[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Russia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":640},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,421,0,25,[9,39,72,99,121,164,195,216,242,266,297,320,340,364,387,411,430,453,475,494,516,540,563,585,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100599784","clinical-and-demographic-characteristics-of-adult-p-atients-with-neurofibromatosis-in-russia-100599784",false,"NCT07088991","Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia","Clinical and Demographic Characteristics of Adult Patients With NEurofibromatosis in RUSsia","NEREUS","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of inclusion.\n2. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study.\n3. NF1 diagnosed (according to the international consensus criteria for evaluating NF1 \\[18\\]), see Appendix A.\n4. Confirmed PN by clinical assessment, USI, MRI, biopsy; one method is sufficient (histologic confirmation of PN is not necessary in the presence of radiographic findings).\n5. Existing of PN-associated symptoms.\n6. Adult patients (≥18 years) with newly diagnosed PN or established PN naïve to MEK-inhibitor therapy verified by medical records\u002Fhistories (e.g., prior prescriptions, hospitalization data).\n\nExclusion Criteria:\n\n1. The participation in any clinical study currently (patients participating in other non-interventional studies may be included);\n2. Patients with the evidence of a malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy.\n3. In the opinion of the investigator the patient is not able to return for follow-up visits or obtain required follow-up studies.\n4. Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial, if they are unable to undergo radiographic evaluations or MRI scans requested for research purposes, or other studies which might negatively impact on the pregnancy.\n5. Prior receipt of any MEK-inhibitor for PN therapy within 4 months before screening or initiation of therapy prior to age 18 verified by medical records\u002Fhistories (e.g., prior prescriptions, hospitalization data).\n6. Patients who modify their index pathogenetic therapy regimen during the study (for example, pathogenetic antitumor therapy of PN; switching to a different therapy), as determined by the investigator at any protocol-specified visit during the a study, will be excluded from the primary efficacy analysis population from the point of modification onward and will not continue study participation.","ALL",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)",[25],"Neurofibromatosis","RECRUITING","2026-08-24",{"date":29,"type":30},"2026-08-25","ACTUAL",{"date":32,"type":30},"2025-06-06",{"date":34,"type":21},"2028-03-31",{"name":36,"class":37},"AstraZeneca","INDUSTRY",16,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":18,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100345151","phase-3-a-study-of-baricitinib-in-participants-from-1-year-to-less-than-18-years-old-with-juvenile-idiopathic-arthritis-100345151","NCT03773965","A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis","A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to \u003C18 Years of Age With Juvenile Idiopathic Arthritis (JIA)","JUVE-X","Inclusion Criteria:\n\n* Participants must have completed a previous study of baricitinib for the treatment of JIA.\n\nExclusion Criteria:\n\n* Participants must not have had a permanent discontinuation of baricitinib in the prior study.\n* Participants must have not developed an allergy to baricitinib.","1 Year","18 Years",{"count":50,"type":21},190,"INTERVENTIONAL",[53],"PHASE3","The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.",[56],"Juvenile Idiopathic Arthritis",[58,59,60,61,62],"Polyarticular JIA","Oligoarthritis","Juvenile psoriatic arthritis (JPsA)","Enthesitis-related juvenile idiopathic arthritis (ERA)","Systemic JIA with and without systemic features","2026-08-21",{"date":27,"type":30},{"date":66,"type":30},"2019-04-05",{"date":68,"type":21},"2031-07",{"name":70,"class":37},"Eli Lilly and Company",78,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":51,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":80,"type":21},3500,[53],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[84,85],"Solid Tumors","Hematologic Malignancies",[87,88,89,90],"PD1","PD-1","PDL1","PD-L1",{"date":29,"type":30},{"date":93,"type":30},"2018-08-21",{"date":95,"type":21},"2043-08-04",{"name":97,"class":37},"Merck Sharp & Dohme LLC",782,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":51,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100624094","extension-study-for-participants-in-studies-that-include-belzutifan-mk-6482-043litespark-043-100624094","NCT07405164","Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043\u002FLITESPARK-043)","A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.\n* Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.",{"count":107,"type":21},450,[53],"Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:\n\n* Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery\n* Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids\n* VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer\n\nResearchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.",[111,112],"Von Hippel-Lindau Disease","Malignant Neoplasms","2026-08-20",{"date":27,"type":30},{"date":116,"type":30},"2026-03-23",{"date":118,"type":21},"2034-01-14",{"name":97,"class":37},51,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":51,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100321141","phase-1-a-study-of-mevrometostat-for-treatment-of-relapsedrefractory-sclc-castration-resistant-prostate-cancer-and-follicular-lymphoma-100321141","NCT03460977","A Study of Mevrometostat for Treatment of Relapsed\u002FRefractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma","A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED\u002FREFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)","Part 1 and Part 2 (Closed for enrollment).\n\nPart 3 Key Inclusion Criteria:\n\n* Histological or cytological diagnosis of castration resistant prostate cancer.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.