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NCT ID: NCT02576717 Completed - Multiple Sclerosis Clinical Trials

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

Start date: October 16, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

NCT ID: NCT02576639 Completed - Alzheimer's Disease Clinical Trials

Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

Start date: August 10, 2015
Phase: Phase 2
Study type: Interventional

The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.

NCT ID: NCT02576574 Completed - Clinical trials for First Line Non-Small Cell Lung Cancer

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Start date: October 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

NCT ID: NCT02576509 Completed - Clinical trials for Hepatocellular Carcinoma

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

NCT ID: NCT02575742 Completed - Constipation Clinical Trials

Colonic Motility in Constipation and Ageing

Start date: October 2015
Phase:
Study type: Observational

The reason chronic constipation (CC) becomes commoner with age is not fully understood. New studies suggest that bowel contraction patterns, dietary fibre and gut bacteria are important and may differ in older people. Since CC reduces quality of life and is a major reason why elderly are admitted to hospitals and residential care, there is a need to understand how these factors change with age. Currently, placing a pressure sensing catheter inside the large intestine (pancolonic manometry) is the gold standard way to measure how well it contracts. However this involves a camera test (colonoscopy) which is invasive with risks of bowel perforations (~80/100,000). The risk is higher with age (64-80yr: ~90/100,000; 80+yrs: ~120/100,000), making it unethical for elderly. A technique called the 3D-Transit System has been developed, involving a small ingestible capsule, containing a 'trackable' electromagnet. By tracking movements of the capsule swallowed by participants, it provides precise detailed information on the capsule progression inside the whole gut and large bowel's contractile activity in real-time. It is minimally-invasive and radiation-free, making it possible to assess elderly for the first time. This study aims to assess how bowel contraction patterns, dietary fibre intake and gut bacteria differ between young and older adults (with and without CC), to better understand why CC is more common in elderly. It is a pilot, 4 arm, single centre, observational study involving 60 women aged 18-40 years and 70-90 years (15 non-constipated and 15 with CC for each age group). The study lasts 3 weeks, containing 2 weeks of run-in period and 1 week of study period. The four groups participants will be asked to: swallow 2 capsules to assess their large bowel's contractile function using the 3D-transit system; provide stool samples to analyses their gut bacteria; and complete questionnaires to assess their gastrointestinal symptoms.

NCT ID: NCT02575430 Completed - Clinical trials for Retinitis Pigmentosa (RP)

Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT

Start date: December 2015
Phase: N/A
Study type: Observational

To evaluate the natural history of visual function in subjects with IRD phenotypically diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or LRAT gene mutations.

NCT ID: NCT02574455 Completed - Breast Cancer Clinical Trials

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

ASCENT
Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

NCT ID: NCT02574416 Completed - Aging Clinical Trials

An Evaluation of the Determinants of Lifestyle and Health Behaviors in Later Life

LiLL
Start date: February 2015
Phase:
Study type: Observational

Although increasing age is associated with declining health and function, there are wide variations between individuals in the ageing process. Some of these differences are explained by differences in lifestyle, but little is known about the determinants of lifestyle in older age. The proposed project will describe influences on health behaviour and lifestyle in older adults. Investigators will undertake a prospective study of community-dwelling older people who use any of the Medicine for Older People Services in Southampton, allowing us to gain obtain important insights into the relationship between health behaviour, lifestyle and health outcomes in older people. Our principal aim is to identify key points on the ageing pathway when interventions may be best targeted to promote health. The findings of this project will underpin the design for a complex intervention to be conducted in the future to improve the health outcomes of older people.

NCT ID: NCT02574312 Completed - Osteoarthritis Clinical Trials

ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty

SOLO
Start date: October 1, 2015
Phase: N/A
Study type: Interventional

This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.

NCT ID: NCT02574286 Completed - Gaucher Disease Clinical Trials

Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease

Start date: June 29, 2016
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per kilogram [U/kg] every other week [EOW]) in treatment-naive participants with type 1 Gaucher disease on change from baseline in lumbar spine (LS) bone mineral density (BMD) Z-score as measured by dual energy x-ray absorptiometry (DXA) after 24 months of treatment.