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Sample records for prospective clinical pilot

  1. Vagus Nerve Stimulation to Augment Recovery from Severe Traumatic Brain Injury Impeding Consciousness: A Prospective Pilot Clinical Trial

    PubMed Central

    Shi, Chen; Flanagan, Steven R.; Samadani, Uzma

    2015-01-01

    Objectives Traumatic brain injury has a high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently vegetative and minimally conscious states, for which limited treatment options exist, including physical, occupational, speech and cognitive therapies. More than 60,000 patients have received vagus nerve stimulation for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life. Early stimulation of the vagus nerve accelerates the rate and extent of behavioral and cognitive recovery after fluid percussion brain injury in rats. Methods We recently obtained FDA approval for a pilot prospective randomized crossover trial to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe traumatic brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after traumatic brain injury resulting in minimally conscious or persistent vegetative states. Discussion If this study demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed. PMID:23485054

  2. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  3. Birch pollen influence the severity of atopic eczema – prospective clinical cohort pilot study and ex vivo penetration study

    PubMed Central

    Fölster-Holst, Regina; Galecka, Jagoda; Weißmantel, Sigo; Dickschat, Ute; Rippke, Frank; Bohnsack, Kerstin; Werfel, Thomas; Wichmann, Katja; Buchner, Matthias; Schwarz, Thomas; Vogt, Annika; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    There is little clinical evidence for a correlation between the severity of atopic eczema (AE) and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD) score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route. PMID:26604810

  4. Clinical and Financial Impact of Pharmacist Involvement in Discharge Medication Reconciliation at an Academic Medical Center: A Prospective Pilot Study

    PubMed Central

    Parsons, Laura Beth; Pilch, Nicole A. (Weimert); Bullington, Wendy; Hayes, Genevieve L.; Easterling, Heather

    2015-01-01

    Background: Medication reconciliation is one of the more challenging aspects of inpatient care, and its accuracy is paramount to safe transitions of care. Studies have shown that pharmacists have a role in medication reconciliation through improving patient safety and avoiding costs associated with medication errors. The wide-scale use of pharmacists in this process has been limited by time constraints, cost, and lack of resources. Objective: This study evaluates the impact of pharmacists in resolving medication errors, decreasing readmission rates, and reducing institutional costs during the discharge medication reconciliation process. Methods: Pharmacists evaluated discharge medication reconciliation documentation for patients to determine its accuracy, the accuracy of the admission reconciliation documentation, and any potential issues unrelated to accuracy. Analysis of these data determined the time required for pharmacist involvement, the number of errors identified by pharmacists, the quality of pharmacist interventions, the cost avoidance for each error, and the overall impact on hospital readmission. Results: During the 7-week study period, pharmacists performed 67 discharge medication reviews and identified 84 errors. Seventy-five percent were considered to be significant and 6% were considered to be serious. The 30-day readmission rate in the study cohort was 18% compared with 20% in the control group. Based on the clinical severity scale and pharmacist salaries, pharmacist interventions resulted in $42,300 in cost avoidance. Conclusion: Pharmacists involved in this pilot discharge process identified and resolved significant errors on medication reconciliation orders that resulted in a financial benefit to the institution. PMID:26405342

  5. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial

    PubMed Central

    2014-01-01

    Background Recommendations for cardiovascular disease prevention advocate lowering both cholesterol and low-density lipoprotein cholesterol systemic levels, notably by statin intake. However, statins are the subject of questions concerning their impact on male fertility. This study aimed to evaluate, by a prospective pilot assay, the efficacy and the toxicity of a decrease of cholesterol blood levels, induced by atorvastatin on semen quality and sexual hormone levels of healthy, normocholesterolaemic and normozoospermic men. Methods Atorvastatin (10 mg daily) was administrated orally during 5 months to 17 men with normal plasma lipid and standard semen parameters. Spermatozoa parameters, accessory gland markers, semen lipid levels and blood levels of gonadal hormones were assayed before statin intake, during the treatment, and 3 months after its withdrawal. Results Atorvastatin treatment significantly decreased circulating low-density lipoprotein cholesterol (LDL-C) and total cholesterol concentrations by 42% and 24% (p < 0.0001) respectively, and reached the efficacy objective of the protocol. During atorvastatin therapy and/or 3 months after its withdrawal numerous semen parameters were significantly modified, such as total number of spermatozoa (-31%, p < 0.05), vitality (-9.5%, p < 0.05), total motility (+7.5%, p < 0.05), morphology (head, neck and midpiece abnormalities, p < 0.05), and the kinetics of acrosome reaction (p < 0.05). Seminal concentrations of acid phosphatases (p < 0.01), α-glucosidase (p < 0.05) and L-carnitine (p < 0.05) were also decreased during the therapy, indicating an alteration of prostatic and epididymal functions. Moreover, we measured at least one altered semen parameter in 35% of the subjects during atorvastatin treatment, and in 65% of the subjects after withdrawal, which led us to consider that atorvastatin is unsafe in the context of our study. Conclusions Our results show for the first

  6. Clinical, Laboratorial, and Urodynamic Findings of Prostatic Artery Embolization for the Treatment of Urinary Retention Related to Benign Prostatic Hyperplasia. A Prospective Single-Center Pilot Study

    SciTech Connect

    Antunes, Alberto A.; Carnevale, Francisco C. Motta Leal Filho, Joaquim M. da; Yoshinaga, Eduardo M.; Cerri, Luciana M. O.; Baroni, Ronaldo H.; Marcelino, Antonio S. Z.; Cerri, Giovanni G.; Srougi, Miguel

    2013-08-01

    PurposeThis study was designed to describe the clinical, laboratorial, and urodynamic findings of prostatic artery embolization (PAE) in patients with urinary retention due to benign prostatic hyperplasia (BPH).MethodsA prospective study of 11 patients with urinary retention due to BPH was conducted. Patients underwent physical examination, prostate specific antigen (PSA) measurement, transrectal ultrasound, and magnetic resonance imaging. International prostate symptom score (IPSS), quality of life (QoL), and urodynamic testing were used to assess the outcome before and after 1 year.ResultsClinical success was 91 % (10/11 patients) with a mean follow-up of 22.3 months (range, 12-41 months). At the first year follow-up, the mean IPSS score was 2.8 points (p = 0.04), mean QoL was 0.4 points (p = 0.001), mean PSA decreased from 10.1 to 4.3 ng/mL (p = 0.003), maximum urinary flow (Qmax) improved from 4.2 to 10.8 mL/sec (p = 0.009), and detrusor pressure (Pdet) decreased from 85.7 to 51.5 cm H{sub 2}O (p = 0.007). Before PAE, Bladder Outlet Obstruction Index (BOOI) showed values >40 in 100 % of patients. After PAE, 30 % of patients were >40 (obstructed), 40 % were between 20 and 40 (undetermined), and 30 % were <20 (unobstructed). Patients with a BOOI <20 had higher PSA values at 1-day after PAE.ConclusionsClinical and urodynamic parameters improved significantly after PAE in patients with acute urinary retention due to BPH. Total PSA at day 1 after PAE was higher in patients with unobstructed values in pressure flow studies.

  7. Safety and efficacy evaluation of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) in dyslipidemia patients: A pilot prospective cohort clinical study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Gupta, Yogendra Kumar

    2012-01-01

    Cardiovascular disease has multifaceted in which dyslipidemia, inflammation, and immunity play an important role. Arjuna powder and Arogyavardhini Vati used for centuries has potential for combating these factors. Therefore, the objective of this study was to evaluate the safety and efficacy of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) for dyslipidemia patients. Total of 108 patients were screened at CGHS Ayurvedic Hospital, New Delhi. Ninety-six patients satisfied inclusion criteria, and signed informed consent and detailed medical history was recorded. Arjuna powder (5 g, BD) for 3 weeks and then Arogyavardhini Vati (500 mg, BD) for 4 weeks were prescribed to the patients. The primary efficacy endpoint was reduction in serum total cholesterol, LDL, triglycerides, and increased HDL levels. Secondary endpoints included reduction in serum C-Reactive Protein (CRP) and blood glucose levels. Safety assessments included hepatic function (aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), bilirubin, and β2 microglobulin), renal function (urea and creatinine and NGAL) tests, and urine mercury level. The study was completed by 87 patients. The male and female patients were 65.5% (57/87) and 34.5% (30/87), respectively. There was a significant reduction in total cholesterol, LDL, triglycerides, CRP, and blood glucose. However, raised HDL level was also observed. Safety assessment results showed no significant change in serum ALT, AST, ALP and bilirubin, urea, creatinine β2 microglobulin, and NGAL levels at the end of study as compared to the baseline levels. In conclusion, the results of the present prospective cohort study showed that Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) is safe and effective for dyslipidemia. PMID:23559790

  8. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study.

    PubMed

    Srivastava, Adit; Agarwal, Rahul; Chaturvedi, T P; Chandra, Akhilesh; Singh, O P

    2015-01-01

    The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base) for the treatment of oral submucous fibrosis (OSMF). Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS) scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF. PMID:25878464

  9. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study

    PubMed Central

    Srivastava, Adit; Agarwal, Rahul; Chaturvedi, T. P.; Chandra, Akhilesh; Singh, O. P.

    2015-01-01

    The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base) for the treatment of oral submucous fibrosis (OSMF). Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS) scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF. PMID:25878464

  10. Prospective Lymphedema Surveillance in a Clinic Setting.

    PubMed

    Chance-Hetzler, Janet; Armer, Jane; Van Loo, Maggie; Anderson, Blake; Harris, Robin; Ewing, Rebecca; Stewart, Bob

    2015-01-01

    The potential impact of breast cancer-related lymphedema (LE) is quite extensive, yet it often remains under-diagnosed until the later stages. This project examines the effectiveness of prospective surveillance in post-surgical breast cancer patients. A retrospective analysis of 49 out of 100 patients enrolled in a longitudinal prospective study at a Midwestern breast center evaluates: (1) time required for completion of bilateral limb measurements and Lymphedema Breast Cancer Questionnaire (LBCQ); (2) referral to LE management with limb volume increase (LVI) and/or LBCQ symptoms; and (3) cost of LE management at lower LVI (≥5%-≤10%) versus traditional (≥10%). Findings revealed a visit timeframe mean of 40.3 min (range = 25-60); 43.6% of visits were ≤30-min timeframe. Visit and measurement times decreased as clinic staff gained measurement experience; measurement time mean was 17.9 min (range = 16.9-18.9). LBCQ symptoms and LVI were significantly (p < 0.001) correlated to LE referral; six of the nine patients referred (67%) displayed both LBCQ symptoms/LVI. Visits with no symptoms reported did not result in referral, demonstrating the importance of using both indicators when assessing early LE. Lower threshold referral provides compelling evidence of potential cost savings over traditional threshold referral with reported costs of: $3755.00 and $6353.00, respectively (40.9% savings). PMID:26308061

  11. Proton pump inhibitors and vascular function: A prospective cross-over pilot study

    PubMed Central

    Ghebremariam, Yohannes T.; Cooke, John P.; Khan, Fouzia; Thakker, Rahul N.; Chang, Peter; Shah, Nigam H.; Nead, Kevin T.; Leeper, Nicholas J.

    2015-01-01

    Background Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. Methods We conducted a controlled open-label cross-over pilot study among 21 adults aged 18 and older who are healthy (n = 11) or have established clinical cardiovascular disease (n = 10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2 week washout period, participants were crossed-over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. Results We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = −0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow mediated vasodilation during the course of this study. Conclusions In this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies. PMID:25835348

  12. 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…

  13. Recommendations for planning pilot studies in clinical and translational research.

    PubMed

    Moore, Charity G; Carter, Rickey E; Nietert, Paul J; Stewart, Paul W

    2011-10-01

    Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase "pilot study" is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well-designed pilot studies play in the advancement of science and scientific careers. PMID:22029804

  14. Prospective markets and design concepts for civilian remotely piloted aircraft

    NASA Technical Reports Server (NTRS)

    Nelms, W. P., Jr.; Gregory, T. J.; Aderhold, J. R.

    1976-01-01

    This paper summarizes a study that examines the technical, economic, and environmental aspects of remotely piloted vehicles (RPVs) in the civil environment. A market survey was conducted in which 35 civil applications of RPVs were identified. For a number of these uses, vehicle and system concepts were defined, benefit and cost comparisons were made with present methods, and the influence of safety and environmental implications was assessed. The results suggest a sizable potential demand for the use of RPVs in the civil sector, and some of the applications show promising cost savings over established methods. A focussed technology effort could provide the safety assurances needed for routine civilian operation of RPVs.

  15. Nursing Students' Clinical Experience With Death: A Pilot Study.

    PubMed

    Heise, Barbara A; Gilpin, Laura C

    2016-01-01

    Although debriefing in simulation settings is routine in nursing education, debriefing does not routinely take place in clinical settings with nursing students after a patient has died. This pilot study sought to explore nursing students' perceptions of their first experience with the death of a patient. Students reported emotional distress and feelings of inadequacy with regard to communicating with and supporting the family of the dying patient. Only half the students sampled reported debriefing by their clinical instructor or staff. Nurse educators must include debriefing and student support following a patient death in the clinical setting. PMID:27209870

  16. Fibrinogen and rhegmatogenous retinal detachment: a pilot prospective study

    PubMed Central

    Theocharis, IP

    2010-01-01

    Purpose: To examine the correlation, if any, between fibrinogen plasma levels (FPL) and the clinical features of rhegmatogenous retinal detachment (RRD). Methods: FPL were measured preoperatively in 33 patients with primary RRD. Patient characteristics and detachment features such as the numbers of breaks and the extent of the detachment were recorded; Results: No statistically significant correlation was found between FPL and the number of breaks. A statistically significant correlation was found between FPL and the extent of the RRD, even if the influence of the number of breaks was excluded. Conclusions: FPL correlate with retinal detachment extent, which implicates an acute inflammatory response to detachment traumatic phenomenon or a role of the fibrinogen molecule in retinal adhesiveness. PMID:20186280

  17. Enhancing Patient Safety Using Clinical Nursing Data: A Pilot Study.

    PubMed

    Choi, Jeeyae; Choi, Jeungok E

    2016-01-01

    To enhance patient safety from falls, many hospital information systems have been implemented to collect clinical data from the bedside and have used the information to improve fall prevention care. However, most of them use administrative data not clinical nursing data. This necessitated the development of a web-based Nursing Practice and Research Information Management System (NPRIMS) that processes clinical nursing data to measure nurses' delivery of fall prevention care and its impact on patient outcomes. This pilot study developed computer algorithms based on a falls prevention protocol and programmed the prototype NPRIMS. It successfully measured the performance of nursing care delivered and its impact on patient outcomes using clinical nursing data from the study site. Results of the study revealed that NPRIMS has the potential to pinpoint components of nursing processes that are in need of improvement for preventing patient from falls. PMID:27332171

  18. Electronic brachytherapy for superficial and nodular basal cell carcinoma: a report of two prospective pilot trials using different doses

    PubMed Central

    Pons-Llanas, Olga; Candela-Juan, Cristian; Celada-Álvarez, Francisco Javier; Barker, Christopher A.; Tormo-Micó, Alejandro; Pérez-Calatayud, Jose; Botella-Estrada, Rafael

    2016-01-01

    Purpose Basal cell carcinoma (BCC) is a very common cancer in the Caucasian population. Treatment aims to eradicate the tumor with the lowest possible functional and aesthetic impact. Electronic brachytherapy (EBT) is a treatment technique currently emerging. This study aims to show the outcomes of two consecutive prospective pilot clinical trials using different radiation doses of EBT with Esteya® EB system for the treatment of superficial and nodular basal cell carcinoma. Material and methods Two prospective, single-center, non-randomized, pilot studies were conducted. Twenty patients were treated in each study with different doses. The first group (1) was treated with 36.6 Gy in 6 fractions of 6.1 Gy, and the second group (2) with 42 Gy in 6 fractions of 7 Gy. Cure rate, acute toxicity, and late toxicity related to cosmesis were analyzed in the two treatment groups. Results In group 1, a complete response in 90% of cases was observed at the first year of follow-up, whereas in group 2, the complete response was 95%. The differences with reference to acute toxicity and the cosmetic results between the two treatment groups were not statistically significant. Conclusions Our initial experience with Esteya® EB system to treat superficial and nodular BCC shows that a dose of 36.6 Gy and 42 Gy delivered in 6 fraction of 7 Gy achieves a 90% and 95% clinical cure rate at 1 year, respectively. Both groups had a tolerable toxicity and a very good cosmesis. The role of EBT in the treatment of BCC is still to be defined. It will probably become an established option for selected patients in the near future. PMID:26985197

  19. Piloting Augmented Reality Technology to Enhance Realism in Clinical Simulation.

    PubMed

    Vaughn, Jacqueline; Lister, Michael; Shaw, Ryan J

    2016-09-01

    We describe a pilot study that incorporated an innovative hybrid simulation designed to increase the perception of realism in a high-fidelity simulation. Prelicensure students (N = 12) cared for a manikin in a simulation lab scenario wearing Google Glass, a wearable head device that projected video into the students' field of vision. Students reported that the simulation gave them confidence that they were developing skills and knowledge to perform necessary tasks in a clinical setting and that they met the learning objectives of the simulation. The video combined visual images and cues seen in a real patient and created a sense of realism the manikin alone could not provide. PMID:27258807

  20. Coleopteran Antimicrobial Peptides: Prospects for Clinical Applications

    PubMed Central

    Ntwasa, Monde; Goto, Akira; Kurata, Shoichiro

    2012-01-01

    Antimicrobial peptides (AMPs) are activated in response to septic injury and have important roles in vertebrate and invertebrate immune systems. AMPs act directly against pathogens and have both wound healing and antitumor activities. Although coleopterans comprise the largest and most diverse order of eukaryotes and occupy an earlier branch than Drosophila in the holometabolous lineage of insects, their immune system has not been studied extensively. Initial research reports, however, indicate that coleopterans possess unique immune response mechanisms, and studies of these novel mechanisms may help to further elucidate innate immunity. Recently, the complete genome sequence of Tribolium was published, boosting research on coleopteran immunity and leading to the identification of Tribolium AMPs that are shared by Drosophila and mammals, as well as other AMPs that are unique. AMPs have potential applicability in the development of vaccines. Here, we review coleopteran AMPs, their potential impact on clinical medicine, and the molecular basis of immune defense. PMID:22500175

  1. Prospects of Nanotechnology in Clinical Immunodiagnostics

    PubMed Central

    Ansari, Anees A.; Alhoshan, Mansour; Alsalhi, Mohamad S.; Aldwayyan, Abdullah S.

    2010-01-01

    Nanostructured materials are promising compounds that offer new opportunities as sensing platforms for the detection of biomolecules. Having micrometer-scale length and nanometer-scale diameters, nanomaterials can be manipulated with current nanofabrication methods, as well as self-assembly techniques, to fabricate nanoscale bio-sensing devices. Nanostructured materials possess extraordinary physical, mechanical, electrical, thermal and multifunctional properties. Such unique properties advocate their use as biomimetic membranes to immobilize and modify biomolecules on the surface of nanoparticles. Alignment, uniform dispersion, selective growth and diameter control are general parameters which play critical roles in the successful integration of nanostructures for the fabrication of bioelectronic sensing devices. In this review, we focus on different types and aspects of nanomaterials, including their synthesis, properties, conjugation with biomolecules and their application in the construction of immunosensing devices. Some key results from each cited article are summarized by relating the concept and mechanism behind each sensor, experimental conditions and the behavior of the sensor under different conditions, etc. The variety of nanomaterial-based bioelectronic devices exhibiting novel functions proves the unique properties of nanomaterials in such sensing devices, which will surely continue to expand in the future. Such nanomaterial based devices are expected to have a major impact in clinical immunodiagnostics, environmental monitoring, security surveillance and for ensuring food safety. PMID:22163566

  2. Prospects of nanotechnology in clinical immunodiagnostics.

    PubMed

    Ansari, Anees A; Alhoshan, Mansour; Alsalhi, Mohamad S; Aldwayyan, Abdullah S

    2010-01-01

    Nanostructured materials are promising compounds that offer new opportunities as sensing platforms for the detection of biomolecules. Having micrometer-scale length and nanometer-scale diameters, nanomaterials can be manipulated with current nanofabrication methods, as well as self-assembly techniques, to fabricate nanoscale bio-sensing devices. Nanostructured materials possess extraordinary physical, mechanical, electrical, thermal and multifunctional properties. Such unique properties advocate their use as biomimetic membranes to immobilize and modify biomolecules on the surface of nanoparticles. Alignment, uniform dispersion, selective growth and diameter control are general parameters which play critical roles in the successful integration of nanostructures for the fabrication of bioelectronic sensing devices. In this review, we focus on different types and aspects of nanomaterials, including their synthesis, properties, conjugation with biomolecules and their application in the construction of immunosensing devices. Some key results from each cited article are summarized by relating the concept and mechanism behind each sensor, experimental conditions and the behavior of the sensor under different conditions, etc. The variety of nanomaterial-based bioelectronic devices exhibiting novel functions proves the unique properties of nanomaterials in such sensing devices, which will surely continue to expand in the future. Such nanomaterial based devices are expected to have a major impact in clinical immunodiagnostics, environmental monitoring, security surveillance and for ensuring food safety. PMID:22163566

  3. Prospective clinical trial of a human tumor cloning system.

    PubMed

    Von Hoff, D D; Clark, G M; Stogdill, B J; Sarosdy, M F; O'Brien, M T; Casper, J T; Mattox, D E; Page, C P; Cruz, A B; Sandbach, J F

    1983-04-01

    A prospective clinical trial was performed to evaluate the usefulness of a human tumor cloning system for selecting single-agent chemotherapy for patients with advanced cancers. Six hundred four single-agent trials were performed in the 470 patients whose tumors were submitted for drug sensitivity testing. Only 246 of these 604 trials (41%) could be directed by the cloning system results because of inadequate tumor growth and other difficulties. In these 246 prospective trials, there was a 60% true positive and an 85% true negative rate for predicting for response or lack of response of an individual patient's tumor to the single agent. There was also a relationship between the percentage of decrease in survival of tumor colony-forming units and the probability of a clinical response of the patient's tumor to the same drug used in vivo. Despite these encouraging findings, work to improve tumor growth and additional prospective clinical trials of the system are needed before the system can be recommended for routine clinical use. PMID:6339044

  4. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study

    PubMed Central

    Zheng, Yanhua; Stener-Victorin, Elisabet; Ng, Ernest H Y; Li, Juan; Wu, Xiaoke; Ma, Hongxia

    2015-01-01

    Introduction Hyperinsulinaemia and insulin resistance (IR) are key features of polycystic ovary syndrome (PCOS) and metabolic syndrome. The effect of 5 weeks of acupuncture treatment has been investigated in a completed prospective pilot trial (Clinicaltrials.gov: NCT01457209), and acupuncture with electrical stimulation applied to insulin-resistant rats with dihydrotestosterone-induced PCOS was shown to improve insulin sensitivity. Therefore, we now aim to conduct a prospective pilot study to evaluate whether using the same acupuncture treatment protocol given over a longer period of time (6 months) than in the previous pilot trial will improve insulin sensitivity in women with PCOS and IR. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles will improve insulin sensitivity in women with PCOS and IR. Methods/analysis This is a prospective pilot trial. A total of 112 women with PCOS and IR will be recruited and categorised according to their body mass index (BMI) as normal weight (BMI=18.5−23 kg/m2) or as overweight/obese (BMI>23 kg/m2). Acupuncture will be applied three times per week for 6 months at 30 min per treatment. The primary outcome will be the change in insulin sensitivity before and after 6 months of acupuncture treatment, as measured by an oral glucose tolerance test. Ethics/dissemination Ethical approval of this study has been granted from the ethics committee of the First Affiliated Hospital of Guangzhou Medical University (No. 2013039). Written and informed consent will be obtained from each patient before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses. Trial registration numbers NCT02026323 and ChiCTR-OCH-13003921. PMID:25941189

  5. Using clinical audit in practice: a pilot peer review project.

    PubMed

    Holt, V P; Earp, D P

    1996-09-01

    A well-established study group undertook a pilot peer review project testing the use of clinical audit in members' practices. Two peer review groups were formed involving a total of 16 practices. Practice visits were undertaken and a series of meetings were held to prepare and discuss the various projects. The progress of the groups was monitored by questionnaires. All practitioners reported benefits from the project (specifically, from the practice visits) and made changes in areas of their practice other than those specifically chosen for their project. The benefits of carrying out audit projects in a peer review setting are stressed as are the benefits of reciprocal practice visits. The importance of prior establishment of mutual trust and confidence in the peer review group is emphasised. PMID:10332335

  6. A Pilot Prospective Study of Fetomaternal Hemorrhage Identified by Anemia in Asymptomatic Neonates

    PubMed Central

    Stroustrup, Annemarie; Plafkin, Callie

    2016-01-01

    Background Fetomaternal hemorrhage (FMH) is a poorly understood condition in which fetal erythrocytes transfer to the maternal circulation via a faulty placental barrier. Little is known about the true incidence, epidemiology, or pathophysiology of FMH in the general pregnant population as existing studies are based on retrospective cohorts and manifest diagnosis and selection bias. Objective To evaluate the practicability of a prospective study of fetomaternal hemorrhage in the general population based on antepartum maternal blood testing and neonatal anemia. Study Design Prospective cohort study. Result Nineteen pregnant women were enrolled prior to the term delivery of twenty well infants. Five neonates were unexpectedly anemic on first postnatal testing. Antenatal maternal blood samples associated with 2 of 5 anemic newborns had positive Kleihauer-Betke testing while no newborn with a normal postnatal blood count had an associated abnormal Kleihauer-Betke test. Conclusion Clinically significant FMH may be more common than previously thought. Prospective epidemiological study of FMH is feasible. PMID:26765555

  7. Is alcohol required for effective pancreatic cyst ablation? The prospective randomized CHARM trial pilot study

    PubMed Central

    Moyer, Matthew T.; Dye, Charles E.; Sharzehi, Setareh; Ancrile, Brooke; Mathew, Abraham; McGarrity, Thomas J.; Gusani, Niraj; Yee, Nelson; Wong, Joyce; Levenick, John; Dougherty-Hamod, Brandy; Mathers, Bradley

    2016-01-01

    Background and study aims: In this study, we aim to determine the safety and feasibility of an alcohol-free approach to pancreatic cyst ablation using a chemotherapeutic ablation cocktail. Patients and methods: In this prospective, randomized, double-blinded pilot study, 10 patients with known mucinous type pancreatic cysts underwent endoscopic ultrasound (EUS)-guided fine needle aspiration and then lavage with either 80 % ethanol or normal saline. Both groups were then treated with a cocktail of paclitaxel and gemcitabine. Primary outcomes were reduction in cyst volume and rates of complications. Results: At 6 months, patients randomized to the alcohol arm had an 89 % average volume reduction, with a 91 % reduction noted in the alcohol-free arm. Complete ablation was achieved in 67 % of patients in the alcohol-free arm at both 6 and 12 months, whereas the alcohol group recorded complete ablation rates of 50 % and 75 % at 6 and 12 months, respectively. One patient in the alcohol arm developed acute pancreatitis (20 %) with no adverse events in the alcohol-free arm. Conclusions: This study revealed similar ablation rates between the alcohol ablation group and the alcohol-free arm and demonstrates the safety and feasibility of an alcohol-free ablation protocol. This pilot study suggests that alcohol may not be required for effective cyst ablation. PMID:27227122

  8. Predictors of tolerance to chemotherapy in older cancer patients: a prospective pilot study.

    PubMed

    Extermann, M; Chen, H; Cantor, A B; Corcoran, M B; Meyer, J; Grendys, E; Cavanaugh, D; Antonek, S; Camarata, A; Haley, W E; Balducci, L

    2002-07-01

    Few data are available to help predict which older cancer patient is at risk of developing chemotherapy-related toxicity. This study was a pilot for a project designing a predictive risk score. Chemotherapy patients aged 70 years and older were prospectively enrolled. Chemotherapies were adjusted for their published toxicity. 60 patients were enrolled, 59 were evaluable. Mean dose-intensity was 90.3%, range 33.3-129.0%. 47% of the patients experienced grade 4 haematological and/or grade 3-4 non-haematological toxicity. Published toxicity (MAX2), diastolic blood pressure, marrow invasion and lactate dehydrogenase (LDH) were all associated with toxicity (P<0.1); Body Mass Index, previous chemotherapy, red blood cells, platelets, polymedication with dose-intensity; and polymedication with FACT-G change. After adjustment for the published toxicity, the variables retained their significance, except for LDH and polymedication (for dose-intensity). Although the size of this pilot study imposes a cautious interpretation, patient-related and chemotherapy-related variables correlated independently with toxicity. Designing a composite predictive score to use in assessing the toxicity of multiple chemotherapy regimens therefore appears to be a valid undertaking. PMID:12110492

  9. Building sustainable multi-functional prospective electronic clinical data systems.

    PubMed

    Randhawa, Gurvaneet S; Slutsky, Jean R

    2012-07-01

    A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders. PMID:22692255

  10. Current clinical practices in stroke rehabilitation: regional pilot survey.

    PubMed

    Natarajan, Pradeep; Oelschlager, Ashley; Agah, Arvin; Pohl, Patricia S; Ahmad, S Omar; Liu, Wen

    2008-01-01

    This study was aimed at understanding the current physical and occupational therapy practices in stroke rehabilitation in the Midwest. The insights gained from this pilot study will be used in a future study aimed at understanding stroke rehabilitation practices across the nation. Researchers and clinicians in the field of stroke rehabilitation were interviewed, and past studies in the literature were analyzed. Through these activities, we developed a 37-item questionnaire that was sent to occupational and physical therapists practicing in Kansas and Missouri who focus on the care of people who have had a stroke (n = 320). A total of 107 respondents returned a com pleted questionnaire, which gives a response rate of about 36%. The majority of respondents had more than 12 years of experience treating patients with stroke. Consensus of 70% or more was found for 80% of the items. The preferred approaches for the rehabilitation of people who have had a stroke are the Bobath and Brunnstrom methods, which are being used by 93% and 85% of the physical and occupational therapists, respectively. Even though some variability existed in certain parts of the survey, in general clinicians agreed on different treatment approaches in issues dealing with muscle tone, weakness, and limited range of motion in stroke rehabilitation. Some newer treatment approaches that have been proven to be effective are practiced only by a minority of clinicians. The uncertainty among clinicians in some sections of the survey reveals that more evidence on clinical approaches is needed to ensure efficacious treatments. PMID:19009470

  11. Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

    PubMed Central

    2013-01-01

    Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for ‘real life’ variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study. PMID:23758922

  12. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    SciTech Connect

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen Yipei; Zhang Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  13. Prospective Genotyping of Mycobacterium tuberculosis from Fresh Clinical Samples

    PubMed Central

    Bidovec-Stojkovič, Urška; Seme, Katja; Žolnir-Dovč, Manca; Supply, Philip

    2014-01-01

    Shorter time-to-result is key for improving molecular-guided epidemiological investigation of tuberculosis (TB) cases. We performed a prospective study to evaluate the use of standardized MIRU-VNTR (mycobacterial interspersed repetitive-unit-variable-number tandem-repeat) typing of Mycobacterium tuberculosis directly on 79 fresh clinical samples from 26 TB patients consecutively enrolled over a 17-month period. Overall, complete 24-locus types were obtained for 18 out of the 26 (69.2%) patients and 14 of the 16 grade 3+ and grade 2+ samples (87.5%). The degree of completion of the genotypes obtained significantly correlated with smear microscopy grade both for 26 first samples (p = 0.0003) and for 53 follow-up samples (p = 0.002). For 20 of the 26 patients for whom complete or even incomplete M. tuberculosis isolate genotypes were obtained, typing applied to the clinical samples allowed the same unambiguous conclusions regarding case clustering or uniqueness as those that could have been drawn based on the corresponding cultured isolates. Standard 24 locus MIRU-VNTR typing of M. tuberculosis can be applied directly to fresh clinical samples, with typeability depending on the bacterial load in the sample. PMID:25313883

  14. Prospective epidemiological pilot study on the morbidity of bathers exposed to tropical recreational waters and sand.

    PubMed

    Sánchez-Nazario, Elia E; Santiago-Rodriguez, Tasha M; Toranzos, Gary A

    2014-06-01

    A prospective cohort epidemiological pilot study was performed at three tropical beaches with point- and non-point-sources of fecal pollution to characterize the risk of illness among swimmers and non-swimmers. There was an increased risk of illness in swimmers as compared to non-swimmers, even when waters met current microbial standards for recreational water quality. Illnesses included gastrointestinal (GI), skin and respiratory symptoms, earache and fever. Odds ratios (ORs) ranged from 0.32 to 42.35 (GI illness), 0.69 to 3.12 (skin infections), 0.71 to 3.21 (respiratory symptoms), 0.52 to 15.32 (earache) and 0.80 to 1.68 (fever), depending on the beach sampled. The indicators that better predicted the risks of symptoms (respiratory) in tropical recreational waters were total (somatic and male-specific) coliphages (OR = 1.56, p < 0.10, R(2) = 3.79%) and Escherichia coli (OR = 1.38, p < 0.10, R(2) = 1.97%). The present study supports the potential of coliphages as good predictors of risks of respiratory illness in tropical recreational waters. This is the first study that has determined risks of illness after exposure to tropical recreational waters with point- and non-point sources of fecal contamination. The results give an opportunity to perform epidemiological studies in tropical recreational waters in Puerto Rico which can include more participants and other indicators and detection techniques. PMID:24937216

  15. Dysphonia: medical treatment and a medical voice hygiene advice approach. A prospective randomised pilot study.

    PubMed

    Pedersen, M; Beranova, A; Møller, S

    2004-07-01

    For many years all patients with dysphonia referred to in the literature as resulting from non-organic (functional) voice disorders were sent to speech therapy. Medical diagnoses were not taken into account. In our earlier Cochrane review on vocal cord nodules we discovered that evidence-based research in the area of benign voice disorders with dysphonia, and with or without slight benign swellings including nodules on the vocal cords, was lacking at that time. Therefore, a prospective randomised pilot study based on our Cochrane review has been made on dysphonic patients with non-organic (function provoked?) voice disorders as the basis for further evidence-based studies. Medical treatment was based on the scientific approach that once a micro-organic disorder caused by reflux, infection, allergy or environmental irritatants (e.g., dust or noise in the workplace) was discovered by very careful anamnesis and systematic objective routine analyses and was treated effectively, with documentation, the non-organic voice disorder disappeared, as, e.g., in the case of a diagnosis and treatment of helicobakter pylori. The reason is that the mucosal swelling/dysfunction of the vocal cords is secondary. In order to try to understand why the recommendation to all these patients for many years was only voice therapy, which the speech therapists "felt to be effective", updated voice-hygiene advice (for posture, accents of the diaphragm, intonation pattern and resonance) was given by experienced laryngologists, randomised with the updated medical diagnosis/therapy in order to elucidate what effect the training might have. No evidence-based studies in the literature document any effect. The crucial point seemed to be that doctors mostly did not examine any other diagnoses other than the "dysphonia" and did not dig down to any of the medical reasons when the vocal fold diagnosis of "non- organic disorders" was made. This should be changed in the future. This pilot study was based

  16. Clinical Impact of Sample Interference on Intensive Insulin Therapy in Severely Burned Patients: A Pilot Study

    PubMed Central

    Tran, Nam K.; Godwin, Zachary R.; Bockhold, Jennifer C.; Passerini, Anthony G.; Cheng, Julian; Ingemason, Morgan

    2013-01-01

    Objective Severely burned patients benefit from intensive insulin therapy (IIT) for tight glycemic control (TGC). We evaluated the clinical impact of automatic correction of hematocrit and ascorbic acid interference for bedside glucose monitoring performance in critically ill burn patients. Methods The performance of two point-of-care glucose monitoring systems (GMS): (a) GMS1, an autocorrecting device, and (b) GMS2, a non-correcting device were compared. Sixty remnant arterial blood samples were collected in a prospective observational study to evaluate hematocrit and ascorbic acid effects on GMS1 vs. GMS2 accuracy paired against a plasma glucose reference. Next we enrolled 12 patients in a pilot randomized controlled trial (RCT). Patients were randomized 1:1 to receive IIT targeting a TGC interval of 111–151 mg/dL and guided by either GMS1 or GMS2. GMS bias, mean insulin rate, and glycemic variability were calculated. Results In the prospective study, GMS1 results were similar to plasma glucose results (mean bias: −0.75[4.0] mg/dL, n=60, P=0.214). GMS2 results significantly differed from paired plasma glucose results (mean bias: −5.66[18.7] mg/dL, n=60, P=0.048). Ascorbic acid therapy elicited significant GMS2 performance bias (29.2[27.2], P<0.001). RCT results reported lower mean bias (P<0.001), glycemic variability (P<0.05), mean insulin rate (P<0.001), and frequency of hypoglycemia (P<0.001) in the GMS1 group than the GMS2 group. Conclusions Anemia and high dose ascorbic acid therapy negatively impact GMS accuracy and TGC in burn patients. Automatic correction of confounding factors improves glycemic control. Further studies are warranted to determine outcomes associated with accurate glucose monitoring during IIT. PMID:23884048

  17. Gender effect on clinical features of achalasia: a prospective study

    PubMed Central

    Mikaeli, Javad; Farrokhi, Farnoosh; Bishehsari, Faraz; Mahdavinia, Mahboobeh; Malekzadeh, Reza

    2006-01-01

    Background Achalasia is a well-characterized esophageal motor disorder but the rarity of the disease limits performing large studies on its demographic and clinical features. Methods Prospectively, 213 achalasia patients (110 men and 103 women) were enrolled in the study. The diagnosis established by clinical, radiographic, and endoscopic as well as manometry criteria. All patients underwent a pre-designed clinical evaluation before and within 6 months after the treatment. Results Solid dysphagia was the most common clinical symptom in men and women. Chest pain was the only symptom which was significantly different between two groups and was more complained by women than men (70.9% vs. 54.5% P value= 0.03). Although the occurrence of chest pain significantly reduced after treatment in both groups (P < 0.001), it was still higher among women (32% vs. 20.9% P value= 0.04). In both sexes, chest pain did not relate to the symptom duration, LES pressure and type of treatment patients received. Also no significant relation was found between chest pain and other symptoms expressed by men and women before and after treatment. Chest pain was less frequently reported by patients over 56 yrs of age in comparison to those less than 56 yrs (p < 0.05). Conclusion It seems that chest pain is the distinct symptom of achalasia which is affected by sex as well as age and does not relate to the duration of illness, LESP and the type of treatment achalasia patients receive. PMID:16579859

  18. Adaptive Radiotherapy for Head and Neck Cancer: Initial Clinical Outcomes from a Prospective Trial

    PubMed Central

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen, Yipei; Zhang, Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2011-01-01

    Purpose To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods Twenty-four patients enrolled onto an IRB-approved clinical trial. Twenty-two patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of CTVs and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6, and glossopharyngeal sulcus in 1. Twenty (91%) patients had AJCC stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4 and N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Twenty-one (95%) patients received systemic therapy. Results With 31 month median follow up (range: 13-45), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to conventional IMRT results. Chronic toxicity and functional outcomes beyond 1 year were tabulated. Discussion This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head and neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only 1 or 2 mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at one-year follow-up and beyond. PMID:22138459

  19. Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation

    PubMed Central

    Thomson, Angus W.; Zahorchak, Alan F.; Ezzelarab, Mohamed B.; Butterfield, Lisa H.; Lakkis, Fadi G.; Metes, Diana M.

    2016-01-01

    Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients’ dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP)-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail. PMID:26858719

  20. Influence of Two Colloidal Extracorporeal Primes on Coagulation of Cardiac Surgical Patients: A Prospectively Randomized Open-Label Pilot Trial.

    PubMed

    Bethlehem, Irene; Wierda, Korry; Visser, Cornelis; Jekel, Lilian; Koopmans, Matty; Kuiper, Michael A

    2014-12-01

    The search for the ideal priming fluid continues as more evidence is discovered about side effects of volume expanders. With the availability of modern, balanced hydroxyethyl starch (HES) solutions with less side effects than former HES solutions, we considered to replace our gelatin- (modified gelatin) based extracorporeal circuit prime for a HES (130/.42) prime. Therefore, we studied the influence of two colloidal priming fluids on postoperative coagulation in patients undergoing cardiac surgery. The primary endpoint was to compare clot formation time between the HES group and the gelatin group with rotational thromboelastometry (ROTEM). Additionally we compared colloid osmotic pressure and fluid balance of both groups. Forty patients, undergoing elective first time coronary artery bypass grafting or single-valve surgery, were included in this prospectively randomized open-label pilot study. Laboratory data and ROTEM data were collected and analyzed for differences between the two groups. ROTEM data show significantly more prolongation in Extem clot formation time and significant more decrease in Extem alpha in the HES group. Fibtem maximum clot firmness was significantly smaller in the HES group; this was consistent with fibrinogen concentration measurement, which decreased more in the HES group than in the gelatin group and recovered more over time in the gelatin group. We found no significant difference in colloid. osmotic pressure between the groups. In this trial, HES (130/.42) impairs coagulation significantly more compared with gelatin. These differences in influence on coagulation did not lead to a difference in blood loss or fluid balance, so clinical relevance could not be proven. PMID:26357798

  1. Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

    PubMed Central

    Kapoor, Akhil; Beniwal, Surender Kumar; Kalwar, Ashok; Singhal, Mukesh Kumar; Nirban, Raj Kumar; Kumar, Harvindra Singh

    2016-01-01

    Introduction: Acute myeloid leukemia (AML) in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT) could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years) not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m2. The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS) was calculated using Kaplan–Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61–86 years) with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4–7.6). Males had median OS of 7 months (95% CI: 5.4–8.6) versus females with OS of 3 months (95% CI: 1.5–4.4; P = 0.008). There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities. PMID:27275453

  2. Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study

    PubMed Central

    Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

    2015-01-01

    Objectives To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Design Prospective pilot study. Setting Single centre study in the USA. Participants 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. Primary and secondary outcome measures A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Results Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). Conclusions The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. PMID:25872940

  3. Early Intervention Following Trauma May Mitigate Genetic Risk for PTSD in Civilians: A Pilot Prospective Emergency Department Study

    PubMed Central

    Rothbaum, Barbara O.; Kearns, Megan C.; Reiser, Emily; Davis, Jennifer S.; Kerley, Kimberly A.; Rothbaum, Alex O.; Mercer, Kristina B.; Price, Matthew; Houry, Debra; Ressler, Kerry J.

    2015-01-01

    intervention group, even after controlling for age, sex, race, education, income, and childhood trauma. Using logistic regression, the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 (P < .05). Conclusions This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma. A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk. The role of genetic predictors of risk and resilience should be further evaluated in larger, prospective intervention and prevention trials. Trial Registration ClinicalTrials.gov identifier: NCT00895518 PMID:25188543

  4. Comparison of Alpha Blockers in Treatment of Premature Ejaculation: A Pilot Clinical Trial

    PubMed Central

    Akin, Yigit; Gulmez, Hakan; Ates, Mutlu; Bozkurt, Aliseydi; Nuhoglu, Baris

    2013-01-01

    Background: Premature ejaculation (PE) is the most common sexual disorder in men and studies reported prevalence up to 30% (1, 2). PE is not a life-threatening medical condition but it influences the quality of life (QoL). Objectives: The aim of this study was to compare the efficiency, and safety of alpha blocker drugs in the treatment of patients with premature ejaculation (PE). Additionally we investigated the quality of life (QoL) in patients with PE who were treated with alpha blocker drugs. Materials and Methods: This study was a pilot clinical trial. Prospectively documented 108 patients with PE were treated and were followed-up in urology outpatient clinic. All patients were divided into 5 groups according to used alpha blocker agents which were determined by simple randomization. Silodosin 4mg (Group 1, n = 21), tamsulosin hydrochloride 0.4mg (Group 2, n = 23), alfuzosin 10mg (Group 3, n = 22), terazosin 5mg (Group 4, n = 21), doksazosin mesylate 4mg (Group5, n = 21), were used for treatment. The demographic parameters of patients, pre and post treatment intravaginal ejaculation latency time (IELT), PE Profile (PEP), and QoL index were recorded and evaluated. Effectiveness of treatment was evaluated by measuring IELT. Additionally, side effects of drugs were recorded. P < 0.05 was considered statistically significant. Results: All alpha blocker drugs were statistically effective for preventing PE. Notably, silodosin seemed to be more effective for preventing PE than other alpha blockers (P < 0.05). However all alpha blockers provided development in QoL scores, silodosin was a little better than other drugs in statistical analyses. Furthermore statistical increase in IELT and decrease in PEP were provided more in Group 1 than other groups (P < 0.05). Conclusions: Silodosin seems to be able to even more prevent PE. Silodosin may provide development in QoL than other alpha blocker agents. Additionally, lower systemic adverse events and more effectivity are

  5. Children's Views Matter Too! A Pilot Project Assessing Children's and Adolescents' Experiences of Clinical Psychology Services

    ERIC Educational Resources Information Center

    Gordon, Michael; Russo, Kate

    2009-01-01

    This pilot study explored the experiences and understanding of clinical psychology practices and services of children and adolescents attending clinical psychology outpatient appointments. Fifteen young participants took part in the study. A content analysis indicated that young children and adolescents have an appropriate understanding of the…

  6. Idiopathic intracranial hypertension: ongoing clinical challenges and future prospects

    PubMed Central

    Julayanont, Parunyou; Karukote, Amputch; Ruthirago, Doungporn; Panikkath, Deepa; Panikkath, Ragesh

    2016-01-01

    Idiopathic intracranial hypertension (IIH) is an uncommon disorder characterized by increased intracranial pressure without radiological or laboratory evidence of intracranial pathology except empty sella turcica, optic nerve sheath with filled out cerebrospinal fluid spaces, and smooth-walled nonflow-related venous sinus stenosis or collapse. This condition typically affects obese women. The incidence of IIH is increasing with the rising prevalence of obesity. Persistent headache is the most common symptom. Visual impairment is a serious complication that may not be recognized by the patients. This paper reviews clinical manifestations, diagnostic challenges, and current treatments of IIH in adults. Various imaging modalities have been studied on their validity for detection of IIH and papilledema. This review also includes new studies on medical, surgical, and interventional management of this condition. Acetazolamide and topiramate are the only two medications that have been studied in randomized controlled trials about their efficacy in treatment of IIH. In patients who have severe visual impairment or progressive visual deterioration despite medical management, surgical or interventional treatment may be considered. The efficacy and complications of cerebrospinal fluid diversion, optic nerve sheath fenestration, and endovascular venous stenting reported in the last 3 decades have been summarized in this review. Finally, the prospective aspects of biomarkers and treatments are proposed for future research. PMID:26929666

  7. Idiopathic intracranial hypertension: ongoing clinical challenges and future prospects.

    PubMed

    Julayanont, Parunyou; Karukote, Amputch; Ruthirago, Doungporn; Panikkath, Deepa; Panikkath, Ragesh

    2016-01-01

    Idiopathic intracranial hypertension (IIH) is an uncommon disorder characterized by increased intracranial pressure without radiological or laboratory evidence of intracranial pathology except empty sella turcica, optic nerve sheath with filled out cerebrospinal fluid spaces, and smooth-walled nonflow-related venous sinus stenosis or collapse. This condition typically affects obese women. The incidence of IIH is increasing with the rising prevalence of obesity. Persistent headache is the most common symptom. Visual impairment is a serious complication that may not be recognized by the patients. This paper reviews clinical manifestations, diagnostic challenges, and current treatments of IIH in adults. Various imaging modalities have been studied on their validity for detection of IIH and papilledema. This review also includes new studies on medical, surgical, and interventional management of this condition. Acetazolamide and topiramate are the only two medications that have been studied in randomized controlled trials about their efficacy in treatment of IIH. In patients who have severe visual impairment or progressive visual deterioration despite medical management, surgical or interventional treatment may be considered. The efficacy and complications of cerebrospinal fluid diversion, optic nerve sheath fenestration, and endovascular venous stenting reported in the last 3 decades have been summarized in this review. Finally, the prospective aspects of biomarkers and treatments are proposed for future research. PMID:26929666

  8. Toward Fully Automated Multicriterial Plan Generation: A Prospective Clinical Study

    SciTech Connect

    Voet, Peter W.J.; Dirkx, Maarten L.P.; Breedveld, Sebastiaan; Fransen, Dennie; Levendag, Peter C.; Heijmen, Ben J.M.

    2013-03-01

    Purpose: To prospectively compare plans generated with iCycle, an in-house-developed algorithm for fully automated multicriterial intensity modulated radiation therapy (IMRT) beam profile and beam orientation optimization, with plans manually generated by dosimetrists using the clinical treatment planning system. Methods and Materials: For 20 randomly selected head-and-neck cancer patients with various tumor locations (of whom 13 received sequential boost treatments), we offered the treating physician the choice between an automatically generated iCycle plan and a manually optimized plan using standard clinical procedures. Although iCycle used a fixed “wish list” with hard constraints and prioritized objectives, the dosimetrists manually selected the beam configuration and fine tuned the constraints and objectives for each IMRT plan. Dosimetrists were not informed in advance whether a competing iCycle plan was made. The 2 plans were simultaneously presented to the physician, who then selected the plan to be used for treatment. For the patient group, differences in planning target volume coverage and sparing of critical tissues were quantified. Results: In 32 of 33 plan comparisons, the physician selected the iCycle plan for treatment. This highly consistent preference for the automatically generated plans was mainly caused by the improved sparing for the large majority of critical structures. With iCycle, the normal tissue complication probabilities for the parotid and submandibular glands were reduced by 2.4% ± 4.9% (maximum, 18.5%, P=.001) and 6.5% ± 8.3% (maximum, 27%, P=.005), respectively. The reduction in the mean oral cavity dose was 2.8 ± 2.8 Gy (maximum, 8.1 Gy, P=.005). For the swallowing muscles, the esophagus and larynx, the mean dose reduction was 3.3 ± 1.1 Gy (maximum, 9.2 Gy, P<.001). For 15 of the 20 patients, target coverage was also improved. Conclusions: In 97% of cases, automatically generated plans were selected for treatment because of

  9. Prospective Pilot Study of a Tablet Computer in an Emergency Department

    PubMed Central

    Horng, Steven; Goss, Foster R.; Chen, Richard S.; Nathanson, Larry A.

    2012-01-01

    Background The recent availability of low-cost tablet computers can facilitate bedside information retrieval by clinicians. Objective To evaluate the effect of physician tablet use in the emergency department. Design Prospective cohort study comparing physician workstation usage with and without a tablet. Setting 55,000 visits/year Level 1 Emergency Department at a tertiary academic teaching hospital. Participants 13 emergency physicians (7 Attendings, 4 EM3s, and 2 EM1s) worked a total of 168 scheduled shifts (130 without and 38 with tablets) during the study period. Intervention Physician use of a tablet computer while delivering direct patient care in the Emergency Department. Main Outcome Measures The primary outcome measure was the time spent using the Emergency Department Information System (EDIS) at a computer workstation per shift. The secondary outcome measure was the number of EDIS logins at a computer workstation per shift. Results Clinician use of a tablet was associated with a 38-minute (17-59) decrease in time spent per shift using the EDIS at a computer workstation (p<0.001) after adjusting for clinical role, location, and shift length. The number of logins was also associated with a 5-login (2.2-7.9) decrease per shift (p<0.001) after adjusting for other covariates. Conclusion Clinical use of a tablet computer was associated with a reduction in the number of times physicians logged into a computer workstation and a reduction in the amount of time they spent there using the EDIS. The presumed benefit is that decreasing time at a computer workstation increases physician availability at the bedside. However, this association will require further investigation. PMID:22226927

  10. A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic.

    PubMed

    Guzek, Lindsay M; Fadel, William F; Golomb, Meredith R

    2015-09-01

    Missed clinic appointments lead to decreased patient access, worse patient outcomes, and increased healthcare costs. The goal of this pilot study was to identify reasons for and risk factors associated with missed pediatric neurology outpatient appointments ("no-shows"). This was a prospective cohort study of patients scheduled for 1 week of clinic. Data on patient clinical and demographic information were collected by record review; data on reasons for missed appointments were collected by phone interviews. Univariate and multivariate analyses were conducted using chi-square tests and multiple logistic regression to assess risk factors for missed appointments. Fifty-nine (25%) of 236 scheduled patients were no-shows. Scheduling conflicts (25.9%) and forgetting (20.4%) were the most common reasons for missed appointments. When controlling for confounding factors in the logistic regression, Medicaid (odds ratio 2.36), distance from clinic, and time since appointment was scheduled were associated with missed appointments. Further work in this area is needed. PMID:25503257

  11. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  12. An Occupation and Participation Approach to Reading Intervention (OPARI) Part II: Pilot Clinical Application

    ERIC Educational Resources Information Center

    Grajo, Lenin C.; Candler, Catherine

    2016-01-01

    The Occupation and Participation Approach to Reading Intervention (OPARI) is an intervention approach for children with reading difficulties that emphasizes reading as an important occupation of children. Part I presented the theoretical basis of the OPARI. Part II describes a pilot clinical application of the OPARI. Guided by Schkade and…

  13. Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

    ERIC Educational Resources Information Center

    Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

    2014-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

  14. Levetiracetam in the preventive treatmentof transformed migraine: A prospective, open-label, pilot study

    PubMed Central

    Rapoport, Alan M.; Sheftell, Fred D.; Tepper, Stewart J.; Bigal, Marcelo E.

    2005-01-01

    Background: Most preventive agents used for transformed migraine (TM)have not been studied specifically for the treatment of this syndrome. Open-label trials have demonstrated the effectiveness of levetiracetam in the treatment of refractory headaches. Objective: The aim of this study was to assess the effectiveness and tolerabilityof levetiracetam in the preventive treatment of refractory TM. Methods: This prospective, open-label, pilot study was conducted at TheNew England Center for Headache, Stamford, Connecticut. We included patients aged ≥ 18 years with refractory TM according to the criteria proposed by Silberstein et al. All participants had failed on at least 1 but not more than 3 preventive drugs. Other preventive drugs were allowed if they had been received at a stable dose for > 30 days. The dosage of the levetiracetam tablets ranged from 1000 to 3000 mg/d in 2 divided doses. The treatment phase lasted 3 months. The primary end point was headache frequency (expressed as the number of headache days per month), and the secondary end point was the frequency of moderate or severe headache (d/mo). Other end points were headache score, Migraine Disability Assessment (MIDAS) Questionnaire score, and Headache Impact Test (HIT-6) score. Statistical analyses were performed in the intent-to-treat (ITT) population (patients who received at least 1 dose of study medication) using data subjected to the last-observation-carried-forward algorithm. We also conducted per-protocol (PP) analyses in patients who completed the study. Results: The ITT population consisted of 36 patients (26 women, 10 men;mean [SD] age, 46.5 [17.4] years). The mean headache frequency at baseline was 24.9 d/mo, and a significant reduction in headache frequency was obtained at l, 2, and 3 months of treatment (19.4, 18.4, and 16.2 d/mo, respectively; all, P < 0.001 Reproduction in whole or part is not permitted. vs baseline). At baseline, the mean number of moderate or severe headache days was

  15. Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

    PubMed Central

    Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

    2013-01-01

    Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

  16. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study

    PubMed Central

    Wolf, Joshua; Tang, Li; Rubnitz, Jeffrey E.; Brennan, Rachel C.; Shook, David R.; Stokes, Dennis C.; Monagle, Paul; Curtis, Nigel; Worth, Leon J.; Allison, Kim; Sun, Yilun; Flynn, Patricia M.

    2015-01-01

    Background Long-term central venous catheters are essential for the management of chronic medical conditions, including childhood cancer. Catheter occlusion is associated with an increased risk of subsequent complications, including bloodstream infection, venous thrombosis, and catheter fracture. Therefore, predicting and pre-emptively treating occlusions should prevent complications, but no method for predicting such occlusions has been developed. Methods We conducted a prospective trial to determine the feasibility, acceptability, and efficacy of catheter-resistance monitoring, a novel approach to predicting central venous catheter occlusion in pediatric patients. Participants who had tunneled catheters and were receiving treatment for cancer or undergoing hematopoietic stem cell transplantation underwent weekly catheter-resistance monitoring for up to 12 weeks. Resistance was assessed by measuring the inline pressure at multiple flow-rates via a syringe pump system fitted with a pressure-sensing transducer. When turbulent flow through the device was evident, resistance was not estimated, and the result was noted as “non-laminar.” Results Ten patients attended 113 catheter-resistance monitoring visits. Elevated catheter resistance (>8.8% increase) was strongly associated with the subsequent development of acute catheter occlusion within 10 days (odds ratio = 6.2; 95% confidence interval, 1.8–21.5; p <0.01; sensitivity, 75%; specificity, 67%). A combined prediction model comprising either change in resistance greater than 8.8% or a non-laminar result predicted subsequent occlusion (odds ratio = 6.8; 95% confidence interval, 2.0–22.8; p = 0.002; sensitivity, 80%; specificity, 63%). Participants rated catheter-resistance monitoring as highly acceptable. Conclusions In this pediatric hematology and oncology population, catheter-resistance monitoring is feasible, acceptable, and predicts imminent catheter occlusion. Larger studies are required to validate

  17. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    ERIC Educational Resources Information Center

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  18. Breath analysis for in vivo detection of pathogens related to ventilator-associated pneumonia in intensive care patients: a prospective pilot study.

    PubMed

    Filipiak, Wojciech; Beer, Ronny; Sponring, Andreas; Filipiak, Anna; Ager, Clemens; Schiefecker, Alois; Lanthaler, Simon; Helbok, Raimund; Nagl, Markus; Troppmair, Jakob; Amann, Anton

    2015-03-01

    Existing methods for the early detection of infections in mechanically ventilated (MV) patients at intensive care units (ICUs) are unsatisfactory. Here we present an exploratory study assessing the feasibility of breath VOC analyses for the non-invasive detection of pathogens in the lower respiratory tract of ventilated patients. An open uncontrolled clinical pilot study was performed by enrolling 28 mechanically ventilated (MV) patients with severe intracranial disease, being at risk for the development of or already with confirmed ventilation-associated pneumonia (VAP). The recently developed sampling technique enabled the collection of breath gas with a maximized contribution of alveolar air directly from the respiratory circuit under continuous capnography control, adsorptive preconcentration and final analysis by means of gas chromatography-mass spectrometry (GC-MS).VAP was confirmed in 22/28 preselected patients (78%). The most common microorganisms were Staphylococcus aureus (5/22 VAP patients), Escherichia coli (5/22 VAP patients) and Candida spp. (5/22 VAP patients). 12/32 metabolites released by S. aureus in our previous in vitro studies were also detected in the end-tidal air of VAP patients infected with this pathogen. A similar overlap was seen in Candida albicans infections (8/29 VOCs). Moreover, the concentration profile of selected compounds correlated with the course of the infection.This prospective pilot study provides proof of the concept that the appearance and the concentration profile of pathogen-derived metabolites (elucidated from in vitro experiments) in the breath of ventilated patients during clinically confirmed VAP correlates with the presence of a particular pathogen. PMID:25557917

  19. Pilot Study of a Clinical Pathway Implementation in Rectal Cancer

    PubMed Central

    Uña, Esther; López-Lara, Francisco

    2010-01-01

    Background: Rectal cancer is a highly prevalent disease which needs a multidisciplinary approach to be treated. The absence of specific protocols implies a significant and unjustifiable variability among the different professionals involved in this disease. The purpose is to develop a clinical pathway based on the analysis process and aims to reduce this variability and to reduce unnecessary costs. Methods: We created a multidisciplinary team with contributors from every clinical area involved in the diagnosis and treatment in this disease. We held periodic meetings to agree on a protocol based on the best available clinical practice guidelines. Once we had agreed on the protocol, we implemented its use as a standard in our institution. Every patient older than 18 years who was diagnosed with rectal cancer was considered a candidate to be treated via the pathway. Results: We evaluated 48 patients during the course of this study. Every parameter measured was improved after the implementation of the pathway, except the proportion of patients with 12 nodes or more analysed. The perception that our patients had about this project was very good. Conclusions: Clinical pathways are needed to improve the quality of health care. This kind of project helps reduce hospital costs and optimizes the use of limited resources. On the other hand, unexplained variability is also reduced, with consequent benefits for the patients. PMID:21151842

  20. Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator.

    SciTech Connect

    Menard, J. E.; Bromberg, L.; Brown, T.; Burgess, Thomas W; Dix, D.; El-GuebalyUniv. Wisco, L.; Gerrity, T.; Goldston, R. J.; Hawryluk, R.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G. H.; Neumeyer, C. L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D. G.; Zarnstorff, M. C.

    2011-01-01

    A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

  1. Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator

    NASA Astrophysics Data System (ADS)

    Menard, J. E.; Bromberg, L.; Brown, T.; Burgess, T.; Dix, D.; El-Guebaly, L.; Gerrity, T.; Goldston, R. J.; Hawryluk, R. J.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G. H.; Neumeyer, C. L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D.; Zarnstorff, M.

    2011-10-01

    A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

  2. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  3. Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study

    PubMed Central

    2014-01-01

    Background Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. Methods We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show “O”. Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. Results The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. Conclusion A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology. PMID:24920527

  4. A 4-year prospective evaluation of protocols to improve clinical outcomes for patients with lymphangioleiomyomatosis in a national clinical centre.

    PubMed

    Bee, Janet; Bhatt, Rupesh; McCafferty, Ian; Johnson, Simon R

    2015-12-01

    Lymphangioleiomyomatosis (LAM) is a rare multisystem disease. Progressive airflow limitation, pneumothorax and angiomyolipoma-related bleeding are major morbidities. As treatments are available for these complications, we prospectively audited loss of FEV1 (ΔFEV1), pneumothorax and angiomyolipoma bleeding against clinical standards over 4 years at the UK Clinical Centre. ΔFEV1 for these patients is lower than previously reported and rates of pneumothorax and angiomyolipoma haemorrhage are low. This suggests that real-time analysis of clinical data with targeted interventions can reduce morbidity in LAM. These measures could be applied as quality standards to compare the emerging LAM clinical networks worldwide. PMID:26123659

  5. Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

    PubMed Central

    Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

    2014-01-01

    There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community. PMID:25383173

  6. Current Status and Future Prospects of Clinical Psycholog

    PubMed Central

    Baker, Timothy B.; McFall, Richard M.; Shoham, Varda

    2010-01-01

    SUMMARY The escalating costs of health care and other recent trends have made health care decisions of great societal import, with decision-making responsibility often being transferred from practitioners to health economists, health plans, and insurers. Health care decision making increasingly is guided by evidence that a treatment is efficacious, effective–disseminable, cost-effective, and scientifically plausible. Under these conditions of heightened cost concerns and institutional–economic decision making, psychologists are losing the opportunity to play a leadership role in mental and behavioral health care: Other types of practitioners are providing an increasing proportion of delivered treatment, and the use of psychiatric medication has increased dramatically relative to the provision of psychological interventions. Research has shown that numerous psychological interventions are efficacious, effective, and cost-effective. However, these interventions are used infrequently with patients who would benefit from them, in part because clinical psychologists have not made a convincing case for the use of these interventions (e.g., by supplying the data that decision makers need to support implementation of such interventions) and because clinical psychologists do not themselves use these interventions even when given the opportunity to do so. Clinical psychologists’ failure to achieve a more significant impact on clinical and public health may be traced to their deep ambivalence about the role of science and their lack of adequate science training, which leads them to value personal clinical experience over research evidence, use assessment practices that have dubious psychometric support, and not use the interventions for which there is the strongest evidence of efficacy. Clinical psychology resembles medicine at a point in its history when practitioners were operating in a largely prescientific manner. Prior to the scientific reform of medicine in the

  7. A Pilot Evaluation of Portfolios for Quality Attestation of Clinical Ethics Consultants.

    PubMed

    Fins, Joseph J; Kodish, Eric; Cohn, Felicia; Danis, Marion; Derse, Arthur R; Dubler, Nancy Neveloff; Goulden, Barbara; Kuczewski, Mark; Mercer, Mary Beth; Pearlman, Robert A; Smith, Martin L; Tarzian, Anita; Youngner, Stuart J

    2016-03-01

    Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants. PMID:26913652

  8. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

    PubMed Central

    2012-01-01

    Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact

  9. Myopathies of endocrine disorders: A prospective clinical and biochemical study

    PubMed Central

    Sharma, Vikas; Borah, Papori; Basumatary, Lakshya J.; Das, Marami; Goswami, Munindra; Kayal, Ashok K.

    2014-01-01

    Introduction: Major categories of endocrine myopathy include those associated with: Adrenal dysfunction (as in Cushing's disease or steroid myopathy); thyroid dysfunction (as in myxedema coma or thyrotoxic myopathy); vitamin D deficiency; parathyroid dysfunction; and pituitary dysfunction. Steroid myopathy is the most common endocrine myopathy. Objective: To study the etiology, varied presentations, and outcome after therapy of patients with endocrine myopathies. Materials and Methods: Myopathy was evaluated by the standard clinical procedures: Detailed clinical history, manual muscle strength testing, and creatine phosphokinase (CPK). Endocrine disorders were diagnosed as per clinical features and biochemical parameters. The treatment was given to patients as per underlying endocrine disease. Myopathy was assessed before and after treatment. Results: Out of the 37 patients who were diagnosed with endocrine myopathies, thyroid dysfunction was the most common cause (17 cases), followed by vitamin D deficiency in nine, adrenal dysfunction in six, parathyroid dysfunction in three, and pituitary dysfunction in two. Some patients had atypical presentation (repeated falls in one, tongue fasciculations in one, neck weakness in five, one with ptosis and facial weakness, asymmetrical onset in one, and calf hypertrophy in one. The serum creatine kinase (CK) concentration did not correlate with muscle weakness. Following the treatment regimen which was specific for a given myopathy, 26 patients recovered fully. Conclusion: We found varied clinical presentations of endocrine myopathies. All the patients with neuromuscular complaints should be investigated for endocrine causes because significant number of them recovers fully with specific treatment. PMID:25221399

  10. Developing and piloting a new role to enhance the clinical learning environment.

    PubMed

    Beddingham, Elaine; Simmons, Maxine

    2016-09-01

    Environments that support pre- and post-registration students' and staff learning are vital to ensure the delivery of high quality patient care by knowledgeable and competent healthcare practitioners. A project was undertaken at Chesterfield Royal Hospital NHS Foundation Trust to modernise and enhance preceptorship against a background of national and local drivers. This article describes the development, piloting and evaluation of a new role designed to support and enhance practice learning environments for newly qualified nurses, preceptors, pre-registration nursing students and mentors. The article identifies the factors that affect clinical learning environments and discusses some practical solutions to the challenges associated with learning in practice. Finally, the article offers some recommendations and implications for practice in relation to the pilot outcomes. PMID:27581912

  11. Hypertension Education Intervention with Ugandan Nurses Working in Hospital Outpatient Clinic: A Pilot Study

    PubMed Central

    Becker, Kathleen

    2014-01-01

    Noncommunicable diseases (NCDs) pose a significant global burden in both developed and developing countries. It is estimated that, by 2025, 41.7% of males and 38.7% of females in Sub-Saharan Africa will develop high blood pressure (HBP). This is particularly true in Uganda with hypertensive prevalence rates estimated to range from 22.5% to 30.5%. Coupled with low levels of detection, treatment, and control, hypertension represents a Ugandan public health crisis. An innovative WHO-ISH education program culturally was adapted in a pilot study and focused on knowledge, skills, and attitudes (KSA) of nurses caring for hypertensive patients in an outpatient clinic. Pre-post intervention data was collected and analyzed in which significant improvements were noted on all the three outcome measures. This pilot study demonstrated that nurses' knowledge, skills, and attitudes could be significantly improved with a multimodal education program implemented in a low resource environment. PMID:25548662

  12. Procalcitonin is a strong predictor of urine culture results in patients with obstructing ureteral stones: A prospective, pilot study

    PubMed Central

    Papagiannopoulos, Dimitri; Whelan, Patrick; Ahmad, Waseem; Rybak, James; Hota, Bala; Deane, Leslie; Nehra, Ajay

    2016-01-01

    Purpose: The appropriate management of infected obstructing ureteral calculi is prompt genitourinary decompression. Urine cultures are the gold standard for confirming infection but often take 24–48 h to result. Although white blood cell (WBC) count is an important diagnostic laboratory test, it is a nonspecific inflammatory marker. Similarly, urinalysis (UA) can be misleading in the setting of a contaminated sample, bladder colonization, or in cases of a completely obstructed the upper urinary tract. Procalcitonin (PCT) has shown promise in predicting the presence and degree of bacterial infections. In this proof-of-concept study, we explore whether PCT is effective at predicting concomitant infections in the setting of obstructing ureteral stones. Materials and Methods: This is a prospective, single-institution observational pilot study examining adult patients who presented to the emergency room with acute obstructing ureterolithiasis. In total, 22 patients were enrolled. At the time of presentation, data obtained were vital signs, WBC count, PCT, UA, urine, and blood cultures. Fisher-exact two-tailed t-tests and receiver operating characteristic statistics with area under the curve (AUC) calculations were used to determine the correlation between urine culture results and PCT, WBC count, nitrite-positive UA, heart rate, and fever. Results: In total, 5/22 patients had bacteria-positive urine cultures. PCT (P = 0.020) and nitrite-positive UA (0.024) were the only statistically significant predictors of urine culture results. In comparing the AUC, PCT (0.812) was strongly correlated with eventual urine culture results. Conclusions: This proof-of-concept pilot study gives encouraging results, in that PCT was a good predictor of positive cultures (P = 0.02, AUC 0.812). Given, the small sample size, one cannot directly compare PCT to other markers of infection. However, PCT shows promise in this arena and warrants future investigation. PMID:27453647

  13. Lessons Learned from an ICD-10-CM Clinical Documentation Pilot Study

    PubMed Central

    Moczygemba, Jackie; Fenton, Susan H

    2012-01-01

    On October 1, 2013, the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) will be mandated for use in the United States in place of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). This new classification system will used throughout the nation's healthcare system for recording diagnoses or the reasons for treatment or care. A pilot study was conducted to determine whether current levels of inpatient clinical documentation provide the detail necessary to fully utilize the ICD-10-CM classification system for heart disease, pneumonia, and diabetes cases. The design of this pilot study was cross-sectional. Four hundred ninety-one de-identified records from two sources were coded using ICD-10-CM guidelines and codebooks. The findings of this study indicate that healthcare organizations need to assess clinical documentation and identify gaps. In addition, coder proficiency should be assessed prior to ICD-10-CM implementation to determine the need for further education and training in the biomedical sciences, along with training in the new classification system. PMID:22548021

  14. Prospects for a clinical science of mindfulness-based intervention.

    PubMed

    Dimidjian, Sona; Segal, Zindel V

    2015-10-01

    Mindfulness-based interventions (MBIs) are at a pivotal point in their future development. Spurred on by an ever-increasing number of studies and breadth of clinical application, the value of such approaches may appear self-evident. We contend, however, that the public health impact of MBIs can be enhanced significantly by situating this work in a broader framework of clinical psychological science. Utilizing the National Institutes of Health stage model (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), we map the evidence base for mindfulness-based cognitive therapy and mindfulness-based stress reduction as exemplars of MBIs. From this perspective, we suggest that important gaps in the current evidence base become apparent and, furthermore, that generating more of the same types of studies without addressing such gaps will limit the relevance and reach of these interventions. We offer a set of 7 recommendations that promote an integrated approach to core research questions, enhanced methodological quality of individual studies, and increased logical links among stages of clinical translation in order to increase the potential of MBIs to impact positively the mental health needs of individuals and communities. PMID:26436311

  15. The human genome project: Prospects and implications for clinical medicine

    SciTech Connect

    Green, E.D.; Waterston, R.H. )

    1991-10-09

    The recently initiated human genome project is a large international effort to elucidate the genetic architecture of the genomes of man and several model organisms. The initial phases of this endeavor involve the establishment of rough blueprints (maps) of the genetic landscape of these genomes, with the long-term goal of determining their precise nucleotide sequences and identifying the genes. The knowledge gained by these studies will provide a vital tool for the study of many biologic processes and will have a profound impact on clinical medicine.