\n* Adequate bone marrow, renal, and liver function\n\nPart 3 Key Exclusion Criteria:\n\n* Prior irradiation to \\>25% of the bone marrow.\n* QTcF interval \\>480 msec at screening.\n* Hypertension that cannot be controlled by medications (\\>150\u002F90 mmHg despite optimal medical therapy).\n* Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)\n* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n* Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4\u002F5 inducers or inhibitors\n* Prior enzalutamide within the last 4 weeks\n* DDI SUBSTUDY:\n* history of CHF or evidence of ventricular dysfunction\n* fructose intolerance\n* coadministration of CYP3A4 substrates",{"count":129,"type":21},453,[131],"PHASE1","The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed\u002F Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.\n\nPart 3, which is open for enrollment is seeking men who:\n\n* have Castration Resistant Prostate Cancer (CRPC) and\n* have previously received treatment for CRPC and have progressed from the last treatment\n\nAll participants in Part 3 of this study will receive mevrometostat and\u002F or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).\n\nIn the assessment phase:\n\n* participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods.\n* participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and\u002For itraconazole 1 time a day based on a present schedule.\n* participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and\u002For itraconazole 1 time a day based on a present schedule.\n\nAfter completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.\n\nThe study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.",[134,135,136],"Metastatic Castration Resistant Prostate Cancer (mCRPC)","Small Cell Lung Cancer (SCLC)","Follicular Lymphoma (FL)",[138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155],"EZH2","enhancer of zeste homolog 2","castrate resistant prostate cancer","prostatecancer-study.com","mCRPC","efficacy","safety","pharmacokinetics","pharmacodynamics","dose escalation","dose expansion","open-label","small cell lung cancer","SCLC","follicular lymphoma","FL","relapsed","refractory",{"date":27,"type":30},{"date":158,"type":30},"2018-04-17",{"date":160,"type":21},"2029-07-07",{"name":162,"class":37},"Pfizer",84,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":172,"minAge":48,"maxAge":173,"enrollmentInfo":174,"targetDuration":47,"studyType":22,"phases":4,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":194},"100652621","sentinel-node-identification-using-gamma-and-near-infrared-imaging-in-testicular-malignancies-100652621","NCT07777887","Sentinel Node Identification Using Gamma and Near-Infrared Imaging in TesticulAr MaLignancies","Sentinel Node Identification Using Gamma Detection and Near-Infrared Fluorescence in Testicular Malignancies","SIGNAL","Inclusion Criteria:\n\n* Presence of a primary testicular tumor suspicious for a testicular germ cell tumor (TGCT) and considered an indication for radical inguinal orchiectomy (orchifuniculectomy);\n* Male gender;\n* Maximum diameter of the primary testicular tumor (cT) ≤5 cm;\n* One of the following clinical nodal and serum tumor marker criteria:\n* \\- cN0 disease with serum tumor markers corresponding to S1 category: alpha-fetoprotein (AFP) 0-5.8 IU\u002FmL and β-human chorionic gonadotropin (β-hCG) \\>2.5 and \\\u003C1,000 IU\u002FmL; or\n* -cN1-cN2 disease, with no more than two radiologically suspicious retroperitoneal lymph nodes, and serum tumor markers corresponding to S0-S1 category;\n* No evidence of distant metastatic disease (cM0).\n* Patient refusal to undergo adjuvant anticancer treatment (chemotherapy or radiotherapy) following radical inguinal orchiectomy, or unwillingness\u002Finability to undergo close active surveillance.\n* Ability to understand the study requirements and provision of written voluntary informed consent prior to participation in the study.\n\nExclusion Criteria:\n\n* Maximum diameter of the primary testicular tumor (cT) \\>5 cm;\n* Presence of distant metastatic disease (cM1);\n* Serum tumor marker levels corresponding to S2-S3 category.\n* Clinical stage cN1 with ≥2 retroperitoneal lymph nodes suspicious for metastatic involvement;\n* Clinical stage cN3 disease;\n* Any previous specific anticancer treatment for a testicular germ cell tumor, including systemic chemotherapy, radiotherapy, or prior retroperitoneal surgery for testicular cancer;\n* Presence of any contraindication to minimally invasive surgery, administration of indocyanine green (ICG), or administration of the technetium-99m (Tc-99m)-labelled radiopharmaceutical used for sentinel lymph node mapping.","MALE","60 Years",{"count":175,"type":21},60,"Testicular seminoma is a malignant tumor with a very high probability of cure. Current treatment approaches provide excellent long-term cancer outcomes. However, some standard treatments, including radiotherapy and platinum-based chemotherapy, may cause side effects both during treatment and many years after its completion. In the long term, these treatments may be associated with an increased risk of cardiovascular disease, metabolic disorders, and secondary malignancies.\n\nBecause most patients with seminoma are successfully cured and have a long life expectancy, an important goal of modern cancer treatment is not only to achieve effective cancer control, but also to reduce the potential long-term adverse effects of treatment.\n\nOne possible treatment approach is minimally invasive retroperitoneal lymph node dissection (RPLND), performed using laparoscopic or robot-assisted surgery. This procedure allows the disease stage to be determined more accurately by establishing whether cancer cells are present in the retroperitoneal lymph nodes. In some patients, surgery may potentially provide effective disease control without the need for subsequent radiotherapy or chemotherapy.\n\nHowever, currently available imaging methods, including computed tomography (CT), cannot always accurately determine whether individual retroperitoneal lymph nodes contain cancer cells. Studies have shown that in some patients undergoing RPLND for suspected lymph node involvement, no cancer cells are subsequently found in the removed lymph nodes. Therefore, there is a need to develop more accurate methods for identifying the lymph nodes that are most likely to be the first sites of cancer spread.