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NCT ID: NCT03580369 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Start date: October 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

NCT ID: NCT03580148 Completed - Clinical trials for Osteo Arthritis Shoulders

BMA vs Cortisone for Glenohumeral Osteoarthritis

BMAC
Start date: October 8, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This randomized trial seeks to investigate the difference if any between cortisone injection versus bone marrow aspirate injection in the glenohumeral joint of patients with confirmed osteoarthritis. The investigators hope that results from a prospective randomized controlled pilot study on bone marrow aspirate (BMA) glenohumeral joint (GHJ) injections will provide valuable early information on an alternative treatment for GHJ osteoarthritis (OA). This novel study will also contribute clinical data to the growing pool of research around BMA in the treatment of osteoarthritis. This study has the potential to uncover a new and more effective therapy to add to the arsenal of an orthopaedic surgeon in the management of GHJ OA. This would provide improved care and treatment for those disabled by GHJ OA. Additionally, this knowledge would be applicable to a variety of medical practitioners who treat GHJ OA from the general orthopaedic surgeon to pain subspecialists.

NCT ID: NCT03579641 Completed - Heart Failure Clinical Trials

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

PREEMPT-HF
Start date: June 1, 2018
Phase:
Study type: Observational

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

NCT ID: NCT03579264 Completed - Physical Activity Clinical Trials

Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform

Start date: August 28, 2018
Phase: N/A
Study type: Interventional

Dietary choices, quality of life and stress will be evaluated in a sample of 100 undergraduate students who are in their first year of university. Students will be randomized into the following two groups; intervention arm (students who will use a preventative self-care program for 12 weeks) vs. control arm (students who will not use a preventative self-care program for 12 weeks).

NCT ID: NCT03578705 Recruiting - Lower Limb Injury Clinical Trials

Muscle Quality and Percentage of Fat Following a Lower Limb Injury

Start date: March 15, 2016
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to longitudinally evaluate patient muscle quality in trauma patients with bed rest or altered weight-bearing with the help of a consumer approved non-proprietary muscle impedance-measuring device. Secondary objectives are to identify patient characteristics or treatment protocols that are predictive of poor muscle quality.

NCT ID: NCT03578419 Active, not recruiting - Blood Loss Anemia Clinical Trials

Small-Volume Tubes to Reduce Anemia and Transfusion

STRATUS
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.

NCT ID: NCT03578367 Active, not recruiting - Clinical trials for Hematologic Diseases

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Start date: November 22, 2018
Phase: Phase 2
Study type: Interventional

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

NCT ID: NCT03577899 Terminated - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)

Start date: September 25, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

NCT ID: NCT03577522 Completed - Hip Osteoarthritis Clinical Trials

Comparison of Two Hydroxy-apatite Coated Hip Stems

Start date: July 19, 2018
Phase: N/A
Study type: Interventional

In this study, the investigators propose to randomize 80 subjects to receive either the Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and follow these patients for a period of 2 years post-surgery. The investigators aim to determine if the Avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.

NCT ID: NCT03577171 Completed - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Start date: June 19, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)