[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Kazakhstan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":744},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,41,62,93,115,136,174,198,230,252,287,315,354,375,412,444,480,509,534,568,598,620,652,685,710],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100564690","liverage---cirrhosis-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-cirrhosis-100564690",false,"NCT06632457","LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Cirrhosis","A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction Associated Steatohepatitis (NASH\u002FMASH) Cirrhosis","Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg\u002Fm2(≥25 kg\u002Fm2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB\u002Fm, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\\u003C5% or FibroScan® with CAP \\\u003C288 dB\u002Fm is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis\u002Fsteatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\\u003C5 years) of significant alcohol consumption, defined as an average of \\>140 g\u002Fweek in female patients and \\>210 g\u002Fweek in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\\u003C3.5 g\u002FdL (\\\u003C35.0 g\u002FL)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\\u003C20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\\u003C100,000\u002FµL (\\\u003C100 GI\u002FL)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological\u002Fsurgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply","ALL","18 Years",{"count":20,"type":21},1590,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg\u002Fm2 or more or\n* 25 kg\u002Fm2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.",[27],"Metabolic Dysfunction Associated Steatohepatitis","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2024-11-12",{"date":36,"type":21},"2029-06-05",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",445,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100564689","liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689","NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply",{"count":49,"type":21},1800,[24],"This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[53,54],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":31,"type":32},{"date":57,"type":32},"2024-10-14",{"date":59,"type":21},"2031-12-27",{"name":38,"class":39},528,{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","85 Years",{"count":72,"type":21},385,[74],"PHASE2","This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[77,78],"Inflammatory Bowel Diseases","Crohn's Disease",[80,81,82,83,84,68],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":31,"type":32},{"date":87,"type":32},"2024-07-18",{"date":89,"type":21},"2030-06",{"name":91,"class":39},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"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":102,"type":21},1325,[24],"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.",[106],"Acute Ischemic Stroke","2026-08-19",{"date":29,"type":32},{"date":110,"type":32},"2026-02-17",{"date":112,"type":21},"2027-10-02",{"name":38,"class":39},250,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100583174","phase-3-the-airtivity-study-a-study-to-find-out-whether-bi-1291583-helps-people-with-bronchiectasis-100583174","NCT06872892","The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis","A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)","Inclusion criteria:\n\n* Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.\n* Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.\n* Age of participants when signing the informed consent\u002Fassent ≥12 years.\n\n  \\-- Adolescents need to weigh at least 35 kg at Visit 1.\n* Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.\n\nParticipants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.\n\n* Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.\n* History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:\n\n  * at least 2 exacerbations, or\n  * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \\>40 at screening Visit 1 (adults only)\n  * at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.\n\nExclusion criteria:\n\n* Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.\n* Allergic bronchopulmonary aspergillosis being treated or requiring treatment.\n* Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment\n* Any findings in the medical examination and\u002For laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.\n* Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.\n* Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.\n* Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.\n* Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).\n* estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \\\u003C30 mL\u002Fmin at Visit 1.\n* Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.","12 Years",{"count":124,"type":21},1755,[24],"This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).\n\nThe purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.\n\nParticipants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.",[128],"Bronchiectasis",{"date":29,"type":32},{"date":131,"type":32},"2025-06-09",{"date":133,"type":21},"2027-12-20",{"name":38,"class":39},471,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":173},"100648849","digital-dietary-intervention-for-patients-receiving-glp-1-receptor-agonist-therapy-100648849","NCT07728669","Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy","Efficacy of a Digital Dietary Intervention (NutriSteppe Application) in Improving Metabolic Parameters in Adults With Type 2 Diabetes Mellitus, Obesity or Overweight With Comorbidities Who Are Receiving GLP-1 Receptor Agonist Therapy and Other Medications Prescribed Under Routine Clinical Protocols","NutriSteppe","Inclusion Criteria:\n\n* Age 21-65 years inclusive at the time of signing informed consent.\n* Male or female.\n* Overweight with at least one comorbidity, including diabetes mellitus; arterial hypertension of at least 130\u002F85 mmHg or use of antihypertensive medication; dyslipidemia defined as triglycerides of at least 1.7 mmol\u002FL, reduced HDL cholesterol below 1.0 mmol\u002FL in men or below 1.3 mmol\u002FL in women, or use of lipid-lowering medication; cardiovascular disease; respiratory or joint disease; non-alcoholic fatty liver disease; sleep disorders; or other comorbidities.\n* For participants with overweight: body mass index of 25.0-29.9 kg\u002Fm² for the Caucasian population or 23.0-27.4 kg\u002Fm² for the Asian population, together with abdominal obesity defined as waist circumference of at least 94 cm in men and 80 cm in women of the European population, or at least 90 cm in men and 80 cm in women of the Asian population.\n* Class I-III obesity where diet combined with physical activity has been ineffective, defined as weight loss of less than 5% over 3 months.\n* Class I obesity: body mass index of 30.0-34.9 kg\u002Fm² for the Caucasian population or 27.5-32.4 kg\u002Fm² for the Asian population.\n* Class II obesity: body mass index of 35.0-39.9 kg\u002Fm² for the Caucasian population or 32.5-37.4 kg\u002Fm² for the Asian population.\n* Type 2 diabetes mellitus with HbA1c of at least 6.5% (48 mmol\u002Fmol), fasting glucose of at least 6.1 mmol\u002FL in capillary whole blood or at least 7.0 mmol\u002FL in venous plasma, glucose of at least 11.1 mmol\u002FL two hours after an oral glucose tolerance test, or random glucose of at least 11.1 mmol\u002FL.\n* Body mass index of at least 25 kg\u002Fm² and no more than 40 kg\u002Fm² at screening.\n* Already receiving, or prescribed, GLP-1 receptor agonist therapy with semaglutide by the treating physician independently of the study. The study does not prescribe or modify this therapy.\n* Stable doses of medications for chronic conditions, including antihypertensive agents and statins, for at least 8 weeks before screening.\n* Ownership of an iOS or Android smartphone with internet access and willingness to download and use the \"NutriSteppe\" application if assigned to the intervention group.\n* Ability and willingness to provide written informed consent and comply with study procedures.\n* Women of childbearing potential must use effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus.\n* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state.\n* Initiation of GLP-1 receptor agonist therapy less than 4 weeks before screening.\n* Current insulin therapy.\n* Personal or family history of medullary thyroid carcinoma.\n* Personal history of multiple endocrine neoplasia type 2 (MEN2).\n* History of acute or chronic pancreatitis.\n* Active gallbladder disease or history of gallbladder disease within 6 months before screening.\n* Severe gastrointestinal disease, including gastroparesis.\n* Major cardiovascular event within 6 months before screening, including myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention.\n* Uncontrolled arterial hypertension, defined as systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg at screening.