[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Tunisia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":741},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,65,0,25,[9,47,71,106,127,164,197,223,256,285,307,341,377,408,437,476,505,534,556,587,608,638,663,688,712],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500",false,"NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","ALL","50 Years",{"count":20,"type":21},7140,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[27,28],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[30,31,32,33],"Heart Disease","Kidney Disease","Outcomes","Stroke","RECRUITING","2026-08-21",{"date":37,"type":38},"2026-08-24","ACTUAL",{"date":40,"type":38},"2025-12-01",{"date":42,"type":21},"2031-08",{"name":44,"class":45},"Eli Lilly and Company","INDUSTRY",567,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye","18 Years",{"count":57,"type":21},230,[24],"This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[61],"Metastatic Breast Cancer",{"date":63,"type":38},"2026-08-25",{"date":65,"type":38},"2023-09-08",{"date":67,"type":21},"2032-12-28",{"name":69,"class":45},"Hoffmann-La Roche",192,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100652814","high--vs-standard-dose-intravenous-magnesium-for-acute-headache-100652814","NCT07779486","High- vs Standard-Dose Intravenous Magnesium for Acute Headache","Intravenous Magnesium Sulfate Versus Paracetamol for the Treatment of Acute Non-Traumatic Headache in the Emergency Department: A Randomized Double-Blind Controlled Trial","MAGHEAD","Inclusion Criteria:\n\n* Age ≥18 years\n* Presentation to the emergency department with acute non-traumatic headache of less than 72 hours duration\n* Diagnosis consistent with a primary headache disorder, including:\n\n  * Migraine\n  * Tension-type headache\n  * Cluster headache (according to ICHD-3 criteria)\n* Moderate to severe pain intensity (VAS ≥5\u002F10)\n* Ability to understand the study procedures and provide informed consent\n\nExclusion Criteria:\n\n* Suspected or confirmed secondary headache (e.g., intracranial hemorrhage, infection, mass lesion)\n* Recent head trauma\n* Known hypersensitivity or contraindication to magnesium sulfate or paracetamol\n* Use of analgesic medication within the previous 6 hours\n* Pregnancy or breastfeeding\n* Severe renal insufficiency or conditions contraindicating magnesium administration\n* Hemodynamic instability or clinically significant cardiac conduction disorders Prior participation in this study",{"count":80,"type":21},300,[82],"NA","Headache is one of the most common reasons for consultation in emergency departments and represents a significant cause of disability, particularly in patients with migraine and other primary headache disorders. Despite the availability of several analgesic treatments, including nonsteroidal anti-inflammatory drugs and paracetamol, pain relief is often incomplete, and a proportion of patients require additional rescue therapy.\n\nMagnesium sulfate has emerged as a potential therapeutic option in acute headache due to its role in modulating neuronal excitability, vascular tone, and pain-related neurotransmitter release. However, its efficacy as a standalone treatment, the optimal intravenous dose, and its comparative effectiveness versus standard therapy remain unclear.\n\nThis randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of intravenous magnesium sulfate in the treatment of acute non-traumatic headache in the emergency department. Participants will be randomly assigned to receive either low-dose magnesium sulfate (2 g IV), high-dose magnesium sulfate (4 g IV), or intravenous paracetamol (1 g IV) as an active comparator.\n\nThe primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS) at 60 minutes after treatment administration, as well as the proportion of patients achieving at least 50% pain reduction. Secondary outcomes include time course of pain relief, need for rescue medication, adverse events, patient satisfaction, and length of stay in the emergency department.\n\nIn addition, the study will assess baseline ionized magnesium levels to explore their relationship with treatment response and evaluate whether magnesium levels may predict clinical efficacy.\n\nThe results of this study may help clarify the role of intravenous magnesium sulfate in the management of acute headache and potentially improve treatment strategies in emergency settings.",[85,86,87,88],"Acute Headache","Migraine","Tension-type Headache","Cluster Headache",[90,86,91,92,93,94,95],"Acute headache","Emergency department","Intravenous magnesium Magnesium sulfate","Paracetamol","Acute pain","Analgesia","2026-08-19",{"date":35,"type":38},{"date":99,"type":38},"2026-06-01",{"date":101,"type":21},"2030-12-31",{"name":103,"class":104},"University of Monastir","OTHER",1,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":105},"100652412","effectiveness-and-utility-of-telemonitoring-in-improving-the-glycaemic-control-of-diabetes-mellitus-tunisian-patients-100652412","NCT07774078","Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients","Evaluation of the Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Tunisian Patients With Diabetes Mellitus: a Study Protocol","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.\n* Stable antidiabetic treatment for at least 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Serum creatinine \\>200 µmol\u002FL.\n* Acute coronary syndrome or stroke.\n* Dementia.\n* Pregnancy.\n* Inability to participate in or comply with the telemonitoring intervention.\n* Severe diabetic retinopathy.",{"count":114,"type":21},260,[82],"The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.",[118,119],"Diabete Mellitus","Telemonitoring",{"date":121,"type":38},"2026-08-20",{"date":123,"type":38},"2024-08-01",{"date":125,"type":21},"2026-12-31",{"name":103,"class":104},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":134,"targetDuration":136,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100459602","post-marketing-clinical-follow-up-study-to-evaluate-efficacy-and-safety-of-the-occlutech-pda-occluder-in-patients-with-patent-ductus-arteriosus-defects-100459602","NCT05264753","Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects","A Multicenter, International, Prospective, Retrospective, Post Marketing Clinical Follow Up Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects","Inclusion Criteria:\n\n* A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.\n* Male or female subjects.\n* Subjects or their parents\u002Fguardians understanding the nature of the study and providing their informed consent to participation.\n* Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.\n\nExclusion Criteria:\n\nContraindications as laid down in the IFU:\n\n* Silent ductus or serious pulmonary hypertension:\n* Pulmonary Vascular Resistance (PVR) \\> 8 Wood Units\n* Presence of a known coagulation disorder\n* Thrombus at the position allocated for the implantation\n* A vein thrombosis in the blood vessels chosen for the introducing system\n* An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.