  16. Clinical Trials with Oncolytic Viruses: Current and Future Prospects.

    PubMed

    Patil, Shankargouda; Rao, Roopa S; Majumdar, Barnali

    2015-08-01

    Reviewing the research in the field of oncolytic virus therapy (OVT) of the past two decades, it is inspiring to see the enormous amount of success accomplished by the scholars of this innovative therapeutic technique. Though the experimental trials have been ongoing from 1990s, however, it took a leap forward with approval of the clinical trials in China, 2005. The world's first oncolytic virus to be approved by their government was adenovirus (with E1B 55K gene deletion) for head and neck cancer therapy along with chemotherapy. PMID:26423510

  17. Application sorption: experience in clinical use and prospects of development.

    PubMed

    Eretskaya, E V; Sakhno, L A; Nikolaev, V G

    1991-01-01

    The analysis of experimental - clinical results obtained during the last decade in the field of application of adsorptive carbon dressings in wound and burn therapy is given. Possible mechanisms of the therapeutic effect of this material are discussed, the feasibility of their application during different phases of wound process and burn disease treatment is demonstrated. The local absorption may be independent efficient method of treatment in the case of surface burns and wound with a small area of injury and provide a pronounced detoxifying effect in the case of suppurative-septic complication of a mechanical trauma and burns. PMID:1751664

  18. Current Status of Xenotransplantation and Prospects for Clinical Application

    PubMed Central

    Pierson, Richard N.; Dorling, Anthony; Ayares, David; Rees, Michael A.; Seebach, Jörg D.; Fishman, Jay A.; Hering, Bernhard J.; Cooper, David K.C.

    2010-01-01

    Xenotransplantation is one promising approach to bridge the gap between available human cells, tissues, and organs and the needs of patients with diabetes or end-stage organ failure. Based on recent progress using genetically-modified source pigs, improving results with conventional and experimental immunosuppression, and expanded understanding of residual physiologic hurdles, xenotransplantation appears likely to be evaluated in clinical trials in the near future for some select applications. This review offers a comprehensive overview of known mechanisms of xenograft injury, a contemporary assessment of preclinical progress and residual barriers, and our opinions regarding where breakthroughs are likely to occur. PMID:19796067

  19. Anosognosia for hemiplegia: a clinical-anatomical prospective study.

    PubMed

    Vocat, Roland; Staub, Fabienne; Stroppini, Tiziano; Vuilleumier, Patrik

    2010-12-01

    Anosognosia for hemiplegia is a common and striking disorder following stroke. Because it is typically transient and variable, it remains poorly understood and has rarely been investigated at different times in a systematic manner. Our study evaluated a prospective cohort of 58 patients with right-hemisphere stroke and significant motor deficit of the left hemibody, who were examined using a comprehensive neuropsychological battery at 3 days (hyperacute), 1 week (subacute) and 6 months (chronic) after stroke onset. Anosognosia for hemiplegia was frequent in the hyperacute phase (32%), but reduced by almost half 1 week later (18%) and only rarely seen at 6 months (5%). Anosognosia for hemiplegia was correlated with the severity of several other deficits, most notably losses in proprioception, extrapersonal spatial neglect and disorientation. While multiple regression analyses highlighted proprioceptive loss as the most determinant factor for the hyperacute period, and visuospatial neglect and disorientation as more determinant for the subacute phase, patients with both proprioceptive loss and neglect had significantly higher incidence of anosognosia for hemiplegia than those with only one deficit or no deficits (although a few double dissociations were observed). Personal neglect and frontal lobe tests showed no significant relation with anosognosia for hemiplegia, nor did psychological traits such as optimism and mood. Moreover, anosognosia for neglect and prediction of performance in non-motor tasks were unrelated to anosognosia for hemiplegia, suggesting distinct monitoring mechanisms for each of these domains. Finally, by using a voxel-based statistical mapping method to identify lesions associated with a greater severity of anosognosia, we found that damage to the insula (particularly its anterior part) and adjacent subcortical structures was determinant for anosognosia for hemiplegia in the hyperacute period, while additional lesions in the premotor cortex

  20. A Comprehensive Prospective Clinical Study of Hydatid Disease

    PubMed Central

    Kayal, Ankit; Hussain, Akhlak

    2014-01-01

    The actual prevalence of hydatid disease in northern part of India is found more than usually interpreted. The present study has been done on 25 patients suffering from hydatid disease of various sites and treated during June 2009 to November 2011 at JLN Medical College and Hospital, Ajmer, with the aim of studying the clinical manifestations of hydatid disease of different sites and/or organ system and of analysing the morbidity and mortality of hydatid disease. The age, sex, h/o dog contact, duration of hospital stay, clinical presentation, treatment advised, findings and difficulties encountered during operation, and postoperative management of patients as well as morbidity and mortality were recorded and analysed. We observed that the mean age was 40 years. The sex incidence revealed female preponderance in the study (M : F: 1 : 2). Duration of illness in the present study varied from 1 month to 6 years in case of liver hydatid disease. Majority of patients were from rural areas (21) and the remaining (4) from urban areas. Swelling was the most common presenting feature. Incidence of hydatid disease at unusual sites in India is higher than in other parts of the world. PMID:24734188

  1. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study

    PubMed Central

    Lombardi, Francesca; Belmonti, Simone; Fabbiani, Massimiliano; Morandi, Matteo; Rossetti, Barbara; Tordini, Giacinta; Cauda, Roberto; De Luca, Andrea; Di Giambenedetto, Simona; Montagnani, Francesca

    2016-01-01

    Objectives Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) versus the 23-valent polysaccharide vaccine (PPSV23) in HIV-infected adults. Methods We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18–65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50) received two doses of PCV13 eight weeks apart, and group 2 (n = 50) received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100) were also enrolled as baseline controls. Results Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group. Conclusions In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated. Trial Registration ClinicalTrials.gov NCT02123433 PMID:27258647

  2. Trends in vital signs and routine biomarkers in patients with sepsis during resuscitation in the emergency department: a prospective observational pilot study

    PubMed Central

    Quinten, Vincent M; van Meurs, Matijs; ter Maaten, Jan C; Ligtenberg, Jack J M

    2016-01-01

    Objectives Sepsis lacks a reliable and readily available measure of disease activity. Thereby, it remains unclear how to monitor response to treatment. Research on numerous (new) biomarkers associated with sepsis provided disappointing results and little is known about changes in vital signs during sepsis resuscitation. We hypothesised that trends in vital signs together with routine biomarker levels during resuscitation might provide information about the response to treatment at a very early stage of sepsis in the emergency department (ED). We therefore explore trends in vital signs and routine biomarker levels during sepsis resuscitation in the ED. Design Prospective observational pilot study. Setting ED of a tertiary care teaching hospital. Participants 99 Adult non-trauma patients with suspected infection and 2 or more systemic inflammatory response syndrome criteria admitted to the ED. Primary and secondary outcome measures Vital signs and biomarker levels at admittance (T0) and after 3 h in the ED (T1). Results In total, data of 99 patients were analysed. Of these patients, 63 presented with sepsis, 30 with severe sepsis and 6 with septic shock. All vital signs decreased, except for peripheral oxygen saturation which increased. Almost all routine biomarker levels decreased during resuscitation, except for C reactive protein, bands, potassium, troponin T and direct bilirubin which remained stable. Sodium, chloride and N-terminal prohormone of brain natriuretic peptide increased slightly. Conclusions Vital signs and biomarker levels showed descending trends during resuscitation, except for parameters directly affected by treatment modalities. Despite these trends, most patients improved clinically. Trends in vital signs and routine biomarkers might be helpful in predicting clinical course and response to treatment in patients with sepsis during early resuscitation. PMID:27225646

  3. Neglected ends: clinical ethics consultation and the prospects for closure.

    PubMed

    Fiester, Autumn

    2015-01-01

    Clinical ethics consultations (CECs) are sometimes deemed complete at the moment when the consultants make a recommendation. In CECs that involve actual ethical conflict, this view of a consult's endpoint runs the risk of overemphasizing the conflict's resolution at the expense of the consult's process, which can have deleterious effects on the various parties in the conflict. This overly narrow focus on reaching a decision or recommendation in consults that involve profound moral disagreement can result in two types of adverse, lingering sequelae: moral distress or negative moral emotions. The problem, succinctly named, is that such consults have insufficient "closure" for patients, families, and providers. To promote closure, and avoid the ills of moral distress and the moral emotions, I argue that CECs need to prioritize assisted conversation between the different stakeholders in these conflicts, what is often referred to as "bioethics mediation." PMID:25562222

  4. [Clinical problems and prospects in laboratory chemical analysis].

    PubMed

    Kawamura, Takeshi

    2008-01-01

    The first subject of clinical problems is about uncertainty in measurement, but is now going be clarified by the standardization of reference measurement procedure and reference material. On the other hand, physiological uncertainty in samples is unable to be solved. So the establishment of evidence based diagnostic values is important in company with reference value, especially in the field of health examination. The life expectancy of the Japanese population is one of longest in the world. So the preventive medicine of lifestyle-related disease is important to perform an extensive research like as disease preventive biomarkers. Furthermore, we expect the progression of examinations in the pathophysiological diagnosis. I present the paper of development for the diagnostic method of dihydropyrimidine dehydrogenase-deficient as an example. PMID:18320662

  5. A clinic-based pilot intervention to enhance diabetes management for elderly Hispanic patients

    PubMed Central

    Nguyen, Annie L.; Angulo, Marco; Haghi, Linda L.; Cruz, Maya; Nikroo, Nahal; Peraza, Sarah; Bennink, Justin; Duru, O. Kenrik; Moore, Alison A.; Mosqueda, Laura A.

    2016-01-01

    Background and objectives: Successful diabetes self-management requires behavioral and lifestyle changes. However, low-income patients may face challenges related to poverty that make it difficult to engage in lifestyle changes. We piloted an intervention designed to help older, low-income, Hispanic, patients with diabetes access free or low-cost community resources to enhance diabetes self-management. Results from this pilot intervention are reported. Design and Methods: Patients were recruited at baseline to complete surveys assessing diabetes self-care activities, diabetes self-efficacy, and general self-efficacy. Volunteers were trained by a clinic social worker to help patients identify needs and make referrals to local community resources (e.g., housing, transportation, food, clothing, dental and prescription services, employment, or family social services). Identical surveys were administered at 3-month follow-up. Results: 28 patients were recruited at baseline and 18 patients completed the follow-up assessment. No significant changes in diabetes care and self-efficacy were detected. All patients requested at least one referral to a community resource. The most common requests were for low-cost dental clinics, food assistance, and housing support. At follow-up, nine (50%) patients contacted their given referrals. Conclusions: The need for assistance with basic social services is high in this population. The rate of referral uptake (50%) is high for a relatively low intensity intervention. Since the completion of the pilot, the program has trained 21 volunteers and helped over 220 patients in a primary care clinic. Using a volunteer model and creating connections to existing community resources is a cost-conscious way to deliver needed services to patients. PMID:27110482

  6. Neuronal involvement in cisplatin neuropathy: prospective clinical and neurophysiological studies.

    PubMed

    Krarup-Hansen, A; Helweg-Larsen, S; Schmalbruch, H; Rørth, M; Krarup, C

    2007-04-01

    Although it is well known that cisplatin causes a sensory neuropathy, the primary site of involvement is not established. The clinical symptoms localized in a stocking-glove distribution may be explained by a length dependent neuronopathy or by a distal axonopathy. To study whether the whole neuron or the distal axon was primarily affected, we have carried out serial clinical and electrophysiological studies in 16 males with testicular cancer before or early and late during and after treatment with cisplatin, etoposide and bleomycin at limited (<400 mg/m2 cisplatin), conventional (approximately 400 mg/m2 cisplatin) or high (>400 mg/m2 cisplatin) doses. At cumulative doses of cisplatin higher than 300 mg/m2 the patients lost distal tendon and H-reflexes and displayed reduced vibration sense in the feet and the fingers. The amplitudes of sensory nerve action potentials (SNAP) from the fingers innervated by the median nerve and the dorsolateral side of the foot innervated by the sural nerve were 50-60% reduced, whereas no definite changes occurred at lower doses. The SNAP conduction velocities were reduced by 10-15% at cumulative doses of 400-700 mg/m2 consistent with loss of large myelinated fibres. SNAPs from primarily Pacinian corpuscles in digit 3 and the dorsolateral side of the foot evoked by a tactile probe showed similar changes to those observed in SNAPs evoked by electrical stimulation. At these doses, somatosensory evoked potentials (SEPs) from the tibial nerve had increased latencies of peripheral, spinal and central responses suggesting loss of central processes of large dorsal root ganglion cells. Motor conduction studies, autonomic function and warm and cold temperature sensation remained unchanged at all doses of cisplatin treatment. The results of these studies are consistent with degeneration of large sensory neurons whereas there was no evidence of distal axonal degeneration even at the lowest toxic doses of cisplatin. PMID:17301082

  7. Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

    PubMed Central

    Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

    2007-01-01

    Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

  8. Prospective open-label pilot trial of mirtazapine in children and adolescents with social phobia.

    PubMed

    Mrakotsky, Christine; Masek, Bruce; Biederman, Joseph; Raches, Darcy; Hsin, Olivia; Forbes, Peter; de Moor, Carl; DeMaso, David Ray; Gonzalez-Heydrich, Joseph

    2008-01-01

    Mirtazapine is indicated for major depression and used for anxiety in adults; however, little is known about its application in pediatric populations. This is an 8-week open-label pilot study of mirtazapine in children with social phobia age 8-17 years. Primary outcomes were symptom improvement based on clinician rating and self-report, as well as tolerability based on rates of discontinuation due to adverse effects. Fifty-six percent (10/18) responded to treatment, 17% (3/18) achieved full remission. Social phobia symptoms improved significantly during the first 2 weeks of treatment, as did comorbid symptoms of depression and anxiety. Eleven patients (61%) did not complete all 8 weeks of treatment; four patients (22%) discontinued due to adverse effects including fatigue and irritability. The others discontinued due to study burden (28%), insufficient response (6%), or to pursue herbal treatment (6%). Significant weight gain was observed. Larger controlled trials are needed to further evaluate efficacy and safety. PMID:17419001

  9. Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study

    PubMed Central

    2014-01-01

    Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n = 5) (200 mg twice daily for four weeks) or placebo group (n = 5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

  10. Variations of Gonadal Veins: Embryological Prospective and Clinical Significance

    PubMed Central

    Gupta, Raman; Aggarwal, Navita

    2015-01-01

    Introduction: An adequate knowledge of anomalies of gonadal veins will help the radiologists and surgeons in recognition and protection of these veins which play major roles in thermo-regulation that is essential for the efficient functioning of testis on which the survival of the human species depends. Aim: The aim of this work is to present an analysis of the anatomical variations of gonadal veins. An effort has also been made to explicate the possible embryological model of development of such variants and to present the variable clinical aspects concerning them. Materials and Methods: Gonadal veins in 60 dissection room cadavers were examined for variations from the classic anatomic description. Result: In the present study, out of 60 cases, male: female ratio was 2:1(40:20) in which no variation was found in ovarian veins. In the 18 (45%) cases, testicular veins showed variations which consist of duplication and atypical drainage. Discussion: Variations of drainage of gonadal vein are due to error of embryological development in venous shift and alteration in anastomotic channel of post-cardinal, supra-cardinal and sub cardinal veins. Conclusion: The gonadal veins present numeric variations as well as variations in its site of drainage, which attributed to the various pathological conditions as varicocele and pelvic congestion syndrome, leading to infertility in patients. Hence, in -depth knowledge of these developmental anomalies of gonadal veins is important. PMID:25859438

  11. A prospective clinical comparison of two intravenous polyurethane cannulae.

    PubMed

    Russell, W J; Micik, S; Gourd, S; MacKay, H; Wright, S

    1996-12-01

    Tissue irritation, as evidenced by phlebitis, associated with Optiva (Johnson & Johnson Medical) and Insyte (Becton Dickinson) polyurethane cannulae was studied. The integrity of the cannulae on removal, the incidence of infection at the cannula site and the factors which influence phlebitis were also examined. One thousand and eight patients had a polyurethane cannula placed for induction of anaesthesia for cardiac surgery. After surgery, the cannula was examined every 24 hours. If evidence of phlebitis occurred, the cannula was removed and sent for culture. All remaining cannulae were removed at 72 hours and the site examined daily for a further three days. There were 503 Optiva and 505 Insyte cannulae studied. The distributions between the two cannulae with respect to patient characteristics, gauge of cannula, number of attempts and difficulty of insertion, cannula site and anaesthetist inserting were similar. The early removal rate for both groups was 47%. Overall phlebitis rate with Optiva was 31% and Insyte 33%. This difference is not statistically significant. The cumulative phlebitis rate increased with time but did not differ between the two types of cannulae. Minor tip distortion or shaft kinking of the cannulae occurred in 16.2% of Optiva and 23.5% of Insyte. This difference is statistically significant and may relate to the slightly more acute taper at the Optiva cannula tip. Both cannulae were similar in clinical performance. PMID:8971321

  12. Does famotidine enhance tumor infiltrating lymphocytes in breast cancer? Results of a randomized prospective pilot study.

    PubMed

    Parshad, Rajinder; Kapoor, Sorabh; Gupta, Siddhartha Datta; Kumar, Arvind; Chattopadhyaya, Tushar K

    2002-01-01

    Thirty patients with breast cancer were prospectively randomized into case and control groups receiving 40 mg famotidine preoperatively for 10-14 days and routine premedication, respectively. Surgical specimens were evaluated objectively for tumor infiltrating lymphocytes in the center and in the periphery of the tumor along with evaluation of metastatic lymph nodes for reactive changes. Ten famotidine-treated cases (67%) showed significant lymphocytic infiltration in the center compared to 4 controls (27%) (p = 0.03). Eleven cases (77%) had significant lymphocytic infiltration in the periphery (p = 0.03) compared to 5 controls (33%). Considering both sites, lymphocytic response was significant in 9 (60%) cases as opposed to only 3 (20%) controls (p = 0.03). This response did not correlate with the stage, grade of tumor or menopausal status of patients in either group. Seventy-eight percent (78%) of the cases showed significant reactive changes in the metastatic lymph nodes as compared to 22% in controls (p < 0.01). This study suggests that famotidine enhances tumor infiltrating lymphocytes in breast cancer and might have potential as an immunomodulator. A larger confirmatory study is suggested. PMID:12234028

  13. 77 FR 59911 - Request To Make Special Program for the Law School Clinic Certification Patent Pilot Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... law school clinic participating in the USPTO Law School Clinic Certification Pilot Program may file an..., 71 FR 36323 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18, 2006) (notice); Changes to... ] Under the Leahy-Smith America Invents Act, 76 FR 59050 (September 23, 2011); see also MPEP 708.02(a)...

  14. Designing Clinical Trials of Intervention for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders (LIFE) Pilot Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Clinical trials to assess interventions for mobility disability are critically needed, however data for efficiently designing such trials are lacking. Our results are described from the LIFE pilot clinical trial, in which 424 volunteers aged 70-89 years were randomly assigned to one of two intervent...

  15. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    PubMed Central

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    Objectives To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. Design and Setting A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. Participants Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. Interventions Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. Main Outcome Measures Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. Results At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. Conclusions Both interventions were acceptable, and it is promising that they both

  16. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    PubMed

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  17. A Pilot Study of Delivering Peer Health Messages in an HIV Clinic via Mobile Media

    PubMed Central

    Winstead-Derlega, Christopher; Rafaly, Mary; Delgado, Sarah; Freeman, Jason; Cutitta, Katherine; Miles, Tony; Ingersoll, Karen

    2012-01-01

    Abstract Objective: This pilot study tested the feasibility and impact of using mobile media devices to present peer health messages to human immunodeficiency virus (HIV)-positive patients. Subjects and Methods: A convenience sample of 30 adult patients from an outpatient HIV clinic serving a mostly rural catchment area in central Virginia volunteered for the study. Participants viewed short videos of people discussing HIV health topics on an Apple (Cupertino, CA) iPod® touch® mobile device. Pre- and post-intervention surveys assessed attitudes related to engagement in care and disease disclosure. Results: Participants found delivery of health information by the mobile device acceptable in a clinic setting. They used the technology without difficulty. Participants reported satisfaction with and future interest in viewing such videos after using the mobile devices. The majority of participants used the device to access more videos than requested, and many reported the videos “hit home.” There were no significant changes in participant perceptions about engagement in care or HIV disclosure after the intervention. Conclusions: This pilot study demonstrates the feasibility and acceptability of using mobile media technology to deliver peer health messages. Future research should explore how to best use mobile media to improve engagement in care and reduce perceptions of stigma. PMID:22732025

  18. First clinical pilot study with intravascular polarization sensitive optical coherence tomography (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Villiger, Martin; Karanasos, Antonios; Ren, Jian; Lippok, Norman; Shishkov, Milen; Daemen, Joost; Van Mieghem, Nicolas; Diletti, Roberto; Valgimigli, Marco; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; van Soest, Gijs; Nadkarni, Seemantini; Regar, Evelyn; Bouma, Brett E.

    2016-02-01

    Polarization sensitive (PS) OCT measures the polarization states of the light backscattered by tissue and provides measures of tissue birefringence and depolarization in addition to the structural OCT signal. Ex vivo studies have demonstrated that birefringence is increased in tissue rich in collagen and with elevated smooth muscle cell content. Preliminary data further suggests that depolarization can identify regions of macrophage infiltration, lipid, and irregularly arranged collagen fibers. These are important aspects of the mechanical integrity and vulnerability of atherosclerotic plaques. To evaluate the potential of PS-OCT in the clinical setting, we combined our custom PS-OCT system with commercially available OCT catheters (Fastview, Terumo Corporation) and performed a pilot study in 30 patients, scheduled to undergo percutaneous coronary intervention (PCI) on the grounds of stable or unstable angina. A total of 82 pullbacks in 39 vessels were performed, either in the native coronary arteries or post procedure. Comparing consecutive pullbacks of the same coronary artery, we found excellent agreement between the polarization features in the repeat pullbacks, validating the repeatability and robustness of PS-OCT in the clinical in vivo setting. In addition we observed that the birefringence and depolarization features vary significantly across lesions with identical structural OCT appearance, suggesting morphological subtypes. This first human pilot study proved the feasibility and robustness of intravascular PS-OCT. PS-OCT achieves improved tissue characterization and may help in identifying high-risk plaques, with the potential to ultimately improve risk stratification and help guiding PCI.

  19. Anabolic steroids after total knee arthroplasty. A double blinded prospective pilot study

    PubMed Central

    2010-01-01

    Background Total knee arthroplasty is reported to improve the patient's quality of life and mobility. However loss of mobility and pain prior to surgery often results in disuse atrophy of muscle. As a consequence the baseline functional state prior to surgery may result in poorer outcome "post surgery" and extended rehabilitation may be required. The use of anabolic steroids for performance enhancement and to influence muscle mass is well established. The positive effects of such treatment on bone and muscle could therefore be beneficial in the rehabilitation of elderly patients. The purpose of this study was to investigate the effects of small doses of Nandrolone decanoate on recovery and muscle strength after total knee replacement and to establish the safety of this drug in multimorbid patients. Methods This study was designed as a prospective double blind randomized investigation. Five patients (treatment group) with a mean age of 66.2 (58-72), average BMI of 30.76 (24.3-35.3) received 50 mg nandrolone decanoate intramuscular bi-weekly for 6 months. The control group (five patients; mean age 65.2, range 59-72; average BMI 31.7, range 21.2-35.2) was injected with saline solution. "Pre-operatively" and "post-operatively" (6 weeks, 3,6,9 and 12 months) all patients were assessed using the knee society score (KSS), isokinetic strength testing and functional tests (a sit-to-stand and timed walking tests). In addition, a bone density scan was used preoperatively and 6 month postoperatively to assess bone mineral density. Results Whilst the steroid group generally performed better than the placebo group for all of the functional tests, ANOVA failed to reveal any significant differences. The steroid group demonstrated higher levels of quadriceps muscle strength across the postoperative period which reached significance at 3 (p = 0.02), 6 (p = 0.01), and 12 months (p = 0.02). There was a significant difference for the KSS at 6 weeks (p = 0.02), 6 (p = 0.02) and 12 month

  20. Disordered Eating Behaviors in Youth with Type 1 Diabetes: Prospective Pilot Assessment Following Initiation of Insulin Pump Therapy

    PubMed Central

    Markowitz, Jessica T.; Alleyn, Cielo A.; Phillips, Roxanne; Muir, Andrew; Young-Hyman, Deborah

    2013-01-01

    Abstract Background There is risk for disordered eating behaviors in type 1 diabetes, especially related to insulin manipulation. Implementation of insulin pump therapy may encourage either normalization of eating behaviors or a greater focus on food intake due to renewed emphasis on carbohydrate counting. There is need for prospective studies to assess disordered eating behaviors upon implementation of pump therapy using diabetes-specific measurement tools. Subjects and Methods In a multicenter pilot study, 43 youth with type 1 diabetes, 10–17 years old, were assessed prior to pump initiation and after 1 and 6 months of pump therapy. Youth completed the Diabetes-specific Eating Problems Survey-Revised (DEPS-R), a validated measure of risk for both diabetes-specific and general disordered eating behaviors. Results Youth (45% female), 13.3 years old with diabetes for 2.1 years, had a mean hemoglobin A1c of 8.3±1.3% (68±14.5 mmol/mol) at baseline. DEPS-R scores decreased over time (P=0.01). Overall rate of high risk for eating disorders was low. Overweight/obese youth endorsed more disordered eating behaviors than normal-weight participants. DEPS-R scores were correlated with z-score for body mass index at all three time points and with hemoglobin A1c after 1 and 6 months. Hemoglobin A1c did not change significantly over the 6 months and was higher in overweight/obese compared with normal-weight participants. Conclusions Initiation of insulin pump therapy was associated with diminished endorsement of disordered eating behaviors in youth with type 1 diabetes. Longer follow-up studies are needed to assess the impact of insulin pump therapy on glycemic control, weight status, and disordered eating behaviors in this vulnerable population. PMID:23550556

  1. Multiparametric Approach Enhances Detection of Patients with Cerebral TIAs at Risk of Stroke: A Prospective Pilot Case Series

    PubMed Central

    Abd-Allah, Foad; Tawfik, Tarek Zoheir; Shamloul, Reham Mohammed; Hegazy, Montasser M; Hashad, Assem; Kamel, Ayman Ismail; Farees, Dina; Shalaby, Nevin M

    2016-01-01

    Background Patients with transient ischemic attack (TIA) are generally clinically unstable, with fear of developing a handicapping stroke. Identification of those at highest and lowest risk of stroke in the first days and weeks after a TIA would allow appropriate use of worthy secondary prevention strategies. Objective Incorporation of a clinical scoring system, neurovascular imaging, and magnetic resonance-diffusion-weighted imaging (MR-DWI) to help predicting risk of developing an ischemic stroke following a TIA. Subjects and methods A prospective observational study was conducted on 25 patients with TIAs, 64% were females, and 26% were males, with a mean age of 57±10.36. Patients were assessed clinically and an ABCD2 score was applied. Patients have undergone diffusion-weighted imaging (DWI), within 24 h from the event, and intra- and extracranial duplex study. Patients were followed up at intervals of one week, three months, six months, and one year. Results Six patients (24%) developed stroke on their follow-up, most of them (83.3%) had their strokes within the first three months and had an initial ABCD2 score of ≥4. The development of stroke was associated with the presence of significant extra and/or intracranial vessel disease (P=0.006) and the presence of acute lesions on their DWI (P=0.035). Conclusion Incorporation of brain MR-DWIs and neurovascular imaging together with the ABCD2 score improves prediction of ischemic stroke following TIA. PMID:27403225

  2. A collaborative outreach clinic for pregnant youth and adolescent mothers: Description of a pilot clinic and its patients

    PubMed Central

    Harrison, Megan E; Weinstangel, Hannah; Dalziel, Nancy; Moreau, Katherine A

    2014-01-01

    OBJECTIVE: To describe the pregnant youth and adolescent parents seen at an adolescent health outreach clinic in an urban community setting during a two-year pilot project. METHODS: A retrospective chart review of all adolescents who presented at the monthly half-day clinics from January 2008 through January 2010 (n=36) was performed. Measures extracted from charts included demographic information, reason for referral, social history, mental health history and outcome of assessment. RESULTS: All participants were female (mean age 17 years). Forty-two percent were pregnant at initial assessment, while the remainder had one or two children, or a recent pregnancy loss. Sixty-one percent had no primary care physician. The primary reason for referral was mental health concerns, most commonly depression. Almost one-half of patients relied on social assistance and almost one-third were living in shelters. At the time of first visit, 42% of patients were not attending school; the highest level of school completed for most patients was grade 8. The majority had a history of mental health issues and previous drug and/or alcohol use. CONCLUSIONS: Adolescents presenting to the clinic had a history of disadvantage in terms of income, educational attainment, living arrangements and mental health background, and are in need of various health services including primary care practitioners. These findings will help to inform future program development for these vulnerable youth, and have implications for practitioners caring for this population. PMID:24855427

  3. A single center, pilot, double-blinded, randomized, comparative, prospective clinical study to evaluate improvements in the structure and function of facial skin with tazarotene 0.1% cream alone and in combination with GliSODin® Skin Nutrients Advanced Anti-Aging Formula

    PubMed Central

    Goldberg, Lawrence D; Crysler, Corina

    2014-01-01

    Background Superoxide dismutase (SOD) reduces the reactive oxygen species formation associated with oxidative stress. An imbalance between free radicals and antioxidants can lead to accelerated aging. GliSODin® Skin Nutrients Advanced Anti-Aging Formula (GAAF) is an SOD-containing dietary nutricosmetic formulated with other nutraceuticals that promote improvements in the structure and function of the skin, including hydration, elasticity, structural integrity, and photoaging caused by oxidative stress. Tazarotene cream 0.1% (TAZ) is a United States Food and Drug Administration-approved drug indicated for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines when taken in conjunction with a comprehensive skin care and sun avoidance program. Objective To determine if the antioxidant, anti-aging, hydrating and skin-rejuvenating properties of GAAF complement the retinoic actions of TAZ to improve the structure and function of facial skin. Method A 90-day comparative study of ten subjects with facial photodamage; daily topical application of TAZ was used in combination with three capsules of GAAF (780 mg each) or placebo orally, with food, per the randomization allocation. Results After 90 days of treatment, TAZ alone and in combination with GAAF improved fine wrinkles (↓1.2 versus 2.0), mottled hyperpigmentation (↓2.2 versus 2.8) and overall photodamage (↓1.0 versus 1.8), as well as patient-reported response to treatment (↓2.0 versus 1.6). At week 12, TAZ/GAAF combination treatment (Group A) versus TAZ treatment alone (Group C) was of significant clinical benefit, with respect to fine wrinkling (14.7%/41.7%), overall photodamage (15.6%/53.0%), skin moisture (19.1%/103.2%), skin elasticity (12.8%/87.7%), and response to treatment (8.8%/21.4%). Conclusion The study suggests GAAF in combination with TAZ is safe and provides significant clinical benefit with relative improvement in facial fine

  4. Rifaximin therapy for metronidazole-unresponsive Clostridium difficile infection: a prospective pilot trial

    PubMed Central

    Patrick Basu, P.; Dinani, Amreen; Rayapudi, Krishna; Pacana, Tommy; Shah, Niraj James; Hampole, Hemant; Krishnaswamy, N. V.; Mohan, Vinod

    2010-01-01

    Background: Clostridium difficile infection (CDI) is a recent epidemic in the United States, particularly in the hospital setting. Oral metronidazole is standard therapy for C. difficile infection, but resistance to metronidazole is becoming a clinical challenge. Methods: We evaluated the efficacy of the nonsystemic oral antibiotic rifaximin for the treatment of metronidazole-resistant C. difficile infection. Twenty-five patients with C. difficile infection were enrolled in the study. All had mild-to-moderate C. difficile infection (5–10 bowel movements a day without sepsis) unresponsive to metronidazole (i.e. stools positive for toxins A and B after oral metronidazole 500 mg three times daily [t.i.d.] for 5 days). After discontinuation of metronidazole, rifaximin 400 mg t.i.d. for 14 days was prescribed. Patients were followed for 56 days and stool was tested for C. difficile using polymerase chain reaction (PCR) to assess the effect of treatment. A negative PCR test result was interpreted as a favorable response to rifaximin. Results: Sixteen of 22 patients (73%) were eligible for study inclusion and completed rifaximin therapy experienced eradication of infection (stool negative for C. difficile) immediately after rifaximin therapy and 56 days post-treatment. Three patients (12%) discontinued therapy because of abdominal distention. Rifaximin was generally well tolerated. Conclusions: In conclusion, rifaximin may be considered for treatment of mild-to-moderate C. difficile infection that is resistant to metronidazole. Larger randomized trials are needed to confirm these positive findings. PMID:21180604

  5. Pilot Program Using Medical Simulation in Clinical Decision-Making Training for Internal Medicine Interns

    PubMed Central

    Miloslavsky, Eli M.; Hayden, Emily M.; Currier, Paul F.; Mathai, Susan K.; Contreras-Valdes, Fernando; Gordon, James A.

    2012-01-01

    Background The use of high-fidelity medical simulation in cognitive skills training within internal medicine residency programs remains largely unexplored. Objective To design a pilot study to introduce clinical decision-making training using simulation into a large internal medicine residency program, explore the practicability of using junior and senior residents as facilitators, and examine the feasibility of using the program to improve interns' clinical skills. Methods Interns on outpatient rotations participated in a simulation curriculum on a voluntary basis. The curriculum consisted of 8 cases focusing on acute clinical scenarios encountered on the wards. One-hour sessions were offered twice monthly from August 2010 to February 2011. Internal medicine residents and simulation faculty served as facilitators. Results A total of 36 of 75 total interns volunteered to participate in the program, with 42% attending multiple sessions. Of all participants, 88% rated the sessions as “excellent,” 97% felt that the program improved their ability to function as an intern and generate a plan, and 81% reported improvement in differential diagnosis skills. Conclusions Simulation training was well received by the learners and improved self-reported clinical skills. Using residents as facilitators, supervised by faculty, was well received by the learners and enabled the implementation of the curriculum in a large training program. Simulation can provide opportunities for deliberate practice, and learners perceive this modality to be effective. PMID:24294427

  6. Uncomplicated Pregnancies and Ultrasounds for Fetal Growth Restriction: A Pilot Randomized Clinical Trial

    PubMed Central

    Hammad, Ibrahim A.; Chauhan, Suneet P.; Mlynarczyk, Malgorzata; Rabie, Nader; Goodie, Chris; Chang, Eugene; Magann, Everett F.; Abuhamad, Alfred Z.

    2015-01-01

    Objective The purpose of this multicenter pilot study was to determine the feasibility of randomizing uncomplicated pregnancies (UPs) to have third trimester ultrasonographic exams (USE) versus routine prenatal care (RPNC) to improve the detection of small for gestational age (SGA; birth weight < 10% for GA). Material and Methods At three referral centers, 50 UPs were randomized after gestational diabetes was ruled out. Women needed to screen, consenting, and loss to follow-up was ascertained, as was the detection rate of SGA in the two groups. Results During the study period at the three centers, there were 7,680 births, of which 64% were uncomplicated. Of the 234 women approached for randomization, 36% declined. We recruited 149 women and had follow-up delivery data on 97%. The antenatal detection rate of SGA in the intervention group was 67% (95% confidence intervals 31–91%) and 9% (0.5–43%) in control. Conclusion The pilot study provides feasibility data for a multicenter randomized clinical trial to determine if third trimester USE, compared with RPNC, improves the detection of SGA and composite neonatal morbidity. PMID:26929878

  7. Uncomplicated Pregnancies and Ultrasounds for Fetal Growth Restriction: A Pilot Randomized Clinical Trial.

    PubMed

    Hammad, Ibrahim A; Chauhan, Suneet P; Mlynarczyk, Malgorzata; Rabie, Nader; Goodie, Chris; Chang, Eugene; Magann, Everett F; Abuhamad, Alfred Z

    2016-03-01

    Objective The purpose of this multicenter pilot study was to determine the feasibility of randomizing uncomplicated pregnancies (UPs) to have third trimester ultrasonographic exams (USE) versus routine prenatal care (RPNC) to improve the detection of small for gestational age (SGA; birth weight < 10% for GA). Material and Methods At three referral centers, 50 UPs were randomized after gestational diabetes was ruled out. Women needed to screen, consenting, and loss to follow-up was ascertained, as was the detection rate of SGA in the two groups. Results During the study period at the three centers, there were 7,680 births, of which 64% were uncomplicated. Of the 234 women approached for randomization, 36% declined. We recruited 149 women and had follow-up delivery data on 97%. The antenatal detection rate of SGA in the intervention group was 67% (95% confidence intervals 31-91%) and 9% (0.5-43%) in control. Conclusion The pilot study provides feasibility data for a multicenter randomized clinical trial to determine if third trimester USE, compared with RPNC, improves the detection of SGA and composite neonatal morbidity. PMID:26929878

  8. Implementing a clinical ethics needs assessment survey: results of a pilot study (part 2 of 2).

    PubMed

    Frolic, Andrea; Andreychuk, Sandra; Seidlitz, Wendy; Djuric-Paulin, Angela; Flaherty, Barb; Jennings, Barb; Peace, Donna

    2013-03-01

    This paper details the implementation of the Clinical Ethics Needs Assessment Survey (CENAS) through a pilot study in five units within Hamilton Health Sciences. We describe how these pilot sites were selected, how we implemented the survey, the significant results and our interpretation of the findings. The primary goal of this paper is to share our experiences using this tool, specifically the challenges we encountered conducting a staff ethics needs assessment across different units in a large teaching hospital, and the facilitators to our success. We conclude with a discussion of the limitations of this study, our plans for using the results to develop a proactive ethics education strategy, and suggestions for other organizations wishing to adapt the CENAS to assess their staff ethics needs. Our secondary goal is to advance the "quality agenda" for ethics programs by demonstrating how a tool like the CENAS can be used to design more effective educational interventions, and to support strategic planning and proactive priority-setting for ethics programs. PMID:23212651

  9. Prevalence and clinical predictors of pulmonary tuberculosis among isolated inpatients: a prospective study.

    PubMed

    Lagrange-Xélot, M; Porcher, R; Gallien, S; Wargnier, A; Pavie, J; de Castro, N; Molina, J-M

    2011-04-01

    Guidelines help to prevent the transmission of Mycobacterium tuberculosis in healthcare settings, but may also result in the unnecessary isolation of many patients. We performed a prospective study to assess the prevalence and identify clinical predictors of culture-proven tuberculosis among inpatients isolated for suspected pulmonary tuberculosis (PTB) at our hospital. We also wished to validate a pre-existing clinical decision rule to improve our isolation policy. From August 2005 to January 2007, 134 patients isolated on admission to the ward for suspicion of PTB were prospectively enrolled. The admitting team made the decision to isolate patients on the basis of clinical and radiological findings, without the use of the clinical decision rule, and graded the overall suspicion of PTB. Twenty-six of the 134 isolated patients had PTB (prevalence: 19.4%), as well as one patient not isolated at admission. Univariate analysis revealed that PTB was significantly associated with young age, lack of human immunodeficiency virus (HIV) infection, weight loss, night sweats, fever, upper lobe disease and, especially, cavitary lesions on chest X-ray (adjusted OR 25.4, p <0.0001). Low suspicion of PTB by the admitting team and low clinical decision rule score had negative predictive values of 98.5% and 95.8% for PTB, respectively. Use of the clinical decision rule in addition to the team assessment would have led to the isolation of the patient with PTB not isolated on admission, and avoided 16 (14.8%) unnecessary isolations. In conclusion, the prevalence of PTB among isolated inpatients was high, and the use of a clinical decision rule in addition to clinical impression might improve isolation decisions. PMID:20459437

  10. Pilot clinical application of an adaptive robotic system for young children with autism

    PubMed Central

    Bekele, Esubalew; Crittendon, Julie A; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E

    2013-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. PMID:24104517

  11. Development, Implementation, and Evaluation of a Pilot Parenting Educational Intervention in a Pregnancy Buprenorphine Clinic.

    PubMed

    Giles, Averie C; Ren, Dianxu; Founds, Sandra

    2016-01-01

    We developed a pilot evidence-based prenatal educational intervention to increase knowledge of neonatal abstinence syndrome (NAS) and early parenting skills for women with opiate dependency who enrolled in a pregnancy buprenorphine clinic. We developed, implemented, and tested modules regarding expectations during newborn hospitalization for observation or treatment of NAS and regarding evidence-based parenting skills in response to NAS behaviors. Testing evaluated baseline knowledge of early parenting skills with newborns at risk for NAS and change from baseline after the educational intervention. No statistically significant difference in composite knowledge scores was observed. A brief survey completed by the participants postpartum affirmed the perception of women that the educational intervention effectively prepared them for the early postpartum period while their newborns were hospitalized. PMID:27287352

  12. Pilot clinical application of an adaptive robotic system for young children with autism.

    PubMed

    Bekele, Esubalew; Crittendon, Julie A; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E

    2014-07-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. PMID:24104517

  13. Collagen content as a risk factor in breast cancer? A pilot clinical study

    NASA Astrophysics Data System (ADS)

    Pifferi, Antonio; Quarto, Giovanna; Abbate, Francesca; Balestreri, Nicola; Menna, Simona; Cassano, Enrico; Cubeddu, Rinaldo; Taroni, Paola

    2015-07-01

    A retrospective pilot clinical study on time domain multi-wavelength (635 to 1060 nm) optical mammography was exploited to assess collagen as a breast-cancer risk factor on a total of 109 subjects (53 healthy and 56 with malignant lesions). An increased cancer occurrence is observed on the 15% subset of patients with higher age-matched collagen content. Further, a similar clustering based on the percentage breast density leads to a different set of patients, possibly indicating collagen as a new independent breast cancer risk factor. If confirmed statistically and on larger numbers, these results could have huge impact on personalized diagnostics, health care systems, as well as on basic research.

  14. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial.

    PubMed

    Tröger, Wilfried; Zdrale, Zdravko; Tišma, Nevena; Matijašević, Miodrag

    2014-01-01

    Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n = 34) versus untreated control (n = 31). Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P < 0.001 to P = 0.038 in Dunnett-T3 test). The difference was clinically relevant (difference of at least 5 points, range 5.4-12.2) in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P = 0.628). Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here. PMID:24701238

  15. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial

    PubMed Central

    Tröger, Wilfried; Ždrale, Zdravko; Tišma, Nevena; Matijašević, Miodrag

    2014-01-01

    Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n = 34) versus untreated control (n = 31). Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P < 0.001 to P = 0.038 in Dunnett-T3 test). The difference was clinically relevant (difference of at least 5 points, range 5.4–12.2) in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P = 0.628). Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here. PMID:24701238

  16. Application and student evaluation of a Clinical Progression Portfolio: a pilot.

    PubMed

    Cooke, Marie; Mitchell, Marion; Moyle, Wendy; Henderson, Amanda; Murfield, Jenny

    2010-07-01

    Clinical practicums are often limited by a lack of meaningful communication between nursing students and registered nurses (RNs). This pilot study evaluated the utility of the Clinical Progression Portfolio (CPP) to enable students to learn how to initiate engagement with their RNs and to develop their capacity as students to learn. The study employed a descriptive survey design, with a convenience sample of second-year Bachelor of Nursing (BN) students in Brisbane, Australia. Questionnaires were completed by 129 students from 20 clinical practicum groups. Students who used the CPP were more favourable in their usefulness ratings (-rpb=0.531, p<0.001) and, furthermore, those that used the CPP most frequently were also more favourable (r=0.555, p<0.001). Students thought the CPP helped clarify learning and target appropriate practicum opportunities. When used, the CPP was an important part of practicum, used frequently and considered useful. The CPP format met the needs of students as it was pocket-sized. Overall, students reported that the CPP was a useful learning and communication tool as it provided them direction in how they might maximise opportunities to address their learning needs. PMID:20022303

  17. Women's Health Care Minimum Data Set: pilot test and validation for use in clinical practice.

    PubMed

    Farley, Cindy L; Tharpe, Nell; Miller, Liane; Ruxer, Debbie Jenkins

    2006-01-01

    Basic elements of the structure, process, and outcomes of midwifery practice have not been fully determined, particularly in the areas of women's gynecologic and primary health care. The American College of Nurse-Midwives (ACNM) supported the development of clinical data sets to describe structure, process, and outcomes of midwifery practice for use by clinical practitioners. The Woman's Health Care Minimum Data Set was developed using a panel of expert midwives and other women's health care professionals, as well as literature resources. Students of the Graduate Midwifery Program at Philadelphia University performed pilot testing of the Woman's Health Care Minimum Data Set as a service to the profession of midwifery while applying concepts learned in their research methods courses. Each student (n = 19) recruited a midwifery practice in which she had a clinical affiliation, and gathered data sets on the previous 30 consecutive women's health care encounters by CNMs or CMs (n = 569). Item analysis and refinement were done. Criterion-related validity and construct-related validity of the Woman's Health Care Minimum Data Set were explored through comparison with the medical record and through the testing of plausible hypotheses. The Woman's Health Care Minimum Data Set has the potential to be an important instrument in documenting and understanding the evolving nature of the practice of primary women's health care by midwives and other women's health care providers. PMID:17081941

  18. Why clinical nurse educators adopt innovative teaching strategies: a pilot study.

    PubMed

    Phillips, Janet M; Vinten, Sharon A

    2010-01-01

    The purpose of this pilot study was to describe intentions to adopt innovative teaching strategies in clinical educators who have participated in an online course focusing on the role of clinical teaching (N = 71). Innovative teaching strategies were defined as those that embrace the tenets of sociocultural theory, a student-centered approach whereby the role of the nurse educator is to motivate and support the student and, in mutual process, to push students to reach toward their learning potential by using guiding techniques that can be erected or gradually reduced based on the individual student's learning needs. Participants stated that three factors proposed in the Rogers theory of diffusion of innovation (compatibility, trialability, and relative advantage) would be most influential in the adoption of innovative teaching strategies. Encouraging students to explore and apply new knowledge was described as the teaching strategy most likely to be adopted. Intent to adopt innovative teaching strategies may provide insight into the development of organizational climates in schools of nursing that could foster needed changes in clinical teaching. PMID:20882862

  19. Pilot study of cervical cytology screening in a sexually transmitted diseases clinic.

    PubMed Central

    Lyttle, H; Platts, W M; MacLean, A B

    1985-01-01

    A pilot study of cervical cytology was carried out on 500 new patients at the women's sexually transmitted disease (STD) clinic at this hospital. The aim was to discover the incidence of abnormal smears in order to gauge the worth of cervical cytology as a routine clinic procedure. Information was also gathered on each patient's age, sexual history, method of contraception used, previous smears, and genital infection. Smears showing carcinoma in situ, dysplasia, or warty atypia were regarded as abnormal, and the relevant patients were referred for colposcopy. Seventy-three (14.6%) had abnormal smears. Eight women (1.6%), average age 29.7 years, had cervical intraepithelial neoplasia grade III (CIN III) confirmed by histology. One third of the patients with abnormal smears had genital warts, and the incidence of abnormal smears was greater in patients with genital warts than in those without warts. We concluded that STD clinics are useful places in which to carry out cervical cytology screening, and we noted a positive association between infection with genital warts and abnormal smears. PMID:2995239

  20. Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

    ERIC Educational Resources Information Center

    Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

    2004-01-01

    Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

  1. Patient experiences with self-monitoring renal function after renal transplantation: results from a single-center prospective pilot study

    PubMed Central

    van Lint, Céline L; van der Boog, Paul JM; Wang, Wenxin; Brinkman, Willem-Paul; Rövekamp, Ton JM; Neerincx, Mark A; Rabelink, Ton J; van Dijk, Sandra

    2015-01-01

    Background After a kidney transplantation, patients have to visit the hospital often to monitor for early signs of graft rejection. Self-monitoring of creatinine in addition to blood pressure at home could alleviate the burden of frequent outpatient visits, but only if patients are willing to self-monitor and if they adhere to the self-monitoring measurement regimen. A prospective pilot study was conducted to assess patients’ experiences and satisfaction. Materials and methods For 3 months after transplantation, 30 patients registered self-measured creatinine and blood pressure values in an online record to which their physician had access to. Patients completed a questionnaire at baseline and follow-up to assess satisfaction, attitude, self-efficacy regarding self-monitoring, worries, and physician support. Adherence was studied by comparing the number of registered with the number of requested measurements. Results Patients were highly motivated to self-monitor kidney function, and reported high levels of general satisfaction. Level of satisfaction was positively related to perceived support from physicians (P<0.01), level of self-efficacy (P<0.01), and amount of trust in the accuracy of the creatinine meter (P<0.01). The use of both the creatinine and blood pressure meter was considered pleasant and useful, despite the level of trust in the accuracy of the creatinine device being relatively low. Trust in the accuracy of the creatinine device appeared to be related to level of variation in subsequent measurement results, with more variation being related to lower levels of trust. Protocol adherence was generally very high, although the range of adherence levels was large and increased over time. Conclusion Patients’ high levels of satisfaction suggest that at-home monitoring of creatinine and blood pressure after transplantation offers a promising strategy. Important prerequisites for safe implementation in transplant care seem to be support from physicians

  2. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

    PubMed Central

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large

  3. Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia

    PubMed Central

    Barnes, Deborah E.; Mehling, Wolf; Wu, Eveline; Beristianos, Matthew; Yaffe, Kristine; Skultety, Karyn; Chesney, Margaret A.

    2015-01-01

    Background Current dementia medications have small effect sizes, many adverse effects and do not change the disease course. Therefore, it is critically important to study alternative treatment strategies. The goal of this study was to pilot-test a novel, integrative group exercise program for individuals with mild-to-moderate dementia called Preventing Loss of Independence through Exercise (PLIÉ), which focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection. Methods We performed a 36-week cross-over pilot clinical trial to compare PLIÉ with usual care (UC) at an adult day program for individuals with dementia in San Francisco, CA. Assessments of physical performance, cognitive function, physical function, dementia-related behaviors, quality of life and caregiver burden were performed by blinded assessors at baseline, 18 weeks (cross-over) and 36 weeks. Our primary outcomes were effect sizes based on between-group comparisons of change from baseline to 18 weeks; secondary outcomes were within-group comparisons of change before and after cross-over. Results Twelve individuals enrolled (7 PLIÉ, 5 UC) and 2 withdrew (1 PLIÉ, 18 weeks; 1 UC, 36 weeks). Participants were 82% women (mean age, 84 ± 4 years); caregivers were 82% daughters (mean age, 56 ± 13 years). Effect sizes were not statistically significant but suggested potentially clinically meaningful (≥0.25 SDs) improvement with PLIÉ versus UC for physical performance (Cohen’s D: 0.34 SDs), cognitive function (0.76 SDs) and quality of life (0.83 SDs) as well as for caregiver measures of participant’s quality of life (0.33 SDs) and caregiver burden (0.49 SDs). Results were similar when within-group comparisons were made before and after cross-over. Conclusions PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life

  4. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    PubMed Central

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  5. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic.

    PubMed

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-03-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient's admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  6. The UK clinical aptitude test and clinical course performance at Nottingham: a prospective cohort study

    PubMed Central

    2013-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course. The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Methods Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. Results The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). Conclusions This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools. PMID:23442227

  7. "Cancer 2015": A Prospective, Population-Based Cancer Cohort-Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic.

    PubMed

    Parisot, John P; Thorne, Heather; Fellowes, Andrew; Doig, Ken; Lucas, Mark; McNeil, John J; Doble, Brett; Dobrovic, Alexander; John, Thomas; James, Paul A; Lipton, Lara; Ashley, David; Hayes, Theresa; McMurrick, Paul; Richardson, Gary; Lorgelly, Paula; Fox, Stephen B; Thomas, David M

    2015-01-01

    "Cancer 2015" is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61-70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially "actionable" variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice. PMID:26529019

  8. “Cancer 2015”: A Prospective, Population-Based Cancer Cohort—Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic

    PubMed Central

    Parisot, John P.; Thorne, Heather; Fellowes, Andrew; Doig, Ken; Lucas, Mark; McNeil, John J.; Doble, Brett; Dobrovic, Alexander; John, Thomas; James, Paul A.; Lipton, Lara; Ashley, David; Hayes, Theresa; McMurrick, Paul; Richardson, Gary; Lorgelly, Paula; Fox, Stephen B.; Thomas, David M.

    2015-01-01

    “Cancer 2015” is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61–70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially “actionable” variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice. PMID:26529019

  9. Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury

    PubMed Central

    Yue, John K.; Vassar, Mary J.; Lingsma, Hester F.; Cooper, Shelly R.; Okonkwo, David O.; Valadka, Alex B.; Gordon, Wayne A.; Maas, Andrew I. R.; Mukherjee, Pratik; Yuh, Esther L.; Puccio, Ava M.; Schnyer, David M.; Casey, Scott S.; Cheong, Maxwell; Dams-O'Connor, Kristen; Hricik, Allison J.; Knight, Emily E.; Kulubya, Edwin S.; Menon, David K.; Morabito, Diane J.; Pacheco, Jennifer L.; Sinha, Tuhin K.

    2013-01-01

    Abstract Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been central to the discouraging results from clinical trials. Current approaches to the characterization of disease severity and outcome have not changed in more than three decades. This prospective multicenter observational pilot study aimed to validate the feasibility of implementing the TBI Common Data Elements (TBI-CDEs). A total of 650 subjects who underwent computed tomography (CT) scans in the emergency department within 24 h of injury were enrolled at three level I trauma centers and one rehabilitation center. The TBI-CDE components collected included: 1) demographic, social and clinical data; 2) biospecimens from blood drawn for genetic and proteomic biomarker analyses; 3) neuroimaging studies at 2 weeks using 3T magnetic resonance imaging (MRI); and 4) outcome assessments at 3 and 6 months. We describe how the infrastructure was established for building data repositories for clinical data, plasma biomarkers, genetics, neuroimaging, and multidimensional outcome measures to create a high quality and accessible information commons for TBI research. Risk factors for poor follow-up, TBI-CDE limitations, and implementation strategies are described. Having demonstrated the feasibility of implementing the TBI-CDEs through successful recruitment and multidimensional data collection, we aim to expand to additional study sites. Furthermore, interested researchers will be provided early access to the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) data set for collaborative opportunities to more precisely characterize TBI and improve the design of future clinical treatment trials. (ClinicalTrials.gov Identifier NCT01565551.) PMID:23815563

  10. CT-guided Percutaneous Laser Disc Decompression (PLDD): prospective clinical outcome

    NASA Astrophysics Data System (ADS)

    Brat, Hugues G.; Bouziane, Tarik; Lambert, Jean; Divano, Luisa

    2004-09-01

    Percutaneous Laser Disc Decompression (PLDD) is a minimal invasive and effective treatment for contained lumbar disc hernias with correspondent radicular pain. This prospective study evaluates clinical efficacy of patients treated with PLDD under CT-fluoroscopic guidance. An independent observer assessed clinical outcome in a series of 40 consecutive patients at a mean follow-up of 7.5 months after treatment. According to Mac Nab criteria, 80% of patients experienced a good response to PLDD, 12.5% a fair response and 7.5% a poor response. 37 patients (92.5%) were back at work after 3 weeks. This technique could represent an alternative and secure treatment to conventional surgery for contained disc hernias.

  11. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study.

    PubMed

    Ciaramitaro, Palma; Mondelli, Mauro; Rota, Eugenia; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Merola, Aristide; Cocito, Dario; Neuropathies, Italian Network For Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4-6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61-8.76), particularly in the S group (OR 7.25; CI 1.2-43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14-16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450

  12. Clinical orofacial characteristics associated with risk of first-onset TMD: the OPPERA prospective cohort study

    PubMed Central

    Ohrbach, Richard; Bair, Eric; Fillingim, Roger B.; Gonzalez, Yoly; Gordon, Sharon M.; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Diatchenko, Luda; Dubner, Ron; Greenspan, Joel D.; Knott, Charles; Maixner, William; Smith, Shad; Slade, Gary

    2013-01-01

    Case-control studies have documented clinical manifestations of chronic temporomandibular disorders (TMD), whereas clinical predictors of TMD development are largely unknown. We evaluated 41 clinical orofacial characteristics thought to predict first-onset TMD in a prospective cohort study of U.S. adults aged 18-44 years. During the median 2.8-year follow-up period, 2,737 people completed quarterly screening questionnaires. Those reporting symptoms were examined and 260 people were identified with first-onset TMD. Univariate and multivariate Cox regression models quantified associations between baseline clinical orofacial measures and TMD incidence. Significant predictors from baseline self-report instruments included oral parafunctions, prior facial pain and its life-impact, TMJ noises and jaw locking, and non-specific orofacial symptoms. Significant predictors from the baseline clinical examination were pain on jaw opening and pain from palpation of masticatory, neck, and body muscles. Examiner assessments of TMJ noise and tooth wear facets did not predict incidence. In multivariate analysis, non-specific orofacial symptoms, pain from jaw opening and oral parafunctions predicted TMD incidence. The results indicate that only a few orofacial examination findings influenced TMD incidence, and only to a modest degree. More pronounced influences were found for self-reported symptoms, particularly those that appeared to reflect alterations to systems beyond the masticatory tissues. PMID:24275222

  13. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study

    PubMed Central

    Mondelli, Mauro; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Cocito, Dario; Neuropathies, Italian Network for Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4–6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61–8.76), particularly in the S group (OR 7.25; CI 1.2–43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14–16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450

  14. A prospective 9-month human clinical evaluation of Laser-Assisted New Attachment Procedure (LANAP) therapy.

    PubMed

    Nevins, Marc; Kim, Soo-Woo; Camelo, Marcelo; Martin, Ignacio Sanz; Kim, David; Nevins, Myron

    2014-01-01

    This investigation was designed and implemented as a single-center, prospective study to evaluate the clinical response to the Laser-Assisted New Attachment Procedure (LANAP). Eight patients with advanced periodontitis were enrolled and treated with full-mouth LANAP therapy and monitored for 9 months. Fullmouth clinical measurements, including clinical attachment level (CAL), probing depth (PD), and recession, were provided at baseline and after 9 months of healing by a single calibrated examiner, including a total of 930 sites and 444 sites with initial PD equal to or greater than 5 mm. Clinical results for the 930 sites measured pre- and postoperatively revealed that mean PD was reduced from 4.62 ± 2.29 mm to 3.14 ± 1.48 mm after 9 months (P < .05). CAL decreased from 5.58 ± 2.76 mm to 4.66 ± 2.10 mm (P < .05) and recession increased from 0.86 ± 1.31 mm to 1.52 ± 1.62 after 9 months (P < .05). For the subset of 444 sites with initial PD greater than or equal to 5 mm, the PD decreased from 6.50 ± 2.07 mm to 3.92 ± 1.54 mm (P < .05) and CAL decreased from 7.42 ± 2.70 mm to 5.78 ± 2.06 mm (P < .05). As demonstrated by the clinical evaluation, the majority of treated sites demonstrated clinical improvement. LANAP therapy should be further investigated with long-term clinical trials to compare the stability of clinical results with conventional therapy. PMID:24396837

  15. Etiology of Cellulitis and Clinical Prediction of Streptococcal Disease: A Prospective Study

    PubMed Central

    Bruun, Trond; Oppegaard, Oddvar; Kittang, Bård R.; Mylvaganam, Haima; Langeland, Nina; Skrede, Steinar

    2016-01-01

    Background. The importance of bacteria other than group A streptococci (GAS) in different clinical presentations of cellulitis is unclear, commonly leading to treatment with broad-spectrum antibiotics. The aim of this study was to describe the etiological and clinical spectrum of cellulitis and identify clinical features predicting streptococcal etiology. Methods. We prospectively enrolled 216 patients hospitalized with cellulitis. Clinical details were registered. Bacterial culture was performed from blood, cutaneous or subcutaneous tissue, and/or swabs from skin lesions. Paired serum samples were analyzed for anti-streptolysin O and anti-deoxyribonuclease B antibodies. Results. Serology or blood or tissue culture confirmed β-hemolytic streptococcal (BHS) etiology in 72% (146 of 203) of cases. An additional 13% (27 of 203) of cases had probable BHS infection, indicated by penicillin response or BHS cultured from skin swabs. β-hemolytic streptococcal etiology was predominant in all clinical subgroups, including patients without sharply demarcated erythema. β-hemolytic group C or G streptococci (GCS/GGS) were more commonly isolated than GAS (36 vs 22 cases). This predominance was found in the lower extremity infections. Group C or G streptococci in swabs were associated with seropositivity just as often as GAS. Staphylococcus aureus was cultured from swabs as a single pathogen in 24 cases, 14 (64%) of which had confirmed BHS etiology. Individual BHS-associated clinical characteristics increased the likelihood of confirmed BHS disease only slightly; positive likelihood ratios did not exceed 2.1. Conclusions. β-hemolytic streptococci were the dominating cause of cellulitis in all clinical subgroups and among cases with S aureus in cutaneous swabs. Group C or G streptococci were more frequently detected than GAS. No single clinical feature substantially increased the probability of confirmed BHS etiology. PMID:26734653

  16. Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP.

    PubMed

    Williams, William N; Seagle, M Brent; Pegoraro-Krook, Maria Ines; Souza, Telma V; Garla, Luis; Silva, Marcos L; Machado Neto, José S; Dutka, Jeniffer C R; Nackashi, John; Boggs, Steve; Shuster, Jonathan; Moorhead, Jacquelyn; Wharton, William; Graciano, Maria I G; Pimentel, Maria C; Feniman, Mariza; Piazentin-Penna, Silvia H A; Kemker, Joseph; Zimmermann, Maria C; Bento-Gonçalvez, Cristina; Borgo, Hilton; Marques, Ilza L; Martinelli, Angela P M C; Jorge, José C; Antonelli, Patrick; Neves, Josiane F A; Whitaker, Melina E

    2011-02-01

    The goal of this prospective randomized clinical trial was to compare 2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae. The 2 cohorts are randomized to undergo either a conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure. A prospective 2 × 2 × 2 factorial clinical trial was used in which each subject was randomly assigned to 1 of 8 different groups: 1 of 2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow), and 1 of 2 different ages at time of palatal surgery (9-12 months vs. 15-18 months). All surgeries were performed by the same 4 surgeons. A cul-de-sac test of hypernasality and a mirror test of nasal air emission were selected as primary outcome measures for velopharyngeal function. Both a surgeon and speech pathologist examined patients for the presence of palatal fistulae. In this study, the Furlow double-opposing Z-palatoplasty resulted in significantly better velopharyngeal function for speech than the von Langenbeck procedure as determined by the perceptual cul-de-sac test of hypernasality. Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck. Fistulas were more likely to occur in patients with wider clefts and when relaxing incisions were not used. PMID:21042188

  17. Clinical Results of a Pilot Study on Stereovision-Guided Stereotactic Radiotherapy and Intensity Modulated Radiotherapy

    PubMed Central

    Li, Shidong; Kleinberg, Lawrence R.; Rigamonti, Daniele; Wharam, Moody D.; Rashid, Abdul; Jackson, Juan; Djajaputra, David; He, Shenjen; Creasey, Tunisia; DeWeese, Theodore L.

    2011-01-01

    Real-time stereovision-guidance has been introduced for efficient and convenient fractionated stereotactic radiotherapy (FSR) and image-guided intensity-modulated radiation therapy (IMRT). This first pilot study is to clinically evaluate its accuracy and precision as well as impact on treatment doses. Sixty-one FSR patients wearing stereotactic masks (SMs) and nine IMRT patients wearing flexible masks (FMs), were accrued. Daily target reposition was initially based-on biplane-radiographs and then adjusted in six degrees of freedom under real-time stereovision guidance. Mean and standard deviation of the head displacements measured the accuracy and precision. Head positions during beam-on times were measured with real-time stereovisions and used for determination of delivered doses. Accuracy ± precision in direction with the largest errors shows improvement from 0.4 ± 2.3 mm to 0.0 ± 1.0 mm in the inferior-to-superior direction for patients wearing SM or from 0.8 ± 4.3 mm to 0.4 ± 1.7 mm in the posterior-to-anterior direction for patients wearing FM. The image-guidance increases target volume coverage by >30% for small lesions. Over half of head position errors could be removed from the stereovision-guidance. Importantly, the technique allows us to check head position during beam-on time and makes it possible for having frameless head refixation without tight masks. PMID:21070083

  18. A Pilot Clinical Study of Olfactory Mucosa Autograft for Chronic Complete Spinal Cord Injury

    PubMed Central

    IWATSUKI, Koichi; TAJIMA, Fumihiro; OHNISHI, Yu-ichiro; NAKAMURA, Takeshi; ISHIHARA, Masahiro; HOSOMI, Koichi; NINOMIYA, Koshi; MORIWAKI, Takashi; YOSHIMINE, Toshiki

    2016-01-01

    Recent studies of spinal cord axon regeneration have reported good long-term results using various types of tissue scaffolds. Olfactory tissue allows autologous transplantation and can easily be obtained by a simple biopsy that is performed through the external nares. We performed a clinical pilot study of olfactory mucosa autograft (OMA) for chronic complete spinal cord injury in eight patients according to the procedure outlined by Lima et al. Our results showed no serious adverse events and improvement in both the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade and ASIA motor score in five patients. The preoperative post-rehabilitation ASIA motor score improved from 50 in all cases to 52 in case 2, 60 in case 4, 52 in case 6, 55 in case 7, and 58 in case 8 at 96 weeks after OMA. The AIS improved from A to C in four cases and from B to C in one case. Motor evoked potentials (MEPs) were also seen in one patient, reflecting conductivity in the central nervous system, including the corticospinal tract. The MEPs induced with transcranial magnetic stimulation allow objective assessment of the integrity of the motor circuitry comprising both the corticospinal tract and the peripheral motor nerves.We show the feasibility of OMA for chronic complete spinal cord injury. PMID:27053327

  19. A pilot test of WebOSCE: a system for assessing trainees' clinical skills via teleconference.

    PubMed

    Novack, Dennis H; Cohen, Diane; Peitzman, Steven J; Beadenkopf, Scott; Gracely, Ed; Morris, John

    2002-09-01

    WebOSCE is a computer-based system that allows a student at an affiliate site to participate in a 10-station standardized patient-based exam using a videoconference interface, while nine other students take the exam on-site. We pilot-tested this system during a required year-end objective structured clinical exam. We compared performance data between the 26 distance students taking the exam via WebOSCE with 221 on-site students. We also compared both student groups' responses on a post-exam questionnaire, and conducted a post-exam structured interview to elicit the Pittsburgh students' perspectives on the WebOSCE experience. Students taking the exam via WebOSCE scored significantly lower in most categories except for physical exam and information-giving skills, on which the groups did not differ. There were no differences between groups in students' overall evaluation of the exam experiences. In general, Pittsburgh students rated WebOSCE highly and offered many helpful comments to improve the technology and the experience. PMID:12474813

  20. Cardiovascular medicine at face value: a qualitative pilot study on clinical axiology

    PubMed Central

    2013-01-01

    Introduction Cardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter. Results We point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education. Conclusion We establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion. PMID:23531271

  1. Laser speckle contrast imaging of cerebral blood flow in humans during neurosurgery: a pilot clinical study

    NASA Astrophysics Data System (ADS)

    Parthasarathy, Ashwin B.; Weber, Erica L.; Richards, Lisa M.; Fox, Douglas J.; Dunn, Andrew K.

