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Gender clinical trials

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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: 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.

NCT ID: NCT03281213 Completed - Postoperative Pain Clinical Trials

Acute Postthoracotomy Pain - Impact of Gender

Start date: July 1, 2010
Phase: N/A
Study type: Observational

Adequate analgesia in thoracic surgery is essential to prevent severe postoperative complications, especially respiratory problems. Current knowledge about gender-related differences in pain states generally more frequent and intense pain and more demand for analgesics in women. Results about postsurgical pain in particular are very inconclusive. The investigators tried to find out if gender has an influence on postthoracotomy pain and analgesics requirement.

NCT ID: NCT02884856 Completed - Gender Clinical Trials

Color Perception in Dentistry (CPD)

CPD
Start date: August 2014
Phase: N/A
Study type: Observational

Visual shade matching (VSM) is the most common procedure to select an adequate shade in dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical (VC) the most popular among the available guides. VSM is a subjective and inconsistent process with many observer related variables (e.g. color deficiency, experience, gender and eye fatigue) that can influence on the final color appearance. The gender influence on the accuracy of VSM is controversial. The purpose of this study is to evaluate the VSM performed by female (F) and male (M) students, using VC shade guide, testing the null hypothesis that VSM is not influenced by gender.

NCT ID: NCT02651233 Completed - Physical Activity Clinical Trials

Factors That Influence Adipose Derived Regenerative Cells' Yield and Viability

Start date: March 2014
Phase: N/A
Study type: Observational

Human adipose tissue has been shown to contain a group of cells that possess extensive proliferative capacity and the ability to differentiate into multiple cell lineages. Cells isolated from the fatty portion are termed processed lipoaspirate cells that contain adipose-derived regenerative cells (ADRCs). ADRCs are most conveniently extracted from tissue during an elective cosmetic liposuction procedure but may also be obtained from resected adipose tissue. This study is aimed to verify if there are differences between the number and viability of cells obtained from patients with different age, sex, Body Mass Index (BMI), smoking and physical activity, within the different amount of processed fat.

NCT ID: NCT02588118 Completed - Gender Clinical Trials

Gender and PK-PD of Propofol and Cisatracurium

BIS5
Start date: January 2010
Phase:
Study type: Observational

In recent years it has become clear that gender differences exist both in the pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia. Differences in pharmacokinetics are more straightforward to study than differences in clinical effects. However, isolated pharmacokinetic data are of less value if they are not accompanied by measurements of clinical effects. Males are more sensitive than females to propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males. Females have 20-30% greater sensitivity to the muscle relaxant effects.

NCT ID: NCT02532725 Completed - Obesity Clinical Trials

Work-Related Effects of Heat, Activity, and Fat in Middle Aged Men

Start date: June 1972
Phase: N/A
Study type: Observational

Obesity is associated with many undesirable health effects and disease, and middle age is associated with increased risk for disease. Unfortunately, while others have looked at the effects of obesity, gender, and middle age, the combined effects of obesity and middle age on men's ability to do work in hot industrial environments have not been satisfactorily investigated. This small study evaluates the heat tolerance of lean and obese middle aged men both while exercising and resting and the ways in which each compensate for and dissipate increasing environmental heat and heat generated by the body while exercising. As obesity is a worldwide public health crisis and as populations in many industrialized nations age, it is important to understand the combined effects of obesity and middle age for men on their ability to safely work in hot environments. Such information will permit establishing and revising of safe work standards and inform public health outreach to the target population, itself.