\n* Nitinol intolerance (nickel or titanium)\n* Contrast medium intolerance\n* Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath",{"count":135,"type":21},255,"3 Years","OBSERVATIONAL","This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline\u002Fimplantation (including assessments within 36 hours post procedure), as well as at follow up visits occurring between Day 30 and Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation.",[140],"Patent Ductus Arteriosus",[142,143,144,145,146,147,148,149,150,151,152,153],"Occlutech PDA Occluder","Patent ductus arteriosus closure","Transcatheter PDA occlusion","Percutaneous catheter-based intervention","Occluder device","Post-marketing clinical follow-up","PMCF","Prospective and retrospective study","Multicenter international study","Efficacy and safety","Echocardiography follow-up","Pediatric cardiology","2026-08-11",{"date":156,"type":38},"2026-08-12",{"date":158,"type":38},"2021-12-20",{"date":160,"type":21},"2029-11-25",{"name":162,"class":45},"Occlutech International AB",15,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100637093","a-long-term-observational-study-of-patients-with-fucosidosis-100637093","NCT07615400","A Long-Term Observational Study of Patients With Fucosidosis","A Retrospective and Prospective Natural History Study of Patients With Fucosidosis","Inclusion Criteria (Part A):\n\n* Confirmed diagnosis of fucosidosis\n* Patient either with or without previous allogeneic hematopoietic stem cell transplant (HSCT) for treatment of fucosidosis\n\nExclusion Criteria (Part A):\n\n* Patient\u002Fparent\u002Fcaregiver not willing to consent to participate\n* Patient deceased with no availability of appropriate historical consent, and patient's family\u002Fcaregivers are either unable to be contacted, or refuse consent to data sharing\n\nInclusion Criteria (Part B):\n\n* Patient is living\n* Confirmed diagnosis of fucosidosis\n* Patient either with or without previous allogeneic HSCT for treatment of fucosidosis\n\nExclusion Criteria (Part B):\n\n* Patient\u002Fparent\u002Fcaregiver not willing to consent to participate\n* Current participation in any other interventional or therapeutic study (exception: patients who have previously received bone marrow \u002F HSCT as treatment for fucosidosis are not excluded)\n* Patients who, in the opinion of the site investigator, would be unable or unsuitable to participate in the demands of the study",{"count":172,"type":21},57,"The purpose of this observational research study is to learn more about the natural history of fucosidosis, its symptoms, and how it develops over time.\n\nThis study intends to collect information from participants diagnosed with fucosidosis; however, this study does not include any medication or treatment other than the usual medical care provided to study participants.\n\nThe information collected in this study will be used to help understand the disease characteristics of fucosidosis; with this information potentially being able to help design future studies and treatments for this disease.\n\nThere is currently no approved treatment for patients with fucosidosis.\n\nThe study consists of 2 parts: a) Part A - retrospective data collection, and b) Part B - prospective data collection.",[175],"Fucosidosis",[177,178,179,180,181,182,183,184,185,186],"fucosidosis","Lysosomal Storage Diseases","alpha-L-Fucosidase","Genetic Diseases, Inborn","Congenital, Hereditary, and Neonatal Diseases and Abnormalities","Carbohydrate Metabolism, Inborn Errors","Metabolism, Inborn Errors","Alpha-Fucosidase Deficiency","Brain Diseases, Metabolic, Inborn","Lysosomal Storage Diseases, Nervous System","2026-08-04",{"date":189,"type":38},"2026-08-05",{"date":191,"type":38},"2026-03-25",{"date":193,"type":21},"2031-01",{"name":195,"class":45},"JCR Pharmaceuticals Co., Ltd.",16,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":220,"locationsCount":222},"100494919","virtual-care-to-improve-outcomes-and-recovery-from-heart-failure-hospitalization-100494919","NCT05724433","VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization","VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT","VICTORY-HF","Inclusion Criteria:\n\nAdult patients ≥ 18 years old who:\n\n1. Are being discharged after hospitalization or urgent visit for HF as\n\n   1. a primary diagnosis or\n   2. significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.\n2. Have left ventricular ejection fraction (LVEF) \\\u003C 50% within the preceding 3 months.\n3. Have NT-proBNP of \\> 900 pg\u002Fml during hospital admission or within 7 days after discharge from the ED\n4. Have a mailing address for patient or caregiver\n5. Provide verbal consent\n\nExclusion Criteria:\n\n1. Died or left hospital before medically advised hospital discharge\n2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)\n3. Unable to engage with digital health technology or follow up\n4. Severe valve disease\n5. Recipient of or on waiting list for LVAD or cardiac transplant\n6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy\n7. Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) \\\u003C 1 litre, severe pulmonary hypertension with RVSP \\> 60 mm Hg, or on home oxygen\n8. Severe kidney disease (persistent eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2)\n9. Active malignancy\n10. Receiving palliative care or expected life expectancy \\\u003C 6 months",{"count":206,"type":21},891,[82],"The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.",[210],"Heart Failure",[210,212,213,214],"Randomized Controlled Trial","Digital Health","Knowledge Translation",{"date":216,"type":38},"2026-08-07",{"date":218,"type":38},"2023-01-23",{"date":125,"type":21},{"name":221,"class":104},"Population Health Research Institute",9,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":105},"100645632","pilot-trial-of-oral-sodium-bicarbonate-versus-higher-dialysate-bicarbonate-in-hemodialysis-patients-with-metabolic-acidosis-100645632","NCT07688434","Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patients With Metabolic Acidosis","Comparative Pilot Trial of Oral Sodium Bicarbonate Versus Increased Dialysate Bicarbonate in Chronic Hemodialysis Patients With Metabolic Acidosis","Bicarbonate-HD","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Stable hemodialysis prescription: 3 times a week, high-flux dialyzers, no major change in dialysis prescription in the previous weeks.\n* Predialysis low \"alkaline reserves\" (serum bicarbonate concentration) according to the operational threshold used in the unit (e.g., \"alkaline reserves\" \\\u003C 22 mmol\u002FL), consistent with KDIGO 2017 definition of metabolic acidosis.\n* Ability to give written informed consent.\n\nFor the observational group:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Hemodialysis 3 times a week, high-flux dialyzers.\n* Predialysis \"alkaline reserves\" considered stable and within the locally defined normal range (≥ 22mmol\u002FL).\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* Recent hemodynamic instability (e.g., repeated intradialytic hypotension or unstable blood pressure in the previous weeks).\n* Recent hospitalization for an acute condition.\n* Acute infection or major intercurrent acute event at the time of screening.\n* Major change in dialysis prescription in the 2 weeks prior to inclusion (e.g., change in dialysis schedule, duration, or dialysate composition outside the study protocol).\n* Severe digestive disorders limiting oral intake (e.g., persistent vomiting, severe malabsorption, or any condition preventing safe oral Bicardis administration).\n* Known hypernatremia or high risk of uncontrolled sodium and fluid overload (as judged by the investigator).\n* Severe uncontrolled hypercalcemia or hypocalcemia.\n* Any condition that, in the investigator's judgment, would preclude safe participation or interfere with study procedures (e.g., very limited life expectancy, inability to attend scheduled visits).