Clinical Trials Logo

Filter by:
NCT ID: NCT04139668 Not yet recruiting - Clinical trials for Cannabis Use Disorder

Vivitrol Treatment for Cannabis Use Disorder

Start date: September 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of 12 weeks treatment with an extended-release injectable form of naltrexone (Vivitrol) combined with a psychological intervention in 10 treatment-seeking adults with Cannabis Use Disorder. The hypotheses are that Vivitrol combined with a psychological intervention will be well tolerated, and will reduce cannabis use, improve abstinence rates, and reduce cannabis withdrawal and craving.

NCT ID: NCT04139655 Withdrawn - Clinical trials for Myocardial Infarction

Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study

COPMAN
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Perioperative Myocardial Infarction (PMI) is a major contributor to perioperative mortality and morbidity with overall incidence of 5-16%. It is associated with increased 30-day mortality of 11.6% vs 2.2% of patients without PMI in non-cardiac surgical patients. However, its recognition and diagnosis remains challenging as the typical symptoms and findings of ischemic MI may be masked by post-operative changes and pain management. In this study, the investigators hope to determine if colchicine decreases the incidence of MINS in high risk surgical patients undergoing non-cardiac surgery and optimally establish colchicine as a viable therapy to improve perioperative cardiovascular outcome in those patients.

NCT ID: NCT04139616 Recruiting - Clinical trials for Transcatheter Aortic Valve Replacement

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

PROMOTE
Start date: February 25, 2020
Phase:
Study type: Observational [Patient Registry]

The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. The implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-TAVR applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. This may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with TAVR. In the end, the final objective of a pre-specified strategy for managing conduction disturbances post-TAVR should be to obtain a low rate of PPM without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the TAVR procedure.

NCT ID: NCT04139590 Completed - Postoperative Pain Clinical Trials

Evaluation of Smartphone Versions of VAS and NRS for Use in Adults

Panda
Start date: July 25, 2016
Phase: N/A
Study type: Interventional

A large number of patients experience significant pain after surgery, and more patients report pain after discharge from hospital than before. This issue has been observed in patients who receive peripheral nerve blocks, the effects of which often wear off after discharge. There are numerous barriers to the effective control of pain away from the direct supervision of medical professionals, and personalized management strategies are necessary in order to overcome these barriers. The first step of adequate pain management is accurate pain assessment. Therefore, this study aims to validate a smartphone-based pain assessment tool that patients can access at home.

NCT ID: NCT04139317 Terminated - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

NCT ID: NCT04138888 Recruiting - Bioequivalence Clinical Trials

A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions

Start date: October 31, 2019
Phase: Phase 1
Study type: Interventional

This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan medoxomil/ hydrochlorothiazide in the two formulations (Olmesartan Medoxomil/ Hydrochlorothiazide (HCTZ), 40 mg/ 25 mg film-coated tablets (Manufacturer: Pharmtechnology LLC, Republic of Belarus) and Olmetec Plus® (Olmesartan Medoxomil/ Hydrochlorothiazide), 40 mg/25 mg film-coated tablets, (Manufacturer: Daiichi Sankyo Europe GmbH, Germany)) in healthy subjects. As this is a bioequivalence trial where each subject received each study treatment in a crossover fashion, a control group was not included. Within the clinical portion of the study each subject received a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints were the pharmacokinetic (PK) parameters Cmax and AUC0-t of olmesartan and hydrochlorothiazide.

NCT ID: NCT04138706 Recruiting - Clinical trials for Clostridium Difficile Infection

Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection

TAPER-V
Start date: November 19, 2020
Phase: Phase 3
Study type: Interventional

The first line therapy for an initial episode of CDI (Clostridium difficile infection) is 10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018 guidelines from the Association of Medical Microbiologists and Infectious Diseases of Canada (AMMI). Although response rates for the treatment of a first episode of CDI now approach 90%, approximately 25% of patients who have a complete response will develop recurrence (rCDI) within 8 weeks. Doctors' ability to predict recurrence is evolving, but remains very limited. The investigators hypothesize that by extending initial vancomycin therapy with a 2-week tapering regimen this will reduce the risk of rCDI. Starting at the end of the initial 14 days of therapy, participants will be randomized to receive an additional 14-days of placebo or vancomycin taper (125 mg orally twice daily x 7 days followed by 125 mg orally once daily x 7 days). This taper was chosen as it represents two steps of a commonly used 4-week vancomycin taper. The investigators' proposal to evaluate the extension of initial treatment from 14 to 28 days with a tapering dose of vancomycin represents a practical clinical trial that capitalizes on oral vancomycin's safety profile, worldwide availability, and relatively low cost.

NCT ID: NCT04138485 Withdrawn - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Start date: December 20, 2019
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

NCT ID: NCT04138394 Recruiting - Shock Clinical Trials

VItamin C in Thermal injuRY: The VICToRY Trial

VICToRY
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

NCT ID: NCT04138277 Active, not recruiting - Clinical trials for Pompe Disease (Late-onset)

A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD

Start date: December 18, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.