    2010-11-01

    Monitoring cerebral blood flow (CBF) during neurosurgery can provide important physiological information for a variety of surgical procedures. CBF measurements are important for assessing whether blood flow has returned to presurgical baseline levels and for assessing postsurgical tissue viability. Existing techniques for intraoperative monitoring of CBF based on magnetic resonance imaging are expensive and often impractical, while techniques such as indocyanine green angiography cannot produce quantitative measures of blood flow. Laser speckle contrast imaging (LSCI) is an optical technique that has been widely used to quantitatively image relative CBF in animal models in vivo. In a pilot clinical study, we adapted an existing neurosurgical operating microscope to obtain LSCI images in humans in real time during neurosurgery under baseline conditions and after bipolar cautery. Simultaneously recorded ECG waveforms from the patient were used to develop a filter that helped reduce measurement variabilities due to motion artifacts. Results from this study demonstrate the feasibility of using LSCI to obtain blood flow images during neurosurgeries and its capability to produce full field CBF image maps with excellent spatial resolution in real-time with minimal disruption to the surgical procedure.

  2. A Pilot Clinical Study of Olfactory Mucosa Autograft for Chronic Complete Spinal Cord Injury.

    PubMed

    Iwatsuki, Koichi; Tajima, Fumihiro; Ohnishi, Yu-Ichiro; Nakamura, Takeshi; Ishihara, Masahiro; Hosomi, Koichi; Ninomiya, Koshi; Moriwaki, Takashi; Yoshimine, Toshiki

    2016-06-15

    Recent studies of spinal cord axon regeneration have reported good long-term results using various types of tissue scaffolds. Olfactory tissue allows autologous transplantation and can easily be obtained by a simple biopsy that is performed through the external nares. We performed a clinical pilot study of olfactory mucosa autograft (OMA) for chronic complete spinal cord injury in eight patients according to the procedure outlined by Lima et al. Our results showed no serious adverse events and improvement in both the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade and ASIA motor score in five patients. The preoperative post-rehabilitation ASIA motor score improved from 50 in all cases to 52 in case 2, 60 in case 4, 52 in case 6, 55 in case 7, and 58 in case 8 at 96 weeks after OMA. The AIS improved from A to C in four cases and from B to C in one case. Motor evoked potentials (MEPs) were also seen in one patient, reflecting conductivity in the central nervous system, including the corticospinal tract. The MEPs induced with transcranial magnetic stimulation allow objective assessment of the integrity of the motor circuitry comprising both the corticospinal tract and the peripheral motor nerves.We show the feasibility of OMA for chronic complete spinal cord injury. PMID:27053327

  3. Stress perceptions in community clinic: a pilot survey of patients and physicians.

    PubMed

    Goodrick, G Ken; Kneuper, Suzanne; Steinbauer, Jeffrey R

    2005-04-01

    This pilot survey of 103 patients and 17 physicians in an urban family medicine clinic gathered information pertinent to the design of a feasible stress intervention for patients bothered by stress, but who did not have a psychiatric diagnosis. Among patients, 45% reported being excessively bothered by stress in the preceding month, with the chief stressors being job (70% reporting), financial worries (58%) and family concerns (50%). Patients reported a variety of problems perceived to be related to stress, such as headaches, insomnia, eating control, and gastrointestinal symptoms. Although about 80% reported using positive coping methods (e.g., talking, exercising, and relaxing), 42% reported using alcohol, and 10% used non-prescribed drugs to cope with stress. Only 37% of patients had sought help for stress from their physician. The wide variety of responses from the physicians reflected a lack of standardized approaches, inadequate training, and a reluctance to engage patients about their stress problems. About 42% of the physicians reported routinely asking patients about stress, and 77% felt that dealing with patient stress was a significant burden on their practice of medicine. Overall, the findings indicate that opportunities are being missed for helping patients to deal with stress constructively, and that a standardized stress self-management program might be one solution. PMID:15810562

  4. Half-molar sodium lactate infusion improves cardiac performance in acute heart failure: a pilot randomised controlled clinical trial

    PubMed Central

    2014-01-01

    Introduction Acute heart failure (AHF) is characterized by inadequate cardiac output (CO), congestive symptoms, poor peripheral perfusion and end-organ dysfunction. Treatment often includes a combination of diuretics, oxygen, positive pressure ventilation, inotropes and vasodilators or vasopressors. Lactate is a marker of illness severity but is also an important metabolic substrate for the myocardium at rest and during stress. We tested the effects of half-molar sodium lactate infusion on cardiac performance in AHF. Methods We conducted a prospective, randomised, controlled, open-label, pilot clinical trial in 40 patients fulfilling two of the following three criteria for AHF: (1) left ventricular ejection fraction <40%, (2) acute pulmonary oedema or respiratory failure of predominantly cardiac origin requiring mechanical ventilation and (3) currently receiving vasopressor and/or inotropic support. Patients in the intervention group received a 3 ml/kg bolus of half-molar sodium lactate over the course of 15 minutes followed by 1 ml/kg/h continuous infusion for 24 hours. The control group received only a 3 ml/kg bolus of Hartmann’s solution without continuous infusion. The primary outcome was CO assessed by transthoracic echocardiography 24 hours after randomisation. Secondary outcomes included a measure of right ventricular systolic function (tricuspid annular plane systolic excursion (TAPSE)), acid-base balance, electrolyte and organ function parameters, along with length of stay and mortality. Results The infusion of half-molar sodium lactate increased (mean ± SD) CO from 4.05 ± 1.37 L/min to 5.49 ± 1.9 L/min (P < 0.01) and TAPSE from 14.7 ± 5.5 mm to 18.3 ± 7 mm (P = 0.02). Plasma sodium and pH increased (136 ± 4 to 146 ± 6 and 7.40 ± 0.06 to 7.53 ± 0.03, respectively; both P < 0.01), but potassium, chloride and phosphate levels decreased. There were no significant differences in the need for

  5. The relevance of clinical and radiographic features of jaw lesions: A prospective study.

    PubMed

    Araujo, Juliane Piragine; Lemos, Celso Augusto; Miniello, Thais Gimenez; Alves, Fabio Abreu

    2016-01-01

    The study was carried out in a Brazilian population and the aim was to describe the prevalence and the clinic-radiographical features of jaw lesions. In addition, a comparison between the main diagnosis hypothesis and final diagnosis was accessed. A prospective study which evaluated all patients with jaw lesions diagnosed in an Oral Diagnosis Center, between August 2013 and October 2014. A total of 450 patients were observed for the first time, and 130 had some type of jaw lesion. The mean age of the patients was 35.2 years ± 17.86. Among these, 71 were women (54.62%) and 87 were Caucasian (66.92%). The mandible was affected more frequently (71.43%) than the maxilla (28.57%). Swelling and pain were the most frequent clinical signs and symptoms and were observed in 60 (42.85%) and 38 (27.14%) cases, respectively. The panoramic x-ray was the main radiographic exam utilized (88.57%). Radiolucent lesions accounted for 89 cases (63.57%) and the unilocular form was present in 114 cases (81.43%). A total of 93 cases had histopathological analyses and the periapical cyst was the most frequent lesion. In the other 47 lesions, the diagnosis was conducted by clinical and radiographic management. Bone lesions were frequent, being noted on first visit in approximately 30% of patients; in 1/3 of the cases, the diagnoses were completed with a combination of clinical and radiographic exams. PMID:27556683

  6. [Anterior cervical fusion with tantalum interbody implants. Clinical and radiological results in a prospective study].

    PubMed

    Vicario, C; Lopez-Oliva, F; Sánchez-Lorente, T; Zimmermann, M; Asenjo-Siguero, J J; Ladero, F; Ibarzábal, A

    2006-04-01

    Anterior cervical discectomy and interbody fusion (ACDF) is a widely accepted surgical technique in the treatment of cervical disc disease. Tantalum cages have been recently introduced in spine surgery for interbody fusion because of the advantages of their mechanical properties. We present the results of a prospective clinical and radiological study on 24 consecutive patients who underwent an ACDF with tantalum cages. Clinical evaluation was assessed preoperatively and after surgery by a questionnaire that included a Visual Analogic Scale (VAS) of neck and arm pain, the Oswestry Disability Index and the Zung Depression Scale. Results were classified by Odom's criteria. Radiological evaluation included flexion-extension X-rays, and changes in distance between spinous processes and Cobb angle were measured. Postoperatively patients were reviewed 3 and 12 months after surgery. A statistical significative improvement in all clinical data was reported. According to Odom's criteria in 75% of patients the results were considered like excellent or good. Only one case of radiological and clinical pseudoarthrosis was confirmed. No significative differences were reported 3 and 12 months after surgery. Tantalum cages are a very promising and usefull alternative among implants available for ACDF. Compatibility with MRI postoperative studies and the unnecessariness of autograft are some of their advantages. PMID:16721480

  7. Three approaches to use of questioning by clinical lecturers: a pilot study.

    PubMed

    Giddings, L S; Dyson, L C; Entwistle, M J; Macdiarmid, R; Marshall, D C; Simpson, S M

    2000-03-01

    In the current health care climate nurses require very good problem solving and critical thinking skills. Questioning as a teaching strategy is viewed as one way to promote such student learning. Using a comparative descriptive quantitative and a qualitative approach, this pilot study investigated the types of questions asked of students by lecturers working within the preceptorship model in the clinical setting. A convenience sample of five volunteer nursing lecturers were tape recorded during their interactions with undergraduate students (n = 8). Initially two auditing approaches were used to analyse the interview data: relevant parts of Mogan and Warbinek's (1994) Observation of Nursing Teachers in Clinical Settings instrument (ONTICS Tool) and Craig and Page's (1981) conceptual framework as adapted by Sellappah, Hussey, Blackmore and McMurray (1998). The data were further analysed by qualitative content analysis. This study supported the findings of the ONTICS tool and Sellappah et al's framework that teachers asked predominantly directive style and low level questions. What the two approaches did not adequately capture was the complexity of the lecturers' questioning behaviours or the effects of contextual factors. The content analysis process however, identified three broad categories forming a model that effectively integrated aspects of the context of the lecturer/student interaction. It also represented lecturer questioning behaviours more comprehensively. The preliminary model offered has the potential to highlight the importance of lecturers asking questions that lead students to extend their thinking about practice. It could also contribute to student learning by assisting lecturers to understand the value and critical nature of their questioning and serve as a framework for staff development. PMID:11221306

  8. A clinical pilot study of lignin--ascorbic acid combination treatment of herpes simplex virus.

    PubMed

    Lopez, Blanca Silvia Gonzalez; Yamamoto, Masaji; Utsumi, Katsuaki; Aratsu, Chiaki; Sakagami, Hiroshi

    2009-01-01

    Antiviral drugs as well as natural remedies have been used to reduce symptoms and the rate of recurrences of herpes simplex virus type 1 (HSV-1) infection, a common disease. To evaluate anti-HSV-1 activity of a pine cone lignin and ascorbic acid treatment, a clinical pilot study was carried out. Forty-eight healthy patients of both genders between 4 and 61 years old (mean: 31+/-16 years), with active lesions of HSV-1, took part in the study. According to the HSV-1 stage at the presentation, the patients were classified into the prodromic (16 patients), erythema (11 patients), papule edema (1 patient), vesicle/pustule (13 patients) and ulcer stages (7 patients). One mg of lignin-ascorbic acid tablet or solution was orally administered three times daily for a month. Clinical evaluations were made daily the first week and at least three times a week during the second week after the onset and every six months during the subsequent year to identify recurrence episodes. The patients who began the lignin-ascorbic acid treatment within the first 48 hours of symptom onset did not develop HSV-1 characteristic lesions, whereas those patients who began the treatment later experienced a shorter duration of cold sore lesions and a decrease in the symptoms compared with previous episodes. The majority of the patients reported the reduction in the severity of symptoms and the reduction in the recurrence episodes after the lignin-ascorbic acid treatment compared with previous episodes, suggesting its possible applicability for the prevention and treatment of HSV-1 infection. PMID:20023248

  9. Evaluating a Community-Partnered Cancer Clinical Trials Pilot Intervention with African American Communities

    PubMed Central

    Green, Melissa A.; Michaels, Margo; Blakeney, Natasha; Odulana, Adebowale A.; Isler, Malika Roman; Richmond, Alan; Long, Debra G.; Robinson, William S.; Taylor, Yhenneko J.; Corbie-Smith, Giselle

    2015-01-01

    Objectives Cancer Clinical Trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awareness and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Design Four community organizations completed Community Bridges to CCTs training-of-the trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs; a role-play describing one person's experience with CCTs; or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Results Trainers enrolled 125 participants in the Call and Response (n=22), Role-play (n=60), and Workshop (n=43) modules. Module participants were mostly African American, female, and mean age of 53 years. Comparison of pre and post-test responses demonstrates favorable changes in awareness of CCTs and where to access to CCTs across the sample. Analysis by module type indicates significant increases for participants in the Call and Response (p < 0.01) and Role-Play modules (p < 0.001), but not the Workshop module. Conclusion Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment. PMID:25564207

  10. Pre-clinical and clinical experiences with novel somatostatin ligands: advantages, disadvantages and new prospects.

    PubMed

    Hofland, L J; van der Hoek, J; Feelders, R; van der Lely, A J; de Herder, W; Lamberts, S W J

    2005-01-01

    Since the cloning and characterization of the five human somatostatin receptor (SSTR) subtypes, our understanding of the expression and functional role of the five SSTR subtypes in human (neuro-)endocrine tumors has increased significantly. The majority of human (neuro-)endocrine tumors express multiple SSTR. GH-secreting pituitary adenomas preferentially express SSTR2 and SSTR5, prolactinomas SSTR1 and SSTR5, and corticotroph adenomas express SSTR2 (low number) and predominantly SSTR5s. In addition, gastroenteropancreatic (GEP) neuroendocrine tumors frequently express multiple SSTR as well, with SSTR2 being expressed at the highest level. Treatment with the current generation of octapeptide somatostatin-analogs, e.g. octreotide and lanreotide, normalizes circulating GH- and IGF-I levels in approximately 60-70% of acromegalic patients, thereby remaining about one-third of patients uncontrolled. In patients with GEP neuroendocrine tumors, both somatostatin-analogs effectively suppress the production of bioactive peptides and hormones by the tumor cells, resulting in an important improvement of the related clinical symptomatology. However, a considerable proportion of patients experience an escape from treatment within months to several years. Altogether, the current generation of somatostatin analogs are effective medical tools in the treatment of acromegalic patients and of patients with neuroendocrine GEP tumors, but there is certainly a need for novel somatostatin analogs. In recent years, a significant number of novel somatostatin-ligands has been developed. These ligands include SSTR selective-, bi-specific, universal, as well as chimeric dopamine (DA)-somatostatin ligands. In vitro studies using human pituitary adenoma cells demonstrate a more profound inhibition of GH, PRL and ACTH secretion by somatostatin-analogs targeting both SSTR2s and SSTR5s, compared with SSTR2-preferential somatostatin-analogs. This likely reflects the SSTR subtype expression pattern

  11. The clinical outcomes of chronic hepatitis C in South Korea: A prospective, multicenter cohort study.

    PubMed

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-08-01

    This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region.From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival.During the median follow-up of 39.0 months (range 18.0-81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 10/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002).The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  12. Clinical pilot study: efficacy of triple antibiotic therapy in Blastocystis positive irritable bowel syndrome patients

    PubMed Central

    2014-01-01

    Background Blastocystis species are common human enteric parasites. Carriage has been linked to Irritable Bowel Syndrome (IBS). Treatment of Blastocystis spp. with antimicrobials is problematic and insensitive diagnostic methods and re-infection complicate assessment of eradication. We investigated whether triple antibiotic therapy comprising diloxanide furoate, trimethoprim/sulfamethoxazole and secnidazole (TAB) given to diarrhoea-predominant IBS (D-IBS) patients positive for Blastocystis would achieve eradication. Methods In a longitudinal, prospective case study 10 D-IBS Blastocystis-positive patients took 14 days of diloxanide furoate 500 mg thrice daily, trimethoprim/sulfamethoxazole 160/80 mg twice daily and secnidazole 400 mg thrice daily. Faecal specimens were collected at baseline, day 15 and 4 weeks after completion of TAB. Specimens were analysed using faecal smear, culture and polymerase chain reaction (PCR) of the 16 SSU rRNA. Patients kept a concurrent clinical diary. Results Six (60%) patients cleared Blastocystis spp. after TAB, including three who had failed previous therapy. Subtypes detected were ST3 (60%), ST4 (40%), ST1 (20%) and ST7, 8 (10%); four patients had mixed ST infections. Serum immunoglobulin A (IgA) levels were low in 40% of patients. Higher rates of Blastocystis clearance were observed in patients symptomatic for less than a year (Mann–Whitney, p = 0.032, 95% confidence) with no associations found with age, previous antibiotic therapy, faecal parasite load, ST, IgA level or clinical improvement. Conclusions Clearance of Blastocystis spp. was achieved with TAB in 60% of D-IBS patients, an improvement over conventional monotherapy. Higher clearance rates are needed to facilitate investigation of the relevance of this parasite in clinically heterogenous IBS. PMID:25349629

  13. Prospective Study on the Clinical Course and Outcomes in Transfusion-Related Acute Lung Injury

    PubMed Central

    Looney, Mark R.; Roubinian, Nareg; Gajic, Ognjen; Gropper, Michael A.; Hubmayr, Rolf D.; Lowell, Clifford A.; Bacchetti, Peter; Wilson, Gregory; Koenigsberg, Monique; Lee, Deanna C.; Wu, Ping; Grimes, Barbara; Norris, Philip J.; Murphy, Edward L.; Gandhi, Manish J.; Winters, Jeffrey L.; Mair, David C.; Schuller, Randy M.; Hirschler, Nora V.; Rosen, Rosa Sanchez; Matthay, Michael A.; Toy, Pearl

    2014-01-01

    Objective Transfusion-related acute lung injury is the leading cause of transfusion-related mortality. A prospective study using electronic surveillance was conducted at two academic medical centers in the United States with the objective to define the clinical course and outcomes in transfusion-related acute lung injury cases. Design Prospective case study with controls. Setting University of California, San Francisco and Mayo Clinic, Rochester. Patients We prospectively enrolled 89 patients with transfusion-related acute lung injury, 164 transfused controls, and 145 patients with possible transfusion-related acute lung injury. Interventions None. Measurements and Main Results Patients with transfusion-related acute lung injury had fever, tachycardia, tachypnea, hypotension, and prolonged hypoxemia compared with controls. Of the patients with transfusion-related acute lung injury, 29 of 37 patients (78%) required initiation of mechanical ventilation and 13 of 53 (25%) required initiation of vasopressors. Patients with transfusion-related acute lung injury and possible transfusion-related acute lung injury had an increased duration of mechanical ventilation and increased days in the ICU and hospital compared with controls. There were 15 of 89 patients with transfusion-related acute lung injury (17%) who died, whereas 61 of 145 patients with possible transfusion-related acute lung injury (42%) died and 7 of 164 of controls (4%) died. Patients with transfusion-related acute lung injury had evidence of more systemic inflammation with increases in circulating neutrophils and a decrease in platelets compared with controls. Patients with transfusion-related acute lung injury and possible transfusion-related acute lung injury also had a statistically significant increase in plasma interleukin-8, interleukin-10, and interleukin-1 receptor antagonist posttransfusion compared with controls. Conclusions In conclusion, transfusion-related acute lung injury produced a condition

  14. Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

    PubMed Central

    Eslami, Mohammad H.; Doros, Gheorghe; Goodney, Philip P.; Elderup-Jorgenson, Jens; Cronenwett, Jack L.; Malikova, Marina; Farber, Alik

    2014-01-01

    Background We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters’ prospective trials on very modest budget. Methods VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event–free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Conclusions Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates. PMID:25311746

  15. Second Community Pilot Project Programme: Transition of Young People from School to Adult and Working Life: Results and Prospects. Dossier.

    ERIC Educational Resources Information Center

    Eurydice News, 1987

    1987-01-01

    During 1983-87 the Commission of the European Communities helped fund 30 pilot projects that were intended to help young people aged 14-18 make the transition from school to work in 10 member states. The objective of these projects was to use local initiative to identify and develop innovative solutions to the problems facing young people. The…

  16. Heart rate, anxiety and performance of residents during a simulated critical clinical encounter: a pilot study

    PubMed Central

    2014-01-01

    Background High-fidelity patient simulation has been praised for its ability to recreate lifelike training conditions. The degree to which high fidelity simulation elicits acute emotional and physiologic stress among participants – and the influence of acute stress on clinical performance in the simulation setting – remain areas of active exploration. We examined the relationship between residents’ self-reported anxiety and a proxy of physiologic stress (heart rate) as well as their clinical performance in a simulation exam using a validated assessment of non-technical skills, the Ottawa Crisis Resource Management Global Rating Scale (Ottawa GRS). Methods This was a prospective observational cohort study of emergency medicine residents at a single academic center. Participants managed a simulated clinical encounter. Anxiety was assessed using a pre- and post-simulation survey, and continuous cardiac monitoring was performed on each participant during the scenario. Performance in the simulation scenario was graded by faculty raters using a critical actions checklist and the Ottawa GRS instrument. Results Data collection occurred during the 2011 academic year. Of 40 eligible residents, 34 were included in the analysis. The median baseline heart rate for participants was 70 beats per minute (IQR: 62 – 78). During the simulation, the median maximum heart rate was 140 beats per minute (IQR: 137 – 151). The median minimum heart rate during simulation was 81 beats per minute (IQR: 72 – 92), and mean heart rate was 117 beats per minute (95% CI: 111 – 123). Pre- and post-simulation anxiety scores were equal (mean 3.3, IQR: 3 to 4). The minimum and maximum Overall Ottawa GRS scores were 2.33 and 6.67, respectively. The median Overall score was 5.63 (IQR: 5.0 to 6.0). Of the candidate predictors of Overall performance in a multivariate logistic regression model, only PGY status showed statistical significance (P = 0.02). Conclusions Simulation is associated

  17. Affective dysregulation and reality distortion: a 10-year prospective study of their association and clinical relevance.

    PubMed

    van Rossum, Inge; Dominguez, Maria-de-Gracia; Lieb, Roselind; Wittchen, Hans-Ulrich; van Os, Jim

    2011-05-01

    Evidence from clinical patient populations indicates that affective dysregulation is strongly associated with reality distortion, suggesting that a process of misassignment of emotional salience may underlie this connection. To examine this in more detail without clinical confounds, affective regulation-reality distortion relationships, and their clinical relevance, were examined in a German prospective cohort community study. A cohort of 2524 adolescents and young adults aged 14-24 years at baseline was examined by experienced psychologists. Presence of psychotic experiences and (hypo)manic and depressive symptoms was assessed at 2 time points (3.5 and up to 10 years after baseline) using the Munich-Composite International Diagnostic Interview. Associations were tested between level of affective dysregulation on the one hand and incidence of psychotic experiences, persistence of these experiences, and psychotic Impairment on the other. Most psychotic experiences occurred in a context of affective dysregulation, and bidirectional dose-response was apparent with greater level of both affective dysregulation and psychotic experiences. Persistence of psychotic experiences was progressively more likely with greater level of (hypo)manic symptoms (odds ratio [OR] trend=1.51, P<.001) and depressive symptoms (OR trend=1.15, P=.012). Similarly, psychotic experiences of clinical relevance were progressively more likely to occur with greater level of affective dysregulation (depressive symptoms: OR trend=1.28, P=.002; (hypo)manic symptoms: OR trend=1.37, P=.036). Correlated genetic liabilities underlying affective and nonaffective psychotic syndromes may be expressed as correlated dimensions in the general population. Also, affective dysregulation may contribute causally to the persistence and clinical relevance of reality distortion, possibly by facilitating a mechanism of aberrant salience attribution. PMID:19793794

  18. A Systemic Review on Aloe arborescens Pharmacological Profile: Biological Activities and Pilot Clinical Trials.

    PubMed

    Singab, Abdel-Naser B; El-Hefnawy, Hala M; Esmat, Ahmed; Gad, Haidy A; Nazeam, Jilan A

    2015-12-01

    Since ancient times, plants and herbal preparations have been used as medicine. Research carried out in the last few decades has verified several such claims. Aloe arborescens Miller, belonging to the Aloe genus (Family Asphodelaceae), is one of the main varieties of Aloe used worldwide. The popularity of the plant in traditional medicine for several ailments (antitumor, immunomodulatory, antiinflammatory, antiulcer, antimicrobial and antifungal activity) focused the investigator's interest on this plant. Most importantly, the reported studies have shown the plant effectiveness on various cancer types such as liver, colon, duodenal, skin, pancreatic, intestinal, lung and kidney types. These multiple biological actions make Aloe an important resource for developing new natural therapies. However, the biological activities of isolated compounds such as glycoprotein, polysaccharides, enzyme and phenolics were insufficient. Considering all these, this contribution provides a systematic review outlining the evidence on the biological efficacy of the plant including the pharmacology and the related mechanisms of action, with specific attention to the various safety precautions, and preclinical and clinical studies, indicating the future research prospects of this plant. PMID:26768148

  19. A pilot randomized clinical trial evaluating the impact of genetic counseling for serious mental illnesses

    PubMed Central

    Hippman, Catriona; Ringrose, Andrea; Inglis, Angela; Cheek, Joanna; Albert, Arianne Y. K.; Remick, Ronald; Honer, William G.; Austin, Jehannine C

    2016-01-01

    Objective The serious mental illnesses schizophrenia, schizoaffective disorder, and bipolar disorder are complex conditions affecting 1–4% of the population. Individuals with serious mental illnesses express interest in genetic counseling; an intervention showing promise for increasing patient knowledge and adaptation. This trial aimed to evaluate the effects of genetic counseling for people with serious mental illnesses as compared to an educational intervention or waitlist. Methods A pilot three-arm (each n=40; genetic counseling, a control intervention involving an educational booklet, or waitlist), parallel group, randomized clinical trial was conducted from September 2008–November 2011 in Vancouver, Canada. Participants with schizophrenia, bipolar disorder, or schizoaffective disorder (DSM-IV) completed outcome measures assessing knowledge, risk perception, internalized stigma, and perceived control over illness at baseline and one-month follow-up. The Brief Symptom Inventory was administered to control for current symptoms. Analyses included linear mixed effects models and chi-squared tests. Results Knowledge increased for genetic counseling/educational booklet compared to waitlist at follow-up (LRT=19.33, df=1, Holm-adjusted p=0.0003, R2LMM(m)=0.17). Risk perception accuracy increased at follow-up for genetic counseling compared to waitlist (Yates’ continuity corrected χ2=9.1, df=1, Bonferroni p=0.003) and educational booklet (Yates’ continuity corrected χ2=8.2, df=1, Bonferroni p=0.004). There were no significant differences between groups for stigma or perceived control scores. Conclusions Genetic counseling and the educational booklet improved knowledge; and genetic counseling, but not the educational booklet, improved risk perception accuracy for this population. The impact of genetic counseling on internalized stigma and perceived control is worth further investigation. Genetic counseling should be considered for patients with serious mental

  20. Clinical holistic medicine: pilot study on the effect of vaginal acupressure (Hippocratic pelvic massage).

    PubMed

    Ventegodt, Søren; Clausen, Birgitte; Merrick, Joav

    2006-01-01

    This is a pilot study of 20 female patients with a long history of sexual problems (mean is 8.92 years) who received vaginal acupressure (VA) with a quantitative and qualitative evaluation: 56% experienced help and none reported setbacks, 89% rated the treatment to be of high quality, and 89% rated it as valuable. After the treatment, most reported their problems to be less serious and their general quality of life improved. Only 17% reported minor or temporary side effects. VA was found statistically and clinically significant (p < 0.05, improvement more than 0.5 step on a 5-point Likert scale) to help patients with chronic genital pains, pain or discomfort during sexual intercourse, lack of desire or orgasm, and subjective sexual insufficiency, and all patients taken as one group (about 1 step up a 5-point Likert scale). Self-evaluated physical and mental health was significantly improved for the total group; the relationship with partner, the subjective sexual ability, and the quality of life that were measured with QOL1 and QOL5 questionnaires were all significantly improved. VA or Hippocratic pelvic massage is technically a simple procedure corresponding to the explorative phase of the standard pelvic examination, supplemented with the patient's report on the feelings provoked followed by processing and integration of these feelings, but ethical aspects are complicated. Acupressure through the vagina/pelvic massage must be done according to the highest ethical standard with great care, after obtaining consent and the necessary trust of the patient within the framework of the local laws. It must be followed by conversational therapy and further holistic existential processing. PMID:17370006

  1. Optical detection of breast cancer: a pilot clinical trial at the Massachusetts General Hospital

    NASA Astrophysics Data System (ADS)

    Cheng, Xuefeng; Mao, Jian M.; Zhu, Wen; Bush, Robin; Kopans, Daniel B.; Moore, Richard H.; Chorlton, Maryann

    2003-06-01

    X-ray mammography has been the major imaging modality in breast cancer detection for years, despite its high false diagnosis rate for malignant tumors and harmful radiation. In the last decade, optical imaging has been emerging as a promising method for breast cancer detection. Using near infrared (NIR) light ranging from 690 nm to 900 nm, an optical device can measure functional properties of breast tissue, such as total hemoglobin concentration (HbT) and oxygen saturation (SO2). Cancers tend to have higher levels of HbT because of their greater vascularization, and lower SO2 because of greater oxygen consumption, than normal tissue. Thus the NIR technology could be useful in breast cancer detection. In addition, optical detection is totally noninvasive and safe, and can be low cost. Photonify Technologies Inc. has developed an optical device for real-time two-dimensional mapping of HbT and SO2 in breast tissue. The device has been tested in a pilot clinical study for a group of 50 patients at the Department of Radiology of the Masachusetts General Hospital at Harvard Medical School. Preliminary results suggest that contrast-normalized standard deviations in HbT and SO2 might be good indicators for breast cancer detection. A patient may have a higher risk to have cancer in a breast portion where the normalized standard deviation in either HbT or SO2 is greater than 0.3. We demonstrate 92% diagnostic sensitivity and 66% specificity in detecting ductal carcinoma, either invasive or in situ. The device may potentially be used as an adjunctive tool with mammography to reduce unnecessary biopsies.

  2. Plasma C-Reactive Protein and Clinical Outcomes after Acute Ischemic Stroke: A Prospective Observational Study

    PubMed Central

    Matsuo, Ryu; Ago, Tetsuro; Hata, Jun; Wakisaka, Yoshinobu; Kuroda, Junya; Kuwashiro, Takahiro; Kitazono, Takanari; Kamouchi, Masahiro

    2016-01-01

    Background and Purpose Although plasma C-reactive protein (CRP) is elevated in response to inflammation caused by brain infarction, the association of CRP with clinical outcomes after acute ischemic stroke remains uncertain. This study examined whether plasma high-sensitivity CRP (hsCRP) levels at onset were associated with clinical outcomes after acute ischemic stroke independent of conventional risk factors and acute infections after stroke. Methods We prospectively included 3653 patients with first-ever ischemic stroke who had been functionally independent and were hospitalized within 24 h of onset. Plasma hsCRP levels were measured on admission and categorized into quartiles. The association between hsCRP levels and clinical outcomes, including neurological improvement, neurological deterioration, and poor functional outcome (modified Rankin scale ≥3 at 3 months), were investigated using a logistic regression analysis. Results Higher hsCRP levels were significantly associated with unfavorable outcomes after adjusting for age, sex, baseline National Institutes of Health Stroke Scale score, stroke subtype, conventional risk factors, intravenous thrombolysis and endovascular therapy, and acute infections during hospitalization (multivariate-adjusted odds ratios [95% confidence interval] in the highest quartile versus the lowest quartile as a reference: 0.80 [0.65–0.97] for neurological improvement, 1.72 [1.26–2.34] for neurological deterioration, and 2.03 [1.55–2.67] for a poor functional outcome). These associations were unchanged after excluding patients with infectious diseases occurring during hospitalization, or those with stroke recurrence or death. These trends were similar irrespective of stroke subtypes or baseline stroke severity, but more marked in patients aged <70 years (Pheterogeneity = 0.001). Conclusions High plasma hsCRP is independently associated with unfavorable clinical outcomes after acute ischemic stroke. PMID:27258004

  3. Effect of prophylactic antibiotics in acute nonperforated appendicitis: a prospective, randomized, double-blind clinical study.

    PubMed Central

    Busuttil, R W; Davidson, R K; Fine, M; Tompkins, R K

    1981-01-01

    A prospective, randomized, double-blind clinical study was performed to determined the efficacy of short-term (24 hr) perioperative antibiotics in preventing septic complications after emergency appendectomy for nonperforated appendicitis. The patients were stratified into three clinical arms: Group I (placebo, n = 45), Group II (cefamandole, n = 46) and Group III (cefamandole plus carbenicillin, n = 45). The three groups of patients were similar in regard to age, sex, duration of operation and pathologic classification of the appendix. The overall incidence of infection in the study was 5.1%. The infection rates in Groups II (2.2%) and III (0%) were significantly lower than Group I (placebo) (13.3%), (p less than 0.05). No difference was observed between cefamandole alone and cefamandole plus carbenicillin. Average postoperative hospital days per patient for each group was: Group I - 3.8 days; Group II - 2.9 days; Group III - 3.1 days. Cost analysis of hospitalization including cost of prophylactic antibiotics revealed a $247.99 per patient saving for Group II versus Group I and $95.53 for Group III versus Group I. Systemic prophylactic antibiotics can successfully reduce septic complications after appendectomy for nonperforated appendicitis, and a single drug (cefamandole) directed at the facultative pathogens is as effective as double drug therapy, which includes specific anaerobic coverage. PMID:7025769

  4. Prospective assessment of patterns, severity and clinical outcome of Indian poisoning incidents.

    PubMed

    Churi, Shobha; Ramesh, Madhan; Bhakta, Krunal; Chris, Jacob

    2012-01-01

    The objective of this study was to assess the patterns, severity and clinical outcome of poisoning incidents. A prospective assessment was conducted over a period of 1 year in tertiary-care teaching hospitals. Glasgow coma scale (GCS), poisoning severity score (PSS), and snake bite severity score (SSS) were used to predict the severity of poisoning, and then compared to the clinical outcome. The study involved 212 patients with a mean age of 26.7±12.7 years. Pesticides were found to be the most common poisoning agents. The incidents of intentional poisoning (n=178) were higher than accidental (n=34) poisoning. Poisoning incidents were higher in male population (n=132) compared to female population (n=80). The poisoning incidents were predominantly higher among literates (n=155). The poisoning incidents were higher in rural areas (n=129), followed by urban (n=53) and semi-urban (n=30) areas. The poisoning incidents were highest in the middle class population (n=108), followed by poor class (n=101) and rich class (n=3) population. A majority of patients whose severity of illness was predicted to be mild to moderate recovered from the poisoning. In contrast, patients whose illness was predicted to be severe were either discharged with severe morbidity or deceased. There was a moderate correlation between GCS and PSS scoring systems (r=0.51, p<0.001). PMID:22790818

  5. Why do patients not keep their appointments? Prospective study in a gastroenterology outpatient clinic.

    PubMed

    Murdock, A; Rodgers, C; Lindsay, H; Tham, T C K

    2002-06-01

    Unkept outpatient appointments are a drain on resources. In a prospective study we asked non-attenders at a gastroenterology clinic why they had missed their appointment. 103 patients missed their appointment (14% of the total invited); 3 had died. The remaining 100 were asked to complete questionnaires, 68 by mail (43 returned) and 32 by telephone (30 successful); the response rate was thus 73%. 49 of the respondents were new patients, 6 of them with urgent referrals. The explanations for non-attendance by the 73 patients were: forgot to attend or to cancel (30%); no reason (26%); clerical errors (10%); felt better (8%), fearful of being seen by junior doctor (3%); inpatient in another hospital (3%); miscellaneous other (20%). 13 (27%) of the review patients had not kept one or more previous appointments. The non-attendance rates for different clinics ranged from 10% to 25% (average 14%). A substantial number of non-attenders claimed to have forgotten their appointment or to cancel it. If, as we surmise, this reflects apathy, no strategy to improve attendance is likely to have great impact. Since the non-attendance rate is reasonably constant, it can be taken into account when patients are booked. PMID:12042374

  6. Cost Minimisation Using Clinic-Based Treatment for Common Hand Conditions – A Prospective Economic Analysis

    PubMed Central

    Webb, JA; Stothard, J

    2009-01-01

    INTRODUCTION The purpose of this study was to compare the cost of treatment of Dupuytren's disease, ganglia and trigger digits in the out-patient department with the operating theatre. PATIENTS AND METHODS All patients seen in a new patient hand clinic with a diagnosis of Dupuytren's disease, trigger digit or ganglion of the wrist or hand requiring treatment were prospectively identified over a 6-month period. The numbers undergoing a procedure in the out-patient clinic or theatre were recorded. Costings of theatre time and out-patient time, as well as national tariff income, were obtained from the hospital management. RESULTS Over the 6-month period, 80, 26, and 52 patients were treated with regard to Dupuytren's disease, ganglia and trigger digits, respectively. Of these, 37, 23, and 44 were treated by an out-patient procedure, and 43, 3 and 8 underwent a formal operation. The total cost of the out-patient procedures was calculated at £1560 over 6 months. To perform these as formal operations would have cost £64,896. The cost savings were, therefore, £63,336, or £126,672 per annum. CONCLUSIONS Out-patient interventions for Dupuytren's disease, ganglia and trigger digits result in significant cost savings over formal surgical treatment. PMID:19102823

  7. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    PubMed Central

    Plasseraud, Kristen Meldi; Tsai, Tony; Shildkrot, Yevgeniy; Middlebrook, Brooke; Maetzold, Derek; Wilkinson, Jeff; Stone, John; Johnson, Clare; Oelschlager, Kristen; Aaberg, Thomas M.

    2016-01-01

    Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p = 0.003) with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher's exact test p = 2.1 × 10−13 and p = 0.04, resp.). The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920). PMID:27446211

  8. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. 50.52 Section 50.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards...

  9. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study.

    PubMed

    Plasseraud, Kristen Meldi; Cook, Robert W; Tsai, Tony; Shildkrot, Yevgeniy; Middlebrook, Brooke; Maetzold, Derek; Wilkinson, Jeff; Stone, John; Johnson, Clare; Oelschlager, Kristen; Aaberg, Thomas M

    2016-01-01

    Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p = 0.003) with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher's exact test p = 2.1 × 10(-13) and p = 0.04, resp.). The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920). PMID:27446211

  10. Improved patient satisfaction using ingenol mebutate gel 0.015% for the treatment of facial actinic keratoses: a prospective pilot study

    PubMed Central

    Emilio, Joanna; Schwartz, Michelle; Feldman, Eleanor; Bieber, Amy Kalowitz; Bienenfeld, Amanda; Jung, Min-Kyung; Siegel, Daniel M; Markowitz, Orit

    2016-01-01

    Actinic keratoses (AKs), especially on areas of the face, have a negative impact on a patient’s quality of life (QoL). These lesions manifest on sun-damaged skin and have the potential to progress to squamous cell carcinoma. Field-directed therapy alone and in combination with lesion-directed treatment is effective in clearing both visible and nonvisible AK lesions. Topical treatments of AKs thus have the potential to improve a patient’s well-being. However, evidence demonstrating improvements in patient QoL is limited, and is mostly based on observational or retrospective studies. Some prospective studies have reported unchanged or even worsening QoL despite excellent treatment outcomes. Our prospective, pilot study demonstrated a significant increase in QoL in 28 subjects with AKs of the face treated with ingenol mebutate gel 0.015%. QoL was assessed at days 0 and 60 using the Skindex-16 survey. Mean overall scores improved from 24.5% at baseline to 15.5% at day 60 (P=0.031). Improvements in QoL were consistent with an 80% reduction in AK lesion number at day 60. These improved QoL findings are in line with those from a recent retrospective study using ingenol mebutate 0.015% gel. This study therefore further demonstrates the potential for field therapy to improve both treatment outcomes and patient satisfaction. PMID:27143946

  11. The Impact of Type 2 Diabetes on the Efficacy of ADP Receptor Blockers in Patients with Acute ST Elevation Myocardial Infarction: A Pilot Prospective Study

    PubMed Central

    Fedor, Marián; Kovář, František; Galajda, Peter; Bolek, Tomáš; Stančiaková, Lucia; Fedorová, Jana; Staško, Ján; Kubisz, Peter; Mokáň, Marián

    2016-01-01

    Background. The aim of this study was to validate the impact of type 2 diabetes (T2D) on the platelet reactivity in patients with acute ST elevation myocardial infarction (STEMI) treated with adenosine diphosphate (ADP) receptor blockers. Methods. A pilot prospective study was performed. Totally 67 patients were enrolled. 21 patients had T2D. Among all study population, 33 patients received clopidogrel and 34 patients received prasugrel. The efficacy of ADP receptor blocker therapy had been tested in two time intervals using light transmission aggregometry with specific inducer and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P) flow cytometry assay. Results. There were no significant differences in platelet aggregability among T2D and nondiabetic (ND) group. The platelet reactivity index of VASP-P did not differ significantly between T2D and ND group (59.4 ± 30.9% versus 60.0 ± 25.2% and 33.9 ± 25.3% versus 38.6 ± 29.3% in second testing). The number of ADP receptor blocker nonresponders did not differ significantly between T2D and ND patients. The time interval from ADP receptor blocker loading dosing to the blood sampling was similar in T2D and ND patients in both examinations. Conclusion. This prospective study did not confirm the higher platelet reactivity and higher prevalence of ADP receptor blocker nonresponders in T2D acute STEMI patients. PMID:27493970

  12. Improved patient satisfaction using ingenol mebutate gel 0.015% for the treatment of facial actinic keratoses: a prospective pilot study.

    PubMed

    Emilio, Joanna; Schwartz, Michelle; Feldman, Eleanor; Bieber, Amy Kalowitz; Bienenfeld, Amanda; Jung, Min-Kyung; Siegel, Daniel M; Markowitz, Orit

    2016-01-01

    Actinic keratoses (AKs), especially on areas of the face, have a negative impact on a patient's quality of life (QoL). These lesions manifest on sun-damaged skin and have the potential to progress to squamous cell carcinoma. Field-directed therapy alone and in combination with lesion-directed treatment is effective in clearing both visible and nonvisible AK lesions. Topical treatments of AKs thus have the potential to improve a patient's well-being. However, evidence demonstrating improvements in patient QoL is limited, and is mostly based on observational or retrospective studies. Some prospective studies have reported unchanged or even worsening QoL despite excellent treatment outcomes. Our prospective, pilot study demonstrated a significant increase in QoL in 28 subjects with AKs of the face treated with ingenol mebutate gel 0.015%. QoL was assessed at days 0 and 60 using the Skindex-16 survey. Mean overall scores improved from 24.5% at baseline to 15.5% at day 60 (P=0.031). Improvements in QoL were consistent with an 80% reduction in AK lesion number at day 60. These improved QoL findings are in line with those from a recent retrospective study using ingenol mebutate 0.015% gel. This study therefore further demonstrates the potential for field therapy to improve both treatment outcomes and patient satisfaction. PMID:27143946

  13. Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

    PubMed Central

    Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

    2016-01-01

    Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

  14. A Clinical Outcome-Based Prospective Study on Venous Thromboembolism After Cancer Surgery

    PubMed Central

    Agnelli, Giancarlo; Bolis, Giorgio; Capussotti, Lorenzo; Scarpa, Roberto Mario; Tonelli, Francesco; Bonizzoni, Erminio; Moia, Marco; Parazzini, Fabio; Rossi, Romina; Sonaglia, Francesco; Valarani, Bettina; Bianchini, Carlo; Gussoni, Gualberto

    2006-01-01

    Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21–5.71), previous VTE (5.98, 2.13–16.80), advanced cancer (2.68, 1.37–5.24), anesthesia lasting more than 2 hours (4.50, 1.06–19.04), and bed rest longer than 3 days (4.37, 2.45–7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion

  15. Multidisciplinary Team Contributions Within a Dedicated Outpatient Palliative Radiotherapy Clinic: A Prospective Descriptive Study

    SciTech Connect

    Pituskin, Edith; Fairchild, Alysa; Dutka, Jennifer; Gagnon, Lori; Driga, Amy; Tachynski, Patty; Borschneck, Jo-Ann; Ghosh, Sunita

    2010-10-01

    Purpose: Patients with bone metastases may experience pain, fatigue, and decreased mobility. Multiple medications for analgesia are often required, each with attendant side effects. Although palliative-intent radiotherapy (RT) is effective in decreasing pain, additional supportive care interventions may be overlooked. Our objective was to describe the feasibility of multidisciplinary assessment of patients with symptomatic bone metastases attending a dedicated outpatient palliative RT clinic. Methods and Materials: Consecutive patients referred for RT for painful bone metastases were screened for symptoms and needs relevant to their medications, nutritional intake, activities of daily living, and psychosocial and spiritual concerns from January 1 to December 31, 2007. Consultations by appropriate team members and resulting recommendations were collected prospectively. Patients who received RT were contacted by telephone 4 weeks later to assess symptom outcomes. Results: A total of 106 clinic visits by 82 individual patients occurred. As determined by screening form responses, the clinical Pharmacist, Occupational Therapist, Registered Dietician and Social Worker were consulted to provide assessments and recommendations within the time constraints presented by 1-day palliative RT delivery. In addition to pain relief, significant improvements in tiredness, depression, anxiety, drowsiness and overall well-being were reported at 4 weeks. Conclusions: Systematic screening of this population revealed previously unmet needs, addressed in the form of custom verbal and written recommendations. Multidisciplinary assessment is associated with a high number of recommendations and decreased symptom distress. Our findings lend strong support to the routine assessment by multiple supportive care professionals for patients with advanced cancer being considered for palliative RT.

  16. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  17. Clinical outcomes and kinetics of propanil following acute self-poisoning: a prospective case series

    PubMed Central

    Roberts, Darren M; Heilmair, Renate; Buckley, Nick A; Dawson, Andrew H; Fahim, Mohamed; Eddleston, Michael; Eyer, Peter

    2009-01-01

    Background Propanil is an important cause of death from acute pesticide poisoning, of which methaemoglobinaemia is an important manifestation. However, there is limited information about the clinical toxicity and kinetics. The objective of this study is to describe the clinical outcomes and kinetics of propanil following acute intentional self-poisoning. Methods 431 patients with a history of propanil poisoning were admitted from 2002 until 2007 in a large, multi-centre prospective cohort study in rural hospitals in Sri Lanka. 40 of these patients ingested propanil with at least one other poison and were not considered further. The remaining 391 patients were classified using a simple grading system on the basis of clinical outcomes; methaemoglobinaemia could not be quantified due to limited resources. Blood samples were obtained on admission and a subset of patients provided multiple samples for kinetic analysis of propanil and the metabolite 3,4-dichloroaniline (DCA). Results There were 42 deaths (median time to death 1.5 days) giving a case fatality of 10.7%. Death occurred despite treatment in the context of cyanosis, sedation, hypotension and severe lactic acidosis consistent with methaemoglobinaemia. Treatment consisted primarily of methylene blue (1 mg/kg for one or two doses), exchange transfusion and supportive care when methaemoglobinaemia was diagnosed clinically. Admission plasma concentrations of propanil and DCA reflected the clinical outcome. The elimination half-life of propanil was 3.2 hours (95% confidence interval 2.6 to 4.1 hours) and the concentration of DCA was generally higher, more persistent and more variable than propanil. Conclusion Propanil is the most lethal herbicide in Sri Lanka after paraquat. Methylene blue was largely prescribed in low doses and administered as intermittent boluses which are expected to be suboptimal given the kinetics of methylene blue, propanil and the DCA metabolite. But in the absence of controlled studies the

  18. Anterior vertebral body replacement with a titanium implant of adjustable height: a prospective clinical study.

    PubMed

    Lange, Uta; Edeling, Sebastian; Knop, Christian; Bastian, Leonard; Oeser, Michael; Krettek, Christian; Blauth, Michael

    2007-02-01

    In the operative treatment of spinal injuries, the reconstruction of the anterior column of the thoracolumbar spine is still controversial. We conducted a prospective clinical study to investigate the clinical and radiological outcome of 50 patients treated with a vertebral body replacement of adjustable height (Synex). Fifty consecutive patients were evaluated during in-patient treatment and at 12 and 20 months post-operatively in clinical notes and radiographs. 38/50 patients were operated for traumatic fractures. Out of 50 patients 45 attended the follow-up clinic 1 year post-operatively and 39 of these patients were examined after 20 months. Twenty-five patients returned to pre-injury activities within 1 year. This number increased to 29/39 patients at 20 months. Seventy-three percent of the patients returned to their job. After 1 year 25/45 patients complained of little or no back pain and 6 months later six patients were limited in their back function. At 1 year only three patients complained of surgical site pain which was improved at their final follow-up at 20 months. Individual satisfaction was determined using a score on a visual analog scale containing 19 questions on back pain, and functional limitation of the spine that has to be filled in by the patients at three different points of time. The score decreased from 87/100 pre-operatively to 65/100 at 1 year follow-up (P<0.001). The average permanent correction of the injured vertebra was 16.8 degrees (88%) including 2.3 degrees (12%) loss of correction at 12 months after operation. Bony integration was obtained in 83%. Early and intermediate outcome with the Synex vertebral replacement device for reconstruction of the anterior column appears promising. The loss of correction or reduction was only minimal. On the basis of our results we recommend the Synex implant as an alternative for the fixation and stabilisation of thoracolumbar fractures. However, long-term results and a clinically random control

  19. Clinical characteristics of patients with motor disability due to conversion disorder: a prospective control group study

    PubMed Central

    Binzer, M.; Andersen, P.; Kullgren, G.

    1997-01-01

    OBJECTIVES—Previous studies have suggested associations between conversion and many different clinical characteristics. This study investigates these findings in a prospective design including a control group.
METHODS—Thirty consecutive patients with a recent onset of motor disability due to a conversion disorder were compared with a control group of patients with corresponding motor symptoms due to a definite organic lesion. Both groups had a similar duration of symptoms and a comparable age and sex profile and were assessed on a prospective basis. Background information about previous somatic and psychiatric disease was collected and all patients were assessed by means of a structured clinical interview linked to the diagnostic system DSM III-R, the Hamilton rating depression scale, and a special life events inventory.
RESULTS—The conversion group had a higher degree of psychopathology with 33% of the patients fulfilling the criteria for psychiatric syndromes according to DSM-III-R axis I, whereas 50% had axis II personality disorders compared with 10% and 17% respectively in the control group. Conversion patients also had significantly higher scores according to the Hamilton rating depression scale. Although patients with known neurological disease were not included in the conversion group, a concomitant somatic disorder was found in 33% of the patients and 50% complained of benign pain. The educational background in conversion patients was poor with only 13% having dropped out of high school compared with 67% in the control group. Self reported global assessment of functioning according to the axis V on DSM IV was significantly lower in conversion patients, who also registered significantly more negative life events before the onset of symptoms than controls. Logistic regression analysis showed that low education, presence of a personality disorder, and high Hamilton depression score were significantly associated with conversion disorder

  20. Addressing Social Determinants of Health in a Clinic Setting: The WellRx Pilot in Albuquerque, New Mexico.

    PubMed

    Page-Reeves, Janet; Kaufman, Will; Bleecker, Molly; Norris, Jeffrey; McCalmont, Kate; Ianakieva, Veneta; Ianakieva, Dessislava; Kaufman, Arthur

    2016-01-01

    Although it is known that the social determinants of health have a larger influence on health outcomes than health care, there currently is no structured way for primary care providers to identify and address nonmedical social needs experienced by patients seen in a clinic setting. We developed and piloted WellRx, an 11-question instrument used to screen 3048 patients for social determinants in 3 family medicine clinics over a 90-day period. Results showed that 46% of patients screened positive for at least 1 area of social need, and 63% of those had multiple needs. Most of these needs were previously unknown to the clinicians. Medical assistants and community health workers then offered to connect patients with appropriate services and resources to address the identified needs. The WellRx pilot demonstrated that it is feasible for a clinic to implement such an assessment system, that the assessment can reveal important information, and that having information about patients' social needs improves provider ease of practice. Demonstrated feasibility and favorable outcomes led to institutionalization of the WellRx process at a university teaching hospital and influenced the state department of health to require managed care organizations to have community health workers available to care for Medicaid patients. PMID:27170801

  1. Patterns of Clinical Response to PSA Elevation in American Indian/Alaska Native Men: A Multi-center Pilot Study

    PubMed Central

    Tilburt, Jon C.; Koller, Kathryn; Tiesinga, James J.; Wilson, Robin T.; Trinh, Anne C.; Hill, Kristin; Hall, Ingrid J.; Smith, Judith Lee; Ekwueme, Donatus U.; Petersen, Wesley O.

    2016-01-01

    Objective To assess clinical treatment patterns and response times among American Indian/Alaska Native men with a newly elevated PSA. Methods We retrospectively identified men ages 50–80 receiving care in one of three tribally-operated clinics in Northern Minnesota, one medical center in Alaska, and who had an incident PSA elevation (≥ 4 ng/ml) in a specified time period. A clinical response was considered timely if it was documented as occurring within 90 days of the incident PSA elevation. Results Among 82 AI/AN men identified from medical records with an incident PSA elevation, 49 (60%) received a timely clinical response, while 18 (22%) had no documented clinical response. Conclusions One in five AI/AN men in our study had no documented clinical action following an incident PSA elevation. Although a pilot study, these findings suggest the need to improve the documentation, notification, and care following an elevated PSA at clinics serving AI/AN men. PMID:24185163

  2. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial.

    PubMed

    McGhee, William; Michaels, Marian G; Martin, Judith M; Mazariegos, George V; Green, Michael

    2016-03-01

    We conducted a prospective pilot study to evaluate the potential role of combined systemic antifungal and liposomal amphotericin B lock therapy in children with intestinal insufficiency with fungal catheter-related bloodstream infections whose central venous catheters had not been removed. Our results provide supportive evidence for the conduct of larger clinical trials to confirm the efficacy and safety of this approach. PMID:26908494

  3. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

    SciTech Connect

    MacDonald, Shannon M.; Patel, Sagar A.; Hickey, Shea; Specht, Michelle; Isakoff, Steven J.; Gadd, Michele; Smith, Barbara L.; Yeap, Beow Y.; Adams, Judith; DeLaney, Thomas F.; Kooy, Hanne; Lu, Hsiao-Ming; Taghian, Alphonse G.

    2013-07-01

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods.

  4. Bayesian probability analysis: a prospective demonstration of its clinical utility in diagnosing coronary disease

    SciTech Connect

    Detrano, R.; Yiannikas, J.; Salcedo, E.E.; Rincon, G.; Go, R.T.; Williams, G.; Leatherman, J.

    1984-03-01

    One hundred fifty-four patients referred for coronary arteriography were prospectively studied with stress electrocardiography, stress thallium scintigraphy, cine fluoroscopy (for coronary calcifications), and coronary angiography. Pretest probabilities of coronary disease were determined based on age, sex, and type of chest pain. These and pooled literature values for the conditional probabilities of test results based on disease state were used in Bayes theorem to calculate posttest probabilities of disease. The results of the three noninvasive tests were compared for statistical independence, a necessary condition for their simultaneous use in Bayes theorem. The test results were found to demonstrate pairwise independence in patients with and those without disease. Some dependencies that were observed between the test results and the clinical variables of age and sex were not sufficient to invalidate application of the theorem. Sixty-eight of the study patients had at least one major coronary artery obstruction of greater than 50%. When these patients were divided into low-, intermediate-, and high-probability subgroups according to their pretest probabilities, noninvasive test results analyzed by Bayesian probability analysis appropriately advanced 17 of them by at least one probability subgroup while only seven were moved backward. Of the 76 patients without disease, 34 were appropriately moved into a lower probability subgroup while 10 were incorrectly moved up. We conclude that posttest probabilities calculated from Bayes theorem more accurately classified patients with and without disease than did pretest probabilities, thus demonstrating the utility of the theorem in this application.

  5. Weekly injection of histaglobulin produces long-term remission in chronic urticaria: A prospective clinical study

    PubMed Central

    Rajesh, Gurumoorthy; Keerthi, Subramaniam; Karthikeyan, Kaliaperumal; Venkatesan, Murugan

    2016-01-01

    Objective: Treatment of chronic urticaria (CU) can be difficult in many patients. Achieving long-term remission and reducing the requirement of antihistamines are vital in CU. The objective of this study was to assess the effectiveness of injection histaglobulin, a complex of histamine and human immunoglobulin, in producing relief in patients with CU. Materials and Methods: Fifty-one patients with CU were enrolled into this prospective clinical study. Patients were administered 1 ml of injection histaglobulin subcutaneous for 8 consecutive weeks. They were also prescribed tablet levocetirizine 5 mg to be taken when required (but not more than the permitted dosage). Efficacy was assessed using urticaria activity score (UAS) which has a maximum score of 33/day, during each weekly visit. Final assessment was done after 24 weeks. Results: Twenty-nine patients had completed the entire 8-week drug regimen. Mean basal UAS was 18.9 ± 6.3 and it reduced to 80.4% by 8 weeks. The angioedema sub-score reduced by 89.8%. Anti-histamine pill burden also reduced significantly. By 24 weeks of starting the therapy, 23 patients (45%) had attained complete remission. No adverse effects to the drug were observed. Conclusions: Histaglobulin was found to be effective in producing long-term remission and it reduced the antihistamine requirement as well. Thus, it can serve as an effective alternative to existing treatment modalities. PMID:27298500

  6. Translating Ocular Biomechanics into Clinical Practice: Current State and Future Prospects

    PubMed Central

    Girard, Michaël J.A.; Dupps, William J.; Baskaran, Mani; Scarcelli, Giuliano; Yun, Seok H.; Quigley, Harry A.; Sigal, Ian A.; Strouthidis, Nicholas G.

    2014-01-01

    Biomechanics – the study of the relationship between forces and function in living organisms – is thought to play a critical role in a significant number of ophthalmic disorders. This is not surprising, as the eye is a pressure vessel that requires a delicate balance of forces to maintain its homeostasis. Over the past few decades, basic science research in ophthalmology mostly confirmed that ocular biomechanics could explain in part the mechanisms involved in almost all major ophthalmic disorders such as optic nerve head neuropathies, angle closure, ametropia, presbyopia, cataract, corneal pathologies, retinal detachment, and macular degeneration. Translational biomechanics in ophthalmology, however, is still in its infancy. It is believed that its use could make significant advances in diagnosis and treatment. Several translational biomechanics strategies are already emerging, such as corneal stiffening for the treatment of keratoconus, and more are likely to follow. This review aims to cultivate the idea that biomechanics plays a major role in ophthalmology and that its clinical translation, lead by collaborative teams of clinicians and biomedical engineers, will benefit our patients. Specifically, recent advances and future prospects in corneal, iris, trabecular meshwork, crystalline lens, scleral and lamina cribrosa biomechanics are discussed. PMID:24832392

  7. Chemoprevention of Lung Cancer: Prospects and Disappointments in Human Clinical Trials

    PubMed Central

    Greenberg, Alissa K.; Tsay, Jun-Chieh; Tchou-Wong, Kam-Meng; Jorgensen, Anna; Rom, William N.

    2013-01-01

    Decreasing the risk of lung cancer, or preventing its development in high-risk individuals, would have a huge impact on public health. The most effective means to decrease lung cancer incidence is to eliminate exposure to carcinogens. However, with recent advances in the understanding of pulmonary carcinogenesis and the identification of intermediate biomarkers, the prospects for the field of chemoprevention research have improved dramatically. Here we review the most recent research in lung cancer chemoprevention—focusing on those agents that have been investigated in human clinical trials. These agents fall into three major categories. First, oxidative stress plays an important role in pulmonary carcinogenesis; and therefore, antioxidants (including vitamins, selenium, green tea extracts, and isothiocyanates) may be particularly effective in preventing the development of lung cancer. Second, inflammation is increasingly accepted as a crucial factor in carcinogenesis, and many investigators have focused on anti-inflammatory agents, such as glucocorticoids, NSAIDs, statins, and PPARγ agonists. Finally, the PI3K/AKT/mTOR pathway is recognized to play a central role in tobacco-induced carcinogenesis, and inhibitors of this pathway, including myoinositol and metformin, are promising agents for lung cancer prevention. Successful chemoprevention will likely require targeting of multiple pathways to carcinogenesis—both to minimize toxicity and maximize efficacy. PMID:24216701

  8. Hyperbaric Oxygen Therapy Can Diminish Fibromyalgia Syndrome – Prospective Clinical Trial

    PubMed Central

    Efrati, Shai; Golan, Haim; Bechor, Yair; Faran, Yifat; Daphna-Tekoah, Shir; Sekler, Gal; Fishlev, Gregori; Ablin, Jacob N.; Bergan, Jacob; Volkov, Olga; Friedman, Mony; Ben-Jacob, Eshel; Buskila, Dan

    2015-01-01

    Background Fibromyalgia Syndrome (FMS) is a persistent and debilitating disorder estimated to impair the quality of life of 2–4% of the population, with 9:1 female-to-male incidence ratio. FMS is an important representative example of central nervous system sensitization and is associated with abnormal brain activity. Key symptoms include chronic widespread pain, allodynia and diffuse tenderness, along with fatigue and sleep disturbance. The syndrome is still elusive and refractory. The goal of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) on symptoms and brain activity in FMS. Methods and Findings A prospective, active control, crossover clinical trial. Patients were randomly assigned to treated and crossover groups: The treated group patients were evaluated at baseline and after HBOT. Patients in the crossover-control group were evaluated three times: baseline, after a control period of no treatment, and after HBOT. Evaluations consisted of physical examination, including tender point count and pain threshold, extensive evaluation of quality of life, and single photon emission computed tomography (SPECT) imaging for evaluation of brain activity. The HBOT protocol comprised 40 sessions, 5 days/week, 90 minutes, 100% oxygen at 2ATA. Sixty female patients were included, aged 21–67 years and diagnosed with FMS at least 2 years earlier. HBOT in both groups led to significant amelioration of all FMS symptoms, with significant improvement in life quality. Analysis of SPECT imaging revealed rectification of the abnormal brain activity: decrease of the hyperactivity mainly in the posterior region and elevation of the reduced activity mainly in frontal areas. No improvement in any of the parameters was observed following the control period. Conclusions The study provides evidence that HBOT can improve the symptoms and life quality of FMS patients. Moreover, it shows that HBOT can induce neuroplasticity and significantly rectify abnormal

  9. The Clinical Course of Cirrhosis Patients Hospitalized for Acute Hepatic Deterioration: A Prospective Bicentric Study.

    PubMed

    Shi, Yu; Yan, Huadong; Zhou, Zhibo; Fang, Hong; Li, Jiawei; Ye, Honghua; Sun, Wenjie; Zhou, Wenhong; Ye, Jingfen; Yang, Qiao; Yang, Ying; Hu, Yaoren; Chen, Zhi; Sheng, Jifang

    2015-11-01

    Patients with cirrhosis are vulnerable to acute hepatic insults and are more likely to develop rapid hepatic deterioration. The aim of this study is to describe the clinical course of patients with cirrhosis and hospitalized for acute hepatic deterioration (AHD).This is a prospective study involving 163 patients with cirrhosis and AHD. The occurrence of organ failures, systemic inflammatory response syndrome (SIRS), and infections during hospital stay were recorded and the relationship between organ failure and death or SIRS/infection was subsequently analyzed.Of 163 patients, 35 did not develop any organ failure during in-hospital follow-ups (90-day mortality: 0%); 84 had intrahepatic organ failures (IH-OFs, defined by liver and/or coagulation failure) (90-day mortality: 22.0%); and 44 patients developed extra-hepatic organ failures (EH-OFs, defined by kidney, cerebral, circulation, and respiratory failure) on the basis of IH-OF with a 90-day mortality of 90.9%. On multivariable analysis by a Cox proportion hazard model, age, WBC, presence of IH-OF, and EH-OF all predicted 90-day death. A logistic regression analysis identified SIRS being associated with the development of EH-OF. Furthermore, IH-OF at admission and infections occurred during the hospital stay were shown to be another 2 potential risk factors.The clinical course of cirrhosis patients with acute hepatic injury was characterized by 3 consecutive stages (AHD, IH-OF, and EH-OF), which provided a clear risk stratification. The PIRO criteria provided an accurate frame for prognostication of those patients. The systemic inflammatory response syndrome may be a target for blocking the progression to the EH-OF stage. PMID:26632701

  10. The clinical and radiological spectrum of reversible cerebral vasoconstriction syndrome. A prospective series of 67 patients.

    PubMed

    Ducros, Anne; Boukobza, Monique; Porcher, Raphaël; Sarov, Mariana; Valade, Dominique; Bousser, Marie-Germaine

    2007-12-01

    Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by the association of severe headaches with or without additional neurological symptoms and a 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 1-3 months. We present the clinical, neuroimaging and outcome data of 67 consecutive patients prospectively diagnosed over 3 years in our institution with an angiographically confirmed RCVS. There were 43 females and 24 males with a mean age of 42 years (19-70). RCVS was spontaneous in 37% of patients and secondary in the 63% others, to postpartum in 5 and to exposure to various vasoactive substances in 37, mainly cannabis, selective serotonin-recapture inhibitors and nasal decongestants. The main pattern of presentation (94% of patients) was multiple thunderclap headaches recurring over a mean period of 1 week. In 51 patients (76%), headaches resumed the clinical presentation. Various complications were observed, with different time courses. Cortical subarachnoid haemorrhage (cSAH) (22%), intracerebral haemorrhage (6%), seizures (3%) and reversible posterior leukoencephalopathy (9%) were early complications, occurring mainly within the first week. Ischaemic events, including TIAs (16%) and cerebral infarction (4%), occurred significantly later than haemorrhagic events, mainly during the second week. Significant sex differences were observed: women were older, had more frequent single-drug exposure and a higher rate of stroke and cSAH. Sixty-one patients were treated by nimodipine: 36% had recurrent headaches, 7% TIAs and one multiple infarcts. The different time courses of thunderclap headaches, vasoconstriction and strokes suggest that the responsible vasospastic disorder starts distally and progresses towards medium sized and large arteries. No relapse was observed during the 16 +/- 12.4 months of follow-up. Our data suggest that RCVS is more frequent than previously thought, is more often secondary particularly to

  11. Predictors of suppurative complications for acute sore throat in primary care: prospective clinical cohort study

    PubMed Central

    Stuart, Beth; Hobbs, F D Richard; Butler, Chris C; Hay, Alastair D; Campbell, John; Delaney, Brendan; Broomfield, Sue; Barratt, Paula; Hood, Kerenza; Everitt, Hazel; Mullee, Mark; Williamson, Ian; Mant, David; Moore, Michael

    2013-01-01

    Objective To document whether elements of a structured history and examination predict adverse outcome of acute sore throat. Design Prospective clinical cohort. Setting Primary care. Participants 14 610 adults with acute sore throat (≤2 weeks’ duration). Main outcome measures Common suppurative complications (quinsy or peritonsillar abscess, otitis media, sinusitis, impetigo or cellulitis) and reconsultation with new or unresolving symptoms within one month. Results Complications were assessed reliably (inter-rater κ=0.95). 1.3% (177/13 445) of participants developed complications overall and 14.2% (1889/13 288) reconsulted with new or unresolving symptoms. Independent predictors of complications were severe tonsillar inflammation (documented among 13.0% (1652/12 717); odds ratio 1.92, 95% confidence interval 1.28 to 2.89) and severe earache (5% (667/13 323); 3.02, 1.91 to 4.76), but the model including both variables had modest prognostic utility (bootstrapped area under the receiver operator curve 0.61, 0.57 to 0.65), and 70% of complications (124/177) occurred when neither was present. Clinical prediction rules for bacterial infection (Centor criteria and FeverPAIN) also predicted complications, but predictive values were also poor and most complications occurred with low scores (67% (118/175) scoring ≤2 for Centor; 126/173 (73%) scoring ≤2 for FeverPAIN). Previous medical problems, sex, temperature, and muscle aches were independently but weakly associated with reconsultation with new or unresolving symptoms. Conclusion Important suppurative complications after an episode of acute sore throat in primary care are uncommon. History and examination and scores to predict bacterial infection cannot usefully identify those who will develop complications. Clinicians will need to rely on strategies such as safety netting or delayed prescription in managing the uncertainty and low risk of complications. PMID:24277339

  12. Clinical Outcomes and Microbiological Characteristics of Severe Pneumonia in Cancer Patients: A Prospective Cohort Study

    PubMed Central

    Rabello, Ligia S. C. F.; Silva, Jose R. L.; Azevedo, Luciano C. P.; Souza, Ivens; Torres, Viviane B. L.; Rosolem, Maíra M.; Lisboa, Thiago; Soares, Marcio; Salluh, Jorge I. F.