\n* Refusal to participate or inability to provide written informed consent.",{"count":232,"type":21},37,[82],"Metabolic acidosis is frequent in chronic hemodialysis patients and is associated with adverse clinical outcomes. Two commonly used strategies to correct acidosis are oral sodium bicarbonate supplementation and increasing the bicarbonate concentration of the dialysate, but their comparative effectiveness and tolerance in routine care remain uncertain. This pilot, prospective, randomized, open-label, single-center trial will compare oral sodium bicarbonate versus higher dialysate bicarbonate in chronic hemodialysis patients with metabolic acidosis, using predialysis plasma bicarbonate concentrations, so-called \"reserves alcalines\" or \"alkaline reserves\" in local laboratory reports, as a pragmatic marker of acid-base status.\n\nApproximately 30 acidotic patients (serum bicarbonate \\\u003C 22 mmol\u002FL) will be randomized 1:1 to receive either oral sodium bicarbonate or an increase in dialysate bicarbonate for 6 weeks. An additional non-acidotic observational group will provide descriptive reference data. The primary outcome is the change in predialysis serum bicarbonate from baseline (Day 0) to Day 42 between the two randomized arms. Secondary outcomes include the proportion of patients reaching target serum bicarbonate levels, the weekly kinetics of correction, dialysis adequacy (Kt\u002FV and online clearance monitoring), intradialytic tolerance (blood pressure, cramps, hypotension, symptoms), sodium-related safety (natremia, interdialytic weight gain), and the effects of acidosis correction on nutritional and bone-mineral metabolism, including changes in serum albumin, calcium, phosphorus, and parathyroid hormone (PTH). Feasibility indicators such as recruitment, retention, adherence to treatment and dialysate adjustment, and data completeness will also be described to inform the design of a larger definitive trial.",[236,237,238],"End-stage Renal Disease (ESRD)","Chronic Hemodialysis","Metabolic Acidosis",[240,241,238,242,243,244,245],"Hemodialysis","End-Stage Renal Disease","Oral sodium Bicarbonate","Dialysate Bicarbonate","Pilot Trial","Bicarbonate Supplementation","NOT_YET_RECRUITING","2026-07-18",{"date":249,"type":38},"2026-07-21",{"date":251,"type":21},"2026-07",{"date":253,"type":21},"2026-09",{"name":255,"class":104},"University of Sfax",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":266,"conditions":267,"keywords":271,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":105},"100619479","congestion-and-lactate-at-discharge-in-acute-heart-failure-100619479","NCT07345156","Congestion and LActate at diScHarge in Acute Heart Failure","Validation of a Combined Score Combining the Lung Ultrasound Score and Lactate at Discharge for Predicting Early Events After Acute Heart Failure","CLASH-HF","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Hospitalization for acute heart failure\u002Fdecompensation (clinical diagnosis + imaging\u002Flaboratory tests according to local practice).\n* Patient deemed ready for discharge (decision made by the team, discharge within 24 hours).\n\nExclusion Criteria:\n\n* Septic shock\u002Fsevere active infection at the time of discharge.\n* Hypoxemia or respiratory distress requiring high-flow oxygen\u002Fventilation at the scheduled time of discharge.\n* Severe cirrhosis\u002Fadvanced liver failure.\n* Refusal to participate.\n* Technical impossibility of LUS.",{"count":265,"type":21},350,"Acute heart failure (AHF) is a leading cause of hospitalization and is associated with high short-term morbidity and mortality, with 20-30% of patients experiencing rehospitalization or death within 30 days. Early adverse events often reflect incomplete recovery, highlighting the need for improved risk stratification after clinical stabilization .Current prognostic approaches mainly focus on hemodynamic congestion. Persistent pulmonary congestion at discharge is a strong predictor of poor outcomes, but these markers primarily assess macrocirculatory abnormalities and do not capture microcirculatory dysfunction, which may persist despite apparent clinical improvement. Lung ultrasound, through the Lung Ultrasound Score (LUS), provides a validated assessment of pulmonary congestion and has demonstrated prognostic value in AHF. However, LUS does not reflect systemic tissue perfusion. In contrast, blood lactate is a robust marker of tissue hypoperfusion, and even mild elevations have been associated with worse outcomes in AHF. A combined score integrating LUS and lactate may therefore better reflect the dual pathophysiology of AHF-persistent congestion and impaired tissue perfusion-and improve prediction of early adverse events.\n\nThis protocol aims to validate the prognostic value of this combined score for predicting 30-day rehospitalization or death in patients hospitalized for AHF, with the hypothesis that it outperforms LUS alone.",[268,269,270],"Heart Failure Acute","Discharge Follow-up Phone Calls","Mortality Prediction",[272,273,274,275,276],"Lung Ultrasound Score","Lactate","Combined score","Acute Heart Failure","Discharge","2026-07-14",{"date":279,"type":38},"2026-07-15",{"date":281,"type":38},"2026-01-01",{"date":283,"type":21},"2026-12-30",{"name":103,"class":104},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":105},"100591461","phase-3-comparative-efficacy-of-iv-dexamethasone-vs-nebulized-terbutaline-for-renal-colic-pain-in-the-ed-100591461","NCT06980727","Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED","Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical Trial","Inclusion criteria:\n\n* Adults aged 18-65 years\n* Clinical diagnosis of acute renal colic (defined as sudden sharp colicky flank pain with or without radiation to the genitalia or groin, and with or without urinary symptoms)\n* Pain score of 5 or more measured using the 10-cm NRS scale\n\nExclusion Criteria:\n\n* History of cardiovascular, hepatic, renal, or metabolic diseases\n* Evidence of sepsis or clinical suspicion of urinary tract infection\n* Hemodynamically unstable (systolic blood pressure \\\u003C 90 mmHg)\n* Uncontrolled diabetes\n* Pregnancy or breastfeeding\n* Inability to understand verbal and\u002For written information\n* Received any analgesics within 6 hours prior to presentation\n* Serum potassium \\\u003C 3.7 mmol\u002FL\n* Concomitant use of:\n\nAny beta-blockers (including beta-blocker-containing eye drops)\n\nProlonged-release long-acting β-agonists\n\nShort-acting β2-agonists within 6 hours prior to presentation\n\n* Contraindication to terbutaline use\n* Known allergy to paracetamol or terbutaline\n* Abdominal tenderness suggestive of peritoneal inflammation\n* Clinical suspicion of conditions other than urolithiasis, including:\n* Abdominal aortic aneurysm\n* Aortic dissection\n* History of drug dependence or chronic alcohol consumption","65 Years",{"count":294,"type":21},500,[24],"Adult patients (18-55 years of age) with clinical diagnosis of acute renal colic (sudden sharp colic flank pain with or without radiation to genitalia or groin and with or without urinary symptoms) who had pain score of 5 or more measured by 10-cm visual analogue scale (VAS), will be included. Will be excluded those who had history of cardiovascular, hepatic, renal or metabolic diseases, patients with evidence of sepsis or clinical suspicion of urinary tract infection, hemodynamically unstable patients (systolic blood pressure \\&amp;lt;90 mmHg), patients with uncontrolled diabetes, pregnancy, breastfeeding, patients unable to understand verbal and\u002For written information, patients receiving analgesics within 6 hours before presentation, serum potassium less than 3.7 mmol\u002Fl, concomitant use of any beta blockers (including beta-blocker containing