[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Indonesia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":723},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,199,0,25,[9,47,81,106,132,165,190,212,245,281,301,327,353,380,419,442,474,502,537,561,589,633,655,681,702],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387",false,"NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","ALL","1 Month",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[25],"Perimembranous Ventricular Septal Defect",[27,28,29,30,31,32,33,34],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects","RECRUITING","2026-08-24",{"date":38,"type":39},"2026-08-25","ACTUAL",{"date":41,"type":39},"2025-01-01",{"date":43,"type":21},"2027-06-30",{"name":45,"class":46},"Fondation Hôpital Saint-Joseph","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100647303","tegoprazan-versus-lansoprazole-for-endoscopic-ulcer-healing-in-bleeding-peptic-ulcers-100647303","NCT07708545","Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers","A Double-Blind, Double-Dummy, Randomized Controlled Trial Comparing 14-Day Tegoprazan Versus Lansoprazole Therapy for Endoscopic Ulcer Healing in Patients With Bleeding Peptic Ulcers","Inclusion Criteria:\n\n* Subjects aged 18 years and over.\n* Subjects with upper gastrointestinal bleeding caused by peptic ulcers diagnosed by gastroscopy.\n* Willing to participate in the entire clinical study process, including:\n\n  1. . Fluid resuscitation and blood transfusion, if necessary,\n  2. . High-dose PPI therapy for 72 hours,\n  3. . Gastroscopy within 24 hours of hospital admission and endoscopic hemostatic therapy, if necessary,\n  4. . Lansoprazole 30 mg or tegoprazan 50 mg therapy for 14 days,\n  5. . Treatment for H. pylori infection if positive,\n  6. . Repeat gastroscopy after 14 days of treatment to assess the progress of therapy.\n\nExclusion Criteria:\n\n* Subjects with a history of allergy to tegoprazan or lansoprazole\n* Subjects with a history of allergy to tegoprazan or lansoprazole.\n* Subjects with ulcers caused by gastric or duodenal cancer.\n* Subjects with comorbidities such as chronic kidney disease stage 3 or higher and decompensated liver cirrhosis.\n* Patients who are heavy alcohol drinkers and have used chemotherapy drugs, bisphosphonates, or potassium supplements in the past 2 weeks.","18 Years",{"count":56,"type":21},162,"INTERVENTIONAL",[59],"PHASE2","This clinical trial compares two medicines used to treat bleeding stomach ulcers in people in Indonesia. The researchers want to find out whether tegoprazan or lansoprazole is better at healing these ulcers after 2 weeks of treatment.\n\nThe main question this trial aims to answer is:\n\nWhich medicine, tegoprazan or lansoprazole, heals bleeding peptic ulcers better after 2 weeks of treatment? Researchers will compare tegoprazan to lansoprazole to see which one works better.\n\nParticipants in this trial will:\n\n* Receive IV fluids and, if needed, a blood transfusion to stabilize their condition\n* Receive a high dose of acid-reducing medicine for the first 72 hours\n* Have an exam of the stomach using a thin scope (gastroscopy) within 24 hours of hospital admission or after clinical stabilization when the patient was deemed fit to undergo esophagogastroduodenoscopy (EGD). Endoscopic hemostatic therapy was performed when indicated.\n* Take one of two combinations once a day, 30 minutes before breakfast, for 14 days: either lansoprazole (30 mg) plus a tegoprazan placebo, or tegoprazan (50 mg) plus a lansoprazole placebo. A placebo looks identical to the real drug but contains no active medicine. Neither participants nor researchers will know which one each person is taking.\n* Be treated for H. pylori - a stomach bacteria that can cause ulcers - if they test positive for it\n* Have a second gastroscopy after 14 days of treatment to check how well the ulcer has healed",[62],"Peptic Ulcer Bleeding",[64,65,66,67,68,69,70],"Tegoprazan","Lansoprazole","ulcer healing","peptic ulcer bleeding","randomized-controlled trial","double-blind","double-dummy","2026-08-20",{"date":73,"type":39},"2026-08-21",{"date":75,"type":21},"2026-08-06",{"date":77,"type":21},"2027-02-28",{"name":79,"class":46},"Indonesia University",3,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":57,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100620721","phase-3-a-study-to-test-if-tenecteplase-helps-people-to-recover-from-an-acute-stroke-when-given-more-than-45-hours-after-the-person-was-last-seen-well-100620721","NCT07361302","A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well","TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue","TENACITY","Inclusion criteria:\n\n1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well \\>4.5 h before time of presumed randomisation\n4. Pre-stroke modified Rankin scale (mRS) ≤1\n5. Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)\n\nExclusion criteria:\n\n1. Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation\n2. Occlusion of the internal carotid artery (ICA)\n3. High-risk patients (increased risk of thrombolysis related hemorrhage)\n4. Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans\n5. Contra-indication to contrast brain imaging with CT and MRI\n6. Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \\> 25)\n7. Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator\n8. Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h\n9. Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.",{"count":90,"type":21},1325,[92],"PHASE3","This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot.\n\nThe purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke.\n\nParticipants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment.\n\nParticipants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.",[95],"Acute Ischemic Stroke","2026-08-19",{"date":71,"type":39},{"date":99,"type":39},"2026-02-17",{"date":101,"type":21},"2027-10-02",{"name":103,"class":104},"Boehringer Ingelheim","INDUSTRY",250,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":57,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100593980","phase-3-a-study-to-evaluate-v181-dengue-vaccine-in-healthy-participants-2-to-17-years-of-age-v181-005mobilize-1-100593980","NCT07013487","A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005\u002FMOBILIZE-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age","The key Inclusion Criteria include but are not limited to:\n\n* Is generally healthy based on medical history and physical examination.\n\nThe key Exclusion Criteria include but are not limited to:\n\n* Has a known or suspected impairment of immunological function.\n* Has a history of congenital or acquired immunodeficiency.\n* Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.\n* Has a documented history of hepatitis B or C infection.\n* Has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture.\n* Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders.\n* Has a known neurologic or cognitive behavioral disorder, including encephalitis\u002Fmyelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.\n* Previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine).\n* Received systemic corticosteroids \\\u003C30 days before receipt of study intervention or is expected to require systemic corticosteroids ≤28 days after receipt of study intervention.\n* Has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention.\n* Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.",true,"2 Years","17 Years",{"count":117,"type":21},12000,[92],"The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.",[121],"Healthy","2026-08-14",{"date":124,"type":39},"2026-08-18",{"date":126,"type":39},"2025-06-11",{"date":128,"type":21},"2031-10-24",{"name":130,"class":104},"Merck Sharp & Dohme LLC",36,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":57,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100651325","development-of-a-genetic-score-as-a-response-modifier-for-changes-in-weight-body-composition-and-biochemical-parameters-in-obese-adults-undergoing-a-low-energy-high-protein-diet-intervention-100651325","NCT07760870","Development of a Genetic Score as a Response Modifier for Changes in Weight, Body Composition, and Biochemical Parameters in Obese Adults Undergoing a Low-Energy High-Protein Diet Intervention","Gens-HiPro","Inclusion Criteria:\n\n* Adult males or females aged 18 - 40 years.