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An outpatient phase 3 efficacy study of Ecopipam (PSYRX 101) in the symptomatic treatment of self-injurious behavior in subjects with Lesch-Nyhan disease.

The primary objective of this study is to assess the efficacy of Ecopipam to reduce self-injurious behaviors (SIB) in adults and children with Lesch-Nyhan Disease (LND) in an outpatient setting. The secondary objectives of this study are to assess…

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.

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…

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 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…

Varenicline, a partial nicotinic receptor agonist, for the treatment of excessive daytime sleepiness in Parkinson*s disease: a placebo-controlled cross-over study

This study is aimed to determine the efficacy of varenicline in reducing EDS in PD patients.

Resting State functional magnetic resonance imaging of human brain responses to nutrient shakes.

Primary objective of this study is to assess changes in brain connectivity and activity in the Default Mode and Salience Network (hypothalamus, prefrontal cortex, nucleus accumbens, Ventral Tegmental Area) after different sugars and sweeteners.

The impact of EcologicBarrier on neurocognitive measures of emotion & executive functioning

To investigate the impact of the multispecies probiotic product Ecologic*Barrier on neurocognitive measures of emotion and executive functioning.

Effect of Delmopinol on treatment of Peri - implant mucositis : a randomised controlled clinical trial

The primary objective of this study is to evaluate the effect (reduction of bleeding on probing) after mechanical debridement alone or treatment with delmopinol or chlorhexidine mouth rinse as an adjunct to mechanical debridement around implants…

A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults.

Objective: Adequate analgesia during intravenous cannulation.Hypothesis: Xylocaine spray for the placement of an infusion decreases the pain score with two or more points in comparison to placebo spray.Studie questions:Primary: Has xylocaine spray…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

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…

Oral steroids for the treatment of inflammatory Complex Regional Pain Syndrome type-1

Primary Objective: Assessment of a group difference in clinically important improvement in functional outcome of at least 10 points as measured by the DASH questionnaireSecondary Objective(s): 1. To determine if there is a group difference in…

Trigeminovascular effects of propranolol in migraine treatment

To determine the mechanism of action of propranolol in the prophylactic treatment of migraine.

The effect of a single dose of Lycium Barbarum on postprandial energy expenditure in healthy overweight men

The primary objective of this study is to investigate the effect of a single dose of L. Barbarum on postprandial energy expenditure. Secondary objectives are to investigate the effect of a single dose of L. Barbarum on postprandial lipid and…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients with Radiographic Axial Spondyloarthritis

PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W) versus placebo in patients with active rad-axSpA at Week 16.SecondaryThe major secondary objective is:To compare both ixekizumab regimens (80 mg Q2W or 80…

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-…

Spinal Morphine in Robotic Assisted Radical Prostatectomy

The primary goal is to increase the quality of recovery, as measured by the QoR-15-scale.Secundary goals are to decrease the use of systemic opiates, less bladderspasms and pain, reduce the side-effects op opiates, increase the patient-satisfaction…

TElmisartan in the management of abDominal aortic aneurYsm
(TEDY)

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