eye drops), prolonged-release long-acting β-agonists, use of short-acting β2-agonists within the 6 h preceding presentation to the emergency department, any contraindication to the use of terbutaline, history of drug dependence or chronic consumption of alcohol. Will be also excluded patients with known allergy to paracetamol or terbutaline, patients with abdominal tenderness as a sign of peritoneal inflammation and those with any clinical suspicion for diseases other than urolithiasis, including abdominal aortic aneurysm or dissection.",[298],"Renal Colic",[298,300],"Dexamethasone",{"date":279,"type":38},{"date":303,"type":21},"2026-08-08",{"date":305,"type":21},"2028-03-01",{"name":103,"class":104},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":318,"conditions":319,"keywords":324,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":105},"100647362","phase-4-this-a-clinical-trial-to-evaluate-the-efficacy-of-i-prf-povidone-iodine-and-laser-as-adjuncts-to-non-surgical-periodontal-treatment-in-smokers-and-non-smokers-periodontitis-patients-100647362","NCT07707063","This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients","Clinical Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients : A Split Mouth Randomized Clinical Trial","Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket \\> 4 mm minimum in every quadrant.\n\nExclusion: patients who:\n\n* Pregnant \u002FLactating\n* History of radiotherapy or chemotherapy in the head\u002Fneck region.\n* Known hypersensitivity to Iodine or Methylene blue solution\n* Systematic antibiotic use within the last 30 days\n* Long-term use of immunosuppressants or corticosteroids (daily use)\n* type 1 \u002F 2 diabetes",{"count":315,"type":21},50,[317],"PHASE4","This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP\u002FEFP periodontal classification.",[320,321,322,323],"Periodontitis","Smokers","Non Smokers","Periodontal Disease",[325,326,327,328,329,330,331],"Injectable platelet-rich fibrin (I-PRF)","Diode Laser","iodine solution","Periodontal Pockets","periodontal debridement","lasers","Regenerative periodontal therapy","2026-07-10",{"date":334,"type":38},"2026-07-16",{"date":336,"type":38},"2026-05-25",{"date":338,"type":21},"2027-05-18",{"name":340,"class":104},"Military Hospital of Tunis",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":348,"minAge":4,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":359,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":105},"100646011","office-hysteroscopy-in-postmenopausal-women-a-randomized-trial-of-cervical-preparation-strategies-100646011","NCT07697781","Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies","A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women","Inclusion Criteria:\n\n* Women with postmenopausal status.\n* Scheduled for office hysteroscopy for the evaluation of suspected intrauterine pathology.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected hormone-dependent malignancy (e.g., breast or endometrial cancer).\n* Active genital tract infection.\n* Contraindication or known hypersensitivity to misoprostol or vaginal estrogen.\n* Refusal to undergo office hysteroscopy without anesthesia.\n* Active uterine bleeding preventing adequate hysteroscopic visualization on the day of the procedure.","FEMALE",{"count":350,"type":21},120,[82],"The goal of this randomized controlled trial is to evaluate the effectiveness of different cervical preparation strategies before office hysteroscopy in postmenopausal women undergoing evaluation for intrauterine pathology.\n\nThe main questions to answer are:\n\nDoes cervical preparation improve the success rate of complete office hysteroscopy in postmenopausal women? Which cervical preparation strategy provides better patient tolerance, as assessed by pain intensity during the procedure?\n\nResearchers will compare four cervical preparation protocols (14-day vaginal estrogen, 7-day vaginal estrogen, oral misoprostol, and no cervical preparation) to determine their effects on procedural success, pain, procedure duration, and perioperative complications.\n\nParticipants will be randomly assigned to one of the four cervical preparation protocols. They will undergo office hysteroscopy using a vaginoscopic (\"no touch\") approach without anesthesia. Then, they will have pain assessed using a visual analog scale (VAS) during the procedure. Finally, these informations will be collected: procedural success, procedure duration, bleeding, and perioperative complications.",[354,355,356,357,358],"Postmenopausal Women","Intrauterine Diseases","Endometrial Pathology","Postmenopausal Bleeding","Abnormal Uterine Bleeding (AUB)",[360,361,362,363,364,365,366,367,368],"Postmenopausal women","Postmenopausal bleeding","Office hysteroscopy","Cervical preparation","Vaginal estrogen","Oral misoprostol","Visual Analog Scale","Vaginoscopy","No touch approach","2026-07-09",{"date":371,"type":38},"2026-07-13",{"date":373,"type":38},"2026-01-02",{"date":121,"type":21},{"name":376,"class":104},"Faculty of Medicine of Tunis",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":384,"sex":17,"minAge":385,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":389,"briefSummary":390,"conditions":391,"keywords":397,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":105},"100645978","early-time-restricted-eating-combined-with-exercise-in-older-adults-100645978","NCT07695961","Early Time-Restricted Eating Combined With Exercise in Older Adults","Effects of Early Time-Restricted Eating Combined With a Multicomponent Exercise Program on Bone Mineral Density, Gait, Balance, and Fall Risk in Healthy Older Adults: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 60 years or older\n* Community-dwelling and generally healthy older adults\n* Sedentary or moderately physically active\n* Stable body weight during the previous 3 months (no intentional weight loss or gain \\>5%)\n* Able to participate in a supervised exercise program\n* Willing to comply with the time-restricted eating protocol and study procedures\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of osteoporosis requiring pharmacological treatment\n* Severe sarcopenia or major mobility limitations preventing safe exercise participation\n* Cognitive impairment or diagnosed dementia affecting ability to follow instructions\n* Presence of uncontrolled chronic diseases affecting bone metabolism (e.g., advanced renal disease, uncontrolled endocrine disorders)\n* Current use of medications affecting bone metabolism (e.g., corticosteroids, anti-osteoporotic drugs)\n* Participation in another structured exercise or dietary intervention program within the past 3 months\n* Any medical condition that contraindicates moderate-intensity exercise\n* Inability to comply with study protocol or follow-up assessments",true,"60 Years","85 Years",{"count":388,"type":21},44,[82],"This randomized controlled trial aims to investigate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone health, physical function, and fall risk in healthy older adults.\n\nA total of approximately 44 healthy adults aged 60 years and older will be recruited and randomly assigned to one of two groups. The experimental group will follow an Early Time-Restricted Eating schedule combined with a structured multicomponent exercise program. The control group will not receive any dietary timing intervention or structured exercise program and will continue their usual daily lifestyle.