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Risk communication for patients with type 2 diabetes

The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop cardiovascular disease on risk perception, attitude towards a specific behaviour and the intention to change…

A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value <45%Secondary objectives:1) To…

The Effects of Guided Imagery on Pain Management, Pre-operative Anxiety, and Recovery in Burn Wound Patients scheduled for Corrective or Reconstructive Surgery: a Randomized Controlled Pilot Study.

Goals:1.To estimate the effect size for our primary and secondary outcome measures, allowing us to perform a more reliable power estimate for the actual trial.The primary objective of this pilot study is to determine whether a non-pharmacological…

Monitoring of influenza-like symptoms among elderly, an observational study

Primary Objective: • To determine the incidence rate of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To explore the effect of 13vPnC on the incidence of self-…

A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of linagliptin (5 mg), administered orally once daily over 24 weeks in type 2 diabetic patients (age >=70 years) with insufficient glycaemic control (HbA1c >= 7.0) despite metformin and/or sulphonylurea and/or insulin therapy

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with diabetes mellitus…

A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 microgram and 100 mircrogram/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care

The primary objective of this study is to compare the efficacy of eprotirome 50 microgram and eprotirome 100 micorgram versus placebo in terms of the percent change in LDL-C from baseline to Week 12 in HeFH patients with CAD, or who are at high risk…

A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 12 weeks in hypertensive patients with type 2 diabetes mellitus

The objective of the current study is to investigate the efficacy and safety of BI 10773 (10 and 25 mg) compared to placebo on glucose control and bloodpressure over 12 weeks in hypertensive patients with diabetes mellitus type 2.

A multicentre, prospective, randomized open-label pilot study to assess the feasibility and preliminary efficacy of interferon gamma in combination with Anidulafungin for the treatment of candidemia

To evaluate the preliminary efficacy and feasibility of interferon gamma as adjunctive treatment in combination with the standard regimen, for the treatment of patients with candidemia using the following parametersSecondary objective: to evaluate…

Dopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situation

The primary objective of this randomized, open label single centre trial is to compare dopamine versus no dopamine on top of standard treatment in patients with exacerbation of severe heart failure (NYHA class III-IV) in home situation. This study…

Evaluation of the safety and efficacy of the HiFocus V electrode array in adults with severe-to-profound hearing loss through analysis of post-implant benefits of the HarmonyTM HiResolutionTM Bionic Ear cochlear implant system

Sectie 2 van het CIP

TRANSANAL ENDOSCOPIC MICROSURGERY VERSUS ENDOSCOPIC MUCOSAL RESECTION FOR LARGE RECTAL ADENOMAS

In a randomized trial we will compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.

*Pain exposure* physical therapy versus standard therapy for patients with complex regional pain syndrome type 1 (CRPS-1)

Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands for patients with CRPS-1. There are two level C retrospective cohort studies…

A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy + Midostaurin (PKC412) (IND# 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated Acute Myeloid Leukemia (AML)

To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.

Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy

To analyse the effect of preoperative intracutaneous and intraperitoneal instillation of levobupivacaine on postoperative pain after laparoscopic cholecystectomy

TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over encapsulated tablets as first line therapy in patients with Type 2 Diabetes Mellitus and Stage 1 or 2 hypertension: a phase III, eight week, randomised, double-blind, double-dummy, forced titration comparison - a ABPM substudy

This study investigates whether the fixed-dose combination of telmsartan 80 plus amlodipine 5 or 10 is superior as a first line treatment to amlodipine 5 or 10 mg monotherapy of lowering mean sitting systolisch blood pressure in patients with…

An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) for subjects from the control group of the VX-950-TiDP24-C216 trial who failed therapy for virologic reasons

The objectives are:- to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who wererandomized to the control group in the C216 trial and who failed therapy for virologicreasons;- to evaluate efficacy, safety, and…

Closure of oroantral communications using biodegradable polyurethane foam; a prospective clinical trial

Goal of this study is to assess the treatment of OACs with biodegradable polyurethane foam, as carried out in the pilot studies, in a large number of patients.

An exploratory trial to assess naturalistic safety and efficacy outcomes in patients trasitioned to ustekinumab from previous methotrexate therapy

Primary Objective: The primary objective of this exploratory trial is to evaluate the comparative safety through Week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: discontinuation of methotrexate…

The effect of device-guided breathing exercises on blood pressure in diabetic patients with hypertension;A randomized, double-blind controlled trial

Objective: To determine the effect of a device slowing breathing (Resperate©) on office systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP control.