    2015-01-01

    Introduction Pneumonia is the most frequent type of infection in cancer patients and a frequent cause of ICU admission. The primary aims of this study were to describe the clinical and microbiological characteristics and outcomes in critically ill cancer patients with severe pneumonia. Methods Prospective cohort study in 325 adult cancer patients admitted to three ICUs with severe pneumonia not acquired in the hospital setting. Demographic, clinical and microbiological data were collected. Results There were 229 (71%) patients with solid tumors and 96 (29%) patients with hematological malignancies. 75% of all patients were in septic shock and 81% needed invasive mechanical ventilation. ICU and hospital mortality rates were 45.8% and 64.9%. Microbiological confirmation was present in 169 (52%) with a predominance of Gram negative bacteria [99 (58.6%)]. The most frequent pathogens were methicillin-sensitive S. aureus [42 (24.9%)], P. aeruginosa [41(24.3%)] and S. pneumonia [21 (12.4%)]. A relatively low incidence of MR [23 (13.6%)] was observed. Adequate antibiotics were prescribed for most patients [136 (80.5%)]. In multivariate analysis, septic shock at ICU admission [OR 5.52 (1.92–15.84)], the use of invasive MV [OR 12.74 (3.60–45.07)] and poor Performance Status [OR 3.00 (1.07–8.42)] were associated with increased hospital mortality. Conclusions Severe pneumonia is associated with high mortality rates in cancer patients. A relatively low rate of MR pathogens is observed and severity of illness and organ dysfunction seems to be the best predictors of outcome in this population. PMID:25803690

  13. Incidence and clinical variables associated with streptococcal throat infections: a prospective diagnostic cohort study

    PubMed Central

    Little, Paul; Hobbs, FD Richard; Mant, David; McNulty, Cliodna AM; Mullee, Mark

    2012-01-01

    Background Management of pharyngitis is commonly based on features which are thought to be associated with Lancefield group A beta-haemolytic streptococci (GABHS) but it is debatable which features best predict GABHS. Non-group A strains share major virulence factors with group A, but it is unclear how commonly they present and whether their presentation differs. Aim To assess the incidence and clinical variables associated with streptococcal infections. Design and setting Prospective diagnostic cohort study in UK primary care. Method The presence of pathogenic streptococci from throat swabs was assessed among patients aged ≥5 years presenting with acute sore throat. Results Pathogenic streptococci were found in 204/597 patients (34%, 95% CI = 31 to 38%): 33% (68/204) were non-group A streptococci, mostly C (n = 29), G (n = 18) and B (n = 17); rarely D (n = 3) and Streptococcus pneumoniae (n = 1). Patients presented with similar features whether the streptococci were group A or non-group A. The features best predicting A, C or G beta-haemolytic streptococci were patient’s assessment of severity (odds ratio [OR] for a bad sore throat 3.31, 95% CI = 1.24 to 8.83); doctors’ assessment of severity (severely inflamed tonsils OR 2.28, 95% CI = 1.39 to 3.74); absence of a bad cough (OR 2.73, 95% CI = 1.56 to 4.76), absence of a coryza (OR 1.54, 95% CI = 0.99 to 2.41); and moderately bad or worse muscle aches (OR 2.20, 95% CI = 1.41 to 3.42). Conclusion Non-group A strains commonly cause streptococcal sore throats, and present with similar symptomatic clinical features to group A streptococci. The best features to predict streptococcal sore throat presenting in primary care deserve revisiting. PMID:23211183

  14. Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

    SciTech Connect

    Wiegner, Ellen A.; King, Christopher R.

    2010-10-01

    Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged {>=}70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.

  15. A prospective pilot study on the incidence of post-operative lymphedema in women with endometrial cancer

    PubMed Central

    Hopp, Elizabeth E.; Osborne, Janet L.; Schneider, Deborah K.; Bojar, Claudia J.; Uyar, Denise S.

    2015-01-01

    To determine the incidence of lower-extremity lymphedema after surgical therapy including lymphadenectomy in endometrial cancer patients using standardized leg measurements. Also, to determine additional risk factors for the development of lymphedema and to study the effect of lymphedema on one's quality of life. In this prospective cohort study, patients with the diagnosis of endometrial cancer who were to undergo definitive surgical management were evaluated pre-operatively and followed post-operatively over the course of two years. Standardized leg measurements were performed by the same individuals at six time-points. Subjects also completed a standardized quality-of-life survey at each time-point. The incidence of lymphedema in 39 women with endometrial cancer using a standardized leg measurement protocol was 12.8% with lymphedema defined as a 20% increase in post-operative leg measurements. There was no significant association between the development of lymphedema and the number of pelvic or para-aortic lymph nodes removed, medical comorbidities, or surgical approach (p > 0.05). Of the five patients who met criteria for lymphedema, only one had worsening quality-of-life concerns post-operatively on the FACT-En, version 4, survey. This is the first prospective study using standardized leg measurements to calculate the incidence of post-operative lymphedema in endometrial cancer. Medical comorbidities, surgical approach, number of lymph nodes removed, and location of lymph nodes removed did not appear to affect the development of lymphedema in this cohort. A prospective, multicenter trial is needed to confirm these findings and to further assess the impact of lymphedema on one's quality of life. PMID:26937484

  16. A prospective pilot study on the incidence of post-operative lymphedema in women with endometrial cancer.

    PubMed

    Hopp, Elizabeth E; Osborne, Janet L; Schneider, Deborah K; Bojar, Claudia J; Uyar, Denise S

    2016-01-01

    To determine the incidence of lower-extremity lymphedema after surgical therapy including lymphadenectomy in endometrial cancer patients using standardized leg measurements. Also, to determine additional risk factors for the development of lymphedema and to study the effect of lymphedema on one's quality of life. In this prospective cohort study, patients with the diagnosis of endometrial cancer who were to undergo definitive surgical management were evaluated pre-operatively and followed post-operatively over the course of two years. Standardized leg measurements were performed by the same individuals at six time-points. Subjects also completed a standardized quality-of-life survey at each time-point. The incidence of lymphedema in 39 women with endometrial cancer using a standardized leg measurement protocol was 12.8% with lymphedema defined as a 20% increase in post-operative leg measurements. There was no significant association between the development of lymphedema and the number of pelvic or para-aortic lymph nodes removed, medical comorbidities, or surgical approach (p > 0.05). Of the five patients who met criteria for lymphedema, only one had worsening quality-of-life concerns post-operatively on the FACT-En, version 4, survey. This is the first prospective study using standardized leg measurements to calculate the incidence of post-operative lymphedema in endometrial cancer. Medical comorbidities, surgical approach, number of lymph nodes removed, and location of lymph nodes removed did not appear to affect the development of lymphedema in this cohort. A prospective, multicenter trial is needed to confirm these findings and to further assess the impact of lymphedema on one's quality of life. PMID:26937484

  17. A pilot study to evaluate the role of the Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) in clinical decisions for pressure ulcer treatment.

    PubMed

    Thomason, Susan S; Graves, Barbara Ann; Madaris, Linda

    2014-12-01

    The Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) was designed to assess pressure ulcer (PrU) healing in the spinal cord impaired (SCI) population. The tool contains 7 variables: wound surface area, depth, edges, tunneling, undermining, exudate type, and necrotic tissue amount. A 2-phased, quantitative pilot study based on the Theory of Reasoned Action and Theory of Planned Behavior was conducted at a large SCI/Disorders Center in the Department of Veterans Affairs (VA). In the first phase of the study, a convenience sample of 5 physicians, 3 advanced practice registered nurses, and 3 certified wound care nurses (CWCN) was surveyed using a 2-part questionnaire to assess use of the SCI-PUMT instrument, its anticipated improvement in PrU assessment, and intent to use the SCI-PUMT in clinical practice. Attitudes, subjective norms, perceived behavioral controls, and barriers related to the intent to use the SCI-PUMT were evaluated using a 5-point Likert scale (range: 1= extremely likely, 5 = extremely unlikely). In the second phase of the study, the electronic health records (EHR) of 24 veterans (with 30 PrUs) who had at least 2 completed SCI-PUMT scores during a 4-week period were used to evaluate whether an association existed between magnitudes of change of total SCI-PUMT scores and ordered changes in PrU treatment. The overall mean score for intent to use SCI-PUMT was 1.80 (SD 0.75). The least favorable scores were for convenience and motivation to use the SCI-PUMT. Analysis of EHR data showed no significant difference in magnitudes of change in the SCI-PUMT score and changes in PrU treatment recommendations made by the CWCNs. The significance was not affected regardless of an increase or no change in the score (χ2 with 1 degree of freedom = 1.158, P = 0.282) or for a decrease in the score (χ2 with 1 degree of freedom = 0.5, P = 0.478). In this pilot study, the expressed intent to use the SCI-PUMT in making clinical decisions was generally

  18. Real Time Identification of Drug-Induced Liver Injury (DILI) through Daily Screening of ALT Results: A Prospective Pilot Cohort Study

    PubMed Central

    M'Kada, Helmi; Perazzo, Hugo; Munteanu, Mona; Ngo, Yen; Ramanujam, Nittia; Fautrel, Bruno; Imbert-Bismut, Françoise; Ratziu, Vlad; Schuppe-Koistinen, Ina; Leblond, Véronique; Delattre, Jean Yves; Samson, Yves; Caen, Olivier Lyon; Bricaire, François; Khayat, David; Pierrot-Deseilligny, Charles; Herson, Serge; Amoura, Zahir; Tilleul, Patrick; Deckmyn, Olivier; Coriat, Pierre; Delpech, Vincent Nicolas; Boulogne, Philippe; Bonnefont-Rousselot, Dominique; Poynard, Thierry

    2012-01-01

    Objective Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. Design We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium). Results During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9–32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol. Conclusion A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70. PMID:22905129

  19. A pilot evaluation of group-based programming offered at a Canadian outpatient adult eating disorders clinic.

    PubMed

    Mac Neil, Brad A; Leung, Pauline; Nadkarni, Pallavi; Stubbs, Laura; Singh, Manya

    2016-10-01

    Eating disorder clinics across Canada place heavy reliance on group-based programming. However, little work has examined whether this modality of treatment is well-received by patients and results in clinical improvements. The purpose of this pilot study was to evaluate patient satisfaction and outcomes for group-based programming offered through an adult eating disorders clinic. Participants were 81 adults who met DSM-5 criteria for an eating disorder and participated in the study as part of the clinic's program evaluation. Participants received medical monitoring, psychiatric follow-up, adjunct nutrition and pre-psychological treatment, and participated in the clinic's core cognitive behavioural therapy (CBT) group. Demographic information and weight were collected at intake. Participants also completed pre- and post-group programming measures of life satisfaction, depressive and anxiety symptoms, psychological symptoms of the eating disorder, and satisfaction with the programming. Participants' experienced a significant increase in satisfaction with life, and decreases in depressive symptoms and psychological symptoms of the eating disorder post-group. Adults endorsed feeling fairly satisfied with the group-based services provided. Results draw attention to the importance of program evaluation as an integral component of an adult outpatient eating disorder clinic by providing a voice for patients' views of the services received and program outcomes. PMID:27288960

  20. Removal of glucose from the cardiopulmonary bypass prime: a prospective clinical audit.

    PubMed

    Newland, R F; Baker, R A; Mazzone, A L; Ottens, J; Sanderson, A J; Moubarak, J R

    2004-09-01

    To quantify our decision for the removal of glucose and the use of mannitol as a substitute osmotic agent in the cardiopulmonary bypass prime, we conducted a prospective clinical audit to evaluate the effects of this change on patient outcomes. Data were prospectively collected for 172 consecutive routine cardiac surgery patients. The first 85 patients (Surgeon A, 42 patients [Group 1], Surgeon B, 43 patients [Group 2]) received 1000 mL Plasmalyte 148 + 5% glucose as per institutional protocol. The remaining priming volume for each group consisted of 500 mL hemaccel or 4% albumin, 50 mL 8.4% sodium bicarbonate, 100 mL Hartmann's solution. The change to a glucose-free prime was then initiated, substituting Plasmalyte 148 (without 5% glucose) for the Plasmalyte 148 + 5% glucose, in addition 12.5 g mannitol was administered following delivery of cardioplegia to the patients operated on by Surgeon B. Surgeon A would not include mannitol at this time. Forty-one patients operated by Surgeon A (Group 3) subsequently received Plasmalyte 148, and 46 patients operated on by Surgeon B (Group 4) received Plasmalyte 148 plus mannitol. Analysis was performed stratified by surgeon to quantify the effects of removing glucose from the prime. Comparisons were made between groups 1 and 3, and 2 and 4. Net fluid changes were recorded from pre-CPB, up to 24-h postoperatively. Intraoperative data collection included serum glucose, hematocrit, osmolality, return to rhythm, arrhythmias, and blood transfusions. Post-operative variables, including cardiac enzymes, arrhythmias, intubation time, length of stay, and mortality were also collected. Removal of glucose from the CPB prime resulted in a lower serum glucose concentration (mmol/L) during CPB (Gp 1 [13.6] vs. Gp 3 [5.4]; Gp 2 [14.7] vs. Gp 4 [5.4], p < .05). The addition of 12.5 g of mannitol to the CPB prime resulted in a significantly lower net fluid gain (mL) 24 h postoperatively (Gp 2[2792] vs. Gp 4 [1970], p < .05) and greater CPB

  1. A daily-life-oriented intervention to improve prospective memory and goal-directed behaviour in ageing: a pilot study.

    PubMed

    Burkard, Christina; Rochat, Lucien; Blum, Anaëlle; Emmenegger, Joëlle; Juillerat Van der Linden, Anne-Claude; Van der Linden, Martial

    2014-01-01

    Difficulties in the execution of goal-directed behaviours, and particularly their prospective memory component, can arise in ageing and have important consequences for autonomy. The first objective of this article is to present an intervention that trained older individuals who reported prospective memory or goal-directed behaviour problems to use "implementation intentions". This technique, which has been shown to improve different aspects of goal-directed behaviour enactment, consists of establishing a mental (verbal and/or visual) link between the action that must be performed and the situation in which it must be performed. Our programme proposes exercises of progressively increasing difficulty that are targeted at daily life situations. Our second objective was to test the programme in small groups of older adults. Preliminary data regarding the programme's feasibility and its initial efficacy show a significant improvement in the main outcome measure, a questionnaire assessing goal-directed behaviours in everyday life. The participants also reported being significantly less bothered by their difficulties, although there were no significant changes in quality of life, self-esteem, anxiety or depression. Two participants with different psychological profiles, who benefited differently from the intervention, are then presented in more detail. PMID:24559524

  2. Prediction of manifest Huntington disease with clinical and imaging measures: A 12-year prospective observational study

    PubMed Central

    Paulsen, Jane S.; Long, Jeffrey D.; Ross, Christopher A.; Harrington, Deborah L.; Erwin, Cheryl J.; Williams, Janet K.; Westervelt, Holly James; Johnson, Hans J.; Aylward, Elizabeth H.; Zhang, Ying; Bockholt, H. Jeremy; Barker, Roger A.

    2015-01-01

    BACKGROUND Although correlation between cytosine-adenine-guanine (CAG) repeat length and age of Huntington disease (HD) onset is well known, improved prediction of onset would be advantageous for clinical trial design and prognostic counseling. We compared genetic, demographic, motor, cognitive, psychiatric, functional and imaging measures for tracking progression and predicting conversion to manifest HD. METHODS N=1078 research participants with the gene mutation for HD, but without a rating of 4 on the Diagnostic Confidence Level (DCL) following administration of the 15-item motor assessment of the Unified Huntington’s Disease Rating Scale. Participants were from 33 world wide sites and followed for up to 12 years (mean=5, SD=3·3) over the period 2001–2013. A subset of 225 participants prospectively converted to manifest HD according to the DCL (“meets the operational definition of the unequivocal presence of an otherwise unexplained extrapyramidal movement disorder in a subject at risk for HD” with ≥99% confidence). Joint modeling of longitudinal and survival data was used to examine the extent to which baseline and change of 40 variables analyzed separately was predictive of CAG-adjusted age at motor diagnosis. FINDINGS Cross-sectional and longitudinal clinical and imaging measures were significant predictors of motor diagnosis beyond CAG repeat length and age. The strongest predictors in the top three phenotypic domains were total motor score (motor), putamen volume (imaging), and Stroop word test (cognitive). A one standard deviation (SD) difference in total motor score increased the risk of a motor diagnosis by 3·1 times (95% CI=[2·3,4·2]), one SD loss in putamen volume increased risk by 3·3 times ([2·4,4·7]) and one SD cognitive decline increased risk by 2·3 ([1·9,2·9]). INTERPRETATION Prediction of HD diagnosis can be considerably improved beyond that obtained by CAG repeat length and age alone. Such knowledge about potential predictors

  3. Towards Validation of a New Computerised Test of Goal Neglect: Preliminary Evidence from Clinical and Neuroimaging Pilot Studies

    PubMed Central

    Cullen, Breda; Brennan, David; Manly, Tom; Evans, Jonathan J.

    2016-01-01

    Objective Goal neglect is a significant problem following brain injury, and is a target for rehabilitation. It is not yet known how neural activation might change to reflect rehabilitation gains. We developed a computerised multiple elements test (CMET), suitable for use in neuroimaging paradigms. Design Pilot correlational study and event-related fMRI study. Methods In Study 1, 18 adults with acquired brain injury were assessed using the CMET, other tests of goal neglect (Hotel Test; Modified Six Elements Test) and tests of reasoning. In Study 2, 12 healthy adults underwent fMRI, during which the CMET was administered under two conditions: self-generated switching and experimenter-prompted switching. Results Among the clinical sample, CMET performance was positively correlated with both the Hotel Test (r = 0.675, p = 0.003) and the Modified Six Elements Test (r = 0.568, p = 0.014), but not with other clinical or demographic measures. In the healthy sample, fMRI demonstrated significant activation in rostro-lateral prefrontal cortex in the self-generated condition compared with the prompted condition (peak 40, 44, 4; ZE = 4.25, p(FWEcorr) = 0.026). Conclusions These pilot studies provide preliminary evidence towards the validation of the CMET as a measure of goal neglect. Future studies will aim to further establish its psychometric properties, and determine optimum pre- and post-rehabilitation fMRI paradigms. PMID:26824704

  4. Clinical Practice Improvement Approach in Multiple Sclerosis Rehabilitation: A Pilot Study

    ERIC Educational Resources Information Center

    Khan, Fary

    2010-01-01

    The objective of this study was to explore methods examining patient complexity and therapy interventions in relation to functional outcomes from an inpatient multiple sclerosis (MS) rehabilitation program. Retrospective and prospective data for 24 consecutive inpatients at a tertiary rehabilitation facility assessed (i)…

  5. Pilot test and validation of the Peak Day method of prospective determination of ovulation against a handheld urine hormone monitor

    PubMed Central

    2014-01-01

    Background Transient exposures may influence fertility and early embryonic development. To assess the time of conception in vivo and conduct concurrent biomonitoring, ovulation must be identified prospectively. We report on the development and validation of a simple, prospective method, the Peak Day method, to determine likely day of ovulation based upon daily observations of cervical fluid. Methods We recruited 98 women to learn the Peak Day method from a brochure, 26 of whom concurrently used the method with blinded daily urine hormone monitoring (estrone glucuronide and luteinizing hormone). All women were instructed to complete an exposure questionnaire immediately upon identifying ovulation. Briefly, the exposure questionnaire captured time-varying and transient exposures such as medication use, water consumption, and amount of sleep. We assessed timely completion of the exposure questionnaire, agreement of women’s estimated day of ovulation (EDO) and the EDO by expert review, and agreement between the EDO by expert review and by blinded urine monitoring. Results Of 147 cycles evaluated, women selected an EDO in 130 (88%) and subsequently completed the periovulatory exposure questionnaire in 122 (94%) cycles. Of the 26 cycles evaluated with blinded hormonal monitoring, the Peak Day “best quality” algorithm, based upon cervical fluid, identified ovulation ± 3 days of the urine monitor in 24 cycles (92%). Conclusions With simple written instructions, women can identify an estimated day of ovulation and perform periovulatory exposure assessment. The Peak Day method is highly cost-effective and could be applied by researchers to target periconceptional or very early developmental stage exposure assessment. PMID:24400707

  6. Successful use of "Hour 1" transfer of sperm microinjected oocytes in natural cycles of poor responder women: a prospective randomized controlled pilot study.

    PubMed

    Aragona, Cesare; Linari, Antonella; Micara, Giulietta; Tranquilli, Daniela; Gambaro, Agnese Maria Lourdes; Bezerra Espinola, Maria Salome

    2016-05-01

    The aim of the study is to demonstrate the successful use of "Hour 1" transfer of sperm microinjected oocytes in natural cycles of poor responder women. Seventy women were selected from 92 consecutive poor responders undergoing intracytoplasmatic sperm injection (ICSI) in a natural cycle at our Sterility and Assisted Reproduction Unit from September 2009 to July 2013, and randomly distributed in two homogeneous groups: Group A or B. Women in Group A (35) underwent transfer within 1 h after ICSI; Group B (35, control group) underwent transfer 3 days after ICSI. In Group A, seven clinical pregnancy and one miscarriage occurred; in Group B, eight clinical pregnancies and two miscarriages were observed. Pregnancy, miscarriage, term pregnancy and overall live birth rates' difference between the two groups was not statistically significant (p > 0.05). Difference between the two groups in terms of timing, type of delivery and newborn birthweight was not observed. Neither ectopic pregnancy nor multiple pregnancies occurred. "Hour 1" uterine transfer of ICSI oocytes, still to be considered with caution because of the relatively low number of observations of the pilot study, deserves further attention on a larger scale, and might be evaluated for clinical and financial effectiveness in other clinical settings. PMID:26654862

  7. Early sedation and clinical outcomes of mechanically ventilated patients: a prospective multicenter cohort study

    PubMed Central

    2014-01-01

    Introduction Sedation overuse is frequent and possibly associated with poor outcomes in the intensive care unit (ICU) patients. However, the association of early oversedation with clinical outcomes has not been thoroughly evaluated. The aim of this study was to assess the association of early sedation strategies with outcomes of critically ill adult patients under mechanical ventilation (MV). Methods A secondary analysis of a multicenter prospective cohort conducted in 45 Brazilian ICUs, including adult patients requiring ventilatory support and sedation in the first 48 hours of ICU admissions, was performed. Sedation depth was evaluated after 48 hours of MV. Multivariate analysis was used to identify variables associated with hospital mortality. Results A total of 322 patients were evaluated. Overall, ICU and hospital mortality rates were 30.4% and 38.8%, respectively. Deep sedation was observed in 113 patients (35.1%). Longer duration of ventilatory support was observed (7 (4 to 10) versus 5 (3 to 9) days, P = 0.041) and more tracheostomies were performed in the deep sedation group (38.9% versus 22%, P = 0.001) despite similar PaO2/FiO2 ratios and acute respiratory distress syndrome (ARDS) severity. In a multivariate analysis, age (Odds Ratio (OR) 1.02; 95% confidence interval (CI) 1.00 to 1.03), Charlson Comorbidity Index >2 (OR 2.06; 95% CI, 1.44 to 2.94), Simplified Acute Physiology Score 3 (SAPS 3) score (OR 1.02; CI 95%, 1.00 to 1.04), severe ARDS (OR 1.44; CI 95%, 1.09 to 1.91) and deep sedation (OR 2.36; CI 95%, 1.31 to 4.25) were independently associated with increased hospital mortality. Conclusions Early deep sedation is associated with adverse outcomes and constitutes an independent predictor of hospital mortality in mechanically ventilated patients. PMID:25047960

  8. Toxoplasmic Retinochoroiditis: Clinical Characteristics and Visual Outcome in a Prospective Study

    PubMed Central

    Curi, André Luiz Land; Benchimol, Eliezer Israel; Amendoeira, Maria Regina Reis

    2016-01-01

    Purpose To ascertain the clinical features and visual outcome of toxoplasma retinochoroiditis in a large series of cases. Subjects and Methods Two hundred and thirty subjects diagnosed with active toxoplasma retinochoroiditis were prospectively followed for periods ranging from 269 to 1976 days. All patients presented with active retinochoroiditis and positive IgG T. gondii serology at the beginning of the study and received a standardized drug treatment for toxoplasmosis, both in the first episode and in the subsequent recurrences. Results The group involved 118 (51.3%) men and 112 (48.7%) women, with ages ranging from 14 to 77 years, mean of 32.4 years (SD = 11.38). Primary retinochoroidal lesions were observed in 52 (22.6%) cases and active retinochoroiditis combined with old scars in 178 (77.4%) subjects at the beginning of the study. A hundred sixty-two recurrent episodes in 104 (45.2%) patients were observed during follow-up. New subclinical retinochoroidal lesions were detected in 23 of 162 (14.2%) recurrences episodes during the follow-up. Posterior segment complications were observed in 73 (31.7%) subjects. Retinochoroidal lesions adjacent to the optic nerve and in the macular area were observed in 27 of 40 (67.5%) cases of severe visual impairment (VA = 20/200 or worse). Conclusion Toxoplasma retinochoroiditis in this population had a high recurrence rate after an active episode. Severe visual impairment was associated with location of the retinochoroidal scar, recurrences and posterior segment complications. It is crucial to consider the location of the lesion in studies analyzing visual prognosis as a measure for treatment effectiveness and prevention strategies. PMID:27136081

  9. An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee

    PubMed Central

    Nipanikar, Sanjay U.; Saluja, Manjit; Kuber, Vinod V.; Kadbhane, Kalyan P.; Chopra, Arvind; Khade, Namdev R.

    2013-01-01

    Background: Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA). Objectives: The main aim of the study was to assess the efficacy and safety of “TLPL/AY/03/2008”, a polyherbal formulation on knee joint pain assessed on visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Materials and Methods: It was an open label, single center, prospective, clinical study conducted in 36 patients of OA Knee. Two capsules of ‘TLPL/AY/03/2008’ were given to all patients twice daily orally after meals for 180 days. Results: Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. The mean joint pain (as assessed on VAS) reduced significantly (59.85%; P < 0.05) and the mean WOMAC combined score, WOMAC pain sub-score, WOMAC stiffness sub-score, and WOMAC difficulty sub-score also reduced significantly at the end of the study. The mean time taken by the patients to walk 50 feet too, was reduced significantly (25.26%) at the end of the study. At the end of 4 months of the treatment, no patient needed paracetamol as rescue medicine to control pain. Most of the patients had shown good overall improvement assessed by the physician and by the patients. Majority of the patients showed excellent tolerability to the study drug. No significant change in most of the safety laboratory parameters was observed at the end of the study. Conclusion: The study provides good evidence in support of the efficacy and safety of the ‘TLPL/AY/03/2008’ in OA of knee. PMID:23741160

  10. Clinical and echocardiographic characteristics of papillary fibroelastomas: a retrospective and prospective study in 162 patients

    NASA Technical Reports Server (NTRS)

    Sun, J. P.; Asher, C. R.; Yang, X. S.; Cheng, G. G.; Scalia, G. M.; Massed, A. G.; Griffin, B. P.; Ratliff, N. B.; Stewart, W. J.; Thomas, J. D.

    2001-01-01

    BACKGROUND: Cardiac papillary fibroelastoma (CPF) is a primary cardiac neoplasm that is increasingly detected by echocardiography. The clinical manifestations of this entity are not well described. METHODS AND RESULTS: In a 16-year period, we identified patients with CPF from our pathology and echocardiography databases. A total of 162 patients had pathologically confirmed CPF. Echocardiography was performed in 141 patients with 158 CPFs, and 48 patients had CPFs that were not visible by echocardiography (<0.2 cm), leaving an echocardiographic subgroup of 93 patients with 110 CPFs. An additional 45 patients with a presumed diagnosis of CPF were identified. The mean age of the patients was 60+/-16 years of age, and 46.1% were male. Echocardiographically, the mean size of the CPFs was 9+/-4.6 mm; 82.7% occurred on valves (aortic more than mitral), 43.6% were mobile, and 91.4% were single. During a follow-up period of 11+/-22 months, 23 of 26 patients with a prospective diagnosis of CPF that was confirmed by pathological examination had symptoms that could be attributable to embolization. In the group of 45 patients with a presumed diagnosis of CPF, 3 patients had symptoms that were likely due to embolization (incidence, 6.6%) during a follow-up period of 552+/-706 days. CONCLUSIONS: CPFs are generally small and single, occur most often on valvular surfaces, and may be mobile, resulting in embolization. Because of the potential for embolic events, symptomatic patients, patients undergoing cardiac surgery for other lesions, and those with highly mobile and large CPFs should be considered for surgical excision.

  11. Stereotactic Body Radiotherapy for Localized Prostate Cancer: Interim Results of a Prospective Phase II Clinical Trial

    SciTech Connect

    King, Christopher R. Brooks, James D.; Gill, Harcharan; Pawlicki, Todd; Cotrutz, Cristian; Presti, Joseph C.

    2009-03-15

    Purpose: The radiobiology of prostate cancer favors a hypofractionated dose regimen. We report results of a prospective Phase II clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer. Methods and Materials: Forty-one low-risk prostate cancer patients with 6 months' minimum follow-up received 36.25 Gy in five fractions of 7.25 Gy with image-guided SBRT alone using the CyberKnife. The early (<3 months) and late (>6 months) urinary and rectal toxicities were assessed using validated quality of life questionnaires (International Prostate Symptom Score, Expanded Prostate Cancer Index Composite) and the Radiation Therapy Oncology Group (RTOG) toxicity criteria. Patterns of prostate-specific antigen (PSA) response are analyzed. Results: The median follow-up was 33 months. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 patients with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 patients (29%) occurring at 18 months (median) after treatment. At last follow-up, no patient has had a PSA failure regardless of biochemical failure definition. Of 32 patients with 12 months minimum follow-up, 25 patients (78%) achieved a PSA nadir {<=}0.4 ng/mL. A PSA decline to progressively lower nadirs up to 3 years after treatment was observed. Conclusions: The early and late toxicity profile and PSA response for prostate SBRT are highly encouraging. Continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles.

  12. Two-piece zirconia implants supporting all-ceramic crowns: A prospective clinical study

    PubMed Central

    Cionca, Norbert; Müller, Nada; Mombelli, Andrea

    2015-01-01

    Objectives The aim of this prospective clinical study is to evaluate the safety and efficacy of a new all-ceramic implant system to replace missing teeth in partially edentulous patients. Material and methods Thirty-two partially edentulous, systemically healthy patients were treated with 49 two-piece zirconia implants (ZERAMEX® T Implant System). Zirconia abutments were connected with adhesive resin cement. Single-unit full-ceramic crowns were cemented. The cases have been followed for 588±174 days after loading (range 369–889 days). All patients have been re-evaluated 1 year after loading. Results The cumulative survival rate 1 year after loading was 87% implants. All failures were the result of aseptic loosening, and no implants were lost after the first year. The results of the other cases were good, and the patients were very satisfied. The cumulative soft tissue complication rate was 0%, the cumulative technical complication rate was 4% implants, the cumulative complication rate for bone loss >2 mm was 0%, and the cumulative esthetic complication rate was 0%. Including the data from 20 patients treated with an earlier version of the system, an over-all 2-year cumulative survival rate of 86% was calculated for a total of 76 two-piece zirconia implants supporting all-ceramic crowns in 52 patients. Conclusions Replacement of single teeth in the posterior area was possible with this new full-ceramic implant system. Failures were due to aseptic loosening. PMID:24666352

  13. Comparability of ophthalmic diagnoses by clinical and Reading Center examiners in the Visual Acuity Impairment Survey Pilot Study.

    PubMed

    Sperduto, R D; Hiller, R; Podgor, M J; Palmberg, P; Ferris, F L; Wentworth, D

    1986-12-01

    Technologic advances in ophthalmic equipment offer the possibility of replacing direct clinical examinations with Reading Center evaluations of data recorded in epidemiologic studies. Clinical and Reading Center examiners made independent ophthalmic diagnoses of 133 right and 132 left eyes of 138 adults in the Visual Acuity Impairment Survey Pilot Study, carried out in three US cities, Boston, Detroit, and Minneapolis, in August 1981-December 1982. The Reading Center diagnosed eye conditions using only photographic and visual field data collected at the time of the clinical examination. In the comparisons of clinical and Reading Center evaluations reported here, only eyes judged by the examiners to have pathology severe enough to reduce visual acuity to 6/9 or worse were classified as having pathology. (No visual acuity criterion was required for the diagnosis of glaucoma or diabetic retinopathy.) There was agreement in diagnostic assessments between clinical and Reading Center examiners in about 80% of eyes. The kappa statistic, which adjusts for chance agreement, was in the fair to good range: 0.60 for 133 right eyes and 0.62 for 132 left eyes. When the Reading Center examiners were provided with additional information on medical history, refractive error and best corrected visual acuity, the agreement between clinical and Reading Center assessments among the subset of eyes with 6/9 or worse vision again was in the fair to good range, with kappas of 0.61 for 45 right eyes and 0.68 for 48 left eyes. Inter-observer agreement between Reading Center examiners in diagnosing pathology was in the good to excellent range. Use of Reading Centers in future epidemiologic studies should be considered, but elimination of the clinical examinations is not recommended until modifications in the protocol described here have been made and shown to improve levels of agreement between clinical and Reading Center examiners. PMID:3776982

  14. Prospective randomized study comparing clinical, functional, and aesthetic results of minipterional and classic pterional craniotomies.

    PubMed

    Welling, Leonardo C; Figueiredo, Eberval G; Wen, Hung T; Gomes, Marcos Q T; Bor-Seng-Shu, Edson; Casarolli, Cesar; Guirado, Vinicius M P; Teixeira, Manoel Jacobsen

    2015-05-01

    OBJECT The object of this study was to compare the clinical, functional, and aesthetic results of 2 surgical techniques, pterional (PT) and minipterional (MPT) craniotomies, for microsurgical clipping of anterior circulation aneurysms. METHODS Fifty-eight patients with ruptured and unruptured anterior circulation aneurysms were enrolled into a prospective randomized study. The first group included 28 patients who underwent the MPT technique, and the second group comprised 30 patients who underwent the classic PT craniotomy. To evaluate the aesthetic effects, patients were asked to grade on a rule from 0 to 100 the best and the worst aesthetic result. Photographs were also taken, assessed by 2 independent observers, and classified as showing excellent, good, regular, or poor aesthetic results. Furthermore, quantitative radiological assessment (percentage reduction in thickness and volumetric analysis) of the temporal muscle, subcutaneous tissue, and skin was performed. Functional outcomes were compared using the modified Rankin Scale (mRS). Frontal facial palsy, postoperative hemorrhage, cerebrospinal fistula, hydrocephalus, and mortality were also analyzed. RESULTS Demographic and preoperative characteristics were similar in both groups. Satisfaction in terms of aesthetic result was observed in 19 patients (79%) in the MPT group and 13 (52%) in the PT group (p = 0.07). The mean score on the aesthetic rule was 27 in the MPT group and 45.8 in the PT group (p = 0.03). Two independent observers analyzed the patient photos, and the kappa coefficient for the aesthetic results was 0.73. According to these observers, excellent and good results were seen in 21 patients (87%) in the MPT and 12 (48%) in the PT groups. The degree of temporal muscle, subcutaneous tissue, and skin atrophy was 14.9% in the MPT group and 24.3% in the PT group (p = 0.01). Measurements of the temporal muscle revealed 12.7% atrophy in the MPT group and 22% atrophy in the PT group (p = 0.005). The

  15. Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

    PubMed Central

    2011-01-01

    Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score) were analysed with a regression model. Results The sample comprised 192 adolescents admitted during one year (response rate 87%). Mean age was 15.7 years (range 10-18) and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4). The largest groups of main diagnostic conditions were affective (28%) and externalizing (26%) disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA) at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement) in the HoNOSCA total score was 5.1 (SD 6.2), with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission. Conclusions Acute

  16. Effect of zoledronic acid on bone mineral density in patients of celiac disease: A prospective, randomized, pilot study

    PubMed Central

    Kumar, Mukul; Rastogi, Ashu; Bhadada, Sanjay Kumar; Bhansali, Anil; Vaiphei, Kim; Kochhar, Rakesh

    2013-01-01

    Background & objectives: The symptoms of celiac disease (CD) are varied and metabolic bone disease (MBD) is less recognized amongst all manifestations in CD patients. Bone disease in CD is attributed to secondary hyperparathyroidism, which in turn is associated with increased bone remodelling. Improvement in bone mineral density (BMD) with gluten free diet (GFD) is known, but the data on efficacy of bisphosphonates in CD patients are limited. Bisphosphonates being a potent inhibitor of bone resorption may be useful in patients with CD having low BMD. The aim of the present investigation was to study the effect of zoledronic acid on BMD in CD patients. Methods: A total of 28 CD patients were randomized to receive GFD, calcium and cholecalciferol (group A), and zoledronic acid (group B). Baseline biochemical tests and T-score by dual energy x-ray absorptiometer were done and repeated after 12 months. Results: The T-score showed improvement in the control arm (group A) from -3.31 ± 1.46 to -2.12 ± 1.44, a gain of 35.9 per cent (P<0.05) and in drug arm (group B) -2.82 ± 1.27 to -1.06 ± 1.84, registering a gain of 62.4 per cent (P<0.001). However, there was no difference in improvement of T-score in zoledronic acid group as compared to the control group. Interpretation & conclusions: Administration of zoledronic acid was not found to be better than GFD alone in increasing BMD in CD patients with low BMD in this pilot study. PMID:24521630

  17. Organizational development trajectory of a large academic radiotherapy department set up similarly to a prospective clinical trial: the MAASTRO experience

    PubMed Central

    Boersma, L; Dekker, A; Hermanns, E; Houben, R; Govers, M; van Merode, F; Lambin, P

    2015-01-01

    Objective: To simultaneously improve patient care processes and clinical research activities by starting a hypothesis-driven reorganization trajectory mimicking the rigorous methodology of a prospective clinical trial. Methods: The design of this reorganization trajectory was based on the model of a prospective trial. It consisted of (1) listing problems and analysing their potential causes, (2) defining interventions, (3) defining end points and (4) measuring the effect of the interventions (i.e. at baseline and after 1 and 2 years). The primary end point for patient care was the number of organizational root causes of incidents/near incidents; for clinical research, it was the number of patients in trials. There were several secondary end points. We analysed the data using two sample z-tests, χ2 test, a Mann–Whitney U test and the one-way analysis of variance with Bonferroni correction. Results: The number of organizational root causes was reduced by 27% (p < 0.001). There was no effect on the percentage of patients included in trials. Conclusion: The reorganizational trajectory was successful for the primary end point of patient care and had no effect on clinical research. Some confounding events hampered our ability to draw strong conclusions. Nevertheless, the transparency of this approach can give medical professionals more confidence in moving forward with other organizational changes in the same way. Advances in knowledge: This article is novel because managerial interventions were set up similarly to a prospective clinical trial. This study is the first of its kind in radiotherapy, and this approach can contribute to discussions about the effectiveness of managerial interventions. PMID:25679320

  18. A 4-Week Home-Based Aerobic and Resistance Exercise Program During Radiation Therapy: A Pilot Randomized Clinical Trial

    PubMed Central

    Mustian, Karen M.; Peppone, Luke; Darling, Tom V.; Palesh, Oxana; Heckler, Charles E.; Morrow, Gary R.

    2011-01-01

    During radiation therapy, cancer patients may report cancer-related fatigue (CRF), which impairs aerobic capacity, strength, muscle mass, and, ultimately, quality of life (QOL). The purpose of this pilot clinical trial was to examine the feasibility and initial efficacy of a home-based aerobic and progressive resistance exercise intervention for aerobic capacity, strength, muscle mass, CRF, and QOL. Daily steps walked (DSW), daily minutes of resistance exercise (MRE), and number of resistance exercise days (RED) were assessed to evaluate intervention adherence. Breast and prostate cancer patients (n = 38) beginning radiation therapy were randomized to undergo 4 weeks of exercise or no exercise. Participants in the exercise group demonstrated good adherence to the exercise intervention, with significantly more DSW, MRE, and RED at post intervention and 3 month follow-up than controls. Participants in the exercise intervention exhibited significantly higher QOL and significantly lower CRF post intervention and at 3-month follow-up than controls. Results of this pilot study provide positive preliminary evidence that exercise during radiation may be beneficial for cancer patients. PMID:19831159

  19. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    PubMed Central

    Kong, Moonkyoo; Shin, Sung Hee; Lee, Eunmi; Yun, Eun Kyoung

    2014-01-01

    Background There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT). We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients’ evaluation of pain within the RT field was also assessed. Results In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%), five (33.3%), and five patients (33.3%), respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%), nine (47.4%), two (10.5%), and one patient (5.3%), respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%). The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not statistically significant. Conclusion The results of this study show that laughter therapy can have a beneficial role in preventing radiation dermatitis in patients with breast cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes are required. PMID:25395864

  20. Multimodal navigated skull base tumor resection using image-based vascular and cranial nerve segmentation: A prospective pilot study

    PubMed Central

    Dolati, Parviz; Gokoglu, Abdulkerim; Eichberg, Daniel; Zamani, Amir; Golby, Alexandra; Al-Mefty, Ossama

    2015-01-01

    Background: Skull base tumors frequently encase or invade adjacent normal neurovascular structures. For this reason, optimal tumor resection with incomplete knowledge of patient anatomy remains a challenge. Methods: To determine the accuracy and utility of image-based preoperative segmentation in skull base tumor resections, we performed a prospective study. Ten patients with skull base tumors underwent preoperative 3T magnetic resonance imaging, which included thin section three-dimensional (3D) space T2, 3D time of flight, and magnetization-prepared rapid acquisition gradient echo sequences. Imaging sequences were loaded in the neuronavigation system for segmentation and preoperative planning. Five different neurovascular landmarks were identified in each case and measured for accuracy using the neuronavigation system. Each segmented neurovascular element was validated by manual placement of the navigation probe, and errors of localization were measured. Results: Strong correspondence between image-based segmentation and microscopic view was found at the surface of the tumor and tumor-normal brain interfaces in all cases. The accuracy of the measurements was 0.45 ± 0.21 mm (mean ± standard deviation). This information reassured the surgeon and prevented vascular injury intraoperatively. Preoperative segmentation of the related cranial nerves was possible in 80% of cases and helped the surgeon localize involved cranial nerves in all cases. Conclusion: Image-based preoperative vascular and neural element segmentation with 3D reconstruction is highly informative preoperatively and could increase the vigilance of neurosurgeons for preventing neurovascular injury during skull base surgeries. Additionally, the accuracy found in this study is superior to previously reported measurements. This novel preliminary study is encouraging for future validation with larger numbers of patients. PMID:26674155

  1. Assessing experimental visceral pain in dairy cattle: A pilot, prospective, blinded, randomized, and controlled study focusing on spinal pain proteomics.

    PubMed

    Rialland, P; Otis, C; de Courval, M-L; Mulon, P-Y; Harvey, D; Bichot, S; Gauvin, D; Livingston, A; Beaudry, F; Hélie, P; Frank, D; Del Castillo, J R E; Troncy, E

    2014-01-01

    Few studies have verified the validity of behavioral and physiological methods of pain assessment in cattle. This prospective, blinded, randomized controlled experimental study aimed to validate different methods of pain assessment during acute and chronic (up to 21 d postintervention) conditions in dairy cattle, in response to 3 analgesic treatments for traumatic reticuloperitonitis. Cerebrospinal fluid (CSF) biomarkers and mechanical sensitization were measured as indicators of centralized pain. Proteomics in the CSF were examined to detect specific (to pain intensity) and sensitive (responsive to analgesia) markers. Recordings of spontaneous behavior with video analysis, telemetered motor activity, pain scales, electrodermal activity, and plasma cortisol concentration were quantified at regular intervals. Cows were assigned to group 1 (n=4, standard control receiving aspirin), group 2 (n=5, test group receiving preemptive tolfenamic acid), or group 3 (n=3, positive control receiving preemptive multimodal analgesia composed of epidural morphine, plus tolfenamic acid and butorphanol). Rescue analgesia was administered as needed. Generalized estimating equations tested group differences and the influence of rescue analgesia on the measurements. All 3 groups demonstrated a long-term decrease in a CSF protein identified as transthyretin. The decrease in transthyretin expression inversely correlated with the expected level of analgesia (group 1<2<3). Moreover, in group 1, CSF noradrenaline decreased long term, cows were hypersensitive to mechanical stimulation, and they demonstrated signs of discomfort with higher motor activity and "agitation while lying" recorded from video analysis. Decreased "feeding behavior," observer-reported pain scales, electrodermal activity, and plasma cortisol concentration were inconsistent to differentiate pain intensity between groups. In summary, changes in CSF biomarkers and mechanical sensitization reflected modulation of central

  2. Evaluation of factors predicting clinical pleural injury during percutaneous nephrolithotomy: a prospective study.

    PubMed

    Sharma, Kuldeep; Sankhwar, Satya Narayan; Singh, Vishwajeet; Singh, Bhupendra Pal; Dalela, Diwakar; Sinha, Rahul Janak; Kumar, Manoj; Singh, Manmeet; Goel, Apul

    2016-06-01

    The purpose of this study is to prospectively identify factors that predict the chance of pleural injury (detected clinically or on postoperative X-ray chest) during percutaneous nephrolithotomy (PCNL). All patients with renal/upper ureteric stones, undergoing PCNL between January 2013 and June 2014, were evaluated for pleural injury. An erect chest X-ray on inspiration was done within 6 h of PCNL. The patients were divided into Groups A and B depending on whether they developed or did not develop pleural injury. Patient-, stone-, renal-, and procedure-related factors were compared between the two groups. 332 patients with mean age 36.76 ± 15.01 years (range 4-80) and M:F of 172:160 fulfilled the inclusion criteria. Pleural complications occurred in 10 patients (3 %). Of 141 patients with supracostal punctures (59 had additional infracostal punctures), 4.2 % (n = 6) had pleural injury. Of 191 patients with only infracostal punctures, 4 developed pleural injuries (2 %). Patients in group A had significantly lower age (27.00 ± 11.18 vs. 37.06 ± 15.03, p = 0.03) and lower BMI (18.0 ± 1.90 vs. 21.12 ± 2.24 p = 0.002). Incidence of pleural injury was significantly higher (p = 0.001) on right side [4.0 % (7/172) vs. 1.8 %, 3/160)]. Incidence of pleural injury had no association with staghorn calculi, stone surface area (590.51 ± 313.88 for Group A vs. 593.02 ± 387.10 for Group B; p = 0.11), degree of hydronephrosis, and operative time (65.13 ± 19.45 for Group A vs. 72.21 ± 19.56 for Group B; p = 0.06). On multivariate analysis, only low BMI and mean age <27 years were associated with higher risk of pleural injury. Higher incidence of pleural injury was noted in patients with low BMI and younger age. PMID:26362476

  3. Clinical and functional outcomes of the PCCP study: a multi-center prospective study in Italy.

    PubMed

    Antonini, G; Giancola, R; Berruti, D; Blanchietti, E; Pecchia, P; Francione, V; Greco, P; Russo, T C; Pietrogrande, L

    2013-04-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proximal femoral fracture of type AO 31.A1 or 31.A2 were enrolled in eight hospitals in Italy. The primary outcome of interest was the recovery of the pre-fracture functional status at 1-year follow-up; secondary outcomes of interest included blood transfusions, surgical time, complications, and mortality. A total of 273 patients were enrolled. The ASA score was 3 or 4 in 72.5 % of patients. The mean surgical time was 44.1 min; the mean post-surgery blood transfusions was 0.9 units. At 1 year, 48 patients (17.6 %) died, 28 (10.2 %) were lost to follow-up, 4 patients (1.5 %) were excluded, hence 193 patients (70.3 %) were available for final evaluation. At the 1-year follow-up visit, 51.9 % of patients recovered or improved their pre-fracture modified Harris Hip Score, 49.1 % of patients improved or maintained their walking abilities, and 66.6 % of patients residing at home pre-surgery maintained their domicile. The overall mortality rate was 17.6 %. Major complications included two fracture collapses, one excessive sliding of the cephalic screw leading to a partial fracture collapse and one back-out of the diaphyseal screw. This study demonstrates that treatment of trochanteric fractures with PCCP gives good outcomes and significant advantages such as low blood loss, short surgical time, low risk of complications, and good functional recovery in the majority of the patients. PMID:23543403

  4. Untreated clinical course of cerebral cavernous malformations: a prospective, population-based cohort study

    PubMed Central

    Salman, Rustam Al-Shahi; Hall, Julie M; Horne, Margaret A; Moultrie, Fiona; Josephson, Colin B; Bhattacharya, Jo J; Counsell, Carl E; Murray, Gordon D; Papanastassiou, Vakis; Ritchie, Vaughn; Roberts, Richard C; Sellar, Robin J; Warlow, Charles P

    2012-01-01

    Summary Background Cerebral cavernous malformations (CCMs) are prone to bleeding but the risk of intracranial haemorrhage and focal neurological deficits, and the factors that might predict their occurrence, are unclear. We aimed to quantify these risks and investigate whether they are affected by sex and CCM location. Methods We undertook a population-based study using multiple overlapping sources of case ascertainment (including a Scotland-wide collaboration of neurologists, neurosurgeons, stroke physicians, radiologists, and pathologists, as well as searches of registers of hospital discharges and death certificates) to identify definite CCM diagnoses first made in Scottish residents between 1999 and 2003, which study neuroradiologists independently validated. We used multiple sources of prospective follow-up both to identify outcome events (which were assessed by use of brain imaging, by investigators masked to potential predictive factors) and to assess adults' dependence. The primary outcome was a composite of intracranial haemorrhage or focal neurological deficits (not including epileptic seizure) that were definitely or possibly related to CCM. Findings 139 adults had at least one definite CCM and 134 were alive at initial presentation. During 1177 person-years of follow-up (completeness 97%), for intracranial haemorrhage alone the 5-year risk of a first haemorrhage was lower than the risk of recurrent haemorrhage (2·4%, 95% CI 0·0–5·7 vs 29·5%, 4·1–55·0; p<0·0001). For the primary outcome, the 5-year risk of a first event was lower than the risk of recurrence (9·3%, 3·1–15·4 vs 42·4%, 26·8–58·0; p<0·0001). The annual risk of recurrence of the primary outcome declined from 19·8% (95% CI 6·1–33·4) in year 1 to 5·0% (0·0–14·8) in year 5 and was higher for women than men (p=0·01) but not for adults with brainstem CCMs versus CCMs in other locations (p=0·17). Interpretation The risk of recurrent intracranial haemorrhage or

  5. Multiwavelength optoacoustic system for noninvasive monitoring of cerebral venous oxygenation: a pilot clinical test in the internal jugular vein

    NASA Astrophysics Data System (ADS)

    Petrov, Yuriy Y.; Petrova, Irina Y.; Patrikeev, Igor A.; Esenaliev, Rinat O.; Prough, Donald S.

    2006-06-01

    A noninvasive, high-resolution optoacoustic technique is a promising alternative to currently used invasive methods of brain oxygenation monitoring. We present the results of our pilot clinical test of this technique in healthy volunteers. Multiwavelength optoacoustic measurements (with nanosecond optical parametric oscillator as a source of radiation) were performed on the area of the neck overlying the internal jugular vein, a deeply located large vein that drains blood from the brain and from extracranial tissues. Optoacoustic signals induced in venous blood were measured with high resolution and signal-to-noise ratio despite the presence of a thick layer of overlying tissue (up to 10 mm). The characteristic parameters of the signal at different wavelengths correlated well with the spectrum of the effective attenuation coefficient of blood.

  6. Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

    NASA Astrophysics Data System (ADS)

    Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

    2012-11-01

    Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

  7. Preclinical and Pilot Clinical Studies of Docetaxel Chemoradiation for Stage III Non-Small-Cell Lung Cancer

    SciTech Connect

    Chen Yuhchyau; Pandya, Kishan J.; Hyrien, Ollivier; Keng, Peter C.; Smudzin, Therese; Anderson, Joy; Qazi, Raman; Smith, Brian; Watson, Thomas J.; Feins, Richard H.; Johnstone, David W.

    2011-08-01

    Purpose: Local and distant failure rates remain high despite aggressive chemoradiation (CRT) treatment for Stage III non-small-cell lung cancer. We conducted preclinical studies of docetaxel's cytotoxic and radiosensitizing effects on lung cancer cell lines and designed a pilot study to target distant micrometastasis upfront with one-cycle induction chemotherapy, followed by low-dose radiosensitizing docetaxel CRT. Methods and Materials: A preclinical study was conducted in human lung cancer cell lines NCI 520 and A549. Cells were treated with two concentrations of docetaxel for 3 h and then irradiated immediately or after a 24-h delay. A clonogenic survival assay was conducted and analyzed for cytotoxic effects vs. radiosensitizing effects of docetaxel. A pilot clinical study was designed based on preclinical study findings. Twenty-two patients were enrolled with a median follow-up of 4 years. Induction chemotherapy consisted of 75 mg/m{sup 2} of docetaxel and 75 mg/m{sup 2} of cisplatin on Day 1 and 150 mg/m{sup 2} of recombinant human granulocyte colony-stimulating factor on Days 2 through 10. Concurrent CRT was started 3 to 6 weeks later with twice-weekly docetaxel at 10 to 12 mg/m{sup 2} and daily delayed radiation in 1.8-Gy fractions to 64.5 Gy for gross disease. Results: The preclinical study showed potent cytotoxic effects of docetaxel and subadditive radiosensitizing effects. Delaying radiation resulted in more cancer cell death. The pilot clinical study resulted in a median survival of 32.6 months for the entire cohort, with 3- and 5-year survival rates of 50% and 19%, respectively, and a distant metastasis-free survival rate of 61% for both 3 and 5 years. A pattern-of-failure analysis showed 75% chest failures and 36% all-distant failures. Therapy was well tolerated with Grade 3 esophagitis observed in 23% of patients. Conclusions: One-cycle full-dose docetaxel/cisplatin induction chemotherapy with recombinant human granulocyte colony-stimulating factor

  8. Clinical Realization of Sector Beam Intensity Modulation for Gamma Knife Radiosurgery: A Pilot Treatment Planning Study

    SciTech Connect

    Ma, Lijun; Mason, Erica; Sneed, Penny K.; McDermott, Michael; Polishchuk, Alexei; Larson, David A.; Sahgal, Arjun

    2015-03-01

    Purpose: To demonstrate the clinical feasibility and potential benefits of sector beam intensity modulation (SBIM) specific to Gamma Knife stereotactic radiosurgery (GKSRS). Methods and Materials: SBIM is based on modulating the confocal beam intensities from individual sectors surrounding an isocenter in a nearly 2π geometry. This is in contrast to conventional GKSRS delivery, in which the beam intensities from each sector are restricted to be either 0% or 100% and must be identical for any given isocenter. We developed a SBIM solution based on available clinical planning tools, and we tested it on a cohort of 12 clinical cases as a proof of concept study. The SBIM treatment plans were compared with the original clinically delivered treatment plans to determine dosimetric differences. The goal was to investigate whether SBIM would improve the dose conformity for these treatment plans without prohibitively lengthening the treatment time. Results: A SBIM technique was developed. On average, SBIM improved the Paddick conformity index (PCI) versus the clinically delivered plans (clinical plan PCI = 0.68 ± 0.11 vs SBIM plan PCI = 0.74 ± 0.10, P=.002; 2-tailed paired t test). The SBIM plans also resulted in nearly identical target volume coverage (mean, 97 ± 2%), total beam-on times (clinical plan 58.4 ± 38.9 minutes vs SBIM 63.5 ± 44.7 minutes, P=.057), and gradient indices (clinical plan 3.03 ± 0.27 vs SBIM 3.06 ± 0.29, P=.44) versus the original clinical plans. Conclusion: The SBIM method is clinically feasible with potential dosimetric gains when compared with conventional GKSRS.

  9. Head-and-Neck Target Delineation Among Radiation Oncology Residents After a Teaching Intervention: A Prospective, Blinded Pilot Study

    SciTech Connect

    Bekelman, Justin E. Wolden, Suzanne; Lee, Nancy

    2009-02-01

    Purpose: We conducted this study to determine the feasibility of incorporating a teaching intervention on target delineation into the educational curriculum of a radiation oncology residency program and to assess the short-term effects on resident skills. Methods and Materials: The study schema consisted of a baseline evaluation, the teaching intervention, and a follow-up evaluation. At the baseline evaluation, the participants contoured three clinical tumor volumes (CTVs) (70 Gy, 59.4 Gy, and 54 Gy) on six contrast-enhanced axial computed tomography images of a de-identified patient with Stage T2N2bM0 squamous cell carcinoma of the right base of the tongue. The participants attended a series of head-and-neck oncology and anatomy seminars. The teaching intervention consisted of a didactic lecture and an interactive hands-on practical session designed to improve the knowledge and skills for target delineation in the head and neck. At the follow-up evaluation, the residents again contoured the CTVs. Results: Of the 14 eligible residents, 11 (79%) actually participated in the study. For all participants, but especially for those who had not had previous experience with head-and-neck target delineation, the teaching intervention was associated with improvement in the delineation of the node-negative neck (CTV 54 Gy contour). Regardless of clinical experience, participants had difficulty determining what should be included in the CTV 59.4 Gy contour to ensure adequate coverage of potential microscopic disease. Conclusion: Incorporating a teaching intervention into the education curriculum of a radiation oncology residency program is feasible and was associated with short-term improvements in target delineation skills. Subsequent interventions will require content refinement, additional validation, longer term follow-up, and multi-institutional collaboration.

  10. Psychiatric Residents' Attitudes toward and Experiences with the Clinical-Skills Verification Process: A Pilot Study on U.S. and International Medical Graduates

    ERIC Educational Resources Information Center

    Rao, Nyapati R.; Kodali, Rahul; Mian, Ayesha; Ramtekkar, Ujjwal; Kamarajan, Chella; Jibson, Michael D.

    2012-01-01

    Objective: The authors report on a pilot study of the experiences and perceptions of foreign international medical graduate (F-IMG), United States international medical graduate (US-IMG), and United States medical graduate (USMG) psychiatric residents with the newly mandated Clinical Skills Verification (CSV) process. The goal was to identify and…

  11. The use of school teachers to promote oral hygiene in some secondary school students at Hyderabad, Andhra Pradesh, India: A short term prospective pilot study

    PubMed Central

    Chandrashekar, Byalakere R.; Suma, Shankarappa; Kiran, Kaverikana; Manjunath, Badhravathi C.

    2012-01-01

    Study design: It was a short term prospective pilot study on a group of 116 secondary school students. Objectives: To assess the feasibility of using the services of school teachers to promote oral hygiene in secondary school students and compare the effectiveness of dental health education (DHE) offered by school teachers on a fortnightly basis with what is offered by dental professionals at three- monthly intervals. Materials and Methods: Six secondary schools were randomly selected. The base-line Oral Hygiene Index simplified (OHI-S) and Plaque index (PI) scores for all the students were recorded. The teachers were trained on dental health facts. The six schools were divided into three groups of two schools with different intervention techniques: Group 1- Schools given no health education, Group 2 – Schools given health education by their school teachers on a fortnightly basis together with simple screening for deposits of gross calculus , Group 3 – Schools which were given health education by dental professionals at intervals of three months without any screening. Grade nine students were selected for pre and post intervention evaluation. The second examination was done six months following the intervention to find out the OHI-S and Plaque index scores. The examination was done by three trained and calibrated dentists. Data analysis was done with SPSS 16 with relevant statistical tests. Results: The mean OHI-S and PI scores were significantly less in group 2 and there was a statistically significant difference between the baseline OHI – S, PI score and the scores after six months in all the three groups. Conclusion: The concept of utilizing the teachers for frequent DHE and screening for any gross deposits of food debris and calculus is feasible. Also frequent DHE by teachers was more effective than the infrequent DHE by the professionals. PMID:23230385

  12. Pilot Testing Behavior Therapy for Chronic Tic Disorders in Neurology and Developmental Pediatrics Clinics.

    PubMed

    Ricketts, Emily J; Gilbert, Donald L; Zinner, Samuel H; Mink, Jonathan W; Lipps, Tara D; Wiegand, Geoffrey A; Vierhile, Amy E; Ely, Laura J; Piacentini, John; Walkup, John T; Woods, Douglas W

    2016-03-01

    Comprehensive Behavioral Intervention for Tics (CBIT) is an efficacious treatment with limited regional availability. As neurology and pediatric clinics are often the first point of therapeutic contact for individuals with tics, the present study assessed preliminary treatment response, acceptability, and feasibility of an abbreviated version, modified for child neurology and developmental pediatrics clinics. Fourteen youth (9-17) with Tourette disorder across 2 child neurology clinics and one developmental pediatrics clinic participated in a small case series. Clinician-rated tic severity (Yale Global Tic Severity Scale) decreased from pre- to posttreatment, z = -2.0, P < .05, r = -.48, as did tic-related impairment, z = -2.4, P < .05, r = -.57. Five of the 9 completers (56%) were classified as treatment responders. Satisfaction ratings were high, and therapeutic alliance ratings were moderately high. Results provide guidance for refinement of this modified CBIT protocol. PMID:26271790

  13. Integrated genomic and prospective clinical studies show the importance of modular pleiotropy for disease susceptibility, diagnosis and treatment

    PubMed Central

    2014-01-01

    Background Translational research typically aims to identify and functionally validate individual, disease-specific genes. However, reaching this aim is complicated by the involvement of thousands of genes in common diseases, and that many of those genes are pleiotropic, that is, shared by several diseases. Methods We integrated genomic meta-analyses with prospective clinical studies to systematically investigate the pathogenic, diagnostic and therapeutic roles of pleiotropic genes. In a novel approach, we first used pathway analysis of all published genome-wide association studies (GWAS) to find a cell type common to many diseases. Results The analysis showed over-representation of the T helper cell differentiation pathway, which is expressed in T cells. This led us to focus on expression profiling of CD4+ T cells from highly diverse inflammatory and malignant diseases. We found that pleiotropic genes were highly interconnected and formed a pleiotropic module, which was enriched for inflammatory, metabolic and proliferative pathways. The general relevance of this module was supported by highly significant enrichment of genetic variants identified by all GWAS and cancer studies, as well as known diagnostic and therapeutic targets. Prospective clinical studies of multiple sclerosis and allergy showed the importance of both pleiotropic and disease specific modules for clinical stratification. Conclusions In summary, this translational genomics study identified a pleiotropic module, which has key pathogenic, diagnostic and therapeutic roles. PMID:24571673

  14. Evaluation of the efficacy of an hyaluronic acid-based biogel on periodontal clinical parameters. A randomized-controlled clinical pilot study

    PubMed Central

    Pilloni, Andrea; Annibali, Susanna; Dominici, Francesco; Di Paolo, Carlo; Papa, Marco; Cassini, Maria Antonietta; Polimeni, Antonella

    2012-01-01

    Summary Hyaluronic acid (HA) is an ubiquitous form of non-sulphated glycosaminoglycan of the extracellular matrix of all mammalian connective tissues. It is mainly present during tissue’s formation or during most of initial tissue’s repair processess. Cell migration, adhesion and differentiation are only part of several unique biological characteristics of HA which have been under investigation in the past decades. Aim of the study Evaluate the possible positive effect of an esterified form of HA on gingival tissues in mild chronic periodontitis patients, seeking for the reduction of all the periodontal disease clinical parameters PLI (Plaque Index), BOP (Bleeding on Probing), PPD (Probing Pocket Depth), GI (Gingival Index), PAL (Probing Attachment Level). Materials and methods The study is an open, intra-patient, controlled, single center pilot clinical trial including 19 adult patients with mild chronic periodontitis and shallow pockets (< 4 mm) in at least two different quadrants. One quadrant was treated with HA gel after regular toothbrushing (test), the other without (control). Results Although oral hygiene itself had a similar positive influence on the improvement of all the clinical indexes for test and control, the treatment with HA gel showed a greater effect almost always statistically significant. BOP in the HA gel treated areas had a decrease of 92.7% and GI of 96.5%, whereas controls 75.8% and 79.0% respectively. The difference of PPD in both areas was statistically significant (p<0.01) in favour of the HA gel treated zone. Also PAL and Pl were reduced more with gel than with oral hygiene alone, although this did not reach a statistical significant difference. Conclusion It appears that an esterified gel form of HA has shown an effect in reducing the gingival inflammation when used as an adjunct to mechanical home plaque control and that it could be successfully used to improve the periodontal clinical indexes. This pilot study will gain

  15. [Economic aspects of inpatient treatment for decompensated liver cirrhosis: a prospective study employing an evidence-based clinical pathway].

    PubMed

    Hahn, N; Bobrowski, C; Weber, E; Simon, P; Kraft, M; Aghdassi, A; Raetzell, M; Wilke, M; Lerch, M M; Mayerle, J

    2013-03-01

    The introduction of the G-DRG reimbursement system has greatly increased the pressure to provide cost effective treatment in German hospitals. Reimbursement based on diagnosis-related groups, which requires stratification of costs incurred is still not sufficiently discriminating the disease severity and severity in relation to the intensive costs in gastroenterology. In a combined retrospective and prospective study at a tertial referral centre we investigated whether this also applies for decompensated liver cirrhosis. In 2006, 64 retrospective cases (age 57 ± 12.9; ♂ 69.2 %, ♀ 29.8 %) with decompensated liver cirrhosis (ICD code K76.4) were evaluated for their length of hospitalisation, reimbursement as well as Child and MELD scores. In 2008, 74 cases with decompensated liver cirrhosis were treated in a prospective study according to a standardised and evidence-based clinical pathway (age 57 ± 12.2; 73 % ♂, ♀ 27 %). Besides a trend in the reduction of length of hospital stay (retrospective: 13.6 ± 8.6, prospective 13.0 ± 7.2, p = 0.85) overall revenues from patients treated according to a evidence-based clinical pathway were lower than the calculated costs from the InEK matrix. Costs of medication as a percentage of reimbursement amount increased with increasing severity. In both years we could demonstrate an inverse correlation between daily reimbursement and disease severity which precluded cost coverage. For the cost-covering hospital treatment of patients with decompensated liver cirrhosis an adjustment of the DRG based on clinical severity scores such as Child-Pugh or MELD is warranted, if evidence-based treatment standards are to be kept. PMID:23299901

  16. Effects of pitavastatin versus atorvastatin on the peripheral endothelial progenitor cells and vascular endothelial growth factor in high-risk patients: a pilot prospective, double-blind, randomized study

    PubMed Central

    2014-01-01

    Background Circulating endothelial progenitor cells (EPCs) reflect endothelial repair capacity and may be a significant marker for the clinical outcomes of cardiovascular disease. While some high-dose statin treatments may improve endothelial function, it is not known whether different statins may have similar effects on EPCs.This study aimed to investigate the potential class effects of different statin treatment including pitavastatin and atorvastatin on circulating EPCs in clinical setting. Methods A pilot prospective, double-blind, randomized study was conducted to evaluate the ordinary dose of pitavastatin (2 mg daily) or atorvastatin (10 mg daily) treatment for 12 weeks on circulating EPCs in patients with cardiovascular risk such as hypercholesterolemia and type 2 diabetes mellitus (T2DM). Additional in vitro study was conducted to clarify the direct effects of both statins on EPCs from the patients. Results A total of 26 patients (19 with T2DM) completed the study. While the lipid-lowering effects were similar in both treatments, the counts of circulating CD34+KDR+EPCs were significantly increased (from 0.021 ± 0.015 to 0.054 ± 0.044% of gated mononuclear cells, P < 0.05) only by pitavastatin treatment. Besides, plasma asymmetric dimethylarginine level was reduced (from 0.68 ± 0.10 to 0.53 ± 0.12 μmol/L, P < 0.05) by atorvastatin, and plasma vascular endothelial growth factor (VEGF) level was increased (from 74.33 ± 32.26 to 98.65 ± 46.64 pg/mL, P < 0.05) by pitavastatin. In the in vitro study, while both statins increased endothelial nitric oxide synthase (eNOS) expression, only pitavastatin increased the phosphorylation of eNOS in EPCs. Pitavastatin but not atorvastatin ameliorated the adhesion ability of early EPCs and the migration and tube formation capacities of late EPCs. Conclusions While both statins similarly reduced plasma lipids, only pitavastatin increased plasma VEGF level and circulating EPCs in

  17. Effects on the hemostatic system and liver function in relation to Implanon and Norplant. A prospective randomized clinical trial.

