[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Colorado, Colorado Springs\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":187},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,72,96,123,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100552322","timing-of-energy-availability-on-menstrual-cycle-function-100552322",false,"NCT06471582","Timing of Energy Availability on Menstrual Cycle Function","Implications for the Timing of Energy Availability on Menstrual Cycle Function","FAST","Inclusion Criteria:\n\n* participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week\n* accustomed to exercising for 90 minutes or more\n* has regular periods every 21-35 days\n* have not taken hormonal contraceptives for at least the past 6 months\n* is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months\n* does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \\[PCOS\\], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)\n* does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes, congenital adrenal hyperplasia)\n* does not currently have a major cardiovascular or respiratory disease\n\nExclusion Criteria:\n\n* miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)\n* demonstrate clinical low energy availability as defined as energy availability \\\u003C30 kcal\u002Fkg fat free mass\n* report menstrual cycle lengths \\\u003C21 or \\>35 days in the first 2 months of at-home monitoring\n* do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring\n* begin taking a hormonal contraceptive\n* become pregnant\n* are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \\[PCOS\\], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer)\n* are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)\n* are diagnosed with a major cardiovascular or respiratory disease\n* are unable to follow instructions for any of the procedures",true,"FEMALE","18 Years","40 Years",{"count":22,"type":23},64,"ESTIMATED","INTERVENTIONAL",[26],"NA","The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal\u002Fkg lean body mass\u002F day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol.\n\nParticipants will be asked to do the following over a \\~3 month enrollment period:\n\n* attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested\n* monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for \\~3 months\n* complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate\u002F kg body mass\u002F h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month \\~3\n* saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol",[29],"Menstrual Irregularity",[31,32,33],"functional hypothalamic amenorrhea","menstrual cycle","female athlete","RECRUITING","2026-04-27",{"date":37,"type":38},"2026-05-01","ACTUAL",{"date":40,"type":38},"2024-08-01",{"date":42,"type":23},"2027-08-31",{"name":44,"class":45},"University of Colorado, Colorado Springs","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":17,"sex":54,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100626238","the-effectiveness-of-emergency-room-protocols-for-treating-hyperthermia-100626238","NCT07433036","The Effectiveness of Emergency Room Protocols for Treating Hyperthermia","EDCP","Inclusion Criteria:\n\n* Active, healthy individuals\n\nExclusion Criteria:\n\n* Pregnant or planning on becoming pregnant\n* Have a pacemaker\n* Currently taking any prescribed or over the counter medications or nutritional supplements known to influence thermoregulatory responses\n* Experience lingering pain from a previous musculoskeletal injury (i.e. knee, hip, or back pain)\n* Use tobacco\u002Fnicotine products","ALL","65 Years",{"count":57,"type":23},50,[26],"This study will help us as scientists and clinicians understand how effective commonly used cooling protocols in emergency departments are and which of the protocols is the most effective.\n\nIt consists of a single, approximately 1 hour preliminary session and five, approximately 3 hour experimental sessions, equaling an approximate 16 hour total time commitment.\n\nThe purpose of this research is to test the effectiveness of three cooling protocols.\n\n1. Cooling packs\n2. \"Ice Sheets\", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them.\n3. Body bag filled with ice, commonly used in emergency departments to treat hyperthermia\n\nAdditionally, a negative control (passive cooling in air-conditioned room) and a positive control (cold water immersion).",[61],"Hyperthermia",[61,63],"Exercise","2026-02-18",{"date":66,"type":38},"2026-02-25",{"date":68,"type":38},"2025-07-01",{"date":70,"type":23},"2028-12-31",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":46},"100513618","effects-of-physical-and-psychosocial-stress-on-functional-hypothalamic-amenorrhea-in-exercising-women-100513618","NCT05967819","Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women","Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women","FHA","Inclusion Criteria:\n\n* participates in structured running or cycling exercise for at least 30 minutes on 4 days per week