syndrome and the feasibility of studying acute respiratory distress syndrome patients receiving neuromuscular blockade.

Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

ERIC Educational Resources Information Center

Harrison, Bronwyn A.; Mayo-Wilson, Evan

2014-01-01

Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial…

76 FR 48164 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

... using a prospective experimental design (multiple baselines across groups with randomization). The costs... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-11-11FE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

76 FR 44336 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-25

... using a prospective experimental design (multiple baselines across groups with randomization). The costs... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-11-11FE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

The Effect of Interactive Simulations on Exercise Adherence with Overweight and Obese Adults

DTIC Science & Technology

2012-10-01

beneficiaries will be randomized into 2 exercise groups, i.e., enhanced video game exercise bicycle group or standard exercise bicycle group. The...project team developed a prototype stationary exercise bicycle with video game play capabilities. A 6-month prospective repeated measures experimental

Adequacy in dialysis: intermittent versus continuous therapies.

PubMed

Misra, M; Nolph, K D

2000-01-01

A vital conceptual difference between intermittent and continuous dialysis therapies is the difference in the relationship between Kt/V urea and dietary protein intake. For a given level of protein intake the intermittent therapies require a higher Kt/V urea due to the reasons mentioned above. The recently released adequacy guidelines by DOQI for intermittent and continuous therapies are based on these assumptions. The link between adequacy targets and patient survival is well documented for an intermittent therapy like HD. For a continuous therapy like CAPD however, the evidence linking improved peritoneal clearance to better survival is not as direct. However, present consensus allows one to extrapolate results based on HD. The concept of earlier and healthier initiation of dialysis is gaining hold and incremental dialysis forms an integral aspect of the whole concept. Tools like urea kinetic modeling give us valuable insight in making mathematical projections about the timing as well as dosing of dialysis. Daily home hemodialysis is still an underutilized modality despite offering best survival figures. Hopefully, with increasing availability of better and simpler machines its use will increase. Still several questions remain unanswered. Despite availability of data in hemodialysis patients suggesting that an increased dialysis prescription leads to a better survival, optimal dialysis dose is yet to be defined. Concerns regarding methodology of such studies and conclusions thereof has been raised. Other issues relating to design of the studies, variation in dialysis delivery, use of uncontrolled historical standards and lack of patient randomization etc also need to be considered when designing such trials. Hopefully an ongoing prospective randomized trial, namely the HEMO study, looking at two precisely defined and carefully maintained dialysis prescriptions will provide some insight into adequacy of dialysis dose and survival. In diabetic patients, the relationship between outcome and dialysis dose needs to be better defined. Data relating adequacy of dialysis to outcome in a pediatric population is not available. In dialysis therapy, the Risk/Dose (R/D) function does not bear a linear relationship. This together with a lack of proof equating peritoneal to renal clearance lends some uncertainty to the validity of the recommendation that there is a linear and constant decrease in RR for std (Kt/V) [equivalent standardized Kt/V calculated from average predialysis BUN for any frequency and/or combination of intermittent and continuous dialysis ref] up to 2.3 as reported in the CANUSA study. Due to the complex nature of this problem it may be prudent to undertake a multi-center trial with std (Kt/V) prospectively randomized to either 2.0 or 2.4. This would provide a reliable database to evaluate the R/D function over this critical range of normalized peritoneal urea clearance. Likewise in PD, the postulated linearity between dialysis dose and outcome needs to be studied in a prospective randomized manner. The amount of dialysis dose required for malnourished patients, diabetic and pediatric patients needs to be better defined. The role of aggressive dialysis in reversing malnutrition needs to be studied and studies need to be done to identify the most scientific use of V in malnourished patients. Justification of a healthy start/incremental dialysis based on outcome measures needs to be established and it's cost effectiveness validated by clinical trials. Again, a prospective randomized controlled trial comparing incremental dialysis with dietary protein restriction in patients with GFR < or = 10.5 ml/min/1.73 m2 with properly defined outcome measures like morbidity, mortality, decline of GFR and quality of life needs to be conducted. Comparisons of incremental hemodialysis and incremental peritoneal dialysis need to be made especially with regard to technique survival and preservation of residual renal function (RRF). (ABSTR

Autologous Skin Cell Spray for Massive Soft Tissue War Injuries: A Prospective, Case-Control, Multicenter Trial

DTIC Science & Technology

2014-04-01

randomization design, after all patients are treated with dermal matrix, patients will be randomized to Arm 1 (control group; standard skin grafting with... grafts are often “meshed” or flattened and spread out to increase the size of the skin graft to better cover a large wound. Standard “meshing” increases...the size of the donor graft by 1.5 times (1:1.5). Problems with healing and skin irritation remain with such skin grafts when the injured areas are

[Efficacy of a ketogenic diet in urological cancers patients : A systematic review].

PubMed

Maisch, P; Gschwend, J E; Retz, M

2018-03-01

Beside the classical anticancer treatment tumor patients try to find proactive alternative therapies to fight their disease. Lifestyle changes such as introducing a ketogenic diet is one of the most popular among them. The German Association of Urological Oncology (AUO, Arbeitsgemeinschaft Urologische Onkologie) presents a systematic review investigating the evidence of ketogenic diet in cancer patients. A systematic literature research was conducted in the databases Medline, Livivo, and the Cochrane Library. Only clinical studies of tumor patients receiving chemotherapy while on a ketogenic diet were included. The assessment of the results was performed according to the predefined primary endpoints overall survival and progression-free survival and secondary endpoints quality of life and reduction of adverse effects induced by cytostatics. Nine studies met the inclusion criteria: eight prospective and one retrospective study case series respectively cohort-studies, with a total of 107 patients. Currently there is no evidence of a therapeutic effect of a ketogenic diet in patients with malignant tumors regarding the clinical outcome or quality of life. Based on the current data, a ketogenic diet can not be recommended to cancer patients because prospective, randomized trials are missing.

The Relationship of Bilingualism Compared to Monolingualism to the Risk of Cognitive Decline or Dementia: A Systematic Review and Meta-Analysis.

PubMed

Mukadam, Naaheed; Sommerlad, Andrew; Livingston, Gill

2017-01-01

Bilingualism may contribute to cognitive reserve, protect against cognitive decline, and delay the onset of dementia. We systematically reviewed evidence about the effect of bilingualism on subsequent cognitive decline or dementia. We searched electronic databases and references for longitudinal studies comparing cognitive decline in people who were bilingual with those who were monolingual and evaluated study quality. We conducted meta-analyses using random effects models to calculate pooled odds ratio of incident dementia. We included 13/1,156 eligible articles. Meta-analysis of prospective studies of the effects of bilingualism on future dementia gave a combined Odds Ratio of dementia of 0.96 (95% CI 0.74-1.23) in bilingual participants (n = 5,527) compared to monolinguals. Most retrospective studies found that bilingual people were reported to develop symptoms of cognitive decline at a later age than monolingual participants. We did not find that bilingualism protects from cognitive decline or dementia from prospective studies. Retrospective studies are more prone to confounding by education, or cultural differences in presentation to dementia services and are therefore not suited to establishing causative links between risk factors and outcomes.

Surveillance colonoscopy after endoscopic treatment for colorectal neoplasia: From the standpoint of the Asia-Pacific region.

PubMed

Matsuda, Takahisa; Chiu, Han-Mo; Sano, Yasushi; Fujii, Takahiro; Ono, Akiko; Saito, Yutaka

2016-04-01

Colonoscopy is considered the gold standard to detect and remove colorectal neoplasia. The efficacy of colonoscopy with polypectomy to reduce colorectal cancer incidence and mortality has been demonstrated. Recently, post-polypectomy surveillance colonoscopy has become a necessary intervention in daily practice not only in Western countries but also in the Asia-Pacific region. Therefore, it is crucial to establish new clinical practice guidelines to reduce the number of unnecessary surveillance colonoscopies in order to create space for screening colonoscopy. The Asia-Pacific Consensus group recommended that surveillance colonoscopy interval should be tailored according to risk level of index colonoscopy. However, precise guidelines on interval of surveillance cannot be given because of a lack of prospective data. According to Korean and Australian guidelines, surveillance intervals after index colonoscopy of 5 years for low-risk subjects and 3 years for high-risk subjects are recommended in Asia-Pacific regions at present. Prospective data including long-term outcomes from the Japan Polyp Study, which is a multicenter randomized control trial, would be useful to establish the Asia-Pacific consensus in the near future. © 2016 Japan Gastroenterological Endoscopy Society.

Liposuction Assisted Lipoma Removal – Option or Alternative?

PubMed Central

Peev, Igor; Spasevska, Liljana; Mirchevska, Elizabeta; Tudzarova-Gjorgova, Smilja

2017-01-01

BACKGROUND: Lipomas are the most frequent soft -tissue tumors arising from adipose tissue. Traditionally, open surgery is a mainstay of their treatment. Recently, new treatment modalities emerge in order to decrease morbidity, to increase satisfaction rate in patents, but not to raise recurrence risk at the same time. AIM: The aim of this article is to present our experience with liposuction assisted lipoma removal in terms of efficacy, complications, risk of recurrence and patient satisfaction. METHODS: The study was prospective in which treated lipomas with vacuum suction were analyzed. Preoperative diagnosis comprised clinical exam and additional diagnostic tools as to rule out malignancy. Subcutaneous lipomas with diameter of at least 5 cm were taken into account. Tumescent liposuction technique with modification was used. RESULTS: Lipoma’s size, distribution and demographics are given. Total removal with affordable rate of complication was achieved in each case. No recurrences in 12 months follow-up period were seen. Satisfaction rate in patients was high. CONCLUSION: Liposuction assisted lipoma removal is a good alternative to open approach lipectomy and we would recommend its use in selected cases where, it might be more advantageous. However, prospective randomized controlled studies are needed in order to estimate its accurate clinical value. PMID:29104686

Plant extracts: sense or nonsense?