    PubMed

    Egberg, N; van Beek, A; Gunnervik, C; Hulkko, S; Hirvonen, E; Larsson-Cohn, U; Bennink, H C

    1998-08-01

    In this prospective randomized clinical trial, two long-term contraceptive implants were studied with respect to hemostasis and liver function in 86 healthy young women. The two implants used were Implanon, containing the progestagen etonogestrel (the biologically active metabolite of desogestrel) and Norplant, the implant containing the progestagen levonorgestrel. The results of the trial showed that both implants had similar small effects on the hemostatic system that are not suggestive of a tendency towards thrombosis. The effect on liver function was characterized by increases in total bilirubin and gamma-glutamyl transferase and decreases in alanine aminotransferase and aspartate aminotransferase. PMID:9773263

  18. Pre-Operative Status and Quality of Life Following Total Joint Replacement in a Developing Country: A Prospective Pilot Study

    PubMed Central

    Niu, Nina N.; Collins, Jamie E.; Thornhill, Thomas S.; Alcantara Abreu, Luis; Ghazinouri, Roya; Okike, Kanu; Katz, Jeffrey N.

    2011-01-01

    Background: An increasing number of medical relief organizations have launched programs to perform total joint replacements in the developing world. There is a paucity of data on the clinical outcomes of these procedures. We documented pre- and post-operative pain and functional status in a group of low income Dominicans who underwent total hip or knee replacement performed by an American relief organization. Methods: In March 2009 and 2010, we surveyed patients participating in Operation Walk Boston, a medical relief organization that provides total joint replacements to patients in the Dominican Republic. Questionnaires included the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index scales and the Short-Form 36 (SF-36) scales for physical activity and mental health. Scores were transformed to a 0 - 100 point scale (100 is best). Results: 81 individuals (mean age 61 years, 60% female) completed the pre-operative questionnaires. Twenty eight of the 35 who completed preoperative forms in 2009 also completed follow up forms in 2010 (follow-up rate 80%). Patients reported poor pre-operative WOMAC function (mean = 33.6, sd = 22.0) and WOMAC pain (mean = 38.4, sd = 22.9) scores preoperatively. Mean post-operative WOMAC pain and function scores were 86.4 (sd = 13.1) and 88.1 (sd = 11.4) respectively. Improvement in pain and function was similar for patients undergoing hip (n=11) and knee (n=17) replacements. Conclusion: Total joint replacement was effective in relieving pain and restoring function in this program. These results are useful for comparison to outcomes in developed countries and for establishing benchmarks for future programs. PMID:21886686

  19. Effectiveness of Crown Preparation Assessment Software As an Educational Tool in Simulation Clinic: A Pilot Study.

    PubMed

    Tiu, Janine; Cheng, Enxin; Hung, Tzu-Chiao; Yu, Chuan-Chia; Lin, Tony; Schwass, Don; Al-Amleh, Basil

    2016-08-01

    The aim of this pilot study was to evaluate the feasibility of a new tooth preparation assessment software, Preppr, as an educational tool for dental students in achieving optimal parameters for a crown preparation. In February 2015, 30 dental students in their fourth year in a five-year undergraduate dental curriculum in New Zealand were randomly selected from a pool of volunteers (N=40) out of the total class of 85. The participants were placed into one of three groups of ten students each: Group A, the control group, received only written and pictorial instructions; Group B received tutor evaluation and feedback; and Group C performed self-directed learning with the aid of Preppr. Each student was asked to prepare an all-ceramic crown on the lower first molar typodont within three hours and to repeat the exercise three times over the next four weeks. The exercise stipulated a 1 mm finish line dimension and total convergence angles (TOC) between 10 and 20 degrees. Fulfillment of these parameters was taken as an acceptable preparation. The results showed that Group C had the highest percentage of students who achieved minimum finish line dimensions and acceptable TOC angles. Those students also achieved the stipulated requirements earlier than the other groups. This study's findings provide promising data on the feasibility of using Preppr as a self-directed educational tool for students training to prepare dental crowns. PMID:27480712

  20. Prevailing clinical practices regarding screening for retinopathy of prematurity among pediatricians in India: A pilot survey

    PubMed Central

    Patwardhan, Saurabh Dileep; Azad, Rajvardhan; Gogia, Varun; Chandra, Parijat; Gupta, Shikha

    2011-01-01

    Aims: To evaluate the prevailing practices for proper screening and referral scheme among Indian pediatricians for retinopathy of prematurity (ROP). Materials and Methods: Pediatricians registered with Indian Academy of Pediatrics from six states of India were selected randomly and were telephonically interviewed in accordance with a preformed questionnaire which comprised of questions regarding demographic factors, number of premature children seen per month, awareness and referral scheme to ophthalmologist; responses thus obtained were analyzed. Results: Hundred percent knowledge about ROP and need for screening in premature babies was observed among the respondents. However, only 135 (58%) pediatricians always referred for ROP screening, 19 (8%) referred only sometimes and 80 (34%) did not refer at all. Consistent referral protocols taking into account all plausible risk factors for ROP were followed by only 25% of those who always referred. Major deterrent in ROP screening was perceived as non-availability of trained ophthalmologists. Conclusions: Only 14.5% of total pediatricians contacted were following international recommendations for ROP referral. Screening for ROP remains dismal as observed in this pilot survey as a consequence of non-availability of trained ophthalmologists as well as inconsistent screening guidelines. PMID:22011485

  1. Protracted Hypofractionated Radiotherapy for Graves' Ophthalmopathy: A Pilot Study of Clinical and Radiologic Response

    SciTech Connect

    Casimiro de Deus Cardoso, Cejana; Giordani, Adelmo Jose; Borri Wolosker, Angela Maria; Souhami, Luis; Gois Manso, Paulo; Souza Dias, Rodrigo; Comodo Segreto, Helena Regina; Araujo Segreto, Roberto

    2012-03-01

    Purpose: To evaluate the clinical and radiologic response of patients with Graves' ophthalmopathy given low-dose orbital radiotherapy (RT) with a protracted fractionation. Methods and Materials: Eighteen patients (36 orbits) received orbital RT with a total dose of 10 Gy, fractionated in 1 Gy once a week over 10 weeks. Of these, 9 patients received steroid therapy as well. Patients were evaluated clinically and radiologically at 6 months after treatment. Clinical response assessment was carried out using three criteria: by physical examination, by a modified clinical activity score, and by a verbal questionnaire considering the 10 most common signs and symptoms of the disease. Radiologic response was assessed by magnetic resonance imaging. Results: Improvement in ocular pain, palpebral edema, visual acuity, and ocular motility was observed in all patients. Significant decrease in symptoms such as tearing (p < 0.001) diplopia (p = 0.008), conjunctival hyperemia (p = 0.002), and ocular grittiness (p = 0.031) also occurred. Magnetic resonance imaging showed decrease in ocular muscle thickness and in the intensity of the T2 sequence signal in the majority of patients. Treatments were well tolerated, and to date no complications from treatment have been observed. There was no statistical difference in clinical and radiologic response between patients receiving RT alone and those receiving RT plus steroid therapy. Conclusion: RT delivered in at a low dose and in a protracted scheme should be considered as a useful therapeutic option for patients with Graves' ophthalmopathy.

  2. A CONTROLLED RESUSCITATION STRATEGY IS FEASIBLE AND SAFE IN HYPOTENSIVE TRAUMA PATIENTS: RESULTS OF A PROSPECTIVE RANDOMIZED PILOT TRIAL

    PubMed Central

    Schreiber, Martin A.; Meier, Eric N.; Tisherman, Samuel A.; Kerby, Jeffrey D.; Newgard, Craig D.; Brasel, Karen; Egan, Debra; Witham, William; Williams, Carolyn; Daya, Mohamud; Beeson, Jeff; McCully, Belinda H.; Wheeler, Stephen; Kannas, Delores; May, Susanne; McKnight, Barbara; Hoyt, David B.

    2015-01-01

    BACKGROUND Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS Patients were enrolled and randomized in the out-of-hospital setting. 19 EMS systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) ≤ 90 mmHg. CR patients received 250 cc of fluid if they had no radial pulse or a SBP < 70 mmHg and additional 250 cc boluses to maintain a radial pulse or a SBP ≥ 70 mmHg. SR group patients received 2 liters initially and additional fluid as needed to maintain a SBP ≥ 110 mmHg. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival. RESULTS 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. Average crystalloid volume administered during the study period was 1.0 liter (SD 1.5) in the CR group and 2.0 liters (SD 1.4) in the SR group, a difference of 1.0 liter (95% CI: 0.6 to 1.4). ICU-free days, ventilator-free days, renal injury and renal failure did not differ between groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio 0.39 [95% CI: 0.12, 1.26]). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted OR of 0.17 (0.03, 0.92). There was no difference among patients with penetrating trauma: 9% vs 9%, adjusted OR 1.93 (0.19, 19.17). CONCLUSION Controlled resuscitation is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted. PMID:25807399

  3. Patient-centeredness and empathy in a bilingual interprofessional primary care teaching clinic: a pilot study

    PubMed Central

    Mayer, Sallie D; Peterfy, Erika; Crossman, Steven H; Phipps, Lisa Burroughs; Vanderbilt, Allison A

    2016-01-01

    Utilizing the Consultation and Relational Empathy survey, this project examined the perceptions of care team empathy and patient-centeredness between English- and Spanish-speaking patients. From fall through spring semesters, patient surveys from a primary care, interprofessional student-led teaching clinic were collected and analyzed. Overall, mean scores for both English- and Spanish-speaking patients were above the reported normative average for general practitioners. While, overall, patients expressed satisfaction with the student-led teaching clinic in terms of empathy and patient-centeredness, English-speaking patients had higher median scores than Spanish-speaking patients. Analyzed individually, questions related to communication and provider attitudes were scored lower by Spanish-speaking patients. These results demonstrate that student-led clinics can deliver patient-centered care and highlight the continuing need to investigate and address disparities between English- and Spanish-speaking patients with regard to feelings of empathy and patient-centeredness. PMID:27601915

  4. Patient-centeredness and empathy in a bilingual interprofessional primary care teaching clinic: a pilot study.

    PubMed

    Mayer, Sallie D; Peterfy, Erika; Crossman, Steven H; Phipps, Lisa Burroughs; Vanderbilt, Allison A

    2016-01-01

    Utilizing the Consultation and Relational Empathy survey, this project examined the perceptions of care team empathy and patient-centeredness between English- and Spanish-speaking patients. From fall through spring semesters, patient surveys from a primary care, interprofessional student-led teaching clinic were collected and analyzed. Overall, mean scores for both English- and Spanish-speaking patients were above the reported normative average for general practitioners. While, overall, patients expressed satisfaction with the student-led teaching clinic in terms of empathy and patient-centeredness, English-speaking patients had higher median scores than Spanish-speaking patients. Analyzed individually, questions related to communication and provider attitudes were scored lower by Spanish-speaking patients. These results demonstrate that student-led clinics can deliver patient-centered care and highlight the continuing need to investigate and address disparities between English- and Spanish-speaking patients with regard to feelings of empathy and patient-centeredness. PMID:27601915

  5. The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

    PubMed

    Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

    2016-05-01

    Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients. PMID:27154364

  6. Motives for participating in a clinical research trial: a pilot study in Brazil

    PubMed Central

    2013-01-01

    Background In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Methods Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. Results The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. Conclusions The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral

  7. Conception of Learning and Clinical Skill Acquisition in Undergraduate Exercise Science Students: A Pilot Study

    ERIC Educational Resources Information Center

    Johnson, Nathan; Chuter, Vivienne; Rooney, Kieron

    2013-01-01

    Learning clinical skills presents a novel experience for undergraduate students, particularly when it comes to preparing for skill assessment. Compared with the thousands of hours of practice believed to be necessary for the development of motor skill expertise (1), these students have significantly limited exposure time. Furthermore, effective…

  8. The Relationship between Athletic Training Student Critical Thinking Skills and Clinical Instructor Supervision: A Pilot Study

    ERIC Educational Resources Information Center

    Kabay, Michele R.

    2013-01-01

    The purpose of this study was to 1) assess the critical thinking skill level of the athletic training student at onset and end of the clinical education experience 2) to examine the influence of the students' critical thinking skills and the CIs' supervision responses to the changes in the students' critical thinking skills and 3) to compare the…

  9. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    ERIC Educational Resources Information Center

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  10. Help-Seeking Behaviors among Athletic Training Students in the Clinical Education Setting: A Pilot Study

    ERIC Educational Resources Information Center

    Nakajima, Mikiko Aoyagi; Freesemann, Keith W.

    2013-01-01

    Context: Help-seeking is an important self-regulating and proactive strategy that prepares students to be successful learners. It is particularly important in the clinical education setting, in which students must actively engage in learning. Objective: To determine both the type of help-seeking behaviors used by athletic training students in the…

  11. DRIVE it home: making the case for prospective economic data collection in randomized clinical trials.

    PubMed

    Eisenstein, Eric L

    2008-12-01

    Although the results of Pizzi et al. point to the potential economic attractiveness of a ferric gluconate treatment strategy, they may not be sufficient to change public policy and reimbursement practices. What is required is a large, simple trial that will replicate the results of the DRIVE trial in a broader population with longer follow-up and a prospectively defined economic and quality-of-life study conducted from the societal perspective. PMID:19034299

  12. Clinical and Paraclinical Indicators of Motor System Impairment in Hereditary Spastic Paraplegia: A Pilot Study

    PubMed Central

    Martinuzzi, Andrea; Montanaro, Domenico; Vavla, Marinela; Paparella, Gabriella; Bonanni, Paolo; Musumeci, Olimpia; Brighina, Erika; Hlavata, Hana; Rossi, Giuseppe; Aghakhanyan, Gayane; Martino, Nicola; Baratto, Alessandra; D’Angelo, Maria Grazia; Peruch, Francesca; Fantin, Marianna; Arnoldi, Alessia; Citterio, Andrea; Vantaggiato, Chiara; Rizzo, Vincenzo; Toscano, Antonio; Bresolin, Nereo; Bassi, Maria Teresa

    2016-01-01

    Background Hereditary spastic paraplegias (HSP) are a composite and genetically heterogeneous group of conditions mainly expressed by the impairment of the central motor system (“pure” forms). The involvement of other components of the central nervous system or of other systems is described in the “complicate” forms. The definition of an investigation protocol capable, by assembling clinical and paraclinical indicators to fully represent the extent of the motor system impairment, would help both the clinical handling of these conditions and contribute to our understanding of their pathogenesis. Methods We applied a clinical and paraclinical protocol which included tools exploring motor and non motor functioning, neurophysiology and MRI to a composite cohort of 70 molecularly defined HSP patients aged 3 to 65, to define for each indicator its significance in detailing the presence and the severity of the pathology. Results Clinically increased deep tendon reflexes and lower limb (LL) weakness are constant findings in all patients. The “complicated” forms are characterized by peripheral motor impairment, cognitive and cerebellar involvement. The Spastic Paraplegia Rating Scale efficiently reflects the severity of functional problems and correlates with disease duration. Neurophysiology consistently documents the impairment of the central motor pathway to the LLs. Nevertheless, the upper extremities and sensory system involvement is a frequent finding. MRI diffusion tensor imaging (DTI) highlighted a significant alteration of FA and MD. Combining the sampling of the various portion of the cortico-spinal tract (CST) DTI consistently discriminated patients from controls. Conclusion We propose a graded clinical and paraclinical protocol for HSP phenotype definition, indicating for each tool the discriminative and descriptive capacity. Our protocol applied to 9 different forms of HSP showed that the functional impairment often extends beyond the CST. The novel

  13. A Short-Term, Prospective Test of the Interpersonal-Psychological Theory of Suicidal Ideation in an Adolescent Clinical Sample.

    PubMed

    Miller, Adam Bryant; Esposito-Smythers, Christianne; Leichtweis, Richard N

    2016-06-01

    The present prospective study tested a portion of the interpersonal-psychological theory of suicide (IPTS) in an adolescent clinical sample. Participants were 143 adolescents consecutively admitted to a partial hospitalization program who completed assessments at intake and discharge from the program. Results partially supported the IPTS and suggest that (1) perceived burdensomeness may be an important socially based cognition for understanding concurrent risk for suicidal ideation (SI); (2) thwarted belongingness affects depression symptom severity over time, which indirectly predicts SI over a short follow-up time frame; and (3) the IPTS constructs may function differently in a high-risk clinical adolescent sample, compared to adults, although findings are preliminary. PMID:26456085

  14. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today. PMID:24451886

  15. Clinical Characteristics of Dengue Shock Syndrome in Vietnamese Children: A 10-Year Prospective Study in a Single Hospital

    PubMed Central

    Lam, Phung Khanh; Tam, Dong Thi Hoai; Diet, Tran Vinh; Tam, Cao Thi; Tien, Nguyen Thi Hanh; Kieu, Nguyen Tan Thanh; Simmons, Cameron; Farrar, Jeremy; Nga, Nguyen Thi Ngoc; Qui, Phan Tu; Dung, Nguyen Minh; Wolbers, Marcel; Wills, Bridget

    2013-01-01

    Background. Dengue shock syndrome (DSS) is a severe manifestation of dengue virus infection that particularly affects children and young adults. Despite its increasing global importance, there are no prospective studies describing the clinical characteristics, management, or outcomes of DSS. Methods. We describe the findings at onset of shock and the clinical evolution until discharge or death, from a comprehensive prospective dataset of 1719 Vietnamese children with laboratory-confirmed DSS managed on a single intensive care unit between 1999 and 2009. Results. The median age of patients was 10 years. Most cases had secondary immune responses, with only 6 clear primary infections, and all 4 dengue virus serotypes were represented during the 10-year study. Shock occurred commonly between days 4 and 6 of illness. Clinical signs and symptoms were generally consistent with empirical descriptions of DSS, although at presentation 153 (9%) were still febrile and almost one-third had no bleeding. Overall, 31 (2%) patients developed severe bleeding, primarily from the gastrointestinal tract, 26 of whom required blood transfusion. Only 8 patients died, although 123 of 1719 (7%) patients had unrecordable blood pressure at presentation and 417 of the remaining 1596 (26%) were hypotensive for age. The majority recovered well with standard crystalloid resuscitation or following a single colloid infusion. All cases were classified as severe dengue, while only 70% eventually fulfilled all 4 criteria for the 1997 World Health Organization classification of dengue hemorrhagic fever. Conclusions. With prompt intervention and assiduous clinical care by experienced staff, the outcome of this potentially fatal condition can be excellent. PMID:24046311

  16. A clinical pilot study of a modular video-CT augmentation system for image-guided skull base surgery

    NASA Astrophysics Data System (ADS)

    Liu, Wen P.; Mirota, Daniel J.; Uneri, Ali; Otake, Yoshito; Hager, Gregory; Reh, Douglas D.; Ishii, Masaru; Gallia, Gary L.; Siewerdsen, Jeffrey H.

    2012-02-01

    Augmentation of endoscopic video with preoperative or intraoperative image data [e.g., planning data and/or anatomical segmentations defined in computed tomography (CT) and magnetic resonance (MR)], can improve navigation, spatial orientation, confidence, and tissue resection in skull base surgery, especially with respect to critical neurovascular structures that may be difficult to visualize in the video scene. This paper presents the engineering and evaluation of a video augmentation system for endoscopic skull base surgery translated to use in a clinical study. Extension of previous research yielded a practical system with a modular design that can be applied to other endoscopic surgeries, including orthopedic, abdominal, and thoracic procedures. A clinical pilot study is underway to assess feasibility and benefit to surgical performance by overlaying CT or MR planning data in realtime, high-definition endoscopic video. Preoperative planning included segmentation of the carotid arteries, optic nerves, and surgical target volume (e.g., tumor). An automated camera calibration process was developed that demonstrates mean re-projection accuracy (0.7+/-0.3) pixels and mean target registration error of (2.3+/-1.5) mm. An IRB-approved clinical study involving fifteen patients undergoing skull base tumor surgery is underway in which each surgery includes the experimental video-CT system deployed in parallel to the standard-of-care (unaugmented) video display. Questionnaires distributed to one neurosurgeon and two otolaryngologists are used to assess primary outcome measures regarding the benefit to surgical confidence in localizing critical structures and targets by means of video overlay during surgical approach, resection, and reconstruction.

  17. Health literacy screening of patients attending a student-led osteopathy clinic: A pilot investigation.

    PubMed

    Vaughan, Brett; Mulcahy, Jane; Fitzgerald, Kylie

    2016-08-01

    Adequate levels of health literacy (HL) are required for patients to access appropriate health services and develop an understanding of the options for managing their healthcare needs. There is limited literature on HL of patients seeking care for a musculoskeletal complaint. The present study sought to screen the HL of patients presenting to an Australian osteopathy student-led clinic using a single screening question 'Are you confident completing medical forms?'. Less than 10% of patients attending the clinic were considered to have below adequate levels of HL using this question, consistent with other work in Australian populations. Logistic regression analysis identified that the most significant demographic variables associated with lower HL were patients who did not speak English at home, those with lower education levels, and those who were less satisfied with their life. Evaluation of a patients' HL may assist practitioners to improve patient education and management strategies. PMID:27502799

  18. Objective Bayesian fMRI analysis—a pilot study in different clinical environments

    PubMed Central

    Magerkurth, Joerg; Mancini, Laura; Penny, William; Flandin, Guillaume; Ashburner, John; Micallef, Caroline; De Vita, Enrico; Daga, Pankaj; White, Mark J.; Buckley, Craig; Yamamoto, Adam K.; Ourselin, Sebastien; Yousry, Tarek; Thornton, John S.; Weiskopf, Nikolaus

    2015-01-01

    Functional MRI (fMRI) used for neurosurgical planning delineates functionally eloquent brain areas by time-series analysis of task-induced BOLD signal changes. Commonly used frequentist statistics protect against false positive results based on a p-value threshold. In surgical planning, false negative results are equally if not more harmful, potentially masking true brain activity leading to erroneous resection of eloquent regions. Bayesian statistics provides an alternative framework, categorizing areas as activated, deactivated, non-activated or with low statistical confidence. This approach has not yet found wide clinical application partly due to the lack of a method to objectively define an effect size threshold. We implemented a Bayesian analysis framework for neurosurgical planning fMRI. It entails an automated effect-size threshold selection method for posterior probability maps accounting for inter-individual BOLD response differences, which was calibrated based on the frequentist results maps thresholded by two clinical experts. We compared Bayesian and frequentist analysis of passive-motor fMRI data from 10 healthy volunteers measured on a pre-operative 3T and an intra-operative 1.5T MRI scanner. As a clinical case study, we tested passive motor task activation in a brain tumor patient at 3T under clinical conditions. With our novel effect size threshold method, the Bayesian analysis revealed regions of all four categories in the 3T data. Activated region foci and extent were consistent with the frequentist analysis results. In the lower signal-to-noise ratio 1.5T intra-operative scanner data, Bayesian analysis provided improved brain-activation detection sensitivity compared with the frequentist analysis, albeit the spatial extents of the activations were smaller than at 3T. Bayesian analysis of fMRI data using operator-independent effect size threshold selection may improve the sensitivity and certainty of information available to guide neurosurgery

  19. Objective Bayesian fMRI analysis-a pilot study in different clinical environments.

    PubMed

    Magerkurth, Joerg; Mancini, Laura; Penny, William; Flandin, Guillaume; Ashburner, John; Micallef, Caroline; De Vita, Enrico; Daga, Pankaj; White, Mark J; Buckley, Craig; Yamamoto, Adam K; Ourselin, Sebastien; Yousry, Tarek; Thornton, John S; Weiskopf, Nikolaus

    2015-01-01

    Functional MRI (fMRI) used for neurosurgical planning delineates functionally eloquent brain areas by time-series analysis of task-induced BOLD signal changes. Commonly used frequentist statistics protect against false positive results based on a p-value threshold. In surgical planning, false negative results are equally if not more harmful, potentially masking true brain activity leading to erroneous resection of eloquent regions. Bayesian statistics provides an alternative framework, categorizing areas as activated, deactivated, non-activated or with low statistical confidence. This approach has not yet found wide clinical application partly due to the lack of a method to objectively define an effect size threshold. We implemented a Bayesian analysis framework for neurosurgical planning fMRI. It entails an automated effect-size threshold selection method for posterior probability maps accounting for inter-individual BOLD response differences, which was calibrated based on the frequentist results maps thresholded by two clinical experts. We compared Bayesian and frequentist analysis of passive-motor fMRI data from 10 healthy volunteers measured on a pre-operative 3T and an intra-operative 1.5T MRI scanner. As a clinical case study, we tested passive motor task activation in a brain tumor patient at 3T under clinical conditions. With our novel effect size threshold method, the Bayesian analysis revealed regions of all four categories in the 3T data. Activated region foci and extent were consistent with the frequentist analysis results. In the lower signal-to-noise ratio 1.5T intra-operative scanner data, Bayesian analysis provided improved brain-activation detection sensitivity compared with the frequentist analysis, albeit the spatial extents of the activations were smaller than at 3T. Bayesian analysis of fMRI data using operator-independent effect size threshold selection may improve the sensitivity and certainty of information available to guide neurosurgery

  20. Pilot Clinical Trial of Indocyanine Green Fluorescence-Augmented Colonoscopy in High Risk Patients.

    PubMed

    Sheth, Rahul A; Heidari, Pedram; Woods, Kevin; Chung, Daniel; Chan, Andrew T; Mahmood, Umar

    2016-01-01

    White light colonoscopy is the current gold standard for early detection and treatment of colorectal cancer, but emerging data suggest that this approach is inherently limited. Even the most experienced colonoscopists, under optimal conditions, miss at least 15-25% of adenomas. There is an unmet clinical need for an adjunctive modality to white light colonoscopy with improved lesion detection and characterization. Optical molecular imaging with exogenously administered organic fluorochromes is a burgeoning imaging modality poised to advance the capabilities of colonoscopy. In this proof-of-principle clinical trial, we investigated the ability of a custom-designed fluorescent colonoscope and indocyanine green, a clinically approved fluorescent blood pool imaging agent, to visualize polyps in high risk patients with polyposis syndromes or known distal colonic masses. We demonstrate (1) the successful performance of real-time, wide-field fluorescence endoscopy using off-the-shelf equipment, (2) the ability of this system to identify polyps as small as 1 mm, and (3) the potential for fluorescence imaging signal intensity to differentiate between neoplastic and benign polyps. PMID:26989406

  1. Comparison between full face and hemifacial CBCT cephalograms in clinically symmetrical patients: a pilot study

    PubMed Central

    Junqueira, Cintia Helena Zingaretti; Janson, Guilherme; Junqueira, Marisa Helena Zingaretti; Mendes, Lucas Marzullo; Favilla, Eduardo Esberard; Garib, Daniela Gamba

    2015-01-01

    INTRODUCTION: One of the advantages of cone-beam computed tomography (CBCT) is the possibility of obtaining images of conventional lateral cephalograms derived from partial or complete reconstruction of facial images. OBJECTIVE: This study aimed at comparing full face, right and left hemifacial CBCT cephalograms of orthodontic patients without clinical facial asymmetry. METHODS: The sample comprised nine clinically symmetrical patients who had pretreament full face CBCT. The CBCTs were reconstructed so as to obtain full face, right and left hemifacial cephalograms. Two observers, at two different times, obtained linear and angular measurements for the images using Dolphin 3D software. Dependent and independent t-tests were used to assess the reproducibility of measurements. Analysis of Variance and Kruskal-Wallis tests were used to compare the variables obtained in the CBCT derived cephalometric views. RESULTS: There was good reproducibility for CBCT scans and no statistically significant differences between measurements of full face, right and left hemifacial CBCT scans. CONCLUSIONS: Cephalometric measurements in full face, right and left hemifacial CBCT scans in clinically symmetrical patients are similar. PMID:25992992

  2. Asian diabetics attending a British hospital clinic: a pilot study to evaluate their care.

    PubMed Central

    Hawthorne, K

    1990-01-01

    A questionnaire survey of 40 Asian and 31 British non-insulin dependent diabetics attending a hospital clinic showed that both groups remembered receiving education about diabetes (90%) but Asian diabetics knew less about glucose monitoring and diabetic complications. Asians also had a more negative attitude towards the clinic, feeling they were made to wait longer than the British. They were frustrated by a lack of communication with the staff. Forty per cent of both Asian and British diabetics felt that diabetes prevented them from leading a normal lifestyle. Twenty seven per cent of both Asian and British diabetics used herbal or alternative medicines, but Asians differed in that they used these medicines specifically for diabetes. A further sample of 50 Asians had poorer glycaemic control than a sample of British diabetics matched for age, sex and type of diabetes. It is concluded that despite receiving the same education as British diabetics, Asians did not understand it as well. The education was often not relevant to their diets or customs. This may contribute to their poorer glycaemic control. Diabetic clinic facilities need to be improved for Asian diabetics, to improve their understanding of diabetes. PMID:2117948

  3. Pen-based remote data entry system. A pilot clinical trial.

    PubMed

    Beinlich, I; Bokemeyer, C; Räth, U; Walter-Kirst, R; Hartlapp, J; Muschiol, J; Fraass, U; Schneider, H T

    1993-03-01

    This study assesses the feasibility of pen-based remote data entry and measures the acceptance of such systems by patients and physicians. Three clinical investigators participated in a phase-I/II clinical trial of escalated doses of chemotherapy followed by Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF). The study included 20 patients with testicular cancer who were treated at three university hospitals. The patients' data obtained in this trial were recorded and stored on a pen-based computer system. A total of 798 data points were recorded for each patient using 33 electronic forms resembling the paper forms used during an earlier phase of the study. The data recorded include the past medical history, inclusion/exclusion criteria, disease staging, therapy documentation, laboratory values and side effects. Both physicians and patients were interviewed directly after using the pen-based remote data entry system. Patients accepted that their physician was taking notes on an electronic form rather than on paper. All patients noted that a pen-based system is superior to a desktop computer when used during an interview. For the investigators electronic data entry takes additional effort, but time savings are realized later with less data clearing and increased data quality. These benefits are important for the study sponsor as well. In conclusion, pen-based remote data entry is a feasible new mode of recording clinical data with concrete benefits to both investigators and sponsors. PMID:8489574

  4. A Prospective Pilot Study of 89Zr-J591/Prostate Specific Membrane Antigen Positron Emission Tomography in Men with Localized Prostate Cancer Undergoing Radical Prostatectomy

    PubMed Central

    Osborne, Joseph R.; Green, David A.; Spratt, Daniel E.; Lyashchenko, Serge; Fareedy, Shoaib B.; Robinson, Brian D.; Beattie, Bradley J.; Jain, Manu; Lewis, Jason S.; Christos, Paul; Larson, Steven M.; Bander, Neil H.; Scherr, Douglas S.

    2015-01-01

    Purpose In this pilot study we explored the feasibility of 89Zr labeled J591 monoclonal antibody positron emission tomography of localized prostate cancer. Materials and Methods Before scheduled radical prostatectomy 11 patients were injected intravenously with 89Zr-J591, followed 6 days later by whole body positron emission tomography. Patients underwent surgery the day after imaging. Specimens were imaged by ex vivo micro positron emission tomography and a custom 3 Tesla magnetic resonance scanner coil. Positron emission tomography images and histopathology were correlated. Results Median patient age was 61 years (range 47 to 68), median prostate specific antigen was 5.2 ng/ml (range 3.5 to 12.0) and median biopsy Gleason score of the 11 index lesions was 7 (range 7 to 9). On histopathology 22 lesions were identified. Median lesion size was 5.5 mm (range 2 to 21) and median Gleason score after radical prostatectomy was 7 (range 6 to 9). Eight of 11 index lesions (72.7%) were identified by in vivo positron emission tomography. Lesion identification improved with increasing lesion size for in vivo and ex vivo positron emission tomography (each p <0.0001), and increasing Gleason score (p = 0.14 and 0.01, respectively). Standardized uptake values appeared to correlate with increased Gleason score but not significantly (p = 0.19). Conclusions To our knowledge this is the first report of 89Zr-J591/prostate specific membrane antigen positron emission tomography in localized prostate cancer cases. In this setting 89Zr-J591 bound to tumor foci in situ and positron emission tomography identified primarily Gleason score 7 or greater and larger tumors, likely corresponding to clinically significant disease warranting definitive therapy. A future, larger clinical validation trial is planned to better define the usefulness of 89Zr-J591 positron emission tomography for localized prostate cancer. PMID:24135437

  5. Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

    PubMed

    Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

    2016-03-01

    In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety. PMID:27087089

  6. Linked Clinical Trials – The Development of New Clinical Learning Studies in Parkinson’s Disease Using Screening of Multiple Prospective New Treatments

    PubMed Central

    Brundin, Patrik; Barker, Roger A.; Conn, P. Jeffrey; Dawson, Ted M.; Kieburtz, Karl; Lees, Andrew J.; Schwarzschild, Michael A.; Tanner, Caroline M.; Isaacs, Tom; Duffen, Joy; Matthews, Helen; Wyse, Richard K.H.

    2015-01-01

    Finding new therapies for Parkinson’s disease (PD) is a slow process. We assembled an international committee of experts to examine drugs potentially suitable for repurposing to modify PD progression. This committee evaluated multiple drugs currently used, or being developed, in other therapeutic areas, as well as considering several natural, non-pharmaceutical compounds. The committee prioritized which of these putative treatments were most suited to move immediately into pilot clinical trials. Aspects considered included known modes of action, safety, blood-brain-barrier penetration, preclinical data in animal models of PD and the possibility to monitor target engagement in the brain. Of the 26 potential interventions, 10 were considered worth moving forward into small, parallel ‘learning’ clinical trials in PD patients. These trials could be funded in a multitude of ways through support from industry, research grants and directed philanthropic donations. The committee-based approach to select the candidate compounds might help rapidly identify new potential PD treatment strategies for use in clinical trials. PMID:24018336

  7. A Single-Center Pilot Prospective Study of Topical Application of Platelet-Derived Eye Drops for Patients with Ocular Chronic Graft-versus-Host Disease.

    PubMed

    Zallio, Francesco; Mazzucco, Laura; Monaco, Federico; Astori, Maria Rosa; Passera, Roberto; Drago, Giovanna; Tamiazzo, Stefania; Rapetti, Manuela; Dolcino, Daniela; Guaschino, Roberto; Pini, Massimo; Ladetto, Marco

    2016-09-01

    Ocular involvement of chronic graft-versus-host disease (cGVHD) is a complication that occurs in up to 60% of patients after allogeneic hematopoietic stem cell transplantation. Conventional therapeutic options include medical and surgical procedures that are administered depending on the severity of the condition, but most of them have provided unsatisfactory results and, to date, there is no consensus about treatment. We considered that topical application of a platelet lysate, administered as eye drops, might be considered an alternative worthwhile of investigation to treat ocular surface disorders in patients suffering from cGVHD. Therefore, we conducted a single-center prospective pilot study to assess the efficacy and safety of using eye drops made from reconstituted lysed platelet concentrate. Twenty-six patients with ocular cGVHD were eligible for the study; all but 2 completed their scheduled 1-year treatment and complied with the hematologic and ophthalmic regimen. At their first assessment interviews, after 30 days of treatment, 91% of patients reported an improvement in their symptoms and for 32%, substantive objective differences were measured. Remission of corneal damage was seen for 86% of our cohort, and improved National Institutes of Health scores for 73%, of whom 8% achieved the best score of 0 (ie, non-dry eye). Similar results were seen at later time points. Comparing outcomes for our patient cohort to those determined retrospectively for patients in our institutional database revealed a 5-year overall survival (OS) of 65%. This OS is comparable to patients with limited cGVHD (75%) and is superior to that of patients with nonocular extensive cGVHD or without cGVHD (30% and 59%, respectively) (P = .013). Our results suggest that platelet-derived eye drops are a safe, practical, and well-tolerated therapeutic option that offers substantial benefits for most patients affected by ocular cGVHD at onset. The favorable OS of our patient cohort

  8. Impact of Health Portal Enrollment With Email Reminders on Adherence to Clinic Appointments: A Pilot Study

    PubMed Central

    Levy, Janet; L'Engle, Pete; Carlson, Boyd; Ahmad, Asif; Ferranti, Jeffrey

    2011-01-01

    Background Internet portal technologies that provide access to portions of electronic health records have the potential to revolutionize patients’ involvement in their care. However, relatively few descriptions of the demographic characteristics of portal enrollees or of the effects of portal technology on quality outcomes exist. This study examined data from patients who attended one of seven Duke Medicine clinics and who were offered the option of enrolling in and using the Duke Medicine HealthView portal (HVP). The HVP allows patients to manage details of their appointment scheduling and provides automated email appointment reminders in addition to the telephone and mail reminders that all patients receive. Objective Our objective was to test whether portal enrollment with an email reminder functionality is significantly related to decreases in rates of appointment “no-shows,” which are known to impair clinic operational efficiency. Methods Appointment activity during a 1-year period was examined for all patients attending one of seven Duke Medicine clinics. Patients were categorized as portal enrollees or as nonusers either by their status at time of appointment or at the end of the 1-year period. Demographic characteristics and no-show rates among these groups were compared. A binomial logistic regression model was constructed to measure the adjusted impact of HVP enrollment on no-show rates, given confounding factors. To demonstrate the effect of HVP use over time, monthly no-show rates were calculated for patient appointment keeping and contrasted between preportal and postportal deployment periods. Results Across seven clinics, 58,942 patients, 15.7% (9239/58,942) of whom were portal enrollees, scheduled 198,199 appointments with an overall no-show rate of 9.9% (19,668/198,199). We found that HVP enrollees were significantly more likely to be female, white, and privately insured compared with nonusers. Bivariate no-show rate differences between portal

  9. Silibinin Improves the Effects of Methotrexate in Patients with Active Rheumatoid Arthritis: Pilot Clinical Study

    PubMed Central

    Hussain, Saad Abdulrahman; Mortada, Ahmed Hashem; Jasim, Nazar Abdulateef; Gorial, Faiq Isho

    2016-01-01

    Objectives Our study sought to evaluate the effects of silibinin in patients with active rheumatoid arthritis (RA) treated with methotrexate (MTX). Methods We conducted a randomized multi-center, double-blind, placebo-controlled clinical trial over a 16-week treatment period at the Al-Sader and Baghdad Teaching Hospitals in Najaf and Baghdad, respectively. A total of 60 patients (30 of each sex) with active RA, already maintained on 12 mg MTX weekly for at least three consecutive months, were included in the study. Patients were randomly allocated to receive either 120 mg silibinin twice daily or a placebo, combined with their regular MTX regimen. The patients were evaluated by measuring disease activity score using the 28-joint Disease Activity Score, Simple Disease Activity Index, and Health Assessment Questionnaire–Disability Index scores at the start and end of the study. Blood samples were evaluated for the erythrocyte sedimentation rate (ESR), hemoglobin (Hb), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK), anti-cyclic citrullinated peptide (CCP), and the serum cytokine levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6, IL-8, IL-10, and IL-2. Results Silibinin significantly decreases the already elevated clinical scores compared to placebo treatment. ESR, IL-8, IL-6, TNF-α, anti-CCP, hs-CRP levels were significantly reduced. Additionally, the use of silibinin significantly increases Hb, IL-10, and IL-2 levels. Conclusion Silibinin may improve the effects of MTX on certain biochemical and clinical markers of patients with active RA. PMID:27403238

  10. Minimally Invasive Surgical Technique in Periodontal Regeneration: A Randomized Controlled Clinical Trial Pilot Study.

    PubMed

    Ghezzi, Carlo; Ferrantino, Luca; Bernardini, Luigi; Lencioni, Margherita; Masiero, Silvia

    2016-01-01

    The purpose of this study was to compare two minimally invasive surgical techniques (MISTs) for the treatment of periodontal defects: (1) guided tissue regeneration (GTR) using resorbable minimembrane and particulate xenograft (DBBM); and (2) inductive periodontal regeneration (IPR) using enamel matrix derivatives and DBBM. A sample of 20 infrabony periodontal defects in 20 patients were randomly assigned to either the GTR or the IPR group. A follow-up was performed at 12 months postoperative. Significant improvement in clinical parameters was observed in both groups, although no intergroup differences were found. MIST with GTR or IPR demonstrated very good outcomes 1 year after surgery, with no differences between treatment groups. PMID:27333004

  11. A prospective evaluation of leak point pressure, bladder compliance and clinical status in myelodysplasia patients with tethered spinal cords.

    PubMed

    Houser, E E; Bartholomew, T H; Cookson, M S; Marlin, A E; Little, N A

    1994-01-01

    We evaluated prospectively 26 patients with myelodysplasia and a tethered spinal cord to determine whether surgical release of the tethered cord positively influenced leak point pressure, bladder compliance, upper tract status and/or clinical management. Urodynamics were performed immediately before and after the neurosurgical procedure, and at 3 and 6 months postoperatively. Mean patient age was 7.8 years (range 2 days to 34 years) and median interval from onset of symptoms to surgery was 60 days (range 2 days to 4 years). Patient presentation included a combination of orthopedic, neurological and urological symptoms. Of 26 patients 9 (35%) had new hydronephrosis, urinary tract infections or urinary incontinence. Leak point pressure and bladder compliance did not change significantly by 6 months postoperatively. Of the 4 patients who presented with hydronephrosis 1 worsened in status, 2 stabilized and 1 improved. Clinical status was unchanged in 16 patients, improved in 4 and worsened in 6. There was no significant relationship between patient age and urodynamic or clinical outcome. Among patients followed for at least 6 months radiographic and clinical improvement occurred in 25% and 15%, respectively. Urodynamic improvements were transient. Surgical release of a tethered cord improved the urological status in less than a quarter of the patients in this series. PMID:8254809

  12. Clinical and economic outcomes from the UK pilot psychiatric services for personality-disordered offenders.

    PubMed

    Fortune, Zoë; Barrett, Barbara; Armstrong, David; Coid, Jeremy; Crawford, Mike; Mudd, David; Rose, Diana; Slade, Mike; Spence, Ruth; Tyrer, Peter; Moran, Paul

    2011-01-01

    Personality-disordered offenders are difficult individuals to manage, and knowledge about effective treatment is sparse. In the UK, novel forensic psychiatric services were recently established for the treatment of offenders with personality disorder. In this paper we report the clinical and economic findings from a 2-year follow-up of a cohort of service users recruited from these services. Baseline information on developmental, clinical and offending histories was obtained from case records. Case records were checked at 6 and 24 months for new episodes of self-harm, violence, alcohol and substance use, and offending behaviour. Ratings of social functioning and therapeutic alliance were obtained from service users at baseline, 6 and 24 months. Fifty-six percent of service users were still engaged with the services at 24-month follow-up. Service users involved in the greatest number of behavioural incidents had greater impairment in baseline social functioning and lower IQ scores. There was no significant change in either therapeutic alliance or social functioning at 6 or 24 months. The economic analysis showed that although the services were predominantly run by the Health Service, there were considerable economic burdens shared by other service providers. Treatment costs at six-month follow-up were also significantly higher. Implications are discussed. PMID:21338300

  13. A Self-Efficacy Scale for Clinical Nurse Leaders: Results of a Pilot Study.

    PubMed

    Gilmartin, Mattia J; Nokes, Kathleen

    2015-01-01

    Introduced in 2003, the Clinical Nurse Leader (CNL) role is the first new nursing role introduced in more than 30 years. The hallmark of CNL practice is the management of client-centered care and clinical excellence at the point of care. As part of multifaceted efforts to implement the CNL role, understanding how an individual's self-efficacy with the identified role competencies changes over time has important implications for individuals, educational programs preparing CNLs, and health care organizations employing CNLs. In this study, preliminary psychometric analyses assessing the construct validity, reliability, and discriminant validity for a new state-specific scale (CNL Self-Efficacy Scale) that assesses nurses' perceptions of their ability to function effectively as a CNL are reported. Because self-confidence is a key predictor of successful role transition, job satisfaction, and job performance, measuring individuals' self-confidence with the core competencies associated with the CNL role over time will be important to gain the full benefit of this innovative, unit-based advanced generalist role. PMID:26259337

  14. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

    PubMed Central

    Scott, Amelia; Rucklidge, Julia J.; Mulder, Roger T.

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Materials and Methods Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Results Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant

  15. Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers

    PubMed Central

    Wang, Jingen; Zhou, Yongfei; Xia, Shuxia; Zhu, Zunwei; Jia, Linghua; Liu, Yong; Jiang, Min

    2014-01-01

    Background We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd. Material/Methods Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted. Results Intraoperative bleeding volume [3.5±2.7 (15–35) ml vs. 13.1±6.1 (4–25) ml] and mean surgical time [7.6±4.5 (2–23) min vs. 23.6±4.4 (15–35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05). Conclusions This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT. PMID:24647226

  16. A pilot survey of post-deployment health care needs in small community-based primary care clinics

    PubMed Central

    2011-01-01

    Background Relatively little is known regarding to what extent community-based primary care physicians are encountering post-deployment health care needs among veterans of the Afghanistan or Iraq conflicts and their family members. Methods This pilot study conducted a cross-sectional survey of 37 primary care physicians working at small urban and suburban clinics belonging to a practice-based research network in the south central region of Texas. Results Approximately 80% of the responding physicians reported caring for patients who have been deployed to the Afghanistan or Iraq war zones, or had a family member deployed. Although these physicians noted a variety of conditions related to physical trauma, mental illnesses and psychosocial disruptions such as marital, family, financial, and legal problems appeared to be even more prevalent among their previously deployed patients and were also noted among family members of deployed veterans. Conclusions Community-based primary care physicians should be aware of common post-deployment health conditions and the resources that are available to meet these needs. PMID:21801356

  17. Anaesthesia record system on handheld computers--pilot experience and uses for quality control and clinical guidelines.

    PubMed

    Fu, Qiang; Xue, Zhanggang; Zhu, Jie; Fors, Uno; Klein, Gunnar

    2005-02-01

    This paper describes a mobile information system to collect patient information for anesthesia quality control. In this system, a mobile database program was designed for use on handheld computers (Pocket PC). This program is used to collect patient data at the bedside on the handhelds, with a daily synchronization of the data between the anaesthesiologists' handhelds with the anaesthesia database. All collected data are later used for quality control analysis. Furthermore, clinical guidelines will be included on these same handhelds. During the pilot phase, data from a sample set of about 300 patients were incorporated. The processes and interfaces of the system are presented in the paper. The current mobile database system has been designed to replace the original paper-based data collection system. The individual anaesthesiologist's handheld synchronizes patient data daily with anaesthesia database center. This information database is analyzed and used not only to give feedback to the individual doctor or center, but also to review the use of the guidelines provided and the results of their utilization. PMID:15652637

  18. Digital Audio Recording of Initial Patient Visits to an Ocular Oncology Clinic: A Pilot Study.

    PubMed

    Seider, Michael I; Damato, Bertil E

    2015-05-01

    It is challenging for patients to receive a new diagnosis of a life-threatening ocular tumor when visiting an ocular oncology clinic for the first time. Audio recording of patient-physician interactions has been shown to be an effective memory aid and stress-reducing technique for patients with various types of nonophthalmic cancer. This study evaluated a protocol for digitally recording the initial conversation between the ocular oncologist and the patient. Twenty patients were enrolled in the study, and 13 patients (65%) returned the survey. All of the patients who returned the survey reported being "very satisfied" with the audio recording, indicating that patients with a newly diagnosed ocular tumor were highly satisfied with the audio recording of their conversations with the ocular oncologist. Although larger studies are needed to confirm this conclusion, the initial results are encouraging. PMID:26057768

  19. [Ultra-thin, flexible ureteropyeloscopy: a new diagnostic possibility. An animal experiment and clinical pilot study].

    PubMed

    Vorreuther, R; Höher, M; Franzen, W; Ortmann, M; Engelking, R

    1989-09-01

    Recent advances in fiberoptic technology have resulted in the development of fiberscopes with an outer diameter of less than 6 F and an irrigating or working channel. The feasibility, conditions and benefit of ureteropyeloscopy with ultrathin, flexible endoscopes were evaluated in two sets of investigations: (1) in 6 pigs and (2) in 12 patients during routine retrograde pyelography. Prototypes of flexible endoscopes with a passively deflectable tip, an outer diameter of 5.5 F (1.8 mm) and a 1.5 F (0.5 mm) channel were used. Fine-needle aspiration cytology is possible through the channel under endoscopic control. At present, the lack of maneuverability and the fragility of the fiberscopes limit this method. Its use in the clinical routine, in addition to retrograde ureteropyelography, under local anesthesia is of great promise, however. PMID:2815439

  20. Treatment of Idiopathic Parkinson's Disease with Traditional Chinese Herbal Medicine: A Randomized Placebo-Controlled Pilot Clinical Study

    PubMed Central

    Kum, Wan Fung; Durairajan, Siva Sundara Kumar; Bian, Zhao Xiang; Man, Sui Cheung; Lam, Yuen Chi; Xie, Li Xia; Lu, Jia Hong; Wang, Yan; Huang, Xian Zhang; Li, Min

    2011-01-01

    The objective of this clinical study is to examine the effects of a Chinese herbal medicine formula (Jia Wei Liu Jun Zi Tang: JWLJZT) on motor and non-motor symptoms, and on complications of conventional therapy in idiopathic Parkinson's disease (PD), using an add-on design. Fifty-five patients with PD were randomly allocated to receive either Chinese herbal medicine or placebo for 24 weeks. Primary outcome measure was the 39-item Parkinson's Disease Questionnaire (PDQ-39). Secondary outcome measures included the Unified Parkinson's Disease Rating Scale (UPDRS), Short-Form-36 Health Survey (SF-36), Geriatric Depression Scale (GDS), home diaries, and a range of category rating scales. JWLJZT resulted in a significant improvement in the UPDRS IVC when compared with placebo at 12 weeks (P = .039) and 24 weeks (P = .034). In addition, patients in the Chinese herbal medicine group also showed significant improvement in PDQ-39 communication scores at 12 weeks (P = .024) and 24 weeks (P = .047) when compared with the placebo group. There were no significant differences between treatment and control groups for SF-36 variables, GDS score or the mean daily “on-off” time. One case of mild diarrhea was noted in the treatment group. The findings suggest that JWLJZT can relieve some non-motor complications of conventional therapy and improve the communication ability in patients with PD. The results of this pilot study warrant larger multi-center clinical studies to assess long-term efficacy and tolerability of JWLJZT, and to elucidate the mechanisms by which it affects PD function. PMID:19692449

  1. Prospective study of catalase-positive coryneform organisms in clinical specimens: identification, clinical relevance, and antibiotic susceptibility.

    PubMed

    Lagrou, K; Verhaegen, J; Janssens, M; Wauters, G; Verbist, L

    1998-01-01

    During a 6-month period, all clinical isolates of catalase-positive coryneform organisms, which were isolated during the routine processing of clinical specimens, were characterized in the laboratory of the 1800-bed University Hospital of Leuven. The distribution of the species in the corynebacteria was: Corynebacterium amycolatum 70 (53%), Corynebacterium jeikeium 16 (12%), Corynebacterium striatum 11 (8%), Corynebacterium afermentans 10 (7%), Corynebacterium minutissimum 9 (6%), CDC coryneform group G 4 (3%), Corynebacterium urealyticum 4 (3%), Corynebacterium glucuronolyticum 1 (0.7%), and Corynebacterium xerosis 1 (0.7%). Of the 150 isolates, 37 (25%) were considered to be infection related and the remaining 113 (75%) were of questionable clinical significance. Susceptibility of the corynebacteria to 12 antibiotics active against Gram-positive organisms was evaluated. C. amycolatum, C. jeikeium, and C. urealyticum were multiresistant, but all isolates were susceptible to teicoplanin and vancomycin. Most of the C. amycolatum strains, and all strains of C. jeikeium and C. striatum, were susceptible to the vibrocidal compound O/129. PMID:9488824

  2. Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome.

    PubMed

    Richter, Heiko; Seule, Martin; Hildebrandt, Gerhard; Fournier, Jean-Yves

    2016-07-01

    Objective To evaluate clinical and radiologic outcome in patients treated with a dynamic cervical implant (DCI) or anterior cervical diskectomy and fusion (ACDF). Study Design A prospective comparative cohort study. Methods The study included 60 patients with one- or two-level cervical degenerative disk disease (DDD) undergoing treatment with either DCI (n = 30) or ACDF (n = 30). Clinical and radiologic outcomes were assessed 3 and 12 months after surgery. Clinical scoring systems included the Visual Analog Scale for Neck (VAS-N) and Arm pain (VAS-A), the Neck Pain and Disability Scale (NPAD), and the European Quality of Life Scale (EQ-5D). Results Both the DCI and ACDF group showed significant clinical improvement 12 months after surgery using the VAS-N (p = 0.034 and p < 0.001, respectively), VAS-A (p < 0.001 and p < 0.001, respectively), NPAD (p < 0.001 and p < 0.001, respectively), and EQ-5D (p < 0.001 and p < 0.001, respectively). There were no significant differences in clinical outcome comparing both groups at the 3- and 12-month follow-up. The fusion rate at 12 months after surgery was 39.4% and 80.0% in the DCI and ACDF groups, respectively. Radiolucency was found in 90.9% in the DCI group at 12-month follow-up. Conclusion The clinical results for DCI treatment are equivalent to those for ACDF in the treatment of one- and two-level cervical DDD at 12 months after surgery. Further studies are necessary to investigate the high rates of radiolucency and fusion associated with DCI treatment. PMID:27088592

  3. A randomized, controlled clinical pilot study comparing three types of compression therapy to treat venous leg ulcers in patients with superficial and/or segmental deep venous reflux .

    PubMed

    Dolibog, Pawel; Franek, Andrzej; Taradaj, Jakub; Polak, Anna; Dolibog, Patrycja; Blaszczak, Edward; Wcislo, Ligia; Hrycek, Antoni; Urbanek, Tomasz; Ziaja, Jacek; Kolanko, Magdalena

    2013-08-01

    Compression therapy--including inelastic, elastic, and intermittent pneumatic compression--is the standard of care for venous ulcers (VLUs) and chronic venous insufficiency, but there is no consensus in the literature regarding the most effective type of compression therapy. A prospective, randomized, clinical pilot study was conducted among 70 patients with unilateral VLUs treated in a hospital dermatology department in Poland to compare three types of compression therapy (intermittent pneumatic compression, stockings, and short-stretch bandages) in persons with superficial deep venous reflux alone or combined with the segmental variety. Study endpoints were change in ulcer dimensions and proportions healed. Patients with superficial or combined superficial and deep vein insufficiency were randomly allocated to receive one of the three therapies (one of each vein type for each treatment option, six groups total). All patients received saline-soaked gauze dressings along with micronized purified flavonoid fraction, diosmin, hesperidin, and Daflon 500 once daily. Compression treatments were changed or pneumatic compression provided daily for 15 days. Wound size reduction and percentage of wounds healed were significantly higher in groups receiving intermittent pneumatic compression or stockings than in groups using short-stretch bandages (for percentage change of ulcer surface area, P = 0.02; for healing rates P = 0.01). These results warrant additional randomized controlled clinical studies with a larger sample size and longer patient follow-up. PMID:23934375

  4. Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

    PubMed Central

    Laslett, Mark; McDonald, Barry; Tropp, Hans; Aprill, Charles N; Öberg, Birgitta

    2005-01-01

    Background The tissue origin of low back pain (LBP) or referred lower extremity symptoms (LES) may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC) statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216) with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement (PCC) was estimated at 13

  5. A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders

    PubMed Central

    Hammerschlag, Richard; Calabrese, Carlo; Mist, Scott; Aickin, Mikel; Sutherland, Elizabeth; Leben, Joseph; DeBAR, Lynn; Elder, Charles; Dworkin, Samuel F.

    2008-01-01

    Abstract Objectives To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. Design A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). Setting/location Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. Subjects One hundred and sixty (160) women 25–55 years of age attending a KPNW TMD specialty clinic. Interventions Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. Outcome measures TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0–10 where 10 is worst). Results Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = −1.11 ± 0.43, p = 0.010 and −1.02 ± 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (−1.07 ± 0.51, p = 0.037 and −1.27 ± 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference

  6. The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study.

    PubMed

    Brigido, Stephen A

    2006-09-01

    A prospective, single-centre, randomized controlled study was performed to evaluate the effectiveness of Graftjacket, a human acellular regenerative tissue matrix as a treatment option for chronic non healing lower extremity wounds. Twenty-eight diabetic patients with full-thickness wounds that had been present for at least 6 weeks were treated with sharp debridement and randomized to a single application of Graftjacket tissue matrix plus mineral oil-soaked fluff compression dressing or to a control treatment of wound gel with gauze dressings. All patients were seen weekly. By week 16, 12 of 14 patients treated with Graftjacket tissue matrix demonstrated complete wound closure compared with 4 of 14 patients in the control group. Patients treated with Graftjacket tissue matrix showed a statistically significant higher percentage of wound healing with respect to wound area, and clinically significant differences in wound depth and wound volume. This comparison is not performed to demonstrate that the application of the Grafjacket is more effective than sharp debridement. This study is done to help assign a role to the use of Graftjacket matrix in lower extremity wound care. PMID:16984575

  7. The Efficacy and Safety of Jaungo, a Traditional Medicinal Ointment, in Preventing Radiation Dermatitis in Patients with Breast Cancer: A Prospective, Single-Blinded, Randomized Pilot Study

    PubMed Central

    Kong, Moonkyoo; Hwang, Deok-Sang; Lee, Jee Young; Yoon, Seong Woo

    2016-01-01

    Purpose. This study was performed to evaluate the efficacy and safety of Jaungo in preventing radiation dermatitis in patients with breast cancer. Methods. Thirty patients were prospectively enrolled and randomly assigned to receive Jaungo or general supportive skin care. Radiation dermatitis and pain were examined at daily intervals from the start of radiotherapy until 4 weeks after its completion. The primary endpoint of this study was the incidence of radiation dermatitis. The secondary endpoints were time to onset of radiation dermatitis, duration of radiation dermatitis, and maximum pain score. Results. Jaungo reduced the incidence of grade ≥2 (46.7% versus 78.6%) and grade 3 radiation dermatitis (20.0% versus 50.0%) in comparison with general supportive skin care. Jaungo also delayed the onset of grade 2 dermatitis (35 days versus 30 days). In terms of time to onset of grade 3 dermatitis, duration of dermatitis, and maximum pain score, Jaungo showed results comparable to those achieved with general supportive skin care. No patients experienced adverse effects caused by Jaungo administration. Conclusions. Jaungo minimized radiation dermatitis in patients with breast cancer without causing adverse effects. Further randomized studies with a larger sample size are required to assess clinical use of Jaungo. PMID:27066103

  8. Clinical relevance of autophagic therapy in cancer: Investigating the current trends, challenges, and future prospects.

    PubMed

    Mukhopadhyay, Subhadip; Sinha, Niharika; Das, Durgesh Nandini; Panda, Prashanta Kumar; Naik, Prajna Paramita; Bhutia, Sujit Kumar

    2016-08-01

    Oncophagy (cancer-related autophagy) has a complex dual character at different stages of tumor progression. It remains an important clinical problem to unravel the reasons that propel the shift in the role of oncophagy from tumor inhibition to a protective mechanism that shields full-blown malignancy. Most treatment strategies emphasize curbing protective oncophagy while triggering the oncophagy that is lethal to tumor cells. In this review, we focus on the trends in current therapeutics as well as various challenges in clinical trials to address the oncophagic dilemma and evaluate the potential of these developing therapies. A detailed analysis of the clinical and pre-clinical scenario of the anticancer medicines highlights the various inducers and inhibitors of autophagy. The ways in which tumor stage, the microenvironment and combination drug treatment continue to play an important tactical role are discussed. Moreover, autophagy targets also play a crucial role in developing the best possible solution to this oncophagy paradox. In this review, we provide a comprehensive update on the current clinical impact of autophagy-based cancer therapeutic drugs and try to lessen the gap between translational medicine and clinical science. PMID:26743568

  9. A prospective comparative clinical study of peripheral blood counts and indices in patients with primary brain tumors

    PubMed Central

    Subeikshanan, V; Dutt, A; Basu, D; Tejus, MN; Maurya, VP; Madhugiri, VS

    2016-01-01

    Background: Elevation of the neutrophil to lymphocyte ratio (NLR) has been shown to be an indicator of poor prognosis in many malignancies including recurrent glioblastoma multiforme. Objectives: This study was aimed at assessing if the NLR and other leukocyte counts and indices were deranged in treatment-naïve patients with primary brain tumors when compared with an age-matched healthy control group. Materials and Methods: This was a prospective comparative clinical observational study by design. A healthy control population was compared with treatment-naïve patients diagnosed with intra- and extraaxial brain tumors. Leukocyte counts (neutrophil, lymphocyte, monocyte, eosinophil, and basophil counts) as well as leukocyte ratios such as the NLR and the monocyte to lymphocyte ratio (MLR) were calculated. We also evaluated if the counts and indices were related to the tumor volume. Results: In all patients with tumors, the platelet and neutrophil counts were elevated when compared to the controls. In contrast, monocyte counts and the MLR were found to be decreased in patients with tumors when compared to the controls. The subset of patients with glioblastoma showed a significant increase in NLR when compared to the controls. Conclusions: Significant changes in the neutrophil, monocyte, and platelet counts as well as NLR and MLR were observed. Prospective longitudinal studies are required to determine the prognostic and therapeutic implications of these findings. PMID:27089106

  10. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

    PubMed Central

    Teixidor, Pilar; Vidal, Xavier; Montané, Eva

    2016-01-01

    Background During the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas’ patients. Methods National, multicenter and prospective observational study. Inclusion criteria: authorized conditions of use of 5-ALA. Exclusion criteria: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities. Results Between May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance. Conclusion In clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as

  11. Implementation, testing and pilot clinical evaluation of superelastic splints that decrease joint stiffness.

    PubMed

    Pittaccio, Simone; Garavaglia, L; Viscuso, S; Beretta, E; Strazzer, S

    2013-09-01

    The present work aims at demonstrating that a customised choice of shape memory alloy (SMA) composition, thermo-mechanical treatment and shaping can lead to effective rehabilitation devices applicable to sub-acute and chronic spastic paresis in paediatric patients. SMA pseudoelasticity is regarded as a means to implement a corrective action on posture without hindering residual voluntary or reflex mobility of the affected limb. Specific hinges containing NiTi or NiTiNb elements were designed and constructed to transfer pseudoelastic recovery force to fitted splints for the elbow or the ankle joint. The devices were mechanically tested and showed complete stability after 20-100 cycles, and unchanged characteristics after 1000 full-range deflections. Repositioning splints equipped with patient-specific pseudoelastic hinges were prescribed to 25 individuals (aged 7.75 ± 5.40 years) with mild to severe spastic tetraparesis. Clinical and instrumental evaluations were carried out during crossover trials with traditional and pseudoelastic splints. The sequence of treatment steps was randomized for each subject. The results show that, compared to fixed-angle braces, pseudoelastic devices decrease passive joint stiffness while providing the same control on limb posture. Dynamic pseudoelastic braces are therefore an innovative treatment for spastic paresis, which may reduce joint stiffness. PMID:23793385

  12. A digital process for additive manufacturing of occlusal splints: a clinical pilot study.

    PubMed

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-07-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  13. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  14. Arm and wrist surface potential mapping for wearable ECG rhythm recording devices: a pilot clinical study

    NASA Astrophysics Data System (ADS)

    Lynn, W. D.; Escalona, O. J.; McEneaney, D. J.

    2013-06-01

    This study addresses an important question in the development of a ECG device that enables long term monitoring of cardiac rhythm. This device would utilise edge sensor technologies for dry, non-irritant skin contact suitable for distal limb application and would be supported by embedded ECG denoising processes. Contemporary ECG databases including those provided by MIT-BIH and Physionet are focused on interpretation of cardiac disease and rhythm tracking. The data is recorded using chest leads as in standard clinical practise. For the development of a peripherally located heart rhythm monitor, such data would be of limited use. To provide a useful database adequate for the development of the above mentioned cardiac monitoring device a unipolar body surface potential map from the left arm and wrist was gathered in 37 volunteer patients and characterized in this study. For this, the reference electrode was placed at the wrist. Bipolar far-field electrogram leads were derived and analysed. Factors such as skin variability, 50Hz noise interference, electrode contact noise, motion artifacts and electromyographic noise, presented a challenge. The objective was quantify the signal-to-noise ratio (SNR) at the far-field locations. Preliminary results reveal that an electrogram indicative of the QRS complex can be recorded on the distal portion of the left arm when denoised using signal averaging techniques.

  15. Treatment of partial thickness burns with Zn-hyaluronan: lessons of a clinical pilot study

    PubMed Central

    Juhász, I.; Zoltán, P.; Erdei, I.

    2012-01-01

    Summary A clinical investigation to determine the effectiveness of Zn-hyaluronan gel for the treatment of partial thickness burns was carried out. 60 patients were enrolled in the study with an average of 3% TBSA burn. Exudation lasted 3 days, no infectious complications were observed. By day 14 the wounds of 52 patients have healed, average complete healing time was 10,5 days. An overall 93,3% healing rate was achieved within the planned observation period. Reduction of spontaneous and movementrelated pain was reduced to less than half of the initial values by day 5,5 and 6,3 respectively. Development of a thin, elastic, well tolerable and protective membrane-like layer was noted. This kept the wounds moist while clean during wound-healing, and was spontaneously shed as epithelisation proceeded. Zn-hyaluronan gel is a novel topical wound care product that has proven to be suitable for the treatment of partial thickness burns. PMID:23233826

  16. The Volume Behavior of Autogenous Iliac Bone Grafts After Sinus Floor Elevation: A Clinical Pilot Study.

    PubMed

    Gerressen, Marcus; Riediger, Dieter; Hilgers, Ralf-Dieter; Hölzle, Frank; Noroozi, Nelson; Ghassemi, Alireza

    2015-06-01

    Iliac crest is still regarded as one of the most viable source of autogenous graft materials for extensive sinus floor elevation. Three-dimensional resorption behavior has to be taken into account in anticipation of the subsequent insertion of dental implants. We performed 3-dimensional volume measurements of the inserted bone transplants in 11 patients (6 women and 5 men; mean age = 2.3 years) who underwent bilateral sinus floor elevation with autogenous iliac crest grafts. In order to determine the respective bone graft volumes, cone-beam computerized tomography studies of the maxillary sinuses were carried out directly after the operation (T0), as well as 3 months (T1) and 6 months (T2) postoperatively. The acquired DICOM (Digital Imaging and Communications in Medicine) data sets were evaluated using suitable analysis software. We evaluated statistical significance of graft volumes changes using a linear mixed model with the grouping factors for time, age, side, and sex with a significance level of P = .05. 38.9% of the initial bone graft volume, which amounted to 4.2 cm(3), was resorbed until T1. At T2, the average volume again decreased significantly by 18.9 % to finally reach 1.8 cm(3). The results show neither age nor side dependency and apply equally to both sexes. Without functional load, iliac bone grafts feature low-volume stability in sinus-augmentation surgery. Further clinical and animal studies should be done to detect the optimal timing for implant placement. PMID:24303797

  17. Screening for Chronic Obstructive Pulmonary Disease (COPD) in an Urban HIV Clinic: A Pilot Study

    PubMed Central

    Kaner, Robert J.; Glesby, Marshall J.

