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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…

A SYNDEMIC BASED LINKAGE TO CARE INTERVENTION FOR HIGH RISK MEN WHO HAVE SEX WITH MEN

Primary objective: Does a personalised behaviour intervention comprising of targeted in depth screening on mental health problems and drug use increase help seeking behaviour among MSM who are at high risk for STIs and HIV. Secondary objectives:…

An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

Is endometrial withdrawal bleeding necessary prior to ovulation induction with clomiphene citrate?;A randomized controlled trial and feasibility study

To evaluate the effects of withholding progesterone-induced endometrial withdrawal bleeding before ovulation induction on the time to pregnancy and the ongoing pregnancy rate.

Corneal Transplantation by DMEK - is it really better than DSAEK?

The objective of this trial is to assess the effects and costs of DMEK vs. DSAEK in order to determine whether the new technique is effective and cost-effective over the standard technique.

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.

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…

Deep and slow breathing in postsurgical abdominal pain management: an explorative study

To investigate whether deep and slow breathing exercises can reduce pain induced by mobilizing from bed to chair after major abdominal surgery, compared to a reading task.

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…

SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…

Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS),…

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…