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A study to determine the effect of post-infusion scalp cooling time in the high dose FEC-regimen

The primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby improving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen. A…

An open label, randomized phase III trial comparing 2.5 year duration of letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer

PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…

Cost-effectiveness of monitoring of psychotherapeutic treatments: A randomized comparison on the effects of feedback to therapists and patients in three settings of outpatient psychotherapy.

To determine the effects of feedback regarding patient progress on patient outcome and number of treatment sessions. Questions are::1, Is monitoring with feedback to therapists more (cost-)effective than monitoring without feedback; 2, is feedback…

Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH):
A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures

In patients over 60 years of age who have sustained a displaced femoral neck fracture, what is the rate of revision surgery at 24 months when a total hip arthroplasty versus hemi-arthroplasty is used as the surgical treatment? Hypothesis: We…

Intracytoplasmatic Sperm Injection using testicular spermatozoa in men with azoospermia; an observational study with follow-up of the offspring.

To evaluate the efficacy of TESE and to describe the risks of the TESE procedure for the men with a four year follow-up of their offspring.

HOVON 80 NHL: Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with intrathecal rituximab, followed by autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation

Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation. Treatment includes:a. intrathecal administration of rituximab, B. combining R-DHAP with high dose methotrexate intravenously.The following endpoints will be…

Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I)

Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms. Secondary objectives of this study involves toxicity and morbidity, quality of life,…

A phase II study of isolated lung perfusion with melphalan followed by pulmonary metastasectomy in patients with resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma

The main objective of the study is to determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy. Secondary objectives are to assess pulmonary toxicity by…

An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension

To provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…

Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood.

Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…

A randomized, open label, multicentre trial to define the most effective haemoglobin concentration to start erythropoietin beta (neoRecormon) therapy in anaemic subjects with lymphoproliferative malignancy receiving chemotherapy
*REPOS Study*

To compare the efficacy of erythropoietin beta administered weekly using an early start approach (Hb * 7.2 mmol/l) with standard starting approach (Hb * 6.2 mmol/l) in subjects with lymphoproliferative malignancy, receiving chemotherapy during a 16-…

A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab (MDX-010) vs. dacarbazine with placebo.

Vaccination of Multiple Myeloma patients with RNA electroporated mature dendritic cells expressing multiple tumor antigens.

The primary goal is to show the capability of monocyte-derived DC after RNA electroporation for multiple antigens to induce an immune response. The secondary objective is to show clinical response.

A multicentre, randomized controlled trial of neurolysis for mild ulnar neuropathy at the elbow

Primary objective:The primary objective of this study is to compare the short-term and long-term efficacy of neurolysis and a conservative strategy for relieving symptoms in mild cases of UNE. Secondary objectives:- VAS score for paresthesias- VAS…

The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

Evaluation of the capacity of a HPV 16 peptide vaccine to install a long term HPV-specific T cell response, to define the importance of a booster vaccine after 1 year, the induction of Cytotoxic T lymphocyte (CTL) immunity against HPV16E6 and E7 and…

A randomized controlled trial of physiotherapy in patients with fecal incontinence

This study is carried out to assess the effectiveness of rectal balloon training (RBT)combined with pelvic floor muscle training (PFMT) compared to pelvic floor muscle training alone in a population of patients with FI.

Improvement of physical fitness, muscle strength, aspects of quality of life and decrease of fatigue in children on dialysis

The purpose of this study is to show that participation in an exercise programme will increase the exercise tolerance, musle power and health-related quality of life and will diminish the degree of fatigue in children on dialysis.

A Phase 2 Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung Cancer that is Refractory or Progressive within 90 Days of Completion of First Line Platinum-based Chemotherapy

The primary objective is the Objective tumor response rate (RECIST). Secondary objectives are: duration of overall response, time to tumor progression (TTP), progression free survival (PFS), overall survival, toxicity profile, incidence of…

6 months Evaluation of the BIOTRONIK CoCr PRO-Kinetic Coronary Stent System in patients with single de Novo lesions in Native Coronary Arteries

The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary arteries.