\n* Chronic kidney disease with an estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m² using the MDRD or CKD-EPI formula.\n* Severe hepatic impairment classified as Child-Pugh class C, or ALT or AST greater than three times the upper limit of normal.\n* Active malignancy or history of malignancy within 5 years, except successfully treated basal cell or squamous cell carcinoma of the skin.\n* Established HIV infection, active hepatitis B defined as HBsAg positive with detectable HBV DNA, or hepatitis C virus infection.\n* History of bariatric surgery or bariatric surgery planned during the study.\n* Anorexia nervosa, bulimia nervosa, or binge eating disorder diagnosed or active within the past year.\n* Pregnancy or breastfeeding.\n* Planning pregnancy during the study.\n* Woman of childbearing potential unwilling to use effective contraception.\n* Use of weight-loss medication, including orlistat, phentermine, combinations with topiramate, naltrexone-bupropion, or other weight-loss medication within 3 months before screening.\n* Use of systemic corticosteroids, excluding inhaled or topical corticosteroids, for more than 2 weeks within 3 months before screening.\n* Use of antipsychotic medication associated with significant weight gain unless used at a stable dose for more than 6 months.\n* Participation in another interventional clinical study within 30 days before screening.\n* Known hypersensitivity to semaglutide or any excipient.\n* No smartphone or unwillingness to use digital health technology.\n* Severe mental disorder impairing the ability to provide informed consent or comply with the protocol.\n* Active alcohol or drug dependence within the past year.\n* Any condition that, in the investigator's opinion, may compromise participant safety or the integrity of the study.","21 Years","65 Years",{"count":147,"type":21},120,[149],"NA","The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study.\n\nThe main question is:\n\nDoes the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone?\n\nThe study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety.\n\nResearchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support.\n\nParticipants in both groups will:\n\n* Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol.\n* Photograph everything they eat and drink.\n* Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study.\n* Be able to view the results of the food photograph analysis.\n\nThe photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.",[152,153,154,155],"Type 2 Diabetes Mellitus (T2DM)","Obesity (Disorder)","Overweight","Metabolic Syndrome",[142,157,158,159,160,161,162],"Digital Dietary Intervention","Personalized Nutrition","GLP-1 Receptor Agonist","Semaglutide","Glycated Hemoglobin","HbA1c","2026-08-10",{"date":165,"type":32},"2026-08-11",{"date":167,"type":32},"2026-07-20",{"date":169,"type":21},"2027-01",{"name":171,"class":172},"Kazakh Academy of Nutrition","OTHER",1,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100585795","corwave-lvas-fih-study-100585795","NCT06907017","CorWave LVAS FIH Study","First In Human Clinical Study of the CorWave Left Ventricular Assist System for the Treatment of Patients With Advanced Heart Failure","Inclusion Criteria:\n\n* Subject or legal representative has signed Informed Consent Form\n* Age \\> 18 and \\\u003C 75 years old\n* Body Surface Area (BSA) ≥ 1.2 m2\n* Left Ventricular Ejection Fraction (LVEF) ≤ 35%\n* Inotrope dependent OR\n* Cardiac Index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2, while not on inotropes and subjects must also meet one of the following criteria:\n\n  * On Guideline Directed Medical Therapy (GDMT) for at least 45 out of the last 60 days and are failing to respond.\n  * Advanced heart failure (Class III or Class IV for at least 14 days AND support from short term mechanical circulatory support for up to 7 days).\n* Females of childbearing age must agree to use adequate contraception.\n* Patient must be eligible for heart transplantation.\n\nExclusion Criteria:\n\n* Heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.\n* Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator\n* Ongoing mechanical circulatory support (MCS) other than IABP or micro axial pumps\n* INTERMACS Class I patients\n* Subject is on a ventilator\n* Subject is pregnant or breastfeeding\n* Presence of a mechanical aortic valve that will not be converted to a bioprosthesis at the time of LVAD implant\n* History of any organ transplant\n* Platelet count \\\u003C 100,000\u002Fμl\n* Psychiatric disease\u002Fdisorder, illicit drug use, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management\n* History of confirmed untreated abdominal aortic aneurysm (AAA) \\> 5 cm in diameter within 6 months of enrollment\n* Presence of an active, uncontrolled infection\n* Intolerance to anticoagulant or antiplatelet therapies or any other peri\u002Fpost-operative therapy the investigator will require based upon the patient's health status\n* Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n* An INR ≥ 2.0 not due to anticoagulation therapy\n* Total bilirubin \\> 43 µmol\u002FL (2.5 mg\u002FdL), liver function tests greater than 3 times the establish laboratory normal, including Serum Albumin below 3.5 g\u002Fdl, shock liver, or biopsy proven liver cirrhosis\n* History of severe chronic obstructive pulmonary disease (COPD) and restrictive disease (fibrosis); FEV1 \\\u003C 50%, a total FEV1 below 1000 mL and a DLCO \\\u003C 50% predicted.\n* Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention\n* History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (\\> 50%) uncorrected carotid stenosis\n* Serum creatinine ≥ 221 µmol\u002FL (2.5 mg\u002FdL) or the need for chronic renal replacement therapy.\n* Ongoing patient malnutrition evidenced by nonintentional weight loss of greater than 5% of body mass in the previous 30 days, prealbumin \\\u003C 16 mg\u002FdL, or Mini Nutritional Assessment score \\\u003C 17.\n* Poorly controlled diabetes mellitus or a hemoglobin A1c \\> 8.5%.\n* Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.\n* Patient has severe aortic insufficiency without plans for correction during pump implant.\n* Planned Bi-VAD support prior to enrollment.\n* Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia.\n* Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* Any condition other than HF that could limit survival to less than 12 months.\n* Acute myocardial infarction within 14 days of implant as diagnosed by ST elevation (STEMI) changes on ECG, diagnostic biomarkers, and hemodynamic abnormalities. Planned or carried out coronary revascularizations (including PCI requiring (dual) antiplatelet therapies).\n* Pulmonary embolus within 6 weeks of implant as documented by computed tomography (CT) scan or nuclear scan.\n* Subject is unwilling or unable to comply with trial requirements.","75 Years",{"count":183,"type":21},20,[149],"The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.",[187],"Advanced Heart Failure","2026-07-31",{"date":190,"type":32},"2026-08-03",{"date":192,"type":32},"2025-05-06",{"date":194,"type":21},"2028-05",{"name":196,"class":39},"CorWave",3,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":173},"100649854","painhunting-therapy-versus-cognitive-behavioural-therapy-for-event-related-depression-100649854","NCT07738146","Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression","Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation","PH-CBT","Inclusion Criteria:\n\n* Age 18 years or older.\n* PHQ-9 score of 9 or greater at screening.\n* At least one adverse life event within the prior 24 months, documented using the Life Events Threshold (LTE) instrument.\n* Resident of Kazakhstan.\n* Fluent in Russian.\n* Capacity to provide written informed consent.\n* Willing to attend at least six sessions within the protocol treatment schedule.\n\nExclusion Criteria:\n\n* Active suicidal ideation requiring immediate referral, defined as PHQ-9 item 9 score of 3 or clinical judgment of imminent risk.\n* Active psychosis or mania.\n* Active substance use disorder meeting DSM criteria.\n* Current psychotherapy with another provider.\n* Initiation of pharmacotherapy within the prior four weeks.\n* Pre-existing stable antidepressant monotherapy unchanged for eight weeks or longer is permitted.