\n\nThe intervention will last for 6 months. Participants in the exercise program will perform supervised sessions including resistance training, balance exercises, aerobic activity, and flexibility exercises. The Early Time-Restricted Eating protocol will involve consuming all daily food intake within an early daytime window while maintaining usual dietary quality and adequate energy and nutrient intake.\n\nThe main outcomes of the study include changes in bone mineral density, gait performance, balance, and fall risk. These outcomes will be measured at baseline and after the intervention period.\n\nThis study will provide evidence on whether combining early time-restricted eating with structured exercise can improve musculoskeletal health and functional ability, and reduce fall risk in older adults.",[392,393,394,395,396],"Nutrition","Health and Wellbeing","Aging","Time Restricted Eating","Bone Health",[395,398,399,400,401],"Exercise Program","Bone Mineral Density","Gait","Balance",{"date":371,"type":38},{"date":404,"type":21},"2026-06-15",{"date":283,"type":21},{"name":407,"class":104},"University of Manouba",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":422,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":105},"100641977","outpatient-versus-inpatient-management-of-mild-acute-pancreatitis-100641977","NCT07643961","Outpatient Versus Inpatient Management of Mild Acute Pancreatitis","Outpatient Versus Inpatient Management of Mild Acute Pancreatitis: A Randomised Controlled Non-Inferiority Trial","Inclusion Criteria:\n\n* Age 18 years or older Diagnosis of acute pancreatitis based on at least two of three revised Atlanta (2012) criteria: characteristic abdominal pain; serum lipase or amylase ≥3× upper limit of normal; or characteristic imaging findings Classification as mild acute pancreatitis: SIRS score = 0 and HAPS score = 0 at emergency department presentation Ability to tolerate oral intake at the time of randomisation Provision of written informed consent Presence of a competent caregiver at home Residence within 30-45 minutes' travel time from the hospital Ability to communicate by telephone\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding Inability to maintain oral intake for reasons unrelated to acute pancreatitis Acute pancreatitis attributable to tumour, post-ERCP intervention, or abdominal trauma Concurrent choledocholithiasis with or without cholangitis Chronic pancreatitis or history of recurrent acute pancreatitis (≥2 prior episodes) ASA physical status classification ≥ 3 Clinical or radiological features suggesting moderately severe or severe acute pancreatitis Alcohol withdrawal syndrome No competent caregiver at home Residence more than 30-45 minutes from the hospital Inability to communicate by telephone or equivalent means",{"count":416,"type":21},150,[82],"Acute pancreatitis is a sudden inflammation of the pancreas that causes severe abdominal pain. Most cases are mild and get better within a few days with basic supportive treatment such as fluids and pain relief. Currently, all patients with acute pancreatitis are admitted to hospital, even those with a very low risk of complications. This study will test whether patients with mild acute pancreatitis can be safely sent home with close follow-up (telephone calls on days 1, 2, and 3 after discharge and a clinic visit on day 4) instead of staying in hospital. Patients will be randomly assigned to either home management or standard hospitalization. We will compare the rate of treatment failure at 30 days between the two groups. We expect that home management will be as safe as hospitalization, while being more convenient for patients and less costly for the health system.",[420,421],"Acute Pancreatitis (AP)","Biliary Pancreatitis",[423,424,425,426,427,428,429],"acute pancreatitis","outpatient","ambulatory","non-inferiority","randomised controlled trial","HAPS","SIRS",{"date":332,"type":38},{"date":432,"type":21},"2026-07-01",{"date":434,"type":21},"2027-03-31",{"name":436,"class":104},"Center for Traumatology and Major Burns, Ben Arous",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":445,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":459,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":105},"100645772","delayed-versus-immediate-cord-clamping-in-preterm-birth-100645772","NCT07699666","Delayed Versus Immediate Cord Clamping in Preterm Birth","Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center","PREM-CORD","Inclusion Criteria:\n\n* Preterm neonates born at gestational age between 32 and 37 weeks\n* Live-born infants delivered in the study center\n* Singleton pregnancies\n* Parental consent obtained when applicable according to institutional ethical requirements\n\nExclusion Criteria:\n\n* Major congenital malformations or chromosomal abnormalities\n* Need for immediate advanced resuscitation at birth\n* Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation\n* Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)\n* Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry","0 Days",{"count":447,"type":21},200,[82],"The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.\n\nPreterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.\n\nIn this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.\n\nThe study is conducted in a tertiary maternity center in Tunisia.",[451,452,453,454,455,456,457,458],"Preterm Birth Complication","Neonatal Morbidity and Mortality","Cord Clamping","Delayed Cord Clamping","Anemia","NEC - Necrotizing Enterocolitis","Intraventricular Hemorrhage Neonatal","Respiratory Distress Neonatal",[460,461,462,463,464,465,466,467,468,469],"Delayed cord clamping","Immediate cord clamping","Preterm infants","Preterm birth","Umbilical cord clamping","Neonatal outcomes","Placental transfusion","Neonatal morbidity","Neonatal mortality","Tunisia","2026-07-08",{"date":371,"type":38},{"date":473,"type":38},"2025-10-02",{"date":125,"type":21},{"name":376,"class":104},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100647018","evaluation-of-the-effectiveness-of-the-cardiostory-device-in-distinguishing-heart-failure-from-other-causes-in-patients-presenting-with-dyspnea-100647018","NCT07685106","Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.","CARDIOSTORY TN","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Recent onset dyspnea (less than 7 days)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Age inferior to 18 years,\n* Severe comorbidity, hemodynamic compromise or immediate need for mechanical ventilation were exclusion criteria.\n* Dyspnea clearly of traumatic or allergic origin",{"count":484,"type":21},850,"This is a prospective, observational study conducted in the emergency department. Adult patients presenting with dyspnea will be enrolled, and study data will be collected from routine clinical assessments, including medical history, physical examination, laboratory tests, and echocardiography results, as well as non-invasive cardiovascular measurements obtained using the CardioStory device.",[210,487],"Dyspnea",[489,490,491,492,493,494],"dyspnea","Heart failure","non-cardiac causes of dyspnea","cardiostory","cardiac assessment device","cardiac causes of dyspnea","2026-07-02",{"date":497,"type":38},"2026-07-06",{"date":499,"type":38},"2025-09-01",{"date":501,"type":21},"2026-12",{"name":503,"class":45},"CardioStory INC",2,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":520,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":533},"100367421","phase-3-a-study-to-evaluate-long-term-safety-in-participants-who-have-participated-in-other-luspatercept-ace-536-clinical-trials-100367421","NCT04064060","A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be enrolled in this study:\n\n1. Participant is ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:\n\n   1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR\n   2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR\n   3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).