Premenstrual Syndrome (PMS) encompasses a range of physical and emotional symptoms that occur in the luteal phase of the menstrual cycle. Clinical trials in this area examine various treatment evaluations aimed at managing symptoms and improving qual...
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Found 57 Actively Recruiting clinical trials
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Researchers are investigating whether low doses of radiation therapy can help the drug elranatamab improve its ability to kill cancer cells in patients with relapsed or refractory multiple myeloma who also have extramedullary or paramedullary disease. This phase 2 study aims to evaluate the overall response rate at 3 months and to understand safety, time to next treatment, progression-free survival, overall survival, quality of life, and local control of irradiated lesions. Participants will receive elranatamab given intravenously along with radiotherapy aimed at priming the immune system to enhance the drug's effect on cancer cells. The study focuses on treating lesions that have not been previously radiated and can be targeted with radiation. This trial is sponsored by M.D. Anderson Cancer Center and involves monitoring response differences between patients with extramedullary versus paramedullary disease and between high-risk and standard-risk groups. During the study, participants will be closely monitored for safety and adverse events for about one year. Researchers will collect data on treatment effects, quality of life, and disease progression. Assessments will include imaging to confirm disease location, blood tests to monitor blood counts and organ function, and performance status evaluations. The total duration of participation depends on individual treatment and follow-up needs throughout the study.
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Researchers are studying how changes in the gut microbiome relate to hormonal changes during women's ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in women's health.
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Premenstrual dysphoric disorder (PMDD) is a serious mood disorder affecting many women, believed to be caused by changes in sensitivity to hormone fluctuations during the menstrual cycle. This research will study the levels of certain brain-related hormones and receptor proteins in women with and without PMDD during the premenstrual phase. It will also explore how a low-dose antidepressant medication affects these measures in women with PMDD to better understand the disorder and its treatment mechanisms. The study includes three groups: women without premenstrual symptoms, women with PMDD taking sertraline 50 mg daily during the second menstrual cycle, and women with PMDD taking a placebo pill in the second cycle. Participants will track their mood, complete surveys, and have blood samples taken multiple times across one or two menstrual cycles. The sertraline or placebo is taken from ovulation until the start of menstruation in the second cycle. Participants will be involved in mood tracking, self-report questionnaires, and blood draws throughout the study. Researchers will measure neuroactive steroid levels, enzyme expression related to these steroids, and receptor subunit levels during and after the menstrual phases. The study will monitor these changes over cycles lasting up to three months, with careful safety and symptom monitoring. Participation lasts across one or two menstrual cycles depending on the group.
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Researchers are collecting Real-World Data (RWD) to study the ongoing safety and effectiveness of the anovo Surgical System during transvaginal gynecological laparoscopic surgeries. They are also evaluating how the anovo Skills Development Pathway affects surgeon behavior and performance, focusing on the learning curve and procedure outcomes across surgeons with different experience levels. The study aims to minimize bias by including a broad patient population. The study involves surgeons using the anovo Surgical System, an endoscopic instrument control device designed to assist in controlling instrument arms during single site, natural orifice laparoscopic-assisted transvaginal benign gynecological surgeries. The study collects data on surgery times and adverse device events, while tracking surgeon competency development through the Skills Development Pathway. Participants will be patients undergoing gynecological surgery with the anovo Surgical System. Researchers will collect data on conversion rates to other surgical approaches and monitor for unanticipated adverse device effects up to 8 weeks post-surgery. Patients will also complete post-operative questionnaires to provide additional information. This observational registry study provides ongoing safety and performance data to understand device use in real-world settings.
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Researchers are conducting an observational study to improve understanding of the menstrual cycle and various gynecologic health conditions such as polycystic ovary syndrome (PCOS), infertility, and breast cancer. This study focuses on reproductive health and menstrual patterns in women and aims to gather long-term data to describe these aspects epidemiologically. The study is hosted on the Apple Research app, which participants can use to find, enroll in, and take part in this research. It collects data related to menstrual cycle patterns and the prevalence of gynecologic health conditions over a period of up to 10 years. Participants will engage through the app, providing information about their menstrual cycles and health conditions. The study tracks menstrual cycle patterns and collects epidemiologic data over time, also determining the prevalence of related health issues. This observational approach allows long-term monitoring without administering treatments. The study is expected to continue through November 2029.
