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Clinical survey of Oticon Medical Ponto implants and a surgical technique with tissue preservation

The primary objective of the study is to investigate the difference in numbness around the implant between after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for implanting using Oticon…

A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

Primary Objectives•To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed…

A randomized parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY 1021189 over 12 weeks in patients with worsening heart failure and reduced ejection fraction.

To characterize safety, tolerability, pharmacodynamic effects, and pharmacokinetics of the oral sGC stimulator BAY 1021189 in addition to standard therapy for heart failure with reduced EF (HFrEF) over 12 weeks in patients with worsening chronic…

A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of
Inhaled JNJ-49095397 (RV568) in Subjects With Moderate to Severe Chronic Obstructive
Pulmonary Disease

Primary ObjectiveThe primary objective is to assess the efficacy (as measured by change from baseline in prebronchodilator [preBD] percent predicted forced expiratory volume in one second [FEV1]) of JNJ-49095397 compared with placebo in subjects…

A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse

The primary objective is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib versus standard retreatment with bortezomib in combination with dexamethasone on…

A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients with Advanced Solid Malignancies (OAK)

Part A: to compare the PK exposure of a new AZD5363 tablet formulation with that of the AZD5363 capsule formulation in patients with advanced solid malignancies.Part B: to explore the effect of a standardised meal on the PK exposure of a new tablet…

Developing the Pediatric MR Enterography-based Damage Index in Crohn's disease (pMEDIC) and the Pediatric Inflammatory Crohn's MRE Index (PICMI)

The overall objectives of this proposal are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's disease by means of Magnetic Resonance Imaging with Enterography…

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with
Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus
Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…

Pilot study: Dystrophic pathways in human hair follicles after chemotherapy

The objective of this study is to explore molecular damage-response pathways such as p53 expression in hair follicles after chemotherapy.

PSYchological factors and Cardiovascular, Hormonal and Emotional responses to stress in patients with established coronary artery disease (PSYCHE)

The current research proposal therefore aims to examine the relation between a range of psychological risk factors and several mental stress-induced physiological responses in a large sample of PCI patients.

Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.

Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…

Anidulafungin pharmacokinetics given as a single intravenous dose to obese patients (ADOPT).

The primary objective of this trial is as follows:• To determine the pharmacokinetics of anidulafungin administered to obese patients with a BMI >= 40 kg/m2. The secondary objective of this trial is as follows:• To simulate pharmacokinetics…

AMB115811: A randomised, multicentre, double-blind, placebo-controlled study of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Primary: to assess the efficacy of ambrisentan 5mg after treatment period of 16 weeks, in subjects with inoperable CTEPH. Secondary: safety and tolerability.

Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability, and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known

The objective is to define the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is…

An Open Label Study to Investigate the Pharmacokinetics (Absorption, Distribution, Metabolism, and Excretion) of Omacetaxine Mepesuccinate Following Subcutaneous Administration of [14C]c in Patients with Relapsed and/or Refractory Hematologic Malignancies or Advanced Solid Tumors.

Primary Objective: The primary objective of the study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism, and excretion) of [14C]omacetaxine mepesuccinate and its metabolites in patients with relapsed and/or…

Acute Subcutaneous Defibrillation Study

The primary purpose is to assess the defibrillation efficacy of Medtronic subcutaneous defibrillation system.

Safety and Performance of Electrodes implanted in the LV

5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…

A randomized, double-blind, placebo-controlled, parallel group study evaluating efficacy and safety of QAW039 in the treatment of patients with moderate to severe atopic dermatitis (CQAW039X2201)

Primary objective: To evaluate the efficacy of once daily doses of QAW039, as measured by EASI after 12 weeks of treatment, relative to placebo, in adult patients with moderate to severe AD. To evaluate safety and tolerability.Secondary objectives:…

A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Primary objective:The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated…

Changes in food preference and food cue responsivity after bariatric surgery

To determine the effect of gastric bypass surgery on (alterations in) food preferences. Secondly, to assess the effect of gastric bypass surgery on the brain reward response when exposed to sight and smell of food stimuli with different sugar and…