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NCT ID: NCT03564691 Active, not recruiting - Neoplasms Clinical Trials

Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)

Start date: July 11, 2018
Phase: Phase 1
Study type: Interventional

This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.

NCT ID: NCT03561805 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.

NCT ID: NCT03560466 Active, not recruiting - Asthma Clinical Trials

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers. - To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study - To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: - Systemic exposure, - Anti-drug antibodies (ADAs), - Biomarkers

NCT ID: NCT03555734 Active, not recruiting - Obesity Clinical Trials

Umbrella Review and Updated Systematic Review and Meta-analysis of Pulses/Legumes and Incident Cardiometabolic Diseases

Start date: November 21, 2017
Phase:
Study type: Observational

The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding dietary pulses. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an umbrella review and updated systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from prospective cohort studies of the association between dietary pulses/legumes and cardiometabolic disease outcomes (incident cardiovascular diseases, diabetes, hypertension and overweight/obesity).

NCT ID: NCT03555422 Active, not recruiting - Endometrial Cancer Clinical Trials

Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]

ENGOT-EN5
Start date: January 5, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.

NCT ID: NCT03554512 Active, not recruiting - Anxiety Clinical Trials

TelePremie: Telehomecare for Step-down Care Post-NICU Discharge

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge. Participants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant. The study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge. A subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention. The cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.

NCT ID: NCT03553836 Active, not recruiting - Melanoma Clinical Trials

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

Start date: September 12, 2018
Phase: Phase 3
Study type: Interventional

This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

NCT ID: NCT03551483 Active, not recruiting - Aging Clinical Trials

ArtontheBrain: An Inclusive Evidence-based Cognitive Health App for Older Adults to Promote Aging at Home

Start date: July 24, 2018
Phase: N/A
Study type: Interventional

The research proposed here will evaluate whether a web-based recreation intervention, called ArtontheBrain, has positive health benefits to older adult users. ArtontheBrain incorporates three basic activities; learning (history of the artwork), play (telling stories, solving puzzles) and socializing with other users, either in person or online. It can be used alone, with another person, or in a group. It is modeled after participatory arts-based interventions which studies have shown are associated with health benefits in older adults, such as improved sense of well-being, physical health, decreased risk of dementia, and reduced need for health services. Our study will test ArtontheBrain at research sites and health agencies in Canada, the U.S., and the U.K. with older adults with and without cognitive decline. The study will also examine how well that app can support different user play modalities and whether it can effect positive health outcomes similar to face-to-face arts interventions.

NCT ID: NCT03549988 Active, not recruiting - Ulcerative Colitis Clinical Trials

Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

Start date: December 1, 2018
Phase:
Study type: Observational

Hypothesis: Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

NCT ID: NCT03546699 Active, not recruiting - Respiratory Failure Clinical Trials

Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

Start date: October 24, 2018
Phase:
Study type: Observational

The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda. This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide. The purposes of this study are: 1. To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions; 2. To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).