\n* Classified as obese with a Body Mass Index (BMI) of 27 - 35 kg\u002Fm² and a waist circumference of ≥90 cm for men and ≥80 cm for women.\n* Willing to adhere to the prescribed low-energy high-protein diet.\n* Willing to undergo anthropometric measurements, body composition analysis, lipid profile testing, and genetic variation screening.\n* Signed the written informed consent form.\n\nExclusion Criteria:\n\n* Having chronic diseases that affect metabolism or body weight.\n* Diagnosed with chronic kidney disease (CKD).\n* Currently pregnant, lactating, or planning a pregnancy during the study period.\n* Currently participating in an intensive weight loss program or receiving pharmacological therapy for weight loss within the last 3 months.","40 Years",{"count":141,"type":21},29,[143],"NA","The goal of this clinical trial is to evaluate whether a genetic score (Gens-HiPro) acts as a response modifier for weight loss, body composition changes, and biochemical parameters in obese adults undergoing a low-energy high-protein diet intervention.\n\nThe main questions it aims to answer is:\n\nDoes the genetic score (Gens-HiPro) modify responses to changes in weight, body composition, and biochemical parameters following a 12-week low-energy high-protein diet?\n\nParticipants will:\n\n* Undergo initial screening to determine eligibility based on inclusion and exclusion criteria\n* Complete baseline data measurement, including demographic data, anthropometric measurements (weight, BMI, body composition), biochemical blood analysis (total cholesterol, triglycerides, HDL, LDL, CRP), dietary assessment.\n* Attend a small-group educational session on general guidelines, portion control, plate model (\"Isi Piringku\"), and food weighing techniques for a low-energy high-protein diet.\n* Receive a 60-90 minute nutritional counseling session led by a dietitian at the start of intervention\n* Follow the prescribed 12-week low-energy high-protein diet, supported by an active messaging channel on weekdays for daily dietary consultations\n* Participate in at least three in-person monitoring and evaluation visits scheduled every 3-4 weeks (at weeks 4, 8, and 12 or weeks 4, 7, 10 and 12)\n* Complete post-intervention evaluations at the end of week 12, repeating all baseline anthropometric, biochemical, and dietary assessments.",[146],"Obesity",[148,149,150,151,152,153],"obesity","nutrigenetics","genetic variation","low-energy high-protein diet","genetic score","gens-hipro","NOT_YET_RECRUITING","2026-08-11",{"date":157,"type":39},"2026-08-13",{"date":159,"type":21},"2026-09-01",{"date":161,"type":21},"2027-01-31",{"name":163,"class":46},"Gadjah Mada University",1,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":57,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":164},"100651226","effect-of-sunlight-exposure-on-vitamin-d-levels-in-children-with-cerebral-palsy-100651226","NCT07757477","Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy","The Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy at Cipto Mangunkusumo National Referral General Hospital (RSCM)","Inclusion Criteria:\n\n* Children aged 1-5 years.\n* Diagnosed with cerebral palsy, with the diagnosis clinically confirmed by a pediatrician.\n* Parents or legal guardians provide written informed consent to participate in the study.\n* Covered by the Indonesian National Health Insurance or other insurance.\n\nExclusion Criteria:\n\n* Children with chronic liver disease or chronic kidney disease.\n* Children with contraindications to direct sunlight exposure, such as allergies, hypersensitivity, or skin disorders.\n* Children with severe malnutrition.\n* Children with vitamin D deficiency (baseline serum vitamin D level \\\u003C 20 ng\u002FmL).","1 Year","5 Years",{"count":175,"type":21},60,[143],"The goal of this clinical trial is to learn the effect of sunlight exposure on serum vitamin D levels in children aged 1-5 years with cerebral palsy. This study also aims to assess the effect of sunlight exposure on the incidence of acute respiratory tract infections and to evaluate the safety of the intervention.\n\nThe main questions it aims to answer are:\n\n* Does sunlight exposure increase vitamin D levels in children with cerebral palsy?\n* Does sunlight exposure influence the incidence of acute respiratory tract infections in children with cerebral palsy?\n* Does sunlight exposure cause acute adverse effects in children with cerebral palsy?\n\nParticipants will:\n\n* Be randomly assigned to either the sunlight exposure group or the control group.\n* Undergo baseline assessments, including vitamin D levels measurement, anthropometric measurements, dietary assessment, and Fitzpatrick skin phototype assessment before randomization.\n* Receive sunlight exposure for 10 minutes, three times per week between 11:00 AM and 1:00 PM for 8 weeks (intervention group), while participants in the control group will continue their usual sunlight exposure habits.\n* Have caregivers record daily sunlight exposure (intervention group), acute respiratory tract infection episodes, adverse events, and dietary intake during the study period.\n* Undergo repeat vitamin D levels measurement and evaluation of dietary intake, acute respiratory tract infections incidence, and adverse events at the end of the 8-week intervention.",[179],"Cerebral Palsy",[179,181,182,183],"Vitamin D","Children","Sun Exposure",{"date":157,"type":39},{"date":186,"type":39},"2026-06-30",{"date":188,"type":21},"2026-08",{"name":79,"class":46},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":57,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":80},"100586886","phase-2-comprehensive-ambulatory-antibiotics-for-the-treatment-of-congenital-syphilis-100586886","NCT06921213","Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis","Cares-1","Inclusion Criteria:\n\n1. Infants at risk of congenital syphilis at birth defined as:\n\n   1. an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.\n\n      AND\n   2. the mother is untreated in the current pregnancy defined as:\n\n   i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery\n\n   OR c. the mother is inadequately treated in the current pregnancy defined as:\n\n   i. Having received a non-penicillin based treatment regimen; and\u002For ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given \\> 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).\n2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)\n3. Infants who are less than \\\u003C= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).\n4. Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.\n\nExclusion Criteria:\n\n\\- 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\\> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.\n\n2\\. They have a birthweight \\\u003C2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly","0 Days","7 Days",{"count":200,"type":21},90,[59],"CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with \"all-risk\" asymptomatic congenital syphilis.",[204],"Syphilis, Congenital","2026-08-10",{"date":155,"type":39},{"date":208,"type":39},"2026-05-04",{"date":43,"type":21},{"name":211,"class":46},"London School of Hygiene and Tropical Medicine",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":113,"sex":17,"minAge":220,"maxAge":54,"enrollmentInfo":221,"targetDuration":4,"studyType":57,"phases":223,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100650162","ave-neurofeedback-for-academic-anxiety-and-divergent-thinking-100650162","NCT07745335","AVE-Neurofeedback for Academic Anxiety and Divergent Thinking","Efficacy of a Multisensory Audiovisual Entrainment Neurofeedback for Academic Anxiety Regulation and Divergent Thinking: A Randomized Controlled Trial Study","AVE-NFB","Inclusion Criteria:\n\n* Senior high school students aged 15-18 years.