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NCT ID: NCT03783078 Completed - Clinical trials for Merkel Cell Carcinoma

Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

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

This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

NCT ID: NCT03783026 Completed - Psoriatic Arthritis Clinical Trials

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

MOSAIC
Start date: February 6, 2019
Phase: Phase 4
Study type: Interventional

This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.

NCT ID: NCT03782974 Completed - Clinical trials for Protective Qi Insufficiency (a Condition Term From TCM)

A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Deficiency, a TCM Condition

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

This is a follow-up Phase II study of a previously complete pilot trial (Protocol ID: 201875) with the same goal: evaluating the activity of Proglucamune on Protective Qi (PQi) Insufficiency. According to Traditional Chinese Medicine (TCM) principle, Protective Qi is a one specific concept of Qi that provides the vital energy of the body. It works primarily on the body surface as a defensive barrier. In this context, Protective Qi is analogous to anatomical barriers of the innate immune system located for example, at the skin surface and the mucosal surfaces of the respiratory and digestive tract. Individuals with PQi Insufficiency are predisposed to frequent cold and other symptoms caused by invasion of external pathogens ("Wai Xie" or "external evil" in TCM). ß-glucan is a polysaccharide that activates macrophage (Dectin-1) and neutrophil (CR3) receptors, and therefore enhances immune defense at digestive and respiratory mucosa. Clinical trials have shown its immune activity such as preventing upper respiratory tract infection (URTI) and Traveler's diarrhea. Notably, ß-glucan is a component of Ganoderma Lucidum (or Reishi / Lingzhi), one TCM ingredient well-known for improving Qi. Based on this connection, investigators hypothesized that ß-glucan is the active ingredient in Reishi that at least partially accounts for Reishi's activity on Qi. To test our hypothesis, investigators have conducted an uncontrolled pilot trial that investigated the effect of a commercially available, high ß-glucan containing product, Proglucamune®, on PQi status. Proglucamune contains ß-glucan from three different natural sources: Reishi mushroom, Shiitaki mushroom, and Bakers' yeast, each providing ß-glucan that differs slightly in their molecular structure. The data obtained demonstrated a statistically significant effect of Proglucamune on improving PQi in individuals with PQi Insufficiency. The current study is aimed to further determine this effect in a more stringent (placebo-controlled, randomized, and triple-blinded) way.

NCT ID: NCT03782298 Completed - Bunionectomy Clinical Trials

Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in Extremities

Start date: March 12, 2019
Phase:
Study type: Observational

Safety and performance of the study devices in extremities over a time period of 6 months after intervention.

NCT ID: NCT03781973 Completed - Type1diabetes Clinical Trials

Bridging the Gap to Adult Diabetes Care

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

Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of >6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers. Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care. Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.

NCT ID: NCT03781804 Completed - Clinical trials for Chronic Rhinosinusitis

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.

NCT ID: NCT03781635 Completed - Clinical trials for Bolus Versus Infusion Ketamine, Anesthesia Gas Consumption

Comparison of BIS Index Variations: Bolus Versus Infusion Ketamine, and Impact on the Anesthesia Gas Consumption

KETABIS
Start date: September 25, 2018
Phase: Phase 4
Study type: Interventional

The aim of the present study is to show that i.v. ketamine boluses might lead to significant and clinically relevant BIS index increase that might lead to an increase in anesthesia dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any bolus.

NCT ID: NCT03781453 Completed - Health Behavior Clinical Trials

POWERPLAY Phase 2: Development and Evaluation in Male-dominated Workplaces

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

With funding from the Alberta Ministry of Labour (Grant #095244772), a program called POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be evaluated in workplaces in Alberta.

NCT ID: NCT03781297 Completed - PTSD Clinical Trials

Narrative Exposure Therapy Study for PTSD Among the Homeless Population

Start date: February 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the acceptability and feasibility of delivering Narrative Exposure Therapy to homeless individuals with Post-Traumatic Stress Disorder. In Ottawa, in 2015, there were 6,825 people using 500,191 bed nights in the city emergency shelters (Alliance to End Homelessness in Ottawa 2015 Annual Report) with approximately another 500 sleeping on the streets (The Homelessness Community Capacity Building Steering Committee 2008 Ottawa, ON). Mental health disorders, including substance abuse, are common in this population, are often under treated and can be a source of considerable distress and disability. In addition to the high rates of mental disorder, there are three other significant factors which impact morbidity. First, a history of significant childhood trauma is common which impacts relationships and ability to cope with difficulties. It is increasingly recognized that a trauma informed approach to providing services to the homeless population is needed. There have been no randomized controlled trials of treatment of post-traumatic stress disorder in the homeless population. Second, brain dysfunction from head injuries and attention deficit disorder appear to be common. Problems with brain dysfunction can cause difficulties especially with attention, impulsivity and managing relationships. Finally, life for the marginally housed can be chaotic with day-to-day uncertainty over accommodation, income and security. This means that providing health services to this population requires a degree of flexibility in terms of who provides services, where and when. These issues result in a population with complex needs that traditional mental health care is poorly equipped to serve. At present there is a clear gap in the provision of services that address the experience of trauma in homeless individuals. There are no services for trauma in publicly funded hospitals, which leaves private providers as the sole source of treatment. Other potential barriers include accounting for the effects of substance abuse, brain injury and "chaos" in this population. What the investigators are proposing is a pilot study to assess the feasibility and acceptability of providing a time-limited assessment and therapy (six sessions) within the shelter system to homeless individuals diagnosed with post-traumatic stress disorder.

NCT ID: NCT03781167 Completed - Clinical trials for Parkinson's Disease (PD)

A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Start date: April 29, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.