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NCT ID: NCT03166735 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH

Start date: June 6, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.

NCT ID: NCT03165279 Completed - Aneurysm Clinical Trials

ZEnith AlPHa for AneurYsm Repair

ZEPHYR
Start date: December 7, 2016
Phase:
Study type: Observational [Patient Registry]

To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use. To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.

NCT ID: NCT03165227 Completed - Clinical trials for Diabetic Nephropathies

This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)

Start date: October 17, 2017
Phase: Phase 1
Study type: Interventional

The main objective of this trial is the safety and tolerability of 3 multiple rising oral doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important diagnostic marker of nephropathy.

NCT ID: NCT03164928 Completed - Clinical trials for Glucocorticoid-induced Osteoporosis

Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

Start date: May 7, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).

NCT ID: NCT03164434 Completed - Clinical trials for Subarachnoid Hemorrhage

Influence of Drainage on EVD ICP-signal

Start date: September 2014
Phase:
Study type: Observational

This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.

NCT ID: NCT03164343 Completed - Pain Clinical Trials

Pain Neuroscience Education in Healthy Children

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine whether Pain Neuroscience Education for children is able to increase a child's knowledge on the neurophysiology of pain. In addition, this study investigates the influence of PNE on several pain related outcomes; pain-related fear, pain catastrophizing and pain vigilance and awareness.

NCT ID: NCT03163511 Completed - Clinical trials for Type 1 Diabetes Mellitus With Hypoglycemia

A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

Start date: July 6, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

NCT ID: NCT03163446 Completed - Clinical trials for Staphylococcus Aureus Bacteremia

Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

Start date: May 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia. CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

NCT ID: NCT03163004 Completed - Health Behavior Clinical Trials

Implementation of Standing Desks at School

Start date: October 1, 2016
Phase: N/A
Study type: Interventional

Since sedentary time is related to various health outcomes and is already highly prevalent in childhood and adolescence, effective strategies are needed to tackle this health problem. Children and adolescents spend the majority of the day in a classroom while sitting at a desk. Therefore, the classroom is an important setting for implementing specific strategies to reduce sedentary time. One of the strategies that gained more attention during the past years is replacing traditional desks and chairs with standing desks. This project evaluates the implementation of standing desks in primary and secondary schools via a clustered randomized controlled trial using an intervention and control condition. Effects on sedentary time during in class, sedentary activities during leisure time, breaks in sedentary time, and related determinants (secondary outcomes) are evaluated. Next to effect evaluation, it is also equally important to evaluate how teachers and pupils perceive this change in the classroom environment. Both groups need to be positive in order to obtain the adoption and sustainability. Therefore, focus groups with pupils and interviews with teachers are conducted, with a specific focus on the perceived barriers. Moreover, the process evaluation is conducted quantitatively as well by using questionnaires in pupils and teachers. The project results will lead to recommendations on how to broadly implement standing desks into primary and secondary schools.

NCT ID: NCT03162900 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects

B1371023
Start date: June 9, 2017
Phase: Phase 1
Study type: Interventional

This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects. This is a randomized, double blind, positive and placebo controlled study with a 6 day washout between successive periods.