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NCT ID: NCT03523806 Active, not recruiting - Cerebral Palsy Clinical Trials

Children and Teens in Charge of Their Health

CATCH
Start date: March 23, 2018
Phase: N/A
Study type: Interventional

This three year study explores the feasibility and acceptability of conducting a full randomized controlled trial (RCT) of a promising coaching intervention for improving and sustaining physical activity (PA) and healthy dietary habits in children with physical disabilities (CWPD). Thirty children (ages 10 - 18) will spend 12 months in the study. All will receive usual care and basic printed information about healthy lifestyles. In addition, 15 will receive a coaching intervention for the first six months. Pre-defined success criteria will assess the feasibility of trial processes. Acceptability of trial participation and impact of coaching will be explored qualitatively. Health indicators and psychosocial outcomes will be assessed four times, at the start of the trial, immediately post-intervention and at three and six months post-intervention.

NCT ID: NCT03522831 Active, not recruiting - Cystic Fibrosis Clinical Trials

CF Bronchodilation

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

It is estimated that one in every 3,600 children in Canada has cystic fibrosis (CF). CF is a genetic disease that affects the glands that produce mucus and sweat. In CF, mucus production increases and the mucus becomes thick and sticky. This can block the airways, making it difficult to breathe. Mucus production also causes bacteria to grow, which can lead to infections in the lungs. Individuals with CF suffer from shortness of breath, wheezing, cough, and poor exercise capacity. There are limited treatment options to reduce shortness of breath in these individuals. Some medications known as bronchodilators are commonly prescribed to reduce breathlessness in patients with CF. These drugs help open the airways making it easier to breathe. Unfortunately, there is limited scientific proof that these drugs can reduce shortness of breath and improve exercise capacity in patients with CF. As a result, some experts have recommended that these drugs should not be prescribed for patients with CF. The purpose of this study is to examine the effects of a bronchodilator on shortness of breath, exercise performance, and breathing responses compared to a placebo drug in adults with CF.

NCT ID: NCT03522246 Active, not recruiting - Clinical trials for Fallopian Tube Cancer

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

ATHENA
Start date: May 14, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

NCT ID: NCT03520101 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial

Start date: May 10, 2017
Phase: N/A
Study type: Interventional

The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe prosthesis-patient mismatch (PPM) following the procedure.

NCT ID: NCT03519178 Active, not recruiting - Clinical trials for HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer

A Study of PF-06873600 in People With Cancer

Start date: March 7, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer. People may be able to participate in this study if they have the following types of cancer: Hormone Receptor positive (HR+) breast cancer; Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer that is advanced or metastatic (spread to other parts of the body); triple negative breast cancer; epithelial ovarian cancer; fallopian tube cancer; or primary peritoneal cancer. All participants in this study will receive the study medicine by mouth, 1 to 2 times a day at home. The dose of the study medicine may be changed during the study. Some participants will also receive hormone therapy. The hormone therapy will be either letrozole by mouth once a day at home, or fulvestrant as a shot into the muscle. Fulvestrant will be given every two weeks at the study clinic for the first month, and then once a month after that. Participants will take part in this study for at least 7 to 8 months, depending on how they respond to the therapy. During this time participants will visit the study clinic once a week.

NCT ID: NCT03518086 Active, not recruiting - Ulcerative Colitis Clinical Trials

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

NCT ID: NCT03517449 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Start date: June 11, 2018
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

NCT ID: NCT03516981 Active, not recruiting - Clinical trials for Advanced Non-Small Cell Lung Cancer

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

NCT ID: NCT03515668 Active, not recruiting - Hyperthermia Clinical Trials

Dopamine and Muscle Function in the Heat

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

our goal is to study the effects of dopamine activity, using Ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. We hypothesize that Ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

NCT ID: NCT03512314 Active, not recruiting - NLRC4-MAS Clinical Trials

Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency as Open Label Extension

Start date: January 24, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label extension study for patients previously enrolled in the AB2 Bio Ltd. ongoing Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953). This OLE study will evaluate the long-term safety and tolerability of Tadekinig alfa in patients suffering from pediatric monogenic autoinflammatory diseases harboring deleterious mutations of NLRC4 and XIAP.