    2015-01-01

    Abstract Increased smoking and a detrimental response to tobacco smoke in the lungs of HIV/AIDS patients result in an increased risk for COPD. We aimed to determine the predictive value of a COPD screening strategy validated in the general population and to identify HIV-related factors associated with decreased lung function. Subjects at least 35 years of age at an HIV clinic in New York City completed a COPD screening questionnaire and peak flow measurement. Those with abnormal results and a random one-third of normal screens had spirometry. 235 individuals were included and 89 completed spirometry. Eleven (12%) had undiagnosed airway obstruction and 5 had COPD. A combination of a positive questionnaire and abnormal peak flow yielded a sensitivity of 20% (specificity 93%) for detection of COPD. Peak flow alone had a sensitivity of 80% (specificity 80%). Abnormal peak flow was associated with an AIDS diagnosis (p=0.04), lower nadir (p=0.001), and current CD4 counts (p=0.001). Nadir CD4 remained associated in multivariate analysis (p=0.05). Decreased FEV1 (<80% predicted) was associated with lower CD4 count nadir (p=0.04) and detectable current HIV viral load (p=0.01) in multivariate analysis. Questionnaire and peak flow together had low sensitivity, but abnormal peak flow shows potential as a screening tool for COPD in HIV/AIDS. These data suggest that lung function may be influenced by HIV-related factors. PMID:25723842

  18. Clinical value of immunoscintigraphy in colorectal carcinoma patients: a prospective study.

    PubMed

    Bischof-Delaloye, A; Delaloye, B; Buchegger, F; Gilgien, W; Studer, A; Curchod, S; Givel, J C; Mosimann, F; Pettavel, J; Mach, J P

    1989-10-01

    Fifty-seven patients with suspected CEA-producing tumors were studied prospectively by radioimmunoscintigraphy (RIS) using a 123I-labeled anti-CEA monoclonal antibody (MAb) (essentially the F(ab')2 or Fab fragments) and emission computed tomography (ECT). Results of RIS were compared to those of a comprehensive diagnostic study. Final diagnosis was based on surgery, biopsy and autopsy (n = 39) or follow-up findings (n = 18). Three groups of patients were defined: Group A with suspected primary tumors (n = 11), Group B with probable (n = 19) and Group C with questionable (n = 27) tumor relapse. Eighty-eight per cent, 93% and 71% of the anatomic regions studied were correctly identified as being involved, and 97%, 97%, and 87% as being free from tumor in Groups A, B, and C, respectively. In the 27 patients from Group C with no definite diagnosis of relapse, and in whom diagnosis was most difficult, 38 tumor sites were involved. Of these, 21 were detected by both prospective RIS and repeated comprehensive study, six by RIS only and seven by conventional methods only. Four sites remained undetected by both approaches. Ten of the 21 lesions were detected by RIS more than 1 mo earlier than by any other method. Among the seven tumor sites detected by other diagnostic modalities only, three were identified at the time of RIS and four became positive more than 6 mo later. Overall diagnosis was entirely correct in 30, partially correct in 16 and incorrect in six patients studied. RIS with ECT and 123I-labeled anti-CEA MAb allows early detection of recurrence or metastasis of colorectal cancer. It thus contributes to reduced delay between diagnosis and treatment. PMID:2795205

  19. Clinical value of immunoscintigraphy in colorectal carcinoma patients: A prospective study

    SciTech Connect

    Bischof-Delaloye, A.; Delaloye, B.; Buchegger, F.; Gilgien, W.; Studer, A.; Curchod, S.; Givel, J.C.; Mosimann, F.; Pettavel, J.; Mach, J.P. )

    1989-10-01

    Fifty-seven patients with suspected CEA-producing tumors were studied prospectively by radioimmunoscintigraphy (RIS) using a 123I-labeled anti-CEA monoclonal antibody (MAb) (essentially the F(ab')2 or Fab fragments) and emission computed tomography (ECT). Results of RIS were compared to those of a comprehensive diagnostic study. Final diagnosis was based on surgery, biopsy and autopsy (n = 39) or follow-up findings (n = 18). Three groups of patients were defined: Group A with suspected primary tumors (n = 11), Group B with probable (n = 19) and Group C with questionable (n = 27) tumor relapse. Eighty-eight per cent, 93% and 71% of the anatomic regions studied were correctly identified as being involved, and 97%, 97%, and 87% as being free from tumor in Groups A, B, and C, respectively. In the 27 patients from Group C with no definite diagnosis of relapse, and in whom diagnosis was most difficult, 38 tumor sites were involved. Of these, 21 were detected by both prospective RIS and repeated comprehensive study, six by RIS only and seven by conventional methods only. Four sites remained undetected by both approaches. Ten of the 21 lesions were detected by RIS more than 1 mo earlier than by any other method. Among the seven tumor sites detected by other diagnostic modalities only, three were identified at the time of RIS and four became positive more than 6 mo later. Overall diagnosis was entirely correct in 30, partially correct in 16 and incorrect in six patients studied. RIS with ECT and 123I-labeled anti-CEA MAb allows early detection of recurrence or metastasis of colorectal cancer. It thus contributes to reduced delay between diagnosis and treatment.

  20. Big Five Personality Characteristics and Adherence to Clinic-Based Rehabilitation Activities after ACL Surgery: A Prospective Analysis

    PubMed Central

    Hilliard, Robert C.; Brewer, Britton W.; Cornelius, Allen E.; Van Raalte, Judy L.

    2015-01-01

    Purpose A prospective, longitudinal study was conducted to examine Big Five personality characteristics as predictors of adherence to clinic-based rehabilitation activities following anterior cruciate ligament (ACL) reconstruction surgery. Method Participants (72 men, 36 women) completed a questionnaire assessing Big Five personality dimensions prior to surgery. For the first 7 weeks after surgery, participants' rehabilitation session attendance was recorded and rehabilitation professionals rated participants' adherence during rehabilitation sessions.. Results Results of multiple regression analyses indicated that the 5 personality factors explained 11 percent of the variance in attendance and 17 percent of the variance in adherence ratings, that agreeableness was a significant positive predictor of attendance, and that conscientiousness and openness to experience were significant positive predictors of adherence ratings. Conclusion As a potential contributor to adherence, personality warrants consideration when implementing rehabilitation programs after ACL surgery. PMID:25663952

  1. Azithromycin therapy of papillomatosis in dogs: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    PubMed

    Yağci, Buğrahan Bekir; Ural, Kerem; Ocal, Naci; Haydardedeoğlu, Ali Evren

    2008-08-01

    Azithromycin, an azalide subclass macrolide antibiotic, is an effective, well-tolerated and safe therapeutic option for treatment of papillomatosis in humans. This study reports the clinical and histopathological results from a prospective, randomized, double-blinded, placebo-controlled trial of 17 dogs of various breeds with diagnosis of oral (n = 12) and cutaneous papillomatosis (n = 5) treated with azithromycin. Papillomas appeared as whitish, verrucous, hyperkeratotic papules 1-2.7 mm in size. The cases were randomly assigned to azithromycin (n = 10) and placebo treatment groups (n = 7). Both owners and investigators were blinded to the allocation to the groups. Azithromycin (10 mg/kg) was administered per os every 24 h for 10 days. Clinical evaluations were done by the same investigator throughout the trial. Azithromycin treatment significantly decreased clinical scores (P < 0.001), whereas there was no change seen in the placebo group. In the azithromycin treatment group, skin lesions disappeared in 10-15 days. One case in the placebo had spontaneous regression of its papillomas by day 41, but lesions were still evident at day 50 in the remaining six cases. There was no recurrence of papillomatosis in the azithromycin treated dogs (follow up 8 months). No adverse effects were seen in either group. In conclusion, azithromycin appears to be a safe and effective treatment for canine papillomatosis. PMID:18494759

  2. Isotope-dilution assay for urinary methylmalonic acid in the diagnosis of vitamin B12 deficiency. A prospective clinical evaluation

    SciTech Connect

    Matchar, D.B.; Feussner, J.R.; Millington, D.S.; Wilkinson, R.H. Jr.; Watson, D.J.; Gale, D.

    1987-05-01

    Vitamin B12 deficiency is a frequently considered diagnosis for which there is no single, commonly available and accurate test. A urinary methylmalonic acid assay using gas chromatography-mass spectrometry has been proposed as the preferred test. We reviewed vitamin B12 assays on 1599 consecutive patients and prospectively studied all patients with low serum B12 levels (n = 75) and a random sample of patients with normal levels (n = 68). Of 96 evaluable patients, 7 had clinical deficiency. All 7 deficient patients had urinary methylmalonic acid levels greater than 5 micrograms/mg creatine (sensitivity, 100%; confidence interval, 65% to 100%). Of the 89 patients who were not clinically deficient, 88 had urinary methylmalonic acid levels less than or equal to 5 micrograms/mg creatinine (specificity, 99%). The overall test accuracy in this population was 99%. If the high sensitivity and specificity of the gas chromatography-mass spectrometry assay for urinary methylmalonic acid is supported by other clinical studies, the methylmalonic acid assay may become the reference standard for the diagnosis of vitamin B12 deficiency.

  3. Assessment of the subglottic region by ultrasonography for estimation of appropriate size endotracheal tube: A clinical prospective study

    PubMed Central

    Gupta, Kumkum; Gupta, Prashant K.; Rastogi, Bhawna; Krishan, Atul; Jain, Manish; Garg, Gouri

    2012-01-01

    Background: Endotracheal intubation is important to carry out various surgical procedures. The estimation of endotracheal tube size is governed by narrowest diameter of the upper airway. The objective of the study was to assess the narrowest tracheal diameter by ultrasound for selection of the appropriate size endotracheal tube. Materials and Methods: After the approval of institution ethical committee and written informed consent, 112 patients aged 3 to 18 years of both genders with normal airways, scheduled for surgery under general anesthesia and intubation, were enrolled for this prospective clinical observational study. Preanesthetic ultrasonography of the subglottic region was performed by experienced ultrasonologist with a high-resolution linear array transducer in sniffing position for every patient and the subglottic tracheal diameter was estimated to select the appropriate-size endotracheal tube. The endotracheal tube, calculated on the basis of physical indices and by ultrasound, was statistically correlated with the appropriate size endotracheal tube used clinically for intubation. Results: The ultrasound guided selection criterion has estimated the appropriate-sized endotracheal tube better than physical indices (age or height)-based formulas. The estimated endotracheal tube size by ultrasound was significantly correlated with the clinically used endotracheal tube. Conclusion: Ultrasonography may be used for the assessment of the subglottic diameter of trachea in children to estimate the appropriate size endotracheal tube for intubation. PMID:25885609

  4. Association between hypoxemia and anemia following arthroplasty: A pilot clinical study

    PubMed Central

    GAO, FUQIANG; SUN, WEI; GUO, WANSHOU; CHENG, LIMING; LI, ZIRONG; KUSH, NEPALI

    2016-01-01

    Hypoxia and anemia are common complications following joint arthroplasty. Whether hypoxia indicates that a patient is anemic and whether anemia causes a decline in arterial oxygen pressure accompanied by hypoxemia are not completely understood. The aim of the present study was to determine the association between hypoxemia and anemia following arthroplasty. A total of 135 patients who underwent arthroplasty at the China-Japan Friendship Hospital between January and May 2013 were retrospectively analyzed. The patients were divided into five groups depending on the type of arthroplasty they had experienced: Unilateral total knee arthroplasty (TKA), bilateral TKA, unilateral total hip arthroplasty (THA), bilateral THA or unilateral unicompartmental knee arthroplasty. Perioperative peripheral oxygen saturation (SpO2) and hemoglobin (Hb) levels were assessed, and the associations between the changes in SpO2 (ΔSpO2) and hemoglobin (ΔHb) levels on the first and third postoperative days (PODs) were analyzed using Pearson's correlation test for each group. The perioperative SpO2 curves for the various groups were typically at their lowest on the day of surgery. Significant hypoxemia was observed on POD 0–2, although a stable recovery curve was observed on POD 3–5. Trends in ΔHb were observed among the 5 groups, with the lowest Hb value observed predominantly on POD 2 and 3. By POD 4 and 5 Hb levels had recovered, with a steadily and consistently increasing curve. There was no statistically significant correlation between ΔSpO2 and decrease in Hb levels (P>0.05). SpO2 levels should not serve as a clinical indicator of the incidence and severity of anemia in patients who have undergone primary arthroplasty. To a point, the degree of postoperative anemic status does not affect SpO2 levels. PMID:27168828

  5. Sclerostin Antibody Therapy for the Treatment of Osteoporosis: Clinical Prospects and Challenges

    PubMed Central

    MacNabb, Claire; Patton, D.; Hayes, J. S.

    2016-01-01

    It is estimated that over 200 million adults worldwide have osteoporosis, a disease that has increasing socioeconomic impact reflected by unsustainable costs associated with disability, fracture management, hospital stays, and treatment. Existing therapeutic treatments for osteoporosis are associated with a variety of issues relating to use, clinical predictability, and health risks. Consequently, additional novel therapeutic targets are increasingly sought. A promising therapeutic candidate is sclerostin, a Wnt pathway antagonist and, as such, a negative regulator of bone formation. Sclerostin antibody treatment has demonstrated efficacy and superiority compared to other anabolic treatments for increasing bone formation in both preclinical and clinical settings. Accordingly, it has been suggested that sclerostin antibody treatment is set to achieve market approval by 2017 and aggressively compete as the gold standard for osteoporotic treatment by 2021. In anticipation of phase III trial results which may potentially signify a significant step in achieving market approval here, we review the preclinical and clinical emergence of sclerostin antibody therapies for both osteoporosis and alternative applications. Potential clinical challenges are also explored as well as ongoing developments that may impact on the eventual clinical application of sclerostin antibodies as an effective treatment of osteoporosis. PMID:27313945

  6. Clinical Scores for Dyspnoea Severity in Children: A Prospective Validation Study

    PubMed Central

    Eggink, Hendriekje; Brand, Paul; Reimink, Roelien; Bekhof, Jolita

    2016-01-01

    Background In acute dyspnoeic children, assessment of dyspnoea severity and treatment response is frequently based on clinical dyspnoea scores. Our study aim was to validate five commonly used paediatric dyspnoea scores. Methods Fifty children aged 0–8 years with acute dyspnoea were clinically assessed before and after bronchodilator treatment, a subset of 27 children were videotaped and assessed twice by nine observers. The observers scored clinical signs necessary to calculate the Asthma Score (AS), Asthma Severity Score (ASS), Clinical Asthma Evaluation Score 2 (CAES-2), Pediatric Respiratory Assessment Measure (PRAM) and respiratory rate, accessory muscle use, decreased breath sounds (RAD). Results A total of 1120 observations were used to assess fourteen measurement properties within domains of validity, reliability and utility. All five dyspnoea scores showed overall poor results, scoring insufficiently on more than half of the quality criteria for measurement properties. The AS and PRAM were the most valid with good values on six and moderate values on three properties. Poor results were mainly due to insufficient measurement properties in the validity and reliability domains whereas utility properties were moderate to good in all scores. Conclusion This study shows that commonly used dyspnoea scores show insufficient validity and reliability to allow for clinical use without caution. PMID:27382963

  7. A prospective pilot study to evaluate wound outcomes and levels of serum C-reactive protein and interleukin-6 in the wound fluid of patients with trauma-related chronic wounds.

    PubMed

    Liu, Tao; Yang, Fan; Li, Zhanfei; Yi, Chengla; Bai, Xiangjun

    2014-06-01

    If surgical closure of chronic wounds is an option, choosing an appropriate time to definitely close these wounds remains a challenge. Although the underlying mechanisms of nonhealing are not completely understood, serum C-reactive protein (CRP) and interleukin-6 (IL-6) in wound fluid have been found to be markers of the systemic and local inflammation state of chronic wounds. The purpose of this prospective, descriptive pilot study was to evaluate the effect of debridement, systemic antibiotics, and negative pressure wound therapy (NPWT) on the outcomes of trauma-related chronic wounds and changes in local inflammation responses, measured using CRP and IL-6 levels as indicators of cytokine regulation. Between June 2012 and May 2013, 20 consecutive patients (14 men, six women, mean age 40 [range 17-56] years) with various trauma-related, nonhealing chronic wounds were enrolled in the study after failing to heal for an average of 8.5 (range 6-16) weeks using a protocol of regular debridement and gauze dressings. Before the start of the study, wounds were cultured, and laboratory values for white blood cell count (WBC), neutrophils, and levels of serum CRP and IL-6 in the wound fluid obtained. Wounds were surgically debrided and NPWT (continuous at 125 mm Hg) applied. All patients were prescribed systemic antibiotics, and mean time interval between NPWT dressing changes was 5 (range 3-7) days. During an average mean NPWT treatment time of 13 (range 5-20) days, CRP and IL-6 concentrations decreased from 66.4 mg/L to 10.4 mg/L and 44.1 pg/mL to 8.6 pg/mL, respectively (P <0.001). The presence/absence of bacteria, WBC, and neutrophil counts did not change. No complications were noted, and all wounds were successfully closed using various surgical procedures. In this study, clinical wound improvement and a significant decrease in wound fluid CRP and IL-6 levels were observed. Studies with a larger sample size and a more robust study design may help elucidate the

  8. A prospective clinical study of mineral trioxide aggregate for partial pulpotomy in cariously exposed permanent teeth.

    PubMed

    Barrieshi-Nusair, Kefah Mahmood; Qudeimat, Muawia Abdulla

    2006-08-01

    The aim of this study was to evaluate the success of using gray mineral trioxide aggregate (MTA) for partial pulpotomy in cariously exposed young permanent first molars. Thirty-one first permanent molars of 23 patients with a carious exposure were treated using a partial pulpotomy technique. The age of the patients ranged from 7.2 to 13.1 yr with an average of 10 yr. Clinical and radiographic examination revealed a pulpal response within normal limits and normal appearance of the periradicular area respectively. A diagnosis of reversible pulpitis and normal periapex was established. After isolation, caries removal and carious exposure, the exposed pulp tissue was removed with a diamond bur to a depth of 2 to 4 mm. After hemostasis, 2 to 4 mm of gray MTA paste was placed against the fresh wound. The floor of the cavity was covered with a base of glass ionomer. The teeth were restored with amalgam or stainless steel crowns. Teeth were reviewed radiographically and clinically at 3, 6, 12, and 24 month intervals. Twenty-two of the treated teeth did not show any clinical or radiographic signs of failure during the follow-up evaluation period. Six teeth did not respond to vitality testing at the final follow-up period; however, no radiographic signs of failure or clinical symptoms were detected. Gray MTA was a suitable dressing agent for parital pulpotomy in cariously exposed young permanent first molars. PMID:16861071

  9. Progress and prospects of gene therapy clinical trials for the muscular dystrophies.

    PubMed

    Bengtsson, Niclas E; Seto, Jane T; Hall, John K; Chamberlain, Jeffrey S; Odom, Guy L

    2016-04-15

    Clinical trials represent a critical avenue for new treatment development, where early phases (I, I/II) are designed to test safety and effectiveness of new therapeutics or diagnostic indicators. A number of recent advances have spurred renewed optimism toward initiating clinical trials and developing refined therapies for the muscular dystrophies (MD's) and other myogenic disorders. MD's encompass a heterogeneous group of degenerative disorders often characterized by progressive muscle weakness and fragility. Many of these diseases result from mutations in genes encoding proteins of the dystrophin-glycoprotein complex (DGC). The most common and severe form among children is Duchenne muscular dystrophy, caused by mutations in the dystrophin gene, with an average life expectancy around 25 years of age. Another group of MD's referred to as the limb-girdle muscular dystrophies (LGMDs) can affect boys or girls, with different types caused by mutations in different genes. Mutation of the α-sarcoglycan gene, also a DGC component, causes LGMD2D and represents the most common form of LGMD. Early preclinical and clinical trial findings support the feasibility of gene therapy via recombinant adeno-associated viral vectors as a viable treatment approach for many MDs. In this mini-review, we present an overview of recent progress in clinical gene therapy trials of the MD's and touch upon promising preclinical advances. PMID:26450518

  10. Prospective clinical trial of rifaximin therapy for patients with primary sclerosing cholangitis

    PubMed Central

    Tabibian, James H.; Gossard, Andrea; El-Youssef, Mounif; Eaton, John E.; Petz, Jan; Jorgensen, Roberta; Enders, Felicity B.; Lindor, Keith D.

    2014-01-01

    Primary sclerosing cholangitis (PSC) is a rare, chronic, cholestatic liver disease in which emerging data suggest that oral antibiotics may offer therapeutic effects. We enrolled patients with PSC in a 12-week open-label pilot study to investigate the efficacy and safety of oral rifaximin 550 mg twice daily. The primary endpoint was serum alkaline phosphatase (ALK) at 12 weeks. Secondary endpoints included: i) serum bilirubin, gamma-glutamyl transpeptidase, and Mayo PSC risk score; ii) Fisk Fatigue Impact Scale (FFIS), Chronic Liver Disease Questionnaire (CLDQ), and Short Form Health Survey (SF-36) scores; and iii) adverse effects (AEs). Analyses were performed with nonparametric tests. Sixteen patients were enrolled, among whom the median age was 40 years, 13 (81%) were male, 13 had inflammatory bowel disease, and baseline ALK was 342 IU/mL (interquartile range 275-520). Following 12 weeks of treatment, there were no significant changes in ALK (median increase of 0.9% to 345 IU/mL, p=0.47) or any of the secondary biochemical endpoints (all p>0.05). Similarly, there were no significant changes in FFIS, CLDQ, or SF-36 scores (all p>0.05). Three patients withdrew from the study due to AEs; four others reported mild AEs but completed the study. In conclusion, while some antibiotics may have promise in treating PSC, oral rifaximin, based on the results herein, appears inefficacious for this indication. Future studies are needed to understand how the antimicrobial spectra and other properties of antibiotics might determine their utility in treating PSC. (clinicaltrials.gov NCT01695174) PMID:24914504

  11. Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis.

    PubMed

    Tabibian, James H; Gossard, Andrea; El-Youssef, Mounif; Eaton, John E; Petz, Jan; Jorgensen, Roberta; Enders, Felicity B; Tabibian, Anilga; Lindor, Keith D

    2014-06-01

    Primary sclerosing cholangitis (PSC) is a rare, chronic, cholestatic liver disease in which emerging data suggest that oral antibiotics may offer therapeutic effects. We enrolled patients with PSC in a 12-week, open-label pilot study to investigate the efficacy and safety of 550 mg of oral rifaximin twice daily. The primary end point was serum alkaline phosphatase (ALK) at 12 weeks. Secondary end points included (1) serum bilirubin, gamma-glutamyl transpeptidase, and Mayo PSC risk score; (2) fatigue impact scale, chronic liver disease questionnaire, and short form health survey (SF-36) scores; and (3) adverse effects (AEs). Analyses were performed with nonparametric tests. Sixteen patients were enrolled, among whom the median age was 40 years; 13 (81%) were male, 13 had inflammatory bowel disease, and baseline ALK was 342 IU/mL (interquartile range, 275-520 IU/mL). After 12 weeks of treatment, there were no significant changes in ALK (median increase of 0.9% to 345 IU/mL; P = 0.47) or any of the secondary biochemical end points (all P > 0.05). Similarly, there were no significant changes in fatigue impact scale, chronic liver disease questionnaire, or SF-36 scores (all P > 0.05). Three patients withdrew from the study due to AEs; 4 others reported mild AEs but completed the study. In conclusion, although some antibiotics may have promise in treating PSC, oral rifaximin, based on the results herein, seems inefficacious for this indication. Future studies are needed to understand how the antimicrobial spectra and other properties of antibiotics might determine their utility in treating PSC. PMID:24914504

  12. Clinical research in the treatment of tuberculosis: current status and future prospects.

    PubMed

    Chang, K-C; Yew, W-W; Sotgiu, G

    2015-12-01

    To supplement previous state-of-art reviews on anti-tuberculosis treatment and to pave the way forward with reference to the current status, we systematically reviewed published literature on clinical research on tuberculosis (TB) over the past decade in the treatment of drug-susceptible and multidrug-resistant TB (MDR-TB), with a focus on drugs, dosing factors and regimens. Our review was restricted to Phase II/III clinical trials, cohort and case-control studies, and systematic reviews of clinical studies. TB programmatic and patient behavioural factors, non-TB drugs, adjunctive surgery, new vaccines, immunotherapy, antiretroviral therapy and management of latent tuberculous infection are outside the scope of this review. An algorithm was used to systematically search PubMed for relevant articles published in English from 1 January 2005 to 31 December 2014. Articles without evaluated factors (drugs, dosing factors and regimens) or comparative analysis of specified anti-tuberculosis treatment outcomes were excluded. Of the 399 articles initially identified, 294 were excluded. The main findings of the remaining 105 articles are described under two categories: presumed drug-susceptible TB and MDR-TB. Fifty-nine articles included under drug-susceptible TB were divided into 12 subcategories: isoniazid, rifampicin, pyrazinamide, fluoroquinolones, fixed-dose combination drugs, dosing frequency, treatment phases, treatment duration, experimental regimens for pulmonary (surrogate markers vs. clinical outcomes) and extra-pulmonary TB. Forty-nine articles included under MDR-TB were divided into seven subcategories: fluoroquinolones, pyrazinamide, second-line injectable drugs, World Health Organization Group 4 and Group 5 drugs, MDR-TB regimens and novel drugs. Clinical research in the last decade and ongoing trials might furnish new paradigms for improving the treatment of this recalcitrant ancient disease. PMID:26614181

  13. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    SciTech Connect

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-12-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m/sup 2/) six weekly and hydroxyurea (HU, 3.5 gm/m/sup 2/ over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease.

  14. Risk factors for postoperative infectious complications following percutaneous nephrolithotomy: a prospective clinical study.

    PubMed

    Koras, Omer; Bozkurt, Ibrahim Halil; Yonguc, Tarik; Degirmenci, Tansu; Arslan, Burak; Gunlusoy, Bulent; Aydogdu, Ozgu; Minareci, Suleyman

    2015-02-01

    The aim of the study was to assess the preoperative and intraoperative potential risk factors for infectious complications after percutaneous nephrolithotomy (PCNL). A total of 303 patients who underwent PCNL for renal stones were included in the recent study. A detailed history including past renal surgery, nephrostomy insertion and recurrent urinary infection were obtained from all patients. Preoperative urine culture, renal pelvic urine culture and stone culture were obtained from all patients. The intraoperative data were prospectively noted. All patients were followed up postoperatively for signs of systemic inflammatory response syndrome (SIRS) and sepsis. In 83 (27.4%) of the patients, SIRS was observed and of these patients 23 (7.6%) were diagnosed as sepsis. Escherichia coli was the most common organism detected in cultures, followed by Pseudomonas aeruginosa, Enterococcus and Klebsiella spp. in all patients. By multivariate logistic regression analysis, presence of infection stone, stone burden and recurrent urinary tract infection were associated with both SIRS and sepsis development. Presence of infection stone, stone burden ≥800 mm(2) and recurrent urinary tract infection can be identified as independent predictors for the development of SIRS and sepsis. PMID:25269441

  15. Changes of perfusion of microvascular free flaps in the head and neck: a prospective clinical study.

    PubMed

    Mücke, Thomas; Rau, Andrea; Merezas, Andreas; Kanatas, Anastasios; Mitchell, David A; Wagenpfeil, Stefan; Wolff, Klaus-Dietrich; Steiner, Timm

    2014-11-01

    Reconstruction with a free flap is routine in head and neck surgery. However, reliable assessment of perfusion can be difficult, so we prospectively evaluated it in 4 types of microvascular free flaps in the oral cavity (n=196) and assessed differences in blood flow by non-invasive monitoring with a laser Doppler flowmetry unit. We measured oxygen saturation, haemoglobin concentration, and velocity on the surface of the flap preoperatively at the donor site, and on the flap on the first, second, and seventh postoperative days, and after 4 weeks in 186/196 patients, mean (SD) age of 60 (13) years. We studied the radial forearm (n=76, 41%), fibular (n=45, 24%), anterolateral thigh (n=53, 28%), and soleus perforator (n=12, 7%) flaps. The values for the radial forearm flap differed significantly from the others. There were significant differences in haemoglobin concentrations between the fibular and soleus perforator flaps, and between the anterolateral thigh and soleus perforator flaps (p=0.002 each). Free flaps are unique in the way that perfusion develops after microvascular anastomoses. Knowledge of how each flap is perfused may indicate different patterns of healing that could potentially influence long term rehabilitation and detection of future deficits in perfusion. PMID:25149324

  16. Prospective screening for ALK: clinical features and outcome according to ALK status.

    PubMed

    Fallet, Vincent; Cadranel, Jacques; Doubre, Hélène; Toper, Cécile; Monnet, Isabelle; Chinet, Thierry; Oliviero, Gérard; Foulon, Guillaume; De Cremoux, Hubert; Vieira, Thibault; Antoine, Martine; Wislez, Marie

    2014-05-01

    The aim of this study was to analyse the clinico-pathological characteristics and outcomes of a cohort of French patients who were prospectively screened for Anaplastic Lymphoma Kinase (ALK) rearrangement. One hundred and sixteen consecutive patients screened for ALK rearrangement to be recruited into a crizotinib registration trial were included from eight French centres. ALK rearrangement was detected by fluorescence in situ hybridization. Seventeen patients (14.6%) were positive for ALK. ALK+ patients were younger (p = 0.049) and more likely to be males (p=0.032), non- or light-smokers (p = 0.048) and without underlying respiratory disease (p=0.025) compared to ALK- patients. Thyroid-transcription factor-1 expression was present in all ALK+ tumours. ALK+ tumours tended to have lymph node and brain metastases. In multivariate analyses, gender, smoking history and N stage were independently associated with ALK status. Median overall survival (OS) was not reached for ALK+ patients and was significantly longer than for ALK- patients (hazard ratio for death for ALK- patients 2.98; 95% CI [1.29-6.90], p=0.01). French ALK+ patients present a specific phenotype. ALK rearrangement should be determined to improve OS with an effective targeted therapy. PMID:24589437

  17. Prospective Clinical Study of 551 Cases of Liposuction and Abdominoplasty Performed Individually and in Combination

    PubMed Central

    2013-01-01

    Background: Despite the popularity of these procedures, there are limited published prospective studies evaluating liposuction and abdominoplasty. Lipoabdominoplasty is a subject of recent attention. Several investigators have recommended alternative techniques that preserve the Scarpa fascia in an effort to reduce complications, particularly the risk of seromas. Methods: Over a 5-year period, 551 consecutive patients were treated with ultrasonic liposuction alone (n = 384), liposuction/abdominoplasty (n = 150), or abdominoplasty alone (n = 17). In lipoabdominoplasties, the abdomen and flanks were first treated with liposuction. A traditional flap dissection was used for all abdominoplasties. Scalpel dissection was used rather than electrodissection. A supine “jackknife” position was used in surgery to provide maximum hip flexion, allowing a secure deep fascial repair. Results: The complication rate after liposuction was 4.2% vs 50% for patients treated with an abdominoplasty. Approximately half of the abdominoplasty complications were minor scar deformities, including widened umbilical scars (17.3%) that were revised. The seroma rate after abdominoplasties was 5.4%; there were no seromas after liposuction alone. Conclusions: Lipoabdominoplasty may be performed safely, so that patients may benefit from both modalities. The seroma rate is reduced by avoiding electrodissection, making Scarpa fascia preservation a moot point. A deep fascial repair keeps the abdominoplasty scar within the bikini line. Deep venous thrombosis and other complications may be minimized with precautions that do not include anticoagulation. PMID:25289226

  18. Membranoproliferative glomerulonephritis. A prospective clinical trial of platelet-inhibitor therapy

    SciTech Connect

    Donadio, J.V. Jr.; Anderson, C.F.; Mitchell, J.C.; Holley, K.E.; Ilstrup, D.M.; Fuster, V.; Chesebro, J.H.

    1984-05-31

    Forty patients with Type I membranoproliferative glomerulonephritis were treated for one year with dipyridamole, 225 mg per day, and aspirin, 975 mg per day, in a prospective, randomized, double-blind, placebo-controlled study. At the base line, the half-life of /sup 51/Cr-labeled platelets was reduced in 12 of 17 patients. The platelet half-life became longer and renal function stabilized in the treated group, as compared with the placebo group, suggesting a relation between platelet consumption and the glomerulopathy. The glomerular filtration rate, determined by iothalamate clearance, was better maintained in the treated group (average decrease, 1.3 ml per minute per 1.73 m/sup 2/ of body-surface area per 12 months) than in the placebo group (average decrease, 19.6). Fewer patients in the treated group than in the placebo group had progression to end-stage renal disease (3 of 21 after 62 months as compared with 9 of 19 after 33 months). The data suggest that dipyridamole and aspirin slowed the deterioration of renal function and the development of end-stage renal disease.

  19. D-Cycloserine Augmentation of Exposure Therapy for Post-Traumatic Stress Disorder: A Pilot Randomized Clinical Trial

    PubMed Central

    Difede, JoAnn; Cukor, Judith; Wyka, Katarzyna; Olden, Megan; Hoffman, Hunter; Lee, Francis S; Altemus, Margaret

    2014-01-01

    Viewing post-traumatic stress disorder (PTSD) as a disorder of emotional learning, this study used a cognitive enhancer synergistically with virtual reality exposure (VRE) therapy for the treatment of PTSD. The main objective was to determine if a novel pharmacotherapy, D-cycloserine (DCS), enhanced the efficacy of the psychotherapy. Pre-clinical studies suggest that when fear extinction occurs during DCS administration, neuroplasticity may be enhanced. VRE therapy is a particularly promising format to test the hypothesis that DCS enhances extinction learning, as sensory fear cues are standardized across patients. In a pilot randomized, double-blind, placebo-controlled trial, 100 mg of DCS or placebo was administered 90 min before each weekly VRE session, to ensure peak plasma concentrations during the sessions in 25 patients with chronic PTSD. The primary outcome measure was the Clinician Administered PTSD Scale (CAPS). Secondary outcome measures included the Beck Depression Inventory-II and the State-Trait Anger Expression Inventory-2. Assessments occurred at pre-treatment, following sessions 3, 6, 10, post-treatment, and at 6 months. The difference in CAPS between the VRE-DCS (n=13) and VRE-placebo (n=12) groups increased over time beginning at 6 weeks, with medium to large between-group effect sizes immediately post-treatment and 6 months later (d=0.68 and d=1.13, respectively). A similar pattern was observed for depression, anger expression, and sleep. PTSD remission rates were significantly greater for the VRE-DCS group (46% vs 8% at post-treatment; 69% vs 17% at 6 months). Patients in the VRE-DCS group showed earlier and greater improvement in PTSD symptoms compared with the VRE-placebo group. These results suggest a promising new treatment for PTSD. PMID:24217129

  20. A Prospective Study of the Clinical Profile, Outcome and Evaluation of D-dimer in Cerebral Venous Thrombosis

    PubMed Central

    Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali

    2016-01-01

    Introduction Cerebral Venous Thrombosis (CVT) is a well known disease with diverse clinical presentation and causes. With advances in neuroimaging and changing lifestyles, the clinical profile and causes of CVT are changing. D-dimer has been studied in early diagnosis of CVT with variable results. This prospective study was carried out to assess the clinical profile of CVT and role of D-dimer in diagnosis of CVT. Aim To study various aspects of CVT and role of D-dimer. Materials and Methods The study period was September 2012 to July 2014 and included 80 imaging proven patients of CVT. We also included 39 controls for assessing D-dimer. Data was collected according to a preformed format. D-dimer was assessed by a rapid semi-quantitative latex agglutination assay. Discharged patients were followed up to six months. Results Of the total 44 were women and 36 were men (F: M=1.2:1). The mean age of the patients was 29.5±9.68 years. Most common clinical features were headache 77 (96.25%), papilloedema (67.5%) and seizures 51 (63.75%). Pregnancy was the most common cause of CVT. Superior sagittal and transverse sinuses were the most common sinuses to be affected. The sensitivity and specificity of D-dimer for diagnosing CVT was 84.62% and 80% respectively. The risk factors for poor prognosis were altered sensorium, presence of sepsis, increased sinus involvement and deep sinus thrombosis. Conclusion CVT affects both sexes equally. Puerperium still contributes to majority of the cases. Iron deficiency anaemia needs to be evaluated as a contributing factor for incidence of CVT. D-dimer is not useful in puerperal female with CVT. Positive D-dimer will strengthen the suspicion of CVT in patients with acute headache followed by a neurological deficit. PMID:27504325

  1. Prospective Evaluation to Establish a Dose Response for Clinical Oral Mucositis in Patients Undergoing Head-and-Neck Conformal Radiotherapy

    SciTech Connect

    Narayan, Samir Lehmann, Joerg; Coleman, Matthew A.; Vaughan, Andrew; Yang, Claus Chunli; Enepekides, Danny; Farwell, Gregory; Purdy, James A.; Laredo, Grace; Nolan, Kerry A.S.; Pearson, Francesca S.; Vijayakumar, Srinivasan

    2008-11-01

    Purpose: We conducted a clinical study to correlate oral cavity dose with clinical mucositis, perform in vivo dosimetry, and determine the feasibility of obtaining buccal mucosal cell samples in patients undergoing head-and-neck radiation therapy. The main objective is to establish a quantitative dose response for clinical oral mucositis. Methods and Materials: Twelve patients undergoing radiation therapy for head-and-neck cancer were prospectively studied. Four points were chosen in separate quadrants of the oral cavity. Calculated dose distributions were generated by using AcQPlan and Eclipse treatment planning systems. MOSFET dosimeters were used to measure dose at each sampled point. Each patient underwent buccal sampling for future RNA analysis before and after the first radiation treatment at the four selected points. Clinical and functional mucositis were assessed weekly according to National Cancer Institute Common Toxicity Criteria, Version 3. Results: Maximum and average doses for sampled sites ranged from 7.4-62.3 and 3.0-54.3 Gy, respectively. A cumulative point dose of 39.1 Gy resulted in mucositis for 3 weeks or longer. Mild severity (Grade {<=} 1) and short duration ({<=}1 week) of mucositis were found at cumulative point doses less than 32 Gy. Polymerase chain reaction consistently was able to detect basal levels of two known radiation responsive genes. Conclusions: In our sample, cumulative doses to the oral cavity of less than 32 Gy were associated with minimal acute mucositis. A dose greater than 39 Gy was associated with longer duration of mucositis. Our technique for sampling buccal mucosa yielded sufficient cells for RNA analysis using polymerase chain reaction.

  2. Impact of Nonvascular Thoracic MR Imaging on the Clinical Decision Making of Thoracic Surgeons: A 2-year Prospective Study.

    PubMed

    Ackman, Jeanne B; Gaissert, Henning A; Lanuti, Michael; Digumarthy, Subba R; Shepard, Jo-Anne O; Halpern, Elkan F; Wright, Cameron D

    2016-08-01

    Purpose To determine the impact of nonvascular thoracic magnetic resonance (MR) imaging on the clinical decision making and diagnostic certainty of thoracic surgeons. Materials and Methods Seven thoracic surgeons at Massachusetts General Hospital, an academic quaternary referral hospital, participated in this 2-year, prospective, institution review board-approved, HIPAA-compliant pre- and post-MR imaging survey study after completing a one-time demographic survey. Between July 16, 2013, and July 13, 2015, each time a thoracic surgeon ordered a nonvascular thoracic MR imaging study via radiology order entry, he or she was sent a link to the pre-test survey that ascertained the clinical rationale for MR imaging, the clinical management plan if MR imaging was not an option, and pre-test diagnostic certainty. Upon completion of the MR imaging report, the surgeon was sent a link to the post-test survey assessing if/how MR imaging changed clinical management, the surgeon's comfort with the clinical management plan, and post-test diagnostic certainty. Data were analyzed with Student t, Wilcoxon, and McNemar tests. Results A total of 99 pre- and post-test surveys were completed. Most MR imaging studies (64 of 99 [65%]) were requested because of indeterminate computed tomographic findings. The use of MR imaging significantly reduced the number of planned surgical interventions (P < .001), modified the surgical approach in 54% (14 of 26) of surgical cases, and increased surgeon comfort with the patient management plan in 95% (94 of 99) of cases. Increased diagnostic certainty as a result of MR imaging was highly significant (P < .0001). In 21% (21 of 99) of cases, definitive MR imaging results warranted no further follow-up or clinical care. Conclusion In appropriate cases, assessment with nonvascular thoracic MR imaging substantially affects the clinical decision making and diagnostic certainty of thoracic surgeons. (©) RSNA, 2016 Online supplemental material is available

  3. 14-day prulifloxacin treatment of acute uncomplicated cystitis in women with recurrent urinary tract infections: a prospective, open-label, pilot trial with 6-month follow-up.

    PubMed

    Cai, T; Mazzoli, S; Nesi, G; Boddi, V; Mondaini, N; Bartoletti, R

    2009-11-01

    Recurrent urinary tract infections (UTI) are very common in otherwise healthy young women, and can have a very negative social and economic impact. In order to evaluate the tolerability and efficacy of a 14-day course of prulifloxacin orally administered once daily, 51 young female patients, attending the same STD center between may and June 2007 for symptoms of cystitis, with a history of recurrent UTI and urine culture positive for uropathogens, were enrolled in this prospective study. Microbiological and clinical efficacy was tested over three follow-up visits at 1, 3 and 6 months. Quality of life (QoL) was measured and the impact of prulifloxacin in modifying the Lactobacillus vaginal flora was also evaluated. At baseline, the pathogens most commonly isolated were Enterococcus faecalis (43.2%) and Escherichia coli (27.5%). 41 of the 51 women, (80.3%) had Lactobacillus spp. in vaginal samples at baseline. microbiological results at follow-up examinations were as follows: after 1 month, 47 patients were recurrence-free and 4 had recurrence; after 3 months, 41 were recurrence-free, while 6 reported recurrence; finally, after 6 months, 36 were recurrence-free and 5 had recurrence. A statistically significant difference was reported between the QoL questionnaire mean scores at baseline (0.63), 1 (0.77), 3 (0.77) and 6 months (0.78) after treatment (all p<0.001). the vaginal swab cultures demonstrated that Lactobacillus spp. flora was maintained in 38 out of the 41 (92.6%) patients who had positive vaginal swab sample at baseline. in conclusion, a 14-day administration of prulifloxacin 600 mg is a safe, well tolerated and effective treatment for the management of UTI in young women. PMID:19933045

  4. The cognitive profile of prion disease: a prospective clinical and imaging study

    PubMed Central

    Caine, Diana; Tinelli, Renata J; Hyare, Harpreet; De Vita, Enrico; Lowe, Jessica; Lukic, Ana; Thompson, Andrew; Porter, Marie-Claire; Cipolotti, Lisa; Rudge, Peter; Collinge, John; Mead, Simon

    2015-01-01

    Objectives Prion diseases are dementing illnesses with poorly defined neuropsychological features. This is probably because the most common form, sporadic Creutzfeldt-Jakob disease, is often rapidly progressive with pervasive cognitive decline making detailed neuropsychological investigation difficult. This study, which includes patients with inherited, acquired (iatrogenic and variant) and sporadic forms of the disease, is the only large-scale neuropsychological investigation of this patient group ever undertaken and aimed to define a neuropsychological profile of human prion diseases. Methods A tailored short cognitive examination of all of the patients (n = 81), with detailed neuropsychological testing in a subset with mild disease (n = 30) and correlation with demographic, clinical, genetic (PRNP mutation and polymorphic codon 129 genotype), and other variables (MRI brain signal change in cortex, basal ganglia or thalamus; quantitative research imaging, cerebrospinal fluid 14-3-3 protein). Results Comparison with healthy controls showed patients to be impaired on all tasks. Principal components analysis showed a major axis of fronto-parietal dysfunction that accounted for approximately half of the variance observed. This correlated strongly with volume reduction in frontal and parietal gray matter on MRI. Examination of individual patients' performances confirmed early impairment on this axis, suggesting characteristic cognitive features in mild disease: prominent executive impairment, parietal dysfunction, a largely expressive dysphasia, with reduced motor speed. Interpretation Taken together with typical neurological features, these results complete a profile that should improve differential diagnosis in a clinical setting. We propose a tailored neuropsychological battery for early recognition of clinical onset of symptoms with potential for use in clinical trials involving at-risk individuals. PMID:26000326

  5. Environmental and clinical epidemiology of Aspergillus terreus: data from a prospective surveillance study.

    PubMed

    Rüping, M J G T; Gerlach, S; Fischer, G; Lass-Flörl, C; Hellmich, M; Vehreschild, J J; Cornely, O A

    2011-07-01

    Aspergillus terreus may be resistant to amphotericin B and is associated with significant morbidity and mortality in immunocompromised patients. Local incidence is influenced by the density of airborne Aspergillus spp. spores which may in turn depend on meteorological factors. Once-weekly environmental samples were collected prospectively inside and outside the University Hospital of Cologne, Germany (UHC) and haematological patients were screened for nasal Aspergillus spp. colonisation and monitored for invasive fungal disease (IFD). RAPD (rapid amplification of polymorphic DNA)-polymerase chain reaction (PCR) and amphotericin B susceptibility testing were performed on all A. terreus isolates. A total of 4919 colony-forming units (cfu) were isolated (2212 indoors, 2707 outdoors). Further identification revealed A. fumigatus (73.5%), A. niger (4.3%), A. flavus (1.7%), A. terreus (0.2%) and non-Aspergillus fungi (20.3%). RAPD-PCR did not reveal clonal relationships between the A. terreus isolates. All A. terreus isolates displayed complete resistance to amphotericin. The B. Aspergillus spp. conidia exposure was lowest in June and highest in November inside and outside UHC. Conidia load correlated with the season and the relative humidity, with increasing spore counts during dry periods. One out of 855 nasal swabs was positive for A. niger. The patient did not develop IFD. A. terreus is unlikely to be a relevant pathogen at the UHC. Results from RAPD-PCR suggested a wide epidemiological variety of strains rather than a common source of contamination. Nasal swab surveillance cultures for early detection of Aspergillus spp. colonisation were not useful in identifying patients who may develop IFD. The risk of IFD at the UHC may increase in autumn and during dry periods. PMID:21440331

  6. Physician exposure to ionizing radiation during trauma resuscitation: A prospective clinical study

    SciTech Connect

    Weiss, E.L.; Singer, C.M.; Benedict, S.H.; Baraff, L.J.

    1990-02-01

    A prospective study of emergency physician whole body and extremity exposure to ionizing radiation during trauma resuscitation over a three-month period was conducted. Radiation film badges and thermoluminescent dosimeter finger rings were permanently attached to leaded aprons worn by emergency medicine residents during all trauma resuscitations. One set of apron and finger ring dosimeters was designated for the resident who managed the airway and stabilized the neck, when necessary, during cervical spine radiography (A-CS resident). A separate set of dosimeters was designated for the resident supervising the resuscitation. During the study period, 150 major trauma patients requiring 481 radiographic studies were treated. The mean monthly cumulative whole body exposures were 136.7 +/- 85.0 and 103.3 +/- 60.3 mrem for A-CS and supervising residents, respectively. The mean weekly cumulative extremity exposures were 523.3 +/- 611.0 and 46.7 +/- 18.6 mrem for A-CS and supervising residents, respectively. Calculated whole body exposures per patient were 2.7 mrem for the A-CS resident and 2.1 mrem for the supervising resident. Calculated extremity exposures per patient were 41.9 +/- 48.9 and 3.7 +/- 1.5 mrem, respectively. To exceed the annual whole body exposure limit established by the National Council of Radiologic Protection, the A-CS resident, working 200 shifts per year, would have to treat 9.2 trauma patients per shift. To exceed the annual extremity exposure limit, the A-CS resident would have to treat 5.9 trauma patients per shift. Of note, European exposure limits are 10% of current US limits. We conclude that significant exposures may occur to physicians working in trauma centers and that the use of shielding devices is indicated.

  7. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study

    PubMed Central

    2012-01-01

    Background No studies on continuous renal replacement therapy (CRRT) have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Methods Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of illness scores, CRRT-related complications, duration of admission to the pediatric intensive care unit, and mortality. Results The sample comprised 174 critically ill children on CRRT. The median weight of the patients was 10 kg, 35% were under percentile (P) 3, and 56% had a weight/P50 ratio of less than 0.85. Only two patients were above P95. The mean age for patients under P3 was significantly lower than that of the other patients (p = 0.03). The incidence of weight under P3 was greater in younger children (p = 0.007) and in cardiac patients and in those who had previous chronic renal insufficiency (p = 0.047). The mortality analysis did not include patients with pre-existing renal disease. Mortality was 38.9%. Mortality for patients with weight < P3 was greater than that of children with weight > P3 (51% vs 33%; p = 0.037). In the univariate and multivariate logistic regression analyses, the only factor associated with mortality was protein-energy wasting (malnutrition) (OR, 2.11; 95% CI, 1.067-4.173; p = 0.032). Conclusions The frequency of protein-energy wasting in children who require CRRT is high, and the frequency of obesity is low. Protein-energy wasting is more frequent in children with previous end-stage renal disease and heart disease. Underweight children present a higher mortality rate than patients with normal body weight. PMID:23016957

  8. Factors Associated With Pelvic Fracture-Related Arterial Bleeding During Trauma Resuscitation: A Prospective Clinical Study

    PubMed Central

    Toth, Laszlo; King, Kate L.; McGrath, Benjamin

    2014-01-01

    Objectives: To determine predictors of pelvic fracture-related arterial bleeding (PFRAB) from the information available in the Emergency Department (ED). Design: Prospective cohort study. Setting: Single level-1 Trauma Center. Patients: In a 3-year period ending in December 2008, consecutive high-energy pelvic fracture patients older than 18 years were included. Patients who arrived >4 hours after injury or dead on arrival were excluded. Patient management followed advanced trauma life support and institutional guidelines. Collected data included patient demographics, mechanism of injury, vital signs, acid-base status, fluid resuscitation, trauma scores, fracture patterns, procedures, and outcomes. Potential predictors were identified using standard statistical tests: Univariate analysis, Pearson correlation (r), receiver operator characteristic, and decision tree analysis. Intervention: Observational study. Outcome Measures: PFRAB was determined based on angiography or computed tomography angiogram or laparotomy findings. Results: Of the 143 study patients, 15 (10%) had PFRAB. They were significantly older, more severely injured, more hypotensive, more acidotic, more likely to require transfusions in the ED, and had higher mortality rate than non-PFRAB patients. No single variable proved to be a strong predictor but some had a significant correlation with PFRAB. Useful predictors identified were worst base deficit (BD), receiver operator characteristic (0.77, cutoff: 6 mmol/L, r = 0.37), difference between any 2 measures of BD within 4 hours (ΔBD) >2 mmol/L, transfusion in ED (yes/no), and worst systolic blood pressure <104 mm Hg. Demographics, injury mechanism, fracture pattern, temperature, and pH had poor predictive value. Conclusions: BD <6 mmol/L, ΔBD >2 mmol/L, systolic blood pressure <104 mm Hg, and the need for transfusion in ED are independent predictors of PFRAB in the ED. These predictors can be valuable to triage blunt trauma victims for pelvic

  9. Clinical predictors of a low central venous oxygen saturation after major surgery: a prospective prevalence study.

    PubMed

    Litton, E; Silbert, B; Ho, K M

    2015-01-01

    Optimising perioperative haemodynamic status may reduce postoperative complications. In this prospective prevalence study, we investigated the associations between standard haemodynamic parameters and a low central venous oxygen saturation (ScvO2) in patients after major surgery. A total of 201 patients requiring continuous arterial and central venous pressure monitoring after major surgery were recruited. Simultaneous arterial and central venous blood gases, haemodynamic and biochemical data and perfusion index were obtained from patients at a single time-point within 24 hours of surgery. A low ScvO2 (<70%) was observed in 109 patients (54%). Use of mechanical ventilation, mean arterial pressure, central venous pressure, haemoglobin concentrations, arterial pH and lactate concentrations, arterial oxygen (PaO2) and carbon dioxide tensions (PaCO2) were all associated with a low ScvO2 in the univariate analyses. In the multivariate analysis, only a higher perfusion index (odds ratio [OR] 0.87, 95% confidence interval [CI] 0.78 to 0.98), PaO2 (OR 0.98 per mmHg increment, 95% CI 0.97 to 0.99) and PaCO2 (OR 0.88 per mmHg increment, 95% CI 0.82 to 0.95) and a lower central venous pressure (OR 1.14 per mmHg increment, 95% CI 1.04 to 1.25) were significantly associated with a reduced risk of a low ScvO2, all in a linear fashion. In conclusion, PaO2, PaCO2, perfusion index and central venous pressure were significant predictors of a low ScvO2 in patients after major surgery including cardiac surgery. PMID:25579290

  10. Clinical evaluation of neutron beam therapy. Current results and prospects, 1983

    SciTech Connect

    Cohen, L.; Hendrickson, F.R.; Kurup, P.D.; Mansell, J.A.; Awschalom, M.; Rosenberg, I.; Ten Haken, R.K.

    1985-01-01

    Some 9000 patients throughout the world have been treated by some form of neutron beam therapy. These include patients with advanced nonresectable tumors in many different sites treated with a variety of neutron beam generators varying widely in beam energy. Protocols were largely nonrandomized and included both mixed beam studies (neutrons + photons) and neutrons alone in varying doses. In spite of wide variation in equipment, treatment technique, and philosophy, some consistent trends have been identified: (1) in general, the neutron results have been at least as good as those of the photon controls measured in terms of local control, although the incidence of significant side effects have been higher; (2) in none of the randomized studies conducted so far, largely comprising epidermoid carcinomas of the head and neck, has a clear survival advantage for neutrons over photon controls been demonstrated at a statistically significant level; (3) results with mixed beam studies have been uniformly equivocal, with marginally significant differences in favor of the experimental groups compared with the photon controls; (4) adenocarcinomas of the gastrointestinal tract (GI) tract, including tumors of the salivary gland, pancreas, stomach, and bowel, appear to be responsive to high linear energy transfer (LET) radiation; (5) nonepidermoid, radioresistant tumors (sarcoma of bone and soft tissue and melanoma) yield a consistantly high local control rate, with neutron irradiation strikingly superior to those reported with photon therapy; and (6) in the central nervous system, both normal tissues and tumors appear to be exceptionally sensitive to neutron irradiation, therapeutic ratios are small, and the prospect of cure remains remote. It is concluded that neutrons are efficacious for certain specific tumor types, but that essentially new study designs, based on nonrandomized matched case comparisons, will be required to prove the merit of the new modality.

  11. Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.

    PubMed

    Ehling, Rainer; Di Pauli, Franziska; Lackner, Peter; Rainer, Carolyn; Kraus, Viktoria; Hegen, Harald; Lutterotti, Andreas; Kuenz, Bettina; De Zordo, Tobias; Schocke, Michael; Glatzl, Susanne; Löscher, Wolfgang N; Deisenhammer, Florian; Reindl, Markus; Berger, Thomas

    2015-10-15

    Data from in vitro and animal studies support a neuroprotective role of glatiramer acetate (GA) in multiple sclerosis (MS). We investigated prospectively whether treatment with GA leads to clinical and paraclinical changes associated with neuroprotection in patients with relapsing-remitting (RR) MS. Primary aim of this clinical study was to determine serum BDNF levels in RR-MS patients who were started on GA as compared to patients who remained therapy-naive throughout 24 months. Secondary outcomes included relapses and EDSS, cognition, quality of life, fatigue and depression, BDNF expression levels on peripheral immune cells (FACS, RT-PCR), serum anti-myelin basic peptide (MBP) antibody status, evoked potential and cerebral MRI studies. While GA treatment did not alter serum levels or expression levels on peripheral immune cells of BDNF over time it resulted in a transient increase of serum IgG antibody response to MBP, mainly due to subtype IgG1 (p<0.05), after 3 months. However, no significant differences were found between GA treated and therapy-naive patients with regard to serum BDNF and intracellular BDNF expression levels, nerve conduction (including median and tibial nerve somatosensory, pattern-shift visual and upper and lower limb motor evoked potentials) or MRI (including volume of hyperintense lesions, volume of hypointense lesions after CE, mean diffusivity and fractional anisotropy) outcome parameters. In conclusion, our findings do not support a major impact of GA treatment on paraclinical markers of neuroprotection in human RR-MS. PMID:26439969

  12. Comparative Outcomes of the Two Types of Sacral Extradural Spinal Meningeal Cysts Using Different Operation Methods: A Prospective Clinical Study

    PubMed Central

    Sun, Jian-jun; Wang, Zhen-yu; Teo, Mario; Li, Zhen-dong; Wu, Hai-bo; Yen, Ru-yu; Zheng, Mei; Chang, Qing; Yisha Liu, Isabelle

    2013-01-01

    This prospective study compares different clinical characteristics and outcomes of patients with two types of sacral extradural spinal meningeal cysts (SESMC) undergoing different means of surgical excision. Using the relationship between the cysts and spinal nerve roots fibers (SNRF) as seen under microscope, SESMCs were divided into two types: cysts with SNRF known as Tarlov cysts and cysts without. The surgical methods were tailored to the different types of SESMCs. The improved Japanese Orthopedic Association (IJOA) scoring system was used to evaluate preoperative and postoperative neurological function of the patients. Preoperative IJOA scores were 18.5±1.73, and postoperative IJOA scores were 19.6±0.78. The difference between preoperative and postoperative IJOA scores was statistically significant (t = -4.52, p = 0.0001), with a significant improvement in neurological function after surgery. Among the improvements in neurological functions, the most significant was sensation (z=-2.74, p=0.006), followed by bowel/bladder function (z=-2.50, p=0.01). There was a statistically significant association between the types of SESMC and the number (F=12.57, p=0.001) and maximum diameter (F=8.08, p=0.006) of the cysts. SESMC with SNRF are often multiple and small, while cysts without SNRF tend to be solitary and large. We advocate early surgical intervention for symptomatic SESMCs in view of significant clinical improvement postoperatively. PMID:24386317

  13. A prospective multicenter clinical trial to assess safety and efficacy of Menicon SF-P RGP lenses for extended wear.

    PubMed

    MacKeen, D L; Sachdev, M; Ballou, V; Cavanagh, H D

    1992-07-01

    A prospective, multicenter, national clinical trial was undertaken to assess the safety and efficacy of Menicon SF-P (melafocon A) rigid gas permeable (RGP) contact lenses for extended wear in healthy human eyes. Ten investigators enrolled 167 patients (334 eyes), of which 143 (286 eyes) were initially fit with lenses for the 12-month study. Most subjects were reexamined at 18 months or more, with findings essentially unchanged from those noted at 1 year. Two hundred-two eyes (71%) completed the study. Seventy-two eyes (25%) discontinued, and 12 (4%) elected to continue extended wear. During the study, no significant adverse clinical reaction attributable to the lens was observed. Surface irritation, occasional punctate staining, and lens binding were very rare. The average wearing time was 6.2 days, mandated partially by FDA restrictions as well as patient response. As expected, keratometric shifts were principally vertical: less than 0.99 D (69%), 1.00-1.99 D (28%), and 2.00-2.99 D (4%). The majority of changes observed were toward sphericity. Two hundred lens replacements were required, 24% for adjustments in power/base curve. Only 16 lenses were replaced for warpage, and none for discoloration or crazing. Of those completing the study, 76% rated overall lens comfort and satisfaction to be very good. These results suggest that RGP lens extended wear can be safe and effective and offer patients an acceptable alternative to extended wear of disposable hydrogel lenses. PMID:1499126

  14. Clinical outcome of a two-piece implant system with an internal hexagonal connection: a prospective study.

    PubMed

    Andreasi Bassi, M; Lopez, M A; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this prospective clinical study was to evaluate the survival rate (SVR - i.e. fixtures still in place at the end of the observation period) and success rate (SCR - i.e. bone resorption around implant neck) of an implant system characterized by cylindrical and tapered implants, both provided with an internal hexagonal connection. In the period between January 1996 and October 2011, 52 implants with internal hexagonal connection were inserted in 21 females and 31 males, mean age 54±11 years. The mean post-surgical follow-up was 44.6±34.4 months. Several parameters were evaluated as potential outcome conditioners: age, gender, smoking, replaced tooth, periodontal disease, fixture shape (i.e. cylindrical or tapered), jaw location (i.e. maxilla or mandible), bone graft, immediate loading, post-extractive placement, type of prosthesis (i.e. single crown or bridge), edentulism, implant diameter and length. An SPSS statistical program was used and Cox regression analysis performed. SVR was 100% since no fixtures were lost. SCR, expressed through the mean marginal bone loss, was 77%. No significant differences were found, for most of the parameters analyzed, with the exception of prosthetic bridges, where implants supporting this type of rehabilitation showed a worse clinical outcome in comparison to single crown rehabilitations. Internal hexagonal connection is a reliable tool for oral rehabilitation. PMID:27469542

  15. Delivering PrePex Medical Male Circumcision Services Through a Mobile Clinic: The Experience From a Pilot Project in North West Province, South Africa.

    PubMed

    Kufa, Tendesayi; Chetty-Makkan, Candice; Maraisane, Mpho; Charalambous, Salome; Chihota, Violet; Toledo, Carlos

    2016-06-01

    We describe the implementation of a pilot project to demonstrate the safety and feasibility of providing PrePex circumcision from a mobile clinic. We analyzed available project diary entries and staff meeting minutes to identify challenges encountered. The main challenges identified were (1) daily time constraints because of setting up procedures, (2) transportation logistics for clients when the mobile clinic had moved to a different location, (3) integration and coordination of staff responsibilities, and (4) recruitment for PrePex services in the mobile clinic. The provision of PrePex device circumcision through a mobile clinic was feasible but careful planning and review of operational procedures were needed to resolve the implementation challenges. PMID:27331594

  16. Delivering PrePex Medical Male Circumcision Services Through a Mobile Clinic: The Experience From a Pilot Project in North West Province, South Africa

    PubMed Central

    Chetty-Makkan, Candice; Maraisane, Mpho; Charalambous, Salome; Chihota, Violet; Toledo, Carlos

    2016-01-01

    Abstract: We describe the implementation of a pilot project to demonstrate the safety and feasibility of providing PrePex circumcision from a mobile clinic. We analyzed available project diary entries and staff meeting minutes to identify challenges encountered. The main challenges identified were (1) daily time constraints because of setting up procedures, (2) transportation logistics for clients when the mobile clinic had moved to a different location, (3) integration and coordination of staff responsibilities, and (4) recruitment for PrePex services in the mobile clinic. The provision of PrePex device circumcision through a mobile clinic was feasible but careful planning and review of operational procedures were needed to resolve the implementation challenges. PMID:27331594

  17. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  18. Patient punctuality and clinic performance: observations from an academic-based private practice pain centre: a prospective quality improvement study

    PubMed Central

    Williams, Kayode A; Chambers, Chester G; Dada, Maqbool; McLeod, Julia C; Ulatowski, John A

    2014-01-01

    Objectives The aim of this study was to examine the effects of an intervention to alter patient unpunctuality. The major hypothesis was that the intervention will change the distribution of patient unpunctuality by decreasing patient tardiness and increasing patient earliness. Design Prospective Quality Improvement. Setting Specialty Pain Clinic in suburban Baltimore, Maryland, USA. Participants The patient population ranged in age from 18 to 93 years. All patients presenting to the clinic during the study period were included in the study. The average monthly volume was 86.2 (SD=13) patients. A total of 1500 patient visits were included in this study. Interventions We tracked appointment times and patient arrival times at an ambulatory pain clinic. An intervention was made in which patients were informed that tardy patients would not be seen and would be rescheduled. This policy was enforced over a 12-month period. Primary and secondary outcome measures The distribution of patient unpunctuality was developed preintervention and at 12 months after implementation. Distribution parameters were used as inputs to a discrete event simulation to determine effects of the change in patient unpunctuality on clinic delay. Results Data regarding patient unpunctuality were gathered by direct observation before and after implementation of the intervention. The mean unpunctuality changed from −20.5 min (110 observations, SD=1.7) preintervention to −23.2 (169, 1.2) at 1 month after the intervention, −23.8 min (69, 1.8) at 6 months and −25.0 min (71, 1.2) after 1 year. The unpunctuality 12 months after initiation of the intervention was significantly different from that prior to the intervention (p<0.05). Conclusions Physicians and staff are able to alter patient arrival patterns to reduce patient unpunctuality. Reducing tardiness improves some measures of clinic performance, but may not always improve waiting times. Accommodating early arriving patients

  19. Applying Automated MR-Based Diagnostic Methods to the Memory Clinic: A Prospective Study

    PubMed Central

    Klöppel, Stefan; Peter, Jessica; Ludl, Anna; Pilatus, Anne; Maier, Sabrina; Mader, Irina; Heimbach, Bernhard; Frings, Lars; Egger, Karl; Dukart, Juergen; Schroeter, Matthias L.; Perneczky, Robert; Häussermann, Peter; Vach, Werner; Urbach, Horst; Teipel, Stefan; Hüll, Michael; Abdulkadir, Ahmed

    2015-01-01

    Abstract Several studies have demonstrated that fully automated pattern recognition methods applied to structural magnetic resonance imaging (MRI) aid in the diagnosis of dementia, but these conclusions are based on highly preselected samples that significantly differ from that seen in a dementia clinic. At a single dementia clinic, we evaluated the ability of a linear support vector machine trained with completely unrelated data to differentiate between Alzheimer’s disease (AD), frontotemporal dementia (FTD), Lewy body dementia, and healthy aging based on 3D-T1 weighted MRI data sets. Furthermore, we predicted progression to AD in subjects with mild cognitive impairment (MCI) at baseline and automatically quantified white matter hyperintensities from FLAIR-images. Separating additionally recruited healthy elderly from those with dementia was accurate with an area under the curve (AUC) of 0.97 (according to Fig. 4). Multi-class separation of patients with either AD or FTD from other included groups was good on the training set (AUC >  0.9) but substantially less accurate (AUC = 0.76 for AD, AUC = 0.78 for FTD) on 134 cases from the local clinic. Longitudinal data from 28 cases with MCI at baseline and appropriate follow-up data were available. The computer tool discriminated progressive from stable MCI with AUC = 0.73, compared to AUC = 0.80 for the training set. A relatively low accuracy by clinicians (AUC = 0.81) illustrates the difficulties of predicting conversion in this heterogeneous cohort. This first application of a MRI-based pattern recognition method to a routine sample demonstrates feasibility, but also illustrates that automated multi-class differential diagnoses have to be the focus of future methodological developments and application studies PMID:26401773

  20. Applying Automated MR-Based Diagnostic Methods to the Memory Clinic: A Prospective Study.

    PubMed

    Klöppel, Stefan; Peter, Jessica; Ludl, Anna; Pilatus, Anne; Maier, Sabrina; Mader, Irina; Heimbach, Bernhard; Frings, Lars; Egger, Karl; Dukart, Juergen; Schroeter, Matthias L; Perneczky, Robert; Häussermann, Peter; Vach, Werner; Urbach, Horst; Teipel, Stefan; Hüll, Michael; Abdulkadir, Ahmed

    2015-01-01

    Several studies have demonstrated that fully automated pattern recognition methods applied to structural magnetic resonance imaging (MRI) aid in the diagnosis of dementia, but these conclusions are based on highly preselected samples that significantly differ from that seen in a dementia clinic. At a single dementia clinic, we evaluated the ability of a linear support vector machine trained with completely unrelated data to differentiate between Alzheimer's disease (AD), frontotemporal dementia (FTD), Lewy body dementia, and healthy aging based on 3D-T1 weighted MRI data sets. Furthermore, we predicted progression to AD in subjects with mild cognitive impairment (MCI) at baseline and automatically quantified white matter hyperintensities from FLAIR-images. Separating additionally recruited healthy elderly from those with dementia was accurate with an area under the curve (AUC) of 0.97 (according to Fig. 4). Multi-class separation of patients with either AD or FTD from other included groups was good on the training set (AUC >  0.9) but substantially less accurate (AUC = 0.76 for AD, AUC = 0.78 for FTD) on 134 cases from the local clinic. Longitudinal data from 28 cases with MCI at baseline and appropriate follow-up data were available. The computer tool discriminated progressive from stable MCI with AUC = 0.73, compared to AUC = 0.80 for the training set. A relatively low accuracy by clinicians (AUC = 0.81) illustrates the difficulties of predicting conversion in this heterogeneous cohort. This first application of a MRI-based pattern recognition method to a routine sample demonstrates feasibility, but also illustrates that automated multi-class differential diagnoses have to be the focus of future methodological developments and application studies. PMID:26401773

  1. Biopsychosocial influence on shoulder pain: risk subgroups translated across preclinical and clinical prospective cohorts.

    PubMed

    George, Steven Z; Wallace, Margaret R; Wu, Samuel S; Moser, Michael W; Wright, Thomas W; Farmer, Kevin W; Borsa, Paul A; Parr, Jeffrey J; Greenfield, Warren H; Dai, Yunfeng; Li, Hua; Fillingim, Roger B

    2015-01-01

    Tailored treatment based on individual risk factors is an area with promise to improve options for pain relief. Musculoskeletal pain has a biopsychosocial nature, and multiple factors should be considered when determining risk for chronic pain. This study investigated whether subgroups comprised genetic and psychological factors predicted outcomes in preclinical and clinical models of shoulder pain. Classification and regression tree analysis was performed for an exercise-induced shoulder injury cohort (n = 190) to identify high-risk subgroups, and a surgical pain cohort (n = 150) was used for risk validation. Questionnaires for fear of pain and pain catastrophizing were administered before injury and preoperatively. DNA collected from saliva was genotyped for a priori selected genes involved with pain modulation (COMT and AVPR1A) and inflammation (IL1B and TNF/LTA). Recovery was operationalized as a brief pain inventory rating of 0/10 for current pain intensity and <2/10 for worst pain intensity. Follow-up for the preclinical cohort was in daily increments, whereas follow-up for the clinical cohort was at 3, 6, and 12 months postoperatively. Risk subgroups comprised the COMT high pain sensitivity variant and either pain catastrophizing or fear of pain were predictive of heightened shoulder pain responses in the preclinical model. Further analysis in the clinical model identified the COMT high pain sensitivity variant and pain catastrophizing subgroup as the better predictor. Future studies will determine whether these findings can be replicated in other anatomical regions and whether personalized medicine strategies can be developed for this risk subgroup. PMID:25599310

  2. A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders

    PubMed Central

    Geier, David A.; Kern, Janet K.; Davis, Georgia; King, Paul G.; Adams, James B.; Young, John L.; Geier, Mark R.