\n* Inability to provide informed consent in Russian.",{"count":207,"type":21},60,[149],"This randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. The primary outcome is depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) at six weeks after randomization. Secondary outcomes include anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and durability of outcomes at 10 to 12 weeks. The study will also assess treatment fidelity, therapeutic alliance, and selected potential moderators of treatment response. The trial uses a randomized, rater-blinded, parallel-group design with an adaptive sample-size approach.",[211],"Depression - Major Depressive Disorder",[213,214,215,216,217,218,219,220],"painhunting","painhunting therapy","CBT","event-related depression","depression","psychotherapy","Cognitive Behavioral Therapy","Depressive Symptoms","NOT_YET_RECRUITING","2026-07-28",{"date":188,"type":32},{"date":225,"type":21},"2026-09-01",{"date":227,"type":21},"2027-04-30",{"name":229,"class":172},"Painhunting LLP",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":173},"100632011","digital-prep-micro-intervention-for-pwud-in-kazakhstan-100632011","NCT07508137","Digital PrEP Micro-Intervention for PWUD in Kazakhstan","Digital Micro-Interventions to Reduce Stigma-Driven Barriers and Improve PrEP Readiness Among People Who Use Drugs in Kazakhstan","Inclusion Criteria:\n\n* Self-reported drug use within the past six months\n* HIV-negative or unknown HIV status (self-reported)\n* Not currently taking PrEP\n* Able to provide informed consent\n* Have access to a personal mobile phone capable of receiving Telegram or WhatsApp messages\n\nExclusion Criteria:\n\n* Are unable to provide informed consent\n* Do not have access to a mobile device for digital message delivery\n* Are currently enrolled in another PrEP behavioral intervention study",{"count":238,"type":21},40,[149],"This study is a mixed-methods pilot designed to evaluate the feasibility, acceptability, and appropriateness of a brief digital micro-intervention aimed at reducing stigma-related barriers to pre-exposure prophylaxis (PrEP) engagement among people who use drugs (PWUD) in Kazakhstan. Participants will complete baseline and post-intervention surveys and receive structured informational content via Telegram or WhatsApp over approximately 2-3 weeks. The intervention focuses on addressing anticipated stigma, confidentiality concerns, and misinformation that may prevent PWUD from seeking PrEP services. No clinical procedures, medication provision, or biological specimen collection are involved.",[242,243],"Drug Use","HIV","2026-07-27",{"date":222,"type":32},{"date":247,"type":21},"2026-08",{"date":249,"type":21},"2027-10",{"name":251,"class":172},"Yale University",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":262,"studyType":263,"phases":4,"briefSummary":264,"conditions":265,"keywords":270,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100327946","icareme-global-registry-multinational-real-world-evidence-in-cardiorenal-and-metabolic-diseases-100327946","NCT03549754","iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases","Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and\u002For Chronic Kidney Diseases","iCaReMe","Inclusion Criteria:\n\n1. Being 18 years or older\n2. Having type 2 diabetes, Hypertension, Heart Failure and\u002For chronic kidney disease\n3. Providing written informed consent to participate in the registry\n\nExclusion Criteria:\n\n1. Having a life-threatening co-morbidity with life expectancy below 1 year\n2. Participating in an interventional trial requiring informed consent",{"count":261,"type":21},35000,"3 Years","OBSERVATIONAL","To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and\u002For Chronic kidney diseases",[266,267,268,269],"Type 2 Diabetes","Hypertension","Chronic Kidney Disease","Heart Failure",[271,266,272,268,273,267,274,275,269,276,277],"Registry","T2DM","CKD","HTN","Adult population","HF","Early cardiorenal complications",{"date":279,"type":32},"2026-07-22",{"date":281,"type":32},"2018-02-17",{"date":283,"type":21},"2030-12-31",{"name":285,"class":39},"AstraZeneca",76,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":263,"phases":4,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100540241","interstellar---international-study-evaluating-lupus-outcomes-after-anifrolumab-real-world-use-100540241","NCT06314282","INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use","INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice","INTERSTELLAR","Inclusion Criteria:\n\n1. Aged 18 years or older at study enrolment.\n2. Fulfilled the 2019 EULAR\u002FACR criteria1 for SLE at the time of study entry.\n3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.\n4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.\n5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.\n6. Provided informed consent to participate in the study.\n7. Willing and able to participate in all required study evaluations and procedures.\n\nExclusion Criteria:\n\n1. Currently participating in an anifrolumab early access\u002Fcompassionate use program or an interventional clinical trial with an investigational product.\n2. Previous exposure to anifrolumab as part of a clinical trial or early access program.\n3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \\[MMF\\]\u002Fcyclophosphamide \\[CYC\\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.\n4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.",{"count":296,"type":21},200,"INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion\u002Fexclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.",[299],"Systemic Lupus Erythematosus (SLE)",[301,302,303,304,305],"SLE","Systemic lupus erythematosus","autoimmune disease","Lupus","Anifrolumab","2026-07-16",{"date":308,"type":32},"2026-07-17",{"date":310,"type":32},"2024-10-22",{"date":312,"type":21},"2027-12-31",{"name":285,"class":39},32,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":323,"sex":17,"minAge":18,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":173},"100647342","phase-1-safety-of-topical-exosome-containing-liquid-in-healthy-volunteers-for-future-surgical-wound-use-100647342","NCT07707986","Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use","A Phase 1 Split-Site Pilot Study to Evaluate the Safety and Dermal Tolerability of Topical Exosome-Containing Liquid in Healthy Adult Volunteers Before Future Testing in Post-Melanoma-Excision Surgical Wounds","EV-MELSAFE","Inclusion Criteria:\n\n1. Healthy adult volunteers aged 18 to 55 years.\n2. Able and willing to provide written informed consent.\n3. No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.\n4. Intact healthy skin at the planned application sites.\n5. Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.\n6. Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.\n7. Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.\n8. For women of childbearing potential, a negative pregnancy test before first application and willingness to use an acceptable method of contraception during the study period.\n\nExclusion Criteria:\n\n1. Any active skin disease, dermatitis, eczema, psoriasis, urticaria, acneiform eruption, skin infection, open wound, scar, tattoo, burn scar, pigmentation disorder, or clinically significant skin abnormality at the planned application sites.\n2. History of severe allergy, anaphylaxis, or hypersensitivity to topical liquids, dressings, biological products, exosome-containing products, or any component of the investigational product or vehicle liquid.\n3. Current acute illness, fever, or active infection.\n4. Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.\n5. Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.\n6. Use of topical corticosteroids, topical immunomodulators, topical antibiotics, retinoids, keratolytic agents, or other medicated topical products on or near the planned application sites within 14 days before enrollment.\n7. Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.\n8. Known active malignancy or history of malignancy within the past 5 years.\n9. Positive screening test for clinically relevant transmissible infection, if required by the protocol.\n10. Pregnancy or breastfeeding.\n11. Positive pregnancy test at screening or before first application in women of childbearing potential.\n12. Participation in another interventional clinical trial within 30 days before enrollment.\n13. Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.\n14. Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.",true,"55 Years",{"count":326,"type":21},10,[328],"PHASE1","This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be induced in participants in this Phase 1 safety study.",[331,332],"Healthy Volunteers (HV)","Skin Irritation",[334,335,336,337,338,339,340,341,342,343,344,345,346],"exosomes","extracellular vesicles","topical exosome-containing liquid","healthy volunteers","skin tolerability","skin irritation","phase 1","first-in-human","post-melanoma-excision wound","surgical wound repair","postoperative wound healing","Dermal Tolerability","dermal safety","2026-07-12",{"date":306,"type":32},{"date":350,"type":21},"2026-09",{"date":169,"type":21},{"name":353,"class":172},"West Kazakhstan Marat Ospanov Medical University",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":322,"healthyVolunteers":323,"sex":17,"minAge":18,"maxAge":324,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":373,"leadSponsor":374,"locationsCount":173},"100647093","phase-1-safety-of-topical-exosome-containing-liquid-in-healthy-volunteers-100647093","NCT07703969","Safety of Topical Exosome-Containing Liquid in Healthy Volunteers","A Phase 1 Split-Site Pilot Study to Evaluate the Safety and Dermal Tolerability of Topical Exosome-Containing Liquid in Healthy Adult Volunteers","EV-SAFE-1",{"count":326,"type":21},[328],"This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No burn wound or artificial skin wound will be induced in participants in this Phase 1 safety study.",[332,365],"Healthy Volunteers",[334,335,336,337,346,338,339,340,341,367,368,369],"burn wound development","mesenchymal stromal cell-derived extracellular vesicles","dermal tolerability",{"date":371,"type":32},"2026-07-15",{"date":350,"type":21},{"date":169,"type":21},{"name":353,"class":172},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":173},"100636265","phase-2-pollenvax-subcutaneous-immunotherapy-for-mugwort-pollen-induced-allergic-rhinitis-100636265","NCT07563439","PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis","A Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of PollenVax, Emulsion for Subcutaneous Injection, in Patients With Allergic Rhinitis Induced by Mugwort (Artemisia Vulgaris) Pollen","Inclusion Criteria:\n\n1. Signed and dated written informed consent prior to any study-related procedures.