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NCT ID: NCT03009409 Completed - Anesthesia Clinical Trials

The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia

Start date: March 13, 2018
Phase: Phase 1
Study type: Interventional

Closed-loop control of anesthesia involves using feedback from a measure of clinical effect to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a variable rate that is frequently personalized to each individual patient. The aim is to provide greater stability at an optimal depth of anesthesia, reducing the occurrence of under- or overdosing, with the goal of ultimately improving patient outcomes. The purpose of this randomized, controlled equivalence trial is to compare controller performance during closed-loop controlled induction and maintenance of total intravenous anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine versus saline control.

NCT ID: NCT03009396 Completed - Crohn Disease Clinical Trials

Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

MAPUS2
Start date: March 18, 2017
Phase: Phase 3
Study type: Interventional

An open label extension to the RHB-104-01 Study.

NCT ID: NCT03009162 Completed - Migraine Clinical Trials

Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function

Start date: April 1, 2017
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose study. This study will enroll up to 32 participants using an adaptive design that can include up to 3 groups of 8 participants with different degree of renal impairment and one group of 8 control participants with normal renal function. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered in the study. First, approximately 16 participants will be enrolled with severe renal impairment and matched participants with normal renal function. There will be 8 participants in each of the following groups based on renal function at screening: - Group 1: Healthy participants with normal renal function (estimated glomerular filtration rate [eGFR] ≥ 90 milliliters per minute per 1.73 meters squared [mL/min/1.73m²]) - Group 2: Severe renal impairment participants (eGFR < 30 mL/min/1.73m²) Based on safety and pharmacokinetic (PK) results from participants with severe renal impairment (Group 2), Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be enrolled if substantial change in the exposure of lasmiditan is observed in participants with severe renal impairment.

NCT ID: NCT03008928 Completed - Alcohol Consumption Clinical Trials

The Efficacy of the Alcooquizz App to Reduce Hazardous Alcohol Consumption

Start date: January 2017
Phase: N/A
Study type: Interventional

New technologies offer potential ways to provide and deliver preventative interventions. With respect to unhealthy alcohol use, offering people tools to assess and manage their risk at any given time using their smartphone may represent an additional opportunity to disseminate preventative interventions. Nevertheless, there is a lack of knowledge on the acceptability and efficacy of smartphone applications for unhealthy alcohol use. Alcooquizz, a smartphone app, has been previously evaluated using a before/after design without randomization, with participants reporting reductions in drinking over time. The current trial proposes to conduct an RCT, comparing reductions in alcohol consumption between participants provided access to Alcooquizz to a no intervention control. Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be randomized to be provided a link to download the Alcooquizz app or to a no link control condition. At six-months post-baseline, the MTurk portal will be used to send invitation emails that contain a link to the follow-up survey that asks about their drinking and their impressions of the app. The primary hypothesis to be tested is that participants receiving access to the Alcooquizz app will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the no information control condition.

NCT ID: NCT03008070 Completed - Clinical trials for Non-Alcoholic Steatohepatitis (NASH)

Phase 2b Study in NASH to Assess IVA337

NATIVE
Start date: February 7, 2017
Phase: Phase 2
Study type: Interventional

Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.

NCT ID: NCT03006900 Completed - Multiple Sclerosis Clinical Trials

Multiple Sclerosis and Pilates

Start date: December 2016
Phase: N/A
Study type: Interventional

Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to the more traditional exercise programs. Although somewhat limited, previous research has suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded, randomized controlled study has one intervention group (Pilates and massage therapy) and one control group (massage therapy only). The primary outcome of interest is the change in walking ability between groups. Secondary outcomes include other measures of physical performance and quality of life.

NCT ID: NCT03006861 Completed - Muscle Weakness Clinical Trials

Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power

Start date: December 2016
Phase: N/A
Study type: Interventional

Creatine is a nutritional supplement that is often ingested to improve exercise performance. The advent of a new product that is applied to the skin overlying muscle offers potential benefit, if the creatine can be targeted to specific muscles. The investigators are testing a novel creatine cream to determine the effects on human muscular performance. The investigators are assessing whether 7 days of topical creatine application is additive to orally-ingested creatine for improving muscular power (determined by knee extension).

NCT ID: NCT03005145 Completed - Sepsis Clinical Trials

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness

BALANCE
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

The World Health Organization, U.S. Centers for Disease Control and Prevention, Association of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all declared antimicrobial resistance a global threat to health, based on rapidly increasing resistance rates and declining new drug development. Up to 30-50% of antibiotic use is inappropriate, and excessive durations of treatment are the greatest contributor to inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to be as effective as longer antibiotic treatment for a range of mild to moderate infections. A landmark trial in critically ill patients with ventilator-associated pneumonia showed that mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of treatment. Similar adequately powered randomized trial evidence is lacking for the treatment of patients with bloodstream infections caused by a wide spectrum of organisms.

NCT ID: NCT03004924 Completed - Clinical trials for Bacterial Conjunctivitis

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

NCT ID: NCT03004534 Completed - Clinical trials for Breast Cancer Female

A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide

Start date: September 5, 2017
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects. The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.