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NCT ID: NCT03718195 Completed - Clinical trials for Child Nutrition Disorders

Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children

Start date: August 21, 2018
Phase: N/A
Study type: Interventional

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

NCT ID: NCT03717675 Completed - Coronary Occlusion Clinical Trials

Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

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

This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.

NCT ID: NCT03715998 Completed - Clinical trials for Myocardial Infarction

Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction

QUORUM
Start date: June 4, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.

NCT ID: NCT03715634 Completed - Opioid-use Disorder Clinical Trials

Study of a Novel Subcutaneous Depot Formulation of Buprenorphine

Start date: September 20, 2017
Phase: Phase 1
Study type: Interventional

INDV-6200 is being developed for the treatment of opioid dependency and is expected to provide sustained buprenorphine plasma concentrations. The study will be done in healthy volunteers and will administer a non-therapeutic dose of INDV-6200. Study Period 1 will evaluate the oral tolerability of sublingual (SL) buprenorphine dosed over 3 days. Period 2 will administer the investigational medicinal product (IMP) or volume matched placebo.

NCT ID: NCT03715348 Completed - Surgery Clinical Trials

Trial of PCC Versus FFP in Patients Undergoing Heart Surgery

PROPHESY
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

The PROPHESY trial is a single centre pilot trial investigating Fresh Frozen Plasma (FFP) or Prothrombin Complex Concentrate (PCC) treatment for patients who are bleeding during cardiac surgery, and who are NOT receiving a vitamin K antagonist agent (e.g. warfarin). This pilot study will investigate the feasibility of delivering the different components of the trial, so that investigators can determine if it's feasible to move to a future large trial that will aim to compare the efficacy and safety of FFP versus PCC in adult patients who are actively bleeding during cardiac surgery.

NCT ID: NCT03714685 Completed - Healthy Males Clinical Trials

Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations

Start date: February 15, 2019
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label, non-randomised, period fixed sequence study designed to investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet formulations and compare this to a reference Firibastat (QGC001) immediate release (IR) capsule formulation in healthy male subjects. It is planned to enrol 12 subjects to receive single oral doses of investigational medicinal product (IMP).

NCT ID: NCT03714464 Completed - Clinical trials for Gastrointestinal Symptoms

Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study

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

Different physical form of apples had a significant effect on satiety and blood sugar levels which was shown in a 1977 study by Haber and his team (Haber et al.1977).It was suggested that , this effect was due to processing of the apples which modified the bioavailability of carbohydrate and fiber content.However this was not enough to explain the mechanistic effect of the apples. Within the last decade, the role of magenetic resonance imaging has been very promising in understanding gastrointestinal function and physiology. Recent MRI studies have measured changes in gastrointestinal volumes due to the effect of fermentable carbohydrates. Apple contains fermentable carbohydrates or FODMAPs. They are known to be poorly absorbed in the small and exert an osmotic effect by increasing markedly small bowel water content in the intestinal lumen as demonstrated in imaging studies.(Murray et al 2014 and Placidi et al 2012). A reduction of FODMAPs in the diet of IBS sufferers has been found to alleviate functional gut symptoms demonstrated in several randomised controlled trials. In order to fully understand the 1977 Haber study, the investigators would like to repeat the study using modern MRI methods in healthy volunteers and measure the volume changes in the stomach, small bowel and colon. In addition appetite and symptoms would also be investigated after ingesting each test meal.

NCT ID: NCT03714399 Completed - Surgery Clinical Trials

Muscle Recovery Following Aortic Surgery Induced ICUAW.

VARIANCE
Start date: February 19, 2019
Phase:
Study type: Observational

To identify determinants of 'good and bad recovery' from ICUAW and build knowledge around the timing of these processes. Also, the investigators want to discover the effects of ICUAW on physical function and HRQoL following aortic surgery.

NCT ID: NCT03714373 Completed - Clinical trials for Prader-Willi Syndrome

Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.

NCT ID: NCT03714152 Completed - Chronic Hepatitis B Clinical Trials

A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B

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

This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.