\n\nWhy Are We Studying Sentinel Lymph Nodes?\n\nThis study investigates a method for identifying sentinel lymph nodes. Sentinel lymph nodes are the lymph nodes that first receive lymphatic drainage from the area of the primary tumor and may therefore be the first lymph nodes to which cancer cells spread.\n\nIn this study, two complementary methods will be used to identify sentinel lymph nodes. The first involves the administration of a small amount of a radiopharmaceutical containing technetium-99m (Tc-99m), followed by single-photon emission computed tomography combined with computed tomography (SPECT\u002FCT). During surgery, these lymph nodes will also be identified using a special gamma-detection device.\n\nThe second method involves the use of indocyanine green (ICG), a fluorescent dye that allows the surgeon to visualize lymphatic drainage pathways and lymph nodes during surgery using near-infrared fluorescence imaging.\n\nThe combination of these two methods may allow more accurate identification of sentinel lymph nodes and provide a better understanding of lymphatic drainage from testicular tumors.\n\nWhy Are You Being Invited to Participate?\n\nYou are being invited to participate because the characteristics of your disease meet the eligibility criteria for this study.\n\nThe main purpose of the study is to determine how accurately and reliably sentinel lymph nodes can be identified in patients with testicular seminoma using a combination of radionuclide and fluorescence-guided techniques.\n\nThe information obtained from this study may help to develop a more individualized approach to the surgical treatment of patients with seminoma. In the future, accurate identification of sentinel lymph nodes may make it possible to reduce the extent of surgery in selected patients, potentially decreasing surgical trauma and the risk of postoperative complications. At the same time, accurate detection of cancer involvement in lymph nodes may help identify patients who require additional anticancer treatment, such as systemic chemotherapy.\n\nIt is important to understand that the approach being evaluated is investigational, and its advantages over currently established approaches have not yet been conclusively demonstrated. Therefore, participation in this study cannot guarantee any additional direct medical benefit to you. However, the information obtained from your participation may contribute to improving the diagnosis and treatment of patients with testicular seminoma in the future.\n\nParticipation in this study is entirely voluntary. Before making your decision, you will have the opportunity to discuss the purpose of the study, the study procedures, possible benefits and risks, and alternative treatment options with your doctor. Your decision not to participate, or to withdraw from the study at a later time, will not affect your right to receive appropriate medical care.",[178],"Germ Cell Tumor of Testis",[180,181,182,183,184],"germ cell tumor","seminoma","sentinel node","Gamma Detection","minimal invasive surgery","2026-08-17",{"date":113,"type":30},{"date":188,"type":30},"2026-04-01",{"date":190,"type":21},"2029-04-01",{"name":192,"class":193},"N.N. Petrov National Medical Research Center of Oncology","OTHER",1,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":172,"minAge":48,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100596984","aggressive-disease-treatment-patterns-and-ctdna-hrr-evaluation-in-high-volume-metastatic-hormone-sensitive-prostate-cancer-in-russian-federation-100596984","NCT07052578","Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration","A Multicentre Observational Study on Treatment Patterns and ctDNA HRR Evaluation in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russian Federation","CONCORD","Inclusion Criteria:\n\n1. Male patients aged ≥ 18 years old;\n2. Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing;\n3. Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages);\n4. High-aggressive disease (Gleason 8-10);\n5. High-volume disease (according to CHAARTED trial criteria: presence of 4 and more (≥4) bone metastases (including at least one (≥1) outside the vertebral column\u002Fpelvis) and\u002For 1 and more (≥1) visceral metastasis);\n6. Availability of source medical documentation;\n7. Known HRRm status based on tumour sample evaluation performed in routine practice.\n\nExclusion Criteria:\n\n1. Participation in any interventional trial since the mPC diagnosis.\n2. Progression to mCRPC.",{"count":204,"type":21},400,"A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation",[207],"Prostate Cancer",{"date":209,"type":30},"2026-08-18",{"date":211,"type":30},"2025-06-30",{"date":213,"type":21},"2028-11-30",{"name":36,"class":37},26,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":51,"phases":227,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100411524","phase-4-secukinumab-open-label-roll-over-extension-protocol-100411524","NCT04638647","Secukinumab Open Label Roll-over Extension Protocol","An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment","Inclusion Criteria:\n\n1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).\n2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.\n3. Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical \u002F administrative reasons).\n4. Participant is deriving benefit from secukinumab, investigator believes he\u002Fshe would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.\n5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and\u002For reimbursement guidelines.\n\nExclusion Criteria:\n\n1. Participant has prematurely discontinued study treatment in the parent protocol.