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NCT ID: NCT05451979 Recruiting - Pediatric ALL Clinical Trials

HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)

Start date: February 22, 2022
Phase: N/A
Study type: Interventional

Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant. With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This includes strategies aimed at optimizing cardiorespiratory fitness and physical activity levels. Pediatric and adult HTRs have reduced exercise capacity compared with the general population. Previous groups have shown gradual improvements in heart rate response to exercise and exercise capacity in pediatric HTRs. However, after an initial improvement, exercise capacity appears to plateau, or even decline in pediatric HTRs, and remains sub-optimal compared with the general population. Most exercise interventions in HTRs to date have focused on moderate-intensity continuous exercise (MICE), with some resistance components incorporated. More recently, high-intensity interval training (HIIT), consisting of short, intense bursts of exercise with rest periods, has been explored in the adult HTR population, with findings to date suggesting that it may yield greater improvements in cardiorespiratory fitness compared with MICE. Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are linked with improved long-term post-transplant outcomes and well-being. Unfortunately, trials of exercise interventions in pediatric HTRs remain lacking. This study team is proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enable video game linked customizable cycle ergometer (MedBIKE™).

NCT ID: NCT05451875 Not yet recruiting - Hypertension Clinical Trials

Comparison of Continuous Non-invasive All Vital Signs Monitoring Devices With Invasive Gold Standard for Children

VT
Start date: January 15, 2023
Phase:
Study type: Observational

In this clinical study, the investigator will compare vital signs measurements obtained using the non-invasive, wireless VitalTracert monitoring devices (both a VT-Watch and a VT-Patch) to a proprietary continuous physiological data collection tool in 40 patients including 16 patients with an invasive arterial line catheter (radial or femoral) at the pediatric intensive care unit.

NCT ID: NCT05451277 Recruiting - Clinical trials for Cardiovascular Diseases

At the Heart of the Matter - Speckle Tracking Echocardiography in Lupus Mothers and Their Offspring

Start date: April 1, 2021
Phase:
Study type: Observational

Women with systemic lupus erythematosus (SLE) have a high risk of placenta-mediated complications, which can lead to substantial cardiac morbidities in affected women and their offspring. In addition, maternal autoantibodies, which are actively transferred across the placenta during pregnancy, can affect the cardiovascular health of SLE offspring. Hydroxychloroquine (HCQ) is effective in preventing adverse pregnancy outcomes in SLE and might be beneficial in preventing fetal cardiovascular damage mediated by maternal autoantibodies. However, there are concerns that HCQ might cause maternal and neonatal cardiac toxicity. A novel imaging technique (i.e. speckle tracking echocardiography), which allows early identification of cardiac dysfunction, has proven superior to any other in assessing cardiac function in mothers and neonates experiencing placenta-mediated complications and in identifying drug cardiotoxicity. Yet, there has been no study using speckle tracking echocardiography to evaluate the cardiovascular health of pregnant SLE women and their offspring, as well as the potential adverse cardiac effect of HCQ. Moreover, due to unavailability of assays, HCQ dosing in SLE is generally done blindly, without checking drug levels. To fill these key knowledge gaps, the investigators aim to: 1) assess the impact of placenta-mediated complications on maternal and neonatal cardiac function, 2) evaluate if HCQ exposure (as measured by whole-blood levels) is associated with maternal and neonatal outcomes including cardiac toxicity, and 3) determine the effect of maternal autoantibodies on neonatal cardiac function. Ultimately, our proposal will help optimize reproductive and cardiovascular outcomes in lupus women and their offspring.

NCT ID: NCT05451043 Recruiting - Pancreatic Cancer Clinical Trials

Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)

Start date: July 5, 2023
Phase: Phase 2
Study type: Interventional

A single-arm, interventional study combining Immunotherapy and propranolol with/without chemotherapy and propranolol 1. Pancreatic Cancer Durvalumab will be administered once every 4 weeks, in combination with gemcitabine + nab-paclitaxel (day 1/8/15) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients. 2. HCC Durvalumab will be administered once every 4 weeks in combination with continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients. 3. Biliary Tract Cancer (BTC, Cholangiocarcinoma of the gallbladder or bile ducts) Durvalumab will be administered once every 3 weeks, in combination with cisplatin + gemcitabine (day 1/8) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.

NCT ID: NCT05451004 Recruiting - Clinical trials for Oropharyngeal Cancer

SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer

SELECT
Start date: February 10, 2023
Phase: Phase 3
Study type: Interventional

This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?

NCT ID: NCT05450692 Active, not recruiting - Clinical trials for Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

LATIFY
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

NCT ID: NCT05450562 Recruiting - Neoplasm Clinical Trials

Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

Start date: September 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

NCT ID: NCT05450315 Completed - Behaviour Change Clinical Trials

Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors

Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA. The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial. Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months. Secondary endpoints will include changes in TPB constructs and quality of life. It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).

NCT ID: NCT05450198 Completed - Dermatitis, Atopic Clinical Trials

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)

Start date: August 8, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to severe atopic dermatitis who are unresponsive to other therapies.

NCT ID: NCT05450159 Recruiting - Drive Clinical Trials

The Refreshing Older Adults' Driving Skills (ROADSkills) Program

ROADSkills
Start date: October 17, 2023
Phase: N/A
Study type: Interventional

Drivers aged 65+ depend on their car(s) to get to the places and see the people that are important to them. Losing a license in later life has been linked to higher rates of loneliness, depression, and even admission to long-term care; a fact that is particularly relevant when considering the impact of the COVID-19 pandemic. While drivers in this age group are among the safest on the road, they have one of the highest risks of collision when distance driven is considered and are more likely to be seriously injured or killed. Motor vehicle crashes and falls are the top causes of injury-related hospitalizations in seniors. Through a partnership with older adults, driving instructors, and health professionals, we developed the Refreshing Older Adult Driving Skills (ROADSkills) program. This program uses a Global Positioning System (GPS) device that can be placed in people's cars, which can track their real-world, everyday driving patterns, including speeding and hard braking, alongside video data of their behind-the-wheel behaviour. Using this data, a personalized video will be created using information captured by the device in the older driver's car. This study will determine if the older drivers who receive this video feedback perform better than those who do not receive such feedback. Because this is the first time a study will use this type of behavioural intervention, we are interested in hearing from older drivers about their experience of participating in the study. The findings will help us to design a larger, national study of the ROADSkills program in Canada.