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The effectiveness of a microscope during apical surgery; a prospective randomized controlled blinded clinical trial.

The objective of this study is to assess whether or not apical surgery that is carried out with the help of a microscope has a higher success rate than apical surgery without the use of a microscope. No RCT is found in present literature (Del Fabbro…

The effectiveness and evaluation of the online 'Kanker Herstel Hulp' intervention in cancer survivors.

The project primarily aims to study short (3 and 6 months) and long term (12 months) health related effects of the 'Kanker Nazorg Wijzer' on survivors' psychosocial distress and quality of life (QoL). Furthermore, process aspects of…

MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma (MEA115575)

Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor

In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after allo-SCT, will be evaluated

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

The primary objective of this study is to compare the overall survival (OS) distributions between LY2157299 monohydrate plus lomustine therapy with lomustine plus placebo therapy (control arm), in patients who have relapsed or have progressive GB…

RAndomized comParison between the STENTYS self-aPpOSIng Sirolimus-eluting Coronary STent and a balloon-expandable stent In AcuTe MyocardIal InfarctiON

The objective of this study is to evaluate whether two different stent technologies (a self-expandable stent and a balloon-expandable stent) may be associated with different stent strut apposition and a variety of stent strut coverage with…

A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…

A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures.

To determine the efficacy and the safety of PREOB, a proprietary population of autologous bone-forming cells, in the treatment of non-infected hypotrophic non-union fractures of long bones.

Evaluation of the Origo prototype for enhancing women*s labor & delivery experience. A pilot study.

The objective of this study is to gain insights into the value of the proposition *Origo* for women and their loved ones, medical staff and care institution.

LOw versus COnventional Tidal Volumes during One-lung Ventilation for Minimally Invasive Esophagectomy - A Randomized Controlled Trial

We hypothesize a lung*protective mechanical ventilation using lower tidal volumes during general anesthesia for minimally invasive transthoracic esophagectomy to protect against postoperative pulmonary complications in patients undergoing minimally…

Reduction compression period of the arteria radialis after diagnostic cardiac catheterization.

To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.

Cost-effectiveness of a lifestyle intervention on health and sustainable employability among workers of 40 years and older with high physical work demands: a randomized controlled trial

- to evaluate (cost-) effectiveness of a personalized health intervention among workers of 40 years and older with high physical work demands to contribute to a reduction in CVD and sustainable employability.

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…

A multicenter, randomized, double blind, placebo controlled, phase II trial evaluating the safety and efficacy of TKI258 combined with fulvestrant, in postmenopausal patients with HER2- and HR+ breast cancer that have evidence of disease progression on or after prior endocrine therapy

Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…

A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

Primary Objectives:*Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A of the study.*Part A: to…

Use of platelet rich plasma(PRP) as an adjunct in the treatment of high peri-anal fistulas.

Objective: the use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of high peri-anal fistula*s.

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…

Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism* a randomised placebo controlled Trial

Main objective: To test the efficacy of thyroxine replacement for subclinical hypothyroidism (SCH) in older adults. Primary Objective: To determine multi-modal effects (quality of life; cognitive; musculoskeletal and cardiovascular) of levo-…

TElmisartan in the management of abDominal aortic aneurYsm
(TEDY)

The aim of this study is to investigate if telmisartan reduces AAA growth

Efficacy of EMDR Resource Development and Installation in the stabilization phase of treatment of complex posttraumatic stress disorder

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