60 Clinical Trials for Various Conditions
The overall objective of this project is to advance understanding of the causes of normal weight obesity (NWO) in men, namely the hormone profile and related potential mediating mechanisms, and the efficacy of different modes of exercise to restore body composition and cardiometabolic health in this population.
This study aims to investigate the rates of postoperative nausea and vomiting in transgender patients on hormone therapy compared to cisgender patients undergoing the same procedures (hysterectomy, orchiectomy, augmentation mammoplasty).
The goal of this project is to test our central hypothesis that the spinal cord neuroplasticity in females will be modulated by the level of estradiol concentration. under aim 1 we will determine the influence of estradiol fluctuations on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy females and males. We will use an established repetitive peripheral nerve electrical stimulation with a stimulation intensity below the motor threshold to prime the spinal motor circuits. under aim 2 we seek to characterize the input output property of spinal circuit excitability after descending drive (motor) mediated priming in young healthy male participants. in aim 3 we will examine the influence of estradiol fluctuations on descending drive mediated motor priming in young healthy females.
This is a longitudinal study to determine the influence of the menopause transition on autonomic and vascular function. PI Keller-Ross has published data demonstrating that postmenopausal females have greater sympathetic neural reactivity during a stressor compared with age-matched males and younger females and males. A paucity of literature exists, however, on the role of the menopause transition in autonomic function because the majority of experimental studies on menopause physiology are cross-sectional and/or focused on older, postmenopausal females . The influence of age on HTN is robust, whereas the effects of menopause are still unclear. Preliminary data demonstrate a clear association between age and sympathetic activity in females; how the transition through menopause influences these relations, however, remains unknown. The study will enroll 80 midlife (45-55 years of age) females to measure longitudinally the trajectory of autonomic and vascular function during the transition through menopause. The study hypothesizes that through the menopause transition, an increase in sympathetic activity and an impaired baroreflex sensitivity and endothelial function will emerge.
This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD). * The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD. * The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC. * The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood.
Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women, but research on alcohol-related harms in women - including alcohol's impact on sleep - has been minimal. Numerous studies in men show that alcohol impairs sleep, and preliminary evidence suggests that women may be even more sensitive to alcohol-disrupted sleep due to their sex hormones, which fluctuate across both their menstrual cycles and their reproductive lifespans. This study will investigate the influence of sex, menstrual cycle phase, and sex hormones on alcohol-disrupted sleep in adults ages 21-45. Healthy women and men will complete two sets of placebo-controlled lab sessions, during the mid-follicular and late luteal phases of female participants' menstrual cycles. During these sessions, participants will receive a dose of alcohol or a placebo (saline) and they will then be monitored (with polysomnography) while they sleep. At-home sleep and alcohol use will also be measured through actigraphy, daily sleep and wake diaries, and alcohol wrist sensors. Investigators hypothesize that women will show greater disruption of sleep following alcohol use or administration than men, and that alcohol-disrupted sleep will be more pronounced in the late luteal phase compared to the mid-follicular phase. Investigators also expect that estradiol will be negatively associated with alcohol-disrupted sleep, whereas progesterone will be positively associated with alcohol-disrupted sleep.
Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid use. Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors
The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.
The purpose of this research study is to investigate the relationships between sex hormone levels and experimental pain sensitivity and migraine severity will be examined.
The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.
Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.
Although there are numerous studies showing effects of aerobic training on sex hormone concentrations, research analyzing the fluctuation of sex hormones in response to resistance training (RT) is lacking. The objective of this project is to analyze estradiol (E2) and progesterone (P4) responses to an acute resistance training session throughout different phases of the menstrual cycle. This proposed research has strong implications for exercise prescription and for women in general, but more importantly will allow exercise physiologists, coaches, personal trainers, or nutritionists optimize exercise programming around women's menstrual cycle.
The goal of this project is to test our central hypothesis that changes in sex hormone concentration result in changes to the basic elements of motor control - at multiple levels, from the musculotendinous unit to motor control circuitry. Under Aim 1 the investigator will determine the influence of sex hormone fluctuations on the muscle stretch reflex during active and passive states, and the time lag between hormone concentration changes and the reflex response. The investigator will use a technically simple assessment that could be implemented in the field. Under Aim 2 the investigator will determine the influence of sex hormone fluctuations on spinal motor neuron excitability using H-reflex as a probe and the simultaneous change in the muscle mechanics using muscle twitch response. Aims 1 \& 2 will include a focus on the differential role of oral contraceptives. In Aim 3 the investigator will use paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuation.
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
Using an innovative multi-modal imaging approach, this study investigates the role of the neurochemical gamma-aminobutyric acid (GABA), brain activity, as well as hormones in understanding sex differences in Major Depressive Disorder (MDD). Further, the investigators will link these markers to symptoms of depression.
The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also included in the combination products Atripla, Complera, and Stribild. The medication's ability to work effectively may be altered when someone is also taking sex hormone therapy. In order to determine this effect, samples will be collected from some parts of the body where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV virus and sex hormones that are present. The samples that will be looked at in this study include blood, cells from the vagina, semen, and tissue biopsies from the female genital tract and rectum.
As women get older and go through menopause, levels of the female reproductive hormone estradiol decrease to low levels. Also with aging, the functioning of the arteries declines. Over time this vascular dysfunction can lead to health problems such as high blood pressure and heart disease. This study is being done to help determine what causes arteries to become unhealthy in postmenopausal women, who have low levels of the female reproductive hormone estradiol. In this study we will test whether low levels of tetrahydrobiopterin (BH4), a natural substance in the body that can cause the arteries to expand, explains why arteries become unhealthy in women with low levels of estradiol. To answer this question, we will study how vascular function changes with a medication that causes a short-term increase in BH4 levels when estradiol is lowered with a medication, compared to when estradiol is normal. We will also determine whether the administration of the antioxidant vitamin C, along with the medication to increase BH4 levels, will normalize vascular health in perimenopausal and postmenopausal women, and in women who have their estradiol levels lowered.