\n* Elevated academic anxiety according to screening assessment.\n* Able to understand study procedures.\n* Willing to provide written informed consent (and parental consent where required).\n\nExclusion Criteria:\n\n* History of epilepsy or seizure disorders.\n* Neurological disorders.\n* Severe psychiatric disorders.\n* Current psychoactive medication affecting EEG activity.\n* Significant visual impairment incompatible with photic stimulation.\n* Previous neurofeedback training within the last six months.","15 Years",{"count":222,"type":21},120,[143],"Academic anxiety is one of the most prevalent psychological challenges among adolescents and has been associated with impaired executive functioning, attentional control, autonomic dysregulation, and reduced creative performance. Although neurofeedback and audiovisual entrainment have independently demonstrated beneficial effects on neural self-regulation, evidence regarding their integration within an adaptive closed-loop intervention remains limited.\n\nThis multicenter, parallel-group, randomized controlled trial aims to evaluate the efficacy of an Audiovisual Entrainment Neurofeedback (AVE-NFB) system for improving neural self-regulation, reducing academic anxiety, enhancing autonomic regulation, and promoting divergent thinking among senior high school students. A total of 120 participants recruited from two school centers will be randomly allocated to one of four intervention groups: Combined AVE-Neurofeedback, Neurofeedback Only, Audiovisual Entrainment Only, or Sham Control.\n\nEach participant will complete six intervention sessions over a six-week intervention period. During every session, brain activity will be continuously acquired using the Muse S Athena wearable electroencephalography (EEG) headset (256 Hz sampling rate). Following a standardized 5-minute resting calibration (3 minutes eyes closed and 2 minutes eyes open), the system will estimate each participant's individualized resting alpha activity (8-12 Hz). The neurofeedback engine continuously monitors alpha-band power from the bilateral frontal (AF7 and AF8) and temporoparietal (TP9 and TP10) electrodes. Positive audiovisual reinforcement is automatically activated whenever the participant maintains alpha power above the individualized reinforcement threshold for at least 2 seconds while satisfying artifact-quality criteria. Reinforcement is automatically attenuated or suspended whenever alpha activity falls below the threshold or excessive ocular or motion artifacts are detected, thereby establishing a fully adaptive closed-loop reinforcement process based on operant conditioning principles.\n\nOutcome assessments will be performed at baseline, immediately after completion of the intervention, one week after the intervention, and one month after the intervention. Primary neural outcomes will include resting-state absolute alpha power measured using Muse S Athena EEG. Secondary outcomes will include academic anxiety assessed using the Spielberger Test Anxiety Inventory (TAI), autonomic regulation assessed using Heart Rate Variability using the Root Mean Square of Successive Differences (RMSSD), and divergent thinking assessed using the Alternative Uses Task (AUT).",[226,227,228],"Academic Anxiety","Test Anxiety","Divergent Thinking",[230,231,232,233,234,235,236],"Closed-Loop Brain-Computer Interface","Neural Oscillation","Alpha-Band Neurofeedback","Neuroplasticity","Cognitive Enhancement","Adolescent Neuroscience","School-Based Intervention","2026-08-08",{"date":155,"type":39},{"date":38,"type":21},{"date":241,"type":21},"2027-01-01",{"name":243,"class":46},"Daniswara Raditya Suprapto",2,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":57,"phases":256,"briefSummary":258,"conditions":259,"keywords":263,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":164},"100651537","phase-1-study-of-atorvastatin-and-its-effects-in-clinical-and-radiological-aspects-in-patients-with-moderate-to-severe-thyroid-eye-disease-100651537","NCT07762105","Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease","Adjunctive Atorvastatin in Moderate-to-severe Thyroid Eye Disease (SEMAR-TED: Structural, Biomarker Expression and Muscle Endpoints of Atorvastatin): Study Protocol for a Randomised, Open-label, Assessor-masked Controlled Trial","SEMAR-TED","Inclusion Criteria:\n\n* Age 18 to 75 years inclusive\n* Graves' orbitopathy graded moderate-to-severe by EUGOGO criteria\n* Active disease, clinical activity score ≥ 3 of 7\n* Rehabilitative orbital decompression anticipated after completion of glucocorticoid therapy, on the usual clinical grounds\n* Able to attend weekly infusion visits and complete follow-up to week 48\n* Written informed consent given\n* For women of childbearing potential, agreement to use effective contraception until week 24\n\nExclusion Criteria:\n\n* Sight-threatening disease at screening: dysthyroid optic neuropathy or corneal breakdown\n* Any other autoimmune disease requiring systemic immunosuppresion\n* Known hypersensitivity to atorvastatin or to any statin\n* Current or recent (within 3 months) use of any lipid-lowering drug\n* Any contraindication to orbital decompression\n* Any independent indication for lipid-lowering therapy: established atherosclerotic cardiovascular disease, more than one cardiovascular risk factor (diabetes mellitus, hypertension, obesity), or LDL cholesterol ≥ 190 mg\u002FdL\n* Systemic glucocorticoid or immunosuppressive treatment for orbitopathy within the preceding 3 months\n* Previous orbital irradiation or orbital surgery\n* Alanine or aspartate aminotransferase \\> 3 × upper limit of normal, or creatine kinase \\> 5 × upper limit of normal, at screening\n* Estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Pregnancy at screening (confirmed by a negative test before randomisation) or breastfeeding\n* Concomitant treatment with a strong CYP3A4 inhibitor\n* Any condition that, in the opinion of the investigator, would prevent completion of the trial","75 Years",{"count":255,"type":21},64,[257],"PHASE1","The trial tests the hypothesis that, in adults with active, moderate-to-severe Graves' orbitopathy, 24 weeks of oral atorvastatin 20 mg daily added to a standard 12-week course of intravenous methylprednisolone produces a greater reduction in extraocular muscle size than intravenous methylprednisolone alone, and that any such reduction is accompanied by lower expression of TSH receptor, IGF-1 receptor, PDGF receptor, PI3K\u002FAKT and miR-155 transcripts, and higher expression of miR-146a. The prespecified direction for miR-146a follows its reported suppression in CD4+ T cells in active disease \\[26\\]. Reported directions of change are compartment-specific and not unanimous, so the transcript analyses are exploratory.",[260,261,262],"Thyroid Eye Disease","Graves Ophthalmopathy","Graves Orbitopathy",[264,265,266,267,268,269,270,271,272],"graves orbitopapathy","thyroid eye disease","atorvastatin","statins","methylprednisolone","randomised controlled trial","orbital computed tomography","microRNA","graves ophthalmopathy","2026-08-07",{"date":157,"type":39},{"date":276,"type":21},"2026-08-30",{"date":278,"type":21},"2027-09-30",{"name":280,"class":46},"Banu Aji Dibyasakti",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":57,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":164},"100651120","effects-of-intermittent-fasting-variations-on-nutrigenomic-profile-metabolic-parameters-inflammation-and-body-composition-in-prediabetic-patients-100651120","NCT07755982","Effects of Intermittent Fasting Variations on Nutrigenomic Profile, Metabolic Parameters, Inflammation, and Body Composition in Prediabetic Patients","Inclusion Criteria:\n\n1. Patients with prediabetes, defined according to ADA criteria (fasting plasma glucose 100-125 mg\u002FdL or 2-hour postprandial glucose 140-199 mg\u002FdL).\n2. Willing to follow the fasting\u002Fdiet intervention protocol for 4-6 weeks (depending on the study duration).