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Efficacy of a guided self-help exercise program targeting speech, swallowing and shoulder problems in laryngectomized patients: a randomized controlled trial

To investigate the efficacy of the guided self-help exercise program of *in Tune without Cords* among laryngectomized patients.

Patient specific osteosynthesis in orthognatic surgery

The main objective is to improve predictability of orthognatic surgery, or in other words to realise a stronger relation between (3D virtual) pre-operative planning and post-operative result. The second objective is to evaluate the surgeon*s…

Effect of Sodium NItroprusside (SNP) on R,S- and S-Ketamine-induced psychotropic side effects, hemodynamic changes and pain relief in healthy volunteers

The objectives of the study are to assess whether:(1) SNP will reduce the occurrence of psychomimetic side effects during exposure to low-dose ketamine;(2) SNP will reduce the ketamine-induced increase in blood pressure and cardiac output;(3) SNP is…

A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C.

PRIMARY OBJECTIVE The primary objective of this study is to evaluate the effect of ALN-PCSSC treatment on LDL-C levels at Day 180. SECONDARY OBJECTIVESThe secondary objectives of this study are to evaluate the effect of ALN-PCSSC on the following…

A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC)

Primary Objective: • Evaluate the treatment effect of NGM282 as measured by the mean change in alkaline phosphatase (ALP) from Baseline to Week 12 in patients with PSC.Secondary Objectives:• Assess the safety and tolerability of NGM282 in patients…

URIKA, continuous ultrasound monitoring of urinary bladder filling in patients with urinary retention

Primary Objective: Is the detection chance of the bladder influenced by the angle in which the ultrasound sensor is fixated? Secondary Objective Can the URIKA Bladder Monitor (UBM) be used to predict the point where the BladderScan reaches the…

Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA

Main objective: The main objective of this open-label, single arm study is to further characterize the safety, tolerability and effectiveness profile of olesoxime in SMAThe primary safety objective for this study is as follows:To evaluate the safety…

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

The primary objective of the research is to find out if treatment with BMS-931699 can improve systemic lupus erythematosus (SLE) disease activity. This will be measured by determining the proportion of BICLA responders who achieve BILAG disease…

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations (CIDH305X2101)

The main objective is to estimate the MTD(s) and/or RDE(s) of IDH305 in patients with IDH1R132 mutant malignancies, as measured by the incidence of dose-limiting toxicities.Secondary objectives are characterization of the safety, tolerability, PK…

Validation of the diffusion MRI signal in kidney tumours: a pilot study

The primary objective of this study is to compare diffusion MRI derived parameters with the histological categorization of kidney tumours.

Markers of Efficacy of Xolair (Omalizumab) in Chronic Spontaneous Urticaria

To relate the reduction of inflammatory characteristics in skin and in peripheral blood to clinical efficacy in patients with CSU. Major focusses of this study are the (early) effects on basophils and other Fc*RI-bearing leukocytes before, during,…

A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer

Primary Objective:To determine the effect of the Topical Gentamicin-Collagen Sponge (gentamicin-sponge) in combination with systemic antibiotic therapy compared to placebo-sponge and no-sponge, both in combination with systemic antibiotic therapy on…

A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia

The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…

Salivary, plasma metanephrines and anxiety levels in pheochromocytomas

To determine the sensitivity and specificity of salivary metanephrines and in patients with PCC/sPGL.

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima* (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn*s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…

A pilot study on magnetic resonance imaging of the distal radial growth plate: defining healthy and pathologic characteristics in a non-invasive manner

1. The primary objective is to evaluate the characteristics of the distal radial growth plate on MRI (including functional imaging techniques) and on conventional radiographs in young gymnasts with wrist pain, compared to young gymnasts without…

Postoperative local stereotactic radiotherapy versus observation following complete resection of a single brain metastasis

To improve local control following complete resection of a single brain metastasis using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life.

A phase I/II *minor histocompatibility antigen UTA2-1 loaded, PD-L silenced Dendritic cell vaccination trial after allogeneic Stem Cell Transplantation to improve the safety and efficacy of Donor Lymphocyte Infusions.

Primary objectives:- To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination in B cell hematological malignancies- To evaluate the effect of a DLI-combined minor H ag UTA2-1…

Nano-MRI on 7 Tesla: A technical validation study in rectal and breast cancer

To validate nano-MRI on 7 Tesla with pathological findings.

The effect of of a spinal orthosis on gait and balance in patients with symptomatic osteoporotic vertebral compression fractures (OVCFs)

The data will be used in order to evaluate statistical variability (mean, SD) in an attempt to predict an appropriate sample size prior to the RCT based on the effect size, alpha and beta. The aim of the RCT is to assess the effects of the Osteoline…