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Gender clinical trials

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NCT ID: NCT04440761 Recruiting - Clinical trials for Myocardial Infarction

Barts-MINOCA Registry

Start date: July 1, 2020
Phase:
Study type: Observational [Patient Registry]

The last 15 years the introduction of primary angioplasty has radically improved outcomes for acute myocardial infarction (AMI). However, the system wide availability of prompt investigation has revealed an important group of patients where progress has stalled, the diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a clinical diagnosis of AMI. These patients present a therapeutic predicament since coronary revascularization is not appropriate. Guidelines do not exist for their management - yet the condition is not benign - the 12-month prognosis, although better than obstructive coronary artery disease patients is still guarded with recent data suggesting many questions remain unanswered.

NCT ID: NCT04157309 Completed - Pregnancy Related Clinical Trials

Alternating Urine Redox Status Of Consecutive Menstrual Cycles

ACDC
Start date: January 6, 2020
Phase:
Study type: Observational

This study will involve the collection and analysis of urine samples from non-pregnant women to determine the existence of alternating redox status between two consecutive menstrual cycles.

NCT ID: NCT04080193 Completed - Clinical trials for Overweight and Obesity

Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity

I-GENDO
Start date: December 7, 2019
Phase: N/A
Study type: Interventional

The major aim of the proposed study is to develop a gender-sensitive individually tailored add-on intervention that focusses on improving individual gender-specific SIRs (subjective illness representations) in obese or overweight individuals. We will investigate whether this will improve compliance with and long-term success of common weight loss interventions. The effectiveness of this intervention in every-day-life with regard to weight-related behavioral changes and weight loss will be evaluated within a randomized controlled setting.To enhance the applicability of the intervention in every-day-life and its dissemination we plan to develop a smart-phone-based intervention.

NCT ID: NCT04077151 Completed - HIV/AIDS Clinical Trials

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

NCT ID: NCT04077138 Completed - HIV/AIDS Clinical Trials

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development

Start date: January 1, 2019
Phase:
Study type: Observational

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

NCT ID: NCT03890237 Active, not recruiting - Adolescent Behavior Clinical Trials

GAGE Act With Her-Ethiopia Evaluation

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the impact of Act With Her Ethiopia (AWH-E), a gender transformative multi-level program that aims to improve the lives of young adolescent boys and girls.

NCT ID: NCT03884608 Active, not recruiting - Cardiomyopathies Clinical Trials

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

BIO-LIBRA
Start date: May 9, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.

NCT ID: NCT03743714 Not yet recruiting - Physical Activity Clinical Trials

Effects of Yoga Training on Postural Stability

Start date: December 2, 2018
Phase: N/A
Study type: Interventional

Postural stability can be affected by multiple factors. Such as; body mass, inactivity, age and etc. This study was planned with the aim of investigating the effects of Yoga training on postural stability of males and females. Yoga is a treatment model for body flexibility, body awareness, and strength.

NCT ID: NCT03652623 Completed - HIV/AIDS Clinical Trials

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study

Start date: July 23, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. The investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

NCT ID: NCT03534375 Completed - Gender Clinical Trials

Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents

Start date: May 14, 2018
Phase:
Study type: Observational

Risk-taking in early adolescence have has been found to be normative and even formative as it might fulfill the youth's needs to experiment different sensations, make independent decisions and learn from their consequences. Several theoretical models have suggested that male and female adolescents differ in risk-taking as a product of individual/contextual factors and neocortical functioning; however, the neurophysiological and neuropsychological correlates of those differences continue to be underexplored. Informed by Evolutionary Neuroandrogenic Theory, the investigators examine the links between gender, risk-proneness, gratification delay, self-control, self-efficacy, executive functions and neurophysiological-neuroanatomical correlates in early adolescents (age 10-12 years). Participants (N=24; 50% females) will complete behavioral measurements on study constructs and perform neuropsychological tests using fMRI scanning (e.g., Go/NoGo continuous performance, stop-signal reaction time, NIH Cognition Battery, delay discounting). Female and male groups will be compared on all outcome measures.