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NCT ID: NCT05629052 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

TrEatment Approach in the Multimodal Era Registry

TEAM
Start date: April 12, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: - surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) - the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) - drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: - How many patients receive a given kind of treatment? - How do expert centers combine the different treatments? - Are patients doing better after they receive a given kind of treatment? - How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.

NCT ID: NCT05628753 Completed - no Conditions Clinical Trials

Lung Ultrasound as a Predictor for Successful Extubation in Preterm Infants

LUSE
Start date: July 14, 2019
Phase:
Study type: Observational

unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Hatch et al (2016) in their prospective study on 162 infants described adverse events in 40% of intubations and severe complications including need for CPR in 9%. Reintubations are frequently associated with hypoxemia, bradycardia, fluctuations in blood pressures and cerebral perfusion. Each intubation attempt increases the risk of traumatic injury to the upper airway, lung atelectasis and infections. Thus, there is a clear need to establish objective criteria that would help avoid extubation failure and the need for reintubation. In recent years, a new imaging application has been introduced in neonatal practice-lung ultrasound (LUS), an accurate and reliable technique for the lung evaluation. LUS is safe, non-ionizing, easy to operate, and low-cost tool. The evaluation of lungs is performed in real-time, on the bedside and without anesthetic drugs. Lung aeration could be assessed in dynamics without extra radiation to the infant. Ultrasound findings combined with clinical information could be used for the prognosis of successful extubation in premature infants.

NCT ID: NCT05628727 Enrolling by invitation - Clinical trials for Psychological Stress

Intermittent Fasting Interventions on Brain Health in Women

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Adults experience high psychological stress due to many factors such as school, workplace, or personal life. Adult women are known to experience higher stress levels than men. Current evidence shows that fasting improves mental health outcomes in men. The research is unclear on fasting interventions and their potential impact on stress levels in women. In this study, investigators will compare two fasting diets over 8 weeks. There will be a control group, one group that fasts for two days per week, and a final group that only eats for 8 hours in the morning. Mental health surveys, brain tests and a blood draw will be done during the study to see any mental or physical changes from the diets. Investigators will study the motivation of women to continue the diet during and beyond the study through online surveys.

NCT ID: NCT05628337 Recruiting - Clinical trials for Coronary Artery Disease

The TEACH (Texting After ACS Discharge) Pilot Randomized Trial

Start date: June 16, 2022
Phase: N/A
Study type: Interventional

Although there have been substantial advances in the treatment of heart disease, heart attacks remain one of the leading causes of death and suffering around the world. Each year, more than 80,000 patients are hospitalized with heart attacks or related conditions in Canada. Even after discharge, patients are at high risk of having complications such that almost one in two patients after a heart attack will be readmitted to hospitals within the first year. Given the shortage of doctors and allied health care professionals, there is an emerging focus of digital health as a way to improve the care and outcomes after heart attacks. With more than 30 million cell phone users across Canada and almost all are already using text message services, the goal of this study is to conduct a pilot test using an innovative clinical trial design to see if the care and outlook of heart attack patients using mobile text messages can be improved.

NCT ID: NCT05628025 Completed - BPH Clinical Trials

Simulation-Based Enucleation Training: Initial Experience Using 3D-printed Organ Phantoms

Start date: November 23, 2021
Phase:
Study type: Observational

There are many possible surgical treatments when a patient presents with lower urinary tract symptoms due to an enlarged prostate, termed benign prostatic hyperplasia or BPH. One technique consists of using a laser to remove prostatic tissue through the penis, called laser enucleation of the prostate or LEP. LEP also has excellent properties to reduce blood loss and results in shorter hospital stays. Trainees must observe and perform several procedures before mastering the LEP technique. Different models have been used to mimic the LEP experience for surgeon trainees, such as virtual simulators or synthetic models. While these simulators offer an alternative to LEP procedures on real patients, they may lack realism which renders the simulator less representative than the real procedure.The 3D-printed prostate model of the present study mimics the properties of real-life prostatic tissue. In the setting of the MasterClass, trainees will perform LEP on the 3D models under the supervision of three experts. While the 3D organ phantom has been used to practice performing other procedures, this is the first time it will evaluated for LEP training. For this reason, the investigators will be assessing this model as a training tool.

