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NCT ID: NCT02277132 Terminated - Clinical trials for Fetal Growth Restriction

The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

STRIDER
Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. Placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. There is currently no therapy available with demonstrated effectiveness. Evidence suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes. Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival. Study design: Multicenter nationwide randomized placebo-controlled clinical trial. Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death. Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected medication-associated risks can't be excluded on beforehand.

NCT ID: NCT02276625 Recruiting - Clinical trials for Rabies Pre-exposure Prophylaxis

One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding

Start date: October 2014
Phase: Phase 2
Study type: Interventional

To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.

NCT ID: NCT02276430 Active, not recruiting - Testicular Cancer Clinical Trials

TACkLE Study - Tackling Adverse Chemotherapy-associated Late Effects

TACkLE
Start date: July 2014
Phase:
Study type: Observational

Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years. Their life expectancy has greatly improved due to the introduction of platinum-containing chemotherapy for disseminated TC in the late 1970s. Given the good prognosis of TC nowadays, prevention or early detection of late adverse effects of TC treatment has become increasingly important. Current literature suggests that TC treatment, and specifically exposure to platinum agents, is associated with increased risk of cardiovascular morbidity and mortality. The precise role of treatment components like platinum in the pathogenesis of cardiometabolic changes and cardiovascular disease (CVD) warrants further investigation, since it is not known if CVD develops through direct platinum-induced damage of the vascular wall or by mediation through development of cardiometabolic riskfactors. The aim of this study is to identify risk factors for development for CVD after treatment for TC. A more profound insight into pathophysiologic mechanisms and identification of risk factors for CVDs is needed to facilitate development of preventive strategies and to optimize survivorship care.

NCT ID: NCT02276313 Completed - Atherosclerosis Clinical Trials

BIOLUX P-III All-Comers Passeo-18 Lux Registry

Start date: October 2014
Phase:
Study type: Observational

BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

NCT ID: NCT02276196 Completed - Diabetes Mellitus Clinical Trials

Effect of LIXIsenatide on the Renal System

ELIXIRS
Start date: September 2014
Phase: Phase 4
Study type: Interventional

Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, may hold promise in preventing the onset and progression of diabetic kidney disease. However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes. Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1 receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes. Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.

NCT ID: NCT02276053 Completed - Clinical trials for Brain Tumor Related Epilepsy (BTRE)

Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors

VIBES
Start date: November 27, 2014
Phase:
Study type: Observational

This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.

NCT ID: NCT02275845 Recruiting - Clinical trials for Gestational Diabetes Mellitus

Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

Medico-GDM
Start date: September 2014
Phase: Phase 3
Study type: Interventional

Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial

NCT ID: NCT02275260 Terminated - Clinical trials for Paroxysmal Atrial Fibrillation

Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

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

The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.

NCT ID: NCT02274896 Withdrawn - Clinical trials for End Stage Renal Disease (ESRD)

Bayston Multicenter Antimicrobial PD Catheter Safety Study

Bayston
Start date: November 2014
Phase: N/A
Study type: Interventional

The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that is impregnated with a "cocktail" of three well known anti-microbials

NCT ID: NCT02274857 Completed - Clinical trials for Persistent Atrial Fibrillation

Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

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

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).