    2011-01-01

    Summary Background L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted. Material/Methods Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing. Results Significant improvements were observed in CARS (−2.03, 95% CI=−3.7 to −0.31), CGI (−0.69, 95% CI=−1.1 to −0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given. Conclusions L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended. PMID:21629200

  3. Complex regional pain syndrome: evidence for warm and cold subtypes in a large prospective clinical sample.

    PubMed

    Bruehl, Stephen; Maihöfner, Christian; Stanton-Hicks, Michael; Perez, Roberto S G M; Vatine, Jean-Jacques; Brunner, Florian; Birklein, Frank; Schlereth, Tanja; Mackey, Sean; Mailis-Gagnon, Angela; Livshitz, Anatoly; Harden, R Norman

    2016-08-01

    Limited research suggests that there may be Warm complex regional pain syndrome (CRPS) and Cold CRPS subtypes, with inflammatory mechanisms contributing most strongly to the former. This study for the first time used an unbiased statistical pattern recognition technique to evaluate whether distinct Warm vs Cold CRPS subtypes can be discerned in the clinical population. An international, multisite study was conducted using standardized procedures to evaluate signs and symptoms in 152 patients with clinical CRPS at baseline, with 3-month follow-up evaluations in 112 of these patients. Two-step cluster analysis using automated cluster selection identified a 2-cluster solution as optimal. Results revealed a Warm CRPS patient cluster characterized by a warm, red, edematous, and sweaty extremity and a Cold CRPS patient cluster characterized by a cold, blue, and less edematous extremity. Median pain duration was significantly (P < 0.001) shorter in the Warm CRPS (4.7 months) than in the Cold CRPS subtype (20 months), with pain intensity comparable. A derived total inflammatory score was significantly (P < 0.001) elevated in the Warm CRPS group (compared with Cold CRPS) at baseline but diminished significantly (P < 0.001) over the follow-up period, whereas this score did not diminish in the Cold CRPS group (time × subtype interaction: P < 0.001). Results support the existence of a Warm CRPS subtype common in patients with acute (<6 months) CRPS and a relatively distinct Cold CRPS subtype most common in chronic CRPS. The pattern of clinical features suggests that inflammatory mechanisms contribute most prominently to the Warm CRPS subtype but that these mechanisms diminish substantially during the first year postinjury. PMID:27023422

  4. Oropharyngeal dysphagia, free water protocol and quality of life: an update from a prospective clinical trial.

    PubMed

    Karagiannis, Martha; Karagiannis, Tom C

    2014-01-01

    Oropharyngeal dysphagia, typically associated with older adults, represents a spectrum of swallowing disorders with potentially serious complications and a negative impact on quality of life. A major complication of dysphagia is caused by aspiration, predominantly of thin liquids, which may cause aspiration pneumonia. Given that thin liquids are typically aspirated, the conventional therapy involves altering the diet to one consisting of modified solid consistencies and thickened fluids. While it is well known that this approach is appropriate for aspiration, it does represent difficulties with compliancy and quality of life. We have undertaken a relatively large scale clinical trial to investigate the relationships between the effects of free access to water and the development of aspiration, aspects of hydration and issues related to quality in people with dysphagia. Along with clinical observations and findings from others we have previously stratified people with dysphagia, namely those that are immobile or who have low mobility and severe degenerative neurological dysfunction, at highest risk of developing aspiration pneumonia following intake of water. In the present study, we have extended our previous clinical results. Our findings indicate that following purposeful selection of people with dysphagia with their own mobility and relatively healthy cognitive function, free access to water did not result in aspiration pneumonia, improved measures of hydration and in particular, significantly increased quality of life when compared to a diet consisting of thickened fluids only. Overall, we conclude that in people with good mobility and cognitive ability, there is no need to deviate from the Frazier Rehabilitation Centre free water protocol, which allows for the provision of water to people with dysphagia with strict guidelines particularly in relation to good physical ability. PMID:24392465

  5. The potential clinical applications and prospects of microRNAs in lung cancer

    PubMed Central

    Gao, Ying; Gao, Fei; Ma, Jin-lu; Sun, Wen-ze; Song, Li-ping

    2014-01-01

    Lung cancer is the major cause of cancer deaths worldwide due to its late diagnosis and poor outcome. Understanding genomic medicine may widen our vision into the oncogenesis of lung cancer and may open the door to improvements in the clinical management of lung cancer. It is well known that almost half of all genes are regulated by microRNAs (miRNAs). This review focuses on the role of miRNAs in lung cancer and also touches on the value of miRNA-based novel therapies for lung cancers. PMID:24940074

  6. Drug use in relation to clinical activities as an instrument for prospective drug budgeting. The Belgian experience.

    PubMed

    Closon, M C; Crott, R; Even-Adin, D

    1996-03-01

    In an effort to control escalating health expenditures, especially in hospitals, many countries are planning or experimenting with prospective budgeting systems. Belgium is no exception and has recently introduced, with some success, limited fixed charges per hospital admission and/or per hospitalisation day for laboratory tests and radiographic investigations. More recently, the focus has shifted to hospital drug expenditures, which have shown high growth rates over the past few years. Until now, such expenditures have been reimbursed on a fee-for-service system, often with limited out-of-pocket charges for hospitalised patients. In order to curb the growth of drug expenditures, it is appropriate to investigate whether the financing of hospital drugs through a prospective budgeting system could be a feasible solution. Therefore, we constructed a database of over 270 000 admissions from a sample of 23 Belgian general and teaching (university) hospitals for the year 1991. Data were obtained from the official Minimum Basic Data Set or Résumé Clinique Minimum, which contains summarised clinical and administrative information, plus detailed expenditures (including medications) for each hospital stay. This information allowed us to categorize each stay into an appropriate diagnosis-related group (DRG). Our first descriptive analysis identified a number of major variables that influenced patients' drug expenditures: all-patient DRG (APDRG), age, disease severity, length of stay in an intensive care unit, emergency admission, death during hospitalisation, and hospital type (teaching or general). A covariance analysis was then performed on all hospital stays combined, and separately on surgical and medical stays. The results indicated that these variables taken together account for between 56.5 and 76.3% of drug expenditures in medical and surgical stays, respectively, with the major variance explained by differences in APDRG category. However, when the data were

  7. Prospective clinical trial of hepatitis B vaccination in adults with and without type-2 diabetes mellitus

    PubMed Central

    Van Der Meeren, Olivier; Peterson, James T.; Dionne, Marc; Beasley, Richard; Ebeling, Peter R.; Ferguson, Murdo; Nissen, Michael D.; Rheault, Paul; Simpson, Richard W.; De Ridder, Marc; Crasta, Priya D.; Miller, Jacqueline M.; Trofa, Andrew F.

    2016-01-01

    ABSTRACT  Objective: Patients with diabetes mellitus are at increased risk for hepatitis B virus (HBV) infection and its complications. HBV vaccination is recommended for adults with diabetes in the United States and other countries. However, few studies have assessed safety and immunogenicity of hepatitis B vaccine in such patients. We assessed the safety and immunogenicity of recombinant hepatitis B vaccine in subjects with and without diabetes mellitus. Methods: Prospective, multi-country controlled study in 21 centers (www.clinicaltrials.gov NCT01627340). Four hundred and sixteen participants with Type-2 diabetes and 258 controls matched for age and body mass index (BMI) (2:1 ratio) received 3-doses of HBV vaccine (Engerix-B™, GSK Vaccines, Belgium) according to a 0, 1, 6 months schedule. Antibodies were measured against HBV surface antigen and expressed as seroprotection rates (anti-HBs ≥10mIU/mL) and geometric mean concentration (GMC). Results: The median age and BMI in patients with diabetes and controls (according-to-protocol cohort) were 54 y and 32.1 kg/m2, and 53 y and 30.8 kg/m2, respectively. Seroprotection rates (GMCs) one month post-dose-3 were 75.4% (147.6 mIU/mL) and 82.0% (384.2 mIU/mL) in patients with diabetes and controls, respectively. Age-stratified seroprotection rates for patients with diabetes were 88.5% (20–39 years), 81.2% (40–49 years), 83.2% (50–59 years), and 58.2% (≥60 years). The overall safety profile of hepatitis B vaccine was similar between groups. Conclusions: Hepatitis B vaccine is immunogenic in patients with diabetes and has a similar safety profile to vaccination in healthy controls. Because increasing age was generally associated with a reduction in seroprotection rates, hepatitis B vaccine should be administered as soon as possible after the diagnosis of diabetes. PMID:27123743

  8. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial.

    PubMed

    Alper, Isik; Yüksel, Esra

    2016-04-01

    We evaluated postoperative pain intensity and the incidence of chronic pain in patients with renal cell carcinoma undergoing laparoscopic or open radical nephrectomy.In this prospective study, 27 laparoscopic nephrectomy (Group LN) and 25 open nephrectomy (Group ON) patients were included. All patients received paracetamol infusion and intramuscular morphine 30 minutes before the end of the operation and intravenous patient controlled analgesia with morphine postoperatively. Data including patients' demographics, visual analog scale (VAS) pain scores at postoperative 0.5, 1, 2, 4, 6, 12, and 24 hours, postoperative morphine consumption, analgesic demand, analgesic delivery, number of patients requiring rescue analgesics, side effects because of analgesic medications, and overall patient satisfaction were recorded and compared between the two groups. Two and 6 months after the operation, patients were evaluated for chronic postsurgical pain (CPSP).Postoperative average VAS pain scores were not different between the two groups. However, only at 2 hours postoperatively, pain score was significantly higher in Group ON than in Group LN. In both groups, the highest pain scores were recorded at 30 minutes and 1 hour after surgery. Ninety-six percent of group ON patients and 88% of group LN patients required additional analgesia in the early postoperative period (P = 0.33). Postoperative morphine consumption and analgesic demand were found to be similar between the two groups. CPSP at 2 months after surgery was observed in 4 out of 25 patients (16%) in the ON group and 3 out of 27 patients (11.1%) in the LN group (P = 0.6). Chronic pain at 6 months after surgery was observed in 1 ON patient (4%) and 1 LN patient (3.7%, P = 0.9).This study demonstrated that postoperative acute pain scores were not different after laparoscopic or open nephrectomy and patients undergoing laparoscopic or open nephrectomy were at equal risk of developing CPSP. Pain control

  9. Perfusion and diffusion MRI of glioblastoma progression in a four-year prospective temozolomide clinical trial

    SciTech Connect

    Leimgruber, Antoine; Ostermann, Sandrine; Yeon, Eun Jo; Buff, Evelyn; Maeder, Philippe P.; Stupp, Roger; Meuli, Reto A. . E-mail: Reto.Meuli@chuv.ch

    2006-03-01

    Purpose: This study was performed to determine the impact of perfusion and diffusion magnetic resonance imaging (MRI) sequences on patients during treatment of newly diagnosed glioblastoma. Special emphasis has been given to these imaging technologies as tools to potentially anticipate disease progression, as progression-free survival is frequently used as a surrogate endpoint. Methods and Materials: Forty-one patients from a phase II temolozomide clinical trial were included. During follow-up, images were integrated 21 to 28 days after radiochemotherapy and every 2 months thereafter. Assessment of scans included measurement of size of lesion on T1 contrast-enhanced, T2, diffusion, and perfusion images, as well as mass effect. Classical criteria on tumor size variation and clinical parameters were used to set disease progression date. Results: A total of 311 MRI examinations were reviewed. At disease progression (32 patients), a multivariate Cox regression determined 2 significant survival parameters: T1 largest diameter (p < 0.02) and T2 size variation (p < 0.05), whereas perfusion and diffusion were not significant. Conclusion: Perfusion and diffusion techniques cannot be used to anticipate tumor progression. Decision making at disease progression is critical, and classical T1 and T2 imaging remain the gold standard. Specifically, a T1 contrast enhancement over 3 cm in largest diameter together with an increased T2 hypersignal is a marker of inferior prognosis.

  10. A Prospective Study of Clinical Outcomes Related to Third Molar Removal or Retention

    PubMed Central

    Cunha-Cruz, Joana; Rothen, Marilynn; Spiekerman, Charles; Drangsholt, Mark; Anderson, Loren; Roset, Gayle A.

    2014-01-01

    Objectives. We investigated outcomes of third molar removal or retention in adolescents and young adults. Methods. We recruited patients aged 16 to 22 years from a dental practice–based research network in the Pacific Northwest from May 2009 through September 2010 who had at least 1 third molar present and had never undergone third molar removal. Data were acquired via questionnaire and clinical examination at baseline, periodic online questionnaires, and clinical examination at 24 months. Results. A total of 801 patients participated. Among patients undergoing third molar removal, rates of paresthesia and jaw joint symptoms lasting more than 1 month were 6.3 and 34.3 per 100 person-years, respectively. Among patients not undergoing removal, corresponding rates were 0.7 and 8.8. Periodontal attachment loss at distal sites of second molars did not significantly differ by third molar removal status. Incident caries at the distal surfaces of second molars occurred in fewer than 1% of all sites. Conclusions. Rates of paresthesia and temporomandibular joint disorder were higher after third molar removal. Periodontal attachment loss and incident caries at the distal sites of second molars were not affected by extraction status. PMID:24524521

  11. Reproductive options for prospective parents in families with Huntington's disease: clinical, psychological and ethical reflections.

    PubMed

    de Die-Smulders, C E M; de Wert, G M W R; Liebaers, I; Tibben, A; Evers-Kiebooms, G

    2013-01-01

    BACKGROUND Huntington's disease (HD) is an autosomal dominant neurodegenerative late onset disorder. This review of reproductive options aims to increase reproductive confidence and to prevent suffering in relation to family planning around HD and possibly other late onset neurodegenerative disorders. METHODS Selected relevant literature and own views and experiences as clinical geneticists, psychologists and ethicists have been used. RESULTS Possible options, with emphasis on prenatal diagnosis (PD) and preimplantation genetic diagnosis (PGD) to prevent the transmission of HD to the next generation, are described and discussed. They are formally presented in a decision tree, taking into account the presence or absence of a fully penetrant allele (FPA), a reduced penetrant allele (RPA) or an intermediate allele (IA). A table compares invasive and non-invasive PD and PGD. From a psychological perspective, the complex process of counselling and decision-making regarding reproductive options is discussed. Special attention is paid to the decision to avoid the transmission of the mutation and to the confrontation and coping of a mutation-free child growing up with a parent developing disease symptoms. From an ethical point of view, reflections on both PD and PGD are brought forward taking into account the difference between FPA, RPA and IA, direct testing or exclusion testing and taking into account the welfare of the child in the context of medically assisted reproduction. CONCLUSION Recommendations and suggestions for good clinical practice in the reproductive care for HD families are formulated. PMID:23377865

  12. Skin-impedance in Fabry Disease: A prospective, controlled, non-randomized clinical study

    PubMed Central

    Gupta, Surya N; Ries, Markus; Murray, Gary J; Quirk, Jane M; Brady, Roscoe O; Lidicker, Jeffrey R; Schiffmann, Raphael; Moore, David F

    2008-01-01

    Background We previously demonstrated improved sweating after enzyme replacement therapy (ERT) in Fabry disease using the thermo-regularity sweat and quantitative sudomotor axon reflex tests. Skin-impedance, a measure skin-moisture (sweating), has been used in the clinical evaluation of burns and pressure ulcers using the portable dynamic dermal impedance monitor (DDIM) system. Methods We compared skin impedance measurements in hemizygous patients with Fabry disease (22 post 3-years of bi-weekly ERT and 5 ERT naive) and 22 healthy controls. Force compensated skin-moisture values were used for statistical analysis. Outcome measures included 1) moisture reading of the 100th repetitive reading, 2) rate of change, 3) average of 60–110th reading and 4) overall average of all readings. Results All outcome measures showed a significant difference in skin-moisture between Fabry patients and control subjects (p < 0.0001). There was no difference between Fabry patients on ERT and patients naïve to ERT. Increased skin-impedance values for the four skin-impedance outcome measures were found in a small number of dermatome test-sites two days post-enzyme infusions. Conclusion The instrument portability, ease of its use, a relatively short time required for the assessment, and the fact that DDIM system was able to detect the difference in skin-moisture renders the instrument a useful clinical tool. PMID:18990229

  13. Pharmacological Chaperone Therapy: Preclinical Development, Clinical Translation, and Prospects for the Treatment of Lysosomal Storage Disorders

    PubMed Central

    Parenti, Giancarlo; Andria, Generoso; Valenzano, Kenneth J

    2015-01-01

    Lysosomal storage disorders (LSDs) are a group of inborn metabolic diseases caused by mutations in genes that encode proteins involved in different lysosomal functions, in most instances acidic hydrolases. Different therapeutic approaches have been developed to treat these disorders. Pharmacological chaperone therapy (PCT) is an emerging approach based on small-molecule ligands that selectively bind and stabilize mutant enzymes, increase their cellular levels, and improve lysosomal trafficking and activity. Compared to other approaches, PCT shows advantages, particularly in terms of oral administration, broad biodistribution, and positive impact on patients' quality of life. After preclinical in vitro and in vivo studies, PCT is now being translated in the first clinical trials, either as monotherapy or in combination with enzyme replacement therapy, for some of the most prevalent LSDs. For some LSDs, the results of the first clinical trials are encouraging and warrant further development. Future research in the field of PCT will be directed toward the identification of novel chaperones, including new allosteric drugs, and the exploitation of synergies between chaperone treatment and other therapeutic approaches. PMID:25881001

  14. Computerized tomographic simulation compared with clinical mark-up in palliative radiotherapy: A prospective study

    SciTech Connect

    Haddad, Peiman; Cheung, Fred; Pond, Gregory; Easton, Debbie; Cops, Frederick; Bezjak, Andrea; McLean, Michael; Levin, Wilfred; Billingsley, Susan; Williams, Diane; Wong, Rebecca . E-mail: Rebecca.Wong@rmp.uhn.on.ca

    2006-07-01

    Purpose To evaluate the impact of computed tomographic (CT) planning in comparison to clinical mark-up (CM) for palliative radiation of chest wall metastases. Methods and Materials In patients treated with CM for chest wall bone metastases (without conventional simulation/fluoroscopy), two consecutive planning CT scans were acquired with and without an external marker to delineate the CM treatment field. The two sets of scans were fused for evaluation of clinical tumor volume (CTV) coverage by the CM technique. Under-coverage was defined as the proportion of CTV not covered by the CM 80% isodose. Results Twenty-one treatments (ribs 17, sternum 2, and scapula 2) formed the basis of our study. Due to technical reasons, comparable data between CM and CT plans were available for 19 treatments only. CM resulted in a mean CTV under-coverage of 36%. Eleven sites (58%) had an under-coverage of >20%. Mean volume of normal tissues receiving {>=}80% of the dose was 5.4% in CM and 9.3% in CT plans (p = 0.017). Based on dose-volume histogram comparisons, CT planning resulted in a change of treatment technique from direct apposition to a tangential pair in 7 of 19 cases. Conclusions CT planning demonstrated a 36% under-coverage of CTV with CM of ribs and chest wall metastases.

  15. Analysis of Cancer Metabolism by Imaging Hyperpolarized Nuclei: Prospects for Translation to Clinical Research

    PubMed Central

    Kurhanewicz, John; Vigneron, Daniel B; Brindle, Kevin; Chekmenev, Eduard Y; Comment, Arnaud; Cunningham, Charles H; DeBerardinis, Ralph J; Green, Gary G; Leach, Martin O; Rajan, Sunder S; Rizi, Rahim R; Ross, Brian D; Warren, Warren S; Malloy, Craig R

    2011-01-01

    A major challenge in cancer biology is to monitor and understand cancer metabolism in vivo with the goal of improved diagnosis and perhaps therapy. Because of the complexity of biochemical pathways, tracer methods are required for detecting specific enzyme-catalyzed reactions. Stable isotopes such as 13C or 15N with detection by nuclear magnetic resonance provide the necessary information about tissue biochemistry, but the crucial metabolites are present in low concentration and therefore are beyond the detection threshold of traditional magnetic resonance methods. A solution is to improve sensitivity by a factor of 10,000 or more by temporarily redistributing the populations of nuclear spins in a magnetic field, a process termed hyperpolarization. Although this effect is short-lived, hyperpolarized molecules can be generated in an aqueous solution and infused in vivo where metabolism generates products that can be imaged. This discovery lifts the primary constraint on magnetic resonance imaging for monitoring metabolism—poor sensitivity—while preserving the advantage of biochemical information. The purpose of this report was to briefly summarize the known abnormalities in cancer metabolism, the value and limitations of current imaging methods for metabolism, and the principles of hyperpolarization. Recent preclinical applications are described. Hyperpolarization technology is still in its infancy, and current polarizer equipment and methods are suboptimal. Nevertheless, there are no fundamental barriers to rapid translation of this exciting technology to clinical research and perhaps clinical care. PMID:21403835

  16. Disc replacement using Pro-Disc C versus fusion: a prospective randomised and controlled radiographic and clinical study

    PubMed Central

    Ahlhelm, F.; Pitzen, T.; Steudel, W. I.; Jung, J.; Shariat, K.; Steimer, O.; Bachelier, F.; Pape, D.

    2006-01-01

    Anterior cervical discectomy and fusion (ACDF) may be considered to be the gold standard for treatment of symptomatic degenerative disc disease within the cervical spine. However, fusion of the segment may result in progressive degeneration of the adjacent segments. Therefore, dynamic stabilization procedures have been introduced. Among these, artificial disc replacement by disc prosthesis seems to be promising. However, to be so, segmental motion must be preserved. This, again, is very difficult to judge and has not yet been proven. The aim of the current study was to first analyse the segmental motion following artificial disc replacement using a disc prosthesis. A second aim was to compare both segmental motion as well as clinical result to the current gold standard (ACDF). This is a prospective controlled study. Twenty-five patients with cervical disc herniation were enrolled and assigned to either study group (receiving a disc prosthesis) or control group (receiving ACDF, using a cage with bone graft and an anterior plate.) Radiostereometric analysis was used to quantify intervertebral motion immediately as well as 3, 6, 12 and 24 weeks postoperatively. Further, clinical results were judged using visual analogue scale and neuro-examination. Cervical spine segmental motion decreased over time in the presence of disc prosthesis or ACDF. However, the loss of segmental motion is significantly higher in the ACDF group, when looked at 3, 6, 12 and 24 weeks after surgery. We observed significant pain reduction in neck and arm postoperatively, without significant difference between both groups (P > 0.05). Cervical spine disc prosthesis preserves cervical spine segmental motion within the first 6 months after surgery. The clinical results are the same when compared to the early results following ACDF. PMID:17106665

  17. Clinical characteristics associated with adverse events in patients with exacerbation of chronic obstructive pulmonary disease: a prospective cohort study

    PubMed Central

    Stiell, Ian G.; Clement, Catherine M.; Aaron, Shawn D.; Rowe, Brian H.; Perry, Jeffrey J.; Brison, Robert J.; Calder, Lisa A.; Lang, Eddy; Borgundvaag, Bjug; Forster, Alan J.; Wells, George A.

    2014-01-01

    Background: To assist physicians with difficult decisions about hospital admission for patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) presenting in the emergency department, we sought to identify clinical characteristics associated with serious adverse events. Methods: We conducted this prospective cohort study in 6 large Canadian academic emergency departments. Patients were assessed for standardized clinical variables and then followed for serious adverse events, defined as death, intubation, admission to a monitored unit or new visit to the emergency department requiring admission. Results: We enrolled 945 patients, of whom 354 (37.5%) were admitted to hospital. Of 74 (7.8%) patients with a subsequent serious adverse event, 36 (49%) had not been admitted after the initial emergency visit. Multivariable modelling identified 5 variables that were independently associated with adverse events: prior intubation, initial heart rate ≥ 110/minute, being too ill to do a walk test, hemoglobin < 100 g/L and urea ≥ 12 mmol/L. A preliminary risk scale incorporating these and 5 other clinical variables produced risk categories ranging from 2.2% for a score of 0 to 91.4% for a score of 10. Using a risk score of 2 or higher as a threshold for admission would capture all patients with a predicted risk of adverse events of 7.2% or higher, while only slightly increasing admission rates, from 37.5% to 43.2%. Interpretation: In Canada, many patients with COPD suffer a serious adverse event or death after being discharged home from the emergency department. We identified high-risk characteristics and developed a preliminary risk scale that, once validated, could be used to stratify the likelihood of poor outcomes and to enable rational and safe admission decisions. PMID:24549125

  18. Risk factors for hip-related clinical signs in a prospective cohort study of four large dog breeds in Norway.

    PubMed

    Krontveit, Randi I; Trangerud, Cathrine; Sævik, Bente K; Skogmo, Hege K; Nødtvedt, Ane

    2012-02-01

    We conducted a prospective cohort study including privately owned dogs from the breeds Newfondland (NF), Labrador Retriever (LR), Leonberger (LEO), and Irish Wolfhound (IW) followed from birth until age 9 yrs. We wanted to investigate whether radiological hip dysplasia status given at approximately age 12-18 mos and other factors during growth influenced development of clinical signs due to hip-joint disease necessitating veterinary consultation. Whether or not such signs occurred due to hip dysplasia or due to secondary or primary DJD could not be distinguished, and we therefore used the term "owner-reported veterinary-diagnosed hip-related clinical signs" ("the event"). The included dogs were followed from birth to the event or until a maximum of 9 yrs of age. Our objectives were to describe breed differences in time to incidence and to evaluate potential risk factors for the time to event. We used Kaplan-Meier curves to describe time to incidence, and potential risk factors were assessed by use of a Cox proportional-hazards model. We enrolled 494 dogs from 103 litters, and 46 dogs were reported as having had the event during the observation period. We observed a significant time-varying effect (TVE): LR and LEO developed clinical signs later in life than NF. If the radiological hip status was either mild, moderate, or severe the hazard of experiencing the event was significantly increased. Access to off-leash exercise at age 12 mos decreased the hazard of the event, and the hazard varied by litter. The findings supported the hypothesis that radiological hip status at screening and exercise conditions during growth influenced the time to incidence of the event and that there were breed differences in time to the event. PMID:21982689

  19. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study.

    PubMed

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes. PMID:27606617

  20. Prospective Molecular Profiling of Canine Cancers Provides a Clinically Relevant Comparative Model for Evaluating Personalized Medicine (PMed) Trials

    PubMed Central

    Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E. J.; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara

    2014-01-01

    Background Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. Methodology A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Conclusions Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week). Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer

  1. Clinical outcome and quality of life after reoperative CABG: off-pump versus on-pump – observational pilot study

    PubMed Central

    2013-01-01

    Background Coronary artery bypass grafting (CABG) on cardiopulmonary bypass (CBP) is associated with significant morbidity and mortality. In high-risk patients, doomed for reoperation the adverse effects of CBP may be more striking. We evaluated the results of reoperative CABG (redo-CABG) by either off-pump (OPCAB) or on-pump (ONCAB). Clinical endpoints were perioperative myocardial infarction, mortality, survival and as the most striking difference between prior studies the quality of life (QoL). Methods We performed a prospective, non-randomized assessment for patients who underwent redo-CABG by redo-OPCAB (n = 40) or redo-ONCAB (n = 40) at our institution between January 2007 and December 2010. For evaluation of QoL the SF-36 health survey was used with self-administered assessment. Results During follow-up 37 of 40 patients were alive in the redo-OPCAB group versus 32 of 40 patients in the redo-ONCAB group (p < 0.05). The shorter operation time, less blood loss, fewer perioperative myocardial infarctions, the higher rate of totally arterial revascularisation and shorter intensive care stay were the significantly beneficial differences for patients in the redo-OPCAB group (p < 0.05). The 3-year survival rate was higher in the redo-OPCAB group with 81 ± 12% versus 63 ± 9%in the redo-ONCAB group. The quality of life survey did not reveal any significant differences between both groups. Conclusion In conclusion, with our present retrospective study, we could demonstrate the safety and efficacy of the redo-OPCAB technique with even higher 3-year survival rate. Both techniques seem to have similar impact on the outcome of patients. PMID:23561396

  2. Frailty Markers and Treatment Decisions in Patients Seen in Oncogeriatric Clinics: Results from the ASRO Pilot Study

    PubMed Central

    de Decker, Laure; Pauly, Vanessa; Rousseau, Frédérique; Bergman, Howard; Molines, Catherine

    2016-01-01

    Background Comprehensive Geriatric Assessment (CGA) is the gold standard to help oncologists select the best cancer treatment for their older patients. Some authors have suggested that the concept of frailty could be a more useful approach in this population. We investigated whether frailty markers are associated with treatment recommendations in an oncogeriatric clinic. Methods This prospective study included 70 years and older patients with solid tumors and referred for an oncogeriatric assessment. The CGA included nine domains: autonomy, comorbidities, medication, cognition, nutrition, mood, neurosensory deficits, falls, and social status. Five frailty markers were assessed (nutrition, physical activity, energy, mobility, and strength). Patients were categorized as Frail (three or more frailty markers), pre-frail (one or two frailty markers), or not-frail (no frailty marker). Treatment recommendations were classified into two categories: standard treatment with and without any changes and supportive/palliative care. Multiple logistic regression models were used to analyze factors associated with treatment recommendations. Results 217 patients, mean age 83 years (± Standard deviation (SD) 5.3), were included. In the univariate analysis, number of frailty markers, grip strength, physical activity, mobility, nutrition, energy, autonomy, depression, Eastern Cooperative Oncology Group Scale of Performance Status (ECOG-PS), and falls were significantly associated with final treatment recommendations. In the multivariate analysis, the number of frailty markers and basic Activities of Daily Living (ADL) were significantly associated with final treatment recommendations (p<0.001 and p = 0.010, respectively). Conclusion Frailty markers are associated with final treatment recommendations in older cancer patients. Longitudinal studies are warranted to better determine their use in a geriatric oncology setting. PMID:26918947

  3. The cellular origin for malignant glioma and prospects for clinical advancements

    PubMed Central

    Zong, Hui; Verhaak, Roel GW; Canoll, Peter

    2012-01-01

    Glioma remains incurable despite great advancements in medicine. Targeting the cell of origin for gliomas could bring great hope for patients. However, as a collection of diverse diseases, each subtype of glioma could derive from a distinct cell of origin. To resolve such a complex problem, one must use multiple research approaches to gain deep insights. Here we review current evidence regarding the cell of origin from clinical observations, whole-genome molecular pathology and glioma animal models. We conclude that neural stem cells, glial progenitors (including oligodendrocyte progenitor cells) and astrocytes could all serve as cells of origin for gliomas, and that cells incurring initial mutations (cells of mutation) might not transform, while their progeny cells could instead transform and act as cells of origin. Further studies with multidisciplinary approaches are needed to link each subtype to a particular cell of origin, and to develop effective therapies that target the signaling network within these cells. PMID:22616703

  4. Ethical issues in and beyond prospective clinical trials of human gene therapy.

    PubMed

    Fletcher, J C

    1985-08-01

    As the potential for the first human trials of somatic cell gene therapy nears, two ethical issues are examined: problems of moral choice for members of institutional review boards who consider the first protocols, for parents, and for the clinical researchers, and the special protections that may be required for the infants and children to be involved, and ethical objections to somatic cell therapy made by those concerned about a putative inevitable progression of genetic knowledge from therapy to mass genetic engineering in human reproduction. The author's viewpoint is that a consensus exists on the required moral approach to somatic cell therapy, but that no moral approach yet exists for experiments beyond this level, especially in the germline cells of human beings. PMID:3900265

  5. Evaluation of Hi-Tec Implant Restoration in Mandibular First Molar Region- A Prospective Clinical Study

    PubMed Central

    Sreeram, Roopa Rani. S.; Prasad, L Krishna; Chakravarthi, P Srinivas; Devi, Naga Neelima; Sreeram, Sanjay Krishna

    2015-01-01

    Background and Aims Missing teeth lead to loss of structural balance, inefficient function, poor aesthetics and psychological effects on human beings, which needs restoration for normal contour, function and aesthetics. Several natural or synthetic substitutes are being used for replacement of missing tooth since centuries. Implants are the latest modality of replacement. So, the study was aimed to assess clinical success rate of Hi-Tec implant; which is economical and new in market. Results of the study will help clinician for appropriate implant selection. Materials and Methods The study included 10 patients from 19 to 31 years and needed restoration of missing mandibular first molar. Restoration had done using Hi Tec Single-tooth implants with metal-ceramic single crown prosthesis after three months of osseointegration. The implants were evaluated clinically (bleeding on probing, probing depth, implant mobility- periotest) and radiographically (marginal bone loss and peri-implant radiolucency) for six years. The observers were blinded for the duration of the study to prevent bias. Results All the patients had uneventful post-surgical healing. No bleeding on probing, Implant mobility, peri-implant radiolucency with minimal marginal bone loss and constant probing depths were observed well within the normal range during follow-up periods. Conclusion Two stage single-tooth Hi Tec implant restoration can be used as a successful treatment modality for replacing mandibular first molar in an economic way. However, these results were obtained after 6 years of follow up with a smaller sample size, so long term multi center studies with a larger sample size is recommended for the predictability of success rate conclusively. PMID:26436053

  6. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety

    PubMed Central

    Malvehy, J; Hauschild, A; Curiel-Lewandrowski, C; Mohr, P; Hofmann-Wellenhof, R; Motley, R; Berking, C; Grossman, D; Paoli, J; Loquai, C; Olah, J; Reinhold, U; Wenger, H; Dirschka, T; Davis, S; Henderson, C; Rabinovitz, H; Welzel, J; Schadendorf, D; Birgersson, U

    2014-01-01

    Summary Background Even though progress has been made, the detection of melanoma still poses a challenge. In light of this situation, the Nevisense electrical impedance spectroscopy (EIS) system (SciBase AB, Stockholm, Sweden) was designed and shown to have the potential to be used as an adjunct diagnostic tool for melanoma detection. Objectives To assess the effectiveness and safety of the Nevisense system in the distinction of benign lesions of the skin from melanoma with electrical impedance spectroscopy. Methods This multicentre, prospective, and blinded clinical study was conducted at five American and 17 European investigational sites. All eligible skin lesions in the study were examined with the EIS-based Nevisense system, photographed, removed by excisional biopsy and subjected to histopathological evaluation. A postprocedure clinical follow-up was conducted at 7 ± 3 days from the initial measurement. A total of 1951 patients with 2416 lesions were enrolled into the study; 1943 lesions were eligible and evaluable for the primary efficacy end point, including 265 melanomas – 112 in situ and 153 invasive melanomas with a median Breslow thickness of 0·57 mm [48 basal cell carcinomas (BCCs) and seven squamous cell carcinomas (SCCs)]. Results The observed sensitivity of Nevisense was 96·6% (256 of 265 melanomas) with an exact one-sided 95% lower confidence bound estimated at 94·2% and an observed specificity of 34·4%, and an exact two-sided 95% confidence bound estimated at 32·0–36·9%. The positive and negative predictive values of Nevisense were 21·1% and 98·2%, respectively. The observed sensitivity for nonmelanoma skin cancer was 100% (55 of 48 BCCs and seven SCCs) with an exact two-sided 95% confidence bound estimated at 93·5–100·0%. Conclusions Nevisense is an accurate and safe device to support clinicians in the detection of cutaneous melanoma. What's already known about this topic? Although progress has been made in the detection of

  7. Transcrestal guided sinus lift without grafting materials: a 36 months clinical prospective study

    PubMed Central

    SPINELLI, D.; DE VICO, G.; CONDÒ, R.; OTTRIA, L.; ARCURI, C.

    2015-01-01

    SUMMARY Purpose This study describes the ability to perform a technique for bone regeneration in maxillary posterior deficit (TGSL) without the use of bone grafting materials using a highly minimally invasive protocol. Materials and methods Sixty six implants have been inserted in the sinus floor of a total of 39 patients through the transcrestal guided sinus lift technique (TGSL). All patients have been followed for at least three years in function. The drilling protocol was adapted on the basis of bone density of each implant site to achieve a torque between 45 and 55 Ncm. Healing titanium abutments tightened to 35 Ncm have been used. A CAD/CAM metal ceramics final prosthetic restoration has been generated a six months after the tissues healing and the provisional functionalization of the occlusion. Survival rate of implants and prostheses, biological and biomechanical complications, changes in marginal bone levels, and total height of alveolar crest bone before and after surgery have been evaluate and measured by the results obtained in this prospective study. It was also measured the periodontal parameters as well as levels of perception of pain by the patient during the entire recovery period. Results The result of the data of follow-up was 41.96 (24 to 36) months. Cumulative implant survival was 98.53% at 3 years. There were no biological and mechanical complications and there were no prosthetic failures during the whole period of follow-up. The Marginal Bone Loss (MBL) average during the first year of operation was from 0.33 to 0.36 mm, while the 3-year follow-up, the MBL average was 0.51 to 0.29 mm. The average of residual bone height of alveolar ridge before treatment was 6.7 to 1.6 mm (range 5.1 to 9.2 mm), while the average bone height was gained 6,4 – 1.6 mm (range 3.2 to 8.1 mm). All patients reported lower pain levels and found to have normal periodontal parameters. Conclusions This study suggests that the use of guided surgery to perform

  8. Maternal Stress and Young Children's Behavioural Development: A Prospective Pilot Study from 8 to 36 Months in a Finnish Sample

    ERIC Educational Resources Information Center

    Haapsamo, Helena; Pollock-Wurman, Rachel A.; Kuusikko-Gauffin, Sanna; Ebeling, Hanna; Larinen, Katja; Soini, Hannu; Moilanen, Irma

    2013-01-01

    The relationship between maternal parenting stress and infant/toddler behavioural development was examined in a longitudinal pilot study. Fifty mothers reported parenting stress via the Parenting Stress Index-Short Form when their infants were eight months old. Parents subsequently rated their children's emotional and behavioural problems…

  9. Intravoxel incoherent motion imaging kinetics during chemoradiotherapy for human papillomavirus-associated squamous cell carcinoma of the oropharynx: preliminary results from a prospective pilot study.

    PubMed

    Ding, Yao; Hazle, John D; Mohamed, Abdallah S R; Frank, Steven J; Hobbs, Brian P; Colen, Rivka R; Gunn, G Brandon; Wang, Jihong; Kalpathy-Cramer, Jayashree; Garden, Adam S; Lai, Stephen Y; Rosenthal, David I; Fuller, Clifton D

    2015-12-01

    This study aims to identify the temporal kinetics of intravoxel incoherent motion (IVIM) MRI in patients with human papillomavirus-associated (HPV+) oropharyngeal squamous cell carcinoma. Patients were enrolled under an Institutional Review Board (IRB)-approved protocol as part of an ongoing prospective clinical trial. All patients underwent two MRI studies: a baseline scan before chemoradiotherapy and a mid-treatment scan 3-4 weeks after treatment initiation. Parametric maps representing pure diffusion coefficient (D), pseudo-diffusion coefficient (D*), perfusion fraction (f) and apparent diffusion coefficient (ADC) were generated. The Mann-Whitney U-test was used to assess the temporal variation of IVIM metrics. Bayesian quadratic discriminant analysis (QDA) was used to evaluate the extent to which mid-treatment changes in IVIM metrics could be combined to predict sites that would achieve complete response (CR) in multivariate analysis. Thirty-one patients were included in the final analysis with 59 lesions. Pretreatment ADC and D values of the CR lesions (n = 19) were significantly lower than those of non-CR lesions (n = 33). Mid-treatment ADC, D and f values were significantly higher (p < 0.0001) than pretreatment values for all lesions. Each increase in normalized ΔADC of size 0.1 yielded a 1.45-fold increase in the odds of CR (p < 0.0003), each increase in normalized ΔD of size 0.1 yielded a 1.53-fold increase in the odds of CR (p < 0.0002), and each unit increase in Δf yielded a 2.29-fold increase in the odds of CR (p < 0.02). Combined ΔD and ΔADC were integrated into a multivariate prediction model and attained an AUC of 0.87 (95% confidence interval: 0.79, 0.96), as well as a sensitivity of 0.63, specificity of 0.85 and accuracy of 0.78, under leave-one-out cross-validation. In conclusion, IVIM is feasible and potentially useful in the prediction and assessment of the early response of HPV+ oropharyngeal squamous cell carcinoma

  10. Efficacy of 0.25% Lemongrass Oil Mouthwash: A Three Arm Prospective Parallel Clinical Study

    PubMed Central

    Mohanty, Pritam; Tangade, Pradeep; Rajput, Prashant; Batra, Manu

    2015-01-01

    Background Chlorhexidine mouthwash has earned eponym of gold standard to treat and/or prevent periodontal diseases. However, the present study was carried out to explore an alternative herbal mouthwash. Aim To compare the anti-plaque and anti-gingivitis efficacy of a 0.25% lemongrass oil mouthwash to that of 0.2% chlorhexidine mouthwash. Materials and Methods A double-blinded parallel designed clinical trial with 60 subjects was taken for the study. Baseline plaque index (PI) & gingival index (GI) score was recorded. Oral prophylaxis was done and the plaque score was set at zero. Then, subjects were randomly allocated into 3 groups (N=20 in each): 0.25% lemongrass oil mouthwash, 0.2% chlorhexidine mouthwash and oral prophylaxis only. Subjects were asked to swish with respective mouthwash twice daily for 21 days. Subjects were again re-evaluated on 14th and 21st day for GI and PI. Comparison of the mean difference among the variables was performed by parametric tests. Results Lemongrass oil mouthwash group showed highest reduction in GI & PI at both 14th and 21st day, which was statistically significant (p≤0.05). Conclusion Lemongrass oil mouthwash can also be used as a good herbal alternative to chlorhexidine mouthwash, so further studies are needed. PMID:26557608

  11. Ponseti casting for club foot - above- or below-knee?: A prospective randomised clinical trial.

    PubMed

    Maripuri, S N; Gallacher, P D; Bridgens, J; Kuiper, J H; Kiely, N T

    2013-11-01

    We undertook a randomised clinical trial to compare treatment times and failure rates between above- and below-knee Ponseti casting groups. Eligible children with idiopathic clubfoot, treated using the Ponseti method, were randomised to either below- or above-knee plaster of Paris casting. Outcome measures were total treatment time and the occurrence of failure, defined as two slippages or a treatment time above eight weeks. A total of 26 children (33 feet) were entered into the trial. The above-knee group comprised 17 feet in 13 children (ten boys and three girls, median age 13 days (1 to 40)) and the below-knee group comprised 16 feet in 13 children (ten boys and three girls, median age 13 days (5 to 20)). Because of six failures (37.5%) in the below-knee group, the trial was stopped early for ethical reasons. The rate of failure was significantly higher in the below-knee group (p = 0.039). The median treatment times of six weeks in the below-knee and four weeks in the above-knee group differed significantly (p = 0.01). This study demonstrates that the use of a below-knee plaster of Paris cast in conjunction with the Ponseti technique leads to unacceptably high failure rates and significantly longer treatment times. Therefore, this technique is not recommended. PMID:24151281

  12. [PARP inhibitors and radiotherapy: rational and prospects for a clinical use].

    PubMed

    Pernin, V; Mégnin-Chanet, F; Pennaneach, V; Fourquet, A; Kirova, Y; Hall, J

    2014-12-01

    Poly(ADP-ribosyl)ation is a ubiquitous protein modification involved in the regulation of many cellular processes that is carried out by the poly(ADP-ribose) polymerase (PARP) family. The PARP-1, PARP-2 and PARP-3 are the only PARPs known to be activated by DNA damage. The absence of PARP-1 and PARP-2, that are both activated by DNA damage and participate in DNA damage repair processes, results in hypersensitivity to ionizing radiation and alkylating agents. PARP inhibitors that compete with NAD(+) at the enzyme's activity site can be used in BRCA-deficient cells as single agent therapies acting through the principle of synthetic lethality exploiting these cells deficient DNA double-strand break repair. Preclinical data showing an enhancement of the response of tumors to radiation has been documented for several PARP inhibitors. However, whether this is due exclusively to impaired DNA damage responses or whether tumor re-oxygenation contributes to this radio-sensitization via the vasoactive effects of the PARP inhibitors remains to be fully determined. These promising results have paved the way for the evaluation of PARP inhibitors in combination with radiotherapy in phase I and phase II clinical trials for malignant glioma, head and neck, and breast cancers. A number of challenges remain that are also reviewed in this article, including the optimization of treatment schedules for combined therapies and the validation of biomarkers that will identify which patients will most benefit from either PARP inhibitors in combination with radiotherapy. PMID:25441760

  13. The road to remyelination in demyelinating diseases: current status and prospects for clinical treatment.

    PubMed

    Wootla, Bharath; Watzlawik, Jens O; Denic, Aleksandar; Rodriguez, Moses

    2013-06-01

    Within CNS disorders, demyelinating diseases are among the most devastating and cost intensive due to long-term disabilities affecting relatively young patients. Multiple sclerosis, a chronic inflammatory demyelinating disease in which the persistent inhibitory microenvironment of the resident oligodendrocyte precursor cells abrogates regeneration of myelin sheaths, is the most prominent disease in the spectrum of demyelinating diseases. The essential goal is to stimulate creation of new myelin sheaths on the demyelinated axons, leading to restoration of saltatory conduction and resolving functional deficits. The past few decades witnessed significant efforts to understand the cellular interactions at the lesion site with studies suggesting efficient remyelination as a prerequisite for functional repair. Despite its proven efficacy in experimental models, immunosuppression has not had profound clinical consequences in multiple sclerosis, which argued for a paradigm shift in the design of therapeutics aiming to achieve remyelination. For example, targeting oligodendrocytes themselves may drive remyelination in the CNS. This group and others have demonstrated that natural autoreactive antibodies directed at oligodendrocyte progenitors participate in remyelination. Accordingly, the authors developed a recombinant autoreactive natural human IgM antibody with therapeutic potential for remyelination. PMID:23730884

  14. Combination therapy with methotrexate and 5-fluorouracil: a prospective randomized clinical trial of order of administration.

    PubMed

    Coates, A S; Tattersall, M H; Swanson, C; Hedley, D; Fox, R M; Raghavan, D

    1984-07-01

    Because of biochemical and tissue culture evidence casting doubt on the physiologic relevance of reported synergy afforded by sequential administration of methotrexate (MTX) followed by 5-fluorouracil (5-FU), a randomized controlled clinical trial was conducted in 108 patients with advanced cancer, including 70 with squamous cell carcinoma (SCC) of the head and neck, nine with SCC of other primary sites, 24 with colorectal, and five with gastric adenocarcinomas. Patients were randomized to receive weekly therapy consisting of MTX followed one hour later by 5-FU, or 5-FU followed one hour later by MTX. There was a trend to higher tumor response rates in patients treated with MTX before 5-FU (45% v 33% overall; 65% v 39% in patients with previously untreated head and neck cancer), but these differences were not significant, either by chi-square test or by multivariate stepwise logistic regression. The trend in survival favoring the reverse sequence of 5-FU before MTX was not significant in univariate analyses. Stepwise multivariate Cox model analysis showed that Eastern Cooperative Oncology Group performance status at study entry was the major prognostic factor for survival (P less than 0.001), but among the 70 patients with head and neck cancer, the sequence of drug administration was the only other significant prognostic factor for survival, and favored the sequence of 5-FU followed by MTX (P less than 0.025). PMID:6376719

  15. Resident trainees do not affect patient satisfaction in an outpatient gastroenterology clinic: A prospective study conducted in a Canadian gastroenterology clinic

    PubMed Central

    Brahmania, Mayur; Young, Madison; Muthiah, Chetty; Ilnyckyj, Alexandra; Duerksen, Donald; Moffatt, Dana C

    2015-01-01

    BACKGROUND: There is little literature regarding how a gastroenterology trainee affects a patient’s interpretation of care during outpatient clinic visits. Improving patient satisfaction is desirable and benefits may include enhanced patient compliance as well as providing trainees with areas for improvement. OBJECTIVES: To evaluate patient satisfaction in an outpatient gastroenterology clinic when seen by a trainee and attending physician versus an attending physician alone. The secondary objective was to evaluate physician characteristics that play a role in creating a positive clinical experience. METHODS: A randomized prospective survey study was conducted over an 11-month period (July 2012 to June 2013) at St Boniface Hospital (Winnipeg, Manitoba). Two gastroenterology fellows (postgraduate year 4 and 5) and nine internal medicine residents (postgraduate year 1 to 3) comprised the ‘trainee’ role, while three academic clinicians comprised the ‘attending’ role. Patients included individuals seen for an initial consultation and were >18 years of age. RESULTS: A total of 211 patients comprised the final study group, with 118 in the attending group and 93 in the trainee group. In univariate analysis, patients more often had a very good experience when seen by an attending physician alone versus a trainee and attending physician (73% versus 56%; P=0.016); however, on multivariate analysis, there was no significant difference in patient satisfaction (OR 0.89; P=0.931). Physician factors found to be associated with high patient satisfaction on multivariate analysis included: addressing all patient concerns (OR 27.56; P=0.021); giving the patient a preliminary diagnosis (OR 78.02; P=0.006); and feeling the physician was thorough (OR 72.53; P=0.029). CONCLUSIONS: The present study did not reveal a difference in patient satisfaction if a patient sees an attending physician alone or with a trainee. Moreover, to improve patient satisfaction in a gastroenterology

  16. Transbuccal versus transoral approach for management of mandibular angle fractures: a prospective, clinical and radiographic study

    PubMed Central

    2016-01-01

    Objectives We compared the transbuccal and transoral approaches in the management of mandibular angle fractures. Materials and Methods Sixty patients with mandibular angle fractures were randomly divided into two equal groups (A, transoral approach; group B, transbuccal approach) who received fracture reduction using a single 2.5 mm 4 holed miniplate with a bar using either of the two approaches. Intraoperatively, the surgical time and the ease of surgical assess for fixation were noted. Patients were followed at 1 week, 3 months, and 6 months postoperatively and evaluated clinically for post-surgical complications like scarring, infection, postoperative occlusal discrepancy, malunion, and non-union. Radiographically, the interpretation of fracture reduction was also performed by studying the fracture gap following reduction using orthopantomogram tracing. The data was tabulated and subjected to statistical analysis. A P-value less than 0.05 was considered significant. Results No significant difference was seen between the two groups for variables like surgical time and ease of fixation. Radiographic interpretation of fracture reduction revealed statistical significance for group B from points B to D as compared to group A. No cases of malunion/non-union were noted. A single case of hypertrophic scar formation was noted in group B at 6 months postsurgery. Infection was noted in 2 patients in group B compared to 6 patients in group A. There was significantly more occlusal discrepancy in group A compared to group B at 1 week postoperatively, but no long standing discrepancy was noted in either group at the 6 months follow-up. Conclusion The transbuccal approach was superior to the transoral approach with regard to radiographic reduction of the fracture gap, inconspicuous external scarring, and fewer postoperative complications. We preferred the transbuccal approach due to ease of use, minimal requirement for plate bending, and facilitation of plate placement in the

  17. Effects of kinesiotherapy, ultrasound and electrotherapy in management of bilateral knee osteoarthritis: prospective clinical trial

    PubMed Central

    2012-01-01

    Background Although recent advances in knee osteoarthritis (OA) treatment and evaluation were achieved, to the best of our knowledge, few studies have evaluated the longitudinal effect of therapeutic modalities on the functional exercise capacity of patients with knee OA. The purpose was to investigate the effects of kinesiotherapy and electrotherapy on functional exercise capacity, evaluated using the six-minute walk test (6-MWT) in patients with bilateral knee OA. Secondary measurements included range of motion (ROM), severity of knee pain (VAS), and a measure of perceived health and physical function, evaluated using the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. Methods A total of 40 women with bilateral knee OA were assigned to three groups: kinesiotherapy (KIN, n = 16), transcutaneous electrical nerve stimulation (TENS, n = 12), or ultrasound (US, n = 10). The groups underwent 12 weeks of intervention twice per week. The participants were subjected to the 6-MWT, ROM, VAS and WOMAC index. These tests were performed before and after the intervention. The study was focused on outpatients and was carried out at Universidade Estadual de Campinas, Brazil. Results At follow-up, the KIN and US groups had significantly higher 6-MWT distances (19.8 ± 21.7 and 14.1 ± 22.5%, respectively) compared with their respective pre-intervention values. All treatments were effective for reducing pain and improving the WOMAC index. Conclusions We demonstrated that the 6-MWT is a tool that can be used to evaluate improvements in the functional exercise capacity of patients submitted to a clinical intervention. PMID:22999098

  18. Treatment Outcomes in Patients with Internet Addiction: A Clinical Pilot Study on the Effects of a Cognitive-Behavioral Therapy Program

    PubMed Central

    Wölfling, K.; Beutel, M. E.; Dreier, M.; Müller, K. W.

    2014-01-01

    Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerous studies assessing clinical characteristics of patients with Internet addiction, the knowledge about the effectiveness of treatment programs is limited. Although a recent meta-analysis indicates that those programs show effects, more clinical studies are needed here. To add knowledge, we conducted a pilot study on the effects of a standardized cognitive-behavioral therapy program for IA. 42 male adults meeting criteria for Internet addiction were enrolled. Their IA-status, psychopathological symptoms, and perceived self-efficacy expectancy were assessed before and after the treatment. The results show that 70.3% of the patients finished the therapy regularly. After treatment symptoms of IA had decreased significantly. Psychopathological symptoms were reduced as well as associated psychosocial problems. The results of this pilot study emphasize findings from the only meta-analysis conducted so far. PMID:25097858

  19. Quantifying the clinical virulence of Klebsiella pneumoniae producing carbapenemase Klebsiella pneumoniae with a Galleria mellonella model and a pilot study to translate to patient outcomes

    PubMed Central

    2014-01-01

    Background Previous studies may have overestimated morbidity and mortality due to Klebsiella pneumoniae producing carbapenemase (KPC) Klebsiella pneumoniae infections because of difficulties in modeling patient comorbidities. This pilot study sought to evaluate KPC virulence by combining clinical and Galleria mellonella models in patients with K. pneumoniae blood stream infections (BSIs). Methods G. mellonella were inoculated using KPC(+) and KPC(−) isolates from these patients. Extent and rapidity of insect mortality was analyzed. Patients were stratified by KPC BSI status. Clinical outcomes of mortality and length of stay post-infection for survivors (LOS) were analyzed. Median virulence scores calculated from the insect studies were imputed in the clinical model. Results The in-vivo model revealed greater mortality in KPC(−) isolates (p < 0.001). Fifteen patients with KPC(+) BSI were matched with 60 patients with KPC(−) BSI. Hospital mortality was greater in the KPC(+) group versus the KPC(−) group (OR 3.79, 95% CI 1.00 - 14.34). LOS was longer in the KPC(+) group (p < 0.01). Conversely the virulence score attenuated the association between KPC(+) status and mortality and LOS in the final translational models. Conclusions KPC(+) status was associated with decreased virulence in GM. Opposite findings were observed in patients. This pilot study demonstrates that measured virulence from GM may differ from human estimates of virulence. PMID:24428847

  20. Treatment outcomes in patients with internet addiction: a clinical pilot study on the effects of a cognitive-behavioral therapy program.

    PubMed

    Wölfling, K; Beutel, M E; Dreier, M; Müller, K W

    2014-01-01

    Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerous studies assessing clinical characteristics of patients with Internet addiction, the knowledge about the effectiveness of treatment programs is limited. Although a recent meta-analysis indicates that those programs show effects, more clinical studies are needed here. To add knowledge, we conducted a pilot study on the effects of a standardized cognitive-behavioral therapy program for IA. 42 male adults meeting criteria for Internet addiction were enrolled. Their IA-status, psychopathological symptoms, and perceived self-efficacy expectancy were assessed before and after the treatment. The results show that 70.3% of the patients finished the therapy regularly. After treatment symptoms of IA had decreased significantly. Psychopathological symptoms were reduced as well as associated psychosocial problems. The results of this pilot study emphasize findings from the only meta-analysis conducted so far. PMID:25097858

  1. Treatment of chronic diabetic lower leg ulcers with activated protein C: a randomised placebo-controlled, double-blind pilot clinical trial.

    PubMed

    Whitmont, Kaley; McKelvey, Kelly J; Fulcher, Gregory; Reid, Ian; March, Lyn; Xue, Meilang; Cooper, Alan; Jackson, Christopher J

    2015-08-01

    Lower leg ulcers are a serious and long-term complication in patients with diabetes and pose a major health concern because of the increasing number of patients diagnosed with diabetes each year. This study sought to evaluate the clinical benefit of topical activated protein C (APC) on chronic lower leg ulcers in patients with diabetes. Twelve patients were randomly assigned to receive either APC (N = 6) or physiological saline (placebo; N = 6) in a randomised, placebo-controlled, double-blind pilot clinical trial. Treatment was administered topically, twice weekly for 6 weeks with final follow-up at 20 weeks. Wound area was significantly reduced to 34·8 ± 16·4% of week 0 levels at 20 weeks in APC-treated wounds (p = 0·01). At 20 weeks, three APC-treated wounds had completely healed, compared to one saline-treated wound. Full-thickness wound edge skin biopsies showed reduced inflammatory cell infiltration and increased vascular proliferation following APC treatment. Patient stress scores were also significantly reduced following APC treatment (p < 0·05), demonstrating improved patient quality of life as assessed by the Cardiff Wound Impact Questionnaire. This pilot trial suggests that APC is a safe topical agent for healing chronic lower leg ulcers in patients with diabetes and provides supporting evidence for a larger clinical trial. PMID:23848141

  2. Comparison of clinical and radiological outcomes after automated open lumbar discectomy and conventional microdiscectomy: a prospective randomized trial

    PubMed Central

    Lee, Sang-Ho; Bae, Jun Seok

    2015-01-01

    Objective: Microdiscectomy (MD) is the gold standard for surgical discectomy. As a minimally invasive discectomy, automated open lumbar discectomy (AOLD) is designed to preserve annular integrity and disc height as well as effectively remove herniated disc and degenerated disc material. However, there have been no prospective clinical studies comparing their effectiveness. The study was designed to compare clinical and radiological outcomes after AOLD with those of MD. Methods: Seventy-eight patients were evaluated for unilateral leg pain with the presence of disc herniation on magnetic resonance imaging (MRI) scans at a single attributable level. Sixty-two patients were enrolled; 33 patients (53%) were randomly assigned to the AOLD group and the remaining 29 patients (47%) were assigned to the MD group. Follow-up assessment was performed for 19 of the AOLD patients and 17 of the MD patients. The average follow-up period was 20 months. Clinical and functional outcomes were assessed using VAS and ODI scores. Change of disc height (DH), instability, and disc degeneration were assessed from radiographs, while Modic change and reherniation were assessed using MRI scans. Results: Postoperative VAS scores for leg pain and ODI scores for function were significantly improved in both groups. Postoperative VAS for back pain tended to decrease in the MD group but the decrease was statistically insignificant (P = 0.081). The postoperative VAS for back pain was significantly reduced in the AOLD group (P = 0.012). Patients from the MD group showed greater DH reduction than the AOLD group (P = 0.049). The MD group experienced greater disc degeneration and Modic change than the AOLD group. Follow-up MRI revealed 2 cases of reherniation in the AOLD group; 1 case was symptomatic, the other was asymptomatic. Conclusions: AOLD showed comparable clinical and radiological outcomes to conventional MD. AOLD preserves the central disc and removes only the loose degenerative disc fragments

  3. Clinical Development and Implementation of an Institutional Guideline for Prospective EEG Monitoring and Reporting of Delayed Cerebral Ischemia.

    PubMed

    Muniz, Carlos F; Shenoy, Apeksha V; OʼConnor, Kathryn L; Bechek, Sophia C; Boyle, Emily J; Guanci, Mary M; Tehan, Tara M; Zafar, Sahar F; Cole, Andrew J; Patel, Aman B; Westover, Michael B; Rosenthal, Eric S

    2016-06-01

    Delayed cerebral ischemia (DCI) is the most common and disabling complication among patients admitted to the hospital for subarachnoid hemorrhage (SAH). Clinical and radiographic methods often fail to detect DCI early enough to avert irreversible injury. We assessed the clinical feasibility of implementing a continuous EEG (cEEG) ischemia monitoring service for early DCI detection as part of an institutional guideline. An institutional neuromonitoring guideline was designed by an interdisciplinary team of neurocritical care, clinical neurophysiology, and neurosurgery physicians and nursing staff and cEEG technologists. The interdisciplinary team focused on (1) selection criteria of high-risk patients, (2) minimization of safety concerns related to prolonged monitoring, (3) technical selection of quantitative and qualitative neurophysiologic parameters based on expert consensus and review of the literature, (4) a structured interpretation and reporting methodology, prompting direct patient evaluation and iterative neurocritical care, and (5) a two-layered quality assurance process including structured clinician interviews assessing events of neurologic worsening and an adjudicated consensus review of neuroimaging and medical records. The resulting guideline's clinical feasibility was then prospectively evaluated. The institutional SAH monitoring guideline used transcranial Doppler ultrasound and cEEG monitoring for vasospasm and ischemia monitoring in patients with either Fisher group 3 or Hunt-Hess grade IV or V SAH. Safety criteria focused on prevention of skin breakdown and agitation. Technical components included monitoring of transcranial Doppler ultrasound velocities and cEEG features, including quantitative alpha:delta ratio and percent alpha variability, qualitative evidence of new focal slowing, late-onset epileptiform activity, or overall worsening of background. Structured cEEG reports were introduced including verbal communication for findings concerning

  4. Maxillary sinus lift without grafting, and simultaneous implant placement: a prospective clinical study with a 51-month follow-up.

    PubMed

    Bassi, A P F; Pioto, R; Faverani, L P; Canestraro, D; Fontão, F G K

    2015-07-01

    A prospective clinical study of maxillary sinus lift procedures in the posterior region of the maxilla, using only blood clot as filling material, was conducted. Seventeen patients underwent a maxillary sinus lift procedure; 20 maxillary sinus regions were operated on and a total of 25 implants were placed. The sinus mucosa was lifted together with the anterior wall of the osteotomized maxilla and supported by the implants placed. Computed tomography (CT) scans were obtained immediately postoperative (T initial) and at 3 (T1) and 51 (T2) months postoperative for the measurement of linear bone height and bone density (by grey tones). Only one implant was lost in the first stage (96% success). After dental prosthesis placement and during up to 51 months of follow-up, no implant was lost (100% success, second stage). The difference in mean bone height between T initial (5.94 mm) and T1 (13.14 mm), and between T initial and T2 (11.57 mm), was statistically significant (both P<0.001); comparison between T1 and T2 also presented a statistical difference (P<0.001). Bone density had increased at the end of the period analyzed, but this was not statistically significant (P>0.05). Thus, the maxillary sinus lift technique with immediate implant placement, filling with blood clot only, may be performed with a high success rate. PMID:25896082

  5. Cutaneous and Labyrinthine Tolerance of Bioactive Glass S53P4 in Mastoid and Epitympanic Obliteration Surgery: Prospective Clinical Study

    PubMed Central

    Bernardeschi, Daniele; Nguyen, Yann; Russo, Francesca Yoshie; Mosnier, Isabelle; Ferrary, Evelyne; Sterkers, Olivier

    2015-01-01

    Objective. To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery. Material and Methods. Forty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC) skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance. Results. All surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study. Conclusion. The bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications. PMID:26504792

  6. State anxiety and depression as factors modulating and influencing postoperative pain in dental implant surgery. A prospective clinical survey

    PubMed Central

    Gómez-de Diego, Rafael; Cutando-Soriano, Antonio; Montero-Martín, Javier; Prados-Frutos, Juan C.

    2014-01-01

    Objetives: To determine whether preoperative state anxiety and depression modulate or influence objective and subjective postoperative pain following dental implant insertion. Study Design: Prospective, clinical study with 7-day follow-up of a sample of 105 subjects who preoperatively completed the state anxiety questionnaire (STAI-E) and Beck Depression Inventory (BDI) and postoperatively, at 2 and 7 days, recorded objective pain with the Semmes-Weinstein mechanical esthesiometer (SW test) and subjective pain with the Visual Analog Scale (VAS). Results: 85.6% and 81.5% of patients, respectively, recorded no signs of state anxiety or depression. The correlation between anxiety and depression for both maxillary bones was the lower (P=0.02). The correlation between subjective and objective pain at 2 and 7 days, and the anatomic regions intervened, was statistically significant in the mandible at day 7 (P<0.01), and highly significant (P<0.001) for the other variables. The correlation between state anxiety and objective pain at day 7 was nearly statistically significant (P=0.07). Conclusions: The correlation between state anxiety and depression, and objective and subjective pain at day 7 was not statistically significant. A strong correlation was found between objective and subjective pain in the immediate postoperative period. Key words:Anxiety, depression, postoperative pain, dental implants. PMID:24880447

  7. Prospective clinical, scintigraphic, angiographic and functional evaluation of patients after inferior myocardial infarction with and without right ventricular dysfunction

    SciTech Connect

    Haines, D.E.; Beller, G.A.; Watson, D.D.; Nygaard, T.W.; Craddock, G.B.; Cooper, A.A.; Gibson, R.S.

    1985-11-01

    To elucidate the functional and prognostic significance of right ventricular dysfunction after acute inferior wall myocardial infarction, 74 consecutive patients with inferior infarction were prospectively evaluated with gated equilibrium blood pool imaging at rest, submaximal exercise thallium-201 scintigraphy and coronary angiography before hospital discharge. In addition, symptom-limited stress thallium-201 scintigraphy was performed in 61 patients at 3 months, and all patients were followed up clinically for 23 +/- 15 months. Utilizing predetermined radionuclide angiographic criteria, 47 patients (Group I) had normal right ventricular function, 12 patients (Group II) had mild to moderate dysfunction and 15 patients (Group III) had severe right ventricular dysfunction. Exercise tolerance as assessed by treadmill time, blood pressure-heart rate product and peak work load in METS was comparable among the three groups, both before hospital discharge and at 3 month follow-up. No differences in indicators of exercise-induced ischemia were noted among the groups, including the prevalence of redistribution thallium-201 defects, ST segment depression or symptoms of chest pain. Finally, cardiac mortality, reinfarction rate and the incidence of medically refractory angina pectoris were similar in the three groups. Thus, right ventricular dysfunction after acute inferior wall myocardial infarction does not appear to limit exercise tolerance or identify a subgroup of patients at higher risk for recurrent cardiac events.

  8. Comfort, satisfaction, and anxiolysis in surgical patients using a patient-adjustable comfort warming system: a prospective randomized clinical trial.

    PubMed

    O'Brien, Denise; Greenfield, Mary Lou V H; Anderson, Jane E; Smith, Beverly A; Morris, Michelle

    2010-04-01

    Comfort warming systems aim to produce a comfortable local environment over which the individual patient has control. We studied a patient-adjustable comfort warming system using the Bair PAWS (Patient Adjustable Warming System) (Arizant Healthcare, Inc, Eden Prairie, MN), specifically to study comfort warming rather than therapeutic warming. One-hundred thirty patients were enrolled in this prospective randomized clinical trial, with 58 patients randomized to the patient warming gown, and 72 randomized to the warm blanket group. Groups were similar for gender, age, height, weight, surgical time, body surface area, and body mass index. The patient-adjustable warming system group had perceived greater control and satisfaction at 30 minutes after treatment was initiated compared with the warmed blanket control group. However, there were no differences in satisfaction levels with thermal comfort among those patients contacted one day postoperatively. Additional research is needed to improve external validity of study findings. Further refinement of a nursing definition of thermal comfort should be explored. PMID:20359643

  9. Postoperative complications and clinical outcomes among patients undergoing thoracic and gastrointestinal cancer surgery: A prospective cohort study

    PubMed Central

    Martos-Benítez, Frank Daniel; Gutiérrez-Noyola, Anarelys; Echevarría-Víctores, Adisbel

    2016-01-01

    Objective This study sought to determine the influence of postoperative complications on the clinical outcomes of patients who underwent thoracic and gastrointestinal cancer surgery. Methods A prospective cohort study was conducted regarding 179 consecutive patients who received thorax or digestive tract surgery due to cancer and were admitted to an oncological intensive care unit. The Postoperative Morbidity Survey was used to evaluate the incidence of postoperative complications. The influence of postoperative complications on both mortality and length of hospital stay were also assessed. Results Postoperative complications were found for 54 patients (30.2%); the most common complications were respiratory problems (14.5%), pain (12.9%), cardiovascular problems (11.7%), infectious disease (11.2%), and surgical wounds (10.1%). A multivariate logistic regression found that respiratory complications (OR = 18.68; 95%CI = 5.59 - 62.39; p < 0.0001), cardiovascular problems (OR = 5.06, 95%CI = 1.49 - 17.13; p = 0.009), gastrointestinal problems (OR = 26.09; 95%CI = 6.80 - 100.16; p < 0.0001), infectious diseases (OR = 20.55; 95%CI = 5.99 - 70.56; p < 0.0001) and renal complications (OR = 18.27; 95%CI = 3.88 - 83.35; p < 0.0001) were independently associated with hospital mortality. The occurrence of at least one complication increased the likelihood of remaining hospitalized (log-rank test, p = 0.002). Conclusions Postoperative complications are frequent disorders that are associated with poor clinical outcomes; thus, structural and procedural changes should be implemented to reduce postoperative morbidity and mortality. PMID:27096675

  10. The clinical application of "jetting suture" technique in annular repair under microendoscopic discectomy: A prospective single-cohort observational study.