NCT ID: NCT05627492 Recruiting - Bipolar Disorder Clinical Trials

Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder

DB2
Start date: November 9, 2022
Phase: N/A
Study type: Interventional

The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. There is no standard reference therapy/comparator against which the study intervention is being compared.

NCT ID: NCT05627362 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

ELMWOOD
Start date: January 27, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

NCT ID: NCT05626725 Recruiting - Type 1 Diabetes Clinical Trials

Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes

AIDE-1
Start date: December 1, 2022
Phase:
Study type: Observational

Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Automated insulin delivery systems (AIDs) combine an insulin pump coupled via an algorithm with a continuous glucose monitor (CGM), allowing constant adjustment of insulin doses according to blood glucose levels. Despite the significant improvement in blood glucose parameters and quality of life with these systems, they are not available to everyone and more and more people with diabetes are resorting to home-made or do-it-yourself (DIY) systems to access this technology. DIY systems are not approved or regulated by Health Canada, despite the growing interest. There have been no studies looking at this type of system in active people living with DbT1, including the risk of exercise-induced hypoglycemia. The primary objective of this study is to evaluate the safety and efficacy of IDA systems in physically active individuals living with type 1 diabetes.This is a real-life observational study in people with commercial IDA (control group) and IDA-DIY. This study includes only one inclusion visit (which may be virtual) and the observation period is 6 weeks. Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They will be required to wear a watch to record physical activity (FitBit). We will ask them to complete information about their diet at least twice a week for a whole day (Keenoa application). Finally, participants will be asked to complete a physical activity diary to complete data (carbohydrates in prevention of activity, insulin suspension, hypoglycemia during or after exercise, etc.).

NCT ID: NCT05626595 Recruiting - Child Development Clinical Trials

PROmoting Early Childhood Outside 2.0

PRO-ECO2
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Licensed early learning and childcare centres (ELCCs) can provide children with rich opportunities for outdoor play that they may not otherwise experience in their home or community. However, many ELCCs struggle to provide high quality and stimulating outdoor play time. The primary aim of this study is to develop, implement and test a comprehensive multi-component project, the PROmoting Early Childhood Outside (PRO-ECO), to build capacity for, and address the complexities of building support for outdoor play in early childcare centre settings. This is to ultimately increase children's access to engaging outdoor spaces for play. The overarching goal of this project is to develop and evaluate a comprehensive multi- component project, called the PROmoting Early Childhood Outside (PRO- ECO). This project is to increase children's outdoor play and the diversity of outdoor play behaviour in Canadian ELCC settings providing full-day licensed care for preschoolers. PRO-ECO integrates development of policies and procedure, early childhood educator (ECE) training and mentorship, outdoor space modifications and, parent/caregiver engagement. The PRO-ECO project will be co-developed, implemented and evaluated in partnership with provincial childcare organizations and ten ELCCs. A wait-list control cluster randomised trial design (RCT) will evaluate the effectiveness of the project and how it can be modified to tackle barriers in diverse settings. This project is an extension of the PRO-ECO pilot study (protocol ID H20-03912-A001, Clinicaltrials.gov ID NCT05073380).

NCT ID: NCT05626374 Not yet recruiting - Clinical trials for Substance Use Disorders

Comparing the Effect of Adding a Remote Self-reporting Tool for Distress and Fit-for-purpose Mental Health & Addictions Service to Usual Case Management on Dropout Rates in a Vocational Training Program

TeachMeToBuild
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Youth unemployment is a chronic problem in most societies. Some young adults are neither in employment, eduction or training (NEET), and are at high risk of chronic unemployment, social disengagement and poor quality of life. Identifying this high risk population and providing them with career skills training and opportunities is critical for their full participation in society. Vocational training programs provide an opportunity for these NEET youth to develop a skilled trade. Barriers to successful completion of these programs include high prevalence of mental health and substance use disorders among NEET youth. This study will use a daily self-report distress tool to identify vocational program trainees at risk of absence or drop-out due to mental health and/or substance abuse issues. These at-risk trainees will then be referred to a mental health crisis program through a fit-for-purpose referral process to accommodate their training program requirements. It is hypothesized that early identification and referral for mental health and substance abuse issues will reduce both program absence and drop-out rates and result in improved in long-term employment for these NEET youth.