Clinical Research Directory

The Impact of Overnight Active Temperature Regulation on Gut Microbiome, Inflammation, and Circadian Rhythm.

This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.

Implementing PrEP for Women Who Inject Drugs

Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs, thereby reducing new HIV infections in this population.

Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women

This study tests the feasibility and acceptability of Waning Moon, a culturally tailored menopause health intervention developed in partnership with the Urban Indian Center of Salt Lake (UICSL) for American Indian/Alaska Native (AI/AN) women. Waning Moon is a 4-session integrative medical group visit program delivered by community health workers and prescribing providers. It covers menopause education, complementary health approaches, and community support. Thirty midlife AI/AN women will participate. The study will assess whether the program is feasible to deliver and acceptable to participants and clinical partners.

Digital Resistance Training for Midlife Women Using GLP-1

The goal of PLAN-RT 1.0 to learn if a 12-week app-based strength training program can help midlife women build and stick with a regular strength training routine while they are taking GLP-1 medication for weight loss. PLAN-RT 1.0 targets women ages 40 to 59 who were not regularly exercising before starting GLP-1 medication. The main questions this study aims to answer are: (1) Is the PLAN-RT 1.0 program feasible and acceptable to participants (based on how many people join, stay in the study, and use the program)? (2) Does the program lead to early changes in muscle strength, body composition, physical function, and exercise habits?

The Impact of the Menstrual Cycle on Physical Exercise and Performance

The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups. The purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise. Female athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks): Group A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase. Group C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase. The exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.

Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS

Cesarean deliveries account for 20.7% of all deliveries in France, according to the latest perinatal survey. At Nice University Hospital, the C-section rate over the last 5 years is around 19%. Caesarean section patients are at greater risk of developing symptoms of anxiety, stress and depression. The post-operative period is also more painful, and there is a positive correlation between immediate post-operative pain and the risk of developing chronic pelvic pain. Numerous attempts to reduce these symptoms have been evaluated, including music therapy, relaxation techniques, acupressure and the use of preoperative melatonin. Virtual reality has demonstrated its effectiveness in reducing pain and anxiety in other disciplines, notably pediatric surgery and neurosurgery. In particular, several trials have demonstrated a reduction in anxiety in the paediatric population and, for pelvic procedures under local anaesthetic, during prostate biopsies or hysteroscopy in consultation, with a reduction in anxiety and pain respectively. It has been used to provide information by showing a film about the caesarean section procedure, and has been shown to be effective in terms of patient satisfaction, but without being able to demonstrate a significant reduction in anxiety (p=0.06). The use of virtual reality during the entire peri- and intra-operative management process (maternity stay, patient transfer to the operating room, locoregional anesthesia procedure and during the operation) has not been studied in the context of cesarean section.

Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal

The purpose of this retrospective chart review was to identify risks factors for patients associated to Cooper IUD fragmentation upon removal resulting in the requirement of a hysteroscopy evaluation.

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Menopause Knowledge Level and Myth Beliefs

This study aims to compare the effects of the Pecha Kucha and PowerPoint presentation methods on menopause knowledge and beliefs in menopause-related myths. By introducing an innovative, concise, focused, and visually based approach to menopause education, this research is expected to strengthen health literacy, reduce myths, and contribute to the development of more positive attitudes toward menopause among women. Furthermore, by evaluating both menopause myths and different educational techniques together, this study is anticipated to be the first in the literature and to serve as a reference for future research. Research questions: 1. Does menopause-related knowledge increase among women who receive education using the Pecha Kucha technique and the PowerPoint method? 2. Do beliefs in menopause-related myths decrease among women who receive education using the Pecha Kucha technique and the PowerPoint method? 3. Is there a difference between the Pecha Kucha technique and the PowerPoint method in terms of women's menopause-related knowledge levels and their beliefs in menopause-related myths?

Health Belief Model-Based Vulvar Self-Examination Education

This randomized controlled trial was conducted to evaluate the effectiveness of a Health Belief Model-based Vulvar Self-Examination (VSE) education program on women's health beliefs, vulvar health awareness, and vulvar self-examination behaviors. Vulvar diseases and symptoms are often overlooked due to insufficient awareness, stigma, and limited knowledge regarding vulvar health. Early recognition of vulvar symptoms may contribute to timely diagnosis and treatment of vulvar disorders. Participants in the intervention group received a structured Health Belief Model-based education program on vulvar self-examination, while the control group received routine information. Data were collected using participant information forms, vulvar health awareness assessments, and Health Belief Model-based scales before and after the intervention. The primary aim of the study was to improve women's awareness and health beliefs regarding vulvar self-examination. Secondary outcomes included changes in vulvar self-examination practices and vulvar health literacy. The findings of this study are expected to contribute to preventive women's health practices and early recognition of vulvar health problems.