PubMed

Madersbacher, Stephan; Berger, Ingrid; Ponholzer, Anton; Marszalek, Martin

2008-01-01

To assess the current role of plant extracts in the medical management of lower urinary tract symptoms due to benign prostatic enlargement/benign prostatic obstruction. In 2006, two clinical trials meeting the WHO benign prostatic hyperplasia consensus conference criteria (randomized against placebo/standard therapy, study duration 12 months) were published. One trial compared a saw palmetto extract with placebo. This industry-independent trial published in the New England Journal of Medicine was negative, that is, this saw palmetto extract had no effect on symptoms, Qmax and postvoid residual volume. In another trial, a saw palmetto/urtica combination was compared with tamsulosin. After 12 months, the improvement of symptoms was identical in both study arms. No detailed data were presented, however, on Qmax, postvoid residual or prostate volume. The biological mechanisms of plant extracts in vivo are still unknown and the numerous metaanalyses cannot supplement high-quality prospective trials. Further prospective studies according to WHO benign prostatic hyperplasia standards are required to reliably determine the role of plant extracts in contemporary lower urinary tract symptoms management and to be able to answer the question in the title: 'plant extracts: sense or nonsense?' Plant extracts are currently not recommended by the American and European Association of Urology benign prostatic hyperplasia guidelines.

Efficacy of Ibuprofen and ibuprofen/acetaminophen on postoperative pain in symptomatic patients with a pulpal diagnosis of necrosis.

PubMed

Wells, L Kevin; Drum, Melissa; Nusstein, John; Reader, Al; Beck, Mike

2011-12-01

The purpose of this prospective, randomized, double-blind study was to determine ibuprofen versus ibuprofen/acetaminophen use for postoperative endodontic pain in symptomatic patients with a pulpal diagnosis of necrosis and an associated periapical radiolucency who were experiencing moderate to severe preoperative pain. We also recorded escape medication use. Seventy-one adult patients presenting for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth with a pulpal diagnosis of necrosis, periapical radiolucent area, and moderate to severe pain participated in this study. The patients were randomly divided into 2 groups by random assignment and numeric coding. An emergency debridement of the tooth was completed with hand and rotary instrumentation. At the end of the appointment, the patients randomly received capsules of either 600 mg ibuprofen or 600 mg ibuprofen combined with 1000 mg acetaminophen (blinded to both operator and patient). Patients also received a 6-day diary to be completed after anesthesia wore off and every morning for 5 days. Patients were asked to record pain, symptoms, and the number of capsules taken. Patients received escape medication (Vicodin) if the study medication did not control their pain. Postoperative data were analyzed by randomization test and step-down Bonferroni method of Holm. There were decreases in pain levels and analgesic use over time for the ibuprofen and ibuprofen/acetaminophen groups. There was no statistically significant difference between the 2 groups for analgesic use or escape medication use. Approximately 20% of patients in both groups required escape medication to control pain. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials.

PubMed

Biederman, Joseph; Petty, Carter R; Woodworth, K Yvonne; Lomedico, Alexandra; O'Connor, Katherine B; Wozniak, Janet; Faraone, Stephen V

2012-03-01

To examine the informativeness of open-label trials toward predicting results in subsequent randomized, placebo-controlled clinical trials of psychopharmacologic treatments for pediatric bipolar disorder. We searched journal articles through PubMed at the National Library of Medicine using bipolar disorder, mania, pharmacotherapy, treatment and clinical trial as keywords. This search was supplemented with scientific presentations at national and international scientific meetings and submitted manuscripts from our group. Selection criteria included (1) enrollment of children diagnosed with DSM-IV bipolar disorder; (2) prospective assessment of at least 3 weeks; (3) monotherapy of a pharmacologic treatment for bipolar disorder; (4) use of a randomized placebo-controlled design or an open-label design for the same therapeutic compound; and (5) repeated use of the Young Mania Rating Scale (YMRS) as an outcome. The following information and data were extracted from 14 studies: study design, name of medication, class of medication, dose of medication, sample size, age, sex, trial length, and YMRS mean and standard deviation baseline and follow-up scores. For both study designs, the pooled effect size was statistically significant (open-label studies, z = 8.88, P < .001; randomized placebo-controlled studies, z = 13.75, P < .001), indicating a reduction in the YMRS from baseline to endpoint in both study designs. In a meta-analysis regression, study design was not a significant predictor of mean change in the YMRS. We found similarities in the treatment effects between open-label and randomized placebo-controlled studies in youth with bipolar disorder indicating that open-label studies are useful predictors of the potential safety and efficacy of a given compound in the treatment of pediatric bipolar disorder. © Copyright 2012 Physicians Postgraduate Press, Inc.

The FIND-CKD study--a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale.

PubMed

Macdougall, Iain C; Bock, Andreas; Carrera, Fernando; Eckardt, Kai-Uwe; Gaillard, Carlo; Van Wyck, David; Roubert, Bernard; Cushway, Timothy; Roger, Simon D

2014-04-01

Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD). FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values <10 g/dL without an increase of ≥ 0.5 g/dL). The background, rationale and study design of the trial are presented here. The study has been completed and results are expected in late 2013. FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.

Finding atrial fibrillation in stroke patients: Randomized evaluation of enhanced and prolonged Holter monitoring--Find-AF(RANDOMISED) --rationale and design.

PubMed

Weber-Krüger, Mark; Gelbrich, Götz; Stahrenberg, Raoul; Liman, Jan; Kermer, Pawel; Hamann, Gerhard F; Seegers, Joachim; Gröschel, Klaus; Wachter, Rolf

2014-10-01

Detecting paroxysmal atrial fibrillation (AF) in patients with ischemic strokes presenting in sinus rhythm is challenging because episodes are often short, occur randomly, and are frequently asymptomatic. If AF is detected, recurrent thromboembolism can be prevented efficiently by oral anticoagulation. Numerous uncontrolled studies using various electrocardiogram (ECG) devices have established that prolonged ECG monitoring increases the yield of AF detection, but most established procedures are time-consuming and costly. The few randomized trials are mostly limited to cryptogenic strokes. The optimal method, duration, and patient selection remain unclear. Repeated prolonged continuous Holter ECG monitoring to detect paroxysmal AF within an unspecific stroke population may prove to be a widely applicable, effective secondary prevention strategy. Find-AFRANDOMISED is a randomized and controlled prospective multicenter trial. Four hundred patients 60 years or older with manifest (symptoms ≥24 hours or acute computed tomography/magnetic resonance imaging lesion) and acute (symptoms ≤7 days) ischemic strokes will be included at 4 certified stroke centers in Germany. Those with previously diagnosed AF/flutter, indications/contraindications for oral anticoagulation, or obvious causative blood vessel pathologies will be excluded. Patients will be randomized 1:1 to either enhanced and prolonged Holter ECG monitoring (10 days at baseline and after 3 and 6 months) or standard of care (≥24-hour continuous ECG monitoring, according to current stroke guidelines). All patients will be followed up for at least 12 months. The primary end point is newly detected AF (≥30 seconds) after 6 months, confirmed by an independent adjudication committee. We plan to complete recruitment in autumn 2014. First results can be expected by spring 2016. Copyright © 2014 Mosby, Inc. All rights reserved.

Minimizing the Disruptive Effects of Prospective Memory in Simulated Air Traffic Control

PubMed Central

Loft, Shayne; Smith, Rebekah E.; Remington, Roger

2015-01-01

Prospective memory refers to remembering to perform an intended action in the future. Failures of prospective memory can occur in air traffic control. In two experiments, we examined the utility of external aids for facilitating air traffic management in a simulated air traffic control task with prospective memory requirements. Participants accepted and handed-off aircraft and detected aircraft conflicts. The prospective memory task involved remembering to deviate from a routine operating procedure when accepting target aircraft. External aids that contained details of the prospective memory task appeared and flashed when target aircraft needed acceptance. In Experiment 1, external aids presented either adjacent or non-adjacent to each of the 20 target aircraft presented over the 40min test phase reduced prospective memory error by 11% compared to a condition without external aids. In Experiment 2, only a single target aircraft was presented a significant time (39min–42min) after presentation of the prospective memory instruction, and the external aids reduced prospective memory error by 34%. In both experiments, costs to the efficiency of non-prospective memory air traffic management (non-target aircraft acceptance response time, conflict detection response time) were reduced by non-adjacent aids compared to no aids or adjacent aids. In contrast, in both experiments, the efficiency of the prospective memory air traffic management (target aircraft acceptance response time) was facilitated by adjacent aids compared to non-adjacent aids. Together, these findings have potential implications for the design of automated alerting systems to maximize multi-task performance in work settings where operators monitor and control demanding perceptual displays. PMID:24059825

Prospective randomized trial compares suction versus water seal for air leaks.