\n2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).","6 Years","100 Years",{"count":226,"type":21},1000,[228],"PHASE4","The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.",[231],"Autoimmunity, Inflammation",[233],"Secukinumab, Post trial access",{"date":209,"type":30},{"date":236,"type":30},"2020-12-22",{"date":238,"type":21},"2030-04-04",{"name":240,"class":37},"Novartis Pharmaceuticals",168,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":250,"targetDuration":47,"studyType":22,"phases":4,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100213888","prospective-global-registry-for-the-study-of-chronic-total-occlusion-intervention-100213888","NCT02061436","Prospective Global Registry for the Study of Chronic Total Occlusion Intervention","Multicenter Registry of Chronic Total Occlusion Interventions","PROGRESS-CTO","Inclusion Criteria:\n\n* Patients undergoing CTO PCI at each of the participating centers.\n\nExclusion Criteria:\n\n* None",{"count":251,"type":21},2000,"Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.",[254],"Coronary Artery Disease",[256],"chronic total occlusion, percutaneous coronary intervention",{"date":258,"type":30},"2026-08-19",{"date":260,"type":30},"2012-01",{"date":262,"type":21},"2030-01",{"name":264,"class":193},"Minneapolis Heart Institute Foundation",48,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":51,"phases":277,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":194},"100390472","d2-vs-d3-lymph-node-dissection-for-left-colon-cancer-100390472","NCT04364373","D2 vs D3 Lymph Node Dissection for Left Colon Cancer","D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)","DILEMMA","Inclusion Criteria:\n\n1. Agreement of the patient to participate in trial\n2. Colon cancer (only adenocarcinoma )\n3. The tumor located between the splenic flexure and rectosigmoid junction\n4. cT3-Т4а,b\n5. cN0-2\n6. cM0\n7. Tolerance of chemotherapy\n8. ASA 1-3\n\nExclusion Criteria:\n\n1. сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder)\n2. Preoperative complications of the tumor (perforation and full bowel 3. obstruction)\n3. Previous radiotherapy or chemotherapy\n4. Synchronous or metachronous tumors\n5. Women during Pregnancy or breast feeding period","75 Years",{"count":276,"type":21},1381,[278],"NA","The efficiency of the D3 lymph node dissection is still controversial for left colon cancer patients. This study will try find difference in 5-year overall survival between D2 and D3 lymph node dissection. Investigation of the functional and short-term outcomes will clarify safety of the D3 lymph node dissection.",[281],"Colon Cancer",[283,284,285,286,287,288],"D2","D3","lymph node dissection","complete mesocolic excision","left colon cancer","CME","2026-08-14",{"date":185,"type":30},{"date":292,"type":30},"2020-03-31",{"date":294,"type":21},"2033-12-31",{"name":296,"class":193},"Russian Society of Colorectal Surgeons",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":304,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":51,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":194},"100556475","ketamine-infusion-as-a-method-of-cerebral-protection-in-children-100556475","NCT06525584","Ketamine Infusion as a Method of Cerebral Protection in Children","Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects","Inclusion Criteria:\n\n* age from 1 to 60 months\n* body weight from 3.5 to 20 kg\n* planned surgical intervention to correct a congenital heart defect (atrial or ventricular septal defect) with CPBё\n* the presence of informed consent for participation in the study signed by the child's legal representative\n\nExclusion Criteria:\n\n* lack of informed consent of the patient and parents to participate in the study,\n* emergency and urgent surgical interventions;\n* the presence of clinically significant anemia;\n* hypo-thermic during operation, episodes of desaturation in the perioperative period;\n* the presence of another congenital heart diseases besides the atrial or ventricular septal defect, as well as their combination;\n* a history of central nervous system diseases;\n* an installed pacemaker;\n* hemodynamic instability requiring preoperative pharmacological and\u002For mechanical support;\n* any episodes of cerebrovascular accidents in the history or periop-erative period;\n* the presence of a patient with severe concomitant diseases that worsen mental and somatic conditio;\n* acute infection and exacerbation of chronic infection in the perioperative period;\n* concomitant autoimmune diseases;\n* the presence of malignant neoplasms;\n* surgical complications in the postoperative period.","1 Month","5 Years",{"count":307,"type":21},196,[278],"The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.",[311],"Brain Injuries","2026-08-13",{"date":185,"type":30},{"date":315,"type":30},"2023-11-05",{"date":317,"type":21},"2028-12-30",{"name":319,"class":193},"Kemerovo State Medical University",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":51,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":194},"100525294","phase-3-comparison-between-the-european-and-japanese-pathological-investigation-for-colon-cancer-space-100525294","NCT06119867","CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)","Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)","SPACE","Inclusion Criteria:\n\n* Patients diagnosed with colon cancer who underwent colectomy;\n* Patients with pathological confirmed adenocarcinoma;\n* Patients agreed to participate in the study.\n\nExclusion Criteria:\n\n* Patients suffered from rectal cancer;\n* Patients diagnosed with colon cancer but did not undergo colectomy;\n* Patients refused participation.",{"count":329,"type":21},430,[53],"In general, the European pathological examination method primarily relies on pathologists and does not require the involvement of surgeons. The Japanese pathological evaluation approach, on the other hand, involves the intervention of surgeons, particularly in the extraction of lymph nodes from fresh specimens and the assessment of specimen quality. Given that the Japanese pathological assessment method lacks systematic evaluation and there is currently no literature clearly demonstrating its diagnostic accuracy, the main objective of this study is to verify whether the diagnostic accuracy of the Japanese pathological investigation method is inferior to that of the European pathological evaluation method.",[333],"Colonic