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A phase II open-label, randomized, multi-centre comparative study of bevacizumab-based therapy in paediatric patients with newly diagnosed supratentorial, infratentorial cerebellar, or peduncular high-grade glioma.

To evaluate the efficacy, safety, tolerability, and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant temozolomide (TMZ) and to determine whether the addition of anti-angiogenic therapy with…

Perforator based interposition flaps for sustainable release of scar contractures: a reliable, simple and versatile technique.

A randomised controlled multcenter trial is performed to evaluate the perforator-based interposition plasty in comparison to full thichness grafts for scar contracture releases.

A randomized phase II study to explore the efficacy and feasibility of upfront bi-monthly rotations between Everolimus and Pazopanib with sequential treatment of first line Pazopanib and second line Everolimus until progression in patients with advanced or metastatic clear cell renal cancer.

Primary objectivesThe primary objective is to assess the progression-free survival (PFS) of patients who receive bi-monthly rotations of Pazopanib and Everolimus versus patients who receive Pazopanib as a first line treatment. Secondary…

Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer…

Efficacy and Cost Efficacy of Prophylactic treatment with Antibiotics during concomitant chemoradiotherapy in patients with locally advanced head and neck cancer to prevent Aspiration Pneumonia. A randomized phase II-III study

To observe a decrease in number of definite and/or suspected pneumonia after prophylactic treatment with antibiotics during CRT in patients with LAHNC.To observe a decrease in the number of admissions in the hospital To observe a decrease in the…

A phase 2 multicentre randomized controlled comparative efficacy and safety study of Tiscover and AS210 in chronic (arterio-)venous ulcers

Determine the safety and efficacy of Tiscover compared to AS210 (acellular donor dermis, construct Tiscover is cultured on) for the treatment of chronic, therapy resistant (arterio-) veneus leg/foot ulcers in an out patient setting.

Multicenter, Controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of AMG 145 (study 20110110)

Primary: Longterm safety and tolerability of AMG 145.Secondary: Longterm efficacy of AMG 145.

Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

To study the immunogenicity and safety of adjuvanrt hepatitis B vaccin (Fendrix) compared to double-dosage of Engerix vaccination in HIV infected patients, previously failing HBV vaccinations.

A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naive Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

The primary objective of this trial is to determine if EMD 1201081 (formerly known as IMO-2055) has anti-tumor activity in subjects by examining its effects on accepted clinical endpoints in combination with cetuximab. • To evaluate progression-free…

Preventive Swallowing Exercises to prevent persistent swallowing dysfunction after curative (chemo)-radiation in head and neck cancer

The proposed phase II study will test the hypothesis that preventive swallowing exercises (PSE) during treatment will reduce the incidence of swallowing dysfunction among patients with HNSCC treated with curatively intended (CH)-RT using SWIMRT. As…

Cisplatin or Cetuximab and conventional versus redistributed radiation for advanced head and neck cancer

This Phase II trial aims to:1 Test the predictive value of Zr89 Cetuximab uptake in vivo for treatment specific outcome 2 Explore the impact of dose redistribution on loco-regional control and disease free survival.If individualized treatment…

High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…

A multicenter, prospective randomized study to compare vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) versus the Everolimus Eluting Stent in patients with Acute Coronary Syndrome by means of Optical Coherence Tomography

See also page 19 (section 6) of the protocol:6. Study ObjectiveIt is the objective of this study to assess vascular healing by Optical Coherence Tomography (OCT) analysis after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo…

DALI: Vitamin D and Lifestyle Intervention for GDM Prevention: dosing study

The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…

A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator*s choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

To investigate the efficacy, safety, and pharmacokinetics of volasertib in combination with low-dose cytarabine versus investigator*s choice of anti-leukemic treatment in patients with relapsed or refractory acute myeloid leukemia with no…

Online self-help CBT for insomnia: With or without feedback?

The objective of this study is to determine whether providing feedback enhances self-help CBT for insomnia.

Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium

Primary objective:· To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations.…

Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma

The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.

Long-term effects of Advanced Driver Assistence Systems (ADAS) on driving performance of older drivers with and without mild cognitive or physical impairments: A driving simulator study

The present PhD thesis focuses on the investigation of ADAS and the older driver. Even though, recent research investigated the effects of ADAS on driving performance, little is known about the long-term effects of the systems on performance.…

CLINICAL INVESTIGATION OF A DES (MISTENT* SYSTEM) WITH SIROLIMUS AND A BIOABSORBABLE POLYMER FOR THE TREATMENT OF PATIENTS WITH DE NOVO LESIONS IN NATIVE CORONARY ARTERIES

The primary objective of this study is to demonstrate whether the MiStent Drug Eluting Coronary Stent System can safely and effectively improve coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo…