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How may exercise reduce fatigue in patients with cancer. A pilot study examining the role of muscular, immune and endocrine systems.

Primary Objective(s): 1. To obtain preliminary data on whether (and to which extend) adjuvant chemotherapy for colon cancer results in (a) deterioration of contractile muscle properties and increased muscle fatigability, (b) increased inflammation…

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment

The primary objective of this study is:- To evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24The secondary objectives of this study are:- To…

Laser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications
A randomized, double blind controlled trial.

To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.

Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group and the Polish Lymphoma Research Group

The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (BEACOPP) in case of a positive FDG-PET after one cycle of ABVD, has non-inferior efficacy…

SYMPATHY: Renal sympathetic denervation as a new treatment for therapy resistant hypertension.

The primary objective is to assess whether RD added to usual care compared to usual care alone reduces BP (24-h or average day-time SBP as determined with the use of ambulatory BP monitoring (ABPM)) in subjects with an average mean day-time SBP of…

A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Primary Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysisSecondary Objective: To characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (…

Psychological treatment of Eating Disorders:
A multi-centered randomized controlled trial on the
(cost-)effectiveness of Enhanced Cognitive Behavior Therapy (CBT-E)
Titel for patients: Effectiveness study on the therapy of eating disorders

The objective of this project is to assess whether CBT-E is more optimal in terms of (cost-)effectiveness than TAU in thetreatment of outpatients with an ED. The results of this study will provide evidence whether or not CBT-E should be delivered…

Screening and treatment of psychological distress in colorectal cancer with metastasized disease: the TES-trial

We have developed the TES program, which involves Targeted selection and Enhanced care, delivered on the basis of Stepped care (TES). The primary study aim is to evaluate the effectiveness of the TES-program compared to usual care in reducing…

CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group

Primary Objective: Investigate whether early valganciclovir treatment of children with SNHL of * 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at follow-up (age 18 * 22 months…

Evaluation of 18F-FDHT PET/CT as a predictor of response in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.

Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…

Efficacy, safety, and tolerability of oral cebranopadol versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer.

The primary objective is to evaluate the efficacy of orally administered cebranopadol in comparison with morphine sulfate PR in subjects suffering from chronic moderate to severe pain related to cancer.The secondary objective is to compare the…

The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients with Primary Hypercholesterolemia Not Treated With a Statin

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen including an alirocumab starting dose of 150 mg Q4W as add-on to non-statin lipid modifying background therapy or as…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Determine efficiency and safety of two different doses of pregabalin as compared to placebo.

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-
Controlled, Multi-center Study to Evaluate the Efficacy, Safety and
Tolerability of Combinations of Solifenacin Succinate and Mirabegron
Compared to Solifenacin Succinate and Mirabegron Monotherapy in the
Treatment of Overactive Bladder

Primary objective *To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron compared to solifenacin and mirabegron monotherapySecondary objectives*To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron…

A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

primary objective: To evaluate the long-term safety and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis (CF), homozygous or heterozygous for the F508del-cystic fibrosis transmembrane conductance regulator (…

Spinal Bupivacaine/Morphine in laparoscopic gastro-intestinal surgery

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

S-1 versus capecitabine in the first line treatment of metastatic colorectal cancer patients, the SALTO randomised phase III study of the Dutch Colorectal Cancer Group. A safety evaluation of oral fluoropyrimidines.

The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…