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NCT ID: NCT05664620 Recruiting - Clinical trials for Post-Concussion Syndrome

Post Concussion Symptoms Risk Stratification Tool

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

Patients with Persisting Concussion Symptoms (PCS) have a multitude of different symptoms. Some patients are at risk of prolonged symptoms but currently there is no tool to assist in identifying patients at high risk. Intensive, multidisciplinary intervention is time-consuming and expensive and may not be warranted for all PCS patients, so it is essential to identify early on which patients are at risk of prolonged symptoms. The aim of this study is to improve the quality of care delivered to patients, especially those who are at high-risk of prolonged PCS by early identification and treatment of all the symptoms. The purpose of this research is to validate the use of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool (RST).

NCT ID: NCT05664399 Recruiting - Clinical trials for Physiologic Responses to Surprise Events

Shock Factor: Effects of Surprise on Cardiovascular Responses.

Start date: November 24, 2022
Phase:
Study type: Observational

This research will determine the breathing, heart rate and other responses to four surprise events. For two events, virtual reality goggles will be used to create a realistic experience of falling out of a boat and rolling out of a boat or falling of a paddleboard. Two final events will involve falling into a dunk tank with either cool (20℃) or cold (10℃) water.

NCT ID: NCT05664009 Recruiting - Fatigue Clinical Trials

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults. The change in the severity of CRF from baseline at week 12 will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, and compared between Redsenol-1 Plus and placebo groups. Additionally, the safety and tolerability of Redsenol-1 Plus, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).

NCT ID: NCT05663970 Recruiting - Clinical trials for Autism Spectrum Disorder

Virtual Group Social ABCs - Multi-site Randomized Controlled Trial

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

The goal of this randomized control trial is to test the efficacy of the Social ABCs 6 week, group-based model using a virtual delivery platform. The Social ABCs is a caregiver-mediated early intervention program, aiming to increase child skills in directed, intentional vocalizations, and shared smiling with a primary caregiver for toddlers identified as early signs or a confirmed diagnosis of autism spectrum disorder (ASD), or having related social communication challenges. A positive RCT was previously completed using the program's in-person individual, 12-week model, and a pilot study showing preliminary promise of the virtual group-based model has also been published. This adaptation to a virtual, group-based model maintains the core components of the intervention, but allows caregivers to meet and discuss the content as a group from their home environments and complete the program in a shorter timeframe. The main questions it aims to answer are: - Is the Social ABCs virtual group-based model an effective early intervention program for toddlers aged 12-42 months with probable or confirmed ASD, or experiencing social communication challenges, when compared to an active control condition? - Can primary caregivers of these toddlers achieve implementation fidelity in the Social ABCs intervention strategies using the 6-week virtual delivery model? Participants will be randomized into the treatment condition (A) where they will receive the Social ABCs virtual group-based intervention or, into a Control condition (B), where they meet virtually with other caregivers in the control groups over the course of 6 weeks, viewing and discussing 3 didactic presentations around general child development content (not autism- or Social ABCs-specific). Video and questionnaire data will be collected before (Time 0) and after (Time 1) the 6 week period. After an additional 6-8 weeks, the same data will be collected from both groups as a follow-up time point (Time 2). Researchers will compare the Treatment group and the Control group to measure change in the target behaviours for the child, the caregiver's use of strategies, as well as caregiver stress and self-efficacy, across time-points.

NCT ID: NCT05663918 Recruiting - Clinical trials for Mild Cognitive Impairment

The Effects of Exercise on Synaptic Plasticity in Individuals With Mild Cognitive Impairment and in Healthy Aging.

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

The research is focused on ameliorating cognitive decline in aging and in individuals diagnosed with Mild Cognitive Impairment (MCI). In the proposed research, we ask whether synaptic plasticity is modified by exercise in these groups and if these changes relate to improved cognition. We know that cognition improves with exercise, but if we discover that synaptic plasticity is indeed modified by exercise, this opens many possibilities for us to explore new approaches to change synaptic plasticity in these populations. We view this project as benefiting all aging individuals, with or without MCI, since we are working to improve cognition. Understanding the mechanisms will help design better therapeutic strategies for older adults.