\n2. Age 18 to 65 years (inclusive) at the time of signing informed consent.\n3. Ability and willingness to comply with all protocol requirements, including attendance at all scheduled visits, completion of study procedures, and maintenance of a patient diary.\n4. Clinically significant symptoms of allergic rhinitis during the mugwort pollen season, for which allergen-specific immunotherapy (ASIT) is indicated in the investigator's judgment.\n5. Diagnosis of allergic rhinitis as the primary condition caused by sensitization to mugwort pollen (Artemisia vulgaris), of moderate or severe intensity, with a duration of at least 2 years, per ARIA guidelines. Comorbid mild-to-moderate well-controlled bronchial asthma (per current GINA guidelines) is permitted (ICD-10: J30.1 and\u002For J45.0).\n6. Confirmed sensitization to Artemisia vulgaris pollen and\u002For its major component Art v 1, established by at least one of the following:\n\n   * Positive skin prick test (SPT) with wheal diameter ≥3 mm compared to negative control, with adequate positive control; co-sensitization to other inhalant allergens (including ragweed) is permitted provided the mugwort reaction is the largest wheal in the tested panel and corresponds to the seasonal pattern of symptoms; AND\u002FOR\n   * Specific IgE to the above allergens by ImmunoCAP: positive result (≥Class 1), i.e., above the positivity threshold per manufacturer instructions.\n7. Physical examination findings (including body temperature, blood pressure, heart rate), laboratory and instrumental parameters without clinically significant abnormalities per investigator assessment.\n8. Negative urine pregnancy test at screening (for women of childbearing potential).\n9. Agreement to use adequate contraception from screening until 90 days after completion of study participation (for women of childbearing potential and their partners).\n10. Participants who received placebo in the Phase I PollenVax study may be enrolled if they meet all inclusion criteria of this study and had no serious adverse events related to Phase I participation.\n\nExclusion Criteria:\n\n1. Prior allergen-specific immunotherapy (ASIT) to Artemisia vulgaris pollen or any other allergen within the last 3 years.\n2. Sensitization and clinically significant symptoms caused by another inhalant allergen that, per medical history and investigator's clinical assessment, dominate over mugwort-related symptoms and may substantially confound efficacy assessment during the observation period.\n3. Severe or uncontrolled bronchial asthma, including any of the following:\n\n   * Forced expiratory volume in 1 second (FEV1) \\\u003C 70% of predicted value at screening;\n   * Clinically significant asthma symptoms despite baseline therapy;\n   * Asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency care within the last 6 months.\n4. History of life-threatening allergic reactions (including anaphylaxis, airway edema, bronchospasm, Stevens-Johnson syndrome, Lyell syndrome) or any allergic reaction to allergen-specific immunotherapy.\n5. Chronic or acute ENT disorders at screening that may substantially affect symptom assessment or safety of study participation, including active bacterial rhinosinusitis, severe polypous rhinosinusitis, or significant anatomical nasal obstruction requiring surgical treatment.\n6. Immunoglobulin therapy within 6 months prior to screening or planned during the study period.\n7. Treatment with biological agents targeting the immune system (including anti-IgE antibodies such as omalizumab, other monoclonal antibodies, or immune checkpoint inhibitors) within the last 12 months prior to screening or planned during the study.\n8. Immune system disorders, including autoimmune diseases and primary or secondary immunodeficiencies, except well-controlled autoimmune thyroiditis and uncomplicated type 1 diabetes mellitus.\n9. Severe acute or chronic inflammatory or infectious diseases in the active phase at screening.\n10. Severe, decompensated, or unstable comorbid conditions, including but not limited to:\n\n    * Severe chronic respiratory failure;\n    * Liver cirrhosis Child-Pugh class B or C;\n    * Unstable angina or clinically significant ischemic heart disease;\n    * Chronic heart failure NYHA class III-IV or decompensated stage;\n    * Uncontrolled arterial hypertension (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg) despite treatment;\n    * Clinically significant cardiac arrhythmias, including high-grade ventricular arrhythmias (Lown classification);\n    * Myocardial infarction, acute stroke, transient ischemic attack, or pulmonary embolism within 6 months prior to Visit 0, or aortic aneurysm \\>6 cm;\n    * Less than 3 months after coronary artery bypass grafting or coronary stenting;\n    * Any other condition that, in the investigator's judgment, may affect patient safety or interpretation of study results;\n    * Active malignancy of any location or malignancy within the last 5 years, except fully treated carcinoma in situ;\n    * Severe renal failure;\n    * Severe hepatic failure.\n11. Serologically confirmed infection with HIV, hepatitis B, or hepatitis C virus.\n12. Exacerbation of chronic allergic skin disease (including atopic dermatitis or generalized urticaria) at screening that may confound assessment of allergic symptoms.\n13. Clinically significant abnormalities in routine laboratory tests per investigator assessment.\n14. Alcohol, drug, or substance dependence within the past year per investigator assessment.\n15. Pregnancy or breastfeeding.\n16. Inability to discontinue beta-blocker therapy (systemic or topical) and\u002For presence of a condition where epinephrine use for anaphylaxis management is substantially limited per investigator's clinical assessment.\n17. Use of immunosuppressive agents or other medications that cannot be discontinued during the study period and may affect patient safety or efficacy assessment.\n18. Severe psychiatric or neurological disorders impairing the ability to provide informed consent or comply with protocol requirements.\n19. Legal incapacity or limited legal capacity.\n20. Factors indicating high risk of non-compliance with study procedures, including inability to attend regular visits, maintain a patient diary, or follow protocol requirements per investigator assessment.",{"count":383,"type":21},138,[74],"This study evaluates the effectiveness and safety of PollenVax, a subcutaneous allergen immunotherapy (SCIT) drug developed for the treatment of allergic rhinitis and asthma caused by mugwort (Artemisia vulgaris) pollen. PollenVax contains a recombinant form of Art v 1 - the major mugwort pollen allergen - combined with the adjuvant Montanide ISA-51. It is the first-in-class product of this type designed for an ultra-short treatment course.\n\nThis is a randomized, double-blind, placebo-controlled Phase II study. Participants will be adults aged 18-65 years diagnosed with moderate-to-severe mugwort pollen-induced allergic rhinitis confirmed by skin prick test and\u002For specific IgE testing. A total of 138 participants will be randomly assigned to one of three groups: placebo, PollenVax at a cumulative dose of 22 µg of recombinant Art v 1, or PollenVax at 44 µg, administered as four weekly subcutaneous injections.\n\nThe primary efficacy outcome is the Combined Symptom and Medication Score (CSMS) during the peak mugwort pollen period (PGPP). Safety and tolerability outcomes are co-primary endpoints, assessed throughout the study. Secondary outcomes include daily symptom scores, quality of life (RQLQ\u002FAQLQ), visual analogue scale for rhinoconjunctivitis discomfort, skin prick test reactivity, and immunological markers (Art v 1-specific IgE and IgG).