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NCT ID: NCT02914561 Completed - Crohn's Disease Clinical Trials

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

DIVERSITY1
Start date: October 31, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

NCT ID: NCT02914522 Completed - Ulcerative Colitis Clinical Trials

Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

SELECTION
Start date: November 14, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

NCT ID: NCT02913261 Completed - Clinical trials for Corticosteroid Refractory Acute Graft vs Host Disease

Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

REACH2
Start date: March 10, 2017
Phase: Phase 3
Study type: Interventional

Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.

NCT ID: NCT02889796 Completed - Clinical trials for Rheumatoid Arthritis

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

FINCH 1
Start date: August 30, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

NCT ID: NCT02886728 Completed - Clinical trials for Rheumatoid Arthritis

Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

FINCH 3
Start date: August 8, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

NCT ID: NCT02881658 Completed - Dyslipidemia Clinical Trials

The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C

Start date: May 2016
Phase: N/A
Study type: Interventional

This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage enriched with plant sterol for 3 weeks. This study also examines if there is other health-benefits by consuming the plant sterols fortified soya beverage in terms of serum total triglyceride, total and HDL cholesterol, other cardiometabolic risk factors and musculoskeletal-related traits including handgrip strength, gait speed, peak expiratory flow rate, bio-impedance and body balance.

NCT ID: NCT02878824 Completed - Children Clinical Trials

Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children

Start date: July 2016
Phase: N/A
Study type: Observational

Difference in autonomic nervous system processes across cultural and ethnic groups was suggested and autonomic regulation differentiation may occur even at an early age. However, the role of ethnicity and environment on regulation of response towards sensory stimulation in children is not well understood yet. This research aims to compare the autonomic activity at resting condition and toward a block of auditory stimulation between typically developing children from different countries and living environments. There will be two phases in this study. In Phase I, two groups of participants will be recruited: (a) 32 typically-developing Chinese children living in Hong Kong, (HK group) and (b) 32 typically developing Filipino children living in Hong Kong (Fil-HK group). In phase II, two groups of participants will be recruited: (a) 32 typically-developing Filipino children who are living at Urban area (PH-U group), and (b) 32 typically developing Filipino children who are living at Philippines-Rural area (PH-R group). Participants will be composed of males and females ages 7-12 years old, and without known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited participants will watch a silent movie, and listen to a block of sound. Autonomic activity (heart rate variability and electrodermal activity) will be measured and recorded using Polar H2 heart rate monitor and eSense skin response. Recordings will be screened for ectopic beats of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and the eSense propriety software, respectively, and according to the standards of editing HRV and EDA artefacts. Autonomic activity (LF, HF and EDA) at resting condition, and hypothesis interaction between conditions (resting condition vs. auditory stimulation) and groups (HK group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested with repeated measures of MANOVA. All significant levels will be set at p≤ 0.05. This study will increase the understanding on the role of culture and environment in the regulation of behaviour in auditory processing. The findings of this research may further shed light on the evaluation and treatment planning for children across and within cultures.

NCT ID: NCT02876835 Completed - Anaemia Clinical Trials

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Start date: September 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

NCT ID: NCT02875132 Completed - Clinical trials for Acral Lentiginous Melanoma

Pembrolizumab in Advanced/Metastatic Acral Lentiginous Melanoma

Start date: February 15, 2017
Phase: Phase 2
Study type: Interventional

To determine the Overall Response Rate (ORR), as defined as rate of complete response (CR) and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral lentiginous melanoma treated with pembrolizumab

NCT ID: NCT02867371 Completed - Lung Cancer Clinical Trials

Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

EAST2
Start date: August 2016
Phase: N/A
Study type: Interventional

The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.