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Researchers are studying how the menstrual cycle affects female cyclists' training and performance. The study focuses on understanding the influence of hormonal changes during the cycle on endurance, recovery, muscle strength, motivation, and mental aspects related to training. This research aims to provide insights that could help customize training programs based on individual menstrual cycles for better effectiveness. The study involves female cyclists who use the JOIN cycling app to track their menstrual cycles alongside subjective and objective training data. Participants can adjust their training advice based on menstrual cycle-related discomfort. The study is observational and will monitor the health of the menstrual cycle and training parameters over one to two years. Participants will be closely monitored through the JOIN app, providing data on their menstrual cycle progress and training metrics such as endurance and power. Researchers will assess both subjective feelings and objective performance measures. The study will explore the feasibility of menstrual cycle-based periodized training and its effects on recovery, with a total participation period of up to two years.
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Females treated with antipsychotics often experience higher rates of metabolic problems compared to males, and this study aims to understand how brain insulin resistance differs in females during different phases of their menstrual cycle. Researchers are investigating how the antipsychotic drug olanzapine affects brain insulin action in healthy young females, focusing on the follicular and luteal phases of the cycle. This study uses brain imaging and intranasal insulin to explore these effects and provides new insights into why females might be more affected by these metabolic side effects. Participants will receive four treatment conditions combining intranasal insulin or placebo with oral olanzapine or placebo in a randomized, crossover design. Each treatment period lasts three days, with olanzapine or placebo given on days 0 and 1, followed by cognitive tests and MRI scans on day 2. Visits occur twice during the follicular phase (days 4-10) and twice during the luteal phase (days 16-22 or near the next expected menses), with menstrual cycle phases confirmed by hormone measurements. During each visit, brain insulin action is assessed using two MRI scans following either intranasal insulin or placebo. Researchers will also collect fasting blood samples to measure glucose, insulin, and olanzapine levels. Cognitive functions such as visuospatial memory and processing speed are tested between scans. Participants are monitored for safety and complete four visits over five to six months. The primary outcome is brain connectivity measured by functional MRI, with secondary outcomes including cognitive performance.
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This observational study focuses on women undergoing elective laparoscopic gynecologic surgery to evaluate how different phases of the menstrual cycle affect the optic nerve sheath diameter (ONSD). The research aims to understand if hormonal changes during the follicular or luteal phases influence intracranial pressure as reflected by ONSD measurements, and how these variations relate to postoperative nausea, vomiting, and cognitive function. Participants will be grouped based on their menstrual cycle phase: follicular phase (around days 12-14) or luteal phase (around days 20-25). During surgery, ONSD will be measured before anesthesia, during the operation, and at the end. Postoperative assessments will include monitoring nausea, vomiting, and cognitive function within 24 hours after surgery. Women in the study will undergo perioperative ONSD measurements and evaluations of postoperative symptoms and cognitive status. Researchers will measure ONSD at specific surgical time points and assess nausea, vomiting, and cognitive function before and after surgery. The full participation period includes the surgical procedure and a 24-hour postoperative follow-up to monitor these outcomes.
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This research aims to evaluate how previous induced termination of pregnancy affects complications and outcomes in later pregnancies. It is a prospective multicenter cohort study focused on reproductive health and abortion. The study seeks to understand the relationship between early pregnancy terminations and future pregnancy risks to improve knowledge in this area. Participants are women who have experienced an induced abortion within the first 12 weeks of pregnancy. The study observes these women over time without providing any experimental treatment, focusing on medical or surgical termination of pregnancy as the prior event. There are no intervention groups as this is an observational study. During the study, participants will be monitored for complications and adverse pregnancy outcomes. Researchers will collect data through follow-up investigations and evaluate pregnancy progress and health status. The primary outcome is adverse pregnancy outcomes reviewed by June 2028, with complications also tracked. Participation includes providing informed consent and cooperating with follow-ups over the study period.
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Researchers are investigating how natural menstrual cycles and oral contraceptive use affect strength, hydration, energy balance, and body composition in female athletes. This observational study focuses on hormonal changes during specific menstrual phases and oral contraceptive cycles to better understand their impact on athletic performance and health. The study addresses gaps in knowledge about how estrogen and progesterone influence muscle strength, hydration status, and energy availability in female athletes. The study involves 40 female athletes divided into two groups: 24 naturally menstruating athletes and 16 oral contraceptive users. Naturally menstruating participants will be assessed during early follicular, late follicular, and mid-luteal menstrual phases, while oral contraceptive users will be evaluated during active pill and withdrawal phases. Testing includes strength measurements using handgrip dynamometry, bench press, and leg press, along with hormonal blood tests, body water and hydration assessments, energy expenditure and balance measurements, and body composition analysis. Participants will attend sessions during each menstrual or contraceptive phase for detailed assessments of strength and hydration. Researchers will monitor hormone levels, body water compartments, hydration markers, energy intake and expenditure, and resting metabolism. The study aims to validate measurement methods and explore relationships between hormone fluctuations and energy availability. Total participation spans multiple menstrual or contraceptive phases, with data collected longitudinally to capture variations over time.
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