\n\nThe study is conducted at a single clinical center (Medcenter-Rakhat, Almaty, Kazakhstan). Sponsor: Kazakh National Agrarian Research University (KazNARU).",[387],"Rhinitis Allergic",[389,390,391,392,393,394,395,396,397,398,399,400,401,402],"PollenVax","Allergen-specific immunotherapy","Subcutaneous immunotherapy","SCIT","Mugwort pollen allergy","Artemisia vulgaris","Art v 1","Recombinant allergen","Montanide ISA-51","Ultra-short immunotherapy","Combined Symptom and Medication Score","Allergic rhinitis treatment","Phase II clinical trial","Kazakhstan","2026-06-25",{"date":405,"type":32},"2026-06-29",{"date":407,"type":32},"2026-05-01",{"date":409,"type":21},"2026-11",{"name":411,"class":172},"Kazakh National Agrarian University",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":427,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":173},"100643108","sure-hf-urinary-sodium-guided-diuretic-therapy-in-heart-failure-100643108","NCT07631780","SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure","Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)","SURE-HF","Inclusion Criteria:\n\n* Age ≥18 years.\n* Confirmed diagnosis of worsening heart failure (WHF), characterized by symptoms and signs of acute decompensation requiring hospitalization for intensification of intravenous diuretic therapy.\n* Previous intake of a loop diuretic (torasemide or furosemide) in any dose for at least 2 days before hospitalization.\n* Presence of clinical signs and symptoms of congestion (e.g., dyspnea, orthopnea, peripheral edema, pulmonary congestion).\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Acute coronary syndrome within the previous 30 days.\n* Acute heart failure requiring urgent invasive intervention, including cardiogenic shock or mechanical circulatory support.\n* Current admission to an intensive care unit.\n* Systolic blood pressure ≤90 mmHg or requirement for inotropic\u002Fvasopressor support.\n* Recent use (≤48 hours) of inotropic agents affecting fluid and electrolyte balance.\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for renal replacement therapy.\n* Hypokalemia (\\\u003C3.5 mmol\u002FL) or hyperkalemia (≥5.5 mmol\u002FL).\n* Clinically significant hyponatremia (\\\u003C130 mmol\u002FL) or hypernatremia (\\>150 mmol\u002FL).\n* Significant comorbidities affecting sodium-water balance (e.g., liver cirrhosis with ascites, nephrotic syndrome, severe infection or sepsis).\n* Pregnancy or breastfeeding.\n* Active malignancy.\n* Inability to comply with the study protocol or participation in another interventional clinical trial.",{"count":421,"type":21},260,[149],"The SURE-HF trial is a pragmatic, multicentre, randomized controlled study evaluating natriuresis-guided optimization of intravenous loop diuretic therapy in patients hospitalized with worsening heart failure (WHF). The study aims to determine whether serial urinary sodium assessment combined with a structured decongestive treatment algorithm improves decongestion, reduces the need for therapy escalation, and enhances discharge readiness compared with standard care.\n\nParticipants will be randomized to standard urine output-guided therapy or natriuresis-guided decongestive strategies using different intravenous loop diuretic administration regimens. The study integrates bedside diagnostic tools including lung ultrasound, inferior vena cava assessment, focused echocardiography, and serial clinical congestion monitoring.\n\nThe primary endpoint is a hierarchical composite outcome including escalation of heart failure therapy, persistent congestion at discharge, inability to transition to oral loop diuretics by Day 5, and residual ultrasound congestion. The findings of the SURE-HF trial may support implementation of urinary sodium-guided and ultrasound-assisted decongestive therapy in routine heart failure management.",[425,426,269],"Worsening Heart Failure","Congestion",[425,426,428,429,430,431,432,433,434],"Natriuresis","Urinary Sodium","Diuretic Therapy","Loop Diuretics","Decongestion","Fluid Overload","Bedside Diagnostics","2026-06-01",{"date":437,"type":32},"2026-06-08",{"date":439,"type":21},"2026-06",{"date":441,"type":21},"2027-12",{"name":443,"class":172},"Nurgul Ablakimova",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":173},"100637250","full-thickness-macular-hole-surgery-a-comparison-of-ten-techniques-100637250","NCT07606404","Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques","Vitreoretinal Surgery for Full-Thickness Macular Hole: A Comparative Study of Ten Techniques","FTMH-10","Inclusion Criteria:\n\nAdults aged ≥18 years.\n\nFull-thickness macular hole (FTMH) eligible for pars plana vitrectomy (PPV).\n\nSymptom duration ≤12 months.\n\nClear ocular media sufficient for high-quality OCT imaging.\n\nNo prior pars plana vitrectomy in the study eye.\n\nNo severe foveal atrophy on OCT.\n\nAble and willing to comply with postoperative positioning and follow-up visits.\n\nWritten informed consent provided.\n\nExclusion Criteria:\n\nA. Etiology-Related \u002F Secondary Macular Holes:\n\nTraumatic macular hole.\n\nHigh myopia with posterior staphyloma (axial length \\>28 mm and\u002For spherical equivalent ≤-8.0 D).\n\nDiabetic tractional retinal detachment (TRD) or significant tractional maculopathy.\n\nRetinal vascular occlusion-related macular hole.\n\nUveitis-related macular hole.\n\nAdvanced age-related macular degeneration (AMD) with foveal atrophy.\n\nB. Prior Interventions:\n\nAny prior pars plana vitrectomy in the study eye.\n\nC. Ocular Conditions That May Affect Outcomes or Safety:\n\nActive or recent ocular infection or inflammation (e.g., uveitis, endophthalmitis, keratitis).\n\nUncontrolled glaucoma (intraocular pressure \\>28 mmHg despite treatment).\n\nMedia opacity precluding adequate OCT (e.g., dense cataract or corneal opacity).\n\nGeographic atrophy involving the fovea.",{"count":147,"type":21},[149],"This study compares ten modern vitreoretinal surgical techniques for full-thickness macular hole repair. Participants will be randomly assigned to one of the surgical approaches during pars plana vitrectomy, using stratified randomization based on macular hole size to ensure balanced groups. The main goal is to determine which technique provides the highest anatomical closure rate on optical coherence tomography (OCT) and the best visual outcomes. Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery to assess OCT findings, visual acuity, safety outcomes, and the need for reoperation.",[456],"Macular Holes",[458,459,460,461,462,463,464,465,466,467,468,469],"Full-Thickness Macular Hole","Pars Plana Vitrectomy","Internal Limiting Membrane Peeling","Inverted ILM Flap","ILM Flap","Optical Coherence Tomography","Macular Hole Closure","Best-Corrected Visual Acuity","Platelet-Rich Plasma","Amniotic Membrane Graft","Macular Hydrodissection","Surgical Technique","2026-05-29",{"date":472,"type":32},"2026-06-02",{"date":474,"type":32},"2026-05-25",{"date":476,"type":21},"2028-05-27",{"name":478,"class":479},"Kazakh Eye Research Institute","NETWORK",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":508},"100578558","phase-2-pd-1-inhibitors-maintenance-for-chl-post-autohct-100578558","NCT06812858","PD-1 Inhibitors Maintenance for cHL Post-autoHCT","A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory\u002FRelapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 18-70 years;\n* Diagnosis of r\u002Fr cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;\n* High-risk cHL (Primary refractoriness after first-line therapy \u002F Relapse after first line therapy within 12 months \u002F PET\u002FCT-positive status at the time of auto-HCT \u002F Late relapse (\\> 12 months) with unfavourable prognosis factors (extranodal lesion and\u002For bulky and\u002For B-symptoms) \u002F More than one salvage regimen performed)\n* Complete or partial response by PET\u002FCT after auto-HSCT\n* No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;\n* Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\\> 1 109\u002FL, absolute neutrophil count\\> 0.5 109\u002FL, platelets \\> 25 109\u002FL);\n* ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI\n\nExclusion Criteria:\n\n* Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy;\n* Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;\n* Respiratory failure of more than 1 degree at the time of inclusion in the study;\n* Unstable haemodynamics at the time of inclusion in the study;\n* Acute bacterial, viral or fungal infection at the time of inclusion;\n* Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible);\n* Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period;\n* Somatic or psychiatric pathology that prevents the signing of informed consent;","70 Years",{"count":489,"type":21},83,[74],"This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R\u002FR) classical Hodgkin Lymphoma (cHL)",[493],"Hodgkin Lymphoma",[495,496,497,498],"Classic Hodgkin lymphoma","autologous hematopoietic stem cell transplantation","nivolumab","pembrolizumab","2026-05-20",{"date":501,"type":32},"2026-05-22",{"date":503,"type":32},"2024-01-09",{"date":505,"type":21},"2030-09",{"name":507,"class":172},"St. Petersburg State Pavlov Medical University",4,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":263,"phases":4,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},"100640957","her2-positive-metastatic-breast-cancer-in-kazakhstan-100640957","NCT07593196","HER2-positive Metastatic Breast Cancer in Kazakhstan","A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Kazakhstan Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion\n* The diagnosis of mBC was established between the 1st January 2022 to 31st December 2023\n* Patients with the availability of at least 24 months of follow-up data (from the date of mBC diagnosis) in the medical records at the participating site, unless patient died\u002Fmoved or refused the therapy within the first 24 months of diagnosis\n* Age ≥18 years at the time of inclusion\n\nExclusion Criteria:\n\n* Presence of other malignancies within the period from mBC diagnosis until the timepoint of data collection\n* Patients received trastuzumab deruxtecan\n* The participation in any interventional trial within period since diagnosis until the end of study","99 Years",{"count":518,"type":21},240,"Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).