PubMed

Cerfolio, R J; Bass, C; Katholi, C R

2001-05-01

Surgeons treat air leaks differently. Our goal was to evaluate whether it is better to place chest tubes on suction or water seal for stopping air leaks after pulmonary surgery. A second goal was to evaluate a new classification system for air leaks that we developed. Patients were prospectively randomized before surgery to receive suction or water seal to their chest tubes on postoperative day (POD) #2. Air leaks were described and quantified daily by a classification system and a leak meter. The air-leak meter scored leaks from 1 (least) to 7 (greatest). The group randomized to water seal stayed on water seal unless a pneumothorax developed. On POD #2, 33 of 140 patients had an air leak. Eighteen patients had been preoperatively randomized to water seal and 15 to suction. Air leaks resolved in 12 (67%) of the water seal patients by the morning of POD #3. All 6 patients whose air leak did not stop had a leak that was 4/7 or greater (p < 0.0001) on the leak meter. Of the 15 patients randomized to suction, only 1 patient's air leak (7%) resolved by the morning of POD #3. The randomization aspect of the trial was ended and statistical analysis showed water seal was superior (p = 0.001). The remaining 14 patients were then placed to water seal and by the morning of POD #4, 13 patients' leaks had stopped. Of the 32 total patients placed to seal, 7 (22%) developed a pneumothorax and 6 of these 7 patients had leaks that were 4/7 or greater (p = 0.001). Placing chest tubes on water seal seems superior to wall suction for stopping air leaks after pulmonary resection. However, water seal does not stop expiratory leaks that are 4/7 or greater. Pneumothorax may occur when chest tubes are placed on seal with leaks this large.

Methylprednisolone therapy in deceased donors reduces inflammation in the donor liver and improves outcome after liver transplantation: a prospective randomized controlled trial.

PubMed

Kotsch, Katja; Ulrich, Frank; Reutzel-Selke, Anja; Pascher, Andreas; Faber, W; Warnick, P; Hoffman, S; Francuski, M; Kunert, C; Kuecuek, O; Schumacher, G; Wesslau, C; Lun, A; Kohler, S; Weiss, S; Tullius, S G; Neuhaus, P; Pratschke, Johann

2008-12-01

To investigate potential beneficial effects of donor treatment with methylprednisolone on organ function and outcome after liver transplantation. It is proven experimentally and clinically that the brain death of the donor leads to increased levels of inflammatory cytokines and is followed by an intensified ischemia/reperfusion injury after organ transplantation. In experiments, donor treatment with steroids successfully diminished these effects and led to better organ function after transplantation. To investigate whether methylprednisolone treatment of the deceased donor is applicable to attenuate brain death-associated damage in clinical liver transplantation we conducted a prospective randomized treatment-versus-control study in 100 deceased donors. Donor treatment (n = 50) consisted of 250 mg methylprednisolone at the time of consent for organ donation and a subsequent infusion of 100 mg/h until recovery of organs. A liver biopsy was taken immediately after laparotomy and blood samples were obtained after brain death diagnosis and before organ recovery. Cytokines were assessed by real-time reverse transcriptase-polymerase chain reaction. Soluble serum cytokines were measured by cytometric bead array system. After methylprednisolone treatment, steroid plasma levels were significantly higher (P < 0.05), and a significant decrease in soluble interleukins, monocyte chemotactic protein-1, interleukin-2, interleukin-6, tumor necrosis factor-alpha, and inducible protein-10 was observed. Methylprednisolone treatment resulted in a significant downregulation of intercellular adhesion molecule-1, tumor necrosis factor-alpha, major histocompatibility complex class II, Fas-ligand, inducible protein-10, and CD68 intragraft mRNA expression. Significantly ameliorated ischemia/reperfusion injury in the posttransplant course was accompanied by a decreased incidence of acute rejection. Our present study verifies the protective effect of methylprednisolone treatment in deceased donor liver transplantation, suggesting it as a potential therapeutical approach.

Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial.

PubMed

Kim, Ho-Joong; Ahn, Hyo Sae; Nam, Yunjin; Chang, Bong-Soon; Lee, Choon-Ki; Yeom, Jin S

2017-11-01

To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery. The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points. The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups. The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

Opening the Internal Hematoma Membrane Does Not Alter the Recurrence Rate of Chronic Subdural Hematomas: A Prospective Randomized Trial.

PubMed

Unterhofer, Claudia; Freyschlag, Christian F; Thomé, Claudius; Ortler, Martin

2016-08-01

Factors determining the recurrence of chronic subdural hematomas (CSDHs) are not clear. Whether opening the so-called internal hematoma membrane is useful has not been investigated. To investigate whether splitting the inner hematoma membrane influences the recurrence rate in patients undergoing burr-hole craniotomy for CSDH. Fifty-two awake patients undergoing surgery for 57 CSDHs were prospectively randomized to either partial opening of the inner hematoma membrane (group A) or not (group B) after enlarged burr-hole craniotomy and hematoma evacuation. Drainage was left in situ for several days postoperatively. Groups were comparable with regard to demographic, clinical, and imaging variables. Outcome was assessed after 3-6 weeks for the combined outcome variable of reoperation or residual hematoma of one third or more of the original hematoma thickness. Fourteen patients underwent reoperation for clinical deterioration or residual hematoma during follow-up (n = 6 in group A, 21%; n = 8 in group B, 28 %) (P = 0.537). Residual hematoma of ≥ one third not requiring surgery was present in 7 patients in group A (25%) and 10 patients in group B (36%) (P = 0.383). The overall cumulative failure rate (reoperation or hematoma thickness ≥ one third) was 13/28 (46%) in group A and 18/28 in group B (P = 0.178; relative risk, 0.722 [95% confidence interval, 0.445-1.172]; absolute risk reduction -16% [95% confidence interval, -38% to 8%]). Opening the internal hematoma membrane does not alter the rate of patients requiring revision surgery and the number of patients showing a marked residual hematoma 6 weeks after evacuation of a CSDH. Copyright © 2016 Elsevier Inc. All rights reserved.

Night driving simulation in a randomized prospective comparison of Visian toric implantable collamer lens and conventional PRK for moderate to high myopic astigmatism.

PubMed

Schallhorn, Steven; Tanzer, David; Sanders, Donald R; Sanders, Monica; Brown, Mitch; Kaupp, Sandor E

2010-05-01

To compare changes in simulated night driving performance after Visian Toric Implantable Collamer Lens (TICL; STAAR Surgical) implantation and photorefractive keratectomy (PRK) for the correction of moderate to high myopic astigmatism. This prospective, randomized study consisted of 43 eyes implanted with the TICL (20 bilateral cases) and 45 eyes receiving conventional PRK (VISX Star S3 excimer laser) with mitomycin C (22 bilateral cases) for moderate to high myopia (-6.00 to -20.00 diopters[D] sphere) measured at the spectacle plane and 1.00 to 4.00 D of astigmatism. As a substudy, 27 eyes of 14 TICL patients and 41 eyes of 21 PRK patients underwent a simulated night driving test. The detection and identification distances of road signs and hazards with the Night Driving Simulator (Vision Sciences Research Corp) were measured with and without a glare source before and 6 months after each procedure. No significant difference was noted in the pre- to postoperative Night Driving Simulator in detection distances with and without the glare source between the TICL and PRK groups. The differences in identification distances without glare were significantly better for business and traffic road signs and pedestrian hazards in the TICL group relative to the PRK group whereas with glare, only the pedestrian hazards were significantly better. A clinically relevant change of Night Driving Simulator performance (>0.5 seconds change in ability to identify tasks postoperatively) was significantly better in the TICL group (with and without glare) for all identification tasks. The TICL performed better than conventional PRK in the pre- to postoperative Night Driving Simulator testing with and without a glare source present. Copyright 2010, SLACK Incorporated.

Dose-Dependent Effects of Statins for Patients with Aneurysmal Subarachnoid Hemorrhage: Meta-Regression Analysis.

PubMed

To, Minh-Son; Prakash, Shivesh; Poonnoose, Santosh I; Bihari, Shailesh

2018-05-01

The study uses meta-regression analysis to quantify the dose-dependent effects of statin pharmacotherapy on vasospasm, delayed ischemic neurologic deficits (DIND), and mortality in aneurysmal subarachnoid hemorrhage. Prospective, retrospective observational studies, and randomized controlled trials (RCTs) were retrieved by a systematic database search. Summary estimates were expressed as absolute risk (AR) for a given statin dose or control (placebo). Meta-regression using inverse variance weighting and robust variance estimation was performed to assess the effect of statin dose on transformed AR in a random effects model. Dose-dependence of predicted AR with 95% confidence interval (CI) was recovered by using Miller's Freeman-Tukey inverse. The database search and study selection criteria yielded 18 studies (2594 patients) for analysis. These included 12 RCTs, 4 retrospective observational studies, and 2 prospective observational studies. Twelve studies investigated simvastatin, whereas the remaining studies investigated atorvastatin, pravastatin, or pitavastatin, with simvastatin-equivalent doses ranging from 20 to 80 mg. Meta-regression revealed dose-dependent reductions in Freeman-Tukey-transformed AR of vasospasm (slope coefficient -0.00404, 95% CI -0.00720 to -0.00087; P = 0.0321), DIND (slope coefficient -0.00316, 95% CI -0.00586 to -0.00047; P = 0.0392), and mortality (slope coefficient -0.00345, 95% CI -0.00623 to -0.00067; P = 0.0352). The present meta-regression provides weak evidence for dose-dependent reductions in vasospasm, DIND and mortality associated with acute statin use after aneurysmal subarachnoid hemorrhage. However, the analysis was limited by substantial heterogeneity among individual studies. Greater dosing strategies are a potential consideration for future RCTs. Copyright © 2018 Elsevier Inc. All rights reserved.

Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial.

