Clinical Trials Logo

Filter by:
NCT ID: NCT02145819 Completed - Clinical trials for Supervision of Pregnancy Resulting From In-vitro Fertilization

Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?

PLUS
Start date: January 2014
Phase: Phase 4
Study type: Interventional

The aim of the study is to determine whether spontaneous LH peak is superior to human chorionic gonadotropin before a transfer of a day 3 frozen embryo.

NCT ID: NCT02145468 Completed - Clinical trials for Acute Coronary Syndrome

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

LATITUDE
Start date: June 3, 2014
Phase: Phase 3
Study type: Interventional

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

NCT ID: NCT02145208 Completed - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Study to Assess the Efficacy of Medi-Tate iTind Device

Start date: October 2014
Phase: N/A
Study type: Interventional

The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.

NCT ID: NCT02143856 Completed - Healthy Clinical Trials

Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects. Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.

NCT ID: NCT02143791 Completed - Chronic Pain Clinical Trials

Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs

Prodigy-I
Start date: June 2014
Phase: N/A
Study type: Observational

The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.

NCT ID: NCT02142127 Completed - Healthy Clinical Trials

Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers

Start date: April 2014
Phase: Phase 1
Study type: Interventional

Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of drug that is recovered over time via different elimination routes of the body, i.e., whole blood, blood cells, plasma, urine, feces, and expired air. The ideal case is to be able to demonstrate a (near) complete recovery (≥95 %) of the administered dose. A good understanding of the metabolic pathway of the study drug is equally important. Mass-balance data, together with metabolic profiles in excreta, are used to characterize the biotransformation pathways of a drug and to help evaluate its drug-drug interaction potential. To this purpose, in this study, blood, urine, and feces are collected to investigate the metabolic profile of GFT505, and plasma and urine are collected to investigate the non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other metabolites will be investigated in plasma and urine according to the radioactivity results. Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated according to the radioactivity results.

NCT ID: NCT02141815 Completed - Clinical trials for Chronic Kidney Disease

AXOS and Microbial Metabolites in CKD

Start date: May 2014
Phase: N/A
Study type: Interventional

Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiota contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, overall mortality and chronic kidney disease progression. The most important regulator of colonic bacterial metabolism is nutrient availability and especially the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in general, and AXOS more specifically, can influence intestinal generation of microbial metabolites in predialysis patients has not been studied to date. An interventional study with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease intestinal generation and serum concentrations of microbial metabolites in patients with CKD not yet on dialysis.

NCT ID: NCT02141607 Completed - Shock Clinical Trials

Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock

Shockomics
Start date: October 2014
Phase:
Study type: Observational

The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic instability, systemic inflammatory response syndrome and multiorgan failure has been extensively investigated, but there is no consensus on the trigger mechanisms of tissue injury at the molecular level. Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are unable to act at the "beginning of the cascade", because of the lack of a model explaining the molecular basis of shock induced tissue injury and ensuing organ damage. The present observational study is aimed at identifying the molecular triggers of acute heart failure (HF) induced by shock and to identify inflammatory mediators and markers that are activated in shock, with a particular emphasis on the role of uncontrolled proteolytic activity.

NCT ID: NCT02139553 Completed - Cerebral Stroke Clinical Trials

Effect of Rhythmic Upper-limb Training in Stroke Patients

Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether rhythmic upper-limb movement training in post-stroke patients allows to improve only this particular type of movements or if it also improves some parameters of discrete movements. Based on our results we hope to be able to answer a fundamental question: are rhythmic and discrete movements two independent primitives?

NCT ID: NCT02139306 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

Start date: August 2014
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.