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NCT ID: NCT02277769 Completed - Dermatitis, Atopic Clinical Trials

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

SOLO 2
Start date: November 30, 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT02275390 Completed - Mental Illness Clinical Trials

Nurse-led Psycho-education Program for People With First-onset Mental Illness (APN-PEP)

APN-PEP
Start date: March 1, 2012
Phase: N/A
Study type: Interventional

The study aims to test the effectiveness of a nurse-led psycho-education program based on motivational interviewing technique for Chinese patients with first-onset mental illness over a 12-month follow-up. A randomized controlled trial will be conducted with 180 Chinese patients with schizophrenia newly referred to one outpatient clinic in Hong Kong. They will be randomly assigned to either the eight-session nurse-led psycho-education program or usual psychiatric outpatient care (both n=90). The patients' general and mental health, illness insight, self-efficacy, services utilization, and hospitalization rates were measured at recruitment and one week, six months and 12 months post-intervention. Note: Those who were approached in the clinic and not eligible to participate in this trial will be invited to participate in another controlled trial. The controlled trial tests the effects of a self-help problem-solving based bibliotherapy program (SPBB) for Chinese family caregivers in recent onset psychosis (not more than 1 year onset) at one psychiatric clinic, in comparison to routine outpatient service and family support (control group) for 116 randomly selected family caregivers of outpatients with psychotic disorders over a 6-month follow-up.)

NCT ID: NCT02258451 Completed - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: June 4, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.

NCT ID: NCT02247804 Completed - Ocular Hypertension Clinical Trials

Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

Start date: December 15, 2014
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

NCT ID: NCT02244996 Completed - Clinical trials for Retinitis Pigmentosa

Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

Start date: November 2014
Phase: N/A
Study type: Interventional

Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB) treatment on retinal functions, especially the cone function, and retinal structure in patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial Setting: Primary Care clinical trial Participants: 120 RP subjects will be recruited from Ophthalmology department at The University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1 year. After the 1st year, both groups will stop the treatment and all subjects will also have the same eye exam in 6-month period for the 2nd year. Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4 programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual acuity.

NCT ID: NCT02239120 Completed - Stroke Clinical Trials

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Start date: November 27, 2014
Phase: Phase 3
Study type: Interventional

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

NCT ID: NCT02234843 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

EINSTEIN Jr
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

NCT ID: NCT02226120 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

NCT ID: NCT02222545 Completed - Clinical trials for Thrombotic Microangiopathies

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

Start date: November 2, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).

NCT ID: NCT02222207 Completed - Clinical trials for Macular Degeneration

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

DREAM
Start date: October 2014
Phase: Phase 2
Study type: Interventional

Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: - how often the regorafenib eye drops need to be given per day - whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.