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NCT ID: NCT03232645 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation

LOCALIZE
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

NCT ID: NCT03232073 Completed - Multiple Sclerosis Clinical Trials

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

OPTIMUM-LT
Start date: July 5, 2017
Phase: Phase 3
Study type: Interventional

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

NCT ID: NCT03232034 Completed - Obesity Clinical Trials

Calcium, Protein and Gut Hormones

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

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.

NCT ID: NCT03231943 Completed - HIV Infections Clinical Trials

GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers

Start date: September 19, 2017
Phase: Phase 1
Study type: Interventional

Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.

NCT ID: NCT03231748 Completed - Acute Renal Failure Clinical Trials

Clearance of Inflammatory Cytokines During Renal Replacement Therapy Using the EMIC®2 Filter

ClicAKI
Start date: July 1, 2017
Phase:
Study type: Observational

This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy. The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.

NCT ID: NCT03231553 Completed - Smoking Cessation Clinical Trials

Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

The trial aims to determine whether or not MiQuit (text-message support programme) is effective when offered in addition to standard behavioural support for smoking cessation in pregnancy.

NCT ID: NCT03231124 Completed - Psoriasis Vulgaris Clinical Trials

Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.

Start date: July 25, 2017
Phase: Phase 1
Study type: Interventional

This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects. Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies.

NCT ID: NCT03231059 Completed - Clinical trials for Coronary Artery Disease

GLOBAL LEADERS Adjudication Sub-Study

GLASSY
Start date: June 1, 2017
Phase:
Study type: Observational

The GLOBAL LEADERS Adjudication Sub-StudY, GLASSY, is based on a re-assessment of all the events reported in the dataset of the parent trial (COMPARATIVE EFFECTIVENESS OF 1 MONTH OF TICAGRELOR PLUS ASPIRIN FOLLOWED BY TICAGRELOR MONOTHERAPY VERSUS A CURRENT-DAY INTENSIVE DUAL ANTIPLATELET THERAPY IN ALL-COMERS PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION WITH BIVALIRUDIN AND BIOMATRIX FAMILY DRUG-ELUTING STENT USE) by an independent Clinical Event Committee (CEC), composed of three physicians not involved in the main trial. The substudy include the first 19 top-enrolling sites of the GLOBAL LEADERS to reach the estimated sample size of 7,186 patients for the two co-primary outcomes of death, any non-fatal myocardial infarction, any non-fatal stroke or urgent target vessel revascularization and bleeding events classified as 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria. To ensure a comprehensive assessment of clinical events, a triggers logic is adopted to identify other potential events qualifying for study endpoints but not reported as such by local investigators.

NCT ID: NCT03231007 Completed - Stillbirth Clinical Trials

Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study

SPiRE
Start date: July 10, 2017
Phase:
Study type: Observational

The study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical Networks totalling approximately 100,000 births. It involves participation by both service users and care providers. To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires. This study will provide practice-based evidence to advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined. This has the potential to translate into substantial improvements in the rate of late stillbirth in the UK should the care bundle be proved effective.

NCT ID: NCT03230916 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

Start date: November 6, 2017
Phase: Phase 1
Study type: Interventional

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.