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NCT ID: NCT03762278 Completed - Clinical trials for Muscle Disuse Atrophy

Can Supplemental Leucine Offset Disuse-induced Muscle Atrophy?

LEU-DIMA
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Ageing is associated with a gradual decline in muscle mass that is detrimental to both physical function and metabolic health, increasing the risk of morbidity and mortality. The loss of protein muscle mass with ageing is poorly understood, but it may partly relate to inactivity/disuse (i.e. during injury or hospitalization). Periods of inactivity/disuse blunt the ability of muscle to grow (termed anabolic blunting), leading to a loss of muscle mass and strength. An accumulation of these periods over a lifetime promotes the devastating loss of muscle protein mass and strength seen with ageing. Disuse-induced muscle loss is underpinned by a blunted muscle anabolic response to protein nutrition. Supplementing the diet with the amino acid leucine may offer a potential solution to alleviate muscle mass and strength loss during disuse. In fact, leucine is suggested to promote muscle protein growth and reduce muscle protein loss during disuse in rats, but this is yet to be shown in humans. Accordingly, the proposed study will investigate whether leucine supplementation can offset muscle and strength loss during short-term disuse. Twenty-four healthy (non-obese, non-diabetic, non-smokers) men aged 18-35 years will initially complete a lower-limb strength assessment and undergo a body composition scan three days later. The following morning, participants will be randomly assigned to ingest either 5g of leucine (n=12) or a caloric-matched placebo (n=12) with each meal over a 7 d period of a single-leg immobilisation. Immediately following immobilisation participants will undergo another body composition scan. Additionally, a stable isotope infusion will be combined with serial muscle biopsies from the thigh of each leg to determine the measure rates of muscle protein synthesis in the fasted state and in the 'early' and 'late' phase of feeding. A day later, the assessment of muscle strength will be repeated.

NCT ID: NCT03762200 Completed - Hemorrhage Clinical Trials

SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of closure. All enrolled subjects will be followed post-operatively through discharge and again at 30 days and 6 months post-surgery via phone call or office visit.

NCT ID: NCT03761849 Completed - Huntingtons Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

NCT ID: NCT03761537 Completed - Atopic Dermatitis Clinical Trials

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

ECZTRA 7
Start date: December 13, 2018
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS. To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

NCT ID: NCT03760913 Completed - Pain Clinical Trials

OLP-1002 is Being Studied in the Treatment of Pain.

Start date: November 21, 2018
Phase: Early Phase 1
Study type: Interventional

The primary objective of the study is to assess the safety and tolerability of single and multiple subcutaneous doses of OLP-1002 in healthy subjects.

NCT ID: NCT03760848 Completed - Healthy Clinical Trials

Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers

Start date: November 12, 2018
Phase: Phase 1
Study type: Interventional

The trial is an open-label, 2-period, single-sequence assessment of CYP3A4 inhibition by aramchol using the probe substrates midazolam and atorvastatin to assess CYP3A4 activity.

NCT ID: NCT03760003 Completed - Ulcerative Colitis Clinical Trials

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

NCT ID: NCT03759795 Completed - Effect of Training Clinical Trials

Bournemouth University Resilience Training for Surgeons

BURTS
Start date: February 14, 2018
Phase: N/A
Study type: Interventional

The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.

NCT ID: NCT03759665 Completed - Sandhoff Disease Clinical Trials

N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)

Start date: June 7, 2019
Phase: Phase 2
Study type: Interventional

This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). There are two phases to this study: the Parent Study, and the Extension Phase. The Parent Study evaluates the safety and efficacy of N-Acetyl-L-Leucine (IB1001) in the symptomatic treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). The Extension Phase evaluates the long-term safety and efficacy of IB1001 for the neuroprotective, disease-modifying treatment of GM2 Gangliosidosis. The Extension Phase was considered exploratory.

NCT ID: NCT03759639 Completed - Clinical trials for Niemann-Pick Disease, Type C

N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)

Start date: September 4, 2019
Phase: Phase 2
Study type: Interventional

This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of Niemann-Pick type C disease (NPC). There are two phases to this study: the Parent Study, and the Extension Phase. The Parent Study evaluates the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the symptomatic treatment of NPC. The Extension Phase evaluates the long-term safety and efficacy of IB1001 for the neuroprotective, disease-modifying treatment of NPC.