\n3. Signing informed consent and willing to be randomized into one of 3 intervention groups (Monday-Thursday Fasting\u002F5:2, Alternate-Day Fasting\u002FADF, or Time-Restricted Fasting\u002FIF).\n\nExclusion Criteria\n\n1. Diagnosis of type 2 diabetes mellitus.\n2. Currently undergoing antidiabetic drug therapy (e.g., metformin, sulfonylurea, insulin).\n3. Has a severe chronic disease (kidney failure, liver failure, heart failure, or eating disorder).\n4. Pregnancy or breastfeeding.\n5. History of eating disorders (anorexia nervosa, bulimia nervosa, or binge eating disorder).\n6. Taking medications that affect glucose metabolism (e.g., systemic steroids, atypical antipsychotics, etc.). Diagnosis of type 2 diabetes","25 Years","60 Years",{"count":222,"type":21},[143],"Prediabetes is a metabolic condition associated with increased risk of type 2 diabetes and cardiovascular disease. Intermittent fasting (IF) has emerged as a potential dietary intervention to improve metabolic health, yet comparative evidence among different IF patterns remains limited.\n\nThis randomized controlled trial aims to evaluate the effects of three intermittent fasting regimens-5:2 fasting, alternate-day fasting, and time-restricted feeding-compared with a control diet on metabolic parameters, inflammatory markers, body composition, and nutrigenomic profiles in adults with prediabetes.",[293],"Pre Diabetic",{"date":205,"type":39},{"date":296,"type":21},"2026-08-01",{"date":298,"type":21},"2026-10-31",{"name":300,"class":46},"Muhammad Aron Pase",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":113,"sex":17,"minAge":288,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":57,"phases":311,"briefSummary":312,"conditions":313,"keywords":316,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":164},"100650902","the-wise-study-whatsapp-intervention-for-sleep-in-the-elderly-100650902","NCT07751458","The WISE Study (WhatsApp Intervention for Sleep in the Elderly)","The WISE Study (WhatsApp Intervention for Sleep in the Elderly): Targeting Insomnia and Loneliness With a Digital Booklet","WISE","Inclusion Criteria:\n\n* Elderly individuals diagnosed with loneliness\n* Reported experiencing sleep disturbances in the past 2 weeks, either continuously or intermittently\n* Experiencing insomnia with a total score of ≥ 8 on the Indonesian version of the Insomnia Severity Index (ISI) during screening\n* Able to communicate in Indonesian\n\nExclusion Criteria:\n\n* Elderly individuals with dementia, delirium, severe mental retardation, or cognitive impairment that prevents them from understanding or assessing their own sleep experience.\n* Currently using new sleeping medication\u002Fstimulants",{"count":310,"type":21},50,[143],"Sleep hygiene education is an educational effort to teach healthy sleep habits and behaviors to improve sleep quality, duration, and regularity naturally without the use of medication; however, this approach has not been established in Indonesia. This study aims to establish a sleep hygiene education care model among lonely older adults with insomnia in Indonesia and to examine the immediate effects of the WISE Study (WhatsApp Intervention for Sleep in the Elderly) led by nurses to older adults loneliness with insomnia using a Digital Booklet. In this assessor-blinded, randomized controlled trial, participants will be randomly allocated to either the nurse-led WISE experimental group or the control group provided with usual care. The outcomes will include sleep parameters measured using the Indonesian version of the Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), Geriatric Depression Scale-Short Form (GDS-SF), Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale (ESS), and sleep diaries. The questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. Generalized estimating equations will be used to test the research hypotheses. Questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. We hypothesized that older adults who were loneliness with insomnia who underwent nurse-led WISE would experience greater improvements in sleep quality compared to participants in a control group who received usual care.",[314,315],"Loneliness","Insomnia",[317,318,314,315],"WiSE","Older adults","2026-08-05",{"date":273,"type":39},{"date":322,"type":21},"2026-07-30",{"date":324,"type":21},"2026-12-03",{"name":326,"class":46},"Halu Oleo University",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":57,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":350,"leadSponsor":351,"locationsCount":164},"100650610","dry-needling-and-low-level-laser-microcurrent-electrical-stimulation-for-myofascial-pain-syndrome-100650610","NCT07750392","Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome","The Role of Dry Needling Therapy and Low-Level Laser Microcurrent Electrical Stimulation on Serum Levels of Tumor Necrosis Factor-alpha (TNF-α) and Malondialdehyde (MDA) in Myofascial Pain Syndrome","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\nAdults aged 20 to 45 years. Clinical diagnosis of acute upper trapezius myofascial pain syndrome (MPS) with symptom duration of less than 1 month.\n\nPresence of at least one active myofascial trigger point in the upper trapezius muscle confirmed by physical examination according to accepted diagnostic criteria (palpable taut band, hypersensitive trigger point, reproduction of the patient's typical pain, and\u002For local twitch response).\n\nModerate or greater neck pain (Numerical Pain Rating Scale \\[NPRS\\] ≥4). Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\nPrevious dry needling or LL MCES treatment for the current episode of myofascial pain.\n\nChronic myofascial pain syndrome (symptom duration ≥1 month). Current use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications that may significantly influence inflammatory biomarkers within the washout period specified in the protocol.\n\nPrevious surgery, fracture, or significant trauma involving the neck or shoulder region.\n\nCervical radiculopathy, cervical myelopathy, fibromyalgia, inflammatory arthritis, or other neurological or musculoskeletal disorders that could explain the symptoms.\n\nLocal skin infection, open wound, or other contraindications to dry needling or LL MCES.\n\nBleeding disorders, anticoagulant therapy, or other contraindications to needling.\n\nPregnancy or breastfeeding. Active malignancy, autoimmune disease, uncontrolled diabetes mellitus, acute infection, or other systemic inflammatory conditions.\n\nHistory of severe psychiatric illness or inability to complete study assessments.\n\nParticipation in another interventional clinical trial within the previous 30 days.","20 Years","45 Years",{"count":337,"type":21},80,[143],"This study aims to evaluate the effectiveness of dry needling and Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) in patients with acute upper trapezius myofascial pain syndrome (MPS) by assessing both biological and clinical outcomes. Specifically, it investigates whether these interventions reduce serum levels of the inflammatory biomarker tumor necrosis factor-alpha (TNF-α) and the oxidative stress biomarker malondialdehyde (MDA), while also improving pain intensity and neck-related disability. The study seeks to address the current knowledge gap regarding the relationship between changes in inflammatory and oxidative stress biomarkers and clinical improvement following these non-pharmacological treatments. The primary research question is: Do dry needling and LL MCES reduce serum TNF-α and MDA levels and improve clinical outcomes in patients with acute upper trapezius myofascial pain syndrome?\n\nParticipants will:\n\nBe randomly assigned to receive dry needling, LL MCES, combined dry needling and LL MCES, or sham dry needling.\n\nReceive treatment according to the assigned intervention protocol. Undergo blood sampling before and after the intervention to measure serum TNF-α and MDA levels.\n\nComplete assessments of pain intensity using the Numerical Pain Rating Scale (NPRS) and neck-related disability using the Neck Disability Index (NDI) before and after treatment.