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NCT ID: NCT02023957 Completed - Clinical trials for Mental Health Disorders

A Pilot With Interactive Computer-assisted Screening for Mental Health in Primary Care

iCAS
Start date: November 2013
Phase: N/A
Study type: Interventional

The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.

NCT ID: NCT02023879 Completed - Clinical trials for Hypercholesterolemia

Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

Start date: December 16, 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. Secondary Objective: - To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo. - To evaluate the safety and tolerability of Alirocumab 150 mg Q4W. Alirocumab 75 mg Q2W was added as a calibrator arm.

NCT ID: NCT02023697 Completed - Prostatic Neoplasms Clinical Trials

Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone

Start date: March 10, 2014
Phase: Phase 2
Study type: Interventional

This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.

NCT ID: NCT02023632 Completed - Motor Activity Clinical Trials

GrOup-based Physical Activity for oLder Adults Trial

GOAL
Start date: January 2014
Phase: N/A
Study type: Interventional

Regular physical activity is associated with a diverse range of physical and mental health outcomes, with the effects being particularly pronounced among older adults. Despite these health benefits, involvement in physical activity has been found to decline over the course of adulthood with older adults in particular risk of inactivity. A growing body of evidence, however, suggests that group-based settings that are sensitive to both the age-composition and gender-composition of their constituent members may represent an opportune means of supporting the improved adoption and maintenance of older adults in physical activity programs. The overall purpose of this feasibility trial is to test the effectiveness of a group-based physical activity program for older adults that is sensitive to both age-congruent and gender-congruent contextual factors, in supporting their sustained involvement in physical activity.

NCT ID: NCT02023164 Completed - Acute Urticaria Clinical Trials

Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria

Start date: July 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.

NCT ID: NCT02023086 Completed - Fabry Disease Clinical Trials

Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Fabry Patients

Start date: August 2014
Phase: N/A
Study type: Observational [Patient Registry]

This study aims to evaluate blood oxygenation at the optic nerve head in relation with visual field losses observed in many Fabry patients. Data collected will allow to evaluate if there is a link between these two entities. Study will last up to 2 years during which a limited number of Fabry patients will be compared to a control group to confirm any relationship between blood flow and field losses, and to see if these results vary over time. HYPOTHESIS 1. Fabry patients will present significant differences in visual fields compared to control 2 There will be variability of the visual field defects on the long term but not on the short term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic nerve head will be the same for both groups.

NCT ID: NCT02022930 Completed - Clinical trials for Osteoarthritis of the Knee

Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.

NCT ID: NCT02022631 Completed - GRADE Approach Clinical Trials

New Alternative Formats vs Standard of SoF Tables. Non-inferiority Controlled Trial

Start date: December 2013
Phase: N/A
Study type: Interventional

The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.

NCT ID: NCT02022163 Completed - Clinical trials for Respiratory Tract Infections

Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.

Start date: December 2013
Phase: Phase 1
Study type: Interventional

A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.

NCT ID: NCT02022020 Completed - Atrial Fibrillation Clinical Trials

Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa

Start date: January 2014
Phase: N/A
Study type: Observational

This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.