PubMed

Kıtlık, Arzu; Erdogan, Mehmet Ali; Ozgul, Ulku; Aydogan, Mustafa Said; Ucar, Muharrem; Toprak, Huseyin Ilksen; Colak, Cemil; Durmus, Mahmut

2017-02-01

Transversus abdominis plane (TAP) block is a peripheral nerve block that reduces postoperative pain, nausea, vomiting and the need for postoperative opioids following various types of abdominal surgery. The primary aim of the present study was to evaluate the effects of TAP block on postoperative analgesia and opioid consumption in living liver donors in whom a right "J" abdominal incision was used. This prospective, double-blinded, randomized controlled study was conducted with 50 living liver donors, aged 18-65years, who were scheduled to undergo right hepatectomy. Patients who received ultrasonography-guided subcostal TAP block were allocated into Group 1, and patients who did not receive TAP block were allocated into Group 2. The TAP blocks were performed bilaterally at the conclusion of surgery using 1.5mg∗kg -1 bupivacaine diluted with saline to reach a total volume of 40mL. For each patient, morphine consumption, pain scores at rest and movement, sedation scores, nausea, vomiting and the need for antiemetic medication were assessed at 0, 2, 4, 6, 12 and 24h postoperatively by researchers who were blinded to the study groups. Morphine consumption was significantly lower in Group 1 than in Group 2 at the 2nd, 6th and 24th hours (P<0.05). The mean total morphine consumption values after 24h were 40mg and 65mg in Groups 1 and 2, respectively. The TAP block significantly reduced postoperative visual analog scale pain scores both at rest and during movement at 0, 2, 4, 6, and 24h postoperatively (P<0.05). The TAP block reduced 24-h postoperative morphine consumption and contributed to analgesia in living liver donors who underwent upper abdominal wall incisions. Copyright © 2016 Elsevier Inc. All rights reserved.

Prospective, Randomized Controlled Trial Exploring the Effect of TachoSil® on Lymphocele Formation after Extended Pelvic Lymph Node Dissection in Prostate Cancer.

PubMed

Buelens, Sarah; Van Praet, Charles; Poelaert, Filip; Van Huele, Andries; Decaestecker, Karel; Lumen, Nicolaas

2018-05-15

To explore whether TachoSil®, a hemostatic patch, can reduce the incidence of lymphocele formation. Development of a lymphocele is a frequent complication after pelvic lymph node dissection (PLND) for nodal staging in prostate cancer. From 2013 - 2017, 100 patients with prostate cancer who were set to undergo a staging PLND before external beam radiotherapy (n = 50) or PLND concomitant with radical prostatectomy (RP) (n = 50) were prospectively randomized 1:1 between bilateral TachoSil® placement or not. Primary end points were radiographic lymphocele development, lymphocele volume (one week and one month postoperatively), the duration and volume of postoperative catheter drainage. Patient, tumor and surgical characteristics of the TachoSil® and control group did not differ significantly. In total 65 (65%) patients experienced a radiographic lymphocele up to three months after surgery, 29 (58%) in the TachoSil® and 36 (72%) in the control group (p = 0.34). Significantly less radiographic lymphoceles were observed one week postoperatively for patients undergoing sole PLND and one month postoperatively for PLND with RP in the TachoSil® compared to control group (16% versus 48%, p = 0.024 and 24% versus 52%, p = 0.047, respectively). The other postoperative characteristics presented no significant differences between both groups neither for patients undergoing sole PLND nor PLND with RP. Patients receiving bilateral TachoSil® placement after PLND seem less likely to develop a radiographic lymphocele early postoperative. Nevertheless, the clinical relevance of the use of TachoSil® remains highly debatable. Copyright © 2018 Elsevier Inc. All rights reserved.

Bleeding and infection with external ventricular drainage: a systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial.

PubMed

Dey, Mahua; Stadnik, Agnieszka; Riad, Fady; Zhang, Lingjiao; McBee, Nichol; Kase, Carlos; Carhuapoma, J Ricardo; Ram, Malathi; Lane, Karen; Ostapkovich, Noeleen; Aldrich, Francois; Aldrich, Charlene; Jallo, Jack; Butcher, Ken; Snider, Ryan; Hanley, Daniel; Ziai, Wendy; Awad, Issam A

2015-03-01

Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.

Effect of number and position of intraocular lens haptics on anterior capsule contraction: a randomized, prospective trial.

PubMed

Choi, Mihyun; Lazo, Marjorie Z; Kang, Minji; Lee, Jeehye; Joo, Choun-Ki

2018-03-20

The present study aimed to evaluate the degree of anterior capsule contraction (capsulorhexis contraction) with three different single-piece, hydrophilic acrylic intraocular lenses (IOLs). Patients were prospectively randomized to be implanted with one of three types of IOLs during cataract surgery: the Ophtec Precizon (IOL A), the Lucid Korea Microflex (IOL B), and the Carl Zeiss Asphina (IOL C). One week, 2 weeks, and 6 months after surgery, the area of the anterior capsule opening was measured using digital retro-illumination images after dilation of the pupil. The data were then evaluated using POCOman software. The study included 236 eyes of 202 patients. The area of the anterior capsule opening reduced by 3.53 ± 3.31 mm (17.06% ± 15.99%) between 1 week and 2 months post-operatively in the IOL A group, by 0.62 ± 1.32 mm (2.87% ± 6.03%) in the IOL B group, and by 1.09 ± 1.53 mm (4.72% ± 6.10%) in the IOL C group. The IOL B group showed minimal anterior capsule contraction 2 months after surgery (p < 0.001). IOLs with a four-plate haptic design (IOL B) showed more anterior capsular stability than those with a two-loop plate haptic (IOL A) or two-plate haptic (IOL C) design. The number and position of haptics in a capsular bag may affect anterior capsule contraction. We assume that supporting the zonules evenly may play a role in anterior capsular stability. Current Controlled Trials ISRCTN76566080 , Retrospectively registered (Date of registration: 14 Feb 2018).

Continuous full-time occlusion of the sound eye vs full-time occlusion of the sound eye periodically alternating with occlusion of the amblyopic eye in treatment of amblyopia: a prospective randomized study.

PubMed

Stanković, B; Milenković, S

2007-01-01

To compare continuous full-time (24 hours per day) occlusion of the sound eye with full-time occlusion (24 hours per day) of the sound eye 1 day more than the years of age periodically alternating with occlusion of the amblyopic eye for 1 day, as treatments for profound strabismic amblyopia in children older than 5 years. A total of 53 patients with visual acuity (VA) of 0.4 and less in the amblyopic eye (tested by crowded Landolt Cs) after previously being provided optimal optical correction were randomly assigned to receive either of the two patching regimens. VA and pattern reversal visual evoked potentials (PVEP) were recorded prospectively at 1-month intervals. Improvement in VA and the reduction in crowding difficulties (CD) were the main outcome measures of the treatment efficiency. Both treatment modalities were equally effective. Of the 51 subjects who completed the study, 21 (41.2%) were cured whereas 32 (62.7%) attained satisfactory improvement. Recovery of VA was related to age, with cure being obtained in 23.5% (4/17) and satisfactory improvement in 52.9% (9/17) of patients older than 9 years. Larger gain in VA influenced the stability of the vision over time. It can be concluded that in clinically monitored parameters both treatment modalities were equally effective without any statistical or clinical significance in the observed groups of patients. However, events like the "trade-off" effect, occurrence of occlusion amblyopia, or prolongation of PVEP latency of the sound eye indicate that full-time continuous occlusion possibly presents a more effective form of treatment.

Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial.

PubMed

Lee, Won-Suk; Lee, Kwang-Beom; Lim, Soyi; Chang, Young Gin

2015-09-03

Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of palonosetron, granisetron, and ramosetron for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery. In this prospective, randomized observational study, 105 healthy female patients who were undergoing laparocopic hystectomy under general anaesthesia were enrolled (clinical trial number: NCT01752374, www.clinicaltrials.gov ). Patients were divided into three groups: the palonostron (0.075 mg i.v.; n = 35), the granisetron group (3 mg i.v.; n = 35), and the ramosetron group (0.3 mg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated. The overall incidence of PONV was 33.3 % for this series. The number of complete responders at 48 h after the surgery was 21 (60.0 %) for palonosetron, 24 (68.6 %) for granisetron, and 26 (71.4 %) for ramosetron, representing no statistical difference (P = 0.086). There were no significant differences in the overall incidence of postoperative nausea and vomiting and complete responders for palonosetron, granisetron and ramosetron group. NCT01752374 , www.clinicaltrials.gov .

Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial.

PubMed

Twamley, Elizabeth W; Jak, Amy J; Delis, Dean C; Bondi, Mark W; Lohr, James B

2014-01-01

Traumatic brain injury (TBI) can result in cognitive impairments and persistent postconcussive symptoms that limit functional recovery, including return to work. We evaluated a 12 wk compensatory cognitive training intervention (Cognitive Symptom Management and Rehabilitation Therapy [CogSMART]) in the context of supported employment for Veterans with mild to moderate TBI. Participants were randomly assigned to receive 12 wk of supported employment plus CogSMART or enhanced supported employment that controlled for therapist attention (control). CogSMART sessions were delivered by the employment specialist and included psychoeducation regarding TBI; strategies to improve sleep, fatigue, headaches, and tension; and compensatory cognitive strategies in the domains of prospective memory, attention, learning and memory, and executive functioning. Compared with controls, those assigned to supported employment plus CogSMART demonstrated significant reductions in postconcussive symptoms (Cohen d = 0.97) and improvements in prospective memory functioning (Cohen d = 0.72). Effect sizes favoring CogSMART for posttraumatic stress disorder symptom severity, depressive symptom severity, and attainment of competitive work within 14 wk were in the small to medium range (Cohen d = 0.35-0.49). Those who received CogSMART rated the intervention highly. Results suggest that adding CogSMART to supported employment may improve postconcussive symptoms and prospective memory. These effects, as well as smaller effects on psychiatric symptoms and ability to return to work, warrant replication in a larger trial.

