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NCT ID: NCT02530580 Completed - Healthy Clinical Trials

Effects of GABA Modulator AZD7325 on Cutaneous Sensation

Start date: February 2016
Phase: Phase 1
Study type: Interventional

GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the human brain. For years, drugs that enhance its effects (e.g., benzodiazepines such as diazepam/Valium) have been used to treat various diseases such as epilepsy, insomnia, anxiety or movement disorders. However, the use of these medications is often compromised because of their side effects, such as sleepiness, memory problems, and addiction. Therefore, effort has been made to develop drugs that act more selectively in the brain to exert the positive therapeutic effects and are devoid of the unwanted side effects. AZD7325 is one of these drugs. It has been tested in more than 700 people and so far proved to be generally well tolerated. Positron emission tomography (PET) study in humans demonstrated that AZD7325 binds to GABA A receptors in the brain after a single dose. Early clinical studies have shown that it has less sedative and cognitive adverse events as compared with a benzodiazepine lorazepam. The investigators now wish to evaluate if effects of AZD7325 can be objectively measured in healthy volunteers and to establish which of the drug's outcomes could be utilised for further studies in patients with neurological diseases. The investigators are especially interested in the effects of AZD7325 on manual dexterity and skin sensation of the hand. This can be assessed by a number of simple non-invasive tests of object manipulation and detection of different sensory stimuli such as touch, vibration, or temperature. Recent studies show that healthy individuals who performed better in similar tasks had more GABA in relevant areas of their brain. If performance in these tasks in healthy volunteers can be improved by enhancing GABA effects in the brain with AZD7325, this would create the grounds for the use of this medication to treat symptoms of certain neurological disorders in which motor control and sensation of the hand is impaired (e.g., polyneuropathy).

NCT ID: NCT02529956 Completed - Clinical trials for Mild to Moderate Psoriasis

A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis

Start date: November 2012
Phase: Phase 1
Study type: Interventional

To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.

NCT ID: NCT02529904 Completed - Influenza Clinical Trials

ADITEC FLU 2 STUDY: Understanding the Genetics Basis for Immune Responses to Flu Vaccines in Children and Adults

Start date: August 2015
Phase: Phase 2
Study type: Interventional

Influenza infection is related to significant morbidity and mortality in children. The trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is unable to be administered to children under 2 years old. The MF59 adjuvanted influenza vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza, including in children. The study aims to assess early gene transcriptional responses to priming and boosting with MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish correlations with haemagglutination inhibition (HAI) titers. It will be an open label study with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults allocated to group 4.

NCT ID: NCT02529423 Completed - Depression Clinical Trials

Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression

MoodFOOD
Start date: July 2015
Phase: N/A
Study type: Interventional

The study examines the feasibility and effectiveness of two different nutritional strategies (multi‐nutrient supplement and food‐related behavioural change) to prevent depression in high‐risk overweight European Union citizens. Interventions will last 12 months. Design is a two‐by‐two factorial randomized controlled prevention trial with four intervention groups: 1. Control group (daily placebo supplements) 2. Multi-nutrient supplementation group (daily multi-nutrient supplement) 3. Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements) 4. Multi-nutrient supplementation + food-related behavioural activation group (daily multi-nutrient supplement + food-related behavioural activation focusing on improving overall diet). Follow‐up assessment will be conducted at 3, 6, and 12 months for primary and secondary endpoints, and during intervention for compliance, adverse events and mediating variables.Data will first be analyzed according to the intention‐to‐treat principle, using (mixed model) analysis of covariance with primary and secondary endpoints, testing for the effects of the two nutritional strategies separately as well as combined.

NCT ID: NCT02529085 Completed - Clinical trials for Prader-Willi Syndrome

PWS European Blood Bank for Infants and Controls From 0 to 48 Months

Start date: March 2013
Phase: N/A
Study type: Interventional

The present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS. The primary objective is to describe the evolution of circulating hormones involved in feeding and appetite regulation during the 4 first years of life. The secondary objective is to make this blood bank available for other research projects and particularly the investigation of hormones involved in hypogonadism. Over the last ten years, the age at diagnosis in PWS has fallen significantly and the majority of cases is now diagnosed during the 1st trimester of life giving the possibility to collect precise clinical data and serum samples at early stages. The investigators of the project are involved in the care of patients with PWS and have a devoted clinic and an organized network in their country through clinical networks or patient associations.

NCT ID: NCT02529059 Completed - HIV Clinical Trials

SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms

Start date: November 2015
Phase: Phase 4
Study type: Interventional

This study aims to investigate whether substitution of Efavirenz (EFV) as the Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity associated with EFV, continued virological suppression and immunological reconstitution and whether this is associated with an improvement in quality of life, sleep, anxiety/depression and neurocognitive function; the impact of switch on adherence will also be investigated.

NCT ID: NCT02529007 Completed - Colonic Neoplasms Clinical Trials

Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening

E-CAP
Start date: September 2014
Phase: N/A
Study type: Interventional

The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

NCT ID: NCT02528968 Completed - Hemophilia A Clinical Trials

National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A

UK-PK
Start date: September 2015
Phase: N/A
Study type: Interventional

Prospective, interventional study of pharmacokinetic (PK)-focused FVIII dosing discussions delivered as part of a patient education package. The study will capture severe haemophilia A patient reported outcome measures before and after PK-focused dosing discussions, including a standardised patient education package, that include personalised PK-guided dosing suggestions from a computational predictive device (myPKFiT®). The pragmatic study design recognises the CE marked myPKFiT® device is being implemented into routine care nationally and consequently only requires a single additional clinic visit for the purpose of consenting.

NCT ID: NCT02528643 Completed - Clinical trials for Advanced Hepatocellular Carcinoma

A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma

Start date: November 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of the study was to evaluate the efficacy of enzalutamide in participants with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS). This study also evaluated the safety of enzalutamide; pharmacokinetics of enzalutamide and the active metabolite N-desmethyl and Progression Free Survival (PFS) of enzalutamide as compared to placebo in participants with advanced HCC.

NCT ID: NCT02528604 Completed - Clinical trials for Persistent Atrial Fibrillation

Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation

CAPAPAF-65
Start date: July 2016
Phase: Phase 4
Study type: Interventional

Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.