The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence
The purpose of the overall parent study is to determine the impact of gender and hormones (estradiol, progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in daily, "real-world" cue presentations compared to a final cue session in a lab. In addition, in the portion of the study that incorporates clinical trials elements and is reported here, the study will examine the impact of a single dose of oxytocin (chemical produced in the body) versus placebo (inactive substance) on reactivity to a stress procedure (Trier Social Stress Task) in smokers. The overall parent study involves a cue presentation technology known as "CREMA" (Cue Reactivity Ecologic Momentary Assessment) which delivers four daily cue presentations to you on a handheld device during your everyday routine. Additionally, the study involves daily collection of saliva samples for hormonal testing. These daily procedures will provide information about the role of cues and hormones in daily life. The clinical trial portion of the study (reported here) consists of measures collected within the laboratory.
Traumatic injury is a major public health problem with an immense societal cost. Despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. Evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. Determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. The goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.
This study is designed to determine the causes of "orthostatic intolerance" which occurs more commonly in women than in men. Orthostatic tolerance is the ability to remain standing up right for long periods of time, or to avoid dizziness when moving to standing from a seated or lying position.
The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women
The goals of the study are to examine the effect in postmenopausal women of a one-year moderate intensity exercise intervention, as compared with a sedentary pattern (low-level stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin, triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.
The purpose of this study is to find out why women's arteries stiffen as they go through menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with the loss of estrogen because of "oxidative stress," the production of molecules that can damage cells and tissues in the body, and because the arteries lose their ability to expand, or dilate.
For many years researchers have been trying to better understand the regulation of sleep and activity by studying circadian (daily) rhythms of human beings. It appears that the hormones estrogen, progesterone, and testosterone play a role in the regulation of circadian rhythm in animals. Researchers believe these hormones may also play a similar role in the regulation of human circadian rhythms. Little research has been conducted on how these hormones affect human circadian rhythms. This study is designed to learn more about how specific hormones influence men and women's daily rhythms. This study will use women from another research study being conducted at the NIMH called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone". Male subjects will be recruited from another NIMH study called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement". In order to test the possibility that gonadal steroids (estrogen, progesterone, and testosterone) change circadian rhythms and the sleep-wake cycle in humans, participants will undergo chronobiologic evaluations. The chronobiologic evaluations will look at sleep and rest periods, activity as measured by a wrist monitor, and 24 hour inpatient electroencephalograph (EEG), rectal temperature, and melatonin monitoring.
This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. Participants of this study will be healthy and will have no benefit from administration of elinzanetant. This study, however, will provide information on how to use elinzanetant in people with vasomotor symptoms. In previous studies, capsules containing smaller amounts of elinzanetant have been used. To reach the daily dose intended for treatment, 3 of these capsules had to be taken once a day. To reduce the pill burden and make it easier for patients to stick to the treatment, capsules with a higher amount of elinzanetant have been developed. The main purpose of this study is to learn how much of the study treatment elinzanetant gets into the participants' blood when the same dose is taken as new capsule formulation compared to the old capsule formulation. To answer this question, the researchers will compare: * The (average) total level of elinzanetant in the blood (also called AUC) * The (average) highest level of elinzanetant in the blood (also called Cmax) between both capsule formulations after taking one dose of each. In addition, the researchers want to compare how much of the new and old elinzanetant formulations get into the blood after intake for 9 subsequent days. All participants will take both formulations by mouth during the study. Each participant will be in the study for up to 12 weeks, including 10 treatment days for each formulation. Participants will stay in-house for 14 days per capsule formulation. In addition, one screening visit to the study site is planned. During the study, the study doctor and their team will: * Do physical examinations * Take blood and urine samples * Check vital signs * Examine the participants' heart health using electrocardiogram (ECG) * Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS). The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone levels. An example of a change in sex hormone levels is when a woman reaches the time in their life where they no longer have their period. Hormones are substances in the blood that help body organs to work in specific ways. Women who no longer have their period may have a protein called neurokinin sending more signals than usual to other parts of the body. Researchers think that this may play a role in causing VMS. In this study, the researchers want to learn more about a new substance called elinzanetant. Researchers think elinzanetant may help people with VMS. It works by blocking neurokinin from sending signals to other parts of the body. There are treatments available for VMS, but these do not work for all people and may cause medical problems for some people. The main purpose of this study is to help the researchers learn more about how elinzanetant moves into, through and out of the body in participants with kidneys that do not work as well as they should compared to healthy participants whose kidneys work normally. To do this, the doctors will take blood samples from the participants at different times during the study and measure the levels of elinzanetant in the blood. This will help the researchers learn more about whether elinzanetant could be given to treat VMS in people who also have kidneys that do not work as well as they should. This study will include adult participants who have kidneys that do not work as well as they should and participants whose kidneys work normally. The participants who have kidneys that do not work as well as they should will be split into 2 groups based on how severe their kidney problems are. All of the participants will take elinzanetant once as a tablet by mouth. The participants will be in the study for about 1 month and will stay at their study site for 7 days in a row. During this visit, the participants will: * have their overall health checked * have scans of their heart taken using an electrocardiogram * have blood and urine samples taken * answer questions about how they are feeling, what medications they are taking, and what adverse events they are having The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.
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.