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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…

Early or Late Intervention in high risk non ST elevation Acute Coronary Syndromes.

Primary 1. An immediate invasive approach (immediate angiography and revascularization when appropriate) results in a reduction of the combined incidence of death, re-infarction or recurrent ischemia at 30 days follow-up. Secondary 1. An immediate…

Prognostic factors for cartilage degeneration in the knee after meniscectomy and cruciate ligament injuries. A prospective observational MRI cohort study.

To identify high risk patient groups for development of knee osteoarthritis (OA) in a cohort 9-10 years after meniscus, cruciate ligament and cartilage lesions.

Intensive five day intravenous insulin treatment combined with enteral feeding in hyperglycemic ischemic stroke patients: a feasibility study

To optimize a safe five-day intensive intravenous insulin treatment post stroke and to assess glucose profiles in patients with stroke and HG on admission, receiving standard continues enteral tube feeding.

Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists

To quantify the impact of outpatient nurse-led prevention clinics on the risk of future clinical events in patients with symptomatic coronary artery disease.

Comparison of pressure- and volume-guided fluid management in the critically ill: the PAC-PiCCO trial.

The primary hypothesis of our study is that volumetric monitoring will allow for more effective and targeted fluid administration compared to pressure (PAC) monitoring, thereby allowing the attending physician to better optimize fluid infusion…

A Phase II Study of Concurrent Radiation and Temozolomide Followed by Temozolomide and Lomustine (CCNU) in the Treatment of Children with High Grade Glioma

Determine whether temozolomide given during radiation therapy followed by the combination of temozolomide and CCNU as adjuvant therapy results in an improvement in event-free survival compared to historical control cohorts.To further assess the…

Influence of long-term administration of fluoxetine on cerebral threshold and muscle activity patterns in chronic stroke patients.

Objective of the study is to measure the effects of long term fluoxetine administration on brain- and muscle activity in combination with the effects on motor function. Main questions are:(1) Influences long-term administration of fluoxetine…

N-Acetylcysteine for Treatment of Sickle Cell Disease

STUDY OBJECTIVESTo determine whether NAC therapy results in decreased red cell PS exposure, endothelial activation, inflammation, and reduction clotting activation in the steady state.

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Primary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy (see Definitions).Subjects will be…

The role of the pelvic floor in Lower Urinary Tract Symptoms (LUTS) in men.

The main objective of this study is to assess the effectiveness of pelvic floor muscle therapy in comparison with α-blockers, in men with LUTS. The second objective is the validation of the questionnaire (MPFS) in this group of patients

An Open-Label Study Investigating Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

To investigate the long-term safety, tolerability and acceptability of Nasalfent in the treatment BTCP

A randomized, open-label, controlled, multi-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a monotherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB.

The primary objective of this study is to demonstrate the superior antiviral efficacy of the combination of peginterferon alpha-2a plus telbivudine vs peginterferon alpha-2a monotherapy as demonstrated by HBV DNA non-detectability using the COBAS…

Effect of a cognitive rehabilitation program: An evaluation study and process evaluation

In this research the effect of a cognitive rehabilitation program will be evaluated. The effect will be defined in terms of increase of quality of life, decrease of emotional complaints, increase in participation in society and better coping of the…

PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY;
Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities

To evaluate whether GH substitution in patients with an isolated GHD after TBI could reverse the severity of symptoms which characterize GHD.

Phase I/II study of oxaliplatin combined with melphalan in isolated hepatic perfusion for the treatment of liver metastases.

Firstly, determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan.Secondly, evaluation of toxicity, tumor response and survival after IHP…

A randomized, double-blind, placebo-controlled, phase 2a study of the efficacy, safety, and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.

This is the first study of MLN3897 in any disease population. It seeks to establish:1) The ability of MLN3897 to modify the signs and symptoms of RA.2)The safety and tolerability of MLN3897 in combination with MTX.3)The PK/PD profile of MLN3897 in…

Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients

Primary objective:The primary objective of this study is to assess the efficacy of lanreotide 30 mg as compared to placebo to relieve clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.Secondary…

Determinants of success of a stance-control-KAFO in former
polio patients with quadriceps weakness.

The aim of the present study is two-fold: 1) To do a survey of patients who have been prescribed a SC-KAFO in the outpatient clinic and evaluate the indication of prescription, compliance, experience and motives for (non) use of the SC-KAFO. 2) To…

Biomarker detection for benign breast diseases and primary breast cancer by serum and tissue protein profiling.

The study objectives are:1. Getting insight into the biological origin of the typical serum protein profile in breast cancer by comparing the protein profiles in breast tissue of benign breast disease patients and primary breast cancer patients with…