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NCT ID: NCT05903651 Completed - Healthy Clinical Trials

Retinal Deep PhenotypingTM

Start date: April 3, 2023
Phase:
Study type: Observational

This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications. A sub-set of the images will also be analyzed by eye specialists to determine if visual inspection of the images could provide useful information in their practice. As an exploratory study, there are no endpoints per se, however the following sub-objective will be evaluated for determining the success of this study: - Collection and characterization of MHRC retinal images from at least 2000 participants that score at least 80 on the real-time Quality Index (included in the MHRC software). - Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting. - At least 5% of participants shall have an MHRC retinal image reviewed by an eye specialist (Optometrist or Ophthalmologist) to assess the image quality and potential clinical usefulness.

NCT ID: NCT05899829 Completed - Healthy Clinical Trials

Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant

Start date: June 21, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.

NCT ID: NCT05896761 Completed - Clinical trials for Human Immunodeficiency Virus Type 1 (HIV-1)

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M [A2M]) study (NCT03299049).

NCT ID: NCT05896748 Completed - Clinical trials for Human Immunodeficiency Virus Type 1 (HIV-1)

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).

NCT ID: NCT05895916 Completed - Clinical trials for Cardiovascular Diseases

Extreme Exercise and Energy Expenditure (4E) Study

Start date: June 7, 2018
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to provide evidence, through an extreme exercise prescription (1,144 km of road cycling on seven consecutive days), that weight loss is not the appropriate outcome to evaluate the effects of exercise on abdominal adiposity and ectopic fat depots (e.g. liver fat and epi/pericardial fat) in eleven recreational middle-aged male cyclists (aged 50 to 66 years) without symptoms of cardiovascular disease. The main questions it aims to answer are: - If energy intake is substantially increased to compensate energy expenditure and prevent weight loss following an extreme exercise prescription, will significant changes in body composition and body fat distribution be observed? - Will these changes translate into improvements in the cardiometabolic health profile even in the absence of weight loss? Participants will be asked to partake in several evaluations: fasting plasma lipoprotein-lipid profile and inflammation markers, glycated hemoglobin, cardiorespiratory fitness, submaximal exercise test including measurement of energy expenditure, resting and exercise blood pressure and heart rate, evaluation of regional adiposity, liver fat content, epi/pericardial fat, nutritional quality, and level of physical activity. After baseline evaluations, participants will be asked to alternately bike 208 km and 104 km per day on a pre-specified course for seven consecutive days. They will be accompanied during each of the seven bike rides by research professionals in a recreational vehicle. Participants' weight, body composition and waist circumference will be measured under standardized conditions in the morning after an overnight fast and after the exercise. Their heart rate will be continuously monitored, and participants will wear accelerometers to estimate their daily exercise-related energy expenditure. Foods and fluids will be provided to participants and recorded. At the end of the 1,144 km/ 7-days bike ride, baseline evaluations will be repeated with the exception of the maximal exercise treadmill test, nutritional quality, and level of physical activity. To facilitate the conduct of the protocol, the eleven participants will be evaluated and followed in two distinct groups.

NCT ID: NCT05894356 Completed - Infertility, Male Clinical Trials

The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation

Paternal Clock
Start date: June 10, 2023
Phase:
Study type: Observational

Sperm DNA fragmentation (SDF) serves as a marker for chromatin and DNA damage in sperm. Assessing sperm DNA integrity is crucial in male fertility evaluation since high levels of SDF are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects. Recent research suggests that advanced paternal age (APA) may lead to DNA damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high SDF levels occur. With the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.

NCT ID: NCT05890144 Completed - Education Clinical Trials

RCT of Intensive, Brief, and Control Indigenous Cultural Safety Training Interventions for Health Care Providers

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Despite Canada's relative global affluence, striking Indigenous/non-Indigenous health disparities persist. Following the release of the Truth and Reconciliation Commission of Canada's Final Report, and the publication of the First Peoples, Second Class Treatment report, there has been a growing recognition that the Canadian healthcare system - and the healthcare professional (HCP) - Indigenous patient relationship in particular - is a critical, necessary, and promising juncture for intervention. There has been a significant increase in the number of Indigenous cultural safety trainings for HCP across Canada. However, these programs have yet to be systematically evaluated. This study will use a randomized parallel group design to understand and compare the effects of an intensive multi-modular Indigenous cultural safety training program (Arm 1); a brief, 2-hour, computer-based training session plus 2 follow-up emails (Arm 2); and primary care-related training program (Arm 3, control) for staff physicians, nurse practitioners, and resident physicians affiliated at large urban academic teaching hospitals in Toronto, Canada. 60 participants will be recruited and randomized into one of the three study arms. Participants will complete a series of surveys and questionnaires at baseline and 9-11 weeks post-intervention that include measures of explicit and implicit race bias. We predict that the educational intervention in Arm 1 will have the most positive effect, followed by Arm 2 and 3 respectively. We anticipate that the results of this study will help urban hospitals implement Indigenous cultural safety training programs that are beneficial to their staff and ultimately improve the quality of care provided to Indigenous patients across Canada.

NCT ID: NCT05886153 Completed - Blood Pressure Clinical Trials

Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (VERDICT-2)

VERDICT-2
Start date: August 22, 2023
Phase: N/A
Study type: Interventional

The VERDICT-2 verification study will examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants. The objective is to determine the accuracy of continuous non-invasive vital signs metrics including respiration, pulse rate, oxyhemoglobin saturation (SpO2), core temperature, heart rate, and cNIBP against standard comparator devices guided by consensus standards.

NCT ID: NCT05881395 Completed - Labor Pain Clinical Trials

Assessment of Sensory Block During Labour Epidural Analgesia in Patients Experiencing Pain During First Stage of Labour.

Start date: June 16, 2023
Phase:
Study type: Observational

Epidural analgesia is the gold standard for pain control during labour and an essential component of delivering effective and safe epidural analgesia is the assessment of the epidural sensory block. There is significant literature on the assessment of sensory block during spinal anesthesia for cesarean section but limited studies exploring the assessment of sensory blockade in labour analgesia. Prior studies have documented two thresholds of sensory block to both ice and pinprick: one defined as the lower sensory block level (LSBL) where the patient is able to notice a cold or sharp sensation but perceives that is not as sharp or cold as a control area and the other the upper sensory block level (USBL) where the patient perceives the cold or sharp sensation is at the same temperature or sharpness as the control area. The goal of this study is to contribute to the standardization of the assessment of sensory block levels during labour epidural analgesia by studying patients with labour epidurals who are experiencing pain and determining the LSBL and USBL and how these change as the patients become comfortable following the administration of manual epidural top ups.

NCT ID: NCT05881122 Completed - Multiple Sclerosis Clinical Trials

Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability

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

This study investigated the effects of a 2-part dietary consultation on adherence to an anti-inflammatory diet in individuals with neuromuscular disability. The effects on self-efficacy for adhering to the diet as well as neuropathic pain and depression one month post-consult were also determined.