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis

PubMed Central

Papachristou, Georgios I.; Machicado, Jorge D.; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C.; Singh, Vikesh K.; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A.; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O.; Triantafyllou, Konstantinos; Barbu, Sorin T.; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A.; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch.; Nawaz, Haq; Park, Walter G.; de-Madaria, Enrique; Lee, Peter J.; Wu, Bechien U.; Greer, Phil J.; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

Background We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. Methods The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Results Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. Conclusion APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials. PMID:28042246

Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial.

PubMed

Mahure, Siddharth A; Rokito, Andrew S; Kwon, Young W

2017-09-01

Arthroscopic rotator cuff repair (ARCR) can be associated with significant postoperative pain. Concern for opioid abuse has led surgeons to identify alternative, efficacious methods of postoperative analgesia. To determine whether transcutaneous electrical nerve stimulation (TENS) can have a similarly beneficial effect after shoulder procedures, we conducted a prospective double-blinded randomized trial in patients undergoing outpatient ARCR. All patients undergoing ARCR of a full-thickness rotator cuff tear by the senior authors were identified. Patients with a history of recent narcotic use or prior narcotic abuse and those under management of a pain control specialist were excluded. Patients were randomized into 2 groups, active or placebo TENS, and used the device for 4 sessions/day for 45 minutes/session for the first postoperative week. All patients received Percocet 5/325 mg (oxycodone/acetaminophen) for use as rescue pain pills. One-week narcotic consumption and visual analog scale pain scores were compared between groups. The final analysis included 37 patients (21 active,16 placebo). Baseline and procedural differences were not different between groups. At 1 week postoperatively, patients in the active group had significantly lower pain scores (3.6 ± 2.1 vs. 5.8 ± 1.2; P= .008). Postoperative Percocet consumption during the initial 48 hours (12.8 ± 4.7 vs. 17.2 ± 6.3; P = .020) and during the first week (25.2 ± 9.9 vs. 33.8 ± 14.3; P = .037) was also significantly lower in the active group. Results from this prospective double-blinded randomized trial demonstrate that compared with placebo TENS, active TENS can result in significantly less pain and reduced opioid use in the immediate postoperative period after ARCR, suggesting that TENS may be potentially useful in a multimodal approach to managing postoperative pain. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis: a prospective, randomized controlled study of 51 patients.

PubMed

Rajasekaran, S; Thomas, Ashok; Kanna, Rishi M; Prasad Shetty, Ajoy

2013-09-15

Prospective, randomized controlled study. To compare the functional outcomes and extent of paraspinal muscle damage between 2 decompressive techniques for lumbar canal stenosis. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and liga-mentous attachments of the posterior elements of the spine. It can potentially avoid problems such as paraspinal muscle atrophy and trunk extensor weakness that can occur after conventional midline decompression. However, large series prospective randomized controlled studies are lacking. Patients with lumbar canal stenosis were randomly allocated into 2 groups: LSPSD (28 patients) and conventional midline decompression (23 patients). The differences in operative time, blood loss, time to comfortable mobilization, and hospital stay were studied. Paraspinal muscle damage was assessed by postoperative rise in creatine phosphokinase and C-reactive protein levels. Functional outcome was evaluated at 1 year by Japanese Orthopaedic Association score, neurogenic claudication outcome score, and visual analogue scale for back pain and neurogenic claudication. Fifty-one patients of mean age 56 years were followed-up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at 1 year. Between the 2 groups, the Japanese Orthopaedic Association score, neurogenic claudication outcome score improvement, visual analogue scale for back pain, neurogenic claudication visual analogue scale, and the postoperative changes in serum C-reactive protein and creatine phosphokinase levels did not show any statistically significant difference. On the basis of the Japanese Orthopaedic Association recovery rate, it was found that 73.9% of conventional midline decompression group had good outcomes compared with only 60.7% after LSPSD. The functional outcome scores, back pain, and claudication pain in the immediate period and at the end of 1 year are similar in both the techniques. More patients had better functional outcomes after conventional decompression than the LSPSD technique. On the basis of this study, the superiority of one technique compared with the other is not established, mandating the need for further long-term studies. 2.

Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti-T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease-Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation.

PubMed

Soiffer, Robert J; Kim, Haesook T; McGuirk, Joseph; Horwitz, Mitchell E; Johnston, Laura; Patnaik, Mrinal M; Rybka, Witold; Artz, Andrew; Porter, David L; Shea, Thomas C; Boyer, Michael W; Maziarz, Richard T; Shaughnessy, Paul J; Gergis, Usama; Safah, Hana; Reshef, Ran; DiPersio, John F; Stiff, Patrick J; Vusirikala, Madhuri; Szer, Jeff; Holter, Jennifer; Levine, James D; Martin, Paul J; Pidala, Joseph A; Lewis, Ian D; Ho, Vincent T; Alyea, Edwin P; Ritz, Jerome; Glavin, Frank; Westervelt, Peter; Jagasia, Madan H; Chen, Yi-Bin

2017-12-20

Purpose Several open-label randomized studies have suggested that in vivo T-cell depletion with anti-T-lymphocyte globulin (ATLG; formerly antithymocyte globulin-Fresenius) reduces chronic graft-versus-host disease (cGVHD) without compromising survival. We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovii Biotech, Lexington, MA) on cGVHD-free survival. Patients and Methods Two hundred fifty-four patients 18 to 65 years of age with acute leukemia or myelodysplastic syndrome who underwent myeloablative HLA-matched unrelated hematopoietic cell transplantation (HCT) were randomly assigned one to one to placebo (n =128 placebo) or ATLG (n = 126) treatment at 27 sites. Patients received either ATLG or placebo 20 mg/kg per day on days -3, -2, -1 in addition to tacrolimus and methotrexate as GVHD prophylaxis. The primary study end point was moderate-severe cGVHD-free survival. Results Despite a reduction in grade 2 to 4 acute GVHD (23% v 40%; P = .004) and moderate-severe cGVHD (12% v 33%; P < .001) in ATLG recipients, no difference in moderate-severe cGVHD-free survival between ATLG and placebo was found (2-year estimate: 48% v 44%, respectively; P = .47). Both progression-free survival (PFS) and overall survival (OS) were lower with ATLG (2-year estimate: 47% v 65% [ P = .04] and 59% v 74% [ P = .034], respectively). Multivariable analysis confirmed that ATLG was associated with inferior PFS (hazard ratio, 1.55; 95% CI, 1.05 to 2.28; P = .026) and OS (hazard ratio, 1.74; 95% CI, 1.12 to 2.71; P = .01). Conclusion In this prospective, randomized, double-blind trial of ATLG in unrelated myeloablative HCT, the incorporation of ATLG did not improve moderate-severe cGVHD-free survival. Moderate-severe cGVHD was significantly lower with ATLG, but PFS and OS also were lower. Additional analyses are needed to understand the appropriate role for ATLG in HCT.

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.

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.

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with lateral epicondylitis, a combination injection of HA + CS may offer better pain benefits for 6 months after injection, when compared to triamcinolone. Level II, Randomized Clinical Trial, Prospective Comparative Study.

Non-invasive brain stimulation and computational models in post-stroke aphasic patients: single session of transcranial magnetic stimulation and transcranial direct current stimulation. A randomized clinical trial.

PubMed

Santos, Michele Devido Dos; Cavenaghi, Vitor Breseghello; Mac-Kay, Ana Paula Machado Goyano; Serafim, Vitor; Venturi, Alexandre; Truong, Dennis Quangvinh; Huang, Yu; Boggio, Paulo Sérgio; Fregni, Felipe; Simis, Marcel; Bikson, Marom; Gagliardi, Rubens José

2017-01-01

Patients undergoing the same neuromodulation protocol may present different responses. Computational models may help in understanding such differences. The aims of this study were, firstly, to compare the performance of aphasic patients in naming tasks before and after one session of transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS) and sham, and analyze the results between these neuromodulation techniques; and secondly, through computational model on the cortex and surrounding tissues, to assess current flow distribution and responses among patients who received tDCS and presented different levels of results from naming tasks. Prospective, descriptive, qualitative and quantitative, double blind, randomized and placebo-controlled study conducted at Faculdade de Ciências Médicas da Santa Casa de São Paulo. Patients with aphasia received one session of tDCS, TMS or sham stimulation. The time taken to name pictures and the response time were evaluated before and after neuromodulation. Selected patients from the first intervention underwent a computational model stimulation procedure that simulated tDCS. The results did not indicate any statistically significant differences from before to after the stimulation.The computational models showed different current flow distributions. The present study did not show any statistically significant difference between tDCS, TMS and sham stimulation regarding naming tasks. The patients'responses to the computational model showed different patterns of current distribution.

Patterns of antimicrobial use for respiratory tract infections in older residents of long-term care facilities

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: To describe patterns of antimicrobial use for respiratory tract infections (RTIs) among elderly residents of long-term care facilities (LTCFs). DESIGN: Data from a prospective, randomized, controlled study conducted from April 1998 through August 2001 to investigate the effect of vitamin ...

REDUCTION IN ASTHMA MORBIDITY IN CHILDREN AS A RESULT OF HOME REMEDIATION AIMED AT MOISTURE SOURCES

EPA Science Inventory

Objective: Home dampness, presence of mold and allergens have been associated with asthma morbidity. We examined changes in asthma morbidity in children as a result of home remediation aimed at moisture sources.

