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NCT ID: NCT04058392 Completed - HIV Infections Clinical Trials

Camu Camu in ART-treated People Living With HIV

Start date: November 9, 2020
Phase: Phase 1
Study type: Interventional

Persons living with HIV and receiving antiretroviral therapy (ART) remain with inflammation leading to higher risks of cardiovascular diseases, fatty liver and cancer. It has been observed in colitis and in HIV infection that abnormal composition of the gut microbes and leaky gut induce inflammation contributing to diabetes, fatty liver and cardiovascular risks. Abundance of Akkermansia muciniphila in stool, a type of good bacteria acting as a shield on the gut barrier has been shown to prevent obesity, diabetes and to improve cancer treatment response. Health food (prebiotic) increases the frequency of A. muciniphila in overweight individuals. Dr Marette, a study collaborator from Laval University, has recently published (Gut, 2018) that an extract from a Brazilian fruit called Camu Camu (CC) protects mice from obesity, reduce LPS, a marker for passage of microbes from the gut into the blood and decreases inflammation in association with the frequency of A. muciniphila in stools. The extract of CC is sold in nutritional stores to regulate body fat. The investigators will invite 22 participants to take 2 capsules of CC daily for 12 weeks in addition to their ART. CC tolerance and changes in blood and stools for inflammation and microbe composition will be evalutated at the end of the 12-week treatment and 8 weeks post-intake. An optional sub study will assess the changes of gut barrier by doing biopsies by colonoscopy. CC is expected to beassociated with an enrichment of A. muciniphila in stools, combined with reduced gut damage and inflammation.

NCT ID: NCT04058366 Completed - Cystic Fibrosis Clinical Trials

Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Start date: December 5, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).

NCT ID: NCT04058353 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Start date: August 28, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).

NCT ID: NCT04058171 Completed - Low Back Pain Clinical Trials

Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication

Start date: May 1, 2018
Phase:
Study type: Observational

The first aim of this study was to elaborate and validate a treadmill walking test that would help discriminate between neurogenic claudication from vascular claudication. The second objective of this study is to determine if the treadmill walking test can discriminate spinal stenosis from low back pain with radiating pain in lower limb.

NCT ID: NCT04058028 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

NCT ID: NCT04057859 Completed - Clinical trials for Cancer of the Prostate

PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training

ELIFIT
Start date: November 2013
Phase:
Study type: Observational

The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).

NCT ID: NCT04057573 Completed - Clinical trials for Non-segmental Vitiligo

Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

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

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

NCT ID: NCT04057300 Completed - Clinical trials for Acute Coronary Syndrome

Ticagrelor Compared to Clopidogrel in Acute Coronary Syndromes

TC4
Start date: October 1, 2018
Phase: Phase 4
Study type: Interventional

The McGill University Health Center (MUHC) Division of Cardiology, with funding from the Canadian Institute of Health Research, is performing this randomized controlled trial to determine which dual antiplatelet therapy (DAPT), ticagrelor + aspirin (T+A) or clopidogrel and aspirin (C+A), is the most effective and safest for our patients. While the PLATO trial reported that T+A was superior, the prespecified group of North American patients (about 1/10 of the total study sample) actually did better with C+A, although this difference was not statistically significant. When the FDA approved T, they also stated: "Lack of Robustness of PLATO Superiority with Failure in the US Makes a Confirmatory Study Mandatory." As no confirmatory study has been done, this TC4 study aims to fill that void. Study design: A cluster randomization design, so all patients will receive either T+A or C+A, depending on the month they arrive at the MUHC when they start their DAPT. We will follow patients through their electronic health records. The patients have no follow-up visits for this research project.

NCT ID: NCT04057157 Completed - Clinical trials for Cerebrospinal Fluid Leak

Post-market Assessment of Biodesign Dural Repair Grafts

Start date: September 3, 2019
Phase:
Study type: Observational

The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.

NCT ID: NCT04057092 Completed - Clinical trials for Surgical Site Infection

Perioperative Immunonutrition in Patients Undergoing Gynecologic or General Elective Surgery (PURPOSE)

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

The objective of the implementation pilot is to assess the practicality of introducing a perioperative immunonutrition protocol into a hospital environment as well as a true measure of impact on the rate of surgical site infection (SSI).