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A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).

The primairy objective of this fase II study, is to compare two treatment regimens of vismodegib in two populations of patients with multiple BCC's (patients with Gorlin syndrome and patients who do not have Gorlin syndrome). Primary to assess…

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the
efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with
chronic lymphocytic leukemia following first-line therapy

To compare the efficacy and safety of lenalidomide versus placebo maintenance therapy (standard care).

A randomised controlled trial of optimised surgical recovery after left lateral hepatic sectionectomy: open versus laparoscopic surgery within an enhanced recovery programme.

The ORANGE-II trial is a randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery programme.

A prospective double-blind randomized Phase III study of 300 mg vs. 150 mg erlotinib in current smokers with locally advanced or metastatic NSCLC in second-line setting after failure on chemotherapy

To compare the efficacy of two dose levels of erlotinib (150 mg and 300 mg) on progression-free survival (PFS) in current smokers with stage IIIB/IV NSCLC after failure of first-line platinum-based chemotherapy.

A phase II, randomized double-blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma

The purpose of this phase II study is to assess the efficacy and safety of oral treatment with two dose levels of LDE225, as measured by objective response rate (ORR), in patients with locally advanced or metastatic BCC. Additional assessments…

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Primary: To demonstrate the superior efficacy of Nasalfent in the treatment of BTCP in opioid tolerant subjects who are receiving regular opioid therapy.Secondary: To demonstrate the safety, tolerability, and acceptability of Nasalfent in the…

Effect of colostrum on immune function after intense strenuous exercise in well-trained cyclists.

The primary objective of this study is to evaluate the effect of colostrum supplementation on the immune response after intense strenuous exercise.The secondary objective is to study the effect of intense strenuous exercise - and its possible…

A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic;Pharmacogenetics Blood Sample Amendment Number 01

The objective of this study is to determine how well two different doses of ipilimumab work in patients with prostate cancer who are no longer responding to hormone therapy (castration resistant), and whom have the best radiographic progression-…

A single center, randomized, double-blind, 3-arm parallel Phase I study to assess pharmacokinetics, safety and tolerability of MYL-1402O solution for intravenous infusion after 90 minute intravenous infusion at one dose level (equivalent weight-adjusted dose (1 mg/kg) compared to the EU and US marketed drug product (Avastin®) in healthy male volunteers.

The purpose of the study is to assess the concentrations of bevacizumab in the blood at different times after the volunteers have been administered MYL-14020 or Avastin® . In addition, it will be investigated to what extent MYL-10420 is tolerated.…

Ulipristal versus Gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy: a double blind randomized controlled trial

Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.

Reduced contrast administration in contrast-enhanced spectral mammography (CESM)

CESM is a novel mammography technique that has been shown to be superior to conventional full-field digital mammography (FFDM). In a CESM exam, iodine based contrast agents, similar to those used in for example computed tomography (CT) exams, are…

Conversion of unresponsiveness to immunotherapy by Fecal Microbiota Transplantation in patients with metastatic melanoma and non-melanoma skin cancer: a randomized phase Ib/IIa trial

Primary objective:• To investigate the efficacy, defined as clinical benefit (stable disease (SD), partial response (PR), complete response (CR)) at 12 weeks, confirmed on a second scan after 4 weeks, of an FMT-intervention with responder and non-…

A phase II study of the anti-PDL1 antibody atezolizumab, bevacizumab and acetylsalicylic acid to investigate safety and efficacy of this combination in recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal adenocarcinoma

The primary objective of the study is to assess the efficacy and safety of 3 different treatment arms (bevacizumab alone, atezolizumab-bevacizumab combination with acetylsalicylic acid and atezolizumab-bevacizumab combination with placebo) in…

The influence of the new HME Energy on physical activity and patient satisfaction in laryngectomized patients

-To describe the differences in the parameters of physical exertion during physical activity with two different HMEs in both a lab and daily life setting-To asses patients* satisfaction with both types of HMEs