[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Valladolid\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":163},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,75,110,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100638603","early-phase-1-effect-of-ginger-on-heavy-menstrual-bleeding-in-women-with-coagulation-disorders-100638603",false,"NCT07595640","Effect of Ginger on Heavy Menstrual Bleeding in Women With Coagulation Disorders","GINGER-BLEED","Inclusion Criteria:\n\n* Women of childbearing age with coagulopathies, -Regular menstrual cycles, -heavy menstrual bleeding (demonstrated by recording 3 menstrual cycles), -who voluntarily wish to participate in the study.\n\nExclusion Criteria:\n\n* Women with coagulopathy who have a gynecological disease such as endometriosis, -who are taking any type of hormonal treatment including contraception, -who take nonsteroidal anti-inflammatory drugs during their menstruation, -who have active vaginal infections or pelvic inflammatory disease, -who are overweight (BMI\\>25) or underweight (BMI\\\u003C25), -who lack the cognitive ability to understand the menstrual cycle and the instructions to follow, -who are allergic to ginger and\u002For Stevia.","FEMALE","18 Years","45 Years",{"count":20,"type":21},74,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The GINGER-BLEED study is a randomized, double-blind, placebo-controlled clinical trial evaluating the effect of ginger powder on heavy menstrual bleeding in women with coagulopathies. This type of bleeding, defined as a loss of more than 80 ml per cycle, significantly affects women's quality of life, causing anemia, pain, and social limitations. Although conventional treatments exist, they can cause adverse effects, especially in women with coagulation disorders.\n\nThe hypothesis is that administering 750 mg of ginger daily for six months can reduce menstrual bleeding. The main objective is to analyze this effect, while specific objectives include evaluating changes in coagulation parameters and prostaglandin levels.\n\nThe study will be conducted between March 2028 and January 2029 at the University of Valladolid. Seventy-four women with coagulopathies, selected after a gynecological evaluation, ultrasound, and blood tests, will participate. They will be divided into two groups: one will receive ginger capsules and the other a placebo (Stevia) during the first three days of each menstrual cycle for six consecutive cycles.\n\nThe PBAT tool will be used to estimate bleeding, and statistical analyses will be performed using SPSS v29. Variables such as adverse effects, treatment adherence, and clinical parameters will be considered. The study complies with current ethical standards, including the Declaration of Helsinki and Spanish data protection legislation. The results will be disseminated in scientific journals and patient associations, proposing improvements in public health policies.",[27],"Women With Coagulation Disorders",[29,30,31,32],"Ginger (Zingiber officinale)","Coagulation disorders","Women","Heavy menstrual bleeding","NOT_YET_RECRUITING","2026-05-14",{"date":36,"type":37},"2026-05-19","ACTUAL",{"date":39,"type":21},"2028-02-01",{"date":41,"type":21},"2029-07-31",{"name":43,"class":44},"University of Valladolid","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100611349","use-of-transcranial-direct-current-stimulation-tdcs-in-an-active-pain-coping-program-for-patients-with-fibromyalgia-a-randomized-control-trial-100611349","NCT07239427","Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.","Inclusion Criteria:\n\n* Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.\n\nExclusion Criteria:\n\n* Neurological Conditions: History of epilepsy or any other decompensated neurological condition that could contraindicate Transcranial Direct Current Stimulation (tDCS).\n* Active Pathologies: Presence of other active or recent pathologies (e.g., cancer, fractures, fissures, or severe traumatic accidents of the skull) that could interfere with treatment or evaluation.\n* Pregnancy: Currently pregnant or planning to become pregnant during the study period.\n* Metallic Implants: Presence of metallic implants in the skull that may interact with or contraindicate the use of tDCS.\n* Concurrent Studies: Active participation in another concurrent clinical research study involving treatments for fibromyalgia.