\n\nPlanned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.",[521],"Metastatic Breast Cancer",[523,524],"Breast cancer","HER2+","2026-05-12",{"date":527,"type":32},"2026-05-18",{"date":529,"type":21},"2026-05-19",{"date":531,"type":21},"2027-01-30",{"name":285,"class":39},12,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100445032","phase-3-pirfenidone-to-prevent-fibrosis-in-ards-100445032","NCT05075161","Pirfenidone to Prevent Fibrosis in Ards.","Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER","PIONEER","Inclusion Criteria:\n\nConcomitant presence of:\n\n* ARDS (moderate and severe) - Berlin definition\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral opacities on CXR which are not fully explained by effusions, lobar\u002Flung collapse or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2\\\u003C200 mmHg with PEEP\\\u003C=5 cmH2O (invasive mechanical ventilation)\n* Inflammatory ARDS phenotype (28), defined by at least one of the following:\n\n  1. High plasma levels of inflammatory biomarkers\n  2. Vasopressor dependence\n  3. Lower serum bicarbonate or increased serum lactate\n* Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.\n* Age \\>=18 years\n\nExclusion Criteria:\n\n* Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\\>7 days) up to the time of randomization\n* ARDS severe or moderate for more than 36 hours\n* Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF\n* ARF fully explained by left ventricular failure or fluid overload\n* Consent declined\n* Severe chronic respiratory disease requiring domiciliary ventilation\n* Clinical suspicion for significant restrictive lung disease\n* Pregnant women or women of childbearing potential who are sexually active\n* Known allergy to pirfenidone\n* Concomitant use of fluvoxamine\n* Known severe hepatic failure\n* Known severe renal failure or necessity of dialysis not related to acute disease\n* Little chance of survival (SAPS II score\\>75)",{"count":543,"type":21},130,[24],"Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.\n\nFibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution.\n\nPirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models.\n\nThis is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.",[547],"Acute Respiratory Distress Syndrome (ARDS)",[549,550,551,552,553,554,555,556,557],"ARDS","Pulmonary Fibrosis","Mechanical Ventilation","Antifibrotic drug","Intensive Care Unit","ICU discharge","Mortality","Spirometry","Quality of life","2026-05-05",{"date":560,"type":32},"2026-05-08",{"date":562,"type":32},"2022-06-01",{"date":564,"type":21},"2026-12",{"name":566,"class":172},"Università Vita-Salute San Raffaele",17,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":579,"conditions":580,"keywords":584,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":173},"100631003","the-transit-bipartition-with-the-use-of-a-metallic-anastomosis-clip-and-circular-fundocorporeal-gastroplication-100631003","NCT07495020","The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication","The Laparoscopic Transit Bipartition Without Gastrectomy With Use of Metallic Anastomosis Clip (MAC) and Circular Fundocorporeal Gastroplication for Treating Type 2 Diabetes Mellitus and Obesity","MACBIPARTFCG","Inclusion Criteria:\n\n* Clinical diagnosis of Type 2 Diabetes Mellitus\n* BMI 25-35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Insulin dependent diabetes\n* BMI \\\u003C25 and \\>35 kg\u002Fm2\n* History of surgery on the stomach\n* Less than 18 or more than 65 years of age\n* Psychiatric illness\n* Patients unwilling or unable to provide informed consent",{"count":577,"type":21},90,[149],"This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition \u002F \"dual-path\" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg\u002Fm²).\n\nCurrently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg\u002Fm². However, many T2DM patients have BMI less 34.9 kg\u002Fm2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation.\n\nThe MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs.\n\nParticipants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.",[152,581,582,583],"Obesity & Overweight","Marginal Ulcer (Peptic) or Erosion","Leakage, Anastomotic",[585,586,587,588],"Metallic Anastomotic Clip","Metabolic bariatric surgery","obesity","Type 2 diabetes mellitus","2026-05-02",{"date":591,"type":32},"2026-05-07",{"date":593,"type":32},"2026-04-30",{"date":595,"type":21},"2028-05-30",{"name":597,"class":172},"The Society of Bariatric and Metabolic Surgeons of Kazakhstan",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":604,"maxAge":70,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":173},"100632731","the-course-of-acute-respiratory-failure-in-geriatric-patients-with-hip-fracture-using-different-modes-of-a-vibroacoustic-device-for-the-lungs-100632731","NCT07517497","The Course of Acute Respiratory Failure in Geriatric Patients With Hip Fracture Using Different Modes of a Vibroacoustic Device for the Lungs","* respiratory failure;\n* hip fracture;\n* Injury Severity Score no higher than 8 points.\n\nExclusion Criteria:\n\n* All contraindications for use of the device:\n* terminal condition of the patient;\n* shock;\n* paradoxical pathological breathing;\n* hypertensive crisis;\n* severe hypocoagulation with a risk of hematoma formation or bleeding in the projection of exposure;\n* severe hypercoagulation, risk of thrombus\u002Fembolus migration along the main vessels in the area of exposure;\n* acute cerebrovascular accident in the first 1-3 days;\n* brain edema;\n* presence of multiple purulent or burn wound surfaces in the area of exposure;\n* presence of unstable rib fractures;\n* pneumomediastinum and\u002For subcutaneous emphysema of the chest;\n* osteomyelitis of the ribs and\u002For thoracic spine;\n* spinal fracture without orthopedic fixation;\n* chest or abdominal trauma with bleeding;\n* Injury Severity Score greater than 8 points;\n* concomitant diseases in the stage of decompensation.","60 Years",{"count":207,"type":21},[149],"A medical professional trained in the procedure and use of the device will conduct the vibroacoustic therapy session. He will also take blood samples.\n\nIn the control group, patients will undergo vibroacoustic pulmonary therapy in the \"Pneumonia\" mode, and in the control group, in the \"Prevention\" mode. Vibroacoustic pulmonary therapy will be conducted over a period of 5 days. A similar algorithm of actions is planned for both groups. VALT sessions will be conducted 4-6 times a day for 5 minutes in combination with treatment according to the protocol for the use of \"Vibroacoustic Therapy\" of the lungs of the Ministry of Health of the Republic of Kazakhstan. The device's emitters will be applied to the affected areas of the lungs. Since the device has long cords for the emitters and is portable, it is not difficult to change the patient's position and does not require their active participation, which is important for patients on ventilators and with limited mobility.",[609,610],"Vibration","Respiratory Complications","2026-04-02",{"date":613,"type":32},"2026-04-08",{"date":615,"type":32},"2025-03-01",{"date":617,"type":21},"2027-12-01",{"name":619,"class":172},"Astana Medical University",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":628,"enrollmentInfo":629,"targetDuration":4,"studyType":263,"phases":4,"briefSummary":631,"conditions":632,"keywords":635,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":173},"100632380","assessment-of-pancreatic-dysfunction-in-patients-with-type-2-diabetes-100632380","NCT07512934","Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes","Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol","T3cDM-AKT","Inclusion Criteria:\n\n* • adult patients of Kazakh nationality aged 18 to 74 years\n* diagnosis of T2DM established according to ADA criteria and documented in medical records\n* disease duration ≤5 years\n* absence of ketoacidosis episodes within the last 6 months\n\nExclusion Criteria:\n\n* positive anti-glutamic acid decarboxylase antibodies (anti-GAD65);\n* acute or chronic infections affecting metabolic status within the previous 4 weeks;\n* any history of malignant neoplasms;\n* pregnancy or lactation;\n* previously diagnosed type 1 diabetes mellitus or other specific types of diabetes;\n* severe decompensated chronic diseases;\n* conditions associated with systemic fibrosis (e.g., liver cirrhosis or autoimmune diseases);\n* refusal to participate.","74 Years",{"count":630,"type":21},310,"The goal of this observational study is to better understand how the pancreas works in adults with type 2 diabetes. The study focuses on both hormone production (endocrine function) and digestive function (exocrine function) of the pancreas.