Clinical Trials Logo

Filter by:
NCT ID: NCT03762265 Terminated - Pemphigus Clinical Trials

A Study of PRN1008 in Patients With Pemphigus

Start date: January 8, 2019
Phase: Phase 3
Study type: Interventional

This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.

NCT ID: NCT03760484 Terminated - Clinical trials for Clostridium Difficile

Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection

Start date: January 21, 2019
Phase: Phase 2
Study type: Interventional

Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI. Current evidence suggests that FMT in combination with vancomycin is required, and that multiple treatments are necessary. The investigators think fidaxomicin may be a better option in the context and may potentially reduce the number of FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to determine efficacy and safety in treating patients with severe or fulminant CDI. The investigators want to see if this approach may reduce the number of FMT treatment required, and/or the length of hospital stay.

NCT ID: NCT03759288 Terminated - Crohn's Disease Clinical Trials

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

INTREPID
Start date: December 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

NCT ID: NCT03759041 Terminated - Ulcerative Colitis Clinical Trials

A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

ECO-RESET
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

NCT ID: NCT03758443 Terminated - Clinical trials for Ulcerative Colitis (UC)

Efficacy & Safety of TD-1473 in Ulcerative Colitis

RHEA
Start date: March 11, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

NCT ID: NCT03758378 Terminated - Obesity Clinical Trials

Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

Start date: November 12, 2018
Phase: N/A
Study type: Interventional

The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

NCT ID: NCT03755063 Terminated - Stroke Sequelae Clinical Trials

Recovernow: Tablet-Based Speech Therapy For Post-Stroke Aphasia

Start date: November 13, 2019
Phase: N/A
Study type: Interventional

RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Primary outcome is improvement in the Western Aphasia Battery Aphasia (WAB-R) Overall Study Aim: The primary study aim is to determine the futility and potential efficacy of mobile tablet-based speech therapy for post stroke aphasia. Primary Endpoint: The primary outcome measure is change in the Aphasia quotient (AQ) from the WAB-R at 90 days. The WAB-R is a standardized aphasia battery. The AQ is calculated from four language sub-tests measuring spontaneous speech, word comprehension, repetition, and word finding.) Secondary Endpoints: The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained. Population: 226 participants will be enrolled over 3 years. Males and females, >18 years of age, with diagnosis of acute ischemic/hemorrhagic stroke confirmed by routine head computerized tomography (CT) scan with mild to moderate aphasia. Phase: II Number of Sites: It is anticipated that this will be a multi-center study, with the following facilities participating: The Ottawa Hospital, Ottawa, ON, Foothills Medical Centre, Calgary, Alberta and Toronto Western Hospital. Protocol Therapy: Patients will be randomized 1:1 to receive either tablets with speech therapy apps (intervention group) or standard of care. Study Duration: It is estimated that recruitment will take place over 3 years in the three participating centers. Subject Participation Duration: All patients will be assessed clinically at baseline and Day 90 (+/-10).

NCT ID: NCT03752385 Terminated - Sedentary Lifestyle Clinical Trials

The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Previous studies suggest that screen use (phones, TV, computers, etc) may negatively impact both sleep and mental health (1-3). The purpose of this study is to determine the impact of reducing smartphone use on sleep, physical activity, sedentary behaviour, and mental health in adolescents and young adults aged 13-25.

NCT ID: NCT03745222 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer

RATIONALE001
Start date: May 22, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

NCT ID: NCT03744910 Terminated - Clinical trials for Antibody-mediated Rejection

Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients

IMAGINE
Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.