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Effects of Percutaneous Aortic Valve Implantation on sympathetic activity

The main objective is to assess the effects of TAVI on cardiac sympathetic activity.

THE EFFECTS OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 ON THE NUTRITIONAL STATUS IN PATIENTS WITH LIVER CIRRHOSIS: A PILOT STUDY.

The primary objective of this pilot study is to evaluate the effects of 6 months of recombinant human IGF-I (rhIGF-I) treatment on the body composition.The secondary objective is to assess the effects of the treatment on the liver function,…

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Pain from Osteoarthritis of the Knee

The primary objective for this study is to compare the safety, tolerability and analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of 2 doses to placebo in subjects with pain due to osteoarthritis (OA…

Pharmacokinetics of intravenous acetaminophen and its metabolites in morbidly obese patients

Primary objective: - To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients. Secondary objectives: - To compare the pharmacokinetics of acetaminophen and metabolites in…

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

The primary objective of this study is to compare the overall survival (OS) distributions between LY2157299 monohydrate plus lomustine therapy with lomustine plus placebo therapy (control arm), in patients who have relapsed or have progressive GB…

ACURATE TA* Transapical Aortic Bioprosthesis for Implantation in Patients with Severe Aortic Stenosis

Primary: To evaluate the safety of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.Secondary: To evaluate adverse events and study device performance.

RAndomized comParison between the STENTYS self-aPpOSIng Sirolimus-eluting Coronary STent and a balloon-expandable stent In AcuTe MyocardIal InfarctiON

The objective of this study is to evaluate whether two different stent technologies (a self-expandable stent and a balloon-expandable stent) may be associated with different stent strut apposition and a variety of stent strut coverage with…

A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…

A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures.

To determine the efficacy and the safety of PREOB, a proprietary population of autologous bone-forming cells, in the treatment of non-infected hypotrophic non-union fractures of long bones.

Evaluation of the Origo prototype for enhancing women*s labor & delivery experience. A pilot study.

The objective of this study is to gain insights into the value of the proposition *Origo* for women and their loved ones, medical staff and care institution.

Using the Vestibular Labyrinthine Substitution system in daily life

To objectify the effect of the VLS-system during daily use regarding postural stability and quality of life.

Reduction compression period of the arteria radialis after diagnostic cardiac catheterization.

To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.

The effectiveness of a serious game for children with ADHD: A randomized, controlled, multicenter trial.

The primary objective of this study is to examine the effectiveness of the serious game called HealSeeker for improving time management, planning and organisation and social behaviour skills of children with ADHD. The secondary objective of this…

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years.;A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of tosedostat added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…

A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia

This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…

Feasibility study of an ambulatory closed-loop system for the automated control of blood glucose with remote monitoring in type 1 diabetes (The Diabetes Assistant) - DiAs Trial

The objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprising two algorithmic components: a Safety Supervision Module (SSM) and an automated Range…

A phase I, multi-center, open-label, drug-drug interaction study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on TKI258 (dovitinib) pharmacokinetics in patients with advanced solid tumors.

Primary objectivesTo evaluate the effect of the CYP1A2 inhibitor, fluvoxamine, on steady state pharmacokinetics of TKI258 in patients with advanced solid tumors, excluding breast cancerSecondary objectives• To characterize the safety and…

Effect of cholecalciferol on the systolic blood pressure in hypertensive, vitamine D insufficient patients.

To evaluate the effect of cholecalciferol supplection on the systolic blood pressure in hypertensive patients with a 25-hydroxycholecalciferol insufficiency. Secondly, the effects on PRA, aldosteron, 25-hydroxycholecalciferol, alkaline phosphatase,…

Phase I clinical study of a combined modality treatment of sarcomas of the extremities or in head and neck area with radiotherapy (RT) and dose-escalation of Pazopanib

To study the safety and feasibility of adding 6 weeks of orally administered Pazopanib to 25 x 2Gy in 5 weeks preoperative radiotherapy in soft tissue sarcoma patients (to identify the Dose Limiting Toxicity (DLT) and the Recommend Phase II Dose (…

An Open-Label Study to Evaluate the Effects of Repeated Treatments of Oral QLT091001 on Safety and Vision Outcome in Subjects with Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Inherited Deficiencies of Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) (Extension of Study RET IRD 01)

• To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects with LCA or RP caused by RPE65 or LRAT gene mutations who have been treated previously with a single 7-day course of QLT091001 in…