    PubMed

    Qi, Lei; Li, Mu; Si, Haipeng; Wang, Liang; Jiang, Yunpeng; Zhang, Shuai; Li, Le

    2016-08-01

    To introduce a new designed suture technique in annular repair under the microendoscopic discectomy (MED) surgery and to evaluate the clinical application of the technique in annular repair under MED with at least 2-year follow-up period.A new method of annular repair was designed and named "jetting suture" technique. Thirty consecutive patients with lumbar disc herniation were enrolled in the prospective single-cohort observational study. Patients were followed up at intervals of preoperative, postoperative 1 week, 3 months, 6 months, 1 year, and last follow-up. The clinical outcomes were evaluated by using Japanese Orthopaedic Association (JOA) score, Oswestry Disability Index, and modified Mcnab criteria.The procedure was successfully performed in all cases. No case required conversion to an open procedure. The mean age of patients was 36.6 years. Average blood loss was 45.8 ± 10.2 mL. The preoperative symptoms were alleviated significantly after surgery. All the standardized measures improved significantly at the last follow-up, including JOA score (10.1 to 26.6; P < 0.05) and Oswestry Disability Index (75.3 to 9.6; P < 0.05). Improvement rate of JOA score was 86.4%. Approximately 83.4% of patients reported good or excellent outcomes based on modified Mcnab criteria. No postoperative complication and recurrence of disc herniation was reported.The designed "jetting suture" technique in annular repair under MED can be performed safely and effectively. It could be a viable alternative to annular repair under lumbar discectomy. PMID:27495101

  11. The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study

    PubMed Central

    2013-01-01

    Objective To compare regimens consisting of either efavirenz or nevirapine and two or more nucleoside reverse transcriptase inhibitors (NRTIs) among HIV-infected, antiretroviral-naive, and AIDS-free individuals with respect to clinical, immunologic, and virologic outcomes. Design Prospective studies of HIV-infected individuals in Europe and the US included in the HIV-CAUSAL Collaboration. Methods Antiretroviral therapy-naive and AIDS-free individuals were followed from the time they started an NRTI, efavirenz or nevirapine, classified as following one or both types of regimens at baseline, and censored when they started an ineligible drug or at 6 months if their regimen was not yet complete. We estimated the ‘intention-to-treat’ effect for nevirapine versus efavirenz regimens on clinical, immunologic, and virologic outcomes. Our models included baseline covariates and adjusted for potential bias introduced by censoring via inverse probability weighting. Results A total of 15 336 individuals initiated an efavirenz regimen (274 deaths, 774 AIDS-defining illnesses) and 8129 individuals initiated a nevirapine regimen (203 deaths, 441 AIDS-defining illnesses). The intention-to-treat hazard ratios [95% confidence interval (CI)] for nevirapine versus efavirenz regimens were 1.59 (1.27, 1.98) for death and 1.28 (1.09, 1.50) for AIDS-defining illness. Individuals on nevirapine regimens experienced a smaller 12-month increase in CD4 cell count by 11.49 cells/μl and were 52% more likely to have virologic failure at 12 months as those on efavirenz regimens. Conclusions Our intention-to-treat estimates are consistent with a lower mortality, a lower incidence of AIDS-defining illness, a larger 12-month increase in CD4 cell count, and a smaller risk of virologic failure at 12 months for efavirenz compared with nevirapine. PMID:22546987

  12. Heterogeneity of Monosymptomatic Resting Tremor in a Prospective Study: Clinical Features, Electrophysiological Test, and Dopamine Transporter Positron Emission Tomography

    PubMed Central

    Zheng, Hua-Guang; Zhang, Rong; Li, Xin; Li, Fang-Fei; Wang, Ya-Chen; Wang, Xue-Mei; Lu, Ling-Long; Feng, Tao

    2015-01-01

    Background: The relationship between monosymptomatic resting tremor (mRT) and Parkinson's disease (PD) remains controversial. In this study, we aimed to assess the function of presynaptic dopaminergic neurons in patients with mRT by dopamine transporter positron emission tomography (DAT-PET) and to evaluate the utility of clinical features or electrophysiological studies in differential diagnosis. Methods: Thirty-three consecutive patients with mRT were enrolled prospectively. The Unified Parkinson's Disease Rating Scale and electromyography were tested before DAT-PET. Striatal asymmetry index (SAI) was calculated, and a normal DAT-PET was defined as a SAI of <15%. Scans without evidence of dopaminergic deficits (SWEDDs) were diagnosed in patients with a subsequent normal DAT-PET and structural magnetic resonance imaging. Results: Twenty-eight mRT patients with a significant reduction in uptake of DAT binding in the striatum were diagnosed with PD, while the remained 5 with a normal DAT-PET scan were SWEDDs. As for UPRDS, the dressing and hygiene score, walking in motor experiences of daily living (Part II) and motor examination (Part III) were significant different between two groups (P < 0.05 and P < 0.01, respectively). Bilateral tremor was more frequent in the SWEDDs group (P < 0.05). The frequency of resting tremor and the amplitude of postural tremor tend to be higher in the SWEDDs group (P = 0.08 and P = 0.05, respectively). Conclusions: mRT is heterogeneous in presynaptic nigrostriatal dopaminergic degeneration, which can be determined by DAT-PET brain imaging. Clinical and electrophysiological features may provide clues to distinguish PD from SWEDDs. PMID:26112718

  13. Prospective Clinical Trial of Bladder Filling and Three-Dimensional Dosimetry in High-Dose-Rate Vaginal Cuff Brachytherapy

    SciTech Connect

    Stewart, Alexandra J.; Cormack, Robert A.; Lee, Hang; Xiong Li; Hansen, Jorgen L.; O'Farrell, Desmond A.; Viswanathan, Akila N.

    2008-11-01

    Purpose: To investigate the effect of bladder filling on dosimetry and to determine the best bladder dosimetric parameter for vaginal cuff brachytherapy. Methods and Materials: In this prospective clinical trial, a total of 20 women underwent vaginal cylinder high-dose-rate brachytherapy. The bladder was full for Fraction 2 and empty for Fraction 3. Dose-volume histogram and dose-surface histogram values were generated for the bladder, rectum, and urethra. The midline maximal bladder point (MBP) and the midline maximal rectal point were recorded. Paired t tests, Pearson correlations, and regression analyses were performed. Results: The volume and surface area of the irradiated bladder were significantly smaller when the bladder was empty than when full. Of the several dose-volume histogram and dose-surface histogram parameters evaluated, the bladder maximal dose received by 2 cm{sup 3} of tissue, volume of bladder receiving {>=}50% of the dose, volume of bladder receiving {>=}70% of the dose, and surface area of bladder receiving {>=}50% of the dose significantly predicted for the difference between the empty vs. full filling state. The volume of bladder receiving {>=}70% of the dose and the maximal dose received by 2 cm{sup 3} of tissue correlated significantly with the MBP. Bladder filling did not alter the volume or surface area of the rectum irradiated. However, an empty bladder did result in the nearest point of bowel being significantly closer to the vaginal cylinder than when the bladder was full. Conclusions: Patients undergoing vaginal cuff brachytherapy treated with an empty bladder have a lower bladder dose than those treated with a full bladder. The MBP correlated well with the volumetric assessments of bladder dose and provided a noninvasive method for reporting the MBP dose using three-dimensional imaging. The MBP can therefore be used as a surrogate for complex dosimetry in the clinic.

  14. The effect of hydroxyapatite coated screw in the lateral fragility fractures of the femur. A prospective randomized clinical study.

    PubMed

    Pesce, V; Maccagnano, G; Vicenti, G; Notarnicola, A; Moretti, L; Tafuri, S; Vanni, D; Salini, V; Moretti, B

    2014-01-01

    Due to a growing numbers of lateral fragility fractures of the femur and their high social costs the need to work out an effective strategy in order to find a better solution for these patients is warranted. From January 2010 to July 2011, we carried out a prospective randomized clinical study comparing the results of patients with femoral lateral fractures treated by nail and cephalic hydroxyapatite coated screws (study group including 27 patients) compared to the patients with the same fractures treated with nail and head standard screws (control group including 27 patients). We defined the two parts of the femoral neck as ROI 1 (under the head screw) and ROI 2 (above the femoral screw) on the AP view. The bone density of the two areas was calculated using DEXA at T0 (1st day post-surgery), at T1 (40th day post-surgery), at T2 (3 months later), at T3 (1 year later). The clinical-radiography evaluations were based on the Harris Hip Score (HHS), ADL test and x-ray views of the hip. As far as the bone mineral density average of ROI 1 and ROI 2 is concerned, we found a significant statistical increase at T1 and T3 in the study group, while it was not significant in the control group. We could account for this data through the higher mechanical stability of hydroxyapatite coated screws than standard screws. In fact, this material was responsible for improved implant osteointegration. Thanks to a 1 year follow-up we were able to demonstrate the implant utility associated with augmentation and the importance of densitometry exams such as easily repeatable and low cost diagnostics to prevent the onset of complications linked to screw loosening. PMID:24750798

  15. Immediate implants and immediate loading in periodontally compromised patients-a 3-year prospective clinical study.

    PubMed

    Alves, Celia Coutinho; Correia, Andre Ricardo; Neves, Manuel

    2010-10-01

    To avoid the necessity of a removable provisional prosthesis, and therefore preserve the patient's functional outcome, esthetics, and quality of life, a clinical protocol was developed to approach periodontally compromised patients presenting a full-arch irreversibly lost dentition: full-arch extraction and immediate replacement with a provisional acrylic resin implant-supported fixed partial denture (FPD). A total of 23 periodontally compromised patients (11 women, 12 men; 4 smokers, 4 controlled diabetics) were included in this study. Pretreatment casts were taken and vertical dimension of occlusion was determined. In most patients, 6 Straumann implants were distributed along the arch according to the surgical guide or bone availability, with the most distal ones in the maxilla slightly tilted so they could emerge more distally. A total of 168 implants (146 Straumann, 10 Nobel Biocare, 8 Biomet 3i, and 4 Lifecore) were placed (83 in the maxilla, 85 in the mandible). Of those in the maxilla, 74 were loaded immediately (implant stability quotient mentor [ISQm] > 70) and 9 placed with delayed loading (ISQm =/< 70). Of the 85 implants placed in the mandible, all were loaded immediately (ISQm > 70). If an FPD had not been fabricated already, impressions were taken during surgery to do so. The prosthesis was then adapted (cemented or screwed) to the 6 implants within the first 48 hours postsurgery. After 2 months, definitive impressions were taken, and a definitive porcelain-fused-to-metal implant-supported 12-element FPD was fabricated and cemented or screwed to all 6 implants. Of the 168 implants, 108 were immediate implants and 159 immediately loaded. Only 2 implants (1 in the mandible, 1 in the maxilla) did not osseointegrate. This yields a 3-year cumulative survival rate of 98.74% (98.65% in the maxilla, 98.82% in the mandible). From a total of 26 immediately loaded prostheses (12 in the maxilla, 14 in the mandible), 6 were cemented and 20 screw-retained. The 3

  16. Dose properties of a laser accelerated electron beam and prospects for clinical application.

    PubMed

    Kainz, K K; Hogstrom, K R; Antolak, J A; Almond, P R; Bloch, C D; Chiu, C; Fomytskyi, M; Raischel, F; Downer, M; Tajima, T

    2004-07-01

    Laser wakefield acceleration (LWFA) technology has evolved to where it should be evaluated for its potential as a future competitor to existing technology that produces electron and x-ray beams. The purpose of the present work is to investigate the dosimetric properties of an electron beam that should be achievable using existing LWFA technology, and to document the necessary improvements to make radiotherapy application for LWFA viable. This paper first qualitatively reviews the fundamental principles of LWFA and describes a potential design for a 30 cm accelerator chamber containing a gas target. Electron beam energy spectra, upon which our dose calculations are based, were obtained from a uniform energy distribution and from two-dimensional particle-in-cell (2D PIC) simulations. The 2D PIC simulation parameters are consistent with those reported by a previous LWFA experiment. According to the 2D PIC simulations, only approximately 0.3% of the LWFA electrons are emitted with an energy greater than 1 MeV. We studied only the high-energy electrons to determine their potential for clinical electron beams of central energy from 9 to 21 MeV. Each electron beam was broadened and flattened by designing a dual scattering foil system to produce a uniform beam (103%>off-axis ratio>95%) over a 25 x 25 cm2 field. An energy window (deltaE) ranging from 0.5 to 6.5 MeV was selected to study central-axis depth dose, beam flatness, and dose rate. Dose was calculated in water at a 100 cm source-to-surface distance using the EGS/BEAM Monte Carlo algorithm. Calculations showed that the beam flatness was fairly insensitive to deltaE. However, since the falloff of the depth-dose curve (R10-R90) and the dose rate both increase with deltaE, a tradeoff between minimizing (R10-R90) and maximizing dose rate is implied. If deltaE is constrained so that R10-R90 is within 0.5 cm of its value for a monoenergetic beam, the maximum practical dose rate based on 2D PIC is approximately 0.1 Gy min

  17. Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever.

    PubMed

    Pal, Subhamoy; Dauner, Allison L; Valks, Andrea; Forshey, Brett M; Long, Kanya C; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C; Halsey, Eric S; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J; Jasper, Louis E; Wu, Shuenn-Jue L

    2015-04-01

    We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks. PMID:25588659

  18. Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever

    PubMed Central

    Dauner, Allison L.; Valks, Andrea; Forshey, Brett M.; Long, Kanya C.; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C.; Halsey, Eric S.; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G.; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J.; Jasper, Louis E.; Wu, Shuenn-Jue L.

    2015-01-01

    We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks. PMID:25588659

  19. Application of IVIVE and PBPK modeling in prospective prediction of clinical pharmacokinetics: strategy and approach during the drug discovery phase with four case studies.

    PubMed

    Chen, Yuan; Jin, Jin Y; Mukadam, Sophie; Malhi, Vikram; Kenny, Jane R

    2012-03-01

    Prospective simulations of human pharmacokinetic (PK) parameters and plasma concentration-time curves using in vitro in vivo extrapolation (IVIVE) and physiologically based pharmacokinetic (PBPK) models are becoming a vital part of the drug discovery and development process. This paper presents a strategy to deliver prospective simulations in support of clinical candidate nomination. A three stage approach of input parameter evaluation, model selection and multiple scenario simulation is utilized to predict the key components influencing human PK; absorption, distribution and clearance. The Simcyp® simulator is used to illustrate the approach and four compounds are presented as case studies. In general, the prospective predictions captured the observed clinical data well. Predicted C(max) was within 2-fold of observed data for all compounds and AUC was within 2-fold for all compounds following a single dose and three out of four compounds following multiple doses. Similarly, t(max) was within 2-fold of observed data for all compounds. However, C(last) was less accurately captured with two of the four compounds predicting C(last) within 2-fold of observed data following a single dose. The trend in results was towards overestimation of AUC and C(last) , this was particularly apparent for compound 2 for which clearance was likely underestimated via IVIVE. The prospective approach to simulating human PK using IVIVE and PBPK modeling outlined here attempts to utilize all available in silico, in vitro and in vivo preclinical data in order to determine the most appropriate assumptions to use in prospective predictions of absorption, distribution and clearance to aid clinical candidate nomination. PMID:22228214

  20. Comparison of organochlorine chemical body burdens of female breast cancer cases with cancer free women in Rio Grande do Sul, Brazil--Pilot Study

    SciTech Connect

    Erdmann, C.A.; Petreas, M.X.; Caleffi, M.; Barbosa, F.S.; Goth-Goldstein, R.

    1999-12-01

    This pilot study collected preliminary data to examine known and suspected breast cancer risk factors among women living in rural and urban areas in the state of Rio Grande do Sul, Brazil by questionnaire. In addition, the body burden levels of a panel of organochlorines was measured in a small clinic-based prospective sample.

  1. Vertebral pain in helicopter pilots

    NASA Technical Reports Server (NTRS)

    Auffret, R.; Delahaye, R. P.; Metges, P. J.; VICENS

    1980-01-01

    Pathological forms of spinal pain engendered by piloting helicopters were clinically studied. Lumbalgia and pathology of the dorsal and cervical spine are discussed along with their clinical and radiological signs and origins.

  2. Colloids versus crystalloids as priming solutions for cardiopulmonary bypass: a meta-analysis of prospective, randomised clinical trials.

    PubMed

    Himpe, D

    2003-01-01

    Using Cochrane methodology a review was performed of prospective randomized clinical trials comparing colloidal pump priming solutions for cardiopulmonary bypass. Dextrans were not considered. Database searches from 1966 through December 2002 delivered 265 articles. Seventeen studies finally met the eligibility criteria involving 997 patients. Summary odds ratio estimates from the 5 studies reporting mortality were 1.46 (n = 326; 95%-Confidence-Interval: .55 to 3.85; p = .49) for crystalloids against colloids and .74 (n = 150; 95%-Confidence-Interval: .17 to 3.36; p = .49) for albumin versus synthetic colloids. Most commonly used outcome measures further included postoperative blood loss, platelet-count, fluid-balance and, colloid osmotic pressures from which Standardized Mean Differences (SMD) and their 95%-Confidence-Interval (95%CI) were extracted. Colloids produced significantly higher oncotic pressures and less positive fluid-balances. Although across 9 studies postoperative bleeding between colloids and crystalloids did not differ (n = 663; SMD: -.03, 95%CI: -.18 to .12; p = .69), platelet counts significantly favoured crystalloids (n = 465; SMD: -.42; 95%CI: -.68 to -.16; p = .00). However, compared to albumin platelet counts were significantly disfavoured only by starches (n = 321; SMD: -.55; 95%CI: -.77 to -.32; p = .00). To conclude, using mere crystalloids produced more pronounced positive fluid balances and their avoidance as a single pump-prime component can be suggested. Since albumin is not necessarily associated with better outcomes and is more expensive, it is hard to continue its use. However, there is still insufficient evidence available to allow definitive conclusions. PMID:14598617

  3. Protocol of a Thyroid Cancer Longitudinal Study (T-CALOS): a prospective, clinical and epidemiological study in Korea

    PubMed Central

    Lee, Kyu Eun; Park, Young Joo; Cho, Belong; Hwang, Yunji; Choi, June Young; Kim, Su-jin; Choi, Hoonsung; Choi, Ho-Chun; An, Ah Reum; Park, Do Joon; Park, Sue K; Youn, Yeo-Kyu

    2015-01-01

    Introduction Thyroid cancer incidence in Korea is the highest in the world and has recently increased steeply. However, factors contributing to this sudden increase have not been fully elucidated, and few studies have explored the postoperative prognosis. The Thyroid Cancer Longitudinal Study (T-CALOS) was initiated with three aims: (1) to identify factors predicting quality of life, recurrence, and incidence of other diseases after thyroid cancer treatments; (2) to investigate environmental exposure to radiation, toxicants and molecular factors in relation to tumour aggressiveness; and (3) to evaluate gene–environment interactions that increase thyroid cancer in comparison with healthy participants from a pool of nationwide population-based healthy examinees. Methods and analysis T-CALOS enrols patients with incident thyroid cancer from three general hospitals, Seoul National University Hospital, Seoul National University Bundang Hospital and National Medical Center, Korea. The study is an ongoing project expecting to investigate 5000 patients with thyroid cancer up until 2017. Healthy examinees with a normal thyroid confirmed by sonography have been enrolled at the Healthy Examination Center at Seoul National University Hospital. We are also performing individual matching using two nationwide databases that are open to the public. Follow-up information is obtained at patients’ clinical visits and by linkage to the national database. For statistical analysis, we will use conditional logistic regression models and a Cox proportional hazard regression model. A number of stratifications and sensitivity analyses will be performed to confirm the results. Ethics and dissemination Based on a large sample size, a prospective study design, comprehensive data collection and biobank, T-CALOS has been independently peer-reviewed and approved by the three hospitals and two funding sources (National Research Foundation of Korea and Korean Foundation for Cancer Research

  4. Recombinant factor IX (BAX326) in previously treated paediatric patients with haemophilia B: a prospective clinical trial.

    PubMed

    Urasinski, T; Stasyshyn, O; Andreeva, T; Rusen, L; Perina, F G; Oh, M S; Chapman, M; Pavlova, B G; Valenta-Singer, B; Abbuehl, B E

    2015-03-01

    A newly developed recombinant factor IX (BAX326(1) ) was investigated for prophylactic use in paediatric patients aged <12 years with severe (FIX level <1%) or moderately severe (FIX level 1-2%) haemophilia B. The aim of this prospective clinical trial was to assess the safety, haemostatic efficacy and pharmacokinetic profile of BAX326 in previously treated paediatric patients. BAX326 was administered as prophylaxis twice a week for a period of 6 months, and on demand for treatment of bleeds. Safety was assessed by the occurrence of related AEs, thrombotic events and immunologic assessments. Efficacy was evaluated by annualized bleeding rate (ABR), and by treatment response rating (excellent, good, fair, none). PK was assessed over 72 h. None of the 23 treated paediatric subjects had treatment-related SAEs or AEs. There were no thrombotic events, inhibitory or specific binding antibodies against FIX, rFurin or CHO protein. Twenty-six bleeds (19 non-joint vs. 7 joint bleeds) occurred (mean ABR 2.7 ± 3.14, median 2.0), of which 23 were injury-related. Twenty subjects (87%) did not experience any bleeds of spontaneous aetiology. Haemostatic efficacy of BAX326 was excellent or good for >96% of bleeds (100% of minor, 88.9% of moderate and 100% of major bleeds); the majority (88.5%) resolved after 1-2 infusions. Longer T1/2 and lower IR were observed in younger children (<6 years) compared to those aged 6 to 12 years. BAX326 administered as prophylactic treatment as well as for controlling bleeds is efficacious and safe in paediatric patients aged <12 years with haemophilia B. PMID:25495591

  5. A Global View of the Relationships between the Main Behavioural and Clinical Cardiovascular Risk Factors in the GAZEL Prospective Cohort.

    PubMed

    Meneton, Pierre; Lemogne, Cédric; Herquelot, Eléonore; Bonenfant, Sébastien; Larson, Martin G; Vasan, Ramachandran S; Ménard, Joël; Goldberg, Marcel; Zins, Marie

    2016-01-01

    Although it has been recognized for a long time that the predisposition to cardiovascular diseases (CVD) is determined by many risk factors and despite the common use of algorithms incorporating several of these factors to predict the overall risk, there has yet been no global description of the complex way in which CVD risk factors interact with each other. This is the aim of the present study which investigated all existing relationships between the main CVD risk factors in a well-characterized occupational cohort. Prospective associations between 12 behavioural and clinical risk factors (gender, age, parental history of CVD, non-moderate alcohol consumption, smoking, physical inactivity, obesity, hypertension, dyslipidemia, diabetes, sleep disorder, depression) were systematically tested using Cox regression in 10,736 middle-aged individuals free of CVD at baseline and followed over 20 years. In addition to independently predicting CVD risk (HRs from 1.18 to 1.97 in multivariable models), these factors form a vast network of associations where each factor predicts, and/or is predicted by, several other factors (n = 47 with p<0.05, n = 37 with p<0.01, n = 28 with p<0.001, n = 22 with p<0.0001). Both the number of factors associated with a given factor (1 to 9) and the strength of the associations (HRs from 1.10 to 6.12 in multivariable models) are very variable, suggesting that all the factors do not have the same influence within this network. These results show that there is a remarkably extensive network of relationships between the main CVD risk factors which may have not been sufficiently taken into account, notably in preventive strategies aiming to lower CVD risk. PMID:27598908

  6. Gender-related outcome difference is related to course of sepsis on mixed ICUs: a prospective, observational clinical study

    PubMed Central

    2011-01-01

    Introduction Impact of gender on severe infections is in highly controversial discussion with natural survival advantage of females described in animal studies but contradictory to those described human data. This study aims to describe the impact of gender on outcome in mixed intensive care units (ICUs) with a special focus on sepsis. Methods We performed a prospective, observational, clinical trial at Charité University Hospital in Berlin, Germany. Over a period of 180 days, patients were screened, undergoing care in three mainly surgical ICUs. In total, 709 adults were included in the analysis, comprising the main population ([female] n = 309, [male] n = 400) including 327 as the sepsis subgroup ([female] n = 130, [male] n = 197). Results Basic characteristics differed between genders in terms of age, lifestyle factors, comorbidities, and SOFA-score (Sequential Organ Failure Assessment). Quality and quantity of antibiotic therapy in means of antibiotic-free days, daily antibiotic use, daily costs of antibiotics, time to antibiotics, and guideline adherence did not differ between genders. ICU mortality was comparable in the main population ([female] 10.7% versus [male] 9.0%; P = 0.523), but differed significantly in sepsis patients with [female] 23.1% versus [male] 13.7% (P = 0.037). This was confirmed in multivariate regression analysis with OR = 1.966 (95% CI, 1.045 to 3.701; P = 0.036) for females compared with males. Conclusions No differences in patients' outcome were noted related to gender aspects in mainly surgical ICUs. However, for patients with sepsis, an increase of mortality is related to the female sex. PMID:21693012

  7. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial

    PubMed Central

    Ruha, Anne-Michelle; Seifert, Steven A.; Morgan, David L.; Lewis, Brandon J.; Arnold, Thomas C.; Clark, Richard F.; Meggs, William J.; Toschlog, Eric A.; Borron, Stephen W.; Figge, Gary R.; Sollee, Dawn R.; Shirazi, Farshad M.; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D.; Boyer, Leslie V.

    2015-01-01

    Background. Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. Methods. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count < 150 K/mm3, fibrinogen level < 150 mg/dL) between end of maintenance dosing and day 8. Results. 121 patients were randomized at 18 clinical sites and received at least one dose of study drug. 114 completed the study. Of these, 11/37 (29.7%) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. Conclusions. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation

  8. Effectiveness of intravenous Dexamethasone versus Propofol for pain relief in the migraine headache: A prospective double blind randomized clinical trial

    PubMed Central

    2012-01-01

    Background There are many drugs recommended for pain relief in patients with migraine headache. Methods In a prospective double blind randomized clinical trial, 90 patients (age ≥ 18) presenting to Emergency medicine Department with Migraine headache were enrolled in two equal groups. We used intravenous propofol (10 mg every 5–10 minutes to a maximum of 80 mg, slowly) and intravenous dexamethasone (0.15 mg/kg to a maximum of 16 mg, slowly), in group I and II, respectively. Pain explained by patients, based on VAS (Visual Analogue Scale) was recorded at the time of entrance to ED, and after injection. Data were analyzed by paired samples t test, using SPSS 16. P < 0.05 was considered to be statistically significant. Results The mean of reported pain (VAS) was 8 ± 1.52 in propofol group and 8.11 ± 1.31 in dexamethasone group at presenting time (P > 0.05). The VAS in propofol group was obviously decreased to 3.08 ± 1.7, 1.87 ± 1.28 and 1.44 ± 1.63 after 10, 20 and 30 minutes of drug injection, respectively. The VAS in dexamethasone group was 5.13 ± 1.47, 3.73 ± 1.81 and 3.06 ± 2 after 10, 20 and 30 minutes of drug injection, respectively. The mean of reported VAS in propofol group was less than dexamethasone group at the above mentioned times (P < 0.05). The reduction of headache in propofol group, also, was very faster than dexamethasone group (P < 0.05). There were no adverse side effects due to administration of both drugs. Conclusions Intravenous propofol is an efficacious and safe treatment for patients presenting with Migraine headache to the emergency department. Trial registration Clinical Trials IRCT201008122496N4 PMID:23020264

  9. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial

    PubMed Central

    2014-01-01

    Background Erosive degenerative disc disease, also known as Modic type 1 changes, is usually characterized by low back pain with an inflammatory pain pattern, as seen in spondyloarthropathies. Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs, and in painful bone diseases in general, such as Paget’s disease, fibrous dysplasia or vertebral fractures. We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes. Methods/Design This study, called PEPTIDE (short for the French title “Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives”), will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug-induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale (VAS) at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit (inclusion, at six weeks, three months, and six months). If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group. Discussion To date, only local treatments, for example intradiscal corticosteroid therapy, lumbar arthrodesis or back braces have been studied in randomized, controlled trials, with controversial results. This trial is

  10. Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

    PubMed Central

    Pellicoro, C.; Marsella, R.; Ahrens, K.

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

  11. Development of a Learning-Oriented Computer Assisted Instruction Designed to Improve Skills in the Clinical Assessment of the Nutritional Status: A Pilot Evaluation

    PubMed Central

    García de Diego, Laura; Cuervo, Marta; Martínez, J. Alfredo

    2015-01-01

    Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient’s nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient’s needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum. PMID:25978456

  12. Analysis of the relationship between periodontal disease and atherosclerosis within a local clinical system: a cross-sectional observational pilot study.

    PubMed

    Kudo, Chieko; Shin, Wee Soo; Minabe, Masato; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Sasaki, Nobuhiro; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Maeda, Hiroshi; Takashiba, Shogo

    2015-09-01

    It has been revealed that atherosclerosis and periodontal disease may have a common mechanism of "chronic inflammation". Several reports have indicated that periodontal infection is related to atherosclerosis, but none have yet reported such an investigation through the cooperation of local clinics. This study was performed in local Japanese clinics to examine the relationship between periodontal disease and atherosclerosis under collaborative medical and dental care. A pilot multicenter cross-sectional study was conducted on 37 medical patients with lifestyle-related diseases under consultation in participating medical clinics, and 79 periodontal patients not undergoing medical treatment but who were seen by participating dental clinics. Systemic examination and periodontal examination were performed at baseline, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed. There was a positive correlation between LDL-C level and plasma IgG antibody titer to Porphyromonas gingivalis. According to the analysis under adjusted age, at a cut-off value of 5.04 for plasma IgG titer to Porphyromonas gingivalis, the IgG titer was significantly correlated with the level of low-density lipoprotein cholesterol (LDL-C). This study suggested that infection with periodontal bacteria (Porphyromonas gingivalis) is associated with the progression of atherosclerosis. Plasma IgG titer to Porphyromonas gingivalis may be useful as the clinical risk marker for atherosclerosis related to periodontal disease. Moreover, the application of the blood examination as a medical check may lead to the development of collaborative medical and dental care within the local medical clinical system for the purpose of preventing the lifestyle-related disease. PMID:25119713

  13. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation

    PubMed Central

    Webster, Craig S; Hannam, Jacqueline; Mitchell, Simon J; Henderson, Robert; Reid, Papaarangi; Edwards, Kylie-Ellen; Jardim, Anisoara; Pak, Nick; Cooper, Jeremy; Hopley, Lara; Frampton, Chris; Short, Timothy G

    2011-01-01

    Objective To clinically evaluate a new patented multimodal system (SAFERSleep) designed to reduce errors in the recording and administration of drugs in anaesthesia. Design Prospective randomised open label clinical trial. Setting Five designated operating theatres in a major tertiary referral hospital. Participants Eighty nine consenting anaesthetists managing 1075 cases in which there were 10 764 drug administrations. Intervention Use of the new system (which includes customised drug trays and purpose designed drug trolley drawers to promote a well organised anaesthetic workspace and aseptic technique; pre-filled syringes for commonly used anaesthetic drugs; large legible colour coded drug labels; a barcode reader linked to a computer, speakers, and touch screen to provide automatic auditory and visual verification of selected drugs immediately before each administration; automatic compilation of an anaesthetic record; an on-screen and audible warning if an antibiotic has not been administered within 15 minutes of the start of anaesthesia; and certain procedural rules—notably, scanning the label before each drug administration) versus conventional practice in drug administration with a manually compiled anaesthetic record. Main outcome measures Primary: composite of errors in the recording and administration of intravenous drugs detected by direct observation and by detailed reconciliation of the contents of used drug vials against recorded administrations; and lapses in responding to an intermittent visual stimulus (vigilance latency task). Secondary: outcomes in patients; analyses of anaesthetists’ tasks and assessments of workload; evaluation of the legibility of anaesthetic records; evaluation of compliance with the procedural rules of the new system; and questionnaire based ratings of the respective systems by participants. Results The overall mean rate of drug errors per 100 administrations was 9.1 (95% confidence interval 6.9 to 11.4) with the new

  14. The effect of a monocular helmet-mounted display on aircrew health: a 10-year prospective cohort study of Apache AH MK 1 pilots: study midpoint update

    NASA Astrophysics Data System (ADS)

    Hiatt, Keith L.; Rash, Clarence E.; Watters, Raymond W.; Adams, Mark S.

    2009-05-01

    A collaborative occupational health study has been undertaken by Headquarters Army Aviation, Middle Wallop, UK, and the U.S. Army Aeromedical Research Laboratory, Fort Rucker, Alabama, to determine if the use of the Integrated Helmet and Display Sighting System (IHADSS) monocular helmet-mounted display (HMD) in the Apache AH Mk 1 attack helicopter has any long-term (10-year) effect on visual performance. The test methodology consists primarily of a detailed questionnaire and an annual battery of vision tests selected to capture changes in visual performance of Apache aviators over their flight career (with an emphasis on binocular visual function). Pilots using binocular night vision goggles serve as controls and undergo the same methodology. Currently, at the midpoint of the study, with the exception of a possible colour discrimination effect, there are no data indicating that the long-term use of the IHADSS monocular HMD results in negative effects on vision.

  15. The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol

    PubMed Central

    van den Bos, W; de Bruin, D M; Muller, B G; Varkarakis, I M; Karagiannis, A A; Zondervan, P J; Laguna Pes, M P; Veelo, D P; Savci Heijink, C D; Engelbrecht, M R W; Wijkstra, H; de Reijke, T M; de la Rosette, J J M C H

    2014-01-01

    Introduction Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer. Methods and analysis In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone. Ethics and dissemination The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. Conclusions This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate

  16. Comparison of Manual Therapy Techniques with Therapeutic Exercise in the Treatment of Shoulder Impingement: A Randomized Controlled Pilot Clinical Trial

    PubMed Central

    Kachingwe, Aimie F.; Phillips, Beth; Sletten, Eric; Plunkett, Scott W.

    2008-01-01

    The purpose of this double-blind, randomized controlled pilot study was to compare the effectiveness of four physical therapy interventions in the treatment of primary shoulder impingement syndrome: 1) supervised exercise only, 2) supervised exercise with glenohumeral mobilizations, 3) supervised exercise with a mobilization-with-movement (MWM) technique, or 4) a control group receiving only physician advice. Thirty-three subjects diagnosed with primary shoulder impingement were randomly assigned to one of these four groups. Main outcome measures included 24-hour pain (VAS), pain with the Neer and Hawkins-Kennedy tests, shoulder active range of motion (AROM), and shoulder function (SPADI). Repeated-measures analyses indicated significant decreases in pain, improved function, and increases in AROM. Univariate analyses on the percentage of change from pre- to post-treatment for each dependent variable found no statistically significant differences (P<0.05) between the four groups. Although not significant, the MWM and mobilization groups had a higher percentage of change from pre- to post-treatment on all three pain measures (VAS, Neer, Hawkins-Kennedy). The three intervention groups had a higher percentage of change on the SPADI. The MWM group had the highest percentage of change in AROM, and the mobilization group had the lowest. This pilot study suggests that performing glenohumeral mobilizations and MWM in combination with a supervised exercise program may result in a greater decrease in pain and improved function although studies with larger samples and discriminant sampling methods are needed. PMID:19771196

  17. Clinical outcomes of a novel therapeutic vaccine with Tax peptide-pulsed dendritic cells for adult T cell leukaemia/lymphoma in a pilot study.

    PubMed

    Suehiro, Youko; Hasegawa, Atsuhiko; Iino, Tadafumi; Sasada, Amane; Watanabe, Nobukazu; Matsuoka, Masao; Takamori, Ayako; Tanosaki, Ryuji; Utsunomiya, Atae; Choi, Ilseung; Fukuda, Tetsuya; Miura, Osamu; Takaishi, Shigeo; Teshima, Takanori; Akashi, Koichi; Kannagi, Mari; Uike, Naokuni; Okamura, Jun

    2015-05-01

    Adult T cell leukaemia/lymphoma (ATL) is a human T cell leukaemia virus type-I (HTLV-I)-infected T cell malignancy with poor prognosis. We herein developed a novel therapeutic vaccine designed to augment an HTLV-I Tax-specific cytotoxic T lymphocyte (CTL) response that has been implicated in anti-ATL effects, and conducted a pilot study to investigate its safety and efficacy. Three previously treated ATL patients, classified as intermediate- to high-risk, were subcutaneously administered with the vaccine, consisting of autologous dendritic cells (DCs) pulsed with Tax peptides corresponding to the CTL epitopes. In all patients, the performance status improved after vaccination without severe adverse events, and Tax-specific CTL responses were observed with peaks at 16-20 weeks. Two patients achieved partial remission in the first 8 weeks, one of whom later achieved complete remission, maintaining their remission status without any additional chemotherapy 24 and 19 months after vaccination, respectively. The third patient, whose tumour cells lacked the ability to express Tax at biopsy, obtained stable disease in the first 8 weeks and later developed slowly progressive disease although additional therapy was not required for 14 months. The clinical outcomes of this pilot study indicate that the Tax peptide-pulsed DC vaccine is a safe and promising immunotherapy for ATL. PMID:25612920

  18. The Performance of a Modified Glasgow Blatchford Score in Predicting Clinical Interventions in Patients with Acute Nonvariceal Upper Gastrointestinal Bleeding: A Vietnamese Prospective Multicenter Cohort Study

    PubMed Central

    Quach, Duc Trong; Dao, Ngoi Huu; Dinh, Minh Cao; Nguyen, Chung Huu; Ho, Linh Xuan; Nguyen, Nha-Doan Thi; Le, Quang Dinh; Vo, Cong Minh Hong; Le, Sang Kim; Hiyama, Toru

    2016-01-01

    Background/Aims To compare the performance of a modified Glasgow Blatchford score (mGBS) to the Glasgow Blatchford score (GBS) and the pre-endoscopic Rockall score (RS) in predicting clinical interventions in Vietnamese patients with acute nonvariceal upper gastrointestinal bleeding (AN-VUGIB). Methods A prospective multicenter cohort study was conducted in five tertiary hospitals from May 2013 to February 2014. The mGBS, GBS, and pre-endoscopic RS scores were prospectively calculated for all patients. The accuracy of mGBS was compared with that of GBS and pre-endoscopic RS using area under the receiver operating characteristic curve (AUC). Clinical interventions were defined as blood transfusions, endoscopic or radiological intervention, or surgery. Results There were 395 patients including 128 (32.4%) needing endoscopic treatment, 117 (29.6%) requiring blood transfusion and two (0.5%) needing surgery. In predicting the need for clinical intervention, the mGBS (AUC, 0.707) performed as well as the GBS (AUC, 0.708; p=0.87) and outperformed the pre-endoscopic RS (AUC, 0.594; p<0.001). However, none of these scores effectively excluded the need for endoscopic intervention at a threshold of 0. Conclusions mGBS performed as well as GBS and better than pre-endoscopic RS for predicting clinical interventions in Vietnamese patients with ANVUGIB. PMID:26601829

  19. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  20. A Clinical Algorithm to Identify HIV Patients at High Risk for Incident Active Tuberculosis: A Prospective 5-Year Cohort Study

    PubMed Central

    Lee, Susan Shin-Jung; Lin, Hsi-Hsun; Tsai, Hung-Chin; Su, Ih-Jen; Yang, Chin-Hui; Sun, Hsin-Yun; Hung, Chien-Chin; Sy, Cheng-Len; Wu, Kuan-Sheng; Chen, Jui-Kuang; Chen, Yao-Shen; Fang, Chi-Tai

    2015-01-01

    Background Predicting the risk of tuberculosis (TB) in people living with HIV (PLHIV) using a single test is currently not possible. We aimed to develop and validate a clinical algorithm, using baseline CD4 cell counts, HIV viral load (pVL), and interferon-gamma release assay (IGRA), to identify PLHIV who are at high risk for incident active TB in low-to-moderate TB burden settings where highly active antiretroviral therapy (HAART) is routinely provided. Materials and Methods A prospective, 5-year, cohort study of adult PLHIV was conducted from 2006 to 2012 in two hospitals in Taiwan. HAART was initiated based on contemporary guidelines (CD4 count < = 350/μL). Cox regression was used to identify the predictors of active TB and to construct the algorithm. The validation cohorts included 1455 HIV-infected individuals from previous published studies. Area under the receiver operating characteristic (ROC) curve was calculated. Results Seventeen of 772 participants developed active TB during a median follow-up period of 5.21 years. Baseline CD4 < 350/μL or pVL ≥ 100,000/mL was a predictor of active TB (adjusted HR 4.87, 95% CI 1.49–15.90, P = 0.009). A positive baseline IGRA predicted TB in patients with baseline CD4 ≥ 350/μL and pVL < 100,000/mL (adjusted HR 6.09, 95% CI 1.52–24.40, P = 0.01). Compared with an IGRA-alone strategy, the algorithm improved the sensitivity from 37.5% to 76.5%, the negative predictive value from 98.5% to 99.2%. Compared with an untargeted strategy, the algorithm spared 468 (60.6%) from unnecessary TB preventive treatment. Area under the ROC curve was 0.692 (95% CI: 0.587–0.798) for the study cohort and 0.792 (95% CI: 0.776–0.808) and 0.766 in the 2 validation cohorts. Conclusions A validated algorithm incorporating the baseline CD4 cell count, HIV viral load, and IGRA status can be used to guide targeted TB preventive treatment in PLHIV in low-to-moderate TB burden settings where HAART is routinely provided to all PLHIV. The

  1. Clinical features and predictors for disease natural progression in adults with Pompe disease: a nationwide prospective observational study

    PubMed Central

    2012-01-01

    Background Due partly to physicians’ unawareness, many adults with Pompe disease are diagnosed with great delay. Besides, it is not well known which factors influence the rate of disease progression, and thus disease outcome. We delineated the specific clinical features of Pompe disease in adults, and mapped out the distribution and severity of muscle weakness, and the sequence of involvement of the individual muscle groups. Furthermore, we defined the natural disease course and identified prognostic factors for disease progression. Methods We conducted a single-center, prospective, observational study. Muscle strength (manual muscle testing, and hand-held dynamometry), muscle function (quick motor function test), and pulmonary function (forced vital capacity in sitting and supine positions) were assessed every 3–6 months and analyzed using repeated-measures ANOVA. Results Between October 2004 and August 2009, 94 patients aged between 25 and 75 years were included in the study. Although skeletal muscle weakness was typically distributed in a limb-girdle pattern, many patients had unfamiliar features such as ptosis (23%), bulbar weakness (28%), and scapular winging (33%). During follow-up (average 1.6 years, range 0.5-4.2 years), skeletal muscle strength deteriorated significantly (mean declines of −1.3% point/year for manual muscle testing and of −2.6% points/year for hand-held dynamometry; both p<0.001). Longer disease duration (>15 years) and pulmonary involvement (forced vital capacity in sitting position <80%) at study entry predicted faster decline. On average, forced vital capacity in supine position deteriorated by 1.3% points per year (p=0.02). Decline in pulmonary function was consistent across subgroups. Ten percent of patients declined unexpectedly fast. Conclusions Recognizing patterns of common and less familiar characteristics in adults with Pompe disease facilitates timely diagnosis. Longer disease duration and reduced pulmonary function

  2. The clinical assessment study of the foot (CASF): study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

    PubMed Central

    2011-01-01

    Background Symptomatic osteoarthritis (OA) affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only) and three years (clinic attenders and survey participants), and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and clinical examination findings

  3. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study

    PubMed Central

    2013-01-01

    Introduction Contemporary information on mechanical ventilation (MV) use in emerging countries is limited. Moreover, most epidemiological studies on ventilatory support were carried out before significant developments, such as lung protective ventilation or broader application of non-invasive ventilation (NIV). We aimed to evaluate the clinical characteristics, outcomes and risk factors for hospital mortality and failure of NIV in patients requiring ventilatory support in Brazilian intensive care units (ICU). Methods In a multicenter, prospective, cohort study, a total of 773 adult patients admitted to 45 ICUs over a two-month period requiring invasive ventilation or NIV for more than 24 hours were evaluated. Causes of ventilatory support, prior chronic health status and physiological data were assessed. Multivariate analysis was used to identifiy variables associated with hospital mortality and NIV failure. Results Invasive MV and NIV were used as initial ventilatory support in 622 (80%) and 151 (20%) patients. Failure with subsequent intubation occurred in 54% of NIV patients. The main reasons for ventilatory support were pneumonia (27%), neurologic disorders (19%) and non-pulmonary sepsis (12%). ICU and hospital mortality rates were 34% and 42%. Using the Berlin definition, acute respiratory distress syndrome (ARDS) was diagnosed in 31% of the patients with a hospital mortality of 52%. In the multivariate analysis, age (odds ratio (OR), 1.03; 95% confidence interval (CI), 1.01 to 1.03), comorbidities (OR, 2.30; 95% CI, 1.28 to 3.17), associated organ failures (OR, 1.12; 95% CI, 1.05 to 1.20), moderate (OR, 1.92; 95% CI, 1.10 to 3.35) to severe ARDS (OR, 2.12; 95% CI, 1.01 to 4.41), cumulative fluid balance over the first 72 h of ICU (OR, 2.44; 95% CI, 1.39 to 4.28), higher lactate (OR, 1.78; 95% CI, 1.27 to 2.50), invasive MV (OR, 2.67; 95% CI, 1.32 to 5.39) and NIV failure (OR, 3.95; 95% CI, 1.74 to 8.99) were independently associated with hospital mortality

  4. An evaluation of Polaroid photographic imaging for cutaneous-lesion referrals to an outpatient clinic: a pilot study.

    PubMed

    Singh, S; Stevenson, J H; McGurty, D

    2001-03-01

    A pilot study consisted of 65 patient referrals to a Regional Plastic Surgery Department in which the referral letter, accompanied by a high-quality Polaroid photograph, was assessed by four consultants. The diagnosis, degree of urgency of treatment, grade of surgeon (to undertake the operation) and anticipated time for the procedure were recorded. The results were statistically analysed. Our aim was to evaluate the diagnostic accuracy and consistency of the four observers. The majority of malignant skin lesions were detected accurately; those that were missed received urgent attention due to a high degree of suspicion. This study supports the view that 'triage' of referrals using high-quality photographic images in association with an accurate referral letter can offer a significant reduction in pressure on waiting time and inconvenience for patients by avoiding an additional outpatient visit. Advantages to purchasers in terms of cost savings on outpatient visits and travelling reimbursement can result from this initiative. PMID:11207125

  5. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  6. Fully Automated Simultaneous Integrated Boosted-Intensity Modulated Radiation Therapy Treatment Planning Is Feasible for Head-and-Neck Cancer: A Prospective Clinical Study

    SciTech Connect

    Wu Binbin; McNutt, Todd; Zahurak, Marianna; Simari, Patricio; Pang, Dalong; Taylor, Russell; Sanguineti, Giuseppe

    2012-12-01

    Purpose: To prospectively determine whether overlap volume histogram (OVH)-driven, automated simultaneous integrated boosted (SIB)-intensity-modulated radiation therapy (IMRT) treatment planning for head-and-neck cancer can be implemented in clinics. Methods and Materials: A prospective study was designed to compare fully automated plans (APs) created by an OVH-driven, automated planning application with clinical plans (CPs) created by dosimetrists in a 3-dose-level (70 Gy, 63 Gy, and 58.1 Gy), head-and-neck SIB-IMRT planning. Because primary organ sparing (cord, brain, brainstem, mandible, and optic nerve/chiasm) always received the highest priority in clinical planning, the study aimed to show the noninferiority of APs with respect to PTV coverage and secondary organ sparing (parotid, brachial plexus, esophagus, larynx, inner ear, and oral mucosa). The sample size was determined a priori by a superiority hypothesis test that had 85% power to detect a 4% dose decrease in secondary organ sparing with a 2-sided alpha level of 0.05. A generalized estimating equation (GEE) regression model was used for statistical comparison. Results: Forty consecutive patients were accrued from July to December 2010. GEE analysis indicated that in APs, overall average dose to the secondary organs was reduced by 1.16 (95% CI = 0.09-2.33) with P=.04, overall average PTV coverage was increased by 0.26% (95% CI = 0.06-0.47) with P=.02 and overall average dose to the primary organs was reduced by 1.14 Gy (95% CI = 0.45-1.8) with P=.004. A physician determined that all APs could be delivered to patients, and APs were clinically superior in 27 of 40 cases. Conclusions: The application can be implemented in clinics as a fast, reliable, and consistent way of generating plans that need only minor adjustments to meet specific clinical needs.

  7. Pilot study of non-contrast-enhanced MRI vs. ultrasound in renal transplant recipients with acquired cystic kidney disease: a prospective intra-individual comparison.

    PubMed

    Mühlfeld, Anja S; Lange, Christian; Kroll, Gisela; Floege, Jürgen; Krombach, Gabriele A; Kuhl, Christiane; Eitner, Frank; Schrading, Simone

    2013-01-01

    The incidence of renal cell carcinoma (RCC) after kidney transplantation is 15-fold increased. Acquired cystic kidney disease (ACKD) is one of the known risk factors. We performed a small pilot study to assess the role of non-enhanced magnetic resonance imaging (MRI) as a tool for intensified screening in renal transplant recipients with ACKD. Renal ultrasound was used to assess the native kidneys of 215 renal transplant recipients. Thirty patients with 54 kidneys, fulfilling the criteria of ACKD, underwent non-enhanced MRI at 1.5T using T2- and T1-weighed as well as diffusion-weighted sequences with a high spatial resolution. Among the 54 kidneys assessed by both methods, three RCCs were identified (6%). Of those, one RCC was detected by both imaging methods (33%), while two RCCs were diagnosed by MRI alone (67%). MRI identified an additional four proteinaceous or hemorrhagic cysts that did not fulfill the criteria for RCC but were classified as suspicious. All of these lesions were stable in size and appearance in follow-up studies. In conclusion, non-enhanced MRI was more sensitive than ultrasound in identifying RCCs and lesions suspicious for RCC and thus appears to be a useful secondary screening tool in patients with ACKD after renal transplantation. PMID:24118352

  8. Five-year results of a prospective randomised controlled clinical trial of posterior computer-aided design-computer-aided manufacturing ZrSiO4 -ceramic crowns.

    PubMed

    Passia, N; Stampf, S; Strub, J R

    2013-08-01

    The aim of this prospective randomised controlled clinical trial was to evaluate the clinical outcome of shrinkage-free ZrSiO4 -ceramic full-coverage crowns on premolars and molars in comparison with conventional gold crowns over a 5-year period. Two hundred and twenty-three patients were included and randomly divided into two treatment groups. One hundred and twenty-three patients were restored with 123 ZrSiO4 -ceramic crowns, and 100 patients received 100 gold crowns, which served as the control. All crowns were conventionally cemented with glass-ionomer cement. After an observation period of 6, 12, 24, 36, 48 and 60 months, the survival probability (Kaplan-Meier) for the shrinkage-free ZrSiO4 -ceramic crowns was 98·3%, 92·0%, 84·7%, 79% and 73·2% and for the gold crowns, 99%, 97·9%, 95·7%, 94·6% and 92·3%, respectively. The difference between the test and control group was statistically significant (P = 0·0027). The gold crowns showed a better marginal integrity with less marginal discoloration than the ceramic crowns. The most common failure in the ceramic crown group was fracture of the crown. The 60-month results of this prospective randomised controlled clinical trial suggest that the use of these shrinkage-free ZrSiO4 -ceramic crowns in posterior tooth restorations cannot be recommended. PMID:23745725

  9. Ultrasound Imaging Improves Identification of Prominent Hardware in the Surgical Treatment of Distal Radius Fractures: A Cadaveric and Prospective Clinical Study.

    PubMed

    Watchmaker, Jacqueline D; Daley, Roger A; Watchmaker, Greg P; Grindel, Steven I

    2016-03-01

    Background Volarly applied locking plates are one of several current treatment options for displaced fractures of the distal radius. Presently, surgeons use intraoperative depth gauges and fluoroscopy to select and confirm proper screw length. The contour of the dorsal cortex beneath the extensor compartments along with fracture comminution may limit the accuracy of screw length selection. Question/Purpose To evaluate the accuracy of ultrasound (US) and fluoroscopy in the detection of dorsally prominent screws placed during volar plating of experimentally created distal radius fractures and extend this prospectively into the clinical setting. Patients and Methods Distal radius fractures were experimentally induced in fresh cadaveric arms. The fractures were then internally fixated with volar locking plates utilizing fluoroscopic imaging. US imaging of the dorsal surface of the radius was then performed followed by dorsal dissection and direct caliper measurements to quantitate screw tips as recessed, flush, or protruding from the dorsal cortex. A small, prospective clinical study was also conducted to validate the clinical usefulness of using US to provide additional information regarding screw tip prominence. Results Our study demonstrated that US was able to detect dorsally prominent screw tips not visible on fluoroscopy. Cadaveric dissection showed a higher statistical correlation between US imaging and actual prominence than between fluoroscopy and actual prominence. Conclusions US examination after volar plate fixation of comminuted distal radius fractures may detect dorsal screw tip prominence when screw lengths are selected to engage the dorsal cortex. Level of Evidence IV. PMID:26855834

  10. Emotional Reasoning and Parent-Based Reasoning in Non-Clinical Children, and Their Prospective Relationships with Anxiety Symptoms

    ERIC Educational Resources Information Center

    Morren, Mattijn; Muris, Peter; Kindt, Merel; Schouten, Erik; van den Hout, Marcel

    2008-01-01

    Emotional and parent-based reasoning refer to the tendency to rely on personal or parental anxiety response information rather than on objective danger information when estimating the dangerousness of a situation. This study investigated the prospective relationships of emotional and parent-based reasoning with anxiety symptoms in a sample of…

  11. Feasibility of studying brain morphology in major depressive disorder with structural magnetic resonance imaging and clinical data from the electronic medical record: A pilot study

    PubMed Central

    Hoogenboom, Wouter S.; Perlis, Roy H.; Smoller, Jordan W.; Zeng-Treitler, Qing; Gainer, Vivian S.; Murphy, Shawn N.; Churchill, Susanne E.; Kohane, Isaac S.; Shenton, Martha E.; Iosifescu, Dan V.

    2012-01-01

    For certain research questions related to long-term outcomes or to rare disorders, designing prospective studies is impractical or prohibitively expensive. Such studies could instead utilize clinical and magnetic resonance imaging data (MRI) collected as part of routine clinical care, stored in the electronic medical record (EMR). Using major depressive disorder (MDD) as a disease model, we examined the feasibility of studying brain morphology and associations with remission using clinical and MRI data exclusively drawn from the EMR. Advanced automated tools were used to select MDD patients and controls from the EMR who had brain MRI data, but no diagnosed brain pathology. MDD patients were further assessed for remission status by review of clinical charts. Twenty MDD patients (eight full-remitters, six partial-remitters, and six non-remitters), and fifteen healthy control subjects met all study criteria for advanced morphometric analyses. Compared to controls, MDD patients had significantly smaller right rostral-anterior cingulate volume, and level of non-remission was associated with smaller left hippocampus and left rostral-middle frontal gyrus volume. The use of EMR data for psychiatric research may provide a timely and cost-effective approach with the potential to generate large study samples reflective of the real population with the illness studied. PMID:23149041

  12. Prospective Analysis of a New Bone Graft in Lumbar Interbody Fusion: Results of a 2- Year Prospective Clinical and Radiological Study

    PubMed Central

    Raskin, Yannic

    2015-01-01

    Background This study examined the efficacy and safety of bone graft material ABM/P-15 (iFACTOR) for use in posterior lumbar interbody fusion. ABM/P-15 has been used safely for more than a decade in dental applications. Methods Forty patients underwent PLIF surgery, with each patient as control. Assessments up to 24 months included radiographs, CT scan, VAS, and ODI. Primary success criteria were fusion and safety. Results Intra-cage bridging bone occurred earlier with ABM/P-15 than autograft (97.73% vs. 59.09% at 6 months). On average pain decreased 29 points and function improved 43 points. Radio dense material outside the disk space occurred more frequently with ABM/P-15 than autograft, without clinical consequence. Conclusions This study suggests that ABM/P-15 has equal or greater efficacy at 6 and 12 months. Pain improvements exceeded success criteria at all time points. Functional improvement exceeded success criteria at all time points. Clinical Relevance This study explores the safety and efficacy of an osteobiologic peptide enhanced bone graft material as a viable alternative to autograft and its attendant risks. PMID:25709887

  13. The hepatoprotective and hypolipidemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population with non-alcoholic fatty liver disease: a prospective pilot study

    PubMed Central

    Mazokopakis, Elias E.; Papadomanolaki, Maria G.; Fousteris, Andreas A.; Kotsiris, Dimitrios A.; Lampadakis, Ioannis M.; Ganotakis, Emmanuel S.

    2014-01-01

    Background A pilot study was conducted to determine the effects of Spirulina (Arthrospira platensis) on Cretan patients with non-alcoholic fatty liver disease (NAFLD). Spirulina is a filamentous cyanobacterium taken as a dietary supplement. Methods Fifteen adult Cretan outpatients (13 men), median age 48 (range: 29-62) years, with NAFLD were orally supplemented with 6 g of Spirulina (Greek production) per day for six months. Anthropometric characteristics (height, weight, waist circumference), systolic and diastolic blood pressure, complete blood count, biochemical assessments, homeostasis model assessment of insulin resistance (HOMA-IR) index, health-related quality of life and abdominal sonographic findings were recorded and measured, before and after Spirulina supplementation. Results At the end of the 6-month intervention period, the mean levels of aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, triglycerides, low-density lipoprotein-cholesterol, total cholesterol, and the ratio of total cholesterol to high-density lipoprotein cholesterol were significantly decreased: 38.5%, 37.5%, 26.7%, 24.8%, 9.6%, 9.1%, and 13.5% respectively, whereas the mean levels of high-density lipoprotein-cholesterol and hemoglobin were significantly increased: 4.2% and 4.1% respectively. Spirulina supplementation resulted also in a significant reduction in weight and HOMA-IR index (8.1% and 19.6% respectively) and a significant improvement in health-related quality of life scale. No changes in sonographic findings were observed. Conclusion Spirulina supplementation at a high dosage of 6 g daily in NAFLD patients has strong and multiple beneficial metabolic effects and improves their health-related quality of life. PMID:25331487

  14. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry--The EXCITING-ILD Registry.

    PubMed

    Kreuter, Michael; Herth, Felix J F; Wacker, Margarethe; Leidl, Reiner; Hellmann, Andreas; Pfeifer, Michael; Behr, Jürgen; Witt, Sabine; Kauschka, Dagmar; Mall, Marcus; Günther, Andreas; Markart, Philipp

    2015-01-01

    Despite a number of prospective registries conducted in past years, the current epidemiology of interstitial lung diseases (ILD) is still not well defined, particularly regarding the prevalence and incidence, their management, healthcare utilisation needs, and healthcare-associated costs. To address these issues in Germany, a new prospective ILD registry, "Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases" (EXCITING-ILD), is being conducted by the German Centre for Lung Research in association with ambulatory, inpatient, scientific pulmonology organisations and patient support groups. This multicentre, noninterventional, prospective, and observational ILD registry aims to collect comprehensive and validated data from all healthcare institutions on the incidence, prevalence, characteristics, management, and outcomes regarding all ILD presentations in the real-world setting. Specifically, this registry will collect demographic data, disease-related data such as ILD subtype, treatments, diagnostic procedures (e.g., HRCT, surgical lung biopsy), risk factors (e.g., familial ILD), significant comorbidities, ILD managements, and disease outcomes as well as healthcare resource consumption. The EXCITING-ILD registry will include in-patient and out-patient ILD healthcare facilities in more than 100 sites. In summary, this registry will document comprehensive and current epidemiological data as well as important health economic data for ILDs in Germany. PMID:26640781

  15. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry—The EXCITING-ILD Registry

    PubMed Central

    Kreuter, Michael; Herth, Felix J. F.; Wacker, Margarethe; Leidl, Reiner; Hellmann, Andreas; Pfeifer, Michael; Behr, Jürgen; Witt, Sabine; Kauschka, Dagmar; Mall, Marcus; Günther, Andreas; Markart, Philipp

    2015-01-01

    Despite a number of prospective registries conducted in past years, the current epidemiology of interstitial lung diseases (ILD) is still not well defined, particularly regarding the prevalence and incidence, their management, healthcare utilisation needs, and healthcare-associated costs. To address these issues in Germany, a new prospective ILD registry, “Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases” (EXCITING-ILD), is being conducted by the German Centre for Lung Research in association with ambulatory, inpatient, scientific pulmonology organisations and patient support groups. This multicentre, noninterventional, prospective, and observational ILD registry aims to collect comprehensive and validated data from all healthcare institutions on the incidence, prevalence, characteristics, management, and outcomes regarding all ILD presentations in the real-world setting. Specifically, this registry will collect demographic data, disease-related data such as ILD subtype, treatments, diagnostic procedures (e.g., HRCT, surgical lung biopsy), risk factors (e.g., familial ILD), significant comorbidities, ILD managements, and disease outcomes as well as healthcare resource consumption. The EXCITING-ILD registry will include in-patient and out-patient ILD healthcare facilities in more than 100 sites. In summary, this registry will document comprehensive and current epidemiological data as well as important health economic data for ILDs in Germany. PMID:26640781

  16. A pilot prospective study of the relationship among cognitive factors, shame, and guilt proneness on posttraumatic stress disorder symptoms in female victims of sexual violence.

    PubMed

    Shin, Kyoung Min; Cho, Sun-Mi; Lee, Su Hyun; Chung, Young Ki

    2014-06-01

    This study prospectively examined the relationships among cognitive factors and severity of Posttraumatic stress disorder (PTSD) symptoms in female victims of sexual violence. Thirty-eight victims of sexual violence recruited from Center for Women Victims of Sexual and Domestic Violence at Ajou University Hospital. Cognitive factors and PTSD symptom were assessed within 4 months of sexual violence and 25 victims were followed-up 1 month after initial assessment. Repeated-measured ANOVA revealed that PTSD incidence and severity decreased over the month (F [1, 21]=6.61). Particularly, avoidant symptoms might decrease earlier than other PTSD symptoms (F [1, 21]=5.92). This study also showed the significant relationship between early negative trauma-related thoughts and subsequent PTSD severity. Shame and guilt proneness had significant cross-sectional correlations with PTSD severity, but did not show associations when depression severity is controlled. Our results suggest that avoidant symptoms might decrease earlier than other PTSD symptoms during the acute phase and that cognitive appraisals concerning the dangerousness of the world seem to play an important role in the maintenance of PTSD (r=0.499, P<0.05). PMID:24932086

  17. The feasibility and applications of non-invasive cardiac output monitoring, thromboelastography and transit-time flow measurement in living-related renal transplantation surgery: results of a prospective pilot observational study

    PubMed Central

    2014-01-01

    allograft reperfusion. Conclusions Reduced renal arterial blood flow (falling without the 95% CI of the mean), was able to accurately predict anastomotic complications within this pilot study. TEG data suggest the emergence of a prothrombotic state, of uncertain clinical significance, following allograft reperfusion. Abrogation of characteristic haemodynamic trends, as determined by NICOM, following allograft reperfusion may permit prediction of individuals at risk of DGF. The findings of this pilot study mandate a larger definitive trial to determine the clinical applications and predictive value of these technologies. PMID:25206974

  18. Thermal effects of white light illumination during microsurgery: clinical pilot study on the application safety of surgical microscopes

    NASA Astrophysics Data System (ADS)

    Hibst, Raimund; Saal, David; Russ, Detlef; Kunzi-Rapp, Karin; Kienle, Alwin; Stock, Karl

    2010-07-01

    Modern operating microscopes offer high power illumination to ensure optimal visualization, but can also cause thermal damage. The aim of our study is to quantify the thermal effects in vivo and discuss conditions for safe use. In a pilot study on volunteers, we measured the temperature at the skin surface during microscope illumination, including the influence of anaesthesia and the effects of staining, draping, or moistening of the skin. Irradiation within the limit given by safety regulations (200 mW/cm2) results in skin surface temperature of 43 °C. Higher intensities (forearm 335 mW/cm2, back 250 mW/cm2) are tolerated, resulting in reversible hyperaemia. At a very high illumination intensity (750 mW/cm2), pain occurs within 30 s at temperatures of 46 °C+/-1 °C (hand and forearm), and 43 °C+/-2 °C (back), respectively. Anaesthesia has no distinct effect on the temperature, whereas staining and drapes result in much higher temperatures (>100 °C). Moistening at practicable flow rates can reduce temperature efficiently when combined with a light absorbing and water absorbent drape. In conclusion, surgeons must be aware that surgical microscope illumination without protective means can cause skin temperatures to rise much above pain threshold, which in our study serves as a (conservative) benchmark for potential damage.

  19. Breaking the mould without breaking the system: the development and pilot of a clinical dashboard at The Prince Charles Hospital.

    PubMed

    Clark, Kevin W; Whiting, Elizabeth; Rowland, Jeffrey; Thompson, Leah E; Missenden, Ian; Schellein, Gerhard

    2013-06-01

    There is a vast array of clinical and quality data available within healthcare organisations. The availability of this data in a timely and easy to visualise way is an essential component of high-performing healthcare teams. It is recognised that good quality information is a driver of performance for clinical teams and helps ensure best possible care for patients. In 2012 the Internal Medicine Program at The Prince Charles Hospital developed a clinical dashboard that displays locally relevant information alongside relevant hospital and statewide metrics that inform daily clinical decision making. The data reported on the clinical dashboard is driven from data sourced from the electronic patient journey board in real time as well as other Queensland Health data sources. This provides clinicians with easy access to a wealth of local unit data presented in a simple graphical format that is being captured locally and arranged on a single screen so the information can be monitored at a glance. Local unit data informs daily decisions that identify and confirm patient flow problems, assist to identify root causes and enable evaluation of patient flow solutions. PMID:23701819

  20. Prospective Randomized Double-Blind Pilot Study of Site-Specific Consensus Atlas Implementation for Rectal Cancer Target Volume Delineation in the Cooperative Group Setting

    SciTech Connect

    Fuller, Clifton D.; Nijkamp, Jasper; Duppen, Joop C.; Rasch, Coen R.N.; Thomas, Charles R.; Wang, Samuel J.; Okunieff, Paul; Jones, William E.; Baseman, Daniel; Patel, Shilpen; Demandante, Carlo G.N.; Harris, Anna M.; Smith, Benjamin D.; Katz, Alan W.; McGann, Camille

    2011-02-01

    Purpose: Variations in target volume delineation represent a significant hurdle in clinical trials involving conformal radiotherapy. We sought to determine the effect of a consensus guideline-based visual atlas on contouring the target volumes. Methods and Materials: A representative case was contoured (Scan 1) by 14 physician observers and a reference expert with and without target volume delineation instructions derived from a proposed rectal cancer clinical trial involving conformal radiotherapy. The gross tumor volume (GTV), and two clinical target volumes (CTVA, including the internal iliac, presacral, and perirectal nodes, and CTVB, which included the external iliac nodes) were contoured. The observers were randomly assigned to receipt (Group A) or nonreceipt (Group B) of a consensus guideline and atlas for anorectal cancers and then instructed to recontour the same case/images (Scan 2). Observer variation was analyzed volumetrically using the conformation number (CN, where CN = 1 equals total agreement). Results: Of 14 evaluable contour sets (1 expert and 7 Group A and 6 Group B observers), greater agreement was found for the GTV (mean CN, 0.75) than for the CTVs (mean CN, 0.46-0.65). Atlas exposure for Group A led to significantly increased interobserver agreement for CTVA (mean initial CN, 0.68, after atlas use, 0.76; p = .03) and increased agreement with the expert reference (initial mean CN, 0.58; after atlas use, 0.69; p = .02). For the GTV and CTVB, neither the interobserver nor the expert agreement was altered after atlas exposure. Conclusion: Consensus guideline atlas implementation resulted in a detectable difference in interobserver agreement and a greater approximation of expert volumes for the CTVA but not for the GTV or CTVB in the specified case. Visual atlas inclusion should be considered as a feature in future clinical trials incorporating conformal RT.

  1. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test.

    PubMed

    Bedard, Marc; Verma, Shailendra; Collins, Barbara; Song, Xinni; Paquet, Lise

    2016-01-01

    We report the results of a secondary analysis of a cross-sectional study (Paquet et al., 2013 ) to evaluate the cognitive operations involved in prospective memory (PM) deficits exhibited by chemotherapy-exposed breast cancer (BC) survivors. PM was assessed with the memory for intentions screening test administered to 80 patients and 80 healthy controls. Patients performed worse than controls on the PM tasks and had more "omission" errors (indices of the prospective component of the tasks) than the controls. No group differences emerged on a recognition test. Although further studies will be needed to disentangle the multiple cognitive operations involved in PM, these findings are consistent with the notion that self-initiated retrieval processes rather than encoding are implicated in PM impairment among BC survivors. PMID:27123566

  2. Clinical effects of rifaximin in patientswith hepatic encephalopathy intolerant or nonresponsive to previous lactulose treatment: An open-label, pilot study

    PubMed Central

    Sama, Claudia; Morselli-Labate, Antonio Maria; Pianta, Paolo; Lambertini, Laura; Berardi, Sonia; Martini, Gabriella

    2004-01-01

    Background: Hepatic encephalopathy (HE) is a metabolic-neurophysiologicsyndrome that occurs in patients with advanced hepatic disease. One of the main pathogenic mechanisms is represented by circulating toxins produced by the intestinal metabolism of nitrogenous compounds. The therapeutic approach to HE is mainly based on drugs that eliminate ammonia-producing bacteria. Objectives: The aim of this study was to evaluate the effects of the nonabsorbable antibiotic rifaximin in patients with HE who were intolerant or nonresponsive to treatment with an oral, nonabsorbable disaccharide (lactulose). Methods: This uncontrolled, open-label, pilot study was conducted at the University of Bologna, Bologna, Italy. Patients aged ≥ 18 years with histologically proven liver cirrhosis and HE were studied. All patients were intolerant or nonresponsive to previous treatment with lactulose. Rifaximin tablets were administered to patients at a dosage of 400 mg TID for 10 days. The portal systemic encephalopathy (PSE) index was evaluated at enrollment and at the end of the treatment period. Tolerabil