Female Reproductive Health in Canadian Armed Forces

This is a mixed-method study aimed at gathering new evidence on reproductive health among female service members in the Canadian Armed Forces (CAF). Reproductive health includes four primary domains: contraception; undesired reproductive outcomes (including unintended pregnancy, adverse pregnancy outcomes, and infertility); assisted reproductive care; and pelvic floor dysfunctions. Additional factors that may influence reproductive outcomes will also be explored, including gynecological health (including but not limited to menstrual health, menopause, breast injury, sexually transmitted and blood-borne infections) as well as physical and psychological health (including but not limited to repetitive strain injuries, depression, and post-traumatic stress disorder). Evidence gathered on reproductive health issues will include, but not limited to, the lived experiences (occurrence), associated risk factors, access to care, including barriers and facilitators, service utilization, and career-related impacts among actively serving members and Veterans of the CAF. These will inform the development of recommendations and support services aimed at improving reproductive health care within the CAF. This project is divided into 3 convergent parts: Part 1: An online pan-Canadian survey that will achieve a minimum total sample of 1067 participants. Part 2: Semi-structured individual interviews (open-ended questions) will be conducted with female CAF members and Veterans who have experienced at least one reproductive health issues. A total of 30 participants are estimated to be required to achieve data saturation across the four primary domains. Part 3: Semi-structured group discussion (open-ended questions) will be conducted with healthcare providers, who have experience with treating female reproductive health issues in CAF members, as well as stakeholders and policymakers involved in supporting female members of the CAF/Veterans. A total of 24 healthcare providers/stakeholders/policymakers will form 3 group discussion (8 participants/group). For all 3 parts, efforts in recruitment will be made to ensure representation across CAF elements, minority groups, and native language (French and English).

Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis.

This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program. The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.

A Real-World Evidence Study Evaluating the Effects of the Human Optimization Project Protocol on Methylation Biomarkers and Health-Related Quality of Life in Women

This study looks at whether a daily dietary supplement called HOP Box can improve markers of biological aging and overall health in women. HOP Box contains 19 ingredients selected to support cellular health, metabolism, inflammation, and longevity. Thirty-five women between the ages of 35 and 60 will take the supplement twice a day for 90 days. Researchers will measure changes in biological age using an at-home blood test that analyzes DNA methylation patterns, track sleep quality, heart rate, and heart rate variability using an Oura Ring wearable device, and assess participants' self-reported quality of life using a validated health survey (PROMIS-29). There is no placebo or control group in this pilot study - all participants will receive the supplement and serve as their own comparison over time. The goal is to gather early data on whether HOP Box shows promising health effects in women, which would inform the design of a larger, more rigorous trial in the future.

BeFit Toolbox Collaboration: Building Empowerment Through Fitness

This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population.

Co-Developing an HIV Prevention Program for Women in Ghana

The WISE Woman Study is a research project in Ghana focused on improving HIV prevention among young women aged 18 to 35. In Ghana, young women are at higher risk of HIV but often lack access to the right information and services. This study will first work with young women and community partners to co-develop a youth-friendly and women-centered HIV prevention program. The program will focus on two proven strategies: HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP), a medicine that helps prevent HIV. After the program is created, researchers will test it with 50 young women in Greater Accra and the Eastern Region to see if it's acceptable, easy to use, and if it helps increase knowledge and use of HIVST and PrEP. The intervention will be delivered through WhatsApp and community-based workshops to ensure privacy and reach. Participants will complete surveys and take part in discussions and interviews to share their feedback. This research will help build better HIV prevention strategies tailored to the needs of young women in Ghana.

Sexual Health of Sub-Saharan African Migrant Women Recently Diagnosed With HIV in Île-de-France: Missed Opportunities for Prevention

This study looks at the sexual health of women from Sub-Saharan Africa who recently found out they have HIV after arriving in Île-de-France. It aims to understand their risk factors and identify missed chances for HIV testing and prevention. The goal is to improve care and support for these women by learning more about their experiences and the challenges they face.

The Effect of Continuous Midwife Support on Various Parameters Related to Pregnancy, Childbirth and Postpartum Period

There is a need for studies with a high level of evidence regarding the effect of supportive care given during the preconceptional period, pregnancy, childbirth and postpartum processes. With this planned study, it is aimed to evaluate the effect of continuous midwife support during pregnancy, birth and postpartum periods, starting from the preconceptional period, on various parameters related to pregnancy, birth and postpartum period. The research is planned as a randomized controlled experimental study. It consists of two groups, the study group and the control group. 75 women out of 150 women will form the control group and 75 women will form the study group. The women in the working group will be given individual training in line with their needs. Data will be collected by using the checklist and many scales used by the control and study groups in preconceptional counseling recommended by ACOG (American College of Obstetricians and Gynecologists).