\n* Protocol Adherence: Inability to understand or adhere to the treatment and evaluation protocol.","ALL",{"count":53,"type":21},68,[55],"NA","The trial is designed to determine the added effect of active transcranial direct current stimulation (tDCS) when combined with a multimodal Active Pain Coping Program in individuals with fibromyalgia. The primary objective is to compare the effectiveness of active versus sham tDCS when both are delivered to the same standardized multimodal intervention. All participants will undergo an identical treatment sequence consisting of 8 sessions of Pain Neuroscience Education (PNE), followed by 5 consecutive daily sessions of either active or sham tDCS, and 18 sessions of therapeutic exercise (TE). Active tDCS will be administered over the primary motor cortex (M1) and orbitofrontal region for 20 minutes at 2 mA. The sham procedure will replicate the electrode placement and brief initial stimulation to ensure blinding, with no active current thereafter. Secondary outcomes will examine changes in pain intensity, central pain processing, psychological variables, and physical function.",[58],"Fibromyalgia",[58,60,61,62,63,64],"Transcranial Direct Current Stimulation","Neuromodulation","Therapeutic Exercise","Pain Science Education","Pain Neuroscience Education","RECRUITING","2025-11-15",{"date":68,"type":37},"2025-11-20",{"date":70,"type":21},"2025-12-01",{"date":72,"type":21},"2026-06",{"name":43,"class":44},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":74},"100569602","melatonin-supplementation-and-exercise-program-in-breast-cancer-women-100569602","NCT06696378","Melatonin Supplementation and Exercise Program in Breast Cancer Women","Impact of Melatonin Supplementation Plus Exercise Program in Women Who Have Suffered from Breast Cancer in the Province of Soria, Spain","MEXBSO","Inclusion Criteria:\n\n* Study participants were women with a history of ductal carcinoma in situ, lobular carcinoma in situ, or stage 1 to 3 breast cancer (5 years or more since diagnosis), not currently receiving chemotherapy or hormone therapy, postmenopausal, and Eastern Cooperative Oncology Group (ECOG) score ≤ 1\n\nExclusion Criteria:\n\n* women who had exercised regularly for at least 20 minutes once and at least twice a week in the 3 months before the study\n* Stage IV breast cancer or systemic recurrences\n* Known autoimmune diseases: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and multiple sclerosis.\n* Severe kidney disease\n* Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, luteinizing hormone-releasing hormone agonists currently or within the past 60 days\n* 6-month ≥ post-chemotherapy\n* Concomitant use of sleeping pills every night at bedtime\n* Concomitant use of black cohosh, flaxseed, or soy in pill or supplement form\n* Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value).\n* Uncontrolled hypertension (\\>180\u002F100 mm Hg).\n* Uncontrolled atrial or ventricular arrhythmias, dissecting aortic aneurysm, severe aortic stenosis, acute endocarditis\u002Fpericarditis\n* Acute thromboembolic disease.\n* Moderate\u002Fsevere chronic obstructive pulmonary disease (COPD) with Bodex index C or D Recent bone fracture (last month).\n* Any other circumstance that your doctor considers prevents physical activity.\n* Neoadjuvant chemotherapy or radiotherapy\n* Concomitant use of beta-blockers\n* 6-month ≥ post-radiotherapy\n* Concomitant use of postmenopausal hormone replacement therapy\n* Use of any type of oral melatonin supplement in the past 30 days\n* Acute\u002Fchronic heart failure with NYHA (New York Heart Association) score \\>II\n* Uncontrolled orthostatic hypotension\n* Recent acute myocardial infarction (3 to 6 months) or unstable angina.\n* Acute\u002Fchronic respiratory failure.\n* Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia\n* History of dementia (suspected by the GP environment and diagnosed).\n* Shift-work and night-work","60 Years","80 Years",{"count":86,"type":21},120,[55],"Introduction: Breast cancer (BC) remains the leading cause of cancer in women with nearly 1.4 million new cases worldwide annually and 27.000 in Spain. Increasingly effective oncology therapies, however, have numerous adverse effects such as muscle degeneration, fatigue, decreased physical function and aerobic capacity, and deteriorating quality of life. In this sense, physical activity (PA) seems to be an interesting non-pharmacological strategy to alleviate these serious complications and with potential benefits for women with BC. Melatonin (N-acetyl-5 methoxytryptamine) is an indolic compound present with pleiotropic bioactions that regulates the circadian rhythm, antioxidant, anti-inflammatory, immunostimulant, cardioprotective, antidiabetic, antiobesity, neuroprotective, and antiaging actions. Furthermore, in recent years, many studies have described the key role of melatonin in preventing and developing cancer. The general anticarcinogenic mechanisms include epigenetic control, cell proliferation modulation, cell cycle regulation, apoptosis induction, and telomerase inhibition. Melatonin also exerts antiestrogenic activity, which is particularly significant in hormone-dependent tumors, regulating the expression and transactivation of the estrogen receptor, and modulating the enzymes involved in the local synthesis of estrogens. Despite all the mentioned properties, the use of melatonin in daily clinical practice is very limited, and additional studies are needed to better establish the role of this hormone in oncological clinical applications against different types of cancer.