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NCT ID: NCT04180696 Completed - Heart Failure Clinical Trials

Mid-Q Response Study

Start date: January 23, 2020
Phase: N/A
Study type: Interventional

The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study. The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB). The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group. The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.

NCT ID: NCT04179175 Active, not recruiting - Clinical trials for Hidradenitis Suppurativa

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to evaluate maintenance of HiSCR response in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

NCT ID: NCT04178967 Completed - Atopic Dermatitis Clinical Trials

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

ADvocate2
Start date: October 29, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

NCT ID: NCT04178733 Completed - Healthy Clinical Trials

A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants

Start date: January 10, 2020
Phase: Phase 1
Study type: Interventional

This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.

NCT ID: NCT04177108 Completed - Clinical trials for Triple-Negative Breast Cancer

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

NCT ID: NCT04174404 Recruiting - Surgery Clinical Trials

Intelligent Customer-driven Solution for Pediatric Surgery Care for Parents and Their Children Undergoing Circumcision

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

This study aims to (1) develop an intelligent customer-driven solution for pediatric surgery care for parents of children undergoing circumcision and their children; (2) examine the effectiveness of the intervention on outcomes of parents (self-efficacy in child care, perioperative knowledge, and satisfaction in perioperative care, need for information and anxiety) and children (preoperative anxiety and postoperative pain); and (3) explore users' (parents, children, health care professionals) perceptions of the intervention and suggestions for improvement.

NCT ID: NCT04173494 Completed - Clinical trials for Primary Myelofibrosis

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

Start date: February 7, 2020
Phase: Phase 3
Study type: Interventional

MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.

NCT ID: NCT04172350 Recruiting - Surgery Clinical Trials

An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery

iCareBreast
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

This study aims to develop a mobile app-based periopeartive intervnetion for women undergoing breast cancer surgery and examine the effectiveness of the program on participants' health outcomes of self-efficacy, anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care. This study also aims to explore the perceptions of participants on strengths and weaknesses of using the app.

NCT ID: NCT04172337 Completed - Obesity Clinical Trials

Testing the Effects of Singapore's Front-of-Pack Healthier Choice Symbol Label With or Without a Physical Activity Equivalent Label

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

Poor diets are known risk factors for chronic diseases, and in recent years, food labelling has been increasingly sought-after as a cost-effective intervention to help stem the rising trend in chronic diseases. In efforts to promote a healthy diet, the Singapore Health Promotion Board (HPB) supplements traditional nutrition labelling with the Healthier Choice Symbol (HCS), which identifies food items within a specific category of foods as healthier choices. The original logos were enhanced to include additional information focusing on particular macronutrients, taking one of two themes; it either indicates that a product contains more of a healthier ingredient, or less of a less healthy ingredient. However, to date, no published studies have assessed the role of the original and enhanced HCS logos in influencing food choices. There is a lack of scientific evidence on the role of the existing symbols in assisting consumers make healthier food purchasing decisions. There are also concerns over the unintended consequences of health claims made based on a single aspect of nutrient content, without considering other aspects. That is the goal of this effort. Specifically, the investigators propose to conduct the following: Use a three arm randomized controlled trial (RCT) and an experimental fully functional web-based grocery store to assess the causal effect of the new HCS logos on measures of diet quality either alone, or in combination with a complementary front-of-package (FOP) label: Physical Activity Equivalents (PAEs), which provides information on how long one would need to engage in a certain activity (e.g., jogging) to burn off one serving of the product. The investigators hypothesize that the greatest reduction in calories per serving (primary outcome) will occur in the HCS plus PAEs arm, followed by HCS only, and no logo control arm.

NCT ID: NCT04169594 Completed - Stroke Clinical Trials

Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation

Start date: June 19, 2020
Phase:
Study type: Observational

Gait analysis is commonly performed in clinical practice. However, it is complex and requires an understanding of the activation of muscles in lower limbs, trunk, and upper limbs in a specific spatiotemporal pattern and the appropriate joint positions which support and advance the body weight in different phases of gait cycles. In study, we plan to pilot the application of 3D gait analysis with statistical modelling in 2 common causes of gait deviation: unilateral hemiplegic stroke and unilateral lower limb amputation.