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NCT ID: NCT05693272 Active, not recruiting - Clinical trials for Severe Acute Respiratory Syndrome Coronavirus 2 Infection

A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults

Start date: January 31, 2023
Phase: Phase 1
Study type: Interventional

VIDO has developed a vaccine called COVAC-1. The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0. The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years. Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.

NCT ID: NCT05690815 Active, not recruiting - HIV Prevention Clinical Trials

Express Testing and Same-day Initiation of PrEP Study

Express-PrEP
Start date: January 24, 2023
Phase:
Study type: Observational

This study is an observational cohort study to measure the impact of express testing and same-day initiation of Pre-Exposure Prophylaxis (PrEP) on outcomes related to the PrEP cascade. The investigators expect that same day initiation for PrEP will improve PrEP uptake. The investigators hypothesize that baseline HIV test positivity will be higher than that of general testing for gbMSM in Ontario. This is a key indicator to determine whether this targeted approach is able to access the highest risk population.

NCT ID: NCT05688852 Active, not recruiting - Crohn Disease Clinical Trials

VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease

Harmony-CD
Start date: December 22, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT05678985 Active, not recruiting - Aging Clinical Trials

Evaluating Impact and Implementation of Choose to Move (Phase 4)

CTM
Start date: September 17, 2020
Phase: N/A
Study type: Interventional

The objectives of this study are to: 1) evaluate whether Choose to Move (CTM) Phase 4 improves health outcomes in older adults who participate and 2) assess whether CTM Phase 4 is delivered as planned and what factors support or inhibit its delivery at scale. CTM Phase 4 is a 3-month, choice-based program for low active older adults being scaled-up across British Columbia (BC), Canada. The goals of CTM are to enhance physical activity, mobility and social connectedness in older adults living in BC, Canada.

NCT ID: NCT05669599 Active, not recruiting - Obesity Clinical Trials

Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

The study aims to compare and assess the dose response of 3 selected doses of AMG 133 compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).

NCT ID: NCT05665595 Active, not recruiting - Melanoma Clinical Trials

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Start date: January 19, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

NCT ID: NCT05663346 Active, not recruiting - Nurse's Role Clinical Trials

Cannabis and Cancer, an Online Training for Oncology Nurses

Start date: January 4, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the preliminary effects and impacts of a digital educational intervention to support nurses' professional practice regarding safe cannabis use by young adults (18-39 years) diagnosed with cancer.

NCT ID: NCT05661058 Active, not recruiting - Frailty Clinical Trials

Mapping Sedentary Behaviour in Older Adults Who Are Frail

MAPS-B
Start date: February 13, 2023
Phase:
Study type: Observational

The purpose of this study is to map the context of sedentary behaviour among older adults who are frail. This study uses a unique combination of objective and self-report measures to assess context. The investigators will also hold focus groups to understand which behaviours can be modified and conduct an analysis to understand which types of behaviours are associated with negative health outcomes.

NCT ID: NCT05656404 Active, not recruiting - Lung Transplant Clinical Trials

TorEx Lung Perfusion System

Start date: December 6, 2022
Phase: N/A
Study type: Interventional

Lung transplantation is a life-saving and life-prolonging therapy for patients with end-stage lung disease. However, the number of patients listed for lung transplantation exceeds the number of available donor lungs, leading to long wait times, deterioration in health and death of some listed patients. One way to address this issue is to reduce the number of donor lungs that are deemed unusable (declined) for transplantation. Often, donor lungs are declined for transplantation based on questionable function or inability to fully assess the organ in the donor. Due to this reason, up to 80% of potentially suitable lungs may be discarded. As a result, ex vivo lung perfusion (EVLP) was developed. EVLP is a technique that enables the donor lungs to function in near physiological conditions outside the body, allowing surgeons to evaluate the suitability of the donor lungs for transplantation. Using this technique, centers have reported the recovery of around 70% of donor lungs that would have otherwise been deemed unusable and discarded. The first generation Toronto EVLP technique started as a clinical trial in 2008 and became a part of the clinical standard of care at Toronto General Hospital in 2011. Since then, many clinical studies have shown that short- and long-term outcomes of recipients who received donor lungs assessed by the Toronto EVLP system were similar to those who received donor lungs deemed suitable to go straight to transplantation. In partnership with Traferox Technologies Inc., surgeons and research team members developed the second generation TorEx Lung Perfusion System, which addresses engineering design limitations of the original Toronto EVLP system. It optimizes the Toronto EVLP technique by combining all the necessary equipment required to perform the procedure, while placing their controls within a central location. The technique of perfusion and ventilation as well as the perfusate solution remain the same between the two EVLP systems. Prior to this study, the TorEx Lung Perfusion System has not been used in clinical human lung transplantation. The first purpose of this study is to look at the safety of using the TorEx Lung Perfusion System in 20 consented recipients. The second purpose to compare post-transplant outcomes between recipients who received donor lungs assessed by the TorEx Lung Perfusion System and a historical cohort of recipients who received donor lungs that were assessed by the first generation Toronto EVLP system.

NCT ID: NCT05651711 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

ROCKET-Horizon
Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

The co-primary objectives of the study are to: - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).