\n4. Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.\n5. Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.\n6. Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:\n\n1\\) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must:\n\n1. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence from heterosexual contact.\n2. Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.\n\n   7\\. Applies to on treatment participants only- Male participants must:\n\na. Agrees to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from enrollment:\n\n1. Applies to on treatment participants only- Concomitant use of any medications\u002Fprocedures that are prohibited in the parent luspatercept protocol.\n2. Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.\n3. Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.\n4. Applies to on treatment participants only- Pregnant or breastfeeding females.\n5. Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.\n6. Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study.\n7. Participant has any condition that confounds the ability to interpret data from the study.",{"count":513,"type":21},665,[24],"A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:\n\n* Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept\n* Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met\n* The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase\n* Transition Phase is defined as one Enrollment visit\n* Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol\n* Follow-up Phase includes:\n\n  \\- 42 Day Safety Follow-up Visit\n* During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting\n\n  \\- Long-term Post-treatment Follow-up (LTPTFU) Phase\n* Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies\u002Fpre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule\n\nParticipants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.\n\nThe ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.",[517,518,519],"Myelodysplastic Syndromes (MDS)","Beta-thalassemia","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis",[521,522,523,518,524],"ACE-536","Luspatercept","MDS","Myeloproliferative neoplasm (MPN)-associated myelofibrosis","2026-06-30",{"date":432,"type":38},{"date":528,"type":38},"2019-08-12",{"date":530,"type":21},"2028-05-12",{"name":532,"class":45},"Celgene",143,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":105},"100641852","blood-transfusion-risk-factors-and-cell-saver-impact-in-pediatric-scoliosis-surgery-100641852","NCT07661589","Blood Transfusion Risk Factors and Cell Saver Impact in Pediatric Scoliosis Surgery","Risk Factors for Homologous Blood Transfusion and Impact of Cell Saver Use in Pediatric Scoliosis Surgery: A Retrospective Monocentric Study","Inclusion Criteria:\n\n* Patient aged under 18 years (\\\u003C 18 years old).\n* Programmed surgical correction for scoliosis (including idiopathic, neuromuscular, and congenital etiologies).\n* Instrumented surgery involving posterior spinal arthrodesis.\n\nExclusion Criteria:\n\n* Revision spine surgeries.\n* Known constitutional hemostasis disorders.\n* Non-orthopedic spine surgeries.\n* Missing core clinical or transfusion data.","17 Years",{"count":447,"type":21},"Spine surgery for scoliosis correction in pediatric patients is a major procedure associated with a high risk of perioperative blood loss. Homologous blood transfusion carries inherent risks, including immunological reactions, infections, and increased healthcare costs. Identifying high-risk patients is crucial to optimize blood conservation strategies. This retrospective study aims to identify preoperative and intraoperative risk factors associated with homologous red blood cell (RBC) transfusion and to evaluate the quantitative impact of Cell Saver volume reinfusion on reducing homologous transfusion requirements.",[545],"Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss",[547],"Pediatric scoliosis, Cell Saver, Homologous blood transfusion, Risk factors, Spine surgery, Posterior spinal fusion","2026-06-16",{"date":550,"type":38},"2026-06-22",{"date":552,"type":38},"2023-04-01",{"date":125,"type":21},{"name":555,"class":104},"Mehdi Trifa",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":564,"targetDuration":136,"studyType":137,"phases":4,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":586},"100393633","the-after-registry---follow-up-study-to-monitor-the-efficacy-and-safety-of-the-occlutech-afr-in-heart-failure-patients-100393633","NCT04405583","The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients","A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients","AFR Registry","Inclusion Criteria:\n\n1. Written, informed consent\n2. Age ≥18 years\n3. Presence of chronic symptomatic HF (NYHA class ≥ 2)\n4. Left Atrial Pressure (LAP) \\> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\\*\n5. LVEF ≥ 15%. If LVEF is \\>40% (HFpEF), BMI corrected\\*\\* NT-pro-BNP must be elevated ≥ 125 pg\u002FmL. (BNP \\>35 pg\u002FmL) or ≥ 365pg\u002Fml (BNP \\> 105 pg\u002FmL) for patients with atrial fibrillation (AF)\n6. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C 1 year, or advanced heart failure defined as ACC\u002FAHA Stage D heart failure, or listed for heart transplantation at time of baseline visit\n2. Evidence of right heart failure defined (by ECHO) as:\n\n   1. Severe Right Ventricular Dysfunction (TAPSE \\\u003C 14 mm)\n   2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)\n   3. Severe pulmonary hypertension (PASP \\> 60 mm Hg)\n3. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation\n4. Uncontrolled hypertension, Systolic Blood Pressure of \\>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.\n5. Uncontrolled atrial fibrillation with resting heart rate \\>110bpm, despite medical therapy\n6. Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease\n7. Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.\n8. Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device\n9. Current atrial septal defect, or anatomical anomaly (including \\> 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum\n10. Clinically significant valvular heart disease:\n\n    1. regurgitation grade ≥3+ or\n    2. severe stenosis of mitral or tricuspid valves, or\n    3. significant stenosis of aortic valves\n11. Prior diagnosis of primary pulmonary hypertension\n12. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration\n13. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding\n14. Myocardial Infarction (MI) and\u002For coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent.\n15. ICD or right sided pacemaker placement within 2 months\n16. Clinically significant coagulation disorder, at discretion of investigator\n17. Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment\n18. Chronic kidney disease currently requiring dialysis\n19. Allergy to nickel and\u002For titanium and\u002For nickel\u002Ftitanium-based materials, if not medically manageable\n20. Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy\n21. Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator\n22. Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator\n\nNote: \\* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken\n\n\\*\\*\"Corrected\" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg\u002Fm2 in body mass index (BMI) above a reference BMI of 20kg\u002Fm2)",{"count":416,"type":21},"This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.",[210],[568,569,570,490,571,572,573,574,575,576,577,562],"Occlutech AFR","Atrial Flow Regulator","Interatrial shunt device","HFrEF","HFpEF","Left-to-right shunt","Balloon atrial septostomy","MACNE","Device embolization","AFR","2026-06-05",{"date":580,"type":38},"2026-06-08",{"date":582,"type":38},"2020-10-28",{"date":584,"type":21},"2031-06",{"name":162,"class":45},36,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":606,"locationsCount":105},"100643520","ondansetron-versus-lidocaine-for-preventing-pain-on-propofol-injection-100643520","NCT07632144","Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.","Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection: a Randomized Controlled Trial.","Inclusion Criteria:\n\n* The study included patients who met all of the following criteria:\n\nAged 18 years or older; Classified as ASA physical status I-III (Appendix 1); Provided written informed consent to participate in the study; Scheduled for elective surgery requiring general anesthesia with propofol induction.\n\nExclusion Criteria:\n\n* Patients were not eligible for inclusion if they:\n\nHad received analgesics or antiemetics within 12 hours before surgery; Had communication difficulties or were unable to assess pain adequately (e.g., language barrier, dementia, impaired consciousness); Had a known allergy to ondansetron, lidocaine, or propofol; Did not receive propofol for anesthetic induction; Were pregnant or breastfeeding; Suffered from chronic pain or regularly used opioid medications; Did not have a 20-gauge intravenous catheter inserted on the dorsum of the hand; Declined participation in the study.\n\nPatients were excluded from the study if they experienced any complication during anesthetic induction, including:\n\nAnaphylactic shock or allergic reaction to study medications; Hemodynamic or respiratory instability.\n\nPatients who subsequently withdrew their consent were also excluded from the study.",{"count":595,"type":21},156,[82],"This is a prospective, single-center, randomized, double-blind controlled trial involving patients scheduled for elective surgery requiring general anesthesia with propofol induction. Participants are randomly assigned to one of three groups: the ondansetron group (8 mg IV), the lidocaine group (40 mg IV), or the control group (0.9% normal saline placebo). Study medications are administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.\n\nthe goal: To assess the efficacy of intravenous ondansetron versus lidocaine and placebo in reducing the incidence and intensity of pain associated with propofol injection in patients undergoing general anesthesia.",[599,600],"Anesthesia Induction","Propofol Pain Injection","2026-06-02",{"date":580,"type":38},{"date":580,"type":21},{"date":605,"type":21},"2026-08-15",{"name":607,"class":104},"Mongi Slim Hospital",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":616,"maxAge":617,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":624,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":637},"100638609","phase-3-alirocumab-for-stabilisation-of-symptomatic-vulnerable-carotid-plaque-100638609","NCT07586540","Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque","Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial With High-Resolution Vessel-Wall MRI and Clinical Endpoints","CAROTID-STABIL","Inclusion Criteria:\n\n1. Age ≥ 40 and ≤ 80 years\n2. Recently symptomatic (TIA, amaurosis fugax, or non-disabling ischaemic stroke with mRS ≤ 2) referable to a carotid territory within 28 days of randomisation\n3. Ipsilateral extracranial internal carotid artery stenosis of 50-69% by NASCET criteria on CTA or DSA\n4. HR-VW-MRI evidence of IPH (MPRAGE hyperintensity ≥150% of adjacent sternocleidomastoid) OR LRNC ≥ 10% of plaque volume in the symptomatic plaque\n5. On a stable dose of high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for ≥ 4 weeks, or able and willing to initiate atorvastatin 80 mg daily at randomisation\n6. LDL-C ≥ 70 mg\u002FdL (1.8 mmol\u002FL) at screening\n7. Able to undergo 3T MRI (no contraindications)\n8. Provides written informed consent\n\nExclusion Criteria:\n\n1. Indication for urgent carotid revascularisation within 14 days per treating team\n2. Disabling stroke (mRS \\> 2) or NIHSS \\> 5 at randomisation\n3. Carotid stenosis ≥ 70% or occlusion\n4. Cardioembolic stroke source (atrial fibrillation, LV thrombus, endocarditis, PFO with high-risk features)\n5. Intracranial haemorrhage within 12 months or any history of symptomatic ICH\n6. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n7. Active hepatobiliary disease or ALT\u002FAST \\> 3x ULN\n8. Prior exposure to any PCSK9 inhibitor or inclisiran within 6 months\n9. Known hypersensitivity to alirocumab or excipients\n10. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential\n11. Life expectancy \\\u003C 24 months\n12. Participation in another interventional trial within 30 days\n13. Inability to comply with follow-up or MRI schedule","40 Years","80 Years",{"count":619,"type":21},280,[24],"CAROTID-STABILISE is a phase III, multicentre, randomised, double-blind, placebo-controlled trial evaluating whether alirocumab 150 mg subcutaneously every 2 weeks, added to high-intensity statin therapy, produces greater reduction in intraplaque haemorrhage (IPH) volume at 26 weeks compared with placebo in patients with recently symptomatic carotid stenosis of 50-69% harbouring IPH or lipid-rich necrotic core (LRNC) on high-resolution vessel-wall MRI. The study will enroll 280 participants across multiple centres with a 52-week extension for durability and clinical endpoints assessment.",[623],"Carotid Stenosis",[625,626,627],"vulnerable plaque","alirocumab","PCSK9 inhibitor","2026-05-08",{"date":630,"type":38},"2026-05-14",{"date":632,"type":21},"2027-07",{"date":634,"type":21},"2030-09",{"name":636,"class":104},"Middle East North Africa Stroke and Interventional Neurotherapies Organization",14,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":646,"minAge":55,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":662},"100348615","phase-3-trial-of-acetylsalicylic-acid-and-atorvastatin-in-patients-with-castrate-resistant-prostate-cancer-100348615","NCT03819101","Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer","A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer","PEACE-4","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible\n* Age ≥ 18 years, life expectancy of at least 6 months\n* CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone levels ≤ 1.7 nmol\u002FL (≤ 0.50 ng\u002FmL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated\n* Presence (M1) or absence (M0) of metastases on imaging\n* Performance status 0, 1 or 2\n* No previous use of life- prolonging treatments for CRPC (including abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease is allowed.\n* Adequate renal function within 30 days prior to registration: calculated creatinine clearance ≥ 50 mL\u002Fmin, according to the formula of Cockcroft-Gault and adequate liver function with levels of AST and ALT ≤ 3xULN and no signs for cholestasis.\n* Participation in other clinical trials is allowed except for trials with the same primary endpoint, i.e. OS\n* Patient authorized to participate to a clinical trial by specific country regulation (eg patient affiliated to a social security system or beneficiary of the same)\n* Information delivered to patient and informed consent form signed by the patient.