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NCT ID: NCT04894448 Recruiting - HIV Infections Clinical Trials

Immunogenicity of COVID-19 Vaccination in PLWH

HIV-COV
Start date: June 10, 2021
Phase:
Study type: Observational

Various facts support the study of COVID-19 vaccine immunogenicity in People Living With HIV (PLWH) at this time: (1) Many PLWH in Canada will be eligible to receive COVID-19 vaccination as they are in a high priority risk group, such as residents or staff of shared living facilities for seniors, health care workers with direct patient contact, aged 70 years of age or older, or adults in Indigenous communities; (2) As vaccines against many other pathogens, it is plausible that the current standard vaccination strategy of COVID-19 is less effective in PLWH; (3) The potential burden of significant COVID-19 infection in PLWH is likely large given many PLWH are aging and have co-morbidities known to predispose to worse COVID-19 outcomes; (4) The vaccine clinical trials which include PLWH63, have stringent exclusion criteria, making results non-generalizable to many PLWH such as those with lower CD4 counts. With the rapid roll-out of COVID-19 vaccination, many PLWH will be receiving the COVID-19 vaccine. Through vaccination, the provision of the same dosage of antigen stimulation to all individuals will result in a controlled method to measure immune response in PLWH. Therefore, we propose to develop a pan-Canadian cohort of PLWH receiving a COVID-19 vaccine(s) to assess a spectrum of immune responses. We also aim to assess the safety and tolerability of the COVID-19 vaccines in PLWH. These data may provide support for the use of one vaccine product over another and for exploring alternate vaccination strategies in PLWH (i.e., increased dose or double-dose vaccination and so forth).

NCT ID: NCT04893863 Recruiting - Burns Clinical Trials

A Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries

Start date: October 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajetâ„¢) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.

NCT ID: NCT04893850 Recruiting - Depression Clinical Trials

Building Regulations in Dual Generations at KIDTHINK

Start date: April 14, 2021
Phase: N/A
Study type: Interventional

Neurodevelopmental disorders (NDDs) such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and intellectual disability (ID) are the most frequently diagnosed disability in children, accounting for 7% to 14% of children in developed countries. Developmental concerns emerge early, providing an opportunity to support families years before a diagnosis may occur. Emerging concerns are often predictive of problems with self-regulation, risky behaviours (e.g., substance abuse and over-eating), academic achievement, social functioning, parent-child relationship, and lower overall quality of life. Overall family wellbeing is also commonly affected given the increased challenges faced by parents and caregivers, including socioeconomic disadvantage. Parents facing hurdles to positive parenting, such as poor psychological wellbeing, may struggle further with parenting capacity in the context of the increased parenting demands of caring for a child with specific needs. The objective of this study is to create a novel adaptation of an existing program that is targeted at improving the mental wellness and parenting practices of caregivers (mothers, fathers, guardians) with elevated symptoms of depression who have 3 to 8-year-old children with emerging behavioural, emotional, or developmental concerns. It is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the caregiver, child, and dyad (i.e. parenting interactions) will improve both caregiver capacities and child outcomes. Further, it is hypothesized that this novel adaptation of the program will be tailored to meet the identified needs of this demographic and that the program will show improvement in psychosocial, emotional, and parenting function compared to a services as usual control group. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The ultimate goal of this project is to improve parent wellbeing and promote supportive parenting practices that allow children with early developmental needs to reach their full potential.

NCT ID: NCT04893525 Recruiting - Opioid-use Disorder Clinical Trials

Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments

Start date: July 23, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-centre, open-label RCT at four Emergency Departments (EDs) in British Columbia and Alberta. The purpose of the current study is to compare the effectiveness of buprenorphine/naloxone microdosing and standard dosing take-home induction regimens at enabling patients to successfully complete the induction regimen, and at retaining patients on opioid agonist therapy. We will randomize our enrolled patients to receive take-home microdosing or standard dosing packages of buprenorphine/naloxone. For the microdosing arm, patients immediately start taking low doses that increase to effective levels without requiring them to go into withdrawal. We hypothesize that ED patients provided buprenorphine/naloxone microdosing packages will be more likely to successfully complete the induction period compare to patients provided standard dosing packages. We furthermore hypothesize that those provided microdosing will be more likely to be retained in opioid agonist therapy, and will experience lower overdose, mortality, and healthcare utilization subsequent to their ED visit.