NCT ID: NCT05663892 Recruiting - Hiv Clinical Trials

Drug-Drug Interaction Study in Trans Women Living With HIV

T-DDI
Start date: November 23, 2022
Phase: Phase 4
Study type: Interventional

Introduction: Transgender (trans) women have been found to be at higher risk of and to be disproportionally affected by HIV. Trans women with HIV have also been found to have low usage and adherence rates to antiretroviral therapy (ART). Both healthcare providers and trans women, themselves, have expressed concerns of drug-drug interactions (DDIs) between ART drugs and feminizing hormones, which have in turn been shown to contribute to low rates of ART usage amongst trans women with HIV. The objective of this DDI study is to investigate the pharmacokinetic effects of the common feminizing hormone regimens (oral estradiol with an anti-androgen (pharmaceutical and/or surgical and/or medical) on the antiretroviral combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and vice versa. Methods and Analysis: Participants will be assigned to three groups: group 1 will include 15 trans women with HIV who are taking feminizing hormones and ART (investigational group); group 2 will include 15 premenopausal cis women with HIV taking ART (ART control group); group 3 will include 15 trans women without HIV taking feminizing hormones (hormone control group). Women with HIV will have to be virally suppressed for at least three months and they will have to already be taking B/F/TAF or have their current ART regimen switched to B/F/TAF at baseline. Trans women participants will be required to be on 2 mg oral estradiol or higher and an anti-androgen (pharmaceutical, medical or surgical). Plasma ART drug concentrations will be sampled at the 2-month visit and compared among trans women with HIV on feminizing hormones and premenopausal cis women with HIV. Serum estradiol and total testosterone concentrations will be sampled at the baseline and month 2 visits and compared among trans women with and without HIV. If successful, this trial will serve to provide empirical evidence regarding a lack of, or presence of DDIs between B/F/TAF and feminizing hormones. Dissemination: The findings will be disseminated through publication in peer-reviewed journals as well as presented at national and international conferences and community groups.

NCT ID: NCT05662319 Recruiting - Hemophilia Clinical Trials

A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia

ATLAS-NEO
Start date: February 1, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia. The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment. The total study duration will be up to approximately 50 months (200 weeks, 1 study month is equivalent to 4 weeks) and will include: - A screening period up to approximately 60 days, - A standard of care (SOC) period of approximately 6 study months (24 weeks), - A fitusiran treatment period of approximately 36 study months (144 weeks), - An antithrombin (AT) follow-up period of approximately 6 study months (24 weeks) but may be shorter or longer depending on individual participants AT recovery. The frequency for telephone visits will be approximately every 2 weeks. For site visits the frequency will be approximately every 8 weeks during the SOC period and approximately every 4 weeks during the fitusiran treatment period. If applicable and if allowed by local regulation, home and/or remote visits may be conducted during the study

NCT ID: NCT05662241 Recruiting - Clinical trials for IgG4 Related Disease

A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

INDIGO
Start date: September 30, 2022
Phase: Phase 3
Study type: Interventional

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

NCT ID: NCT05661578 Recruiting - Clinical trials for PD-L1-selected Solid Tumors

A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

SKYSCRAPER-11
Start date: May 4, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.

NCT ID: NCT05661448 Recruiting - Schizophrenia Clinical Trials

Promoting Cognitive Health in Schizophrenia

iCogCA
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to effectively implement virtually-delivered interventions in mental health institutions nationwide to improve the cognitive health of individuals living with schizophrenia. The main objectives are: - To determine the clinical effectiveness of two virtual cognitive health interventions (i.e., Action-Based Cognitive Remediation or MetaCognitive Training). - To evaluate our implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform to train mental health practitioners. Participants will be assessed for the severity of symptoms, cognitive performance, and overall functioning before and after receiving the intervention. Qualitative interviews will also be conducted with participants and therapists to evaluate the implementation strategies.