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NCT ID: NCT04060602 Completed - Cannabis Use Clinical Trials

Personalized Feedback Intervention to Reduce Risky Cannabis Use.

Start date: September 3, 2019
Phase: N/A
Study type: Interventional

The purpose of this project is to determine whether participants who receive a personalized feedback report and educational materials about risky cannabis use will be less likely to report risky cannabis use at follow-up compared to participants who only received educational materials.

NCT ID: NCT04060199 Completed - Clinical trials for Duchenne Muscular Dystrophy

Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)

Start date: April 14, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.

NCT ID: NCT04060095 Completed - Clinical trials for Nociception During Anesthesia in Patients Taking ß1-adrenergic Antagonist Chronic Treatment

Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General Anesthesia

BetaNOL
Start date: August 27, 2019
Phase:
Study type: Observational

The aim of the present study is to investigate the effect of chronic treatment with β1-adrenergic antagonist on the NOL index variation, the heart rate variation and the mean blood pressure variation after a standardized noxious stimulus.

NCT ID: NCT04060043 Completed - Prostate Cancer Clinical Trials

Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

Start date: February 21, 2017
Phase: Early Phase 1
Study type: Interventional

This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.

NCT ID: NCT04059484 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

AMEERA-3
Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health-related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms

NCT ID: NCT04059094 Terminated - Cystic Fibrosis Clinical Trials

A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1

Start date: September 16, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.

NCT ID: NCT04059055 Completed - Pain Management Clinical Trials

Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair

Start date: October 1, 2019
Phase:
Study type: Observational

Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Less frequently observed is the potential for opioid use and misuse in children and adolescents post-surgery. The research to date in this area has been poorly performed with heterogenous data collection, analysis and reporting, as well as large loss of patients to follow-up. The investigators' previous prospective observational deception study identified three areas of concern: 1. There is a culture of postoperative opioid over-prescribing at discharge as demonstrated by heterogenous opioid dosing and duration of treatments across practitioners for single procedures 2. This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids 3. There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community

NCT ID: NCT04058756 Recruiting - Clinical trials for Advanced Solid Tumors

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

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

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

NCT ID: NCT04058561 Recruiting - Clinical trials for Early-Onset Scoliosis Deformity of Spine

Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

MCGR
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.

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.