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Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer

- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.- Secondary study objectives: Establish and compare…

Randomized Phase II, 2-arm study of Pembrolizumab after high dose radiation (SBRT) versus Pembrolizumab alone in patients with advanced non-small cell lung cancer.

Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…

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.

Randomized study with a run-in feasibility phase to assess the added value of Clofarabine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS â*¥ 1.5)

Primary objectivesFor part A of the study: -To determine the feasibility of Clofarabine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS>=1.5 in a prospective…

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation [CEASE AF - Trial]

Currently, no robust clinical data are available comparing interventional ablation strategies in the setting of persistent AF with enlarged Atrium > 4 cm and longstanding persistent AF, which reflects a difficult to treat patient-subgroup.…

IMPROVE: Evaluation of a combined lifestyle intervention program to improve quality of life in long-term ICU-survivors

Evaluation of the effects of a integrative lifestyle intervention program on health related quality of life after ICU-admission.

Pyloric Endoscopic Myotomy as treatment for patients with symptom of gastric outlet obstruction after oesophagectomy with gastric conduit.

Primary objectives 1. To evaluate the efficacy, feasibility and safety of G-POEM in patients with symptoms delayed gastric emptying after oesophagectomy with gastric tube reconstruction, based subsequently on the clinical success rate at 3 months,…

Randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the shortterm and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)

The purpose of this study is to assess short-term and the long-term safety and efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used concomitantly or intermittently with topical corticosteroid (TCS) and/or topical calcineurin…

Hearing preservation in cochlear implantation surgery

Comparison of hearing preservation and outcome of two fundamentally different cochlear implants designs (LW or PM) and the two most used surgical approaches (RW or CO). Secondly, asses the structure preservation (i.e., scalar position) of each…

The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction

To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children.

Mental wellbeing and quality of life after insertion of a LNG-IUD or Cu-IUD. A randomized patient preference trial.

To compare the effects of LNG-IUD (Mirena® of Kyleena®) versus Cu-IUD (T-Safe® or Multi-Safe®) on mental well-being and quality of life.

The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy

Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…

Phase 3, prospective, multi-center, open label study to investigate
safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII
(BAX 855) in previously untreated patients (PUPs) < 6 years with
severe hemophilia A (FVIII < 1%)

Primary Objective:The primary objective of the study is to determine the safety including immunogenicity of BAX 855 based on the incidence of inhibitor development to FVIII (* 0.6 Bethesda unit (BU)/mL using the Nijmegen modification of the Bethesda…

ReBeL study: a randomized phase I/II trial of lenalidomide and rituximab with or without bendamustine in patients >= 18 years with relapsed follicular lymphoma
A HOVON/GLSG/ NCRI study

The objective of the study is to investigate the feasibility and efficacy of treatment with lenalidomide and rituximab with or without bendamustine in patients with relapsed follicular lymphoma.

An Open-Label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the
Treatment of Endogenous Cushing*s Syndrome

The objective of this study is to assess long-term safety and efficacy durability of levoketoconazole as chronic treatment for endogenous Cushing*s Syndrome (CS).

Blink reflex changes after GON-injection in cluster headache: Clinical and pathophysiological implications.

To investigate if the GON-injection affects trigeminal threshold and transmission using the R2 component of the blink reflex.

The treatment of venous thromboembolism with edoxaban in patients with cirrhosis, a pharmacokinetic study.

To assess the safety and effect of edoxaban in Chil-Pugh B cirrhosis.

Characterization of buffy-coat-derived granulocytes for clinical use: - identifying clinical and laboratory parameters for decision making

• To find surrogate markers in plasma in order to identify patients, which may benefit from granulocyte transfusions and which are at risk for transfusion complications.• To determine - in combination with the outcomes of the NEPTUNIS study -…

Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients

The aim of this study is to improve the outcome of both younger and elderly primary plasma cell leukemia patients(pPCL) by using next generation novel agents and in case of younger patients also the tandem of auto-SCT and allo-SCT.

A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

This study intends to evaluate early clinical outcomes and survivorship of the G7 Acetabular System. Ease of instrument use will also be documented.The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7…