Neoplasms",{"date":185,"type":30},{"date":336,"type":30},"2023-11-14",{"date":338,"type":21},"2027-12-01",{"name":296,"class":193},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":347,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":349,"conditions":350,"keywords":353,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":194},"100651614","sarcopenia-in-acute-ischemic-stroke-100651614","NCT07764172","Sarcopenia in Acute Ischemic Stroke","Sarcopenia in Patients During the Acute Phase of Ischemic Stroke: Multimodal Assessment and Three-Month Functional Outcomes","Inclusion Criteria:\n\n* Age 50 years and older\n* Acute ischemic stroke confirmed by CT or MRI\n* Admission within the first 72 hours\n* Written informed consent and availability of a contact telephone number for follow-up\n\nExclusion Criteria:\n\n* TIA without a visible lesion on neuroimaging; bilateral hemiparesis\n* Amputations or severe contractures that preclude anthropometric assessment\n* Active cancer at stage IV or life expectancy of less than 3 months\n* Neuromuscular diseases; chronic use of systemic glucocorticoids for more than 3 months\n* Pregnancy; refusal to participate\n\nDiscontinuation criteria (drop-out)\n\n* Discharge or death within the first 7 days\n* Withdrawal of consent\n* Transfer to another facility resulting in loss of contact","50 Years",{"count":204,"type":21},"The objective of this observational study is to determine the prevalence of sarcopenia in patients aged 50 years and older with acute ischemic stroke, to characterize its trajectory during the acute phase using instrumental verification and functional-cognitive assessments, and to evaluate its impact on functional outcome at three months. The main research question is:\n\nIs the presence of sarcopenia at admission associated with less favorable stroke outcomes, including higher rates of complications and mortality?\n\nParticipants receiving standard medical care for acute ischemic stroke will undergo extended functional assessment for sarcopenia, and a subset will additionally undergo cognitive evaluation.",[351,352],"Sarcopenia","Acute Stroke",[354,355],"sarcopenia","acute stroke","2026-08-12",{"date":312,"type":30},{"date":359,"type":21},"2026-08",{"date":361,"type":21},"2029-12-31",{"name":363,"class":193},"University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":385,"locationsCount":386},"100623671","real-world-evaluation-of-tezepelumab-for-chronic-rhinosinusitis-with-nasal-polyps-in-russia-100623671","NCT07399665","ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia","Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab","ARES","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older at the time of signing the ICF.\n2. Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation.\n3. Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use \u002F nasal polyps surgery (or information about contraindications \u002F intolerance to).\n4. Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks.\n5. The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment.\n6. Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment.\n7. SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment.\n8. Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site.\n9. Provision of signed and dated written informed consent.\n10. Participants are able to read, understand and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\n1. Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.\n2. Administration of concurrent biologic drug for CRSwNP \u002F asthma since the index date, except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Enrolment of patients who were switched from other biologic(s) to tezepelumab is allowed, and an acceptable timeframe since the last prior biologic drug is ≥ 60 days. The number of participants with prior biologic treatment (switching to tezepelumab) should be targeted at 20% or less.\n3. Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.\n4. Pregnancy or lactation period.",{"count":373,"type":21},110,"ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).",[376,377],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","Asthma",[379,380],"Tezepelumab","CRSwNP",{"date":312,"type":30},{"date":383,"type":30},"2025-12-25",{"date":34,"type":21},{"name":36,"class":37},10,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":394,"maxAge":48,"enrollmentInfo":395,"targetDuration":4,"studyType":51,"phases":397,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100348179","phase-3-an-open-label-study-to-assess-safety-and-efficacy-of-szc-in-paediatric-patients-with-hyperkalaemia-100348179","NCT03813407","An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia","PEDZ-K","Inclusion Criteria:\n\n1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate)\n2. Female or male from birth to \\\u003C 18 years of age (for the study duration).\n3. Participants (including those receiving a stable peritoneal dialysis regimen for a minimum of 2 months) requiring long-term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥ 2 years, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort \\\u003C 2 years.\n4. Participants must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol.\n5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening: a. For participants aged 0 to ≤ 3 days after birth: \\\u003C 450 ms b. For participants aged \\>3 days to \\\u003C 12 years: \\\u003C 440 ms c. For participants aged ≥ 12 to \\\u003C 18 years: \\\u003C 450 ms (male), \\\u003C 460 ms (female) All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.\n6. Ability to have repeated blood draws or effective venous catheterisation.\n7. Females of childbearing potential (defined as a female with potential of becoming pregnant who has experienced her menarche) must have a negative pregnancy test within one day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method\n8. Optional open-label, LTMP only:\n\n   1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) to take part in the LTMP.\n   2. Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose.\n   3. Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Neonates with a gestational age \\\u003C 37 weeks at birth or a birth weight \\\u003C 2500 g.\n2. Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).\n3. Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.\n4. Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns. 5. Participants with hyperkalaemia due to a secondary cause, such as dehydration, excessive use of K+ supplements, or drug use (eg, beta-adrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications).\n\n6\\. Participants with transient iatrogenic hyperkalaemia (eg, due to treatment with tacrolimus).\n\n7\\. Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.\n\n8\\. Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days prior to first dose of study treatment.\n\n9\\. Participants with a life expectancy of less than 3 months. 10. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.\n\n11\\. Presence of any condition which, in the opinion of the Investigator, places the participant at undue risk or potentially jeopardises the quality of the data to be generated. 12. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.\n\n13\\. Participants with cardiac arrhythmias that require immediate treatment. 14. Participants with a family history of long QT syndrome. 15. Participants on haemodialysis. 16. Participants with a history of bowel obstruction. 17. Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).\n\n18\\. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n\n19\\. Previous treatment with SZC. 20. Treatment with a drug or device within the last 30 days prior to first dose of study treatment that has not received regulatory approval at the time of study entry.\n\n21\\. Previous enrolment in the present study. 22. Females who are pregnant, breastfeeding, or planning to become pregnant. 23. Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 24. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection) the participant cannot be enrolled in the study.","0 Years",{"count":396,"type":21},140,[53],"Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \\\u003C18 years of age. Approximately 140 participants will enter CP at approximately 46 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. Enrolment will start in 2 cohorts, ages 6 to \\\u003C 12 years and 12 to \\\u003C 18 years. After review of accumulated data, the independent Data Monitoring Committee (iDMC) will recommend whether to open enrolment in the ages 2 to \\\u003C 6 years cohort and later in the ages 0 to \\\u003C 2 years cohort. All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to \\\u003C 18 years, initial participants will be allocated to the dose level (DL) based on body weight equivalent to an adult 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to on body weight equivalent to an adult 10 g TID and then potentially on body weight equivalent to an adult 15 g TID. All participants in the ages 0 to \\\u003C 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. For participants who, at the end of MP, are normokalaemic or hyperkalaemic without being on maximum dose, the MP is followed by the option to continue the study in a long term maintenance phase (LTMP) where the same titration regimen is used as in MP",[400],"Hyperkalaemia",[402,403],"sodium zirconium cyclosilicate","Hyperkalaemia in children",{"date":312,"type":30},{"date":406,"type":30},"2019-04-02",{"date":408,"type":21},"2030-02-21",{"name":36,"class":37},70,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":428,"locationsCount":429},"100611953","epidemiological-study-of-treatment-approaches-in-achr-antibody-positive-generalized-myasthenia-gravis-in-russia-100611953","NCT07247279","Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia","A Multicenter Non Interventional Single Arm Retrospective-prospective Observational Study in Therapeutic Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis (gMG) in Real Clinical Practice in Russia","Inclusion Criteria:\n\n1. Adults (≥18 years) diagnosed with generalized MG positive for acetylcholine receptor (AChR) antibodies.\n2. Provision of signed and dated written informed consent.\n\nExclusion Criteria:\n\n1. Participants currently enrolled in clinical studies for treatment of gMG.\n2. Ocular MG only.",{"count":107,"type":21},"This is a multicenter, non-interventional, retrospective-prospective, single-arm observational study designed to describe real-world treatment approaches and clinical outcomes among adults with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in routine clinical practice in Russia.",[421,422],"Rare Diseases","Generalized Myasthenia Gravis (gMG)","2026-08-11",{"date":356,"type":30},{"date":426,"type":30},"2025-12-23",{"date":361,"type":21},{"name":36,"class":37},7,{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":51,"phases":441,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":215},"100413549","phase-2-posaconazole-mk-5592-intravenous-and-oral-in-children-2-years-with-invasive-fungal-infection-mk-5592-127-100413549","NCT04665037","Posaconazole (MK-5592) Intravenous and Oral in Children (\u003C2 Years) With Invasive Fungal Infection (MK-5592-127)","A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection","Inclusion Criteria:\n\n* Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)\n* Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)\n* Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention.\n* Has a body weight of ≥500 g\n* The participant (or legally acceptable representative) has provided documented informed consent for the study.\n\nExclusion Criteria\n\n* Has received POS within 30 days before Day 1\n* Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis\n* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* Has known or suspected active COVID-19 infection\n* Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used\n* Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention\n* Has received any listed prohibited medications within the specified timeframes before the start of study intervention\n* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Part B)\n* Has suspected\u002Fproven invasive candidiasis (Part B)\n* Has enrolled previously in the current study and been discontinued\n* Has QTc prolongation at screening \\>500 msec\n* Has significant liver dysfunction\n* Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days","1 Day","2 Years",{"count":440,"type":21},40,[442],"PHASE2","This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \\\u003C2 