Design: Prospective, randomized controlled trial.

Part...

Maternal Attachment Behaviors with Adopted and Birth Infants.

ERIC Educational Resources Information Center

Chan, Marilyn M.

This study investigated: (1) effects of teaching mothers the unique behavioral cues of their adopted infants and (2) potential differences between the mothering practices of adoptive and birth mothers. A pretest, posttest experimental prospective design was used with random assignment of mother-infant dyads. Mother-adopted infant dyads were…

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.

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.

Fruit and vegetables consumption and incident hypertension: dose-response meta-analysis of prospective cohort studies.

PubMed

Wu, L; Sun, D; He, Y

2016-10-01

The role of dietary factors on chronic diseases seems essential in the potentially adverse or preventive effects. However, no evidence of dose-response meta-analysis of prospective cohort studies has verified the association between the intake of fruit and/or vegetables and the risk of developing hypertension. The PubMed and Embase were searched for prospective cohort studies. A generic inverse-variance method with random effects model was used to calculate the pooled relative risks (RRs) and 95% confidence intervals (CIs). Generalized least squares trend estimation model was used to calculate the study-specific slopes for the dose-response analyses. Seven articles comprised nine cohorts involving 185 676 participants were assessed. The highest intake of fruit or vegetables separately, and total fruit and vegetables were inversely associated with the incident risk of hypertension compared with the lowest level, and the pooled RRs and 95% CIs were 0.87 (0.79, 0.95), 0.88 (0.79, 0.99) and 0.90 (0.84, 0.98), respectively. We also found an inverse dose-response relation between the risk of developing hypertension and fruit intake, and total fruit and vegetables consumption. The incident risk of hypertension was decreased by 1.9% for each serving per day of fruit consumption, and decreased by 1.2% for each serving per day of total fruit and vegetables consumption. Our results support the recommendation to increase the consumption of fruit and vegetables with respect to preventing the risk of developing hypertension. However, further large prospective studies and long-term high-quality randomized controlled trials are still needed to confirm the observed association.

Analyzing the performance of PROSPECT model inversion based on different spectral information for leaf biochemical properties retrieval

NASA Astrophysics Data System (ADS)

Sun, Jia; Shi, Shuo; Yang, Jian; Du, Lin; Gong, Wei; Chen, Biwu; Song, Shalei

2018-01-01

Leaf biochemical constituents provide useful information about major ecological processes. As a fast and nondestructive method, remote sensing techniques are critical to reflect leaf biochemistry via models. PROSPECT model has been widely applied in retrieving leaf traits by providing hemispherical reflectance and transmittance. However, the process of measuring both reflectance and transmittance can be time-consuming and laborious. Contrary to use reflectance spectrum alone in PROSPECT model inversion, which has been adopted by many researchers, this study proposes to use transmission spectrum alone, with the increasing availability of the latter through various remote sensing techniques. Then we analyzed the performance of PROSPECT model inversion with (1) only transmission spectrum, (2) only reflectance and (3) both reflectance and transmittance, using synthetic datasets (with varying levels of random noise and systematic noise) and two experimental datasets (LOPEX and ANGERS). The results show that (1) PROSPECT-5 model inversion based solely on transmission spectrum is viable with results generally better than that based solely on reflectance spectrum; (2) leaf dry matter can be better estimated using only transmittance or reflectance than with both reflectance and transmittance spectra.

Presentations - Freeman, L.K., 2015 | Alaska Division of Geological &

Science.gov Websites

Communications Alaska Geologic Data Index (AGDI) Volcanology Alaska Volcano Observatory (AVO) Mineral Resources ; Apollo Mine; Arctic Prospect; Bee Creek Prospect; Bokan Mountain; Bornite Prospect; Caribou Dome Prospect

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

PubMed Central

Seidler, Anna Lene; Askie, Lisa M

2018-01-01

Objectives To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Design Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Participants Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Main outcome measures Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Results Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Conclusions Despite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance. PMID:29496896

Effect of iron content on the tolerability of prenatal multivitamins in pregnancy.

PubMed

Nguyen, Patricia; Nava-Ocampo, Alejandro; Levy, Amalia; O'Connor, Deborah L; Einarson, Tom R; Taddio, Anna; Koren, Gideon

2008-05-15

Gastrointestinal irritability can deter pregnant women from starting or continuing prenatal multivitamin supplementation. In a previous study, suboptimal tolerability was observed among pregnant women taking a large tablet (18 mm x 8 mm x 8 mm) multivitamin with high elemental iron content (60 mg as ferrous fumarate). The objective of the present study was to compare rates of adherence and reported adverse events among pregnant women who were randomized to commence supplementation with a small-tablet prenatal multivitamin, containing either low or high iron content. Pregnant women who called the Motherisk Program (Hospital for Sick Children, Toronto) and had not started taking or had discontinued any multivitamin due to adverse events were included in this prospective, randomized, open-label, 2-arm study. Women were randomized to take a small-size (16 mm x 9 mm x 4 mm), low elemental iron content (35 mg as ferrous fumarate) multivitamin ('35 mg' group); or a small-size (5 mm radius, 5 mm thickness), high elemental iron content (60 mg as ferrous sulphate) multivitamin ('60 mg' group). Follow-up interviews documented pill intake and adverse events. Rates of adherence and adverse events were compared between groups using chi-squared tests and Kaplan-Meier survival curves. Of 167 randomized women, 92 in the '35 mg' group and 75 in the '60 mg' group were included in the analysis. Despite ideal conditions and regular follow-ups, mean adherence based on pill intake recall, in both groups was approximately 50%. No statistically significant difference was detected in proportions of women who actually started taking either multivitamin. Among those who started, no difference was detected in rates of adherence or reported adverse events. The present results suggest that iron content is not a major determinant of adherence to prenatal multivitamins. Combined with our previous study, tablet size may be the more definitive factor affecting adherence.

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.

Randomized controlled trial of benzocaine versus placebo spray for pain relief at hysterosalpingogram

PubMed Central

Bachman, Emelia Argyropoulos; Senapati, Suneeta; Sammel, Mary D.; Kalra, Suleena Kansal

2016-01-01

Many women experience pain during hysterosalpingogram (HSG). This prospective, randomized, double-blinded, placebo-controlled study assessed whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, parity, pre-procedure oral analgesic use and history of dysmenorrhoea and/or chronic pelvic pain. Median change in pain score from baseline to procedure was 50.6 mm (−7.4 to 98.8 mm) in the benzocaine group and 70.4 mm (19.8 to 100 mm) in the placebo group. There was no difference between groups after adjusting for history of dysmenorrhoea. There was no difference in resolution of pain in benzocaine versus placebo groups at 5 min post procedure – median pain score difference – 11.1 (−90.1 to 18.5) versus −37.0 (−100 to 1.2) – or at 30 min post procedure. Satisfaction scores did not differ by treatment and did not correlate with pain score during the procedure (rho = 0.005). The use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. PMID:24745839

Effects of pushing techniques during the second stage of labor: A randomized controlled trial.

PubMed

Koyucu, Refika Genç; Demirci, Nurdan

2017-10-01

Spontaneous pushing is a method that is used in the management of the second stage of labor and suggested to be more physiological for the mother and infant. The present study aims to evaluate the effects of pushing techniques on the mother and newborn. This randomized prospective study was performed between June 2013-March 2014 in a tertiary maternity clinic in Istanbul. 80 low risk, nulliparous cases were randomized to pushing groups. Valsalva pushing group was told to hold their breath while pushing. No visual-verbal instructions were given to spontaneous pushing group and they were encouraged to push without preventing respiration. Demographic data, second stage period, perineal laceration rates, fetal heart rate patterns, presence of meconium stained amniotic liquid, newborn APGAR scores, POP-Q examination and Q-tip test results were evaluated in these cases. The second stage of labor was significantly longer with spontaneous pushing. Decrease in Hb levels in valsalva pushing group was determined to be higher than spontaneous pushing group. An increased urethral mobility was observed in valsalva pushing group. Although the duration of the second stage of labor was longer compared to valsalva pushing technique, women were able to give birth without requiring any verbal or visual instruction, without exceeding the limit value of two hours and without affecting fetal wellness and neonatal results. Copyright © 2017. Published by Elsevier B.V.

Photobiomodulation with non-thermal lasers: Mechanisms of action and therapeutic uses in dermatology and aesthetic medicine.

PubMed

Nestor, Mark; Andriessen, Anneke; Berman, Brian; Katz, Bruce E; Gilbert, Dore; Goldberg, David J; Gold, Michael H; Kirsner, Robert S; Lorenc, Paul Z

2017-08-01

Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.

Comparison of flutamide and spironolactone in the treatment of hirsutism: a randomized controlled trial.

PubMed

Cusan, L; Dupont, A; Gomez, J L; Tremblay, R R; Labrie, F

1994-02-01

To compare the clinical efficacy and safety of the pure antiandrogen flutamide and the steroidal derivative spironolactone in the treatment of hirsutism in women. Fifty-three premenopausal women suffering from moderate to severe hirsutism were randomized into two groups and received either flutamide or spironolactone in association with a triphasic oral contraceptive (OC) pill. Hirsutism, acne, seborrhea, alopecia, and side effects were monitored monthly for a treatment period of 9 months and a follow-up after treatment period of 6 months. Blood samples were taken at each visit for assessment of endocrine, biochemical, and hematologic parameters. After only 6 months of therapy, flutamide caused a maximal reduction in the hirsutism score to a value within almost normal range; during the same period, spironolactone caused only a 30% reduction of the hirsutism score. Whereas flutamide caused a dramatic (80%) decrease in total acne, seborrhea, and hair loss score after only 3 months of therapy, spironolactone caused only a 50% reduction in acne and seborrhea, with no significant effect on the hair loss score. Four patients in the spironolactone group but only one in the flutamide group stopped the medication because of adverse side effects. The present data obtained in a randomized prospective study clearly demonstrate that the pure antiandrogen flutamide is superior to spironolactone in the treatment of female hirsutism and its related androgen-dependent symptoms and signs in women.

