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Intensive home visiting program for multiproblem families: Effectiveness, mediators and moderators of effects

The current project aims first to examine whether IPT produces outcomes that are superior to the comprehensive treatments already available ('care as usual'). Primary outcomes include parenting behavior and the quality of the parent-child…

Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH):
A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures

In patients over 60 years of age who have sustained a displaced femoral neck fracture, what is the rate of revision surgery at 24 months when a total hip arthroplasty versus hemi-arthroplasty is used as the surgical treatment? Hypothesis: We…

A Randomised Trial comparing Surveillance with Radio-Frequency Ablation of Barrett*s Esophagus with Low-Grade Dysplasia; the SURF-study

The purpose of this project is to perform a randomized trial comparing BARRX ablation with endoscopic surveillance for patients with a Barrett*s esophagus containing low-grade dysplasia. This study will also assess the effect of RFA ablation in…

Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood.

Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…

Improving mobility in diabetic patients through resistance training

The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and…

Cost-effectiveness of collaborative care for chronic medically ill patients with comorbid depressive disorder in the general hospital setting

The primary aim of the study is to test the effectiveness of a collaborative care model for major depressive disorder for patients with DM, CVD, COPD, and HIV in the general hospital outpatient setting. Secondary aim is to estimate the cost-…

A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab (MDX-010) vs. dacarbazine with placebo.

A multicentre, randomized controlled trial of neurolysis for mild ulnar neuropathy at the elbow

Primary objective:The primary objective of this study is to compare the short-term and long-term efficacy of neurolysis and a conservative strategy for relieving symptoms in mild cases of UNE. Secondary objectives:- VAS score for paresthesias- VAS…

Prediction and Prevention of Posttraumatic Stress Disorder after Road Traffic Accidents in Children and Adolescents
Coping with Traumatic Events in Children and Adolescents

The objective is to investigate wether a brief CBT with parental involvement among children and adolescents with ASD reduces the risk of PTSD compared to a waitlist control group.

Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction.

Primary Objective: Comparison of incidence of post-cataract extraction ocular inflammation with subconjunctival steroid injection versus traditional eye drops.Secondary Objective: Evaluation of usefulness of physostigmine following cataract surgery.

A randomized, open label, multicentre trial to define the most effective haemoglobin concentration to start erythropoietin beta (neoRecormon) therapy in anaemic subjects with lymphoproliferative malignancy receiving chemotherapy
*REPOS Study*

To compare the efficacy of erythropoietin beta administered weekly using an early start approach (Hb * 7.2 mmol/l) with standard starting approach (Hb * 6.2 mmol/l) in subjects with lymphoproliferative malignancy, receiving chemotherapy during a 16-…

Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I)

Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms. Secondary objectives of this study involves toxicity and morbidity, quality of life,…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

A study to determine the effect of post-infusion scalp cooling time in the high dose FEC-regimen

The primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby improving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen. A…

An open label, randomized phase III trial comparing 2.5 year duration of letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer

PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…

Protocol CKI-302 KW-3902IV in the treatment of subjects with acute heart failure syndrome
A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy

To evaluate the effect of KW-3902IV in addition to IV loop diuretic therapy on heart failure signs and symptoms, persistent renal dysfunction, morbidity and mortality, and safety in subjects hospitalized with acute heart failure syndrome, volume…

A randomized controlled trial of physiotherapy in patients with fecal incontinence

This study is carried out to assess the effectiveness of rectal balloon training (RBT)combined with pelvic floor muscle training (PFMT) compared to pelvic floor muscle training alone in a population of patients with FI.

Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study

The objective of this trial is to demonstrate that bosentan delays disease worsening or death in patients with IPF.

A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab

Objectives:Phase 1b: To determine the maximum tolerated dose (MTD) (up to 8mg/kg/day) through safety and tolerability of multiple doses of AMG 951 administered by intravenous (IV) infusion to subjects with NSCLC in combination with chemotherapy and…

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and stage IV Non-Small Cell Lung Cancer (NSCLC)

The objective of this phase III study is to compare the efficacy of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin for first-line treatment of patients with stage IIIB (with effusion) or Stage…