years of age with invasive fungal infection (IFI).",[445],"Invasive Fungal Infection","2026-08-10",{"date":356,"type":30},{"date":449,"type":30},"2022-02-22",{"date":451,"type":21},"2027-04-15",{"name":97,"class":37},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":461,"minAge":48,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100596142","an-observational-study-of-molecular-profiling-of-advanced-and-aggressive-endometrial-cancer-and-1-st-line-treatment-approaches-in-russian-federation-100596142","NCT07041606","An Observational Study of Molecular profIling of Advanced and aggRessive ENdometrial Cancer and 1-st Line Treatment Approaches in Russian Federation","Multicenter, Observational, Prospective Study of Molecular Profiling in Advanced and Aggressive Endometrial Cancer Patients and 1-st Line Treatment Approaches in Russian Federation","IREN","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 years old;\n2. Signed ICF, including consent for archival FFPE tumor tissue block testing;\n3. Newly diagnosed, histologically confirmed, advanced (III-IV stage) EC, with the date of diagnosis of histologically confirmed disease within 4 months before inclusion;\n4. Endometrioid type G3 or any non-endometrioid histological type of EC (such as serous carcinoma, clear cell carcinoma, mixed carcinoma, undifferentiated and dedifferentiated carcinoma, carcinosarcoma, others);\n5. The presence of biopsy or postoperative archival FFPE tumor sample (block);\n6. Availability of source medical documentation.\n\nExclusion Criteria:\n\n1\\. Patients participating in clinical (interventional) studies since the diagnosis of histologically confirmed, advanced EC.","FEMALE",{"count":463,"type":21},500,"Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation",[466],"Endometrial Cancer","2026-08-07",{"date":446,"type":30},{"date":470,"type":30},"2025-06-24",{"date":472,"type":21},"2027-06-30",{"name":36,"class":37},19,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":493},"100595936","treatment-approaches-and-biomarkers-prevalence-in-bladder-cancer-in-russian-federation-100595936","NCT07038928","TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation","A Multicentre Observational Study on Treatment Approaches and HER2 Positive Status Prevalence in Different Stages of Bladder Cancer and PD-L1-positive Status in Metastatic Bladder Cancer in Russian Federation","RIVERS","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Signed ICF, including consent for FFPE tumor tissue sample testing;\n* Confirmed diagnosis of urothelial bladder cancer at NMIBC, MIBC, or mBC stage at study entry;\n* For patients with NMIBC: 1. TURBT performed at least 1 month but not more than 12 months prior to study entry; 2. Presence of ≥1 high-risk feature:\n\n  * T1 tumor\n  * High grade\u002FG3 tumor\n  * CIS (carcinoma in situ)\n  * Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point);\n* For patients with MIBC: Сystectomy performed at least 2 months but not more than 12 months prior to study entry;\n* For patients with mBC: mBC diagnosed during 12 months prior to study entry;\n* Availability of medical history data;\n* Availability of FFPE tumour tissue sample obtained during biopsy and\u002For surgery.\n\nExclusion Criteria:\n\n• Participation in any interventional trial since the urothelial bladder cancer diagnosis.",{"count":484,"type":21},600,"A multicentre observational study on treatment approaches and HER2 positive status prevalence in different stages of bladder cancer and PD-L1-positive status in metastatic bladder cancer in Russian Federation",[487],"Bladder Cancer",{"date":446,"type":30},{"date":211,"type":30},{"date":491,"type":21},"2026-12-31",{"name":36,"class":37},20,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":51,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100505507","a-rollover-study-for-participants-previously-enrolled-in-a-genentech-andor-f-hoffman-la-roche-sponsored-study-100505507","NCT05862285","A Rollover Study for Participants Previously Enrolled in a Genentech and\u002For F. Hoffman-La Roche Sponsored Study","An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and\u002For F. Hoffmann-La Roche Ltd Sponsored Study","UmbrellaMAX","Inclusion Criteria:\n\n* Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR\n* Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent\n* First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study\n* Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator\n* Ability to comply with the extension study protocol, per Investigator's judgement\n\nExclusion Criteria:\n\n* Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study\n* Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant\n* Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study\n* Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)\n* Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study\n* Concurrent participation in any therapeutic clinical trial (other than the parent study)",{"count":503,"type":21},100,[53],"The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\\[s\\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.",[507],"Cancer",{"date":446,"type":30},{"date":510,"type":30},"2023-06-01",{"date":512,"type":21},"2033-03-01",{"name":514,"class":37},"Hoffmann-La Roche",68,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":194},"100650117","pneumonia-after-cardiovascular-surgery-with-an-artificial-intelligence-100650117","NCT07745491","Pneumonia After Cardiovascular Surgery With Artificial Intelligence","Hospital-acquired Pneumonia After Cardiovascular Surgery (CS): the Prediction and Assessment of Long-term Cardiovascular and Pulmonary Outcomes With Artificial Intelligence (AI) - (PNEUMONIA-CS-AI)","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Cardiac and\u002For vascular surgical intervention during the current hospitalization;\n* Signed informed consent from the patient for the use of their anonymized data for scientific purposes.\n\nExclusion Criteria:\n\n* Use of systemic antibacterial drugs within 30 days prior to the surgical intervention;\n* Prescription of systemic antibacterial drugs during the hospitalization period for any indication other than hospital-acquired pneumonia;\n* HIV infection.",{"count":524,"type":21},700,"This multicenter, prospective, observational study aims to address two primary objectives.