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NCT ID: NCT03904693 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

A DUE
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.

NCT ID: NCT03904147 Active, not recruiting - Clinical trials for Tricuspid Regurgitation

TRILUMINATE Pivotal Trial

Start date: August 21, 2019
Phase: N/A
Study type: Interventional

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

NCT ID: NCT03901963 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

AURIGA
Start date: April 26, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

NCT ID: NCT03900429 Active, not recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

MAESTRO-NASH
Start date: March 28, 2019
Phase: Phase 3
Study type: Interventional

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

NCT ID: NCT03898180 Active, not recruiting - Clinical trials for Urothelial Carcinoma

Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

Start date: May 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: 1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and 2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). With Amendment 3 (effective: September [Sep]-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up.

NCT ID: NCT03894059 Active, not recruiting - Cardiac Arrest Clinical Trials

An Educational Program to Improve Cardiac Arrest Diagnostic Accuracy of Ambulance Telecommunicators

Start date: December 14, 2020
Phase:
Study type: Observational

Cardiac arrest is the number one cause of death in Canada. It is often the first symptom of cardiac disease for the victims. Eighty-five percent of victims collapse in their own home. Fifty percent collapse in the presence of a family member. Bystander cardiopulmonary resuscitation (CPR) can improve the chance to survive a cardiac arrest by three to four times, but needs to be started quickly. In most communities, less than 30% of victims receive CPR before the ambulance arrives. Currently, only 8% of cardiac arrest victims can leave the hospital alive. Many things have been tried to improve the number of times people do CPR. So far, the only thing that really increased the number of times that someone did CPR is when 9-1-1 attendants started to give CPR instructions to callers over the phone. The only problem is that about 25% of cardiac arrest victims gasp for air in the first few minutes. This can fool the 9-1-1 callers and attendants into thinking that the victim is still alive. The investigators have looked at all the studies on how to help 9-1-1 attendants to recognize abnormal breathing over the phone. The investigators have also learned what should be taught after finishing a large survey with 9-1-1 attendants from across Canada. This survey was done with the help of psychologists and other education experts. It measured the impact of attitudes, social pressures, and 9-1-1 attendants' perceived control over their ability to recognize abnormal breathing and cardiac arrest. Then the investigators developed a teaching tool which helped Ottawa 9-1-1 attendants recognize abnormal breathing. When they could do that, they could also recognize more cardiac arrest. The main goal of this project is to use the tool developed in Ottawa in more centres to help 9-1-1 attendants save the lives of even more cardiac arrest victims across Canada.

NCT ID: NCT03891563 Active, not recruiting - Clinical trials for Femoroacetabular Impingement

Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip

PREVIEW
Start date: October 18, 2017
Phase:
Study type: Observational

Femoroacetabular impingement (FAI) is a condition of the hip where there is a mis-fit between the femoral head (ball) and hip acetabulum (socket). The abnormalities on the hip bones collide or "impinge" during movements such as hip flexion and rotation. Typically, patients with this condition are young adults who present with hip pain, loss of hip function, and in many cases, osteoarthritis later in life. The rate of diagnoses of FAI has dramatically risen across all age groups, but it has been especially notable within adolescent populations. There has been a corresponding increase in the number of surgeries performed on younger and younger hips to treat pain and loss of function due to this condition. Preliminary small-scale research has hypothesized that increased activity, such as sport specialization (i.e. playing only one sport for most of the year) at an early age when the hip is still developing, may be the cause. In the past 20 years, sport injuries among children have dramatically increased, where close to 45 million young athletes participate in organized sports annually in Canada and the US alone. There is a current trend among coaches and parents to have children focus on one sport with the thought that this dedication will allow them to reach an elite level. We are proposing the first international, longitudinal cohort study to determine the effect of sport specialization on the development of FAI during the critical phase of hip development (i.e. between the ages of 12-14 years). Volunteer participants will be recruited across Canada and internationally and will be evaluated clinically and radiographically (i.e. using MRI) over 2 years. This study will not only prospectively evaluate the role of sport activity the development of FAI, but also inform preventative training protocols to potentially reduce its incidence among adolescents, and later as adults, as well as identify parameters to detect hips that are at risk for developing FAI.

NCT ID: NCT03888027 Active, not recruiting - Frailty Clinical Trials

WalkMORE: A Volunteer-driven Walking Intervention

WalkMORE
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Patients admitted to hospital typically experience periods of decreased activity or bed-rest. This reduced activity level leads to deconditioning - a loss of muscle mass, muscle strength (by 2-5% per day), and muscle shortening. Even among patients who were ambulatory at the time of admission, deconditioning has been linked with deleterious effects, such as increased rates of falls, functional decline, and frailty. Furthermore, it has been suggested that the physiological stresses associated with hospitalization - including deconditioning, as well as sleep deprivation and poor nutrition - makes discharged patients vulnerable to recurrent or new illnesses and to frailty. This physiological stress-induced vulnerability has been coined "post-hospital syndrome" and is thought to have a role in most hospital readmissions. The investigators hypothesize that by engaging ambulatory patients to walk with trained volunteers, patients will increase their amount of walking, have less deconditioning and functional decline, and consequently, fewer falls. Furthermore, the investigators anticipate that patients who walk with a trained volunteer will have reduced length-of-stay in hospital and decreased likelihood of readmission. Finally, as shown in other similar programs, the investigators anticipate an overall improvement in the patient experience. The investigator's novel initiative focuses on a single, volunteer-based intentional ambulation program that can deliver the benefits of early mobility in a cost-effective way. The program design engages trained volunteers to increase patient ambulation in a way that both increases patient mobility and reduces healthcare professionals' workload.

NCT ID: NCT03887676 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)

ARBA
Start date: March 18, 2019
Phase: Phase 2
Study type: Interventional

This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).

NCT ID: NCT03887455 Active, not recruiting - Clinical trials for Early Alzheimer's Disease

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Clarity AD
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.