or more\n* have regular periods every 21 to 35 days\n* have not used hormonal contraceptives for at least the past 6 months\n* are not currently or trying to become pregnant or are breastfeeding, and have not been pregnant or breastfeeding for the past 12 months\n* have never been diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome \\[PCOS\\], endometriosis, premenstrual dysphoric disorder \\[PMDD\\], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)\n* have never been diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)\n\nExclusion Criteria:\n\n* missing \\> 4 consecutive days of aerobic exercise (i.e., running, cycling, cross training) if assigned to the exercise intervention groups\n* they indicate they \"Could not participate at all due to a health problem\" or have had to modify their exercise training, felt their injury, illness, or other health problem has affected their exercise performance, or experienced symptoms\u002F health complaints greater than \"To a minor extent\" on the Oslo Sports Trauma Research Center Questionnaire (exercise training intervention group)\n* demonstrate clinical low energy availability as defined as energy availability \\\u003C30 Kcal\u002Fkg fat free mass in the first two months of at-home monitoring\n* report menstrual cycle lengths \\\u003C21 days or \\>35 days in the first two months of at-home monitoring\n* do not demonstrate an anticipated rise in progesterone levels during the latter half of their cycle and luteinizing hormone levels at mid-cycle compared to tests taken during the first few days after menses in the first two months of at-home monitoring\n* begin taking a hormonal contraceptive\n* become pregnant\n* are diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome \\[PCOS\\], endometriosis, premenstrual dysphoric disorder \\[PMDD\\], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)\n* are diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes), 10) are diagnosed with a major cardiovascular disease, respiratory disease, or musculoskeletal injury\n* are unable to follow instructions for any of the procedures","35 Years",{"count":82,"type":23},54,[26],"The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are:\n\n* Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length?\n* Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length?\n\nParticipants will be asked to do the following over the \\~3 month enrollment period:\n\n* attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested\n* monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month\n* provide several urine and saliva samples each month\n* either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment.\n\nResearchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.",[86],"Amenorrhea Secondary",[31,32,33],"2026-01-05",{"date":90,"type":38},"2026-01-08",{"date":92,"type":38},"2023-08-09",{"date":94,"type":23},"2026-08-30",{"name":44,"class":45},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":103,"targetDuration":4,"studyType":24,"phases":105,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":46},"100599455","moderate-aerobic-exercise-for-managing-menstrual-cycle-symptoms-100599455","NCT07084714","Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms","Impact of Moderate Aerobic Exercise on Menstrual Cycle Symptoms in Sedentary Women","Inclusion Criteria:\n\n* premenopausal (defined as having regular menstrual periods every 21-35 days)\n* either not using hormonal or non-hormonal contraceptives (i.e., intrauterine device) for the past 6 months OR using combined oral contraceptives (i.e., those that contain progesterone and estrogen) for at least the past 6 months\n* not currently pregnant or trying to become pregnant\n* sedentary lifestyle (score of \"low activity\u002Finactive\" assessed using the IPAQ)\n* have self reported menstrual cycle symptoms (symptoms reported on the PSST or MSi)\n* do not have a medical diagnosis or signs\u002Fsymptoms of diabetes, cardiovascular, or renal disease and are able to participate in moderate intensity physical activity without physician clearance\n\nExclusion Criteria:\n\n* becoming physically active defined as scoring higher than \"low activity\u002Finactive\" on the IPAQ during the first month of the study\n* non compliance with instructions provided for the moderate aerobic exercise intervention (i.e., not adhering to predetermined intensity heart rate targets) or miss more than 25% of exercise sessions in either intervention month\n* becoming pregnant during enrollment\n* being diagnosed with a cardiovascular, metabolic, or renal disease that would require physical clearance to participate in moderate intensity aerobic physical activity\n* begin using hormonal or non-hormonal (i.e., intrauterine devices) contraceptives if assigned to the arm not using hormonal contraceptives\n* either begin a different type of contraceptive or discontinue combined hormonal contraceptive use if assigned to the hormonal contraceptive arm",{"count":104,"type":23},35,[26],"The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are:\n\nIs there a reduction in physical and\u002For psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives?\n\nIs there a difference in physical and\u002For psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users?\n\nIs a moderate aerobic exercise intervention more effective in reducing physical and\u002For psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives?\n\nParticipants will:\n\n* Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention.\n* Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly.\n* Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length.\n* Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly.\n* Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.",[108,109,110,111],"Premenstrual Syndrome","Menstrual Cycle","Menstrual Distress (Dysmenorrhea)","Menstrual Bleeding, Heavy",[32,113,114],"premenstrual syndrome","dysmenorrhea","2025-07-17",{"date":117,"type":38},"2025-07-24",{"date":119,"type":23},"2025-07",{"date":121,"type":23},"2026-08",{"name":44,"class":45},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":17,"sex":54,"minAge":130,"maxAge":19,"enrollmentInfo":131,"targetDuration":4,"studyType":24,"phases":133,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":46},"100539845","the-healthy-families-bright-futures-program-100539845","NCT06309134","The Healthy Families Bright Futures Program","An Online Family-based Program to Prevent Alcohol Use and Dating and Sexual Violence Among Sexual and Gender Minority Youth","Inclusion Criteria:\n\n* Age between 15 and 18 years\n* Self-identify as a sexual and\u002For gender minority or questioning identity\n* In dating\u002Fsexual\u002Fhook up relationship in past three months\n* Ability to read, write, and speak English\n* Current residence in United States\n* Regular Internet access\n* Ability to complete program and assessments\n* Has caregiver willing to complete program who is eligible to participate (18 +, sees teen at least once per week, can read\u002Fwrite\u002Fspeak English, residence in US, Internet access, no current suicidality, psychotic symptoms, or symptoms of serious mental illness)\n\nExclusion Criteria:\n\n* Current enrollment as a college student\n* Current suicidality\n* Current psychotic symptoms\n* Current symptoms of serious mental illness","15 Years",{"count":132,"type":23},160,[26],"The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\\[s\\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers.",[136,137],"Alcohol Drinking","Violence in Adolescence",[139,140,141,142,143],"dating violence","teen drinking","alcohol use","minority stress","parenting behaviors","2025-07-14",{"date":115,"type":38},{"date":147,"type":38},"2025-01-07",{"date":149,"type":23},"2026-08-31",{"name":44,"class":45},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":24,"phases":162,"briefSummary":163,"conditions":164,"keywords":172,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":46},"100557963","improving-maternal-sleep-and-mental-health-100557963","NCT06544941","Improving Maternal Sleep and Mental Health","Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet","SHINE","Inclusion Criteria:\n\n* Pregnant women with a singleton gestation who have a military affiliation\n* Ages 18-45 years\n* Ability to communicate during the screening process\n* Access to a computer, smart phone or tablet with internet service\n* Willing to use bassinet they are randomized to\n* Willing to travel to a local Quest for blood draw\n\nExclusion Criteria:\n\n* Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.\n* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.\n* Under the age of 18 years or \\> 45 years. The goal is to include women of childbearing age.\n* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.\n* Tobacco use (current). Smoking is associated with poor sleep and inflammation.\n* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and\u002For obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.\n* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.","45 Years",{"count":161,"type":23},342,[26],"The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent\u002Fmitigate postpartum mood disorders by augmenting maternal sleep and\u002For enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual\u002Ftraditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nAim 1: Determine the effect of the SB on infant sleep and maternal sleep. \\[primary hypothesis or outcome measure 2\\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.\n\nMilitary-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.",[165,166,167,168,169,170,171],"Postpartum Depression","Postpartum Anxiety","Sleep Disturbance","Infant Behavior","Maternal Behavior","Inflammation","Military Family",[173,174,175,176,177,178],"sleep","postpartum","intervention","inflammation","depression","anxiety","2025-02-06",{"date":181,"type":38},"2025-02-10",{"date":183,"type":38},"2025-01-15",{"date":185,"type":23},"2028-06",{"name":44,"class":45},""]