\n\nThe main questions it aims to answer are:\n\n* Can problems with the pancreas help identify a different type of diabetes called pancreatogenic diabetes?\n* How are blood markers and pancreas structure related to pancreatic function?\n\nParticipants will:\n\n* Have blood tests to measure glucose, insulin, and other markers\n* Provide a stool sample to assess digestive function\n* Undergo an ultrasound examination of the pancreas\n* Answer questions about digestive symptoms\n\nThe study will take place during a single visit in outpatient clinics.",[633,152,634],"Pancreatogenic Diabetes Mellitus","Exocrine Pancreatic Insufficiency (EPI)",[636,637,638,639,640,641,642,643,644],"Type 3c diabetes","Pancreatogenic diabetes","Fecal elastase-1","TGF-beta1","Adiponectin","IL-1 receptor antagonist","Pancreatic ultrasound","PEI-Q","Type 2 Diabetes Mellitus",{"date":646,"type":32},"2026-04-06",{"date":648,"type":32},"2025-07-07",{"date":650,"type":21},"2026-12-01",{"name":353,"class":172},{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":487,"enrollmentInfo":660,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":668,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":173},"100623213","metaphylaxis-of-infected-kidney-stones-after-percutaneous-nephrolithotripsy-100623213","NCT07393711","Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy","Evaluation of the Effectiveness of Intrarenal Dioxidine Metaphylaxis for Preventing Recurrence of Infection Stones After Percutaneous Nephrolithotripsy","DIOX-PCNL","Inclusion Criteria:\n\nAge ≥18 years\n\nPatients undergoing percutaneous nephrolithotripsy (PCNL)\n\nInfection-related kidney stones\n\nAbility to provide written informed consent\n\nExclusion Criteria:\n\nAge \\\u003C18 years\n\nPregnancy or breastfeeding\n\nKnown hypersensitivity to dioxidine\n\nSevere renal insufficiency or end-stage renal disease\n\nSevere comorbid conditions that preclude participation",{"count":661,"type":21},95,[149],"Kidney stone recurrence, particularly infection-related stones, remains a significant clinical problem after percutaneous nephrolithotripsy (PCNL). Bacterial colonization and persistent infection are recognized contributors to stone recurrence.\n\nThis study evaluates the effectiveness of intrarenal dioxidine instillation as a metaphylactic measure to reduce recurrence of infection-related kidney stones following PCNL. Patients undergoing PCNL will receive standard treatment, with or without adjunctive intrarenal dioxidine administration. The study aims to assess whether this approach reduces stone recurrence and infection-related complications.",[665,666,667],"Kidney Calculi","Nephrolithiasis","Urinary Tract Infections",[669,670,671,672,673,674,675,676],"Percutaneous nephrolithotomy","PCNL","Infection stones","Struvite stones","Dioxidine","Intrarenal instillation","Stone recurrence","Metaphylaxis","2026-02-08",{"date":679,"type":32},"2026-02-11",{"date":681,"type":21},"2026-03-01",{"date":683,"type":21},"2026-12-30",{"name":353,"class":172},{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":323,"sex":17,"minAge":18,"maxAge":324,"enrollmentInfo":692,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":695,"conditions":696,"keywords":698,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":173},"100608440","phase-1-a-comparative-bioavailability-study-of-two-torasemide-10-mg-tablets-formulations-in-healthy-adult-participants-under-fasting-conditions-100608440","NCT07201584","A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:","A Comparative Bioavailability of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions: a Prospective, Open-label, Randomized, Single-dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study","Inclusion Criteria:\n\n1. Healthy male and female individuals aged 18 to 55 years inclusive at the time of signing the ICF.\n2. Body weight ≥50 kg and Body Mass Index (BMI) between ≥18.5 and \\\u003C30.0 kg\u002Fm2.\n3. A healthy individual as determined by the Investigator based on medical history and results of standard clinical, laboratory and instrumental methods of examination (individuals with not clinically significant \\[NCS\\] abnormalities are eligible for the study).\n4. A non-smoker (for at least 3 months before screening), verified by the cotinine test at screening.\n5. A negative urine pregnancy test (rapid test) within 24 h before the first IMP dose for female individuals of childbearing potential. Postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) females are exempted from the requirement.\n6. Individuals with preserved reproductive potential should agree to use, with their partner, adequate contraception throughout the study and for 30 days thereafter (contraceptive methods with reliability greater than 90%: cervical caps with spermicide, diaphragms with spermicide, condoms with intravaginal spermicide, non-hormonal intrauterine devices), or true sexual abstinence.\n7. Capable of understanding the ICF and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and the study protocol.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to torasemide, other sulfonylureas, or any other excipient of the IMPs.\n2. History of renal failure with anuria.\n3. History of hepatic precoma, coma.\n4. History of hypotension.\n5. History of hypovolemia.\n6. History of hyponatremia and\u002For hypokalemia.\n7. History of substantial micturition disorders (e.g. due to prostatic hypertrophy).\n8. History of gout.\n9. History of cardiac arrhythmias (e.g. SA block, 2nd or 3rd degree AV block).\n10. History of latent or manifest diabetes mellitus or any form of hyperglycemia.\n11. History of pathological changes in the acid-base balance.\n12. History of pathological changes in the blood count (e.g. thrombocytopenia, anemia in patients without renal insufficiency).\n13. History of abnormally high (≥190 mg\u002FdL \\[≥4.9 mmol\u002FL\\]) low-density lipoprotein (LDL) cholesterol levels within 3 months before the first IMP dose.\n14. Abnormally high triglycerides levels (\\>150 mg\u002FdL \\[\\>1.7 mmol\u002FL\\]) within 3 months before the first IMP dose.\n15. History of renal insufficiency (creatinine clearance between 20 mL and 30 mL\u002Fmin and\u002For serum creatinine concentrations between 3.5 mg\u002FdL and 6 mg\u002FdL) due to nephrotoxic substances.\n16. History of other clinically significant cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, hematological, genito-urinary disease, bleeding disorders, neurological or psychiatric pathology, oncologic disease, autoimmune disease, dermatological disease or other chronic disease, that makes the individual ineligible for the study.\n17. Acute infectious diseases (e.g. influenza, acute respiratory bacterial or viral infections incl. COVID-19) less than 4 weeks before the first IMP dose.\n18. Hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n19. Systolic blood pressure \\\u003C 90 mmHg or ≥ 130 mmHg and\u002For diastolic blood pressure \\\u003C 60 mmHg or ≥ 85 mmHg.\n20. Heart rate \\\u003C 60 or \\> 100 beats per minute.\n21. The presence of any other condition which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n22. Use of the following medications within the relevant period before the first IMP dose:\n\n    1. Use of medications (including hormonal contraceptives) that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, diuretics, etc.) within 2 months before the first IMP dose.\n    2. Use of depot-forms of any medications within 3 months before the first IMP dose.\n    3. Use of any other prescribed or non-prescribed medication, herbal remedies, vitamins and minerals within 2 weeks before the first IMP dose or longer (at least 5 elimination half-lives) if the medication has a long half-life.\n23. Female individuals who are lactating.\n24. Female individuals of childbearing potential, having unprotected sexual intercourse with any unsterilized male partner (i.e., a man who is not sterilized by vasectomy for at least 6 months) within 30 days before the first IMP dose.\n25. Blood donation\u002Fblood loss \\>450 mL within 60 days or apheresis donation within 30 days before the first IMP dose.\n26. Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 h before the first IMP dose.\n27. Positive test result for COVID-19 rapid antigen test at admission to the Study Site.\n28. Positive test results for HIV or hepatitis B (HBsAg, anti-HBc) or C (anti-HCV) or syphilis at screening.\n29. History of drug or alcohol abuse within 1 year before the screening. Alcohol abuse is defined as regular intake of more than 10 units of alcohol a week (1 unit equivalent to 200 mL of dry wine or 50 mL of strong alcoholic drinks or 500 mL of beer).