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What is the effect of 2 different treatment strategies of Vitamin D supplementation on 25(OH)D3 serum concentration? And what are the benefits for older people? A prospective observational clinical study.

Primary objective of the study is to determine the effect of 2 different treatment strategies of vitamin D supplementation on 25(OH)D3 serum concentration after 12 months of supplementation. Secondary objectives are to determine the effects on the…

a phase III randomised trial of intravesical chemotherapy vs thermo-chemotherapy in intermediate risk non-muscle invasive bladder cancer

To compare standard treatment with intravesical chemotherapy with loco-regional thermo-chemotherapy in patients with an intermediate risk non-muscle invasive urothelial carcinoma of the bladder after complete transurethral resection of the tumour(s…

Evaluation of the DogBone Button technique as a surgical intervention for AC ligament reconstruction on functionality and/or patient satisfaction; a case series.

What is the functional status of patients who have been treated using the dogbone Button technique as surgical treatment or by means of conservative treatment of acute acromioclavicular luxation at least 3 months and up to 24 months after surgery?

GM-11: A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®-R, a non-invasive neurostimulator device, for the prevention of episodic migraine

Primary objective:The primary objective is the difference between the gammaCore®-R and the sham treatment groups in mean reduction in number of episodic migraine days during the last four weeks in the twelve-week randomized period compared with the…

The Efficacy of Pro- and Anticoagulant Therapy in Plasma of Patients with Cirrhosis undergoing Orthotopic Liver Transplantation

To investigate the in vitro effect of both pro- and anticoagulation therapy on thrombin generation by Calibrated Automated Thrombography in plasma from patients with cirrhosis undergoing liver transplantation.

Long-term follow-up of the FAST-Trial; catheter ablation and surgical ablation for the treatment of atrial fibrillation

To evaluate the long-term (up to 5-years after procedure) efficacy and safety of CA against SA in preventing the recurrence of LA arrhythmias in patients with a history of paroxysmal and/or persistent AF

Effectiveness of manual therapy compared to usual care by the general practitioner for migraine: a pilot study

Objective of the pilot study is to examine whether a pragmatic randomised trial on the effectiveness of manual therapy compared to general practice care in migraine is feasible.For this purpose we use the following questions.* Is it possible to…

Single centre, randomised, open-label, 2-dose, parallel trial to compare immunogenicity, safety, tolerability, and pharmacodynamics of MYL-1401H and US-licensed Pegfilgastrim (NEULASTA®) after two subcutaneous (SC) injections at one dose level (6 MG) in healthy subjects.

The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…

TRIENTINE DIHYDROCHLORIDE VS. TETRAHYDROCHLORIDE: A PHASE 1, SINGLE CENTER, RANDOMIZED, INTERVENTIONAL, SINGLE DOSE, OPEN-LABEL, CROSSOVER STUDY IN ADULT HEALTHY MALE AND FEMALE SUBJECTS TO EVALUATE THE PHARMACOKINETICS AND THE SAFETY, TOLERABILITY OF TWO DIFFERENT ORAL FORMULATIONS

The principal aim of this study is to evaluate the PK parameters of both oral formulations in adult healthy volunteers in order to propose forMarketing Authorization Application an adequate strength for TETA•4HCl (i.e. a strength providing a PK…

A phase III, randomized, placebo-controlled clinical trial to study the efficacy and safety of MK-0517/fosaprepitant and ondansetron versus ondansetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric subjects receiving emetogenic chemotherapy

The objective of the study is to evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone, in subjects birth to 17 years of age receiving emetogenic…

A Prospective Safety and Feasibility Study of the RejuvenAir* System Metered Cryospray Therapy
for Chronic Bronchitis Patients.

Primary:• To evaluate the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions• To evaluate the feasibility of the planned liquid nitrogen cryospray treatment.Secondary:• To evaluate…

Long-term results of the Scarf and Chevron Osteotomy for the correction of Hallux Valgus.
A PROSPECTIVE, RANDOMISED TRIAL WITH MORE THAN 12 YEAR FOLLOW-UP.

The present study is designed 1) to compare the long-term survival using the recurrence rate of hallux valgus in the scarf and chevron osteotomy group; 2) to compare the long-term results with the results at 27 months; and 3) to asses patients* view…

A phase 2, randomized, double-blind, parallel-group study to assess the pharmacodynamics, safety/tolerability and efficacy of topical omiganan in patients with usual type vulvar intraepithelial neoplasia

Primary Objective• To explore the pharmacodynamic effects of topically applied omiganan • To explore the treatment effect of omiganan compared to placebo in uVIN patients Secondary Objectives• To assess safety and tolerability • To explore the…

A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain; Protocol 28-SMI-2015

The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not…

Open-label Phase-4 study to examine the change of vision-related quality of life in subjects with diabetic macular edema (DME) during treatment with intravitreal injections of 2 mg aflibercept according to EU label for the first year of treatment.

Primary objectiveTo evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU label for DMESecondary objectives• To assess further the safety and tolerability of…

The haemodynamic effects of spinal anaesthesia with versus without sufentanil added to bupivacaine heavy

Will spinal anaesthesia with sufentanil and bupivacaine heavy cause less hypotension compared to bupivacaine heavy alone? Will there be less use of ephedrine/fenylefrine/noradrenaline if sufentanil is added to bupivacaine heavy for spinal…

A phase 1, open-label study to characterize the absorption, metabolism and excretion of
14C-JNJ-63623872 after a single dose in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent JNJ-63623872 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The compound to be administered will be…

Pharmacokinetic analysis of HPV16 synthetic long peptide vaccination in healthy volunteers using optical imaging

To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.

A study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of BN201, an investigational compound for the treatment of acute optic neuritis.

The study will be performed in 2 parts, Parts A and B. The purpose of the study is to investigate to what extent BN201 is tolerated. It will also be investigated how quickly and to what extent BN201 is absorbed and eliminated from the body (this is…

A Phase 3, randomized, active-comparator controlled clinical trial to study the contraceptive efficacy and safety of the MK-8342B (etonogestrel + 17*-estradiol) vaginal ring and the levonorgestrel-ethinylestradiol (LNG-EE) 150/30 µg combined oral contraceptive (COC) in healthy women 18 years of age and older, at risk for pregnancy.

assess the contraceptive efficacy and safety of the etonogestrel (ENG) 125 + 17*-estradiol (E2) 300 µg /day vaginal ring