\n\nAttend scheduled follow-up visits for clinical evaluation and outcome assessment.",[341],"Myofacial Pain Syndrome",[343,344,345,346,347],"myofascial","dry needling","laser","tnf-alpha","Malondialdehyde",{"date":205,"type":39},{"date":322,"type":39},{"date":77,"type":21},{"name":352,"class":46},"Udayana University",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":164},"100650062","effectiveness-of-pacu-vs-hcu-postoperative-care-100650062","NCT07740772","Effectiveness of PACU vs HCU Postoperative Care","Comparison of the Effectiveness of Elective Postoperative Care in the PACU Versus HCU Based on Postoperative Length of Stay and Number of Step-Up Cases","Inclusion Criteria:\n\n* Adult patients aged more than 18 years.\n* Patients undergoing elective surgery in the Kanigara RSCM, PESC, RPT, or Kirana operating rooms.\n* Patients undergoing postoperative observation in the PACU or HCU.\n* Patients classified as Level II or III based on the Modified Johns Hopkins Surgical Criteria.\n* Patients who are willing to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients undergoing postoperative observation directly in the ICU.\n* Patients undergoing open-heart surgery.\n* Patients undergoing emergency surgery in the emergency operating room.",{"count":361,"type":21},386,"To determine the effectiveness of postoperative hospital length of stay and the number of ICU or HCU step-up cases among elective postoperative patients observed in the PACU and HCU.",[364,365,366],"Hospital Length of Stay","Step up Cases","Complication Postoperative",[368,369,370,371,372],"PACU","HCU","hospital length of stay","step-up cases","postoperative","2026-07-29",{"date":375,"type":39},"2026-08-03",{"date":377,"type":39},"2026-05-01",{"date":298,"type":21},{"name":79,"class":46},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":388,"minAge":54,"maxAge":288,"enrollmentInfo":389,"targetDuration":4,"studyType":57,"phases":391,"briefSummary":392,"conditions":393,"keywords":402,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":164},"100649711","analgesic-efficacy-of-combined-pecs-ii-and-pip-block-versus-thoracic-paravertebral-block-post-mastectomy-100649711","NCT07738770","Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy","Analgesic Efficacy Comparison of Combined PECS II and Superficial Parasternal Intercostal Plane (PIP) Block Versus Thoracic Paravertebral Block Post-Mastectomy: An Assessment of Pain Severity, Analgesia Duration, and Recovery Quality","PECS-TPVB","Inclusion Criteria:\n\n1. Female patients aged 18 to 60 years.\n2. Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection \\[ALND\\]).\n3. American Society of Anesthesiologists (ASA) physical status I to III.\n4. Provided signed written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patient refusal to participate in the study.\n2. Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine).\n3. Coagulation disorders or coagulopathy.\n4. Mastectomy procedure with immediate breast reconstruction.\n5. Pre-existing chronic cancer pain with active usage of strong opioids (e.g., morphine, fentanyl).\n6. Cognitive impairment or inability to comprehend the pain assessment scale (NRS).\n7. Pregnancy.\n8. Active infection at the planned regional block injection site.","FEMALE",{"count":390,"type":21},72,[143],"Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall.\n\nThe purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND).\n\nParticipants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.",[394,395,396,397,398,399,400,401],"Acute Pain","Post Operative Analgesia","Post Operative Pain, Acute","Breast Cancer","Mastectomy","Regional Anaesthesia","Analgesia Duration","Quality of Recovery (QoR-15)",[403,404,405,406,398,397,407,408],"Pectoral Nerve Block","PECS II Block","Parasternal Intercostal Plane Block","Thoracic Paravertebral Block","Postoperative Analgesia","Quality of Recovery","2026-07-28",{"date":411,"type":39},"2026-07-31",{"date":413,"type":39},"2026-06-29",{"date":415,"type":21},"2026-12-31",{"name":417,"class":418},"Dharmais National Cancer Center Hospital","OTHER_GOV",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":139,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100633913","a-real-world-study-to-investigate-cardiovascular-risk-profile-among-newly-diagnosed-type-2-diabetes-mellitus-t2dm-participants-100633913","NCT07532863","A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants","A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia","CRISTALSEA","Inclusion Criteria:\n\n* Aged greater than equal to (≥) 40 and less than (\\\u003C) 70 years\n* Male or female\n* Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023\n\nExclusion Criteria:\n\n* If any exclusion criterion is met, the participant will be excluded from the study.\n* T1DM or gestational diabetes\n* Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM\n* Pregnant women\n* With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease\n* Died within 12 months after first diagnosis of T2DM\n* Lost to follow-up i.e., no visit 12 months (± 3 months) after first diagnosis of T2DM","70 Years",{"count":429,"type":21},400,"The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.",[432],"Diabetes Mellitus, Type 2","2026-07-27",{"date":409,"type":39},{"date":436,"type":39},"2026-03-13",{"date":438,"type":21},"2027-03-27",{"name":440,"class":104},"Novo Nordisk A\u002FS",6,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":114,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":57,"phases":452,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":441},"100416617","phase-4-southeast-asia-dose-optimization-of-tafenoquine-100416617","NCT04704999","Southeast Asia Dose Optimization of Tafenoquine","Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia","SEADOT","Inclusion Criteria:\n\n* Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy\n* Fever or history of fever in the previous 7 days\n* Quantitative G6PD activity ≥70% of the population median\n* Weight \\>10 kg and ≥2 years old\n* Ability to understand the study instructions and provide written informed consent.\n* Willing to be followed for 4 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Hb \\\u003C 8 g\u002FdL\n* Severe malaria\n* Blood transfusion in the last 4 months\n* History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine)\n* Any previous history of a haemolytic event Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study (e.g. chronic disease, medications that potentiate or inhibit CYP2D6 or CYP2C8 isoenzyme function)",{"count":451,"type":21},820,[453],"PHASE4","Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg\u002Fkg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg\u002Fkg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.\n\nAddendum for Indonesia: The INSPECTOR trial results showed that tafenoquine 300mg was not efficacious for radical cure (79% probability for recurrence after treatment). The comparator arm, low-dose primaquine 3.5mg\u002Fkg divided equally over 14 days, showed a 48% probability of recurrence after treatment). The standard of care for radical cure in Indonesia is high-dose primaquine 7mg\u002Fkg divided in 7 daily doses).",[456],"Plasmodium Vivax Malaria",[458,459,460,461,462,463,464,465,466],"Plasmodium vivax","Relapse","8-aminoquinoline","Tafenoquine","Radical cure","Drug efficacy","Adults","Pediatrics","Primaquine",{"date":373,"type":39},{"date":469,"type":39},"2024-07-22",{"date":471,"type":21},"2028-02-07",{"name":473,"class":46},"University of Oxford",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":114,"maxAge":481,"enrollmentInfo":482,"targetDuration":4,"studyType":57,"phases":484,"briefSummary":485,"conditions":486,"keywords":490,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":500,"locationsCount":164},"100648951","impact-of-preoperative-oral-carbohydrate-loading-on-insulin-resistance-in-pediatric-cardiac-surgery-patients-100648951","NCT07729280","Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients","The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 2-16 years.