\n30. Positive screen for drugs or alcohol at screening.\n31. Individuals who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet \\[\\\u003C 1000 kcal\u002Fday\\]) within the 28 days before the first IMP dose and throughout the study.\n32. Intake of methylxanthine-containing substances (e.g., coffee, tea, chocolate, cocoa, energy drinks, cola) as well as citrus fruits and cranberry (including juices, fruit drinks, etc.) within the last 48 h before the first IMP dose.\n33. Intake of food or beverages containing poppy seeds within 72 h before the first IMP dose.\n34. Excessive consumption (defined as greater than 6 servings - 1 serving being approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day within 2 weeks before the first IMP dose.\n35. Mental, physical and other reasons that do not allow the individual, according to Investigator's opinion, to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.\n36. Participation in another clinical study (except if no investigational product was administered) within 3 months before the first IMP dose.\n37. Employee or family member of the Sponsor or the involved Contract Research Organization (CRO) or the Study Site.",{"count":693,"type":21},26,[328],"The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under fasting conditions.",[697],"Healthy Adult Male and Female Volunteers",[699,700],"Torasemide","Bioequivalence","2026-01-13",{"date":703,"type":32},"2026-01-14",{"date":705,"type":32},"2025-09-05",{"date":707,"type":21},"2026-04-01",{"name":709,"class":39},"Berlin-Chemie AG Menarini Group",{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":4,"eligibilityCriteria":716,"healthyVolunteers":12,"sex":17,"minAge":717,"maxAge":262,"enrollmentInfo":718,"targetDuration":4,"studyType":263,"phases":4,"briefSummary":720,"conditions":721,"keywords":728,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":736,"startDateStruct":738,"completionDateStruct":740,"leadSponsor":742,"locationsCount":173},"100614389","enhancing-management-algorithms-for-children-conceived-via-assisted-reproductive-technologies-100614389","NCT07278960","Enhancing Management Algorithms for Children Conceived Via Assisted Reproductive Technologies","Enhancing Algorithms for the Management of Children Conceived by Assisted Reproductive Technologies Based on a Comprehensive Assessment of the Impact of Modern Methods of Conception on Their Health Status","Inclusion Criteria:\n\nFor children:\n\n* Born as a result of an ART program (IVF, ICSI, FET, or Fresh-ET).\n* Age at the time of assessment: from birth up to 36 months.\n* Availability of complete perinatal and medical documentation, including ART cycle characteristics and neonatal outcomes.\n* Informed consent provided by parents or legal guardians for participation in the study and for biological sample collection (where applicable).\n\nFor mothers:\n\n* History of pregnancy achieved through ART within the territory of Kazakhstan.\n* Availability of data on pharmacological treatment before and during pregnancy (e.g., hormonal therapy, antithyroid drugs, vitamins, micronutrients).\n* Willingness to provide anamnestic and perinatal information, and consent for access to medical records.\n\nFor fathers (in ICSI subgroup):\n\n* Documented infertility factor necessitating ICSI.\n* Agreement to provide relevant medical history and participate in comparative analyses (e.g., endocrine or reproductive parameters of father-son pairs).","0 Months",{"count":719,"type":21},300,"Research Methods and Ethical Issues\n\n1. Main Scientific Questions and Hypotheses of the Project The primary objective of this project is to investigate the impact of advanced ART methods on the health status of children. The central scientific questions being addressed include: What are the consequences of ICSI and FET on the physical, cognitive, and reproductive health of children? The underlying hypothesis posits that children conceived by advanced ART methods may present with health indicators that deviate from the established norms.\n2. Description of the Experiments\n\nResearch Methods:\n\nTo achieve the goals of the study, the following stages are anticipated:\n\n1. Retrospective Analysis of Anamnestic Data:\n\n   This stage involves studying the relationship between the physical status and morbidity structure of 300 children under the age of three, who were conceived by advanced ART methods. Additionally, the medical history of their mothers regarding the use of various medications during pregnancy-such as estrogen, progesterone, thyroid hormones, antithyroid hormones, vitamins, microelements, and aspirin-will be examined. To facilitate this analysis, individual registration cards will be developed, approved by the ethics committee, and ratified by the Academic Council. The data will be submitted using Google Forms, followed by the inclusion of copyright information into the state register.\n2. Evaluation of Anthropometric Data:\n\n   This stage will assess the anthropometric data of 300 children under three years of age, focusing on those born after FET or fresh embryo transfer (Fresh-ET). Measurements will include weight, height, and head and chest circumference at the time of examination. Measurements for children under one year will utilize scales with a pan balance, a horizontal stadiometer, and a measuring tape. For children over one year, floor electronic scales, a vertical stadiometer, and a centimeter tape will be employed. Birth anthropometric data will be sourced retrospectively, while the WHO Child Growth Standards will be utilized to evaluate weight, height, head, and chest circumference relative to age and gender.\n3. Study of Psychomotor Development:\n\n   The psychomotor development of the 300 children under three years of age conceived via IVF or ICSI in fresh or frozen cycles will be assessed. This evaluation will employ standardized instruments such as the R. Griffiths Mental Development Scale and Denver Developmental Screening Tests. For children under one year, neurosonography will be conducted to assess brain structures, and retrospective results for children over one year of age will be extracted from medical records.\n\n   The assessment aims to determine the functions of the nervous system utilizing the aforementioned standardized scales, focusing on various developmental parameters, including motor skills, social adaptation, communication abilities, and play skills. Scores will be compiled to ascertain overall developmental levels. The Denver II developmental screening test is specifically designed to assess children from birth to six years of age. It enhances diagnostic capabilities and evaluates several critical parameters, including: 1) personal and social characteristics, which examine the child's interactions with others and their ability to meet personal needs; 2) the development of gross and fine motor skills; 3) the development of both motor and sensory speech; and 4) an assessment of the child's behavior during the evaluation process.\n\n   In cases where children are identified as being in the \"risk group,\" a consultation with a neurologist is planned to establish examination protocols and identify the etiopathogenetic basis for potential developmental disorders. Standard methods of neurological examination will be utilized to assess the development of motor, sensory, cognitive, speech, emotional, communicative, and behavioral parameters in conjunction with anamnestic data and the overall state of somatic health.\n4. Assessment of Reproductive Health:\n\nThe study will also evaluate the effect of ICSI, particularly in cases of male infertility, on the reproductive health and development of 200 male children under three years of age, in comparison with children conceived via classic IVF. This evaluation will involve objective examinations conducted by a pediatric andrologist to investigate the prevalence of urogenital pathology, supplemented by ultrasounds of the scrotum, kidneys, and bladder. Additionally, hormonal status will be assessed by Inhibin B and Anti-Müllerian Hormone (AMH). Anamnestic data will be collected to explore the relationship between the reproductive health of fathers and their sons born after ICSI.\n\n3\\) Methods of Data Collection and Processing Data Collection Sources of Information: Data will be sourced from the International clinical center of the reproductology \"PERSONA\" and Institute of Reproductive Medicine (IRM clinic), in addition to direct examinations of participants based",[722,723,724,725,726,727],"Children","ART","Anthropometric Characteristics","Somatic Health Status","Neurological Condition","Urogenital Pathology",[723,729,730,731,732,733,734],"health status","children after ART","offspring","urogenital pathology","anthropometric charachteristics","neurological conditions","2025-12-09",{"date":737,"type":32},"2025-12-12",{"date":739,"type":32},"2025-10-01",{"date":741,"type":21},"2027-11-30",{"name":743,"class":172},"Kazakhstan's Medical University \"KSPH\"",""]