Clinical follow-up after cessation of chronic electrical neuromodulation in patients with severe coronary artery disease: a prospective randomized controlled study on putative involvement of sympathetic activity.

PubMed

Jessurun, G A; DeJongste, M J; Hautvast, R W; Tio, R A; Brouwer, J; van Lelieveld, S; Crijns, H J

1999-10-01

The present study assessed the reoccurrence of myocardial ischemia after withholding electrical neurostimulation. After randomization, in the study or withdrawal group, spinal cord stimulation (SCS) was set active during the first 4 weeks, followed by 4 weeks of withholding stimulation. In the control group, SCS was switched off during 4 weeks before the end of the study. The control group had no crossover period. Measurements were done at baseline, then after 4 and 8 weeks. The first periods at 4 weeks of each sequence of both groups were compared. In addition, a comparison of clinical variables was performed between the study group 4 weeks after withholding stimulation and the control group 4 weeks following randomization. A total number of 24 patients with refractory angina and an implanted spinal cord stimulator were included in the study (n = 12) and control group. Angina pectoris complaints, nitroglycerin intake, ischemia, and heart rate variability using 48-hour ambulatory electrocardiographic monitoring were assessed. In addition, neurohormonal status and symptom-limited aerobic capacity were evaluated. There was no increase of anginal complaints or ischemia after withholding stimulation. Neurohormonal levels and aerobic capacity were not altered. We conclude that there is no adverse clinical rebound phenomenon after withholding neurostimulation in patients with refractory angina pectoris.

Comparison of caudal analgesia between ropivacaine and ropivacaine with clonidine in children: A randomized controlled trial

PubMed Central

Laha, Arpita; Ghosh, Sarmila; Das, Haripada

2012-01-01

Background: Addition of clonidine to ropivacaine (0.2%) can potentially enhance analgesia without producing prolonged motor blockade. The aim of the present study was to compare the post-operative pain relieving quality of ropivacaine 0.2% and clonidine mixture to that of plain ropivacaine 0.2% following caudal administration in children. Methods: In a prospective, double-blinded, randomized controlled trial, 30 ASA 1 pediatric patients undergoing infraumbilical surgery were randomly allocated to receive a caudal injection of either plain ropivacaine 0.2% (1 ml/kg) (group A) or a mixture of ropivacaine 0.2% (1 ml/kg) with clonidine 2 μg/kg (group B). Objective pain score and need for supplemental analgesics were compared during the 1st 24 hours postoperatively. Residual post-operative sedation and motor blockade were also assessed. Results: Significantly prolonged duration of post-operative analgesia was observed in group B (P<0.0001). Heart rate and blood pressure were not different in 2 groups. Neither motor blockade nor post-operative sedation varied significantly between the groups. Conclusion: The combination of clonidine (2 μg/kg) and ropivacaine 0.2% was associated with an improved quality of post-operative analgesia compared to plain 0.2% ropivacaine. The improved analgesic quality of the clonidine-ropivacaine mixture was achieved without causing any significant degree of post-operative sedation or prolongation of motor blockade. PMID:23162389

Current evidence for the safety and efficacy of the bio-engineered dual therapy COMBO stent.

PubMed

Kalkman, Deborah N; Chandrasekhar, Jaya; de Winter, Robbert J; Mehran, Roxana

2018-06-01

The novel dual-therapy COMBO stent aims to promote vessel healing after percutaneous coronary intervention (PCI) in patients with coronary artery disease. The pro-healing technique consists of an anti-CD34+ antibody layer that attracts circulating endothelial progenitor cells (EPCs), which bind to the stent surface and allow rapid endothelialization by differentiation of the EPCs into normal endothelial cells. The COMBO stent combines this pro-healing technique with an abluminal drug elution of sirolimus. The promise of this dual-therapy stent is that it may safely allow a shortened duration of dual-antiplatelet therapy (DAPT) after stent placement. Moreover, with a mature endothelial layer, lower rates of in-stent restenosis may be expected. Clinical outcomes after COMBO stent implantation have been recently evaluated in both randomized trials and large, prospective, multicenter registries, showing low clinical event rates of in-stent restenosis and stent thrombosis. Randomized clinical trials (HARMONEE and RECOVERY) have demonstrated the non-inferiority of COMBO versus "first in class" second generation and newer generation drug-eluting stents. Safety and efficacy of 3 months of DAPT after COMBO stent placement in patients presenting with acute coronary syndrome has been evaluated in the large REDUCE randomized controlled trial, showing non-inferiority to standard duration of 12-month DAPT. In this review we provide an overview of the current pre-clinical and clinical evidence for the performance of the COMBO stent.

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.

Cost-effectiveness of Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: results from a randomized controlled trial.

PubMed

Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Andersson, Gerhard; Rück, Christian; Lindefors, Nils

2011-11-01

Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n=64) or CBGT (n=62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. Copyright © 2011 Elsevier Ltd. All rights reserved.

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.

A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

PubMed

Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

2017-07-01

A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

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.

Pre-injection of magnesium sulfate enhances the efficacy of ibutilide for the conversion of typical but not of atypical persistent atrial flutter.

PubMed

Steinwender, Clemens; Hönig, Simon; Kypta, Alexander; Kammler, Jürgen; Schmitt, Barbara; Leisch, Franz; Hofmann, Robert

2010-06-11

Ibutilide is a class III antiarrhythmic drug, frequently used for conversion of atrial fibrillation and flutter. Retrospective cohort evaluations found that intravenous application of magnesium enhances the efficacy of ibutilide for chemical conversion of these arrhythmias. This prospective study sought to investigate the effects of intravenously pre-injected magnesium on the conversion rate of ibutilide for typical and atypical atrial flutter. We performed a prospective, randomized, placebo-controlled study. Patients with typical atrial flutter (TAF) or atypical atrial flutter (AAF) were randomized to receive either 4 g of intravenous magnesium sulfate or placebo immediately before administration of a maximum dose of 2 mg of ibutilide fumarate. Continuous rhythm monitoring for 4 h provided information on conversion to sinus rhythm. QT interval durations were measured before randomization, after magnesium, as well as 30 min and 4 h after starting ibutilide infusion. We randomized 117 patients (58 with and 59 without pre-injection of magnesium; 65 with TAF and 52 with AAF). In patients with TAF, pre-injection of magnesium significantly improved the efficacy of ibutilide for conversion (85% with magnesium vs. 59% with placebo, p=0.017). In patients with AAF, no significant difference in conversion rates between patients receiving magnesium or placebo was detected (48% vs. 56%, p=0.189). Pre-injection of magnesium did not significantly influence the QT intervals at any time after administration of ibutilide. Pre-injection of magnesium significantly enhances the efficacy of ibutilide for the conversion of TAF but not of AAF. Copyright (c) 2008 Elsevier Ireland Ltd. All rights reserved.

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.

The role of vitamin D in the prevention of late-life depression.

PubMed

Okereke, Olivia I; Singh, Ankura

2016-07-01

In this article, we review current evidence regarding potential benefits of vitamin D for improving mood and reducing depression risk in older adults. We summarize gaps in knowledge and describe future efforts that may clarify the role of vitamin D in late-life depression prevention. MEDLINE and PsychINFO databases were searched for all articles on vitamin D and mood that had been published up to and including May 2015. Observational studies and randomized trials with 50 or more participants were included. We excluded studies that involved only younger adults and/or exclusively involved persons with current depression. Twenty observational (cross-sectional and prospective) studies and 10 randomized trials (nine were randomized placebo-controlled trials [RCTs]; one was a randomized blinded comparison trial) were reviewed. Inverse associations of vitamin D blood level or vitamin D intake with depression were found in 13 observational studies; three identified prospective relations. Results from all but one of the RCTs showed no statistically significant differences in depression outcomes between vitamin D and placebo groups. Observational studies were mostly cross-sectional and frequently lacked adequate control of confounding. RCTs often featured low treatment doses, suboptimal post-intervention changes in biochemical levels of vitamin D, and/or short trial durations. Vitamin D level-mood associations were observed in most, but not all, observational studies; results indicated that vitamin D deficiency may be a risk factor for late-life depression. However, additional data from well-designed RCTs are required to determine the impact of vitamin D in late-life depression prevention. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

PubMed

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

2014-04-01

To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

PubMed

Douglas, Pamela S; Hoffmann, Udo; Lee, Kerry L; Mark, Daniel B; Al-Khalidi, Hussein R; Anstrom, Kevin; Dolor, Rowena J; Kosinski, Andrzej; Krucoff, Mitchell W; Mudrick, Daniel W; Patel, Manesh R; Picard, Michael H; Udelson, James E; Velazquez, Eric J; Cooper, Lawton

2014-06-01

Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Copyright © 2014 Mosby, Inc. All rights reserved.

PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

PubMed Central

Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

2014-01-01

Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

Correlation of the association of serum lactate, random blood sugar, and revised trauma score as predictors of outcome in hemodynamically unstable abdominal emergencies.