\n\nObjective: To analyze the effect of supplementation with 4 g\u002Fday of melatonin for 10 weeks on muscle damage (CK and LDH), hormonal responses (estradiol, testosterone, cortisol and testosterone\u002Fcortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (handgrip strength, RPE and SPPB), anthropometry (body mass, BMI and fat mass) and WHOQOL-BREF (physical and psychological health, social relationships and environment) in women over 60 years of age who have suffered breast cancer and who follow a physical training program.\n\nMethods: A total of 20 female volunteers between 60 and 73 years old (age: 65.5±4.52 years, BMI: 25.83±2.67 and body fat percentage: 33.73±5.54) who followed a physical activity adapted to their age and abilities are the members. of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 5 g\u002Fday of melatonin (GI; n = 10). Differtent test were performed muscle damage (CK, and LDH), hormonal responses (estradiol, testosterone, cortisol, and testosterone\u002Fcortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (Hand-grip strength, RPE and SPPB), anthropometrics (Body mass, BMI and fat mass), and WHOQOL-BREF (physical and psychological health, social relationships and environment) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).",[90,91,92],"Female Breast Cancer","Older Adults","Exercise Trainning Progrmam",[94,95,96,97,98,99,100,101],"Brear Cancer","Melatonin","quality of life","physical performance","health biomarkers","antioxidant capacity","anthropometrics parameters","Exerkins","2024-11-18",{"date":104,"type":37},"2024-11-20",{"date":106,"type":21},"2025-01-15",{"date":108,"type":21},"2026-05-01",{"name":43,"class":44},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":51,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100563439","tdcs-and-tele-rehabilitation-exercise-in-fibromyalgia-100563439","NCT06616181","TDCS and Tele-rehabilitation Exercise in Fibromyalgia","Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 30 and 70 years.\n* Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology.\n* Stable medication for at least 12 weeks prior to the start of the study.\n* Ability to use communication technologies, such as smartphones and computers.\n* Capacity to participate in an aerobic exercise program.\n* Access to the internet.\n* Proficiency in oral and written Spanish.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric disorders.\n* Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.\n* Concurrent chronic inflammatory or autoimmune disease.\n* Contraindications to physical activity.\n* Metal implants in the head.\n* History of cancer, brain tumor, epileptic episodes, stroke, severe head trauma, or brain surgery.\n* Pregnancy or lactation.\n* Use of carbamazepine in the past 6 months.\n* Changes in medication during the study.\n* Participation in other non-pharmacological conservative therapies (e.g., hydrotherapy, electrotherapy, manual therapy, exercise, dry needling) during the study.","30 Years","70 Years",{"count":120,"type":21},45,[55],"This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence.\n\nSecondary objectives include:\n\n* Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients.\n* Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation.\n* Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC.\n\nThe dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention.\n\nExercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.",[124],"Fibromyalgia Syndrome",[126,127,128,129,130],"tDCS","exercise","telerehabilitation","home-based exercise","fibromyalgia","2024-09-24",{"date":133,"type":37},"2024-09-27",{"date":135,"type":21},"2024-12-01",{"date":137,"type":21},"2026-12-01",{"name":43,"class":44},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":74},"100541159","clinical-validation-of-musculoskeletal-icf-core-set-in-primary-care-physiotherapy-100541159","NCT06326229","Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy","Clinical Validation of the Content of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services","Inclusion Criteria:\n\n* 18 years of age or older\n* Patients diagnosed with a musculoskeletal condition by a general practitioner\n* Patients with adequate knowledge of the Spanish language\n\nExclusion Criteria:\n\n* Patients referred for a non-musculoskeletal problem\n* Patients referred from hospital services","99 Years",{"count":148,"type":21},385,"OBSERVATIONAL","The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.\n\nThe main question it aims to answer is:\n\n\\- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?\n\nParticipants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition.",[152],"Musculoskeletal Diseases",[154],"Musculoskeletal Diseases, ICF, Primary Health Care, Physical Therapy Modalities","2024-06-25",{"date":157,"type":37},"2024-06-27",{"date":159,"type":37},"2024-06-17",{"date":161,"type":21},"2025-09-26",{"name":43,"class":44},""]