\n* ASA physical status 2 or 3\n* Good tolerance of enteral feeding\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus.\n* History of thyroid insufficiency treated with thyroid medication.\n* History of adrenal insufficiency treated with corticosteroids.\n* History of gastroesophageal reflux disease.\n* Patients receiving preoperative parenteral nutrition.\n* Emergency or urgent cardiac surgery.","16 Years",{"count":483,"type":21},44,[143],"Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited.\n\nThis randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.",[487,488,489],"Cardiac Surgery","Insulin Resistance","Pediatric Cardiac Surgery",[491,492,493,494],"Cardiac surgery","Carbohydrate loading","Insulin resistance","Glycemic variability","2026-07-24",{"date":433,"type":39},{"date":38,"type":21},{"date":499,"type":21},"2026-11-01",{"name":501,"class":46},"Rifdhani Fakhrudin Nur",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":139,"maxAge":253,"enrollmentInfo":509,"targetDuration":4,"studyType":57,"phases":511,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":164},"100649262","msc-secretome-therapy-for-cognitive-recovery-after-subacute-ischemic-stroke-100649262","NCT07731087","MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke","Efficacy of Mesenchymal Stem Cell Secretome Therapy on Cognitive Recovery in Patients With Subacute Ischemic Stroke: A Pilot Randomized Controlled Trial Using qEEG, BDNF, and Interleukin-1β Evaluation","Inclusion Criteria:\n\n1. Age 40 to 75 years.\n2. Diagnosis of ischemic stroke confirmed by clinical examination and computed tomography or magnetic resonance imaging.\n3. Stroke onset between 7 days and 3 months before enrollment.\n4. Hemodynamically stable.\n5. Able to undergo a basic neuropsychological assessment.\n6. Mild-to-moderate cognitive impairment based on the Indonesian version of the Montreal Cognitive Assessment.\n7. Willing to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Hemorrhagic stroke or mixed ischemic and hemorrhagic stroke.\n2. Severe aphasia, impaired consciousness, or severe sensory deficits that make cognitive assessment invalid.\n3. History of dementia before stroke or a major neurodegenerative disorder.\n4. Active infection, active autoimmune disease, active malignancy, severe renal failure, or severe liver failure.\n5. Uncontrolled epilepsy.\n6. Concurrent participation in another clinical trial.\n7. Contraindication to any study intervention or study procedure.",{"count":510,"type":21},70,[143],"Post-stroke cognitive impairment can limit rehabilitation, independence, and quality of life after ischemic stroke. This pilot randomized controlled trial evaluates whether mesenchymal stem cell-derived secretome, given in addition to standard stroke care and rehabilitation, improves cognitive recovery in patients with subacute ischemic stroke. Participants aged 40 to 75 years with ischemic stroke occurring 7 days to 3 months previously and mild-to-moderate cognitive impairment will be randomly assigned in a 1:1 ratio to receive standard care and rehabilitation plus MSC secretome or standard care and rehabilitation without MSC secretome. The primary outcome is the change in the Indonesian version of the Montreal Cognitive Assessment score. Secondary outcomes include quantitative electroencephalography parameters, serum brain-derived neurotrophic factor, serum interleukin-1β, NIHSS, modified Rankin Scale, and adverse events.",[514,515],"Ischemic Stroke","Post-Stroke Cognitive Impairment",[517,518,519,520,521,522,523,524,525,526,527,528],"Subacute ischemic stroke","Post-stroke cognitive impairment","Mesenchymal stem cell secretome","MSC secretome","Cognitive recovery","MoCA-Ina","Quantitative electroencephalography","qEEG","Brain-derived neurotrophic factor","BDNF","Interleukin-1 beta","IL-1β","2026-07-23",{"date":409,"type":39},{"date":532,"type":39},"2026-07-09",{"date":534,"type":21},"2026-12",{"name":536,"class":46},"Jumraini Tammasse",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":139,"enrollmentInfo":544,"targetDuration":4,"studyType":57,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":560,"locationsCount":164},"100648858","digital-psychoeducational-intervention-for-young-adults-with-fertility-related-distress-following-cancer-diagnosis-100648858","NCT07729696","Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis","Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with cancer.\n* Self-report fertility-related distress.\n* Aged 18 to 40 years old.\n* Able to speak Bahasa (the national language of Indonesia).\n* Have a performance status ECOG score of 0-2.\n\nExclusion Criteria:\n\n* Have a severe medical condition which impacts their level of consciousness.\n* Diagnosed with a major psychiatric comorbidity.\n* Unable to fill out the study questionnaires.\n* Unable to decide to participate due to cognitive impairment, decreasing consciousness level, or difficulty verbalizing their wishes.",{"count":545,"type":21},38,[143],"The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. It will also assess how the intervention supports the development of effective coping strategies and social support networks. The main questions it aims to answer are: Does the digital psychoeducational intervention reduce anxiety and depression severity compared with usual care? Does the digital psychoeducational intervention increase patients' self-efficacy, social support, and coping compared with usual care? Does the digital psychoeducational intervention increase patients' quality of life compared with usual care? Researchers will compare the digital psychoeducational intervention to usual care (standard treatment) to see if the intervention effectively manages psychological problems and improves quality of life. Participants will:Be randomly assigned to either the experimental group or the control group. Attend an initial face-to-face introductory session, followed by four digital psychoeducational modules delivered via a mobile phone application (if assigned to the experimental group). Engage with module content including an e-booklet, video, and quizzes, with a new module opening every two days. Receive standard treatment from healthcare providers, and later receive the psychoeducational materials at the end of the data collection period (if assigned to the control group). Complete a series of validated questionnaires measuring depression, anxiety, coping, self-efficacy, social support, and quality of life at four different time points throughout the study.",[549,550,551,552,553,554,555],"Neoplasm","Cancer","Psychoeducational Intervention","Young Adults","Fertility Outcomes","Psychological Distress","Anxiety",{"date":433,"type":39},{"date":36,"type":21},{"date":559,"type":21},"2026-12-14",{"name":163,"class":46},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":568,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":57,"phases":571,"briefSummary":572,"conditions":573,"keywords":575,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":244},"100649123","phase-3-phase-3-to-evaluate-the-efficacy-and-safety-of-dwp14012-in-patients-with-gastric-ulcer-100649123","NCT07730138","Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer","A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants With Gastric Ulcer","Inclusion Criteria:\n\n1. At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter\n2. The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.\n\nExclusion Criteria:\n\n1. Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.\n2. Participants who, within 30 days prior to the screening visit (Visit 1), have undergone or are scheduled to undergo major surgery that may affect gastric acid secretion.\n3. Participants with a history of malignancy within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed.\n4. Participants who, at the screening visit (Visit 1), have gastrointestinal active bleeding , esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (\\> 3 cm), esophageal dysplasia, duodenal ulcer, refractory ulcer, perforated ulcer, or surgery-induced ulcer\n5. Participants who, at the screening visit (Visit 1), have pancreatitis or inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or intestinal Behçet's disease).","19 Years",{"count":570,"type":21},384,[92],"A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer",[574],"Gastric Ulcer",[576,574,577,578,579,580],"DWP14012","P-CAB","peptic ulcer","stomach ulcer","duodenal ulcer","2026-07-22",{"date":409,"type":39},{"date":584,"type":21},"2026-10-15",{"date":586,"type":21},"2028-10-15",{"name":588,"class":104},"Daewoong Pharmaceutical Co. LTD.",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":197,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":57,"phases":599,"briefSummary":600,"conditions":601,"keywords":606,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":632},"100535583","phase-3-shortened-regimen-for-drug-susceptible-tb-in-children-100535583","NCT06253715","Shortened Regimen for Drug-susceptible TB in Children","SMILE-TB","Inclusion Criteria:\n\n* Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee\u002FInstitutional Review Board (EC\u002FIRB) policies and procedures, potential participant is willing and able to provide assent for study participation.\n* At Entry, age of less than 10 years.\n* At Entry, weight 3 kilograms (kg) or greater.\n* At Entry, diagnosed with TB disease, defined as:\n\n  * Pulmonary (including pleural effusion) and\u002For lymph node (extra-thoracic and\u002For intra-thoracic) TB with or without bacteriologic confirmation;\n  * Clinician has decided to treat with standard first-line drug-susceptible TB regimen.\n* Known HIV status or HIV testing in progress based on meeting testing requirements.\n* Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):\n\n  * Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;\n  * Total bilirubin less than or equal to 2.5 times the upper limit of normal;\n  * Potassium level of 3.0 milliequivalent\u002FL or greater;\n  * Hemoglobin level of 7.0 g\u002FdL or greater;\n  * Platelet count of 100,000\u002Fmm3 or greater;\n  * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL\u002Fmin\u002F1.73m2 or higher.\n* For children living with HIV:\n\n  * On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;\n  * Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.\n* For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.\n* For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include:\n\n  * Male or female condoms\n  * Diaphragm or cervical cap (with spermicide, if available)\n  * Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)\n* At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if\u002Fwhen applicable, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report.\n\nExclusion Criteria:\n\n* Presumed or documented extra-pulmonary TB involving the central nervous system and\u002For bones and\u002For joints, and\u002For miliary TB, and\u002For pericardial TB and\u002For TB of the gastrointestinal (GI) tract and\u002For renal TB.\n* Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.\n* Any known contraindication to taking any study drug:\n\n  * Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;\n  * Any prohibited medications within three days prior to Entry or planned use within the following 6 months;\n  * Unable to take oral medications;\n  * Known history of prolonged QT syndrome not caused by electrolyte derangements.\n* Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs.\n* M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Previously enrolled in this study.\n\nLate Exclusions:\n\n* M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB\u002FRIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum, nasopharyngeal aspirates, stool, or lymph node aspirate obtained around the time of study entry is determined to be resistant to isoniazid and\u002For rifampin and\u002For pyrazinamide and\u002For ethambutol and\u002For fluoroquinolones.\n* Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.","9 Years",{"count":598,"type":21},860,[92],"While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.",[602,603,604,605],"Tuberculosis","Tuberculosis, Pulmonary","Tuberculosis, Lymph Node","Mycobacterium Tuberculosis",[607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625],"tuberculosis","pediatric","stratified medicine","shortened regimen","rifapentine","moxifloxacin","dolutegravir","drug-susceptible","lymph node","pulmonary","infections","TB","mycobacterium infections","respiratory tract infections","lung diseases","antitubercular agents","respiratory tract diseases","child","paediatric",{"date":495,"type":39},{"date":628,"type":39},"2025-01-15",{"date":278,"type":21},{"name":631,"class":46},"Johns Hopkins University",9,{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":17,"minAge":640,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":57,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":164},"100648729","nasal-cannula-versus-single-nasal-prong-for-non-invasive-ventilation-in-preterm-infants-100648729","NCT07725614","Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants","Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants After Birth: A Randomized Controlled Trial","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Preterm infants with a gestational age of 28 to \\\u003C37 weeks who develop respiratory distress and require non-invasive ventilation (NIV) after birth.\n2. Written informed consent is obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n1. Infants with congenital nasal defects, including cleft lip and palate.\n2. Infants with prenatally diagnosed congenital anomalies that contraindicate NIV, including congenital diaphragmatic hernia, choanal atresia, esophageal atresia with tracheoesophageal fistula, or congenital heart disease.\n3. Infants with multiple congenital anomalies.\n4. Infants requiring endotracheal intubation for positive pressure ventilation immediately after birth.","0 Minutes","6 Hours",{"count":643,"type":21},140,[143],"Preterm infants frequently require non-invasive ventilation (NIV) to treat respiratory distress after birth. The effectiveness of NIV may be influenced by the interface used to deliver respiratory support. Nasal cannula and single nasal prong are two interfaces commonly used for NIV; however, evidence directly comparing their efficacy during the early postnatal period remains limited.\n\nThis randomized controlled trial aims to compare the efficacy of a nasal cannula and a single nasal prong as interfaces for non-invasive ventilation in preterm infants after birth. Eligible preterm infants requiring NIV after initial stabilization will be randomly assigned to receive respiratory support using either a nasal cannula or a single nasal prong. The assigned interface will be maintained for one hour following randomization, including during transport from the delivery room to the neonatal intensive care unit.\n\nThe primary outcome is the need for endotracheal intubation within one hour after interface application. Secondary outcomes include the need for endotracheal intubation within 6 hour of age, respiratory effectiveness, assessed by the oxygen saturation index (OSI) and arterial blood gas parameters (pH and partial pressure of carbon dioxide \\[pCO₂\\]), as well as interface-related adverse events, including interface dislodgement and nasal injury.