PubMed

Allwell-Brown, E; Afuwape, O O; Ayandipo, O; Alonge, T

2016-01-01

Elevated levels of serum lactate and glucose during resuscitation have been demonstrated to be predictors of morbidity and mortality in hemodynamically unstable patients with surgical abdominal conditions. However, the rate of return to normal levels of both lactate and blood glucose may be better predictors of mortality and morbidity. The aims of this study are: (I) To determine the pattern of serum lactate and glucose changes in patients with surgical abdominal conditions requiring resuscitation within 48 hours of presentation. (II) To correlate the predictive capability of these two independent parameters. (III) To correlate the predictive values of these parameters with the revised trauma score (RTS). This is a prospective observational study conducted over three months. The patients admitted by the general surgery division requiring resuscitation from shock was included in this study. Resuscitation was carried out with crystalloids. The estimation of serum lactate and glucose levels was done at presentation (0 hours), 12, 24 and 48 hours after admission. The revised trauma score (RTS) was calculated for each patient at presentation and at 12, 24 and 48 hours subsequently. The patients were followed up four weeks or when death occurred within four weeks of presentation. Forty four patients were recruited in the study. There were seven mortalities. The mean serum levels of Plasma glucose and lactate of all the patients were elevated at presentation in the emergency department. Survival was better with a return to normal serum lactate within 12 hours. On the other hand the random plasma glucose (RPG) levels may not be useful in prognosticating patients. However a combination of serum lactate, RTS (at 24 and 48 hours) and RPG at 48 hours may improve predictive parameters in trauma related cases.

Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

PubMed

He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

2009-05-20

To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (p<0.0001). The difference in the mean scores from the baseline to the 3rd cycle in the treatment group (22.71+/-10.33) was significantly lower than the difference in the placebo group (15.50+/-12.94, p<0.0001). Results of PMTS were similar, the total scores for PMTS were significantly lower between the two groups (p<0.01) and within each group (p<0.01). The score was decreased from 26.17+/-4.79 to 9.92+/-9.01 for the treatment group, and from 27.10+/-4.76 to 14.59+/-10.69 for the placebo group. A placebo effect of 50% was found in the present study. No serious adverse event (SAE) occurred in both groups. Vitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study.

PubMed

Younis, Arwa; Eskenazi, Dana; Goldkorn, Ronen; Leor, Jonathan; Naftali-Shani, Nili; Fisman, Enrique Z; Tenenbaum, Alexander; Goldenberg, Ilan; Klempfner, Robert

2017-05-22

Patients with type 2 diabetes present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available. A prospective, randomized, open-label study was performed in 60 patients with coronary artery disease (CAD) and type 2 diabetes, who participated in a cardiac rehabilitation program. After a washout period of 3 weeks, patients were randomized in a 2:1 ratio to receive combined vildagliptin/metformin therapy (intervention group: n = 40) vs. metformin alone (control group: n = 20) for a total of 12 weeks. Blinded assessment of interleukin-1ß (IL-1ß, the primary endpoint), hemoglobin A1c (HbA1c), and high sensitivity C reactive protein (hsCRP), were performed at baseline and after 12 weeks. Mean age of study patients was 67 ± 9 years, 75% were males, and baseline HbA1c and inflammatory markers levels were similar between the two groups. At 12 weeks of follow up, levels of IL-1ß, hsCRP, and HbA1c were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL-1ß among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p < 0.001). The hsCRP was lowered by 60% in the vildagliptin/metformin group vs. 23% in the metformin group (p < 0.01). Moreover, a significant relative reduction of the HbA1c was seen in the intervention group (7% reduction, p < 0.03). The addition of vildagliptin to metformin treatment in patients with type 2 diabetes and CAD led to a significant suppression of the IL-1ß elevation during follow up. A significant relative reduction of hsCRP and HbA1c in the intervention group was also observed. Trial registration NCT01604213.

Prospective randomized trial of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus paclitaxel and FAC (TFAC) in patients with operable breast cancer: impact of taxane chemotherapy on locoregional control.

PubMed

Albert, Jeffrey M; Buzdar, Aman U; Guzman, Reina; Allen, Pamela K; Strom, Eric A; Perkins, George H; Woodward, Wendy A; Hoffman, Karen E; Tereffe, Welela; Hunt, Kelly K; Buchholz, Thomas A; Oh, Julia L

2011-07-01

A previous randomized trial (CALGB 9344/Intergroup 0148) compared four cycles of adjuvant doxorubicin/cyclophosphamide (AC) to four cycles of AC plus four cycles of paclitaxel (AC + T) and demonstrated that the addition of paclitaxel improved locoregional control (LRC) in patients with node-positive breast cancer. However, it could not be determined whether it was the paclitaxel or the increased duration of chemotherapy that led to this improvement. The present study aimed to analyze whether the addition of paclitaxel to a doxorubicin-based regimen improves LRC in a cohort of patients who all received eight total cycles of chemotherapy. Five hundred eleven women with operable breast cancer were randomized on a single-institution prospective trial to receive 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) × 8 cycles (n = 252) or FAC × 4 cycles plus paclitaxel × 4 cycles (TFAC) (n = 259). Rates of LRC and overall survival (OS) were analyzed. Median follow-up was 124 months (range 5-167 months). The 10-year LRC rate was 92.6 versus 93.1% in the FAC versus TFAC arms, respectively (P = 0.26). The LRC between treatment arms did not differ when analyzed by locoregional treatment group: breast conservation therapy (BCT), mastectomy alone (M), and mastectomy + radiation (M + RT). The 10-year LRC rates were 95.1% (FAC) versus 91.2% (TFAC) after BCT (P = 0.98), 89.5% (FAC) versus 93.4% (TFAC) after M (P = 0.24), and 94.7% (FAC) versus 96.5% (TFAC) after M + RT (P = 0.59). Additionally, there was no difference in OS between the treatment arms, with 10-year OS rates of 78.4% (FAC) versus 81.7% (TFAC) (P = 0.93). The addition of paclitaxel to a doxorubicin-based regimen had no impact on LRC, regardless of the type of local therapy received. Historically inferior LRC with AC chemotherapy alone versus AC + T may have been due to an inadequate duration of systemic therapy and not due to the absence of paclitaxel.

Effects of elastic resistance exercise on body composition and physical capacity in older women with sarcopenic obesity: A CONSORT-compliant prospective randomized controlled trial.

PubMed

Liao, Chun-De; Tsauo, Jau-Yih; Lin, Li-Fong; Huang, Shih-Wei; Ku, Jan-Wen; Chou, Lin-Chuan; Liou, Tsan-Hon

2017-06-01

Sarcopenia is associated with loss of muscle mass and an increased risk of physical disability in elderly people. However, the prevalence of sarcopenia has increased in obese elderly populations. The purpose of this study was to identify the clinical efficacy of elastic resistance exercise training (RET) in patients with sarcopenic obesity. This study was conducted at the rehabilitation center of a university-based teaching hospital and was designed as a prospective and randomized controlled trial with an intention-to-treat analysis. A total of 46 women aged 67.3 (5.2) years were randomly assigned to an experimental group (EG) and control group (CG). The EG underwent elastic RET for 12 weeks, and the CG received no RET intervention. All outcome measures were assessed at the baseline and posttest, including body composition measured using dual-energy X-ray absorptiometry, muscle quality (MQ) defined as a ratio of muscular strength to muscle mass, and physical capacity assessed using functional mobility tests. One-way analysis of covariance and Pearson correlation were used to compare outcomes between the 2 groups and to identify the relationship between changes in body composition and physical outcomes, respectively. A chi-square test was performed to identify differences in qualitative data between the 2 groups. At the posttest, a significant between-group difference was observed in fat-free mass, MQ, and physical capacity (all P < .05); and a significant correlation was found between leg-lean-mass change and gait speed (r = 0.36; P < .05). After 12 weeks of elastic RET intervention, the EG had significantly fewer patients exhibiting sarcopenia (P < .05) and experiencing physical difficulty (P < .001) than the CG. The present data suggest that elastic resistance exercise exerted benefits on the body composition, MQ, and physical function in patients with sarcopenic obesity. Regular exercise incorporating elastic RET should be used to attenuate muscle mass loss and prevent physical difficulty in obese older adults with sarcopenia on reconditioning therapy. Chinese Clinical Trial Registry, ChiCTR-IPR-15006069.

Automated external defibrillators and simulated in-hospital cardiac arrests.

PubMed

Rossano, Joseph W; Jefferson, Larry S; Smith, E O'Brian; Ward, Mark A; Mott, Antonio R

2009-05-01

To test the hypothesis that pediatric residents would have shorter time to attempted defibrillation using automated external defibrillators (AEDs) compared with manual defibrillators (MDs). A prospective, randomized, controlled trial of AEDs versus MDs was performed. Pediatric residents responded to a simulated in-hospital ventricular fibrillation cardiac arrest and were randomized to using either an AED or MD. The primary end point was time to attempted defibrillation. Sixty residents, 21 (35%) interns, were randomized to 2 groups (AED = 30, MD = 30). Residents randomized to the AED group had a significantly shorter time to attempted defibrillation [median, 60 seconds (interquartile range, 53 to 71 seconds)] compared with those randomized to the MD group [median, 103 seconds (interquartile range, 68 to 288 seconds)] (P < .001). All residents in the AED group attempted defibrillation at <5 minutes compared with 23 (77%) in the MD group (P = .01). AEDs improve the time to attempted defibrillation by pediatric residents in simulated cardiac arrests. Further studies are needed to help determine the role of AEDs in pediatric in-hospital cardiac arrests.

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.