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NCT ID: NCT03564080 Completed - Clinical trials for Coronary Artery Disease

Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.

Start date: July 18, 2018
Phase: N/A
Study type: Interventional

This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD).

NCT ID: NCT03563261 Completed - Clinical trials for Tendon Stiffness With Age

Muscle-Tendon Mechanics During Locomotor Tasks, Efficacy of Collagen Supplementation for Older Adults

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Older adults are at higher risks of tripping and falling than young adults. These falls may lead to serious injuries (bone fractures, head trauma…) and premature death. They also have an important economic cost for the society. One of the reasons identified for this increased risk of falling is the modification of muscles and tendons functional and architectural parameters with age. It is now well established that muscles of older adults are smaller and weaker, while tendons, that modulate the outcomes of muscle contraction, are less able to resist to tension and transmit forces more slowly than in young age. These changes have functional implications, especially in tasks that require to quickly generate high forces, such as recovering from a trip. This study aims to determine the links between muscle-tendon characteristics and locomotion, and to understand whether they can be improved by a four-months collagen supplementation. The investigators will measure the muscular strength and tendon stiffness of lower limb musculotendinous units (MTU) for older adults using isokinetic dynamometry (IKD) and ultrasounds. Participants' abilities to recover from a trip will then be evaluated using a custom built tripping device while walking on a treadmill (participants will wear a whole body harness attached to a rope secured to the ceiling). These performances will be linked to MTU characteristics and compared between both age groups. Finally, the investigators will evaluate the effect of a nutritional supplementation on the mechanical properties of elderly tendons and its potential impacts on their ability to safely recover from a trip, on their lean mass, and on other life quality related markers (joint pain, balance, stair climbing capacities...). The investigators expect that this study will lead to a new intervention aiming to improve the safety of older adults performing their daily activities using nutritional supplementation, which is known to have better adherence than training interventions.

NCT ID: NCT03563183 Completed - Herpes Zoster Clinical Trials

A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

Start date: June 5, 2018
Phase:
Study type: Observational

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

NCT ID: NCT03562871 Completed - NSCLC Clinical Trials

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

Start date: August 22, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if IO102 combined with pembrolizumab with or without chemotherapy is safe tolerable and effective in the treatment of Non-small Cell Lung Carcinoma (NSCLC). The hypothesis is that IO102 will improve the objective response rate (ORR) in patients with metastatic NSCLC.

NCT ID: NCT03562624 Completed - Contraception Clinical Trials

A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components

INDessa
Start date: June 22, 2018
Phase: Phase 2
Study type: Interventional

This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women. It is designed to investigate the pharmacodynamics (PD) of BAY 987443 (i.e. IUS (intrauterine system) releasing LNG and IND), as well as pharmacokinetics (PK) of both active substances, safety and tolerability. In this study, Jaydess, as an LNG-only IUS, will be used as a comparator.

NCT ID: NCT03561662 Completed - Menopause Clinical Trials

The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.

Start date: May 14, 2015
Phase: N/A
Study type: Interventional

Participants will be randomly assigned to one of three treatment groups to receive soyafoods (Alpro drinks) providing a low (<10 mg), medium (35mg) or high-dose (60 mg) of isoflavones daily for a period of 12 weeks. The group receiving <10mg isoflavones daily will serve as a low-dose control group. Women will be asked to avoid consuming any additional soya foods during the study. Dietary intake will be assessed at baseline using the validated food frequency questionnaire a 4 day food diary will be completed at baseline and post-intervention. Weight and height will be measured and a general health & lifestyle questionnaire will also be completed by participants at baseline. Cognitive function will be assessed at baseline and post-intervention using the well validated and widely used computerised test battery system. Menopausal symptoms, quality of life, mood, stress and coping will also be assessed. Plasma concentrations of the soya isoflavones genistein and daidzein will be measured to assess compliance. Circulating concentrations of equol (a daidzein metabolite), will also be measured to investigate associations between equol and cognition and menopausal symptoms as a potential mechanism for the efficacy of soya.

NCT ID: NCT03559699 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

NCT ID: NCT03559452 Completed - Clinical trials for Muscle Disuse Atrophy

Muscle Damage and Disuse Atrophy

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

Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. In this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. This is designed to replicate the muscle damage and inflammation that occurs with injury. The remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.

NCT ID: NCT03559426 Completed - Schizophrenia Clinical Trials

Research Into Antipsychotic Discontinuation and Reduction Trial

Start date: March 24, 2016
Phase: Phase 4
Study type: Interventional

Psychosis and schizophrenia are common and costly mental health problems. Psychosis is the name given to a group of mental conditions in which cause people to perceive or interpret things differently from those around them. One of the most common causes of psychosis is schizophrenia, a condition that causes a range of psychological symptoms, including hallucinations (hearing and/or seeing things) and delusions (believing something that is not true). One of the main treatment options for psychosis and schizophrenia is long-term treatment with antipsychotic medication, but many patients still find life difficult. Antipsychotic drugs can also have dangerous and unpleasant side effects. Finding alternatives to long-term drug treatment is a priority for patients and services. This study is testing the effects of gradually reducing antipsychotic medication in people with schizophrenia, psychosis or similar conditions in order to see if it can help improve day-to-day functioning and how it affects their chance of suffering a relapse (worsening of their condition).

NCT ID: NCT03559361 Completed - Sleep Clinical Trials

26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults

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

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on a number of objective sleep measures (collected from Activity watches) and subjective sleep measures (collected from the Leeds Sleep Evaluation Questionnaire) before and after 26 weeks of supplementation