[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pain-threshold\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pain-threshold":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,77,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100604392","perception-of-pain-during-gender-affirming-hormone-therapy-100604392",false,"NCT07148921","Perception of Pain During Gender Affirming Hormone Therapy","Changes in Pain and Perception Thresholds Due to Gender Affirming Hormone Therapy: a Prospective Exploratory Cohort Study","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Assigned female at birth (AFAB)\n* Diagnosed gender identity disorder\u002Fgender dysphoria and planned therapy with testosterone OR\n* ≥ 18 years of age\n* Assigned male at birth (AMAB)\n* Diagnosed gender identity disorder\u002F gender dysphoria and planned therapy with estradiol\n\nExclusion Criteria:\n\n* Any sex hormone intake during the last 6 months\n* Acute or chronic pain\n* Polyneuropathy\n* Diagnosis of alcohol or drug addiction\n* BMI under 18 or over 35\n* Pregnancy\n* Breastfeeding\n* Pharmacological analgesic therapy within the previous 7 days before each examination\n* History of significant trauma or surgery to the hands with residual neurological deficit or pain.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","OBSERVATIONAL","It is known from the literature that women and men differ in their perception of pain. Why this is the case has not been conclusively clarified. Sex hormones could have a significant influence on this. The study team suspects that the classic hormone status of women is responsible for the lower pain threshold compared to men.\n\nPeople undergoing gender affirming therapy receive biologically opposite-sex hormones in order to adapt their external appearance as well as their voice, emotional life etc. to the desired gender. The aim of this study is to longitudinally record whether the intake of opposite-sex sex hormones leads to a change in pain and perception thresholds in this patient collective. To this end, potential study participants will be informed about the study and asked whether they would like to participate before the start of hormone therapy during their first visit to the transgender outpatient clinic.\n\nIf consent is given, a questionnaire on mental health (PHQ 9), a blood sample to determine the hormone status and the first QST (quantitative sensory testing) measurement are then carried out. The second measurement with blood sampling takes place 3-4 weeks after the first measurement. The 3rd and 4th measurements with blood sampling are taken 3 and 6 months respectively after the first measurement. The PHQ 9 is measured again at the time of the last measurement. Study participation ends after a total of 6 months. The blood samples, the PHQ 9 and the QST measurements have no influence on the treatment of the study participants.",[24,25,26,27],"Transgender Persons","Pain Threshold","Perception of Pain","Sex Hormones","RECRUITING","2025-08-22",{"date":31,"type":32},"2025-08-29","ACTUAL",{"date":34,"type":32},"2024-12-01",{"date":36,"type":20},"2026-03",{"name":38,"class":39},"Medical University of Vienna","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":64,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":40},"100602461","acuknee-role-of-acupuncture-in-knee-prosthetic-surgery-100602461","NCT07123805","ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery","ACU_Knee - Role of Acupuncture in Knee Prosthetic Surgery: Analgesia, Functional Outcome and Inflammatory Markers","ACU_Knee","Inclusion Criteria:\n\n* Patients aged \\> 18 years\n* Patients capable of providing informed consent\n* Unilateral total knee replacement surgery\n* Indication for surgery: primary osteoarthritis degeneration\n* Surgery performed electively\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Patients incapable of providing informed consent\n* Patients with ASA class \\> 3\n* Pregnant women\n* Patients with rheumatoid arthritis or other autoimmune disorders\n* Patients with active infection under antibiotic treatment\n* Patients on chronic opioid therapy\n* Patients on chronic biological drug therapy\n* Patients with a history of corticosteroid use in the six months prior to surgery\n* Patients with a history of periarticular infiltration in the three months prior to surgery\n* Patients in whom loco-regional anesthesia is contraindicated\n* Patients in whom NSAID, cortisone, and paracetamol therapy is contraindicated\n* Bilateral total knee replacement surgery or prosthetic revision surgeries\n* Indication for surgery for causes other than primary osteoarthritis degeneration",{"count":50,"type":20},80,"INTERVENTIONAL",[53],"NA","Post-operative analgesia after total knee arthroplasty (TKA) has always been a challenge in the anesthesiological setting, having to combine good pain control and the need for early mobilization, both factors that can affect the quality of rehabilitation treatment, prosthetic functional outcome, the onset of chronic pain, joint stiffness and the consequent quality of life of the patient. Recent loco-regional anesthesia (LRA) techniques have made an essential contribution to peri-operative management in the fast-track perspective of surgery, in terms of optimization of analgesia and rapid functional recovery. Inadequate post-operative analgesia, by affecting the normal rehabilitation pathway, is associated with medium-long term complications, such as chronic pain, joint stiffness and patient dissatisfaction, which often compromise functional autonomy and quality of life of the patient and may require invasive treatments (surgical revision, unlocking under general anesthesia). The local and systemic inflammatory state, evidenced by peri-operative dosage of specific biomarkers, appears to be related to prosthetic outcome.",[56,57,58,59,60,25,61,62,63],"Acupuncture Analgesia","Acupuncture","Acupuncture Therapy","Total Knee Anthroplasty","Postoperative Pain Management","Shoulder Pain","Laparoscopies","Acupuncture Ear",[65,66,67],"acupuncture","total knee arthroplasty","pain","2025-08-08",{"date":70,"type":32},"2025-08-14",{"date":72,"type":32},"2024-04-10",{"date":74,"type":20},"2026-12-31",{"name":76,"class":39},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":51,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":40},"100570683","phase-2-a-study-of-the-safety-and-exploratory-efficacy-of-oral-afa-281-in-patients-with-alcohol-use-disorder-100570683","NCT06710431","A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder","A Double-blind, Placebo-controlled, Phase IIA Human Laboratory Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder","Inclusion Criteria:\n\n1. Age between 21 and 65\n2. Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n3. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for moderate or severe AUD\n4. Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent.\n5. Must be surgically sterile (vasectomy, tubal ligation, or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm for 90 days after study drug administration.\n\nExclusion Criteria:\n\n1. Current treatment for alcohol use or a history of treatment in the 30 days before enrollment or treatment seeking\n2. Current (last 12 months) DSM-5 diagnosis of dependence on any psychoactive substances other than nicotine\n3. Current DSM-5 diagnosis of substance use disorder for any substance other than alcohol and nicotine\n4. Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder\n5. Current DSM-5 major depressive disorder with suicidal ideation\n6. Positive urine screen for narcotics, amphetamines, or sedative hypnotics\n7. Clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised\n8. Pregnancy, nursing, or refusal to use reliable method of birth control if female\n9. History of significant sensitivity to any drug.\n10. Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 430 ms.\n11. History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.\n12. Has an estimated creatinine clearance (CrCl) outside of normal range.\n13. History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.\n14. History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.\n15. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.\n16. Liver enzymes AST, ALT, or GGT ≥ 3 times upper normal limit.\n17. Positive urine drug screen for drugs of abuse at Screening or Day -1.\n18. Receipt of any drug by injection within 30 days prior to study drug administration.\n19. A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.\n20. Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.\n21. Pregnant or nursing women.\n22. Receipt of any investigational products within 6 weeks prior to study drug administration.\n23. Current enrollment in another clinical study.\n24. Previous enrollment in this study.\n25. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to participate in the AFA-281 Phase I1a Study.","21 Years","65 Years",{"count":87,"type":20},36,[89],"PHASE2","This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.",[92,93,94,25,95,96],"Alcohol Abuse","Alcohol Abuse\u002Faddiction","Anxiety","Depression Disorders","Sleep Disorder",[98,99,100,101,102,103,104],"AFA-281","alcohol abuse","alcohol","depression","pain threshold","sleep disorder","anxiety","NOT_YET_RECRUITING","2024-11-26",{"date":108,"type":32},"2024-11-29",{"date":110,"type":20},"2025-10-01",{"date":112,"type":20},"2027-12-01",{"name":114,"class":115},"Afasci Inc","INDUSTRY",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":125,"minAge":17,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":51,"phases":129,"briefSummary":130,"conditions":131,"keywords":148,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":40},"100439987","hiit-vs-mict-during-pregnancy-and-health-and-birth-outcomes-in-mothers-and-children-100439987","NCT05009433","HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children","The Effect of Pre- and Postnatal High Intensity Interval Training and Moderate Intensity Continuous Training on Biological, Functional and Psychological Markers of Pregnancy Disorders and Non-communicable Diseases in Mothers and Offsprings","HIIT MAMA","Inclusion Criteria:\n\nCriteria: Inclusion Criteria:\n\nFor pregnant women:\n\n1. course of pregnancy allowing participation in physical activities adapted to pregnant women\n2. consent of the obstetric care provider to participate in the study tests and exercise classes;\n3. taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at each trimester of pregnancy, during the puerperium and one year after childbirth;\n4. participant's consent to use data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in children aged one, two, four and six, routinely performed according to the Polish pediatric care system;\n5. availability to participate in classes three times a week until the day of delivery;\n6. declaration of participation in postpartum classes at least once a week and self-completion of the exercise program according to written instructions prepared by the exercise specialist;\n7. women can participate in the exercise programs regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).\n\nFor nonpregnant women:\n\n1. nulliparous;\n2. lack of diagnosed infertility and other disorders of the reproductive system;\n3. taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at indicated time points: before and after each of the 8-week exercise program during the first 8 months of the study and once every 3 months during the following twelve months of the study\n4. declaration of availability to participate in exercise classes three times a week for the first 8 months of the program (attendance at least 80% is required);\n5. declaration of participation in classes at least once a week and self-completion of the exercise program to the required 150 minutes of physical activity per week, according to the written guidelines prepared by the instructor, for the next 12 months of the program;\n6. women can participate in the exercise program regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).\n\nExclusion Criteria for Pregnant and Nonpregnant Women:\n\n1. contraindications to increased physical effort or to any of the diagnostic or control tests;\n2. allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants);\n3. other conditions that, according to the researchers, will threaten the health or safety of the participants or will significantly affect the quality of the collected data.",true,"FEMALE","45 Years",{"count":128,"type":20},600,[53],"Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children.\n\nHigh-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy.\n\nThe first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc.\n\nPregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited.\n\nThe investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.",[132,133,134,135,136,137,138,139,140,141,142,25,143,144,145,146,147,94],"Pregnancy","Postpartum","Childbirth","Health Status","Physical Fitness","Noncommunicable Diseases","Metabolism","Diabetes Mellitus, Gestational","Pregnancy Induced Hypertension","Body Composition","Back Pain","Biomechanics","Pelvic Floor Disorders","Urinary Incontinence","Cognitive Function","Depression",[149,150,151,152,153,154,155,156,157,158,159,135,160,134,161,162,163],"Pregnant women","Prenatal care","Postpartum women","Postnatal care","Exercise","Physical activity","Exercise intervention","Educational intervention","Exercise test","High-intensity interval training","Moderate-intensity continuous training","Physical fitness","Birth outcomes","Infant","Child","2022-11-30",{"date":166,"type":32},"2022-12-02",{"date":168,"type":32},"2021-06-24",{"date":170,"type":20},"2031-08-31",{"name":172,"class":39},"Gdansk University of Physical Education and Sport"]