\n\nExclusion Criteria:\n\n* Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphocytic Leukemia can be included)\n* Previous metastatic malignancy within 5 years\n* Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months\n* Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis\n* Patients with excessive alcohol intake or history of a relevant liver disease\n* Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or hypersensitivity to any of its components\n* Contra-indication to acetylsalicylic acid or atorvastatin according to label, including known high-risk for haemorrhage,\n* History of or active myopathy or significantly elevated (\\> 5 times ULN) CK levels\n* History of recent stroke or transient ischemic attack (TIA).\n* Any concomitant drugs contraindicated for use with the trial drugs according to the product information (e.g. Fusidic acid, potent inhibitors of CYP3A4 or transport proteins: ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir, telaprevir, saquinavir, darunavir, fosamprenavir, boceprevir, gemfibrozil, fenofibrate, etc)\n* Any serious underlying medical condition (by the investigator's judgement) which could impair the ability of the patient to participate in the trial\n* Patients with hereditary galactose intolerance, Lapp-lactase deficiency or Glucose-Galactose-malabsorption\n* Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons\n* Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake","MALE",{"count":648,"type":21},1210,[24],"This is a 2x2 factorial randomized, multicenter, international, open phase III trial.\n\nThe primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC",[652],"Prostate Cancer","2026-05-05",{"date":655,"type":38},"2026-05-06",{"date":657,"type":38},"2019-06-06",{"date":659,"type":21},"2042-03",{"name":661,"class":104},"Gustave Roussy, Cancer Campus, Grand Paris",30,{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":22,"phases":673,"briefSummary":674,"conditions":675,"keywords":678,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":686,"locationsCount":105},"100607587","phase-4-ginger-to-prevent-nausea-and-vomiting-after-laparoscopic-cholecystectomy-100607587","NCT07190495","Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy","Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial","GINGER-PONV","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Scheduled for elective laparoscopic cholecystectomy under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ginger\n* Documented history of bleeding disorders or current treatment with anticoagulant agents\n* History of severe postoperative nausea and vomiting or an Apfel score of 4\n* Administration of antiemetic drugs or corticosteroids during the preoperative period\n* Pregnancy or breastfeeding\n* Active gastrointestinal or liver disease",{"count":672,"type":21},102,[317],"This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after laparoscopic cholecystectomy.",[676,677],"Postoperative Nausea and Vomiting","Laparoscopic Cholecystectomy",[679,676,677],"Ginger","2026-04-27",{"date":682,"type":38},"2026-04-28",{"date":684,"type":38},"2025-07-05",{"date":501,"type":21},{"name":687,"class":104},"University Tunis El Manar",{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":4,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":695,"enrollmentInfo":696,"targetDuration":698,"studyType":137,"phases":4,"briefSummary":699,"conditions":700,"keywords":702,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":504},"100567093","cruz-tunisia-multivessel-registry-100567093","NCT06663696","CRUZ Tunisia-Multivessel Registry","Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease","Inclusion Criteria:\n\n1. Patient must be at least 18 years of age\n2. Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure\n3. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his\u002Fher medical information by signing a Patient Informed Consent Form\n4. The patient is willing and able to co-operate with study procedures and required follow up visits\n\nExclusion Criteria:\n\n1. Women with known pregnancy or who are lactating\n2. High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)\n3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements\n4. Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation \u002F antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media","99 Years",{"count":697,"type":21},1000,"12 Months","The primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).",[701],"Patient Population With Multivessel Disease",[703],"Multivessel disease, Supraflex Cruz, SES","2026-04-22",{"date":680,"type":38},{"date":707,"type":38},"2024-11-01",{"date":709,"type":21},"2028-05",{"name":711,"class":45},"Sahajanand Medical Technologies Limited",{"id":713,"slug":714,"hasResults":12,"nctId":715,"briefTitle":716,"officialTitle":717,"acronym":4,"eligibilityCriteria":718,"healthyVolunteers":12,"sex":348,"minAge":719,"maxAge":292,"enrollmentInfo":720,"targetDuration":4,"studyType":22,"phases":722,"briefSummary":723,"conditions":724,"keywords":726,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":733,"lastUpdatePostDateStruct":734,"startDateStruct":736,"completionDateStruct":738,"leadSponsor":739,"locationsCount":105},"100635651","intermittent-walking-training-and-cardiometabolic-health-in-premenopausal-and-postmenopausal-women-100635651","NCT07555457","Intermittent Walking Training and Cardiometabolic Health in Premenopausal and Postmenopausal Women","Effects of a 10-Week Moderate-Intensity Intermittent Walking Training Program on Aerobic Capacity, Cardiometabolic Risk Factors, and Inflammatory Markers in Premenopausal and Postmenopausal Women","Inclusion Criteria:\n\n* Women aged 32 to 43 years (premenopausal, with regular menstrual cycles for at least 12 months) or 49 to 65 years (postmenopausal, with absence of menstruation for at least 12 months).\n\nBody mass index (BMI) \\> 24.9 kg\u002Fm².\n\n* For the postmenopausal group: amenorrhea ≥ 12 months.\n* For the premenopausal group: regular menstrual cycles for at least 12 months.\n\nExclusion Criteria:\n\n* Cardiovascular diseases (hypertension, heart failure).\n* Presence of metabolic or inflammatory disorders (e.g., uncontrolled diabetes, autoimmune diseases, active infections).","32 Years",{"count":721,"type":21},32,[82],"The goal of this clinical trial is to compare premenopausal and postmenopausal women regarding the effects of a 10-week moderate-intensity intermittent walking training (MIWT) program on aerobic capacity and selected cardiometabolic and inflammatory markers. The main question it aims to answer is: Does a MIWT program induce differential improvements in aerobic capacity, body composition, lipid profile, and inflammatory markers between premenopausal and postmenopausal women?\n\nParticipants in the premenopausal group will perform a 10-week MIWT program, three sessions per week. Participants in the postmenopausal group will perform the same 10-week MIWT program, three sessions per week. Each training session consists of 5 repetitions of 6-minute walking (6MWT) at 60-80% of the baseline 6MWT distance, interspersed by 6 minutes of active recovery between repetitions. Body composition, aerobic capacity (6-minute walk test), heart rate, blood pressure, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), and C-reactive protein (CRP) will be assessed before and after the intervention in both groups.",[725],"Cardiometabolic Health in Premenopausal and Postmenopausal Women",[727,728,360,729,730,731,732],"Intermittent walking","Premenopausal women","Cardiometabolic health","C-reactive protein","Lipid profile","Aerobic capacity","2026-04-21",{"date":735,"type":38},"2026-04-29",{"date":737,"type":21},"2026-05-21",{"date":121,"type":21},{"name":740,"class":104},"High Institute of Sports and Physical Education of Kef",""]