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A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers

Primary objective- To determine safety and tolerability of a single dose of cRGD-ZW800-1 in healthy volunteers.Secondary objectives- To determine the pharmacokinetics of a single dose of cRGD-ZW800-1 by measuring the fluorescence of blood and urine…

The effect of oxytocin administration on empathy and emotion recognition in healthy and antisocial adolescents

Our primary objective is to investigate whether oxytocin administration can affect empathy and emotion recognition in healthy and antisocial adolescents. We expect that oxytocin will enhance empathy and emotion recognition in both healthy and…

A Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers.

Part A Pilot:The purpose of Part A is to investigate how quickly and to what extent exenatide is absorbed and eliminated from the body and whether the plasma levels of exenatide will reach the levels seen in patients with renal impairment. It will…

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

PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active radiographic axial spondyloarthritis (rad-axSpA) at Week 16.SecondaryThe major…

A randomized double-blind placebo-controlled phase 1 study regarding safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM 8101) in healthy male subjects.

To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.

A Phase I, double-blind, randomised, placebo-controlled, multiple dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dosages of estetrol in healthy men

Primary objectives:* To investigate the safety of multiple dosages of E4;* To investigate the efficacy of multiple dosages of E4 on hormone levels related to prostate function.Secondary objectives:* To investigate the pharmacodynamic effects of E4…

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus * Study two

Primary Objective The primary objective of this study is to compare the change from baseline in HbA1c after 24 weeks of double blinded treatment with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin.…

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-…

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.

Beneficial effects of the amino-acid food supplement L-Citrulline in Participants with Peripheral artery disease

Some studies have reported improved vascular function with the supplementation of L-arginine in participants with CVD. Several clinical studies have also begun the investigation of L-arginine supplementation in participants with PAD. This is…

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 double-blind, placebo controlled, randomised, parallel group study with an open-label cross-over part, investigating safety, tolerability, pharmacokinetics, and pharmacodynamics after single ascending oral doses and a single intravenous dose of the vasopressin V2-receptor agonist FE 201836

The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…

Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndrome

The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…

Web-based attention bias modification treatment for childhood anxiety disorders: a randomized, double-blind, controlled trial

Specific AimsAs reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood…

Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.

A placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability

The primary objective of this study is: To study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for…

A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…

A randomized, double-blind, placebo-controlled study to compare the immune effects of multiple doses of vitamin D3 in patients with allergic rhinitis/rhino-conjunctivitis caused by birch pollen and in healthy control subjects.

The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…

TElmisartan in the management of abDominal aortic aneurYsm
(TEDY)

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