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NCT ID: NCT05231668 Recruiting - Clinical trials for Osteogenesis Imperfecta

Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)

Start date: August 25, 2022
Phase: Phase 1
Study type: Interventional

SAR439459 is a human anti-Transforming growth factor β (TGFβ) monoclonal antibody. This phase 1 clinical study investigates the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with OI. Participants will receive a single IV dose of SAR439459 with safety, pharmacokinetic (PK), and pharmacodynamic (PD) assessments over 24 weeks. There will be up to 3 dose cohorts. In addition to safety, tolerability, and PK assessments, bone mineral density (BMD) will be evaluated by dual-energy Xray absorptimetry (DXA) scan and a series of blood biomarkers will be monitored to document pharmacodynamic effects of the single dose of SAR439459.

NCT ID: NCT05231343 Recruiting - Clavicle Fracture Clinical Trials

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

COMPACT
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.

NCT ID: NCT05230758 Recruiting - Clinical trials for Cognitive Impairment

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

Met Med Can
Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children/adolescents treated for medulloblastoma will be investigated in a multi-site Phase III randomized double-blind placebo-controlled parallel arm superiority trial. Specifically, in children/adolescents aged 7 years to 17 years and 11 months who have completed treatment for medulloblastoma, is oral administration of metformin for 16 weeks associated with greater improvement of cognitive function and brain growth compared to placebo administered for 16 weeks?

NCT ID: NCT05228782 Recruiting - Loneliness Clinical Trials

COVID-19 and Social Isolation and Loneliness Trial

SIL
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada. We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers. Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm. We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.

NCT ID: NCT05228106 Recruiting - Solid Cancers Clinical Trials

68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study

Start date: January 21, 2022
Phase:
Study type: Observational

This project aims to monitor the innocuity/safety profile of cyclotron-produced [68Ga]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for [68Ga]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA. This study also aims to instigate the use of [68Ga]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.

NCT ID: NCT05227989 Recruiting - Clinical trials for Post Intensive Care Syndrome

Outcome of Children Post Mechanical Ventilation

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

Mechanical ventilation is a life-saving therapy widely used in PICU, but not without adverse effects. The mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. This lack of knowledge can lead to delays in management and thus hinder the recovery of children. The aim of this study is to determine the impact on the functional and respiratory outcome of pediatric patients after a stay a PICU of the province of Quebec.

NCT ID: NCT05227287 Recruiting - Clinical trials for Autosomal Dominant Hypocalcemia

ADH1 and ADH2 Disease Monitoring Study (DMS)

CLARIFY
Start date: January 20, 2022
Phase:
Study type: Observational

A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

NCT ID: NCT05227144 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma

Start date: January 6, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options

NCT ID: NCT05226637 Recruiting - Spasticity, Muscle Clinical Trials

Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.

Start date: April 29, 2022
Phase: N/A
Study type: Interventional

Background Effective management of spasticity, a debilitating and challenging condition afflicting many recovering from and living with neurological conditions, may reduce long term consequences such as limb contracture, skin breakdown, compromised mobility, caregiver burden and discomfort. In rehabilitation, spasticity represents a significant barrier to successful rehabilitation outcomes. Effective spasticity management can increases the length of individual functional status, reduces equipment/care needs, hospital admissions and extends the time people can stay safely at home, which would represent an economic benefit to the health system. Extra-corporeal Shock Wave Therapy (ESWT), an intense short energy wave delivered directly at the region of affected muscles has, in past randomized controlled studies, demonstrated positive outcomes for this population (spastic stroke population, TBI), on its own and as an adjunct to current modalities. In fact, one retrospective observational study demonstrated an increased efficacy of Toxin botulinum at 1 month when combined with ESWT. Where existing treatment options may be limited by coverage, access to delivery, complications and side effects, ESWT represents a potential to be a safe, low cost, efficacious alternative that can be administered by any trained clinician. Aims The aims of this pilot study will be to explore the hypothesis that adding ESWT to Botulinum Neurotoxin A (BoNTA) in spasticity post-stroke (TBI)will demonstrate greater clinical and patient reported outcomes compared to standard treatment with BoNTA alone, a comparison only once previously studied. Methods Incorporating randomization and placebo control (n= 20 in each arm), this patient-centric study will examine treatment goals and holistic perception of benefit after the treatment experience. We will use patient reported outcomes at baseline and at defined intervals after intervention. We will test our hypothesis using clinical and patient reported scales, such as the patient reported numeric rating scale (NRS) and goniometric range for spasticity as our primary outcome in conjunction with measures of muscle stiffness, quality of life, feasibility and acceptability of the protocol to help inform future study direction.

NCT ID: NCT05226624 Recruiting - Clinical trials for Neonatal Abstinence Syndrome

The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

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

Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has become more common in the last 10 years. Babies with NAS can be very difficult to care for with poor feeding, diarrhea, and extreme irritability. These babies often receive specialized care and medications in the Neonatal Intensive Care Unit (NICU), which leads to separation of mothers and babies at a time when it is most important that they be together. This separation is traumatic for families and expensive for the health and foster care systems, as babies often end up being cared for by governmental agencies. Recent research has shown that keeping mothers and babies together in a quiet, supportive environment in hospital, called 'rooming in', leads to a decreased need for NICU admission, decreased amount of time spent in the NICU, increased rates of breastfeeding, and an increase in babies going home with their mothers. This project will systematically introduce a program of 'rooming-in' to hospitals in Alberta to determine if the investigators can improve NAS care provided to babies and mothers. The goal is to decrease NICU admission and length of stay, increase the number of babies going home with mothers, increase breastfeeding rates, and increase the number of women enrolled in supportive programs for substance use. The investigators will also determine if this rooming-in model of care decreases health and societal costs associated with caring for babies with NAS.