NCT ID: NCT04893369 Recruiting - Low Back Pain Clinical Trials

Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain

Start date: May 4, 2021
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and to collect data on the effectiveness of a previously validated approach that takes into account all the pain and disability drivers associated with low back pain - the Pain and Disability Drivers Management Model (PDDM). The overall objective is to provide data to assess the feasibility of implementing a multisite pragmatic cluster nonrandomized clinical trial to determine the effectiveness of the PDDM on short-term patient-related outcomes compared to the most recent clinical practice guidelines to improve the management of patients living with low back pain.

NCT ID: NCT04892173 Recruiting - Aged Clinical Trials

NBTXR3 With or Without Cetuximab in LA-HNSCC

Start date: January 5, 2022
Phase: Phase 3
Study type: Interventional

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.

NCT ID: NCT04891640 Recruiting - Clinical trials for Juvenile Spondyloarthritis

Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis

BACK-OFF JSpA
Start date: November 11, 2021
Phase: N/A
Study type: Interventional

This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 29 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.

NCT ID: NCT04891029 Recruiting - Diagnoses Disease Clinical Trials

Early Detection of Endometrial/Ovarian Cancer and Hereditary Predisposition of These Cancers

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Early stage high-grade cancer, endometrial and ovarian, has few, if any, symptoms or signs. When symptoms appear, the disease may be in advanced stage as the disease has left the gynaecological organs and metastasized to the pelvic/abdominal cavity. The McGill research group had showed in the DOvEE trial (NCT02296307), that fast-track assessment with transvaginal ultrasound scans (TVUS) and serial CA125 of women with vague symptoms associated with ovarian and endometrial cancer did diagnose these cancers earlier in the disease trajectory, with low-volume resectable disease, but only after the cancer had already become Stage III. One way to detect these cancers earlier is to screen asymptomatic women. Unfortunately, none of the currently available tests, including TVUS and CA-125 have been shown to be useful for screening for ovarian or endometrial cancer. The McGill team has developed a genomic assay to screen and detect these cancers earlier in the trajectory than is currently the case. The test identifies pathogenic somatic mutations (necessary early steps in the development of these cancers), in an uterine cytological sample. It is able to do so by incorporating a deep machine-learning derived classifier that can discriminate the mutational signature of these cancers from benign disease with a sensitivity of 70% and a specificity of 100% in a population with high background mutational burden. In addition to the intra-uterine cytological sample, the test includes an assay of a saliva sample to identify germline mutations that predispose to hereditary endometrial/ovarian cancers as well as breast and colon cancers. The test was developed in a retrospective population in whom the assay was done pre-operatively and the diagnosis of malignancy versus benign gynecological disease was confirmed by detailed pathological analysis of the uterus, tubes, and ovaries after surgical resection (NCT02288676). The test is now ready to be tested as a phase III diagnostic test in the general population to see if these results are just as promising in the community at large.

NCT ID: NCT04890951 Recruiting - Clinical trials for Pelvic Organ Prolapse

Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

HUPPS
Start date: July 1, 2020
Phase:
Study type: Observational

Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.

NCT ID: NCT04890938 Recruiting - COPD Clinical Trials

Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial

STRIVE
Start date: May 27, 2022
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a lung condition affecting 1 in 6 Canadians and does not have a cure. Flare-ups of COPD are the most common reason someone goes to hospital in Canada. This is made worse because within 30-days of having a flare-up, 1 in 5 patients will come back to hospital for the same problem. Flare-ups of COPD often have many causes and these are different person to person. Sometimes it is related to behaviours such as smoking or not using medicines properly. Other times, it is from lung inflammation. Education programs that help people learn about their disease and maintain healthy behaviours, and using phlegm to decide on which medicines will be useful, have been studied separately and appear to work, but many people still have flare-ups. To help fix this problem, we need to look carefully at each patient, to make sure they are on the right medicine but also have the right behaviours and support to benefit from medical care. The goal of this project is to see if patients who are taught the right behaviours and have their lung inflammation controlled with the right medicines will have fewer COPD flare-ups than those who get normal care.