\n\nThis study is expected to provide evidence to support the selection of an effective non-invasive ventilation interface for preterm infants after birth.",[647],"Prematurity","2026-07-21",{"date":495,"type":39},{"date":651,"type":21},"2026-07-20",{"date":653,"type":21},"2027-07-20",{"name":79,"class":46},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":57,"phases":665,"briefSummary":666,"conditions":667,"keywords":670,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":678,"leadSponsor":680,"locationsCount":164},"100647584","the-effect-of-teleconsultation-on-the-reversibility-of-frailty-in-geriatric-patients-post-hospitalization-100647584","NCT07712276","The Effect of Teleconsultation, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization","The Effect of Structured Teleconsultation, as Part of Discharge Planning, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization: a Clinical Trial Based on Clinical Scores and Biological Markers","TeleFrailty","Inclusion Criteria:\n\n* Age 60 years or older\n* Approved for hospital discharge\n* Diagnosed with pre-frailty or frailty\n* Access to a mobile phone, tablet, or laptop\n\nExclusion Criteria:\n\n* Unwilling to participate in the study\n* Depression, as indicated by a Geriatric Depression Scale (GDS) score ≥10, assessed at the time of discharge\n* Moderate to severe cognitive impairment, as indicated by a Montreal Cognitive Assessment-Indonesian version (MoCA-INA) score \\\u003C26, assessed at the time of discharge\n* Severe frailty, as indicated by a Clinical Frailty Scale (CFS) score \\>8\n* Liver cirrhosis\n* Chronic kidney disease stage 4 or higher\n* Stage 4 malignancy",{"count":664,"type":21},116,[143],"The goal of this clinical trial is to learn if a structured tele-consultation program, delivered 3 times over 12 weeks, can improve (reverse) frailty in geriatric patients recently discharged from the hospital. The main questions it aims to answer are:\n\n* Does structured tele-consultation covering physical exercise, nutrition, and home care education change health behavior in older adults after hospital discharge?\n* Does this change in health behavior lead to improvement in frailty, as measured by Clinical Frailty Scale (CFS) score?\n* Does this change in health behavior lead to improvement in frailty, as measured by decreased interleukin-6 (IL-6) and myostatin levels and increased albumin levels?\n* Does this change in health behavior lead to improvement in frailty, as measured by increased hand grip strength?\n\nResearchers will compare participants receiving structured tele-consultation (delivered 3 times over 12 weeks) to participants receiving usual care to see if tele-consultation leads to greater improvement in health behavior and frailty status.\n\nParticipants will:\n\n* Undergo baseline assessment of CFS score, hand grip strength, and blood sampling for IL-6, albumin, and myostatin shortly after hospital discharge\n* Be randomly assigned to receive either structured tele-consultation (3 sessions over 12 weeks, covering physical exercise, nutrition, and home care education) or usual care\n* Undergo repeat assessment of health behavior, CFS score, hand grip strength, and the same blood markers at the end of the 12-week period",[668,669],"Prefrail Elderly","Frail Elderly",[671,672,673,674,675],"frailty","prefrail","teleconsultation","elderly","reversibility frailty",{"date":581,"type":39},{"date":375,"type":21},{"date":679,"type":21},"2027-08-31",{"name":79,"class":46},{"id":682,"slug":683,"hasResults":12,"nctId":684,"briefTitle":685,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":57,"phases":690,"briefSummary":692,"conditions":693,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":695,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":164},"100648625","early-phase-1-effectiveness-of-amniotic-membrane-combined-with-secretome-as-an-adjunct-to-carpal-tunnel-release-surgery-evaluation-using-the-boston-carpal-tunnel-questionnaire-and-electromyography-100648625","NCT07723313","Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography","Secretome CTS","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with moderate-to-severe Carpal Tunnel Syndrome (CTS) based on electromyography (EMG) according to the Bland classification.\n* Persistent CTS symptoms that have not improved with conservative treatment.\n* Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Previous carpal tunnel release surgery on the affected wrist.\n* History of wrist trauma or previous wrist surgery.\n* Presence of comorbidities that may affect nerve healing or study outcomes, including diabetes mellitus, hypertension, or metabolic disorders.\n* Symptoms resembling CTS are attributable to other conditions, such as cervical spine or cervical nerve disorders (e.g., cervical radiculopathy).",{"count":689,"type":21},30,[691],"EARLY_PHASE1","Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. This study is a randomized controlled trial with a pre- and post-intervention experimental design to evaluate the effectiveness of adjunctive amniotic membrane combined with secretome in patients with moderate-to-severe CTS undergoing carpal tunnel release surgery. Participants will be randomly assigned to receive either standard surgical treatment alone or surgery with the addition of amniotic membrane and secretome. Clinical and electrophysiological outcomes will be evaluated before surgery and at 3 weeks after the intervention using the Boston Carpal Tunnel Questionnaire (BCTQ) and electromyography (EMG) to assess symptom improvement, functional recovery, and median nerve regeneration.",[694],"Carpal Tunnel Syndrome (CTS)",{"date":529,"type":39},{"date":697,"type":39},"2025-12-15",{"date":699,"type":21},"2026-08-15",{"name":701,"class":104},"PT. Prodia Stem Cell Indonesia",{"id":703,"slug":704,"hasResults":12,"nctId":705,"briefTitle":706,"officialTitle":706,"acronym":707,"eligibilityCriteria":708,"healthyVolunteers":12,"sex":388,"minAge":4,"maxAge":4,"enrollmentInfo":709,"targetDuration":4,"studyType":57,"phases":711,"briefSummary":712,"conditions":713,"keywords":714,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":719,"completionDateStruct":720,"leadSponsor":721,"locationsCount":164},"100648413","the-effect-of-channa-striata-and-curcuma-supplementation-on-nutritional-status-interleukin-6-levels-and-quality-of-life-in-patients-with-breast-cancer-100648413","NCT07722156","The Effect of Channa Striata and Curcuma Supplementation on Nutritional Status, Interleukin-6 Levels, and Quality of Life in Patients With Breast Cancer.","CCBreast","Inclusion Criteria:\n\n* Female patients with breast cancer aged ≥18 years who were undergoing chemotherapy.\n* Patients with a body mass index (BMI) of 18-29 kg\u002Fm².\n* Patients currently receiving chemotherapy for breast cancer.\n* Patients with serum albumin levels of 2.0-3.5 g\u002FdL.\n* Patients who were able to consume oral food and were willing to participate in the study by providing written informed consent.\n\nExclusion Criteria:\n\n* Patients with chronic kidney disease, renal failure, or kidney infection.\n* Patients with a known allergy to fish or Channa striata (snakehead fish) albumin-derived products.\n* Patients receiving other protein or amino acid supplements during the study period.\n* Patients who were non-compliant or discontinued the intervention before completion of the study.",{"count":710,"type":21},76,[143],"Breast cancer is frequently accompanied by chronic inflammation, malnutrition, and reduced quality of life, all of which may compromise treatment response and clinical outcomes. Nutritional interventions with immunomodulatory and anti-inflammatory properties have the potential to improve these conditions. Channa striata is rich in high-quality protein, albumin, and essential amino acids that support nutritional recovery and tissue repair, while Curcuma contains curcumin, a bioactive compound with well-established anti-inflammatory and antioxidant effects. This study aims to evaluate the effect of combined Channa striata and Curcuma supplementation on nutritional status, serum interleukin-6 (IL-6) levels, and quality of life in patients with breast cancer undergoing treatment. The findings are expected to provide evidence for the use of this nutritional supplementation as a complementary strategy to improve clinical outcomes, reduce systemic inflammation, and enhance the overall well-being of breast cancer patients.",[397],[715,716],"Breast cancer; Channa striata; Curcuma; Nutritional status; Interleukin-6 (IL-6); Quality of life; Nutritional supplementation; Inflammation.","Breast cancer, Channa striata Curcuma, Interleukin-6, Quality of life","2026-07-19",{"date":529,"type":39},{"date":296,"type":21},{"date":161,"type":21},{"name":722,"class":46},"DINA KEUMALA SARI",""]