\n\nThe first objective is to demonstrate that hospital-acquired pneumonia (nosocomial pneumonia) following cardiac surgery can be predicted using artificial intelligence (AI), and to develop a personalized risk calculator for its development.\n\nThe second objective is to demonstrate that hospital-acquired pneumonia can serve as a risk factor for a 1-year composite cardiovascular and pulmonary outcome after cardiac surgery, and to develop a personalized risk calculator for this composite outcome.\n\nThe composite outcome will include the occurrence of any of the following events:\n\n* Respiratory death\n* Hospitalization for respiratory diseases\n* Development of oxygen dependence\n* New-onset asthma, COPD, or interstitial lung disease\n* Initiation or intensification of bronchodilator or corticosteroid therapy\n* Cardiovascular death\n* Acute myocardial infarction\n* Unstable angina\n* Myocardial revascularization\n* Acute ischemic stroke\n* Transient ischemic attack\n* Acute heart failure\n* Hospitalization for decompensated heart failure\n* New-onset atrial fibrillation or ventricular tachycardia\n* Initiation or intensification of antiarrhythmic therapy Both objectives will be addressed using artificial intelligence technologies applied during the data analysis phase.\n\nThis is a non-interventional study. Patient evaluation and treatment are conducted in strict accordance with approved standards of medical care for the respective conditions. No experimental or unregistered (not approved for use in the Russian Federation) medical or diagnostic procedures will be performed during this study.",[527],"Hospital Acquired Pneumonia",[529,530,531],"Hospital acquired pneumonia","Risk factors","Composite Cardiovascular and Pulmonary outcomes","2026-08-06",{"date":423,"type":30},{"date":535,"type":30},"2026-07-29",{"date":537,"type":21},"2028-09-30",{"name":539,"class":193},"Tomsk National Research Medical Center of the Russian Academy of Sciences",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":224,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":562},"100603880","evaluation-of-1-year-clinical-outcomes-with-early-inclisiran-initiation-in-post-mi-patients-100603880","NCT07142265","Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients","STREAMLINE","Inclusion Criteria:\n\n* Adult patients of both genders\n* Myocardial Infarction diagnosis\n* Dyslipidemia diagnosis\n* The first injection of inclisiran no later than 14 ± 5 days after the STEMI\u002Fnon-STEMI\n* LDL-C \\> 5 mmol\u002FL (statin-naive patients) or LDL-C \\> 2.5 mmol\u002FL (on the basis of statin MTD) at the time of hospitalization or no target LDL-C level (\\> 1.4 mmol\u002FL or no LDL-C level decrease by 50% on statin MTD + ezetimibe)\n* Signed Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Severe oncological and somatic diseases with system and organ failure\\*\n* Competing diseases that caused emergency hospitalization (pulmonary thromboembolism, aortic dissection)\n* History of therapy with PCSK9 inhibitors\n* Active inflammatory liver disease or the levels of AST, ALT \\> 3 times, or total bilirubin \\> 2 times higher than the upper limit of norm\n* Any other MACE in the anamnesis",{"count":548,"type":21},300,"Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI\u002Fnon-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.",[551],"Myocardial Infarction",[553,554,555],"Myocardial infarction","NIS","inclisiran",{"date":446,"type":30},{"date":558,"type":30},"2025-09-30",{"date":560,"type":21},"2027-09-30",{"name":240,"class":37},18,{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":584},"100587628","non-interventional-study-to-assess-the-effectiveness-and-safety-of-ribociclib-in-the-adjuvant-therapy-of-hormone-receptor-positive-hr-her2-negative-stage-ii-and-iii-breast-cancer-in-real-clinical-practice-in-russia-100587628","NCT06930859","Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia","ELEGANCE","Inclusion Criteria:\n\nPatients from the prospective cohort of the study must meet all of the following criteria:\n\n1. Signed and dated Informed Consent Form (ICF) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±GnRH agonists).\n2. Age ≥18 years at the time of signing the ICF.\n3. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.\n4. The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib.\n5. ECOG performance status 0-1\n\nPatients from the retrospective cohort of the study must meet all of the following criteria:\n\n1. Age ≥18 years at the initiation of hormone therapy.\n2. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.\n3. Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020.\n4. Presence of the necessary information in the source documentation.\n\nExclusion Criteria:\n\nPatients enrolled in the study in prospective cohort should not meet any of the following criteria.\n\n1. History of therapy with abemaciclib or palbociclib\n2. Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form\n3. Active therapy for other malignant neoplasms\n4. Participation in interventional clinical studies at the time of signing the Informed Consent Form\n\nPatients enrolled in the study in retrospective cohort should not meet any of the following criteria.\n\n1. Neoadjuvant or adjuvant therapy with CDK4\u002F6 inhibitors\n2. A history of another concomitant malignant neoplasm requiring active therapy\n3. Participation in interventional clinical studies at the time of treatment for breast cancer\n4. Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.","99 Years",{"count":572,"type":21},2766,"This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.",[575],"Breast Cancer",[577],"Breast cancer",{"date":446,"type":30},{"date":580,"type":30},"2025-12-03",{"date":582,"type":21},"2032-12-31",{"name":240,"class":37},42,{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":593,"targetDuration":595,"studyType":22,"phases":4,"briefSummary":596,"conditions":597,"keywords":600,"overallStatus":609,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100650873","non-interventional-study-of-ferretab-comp-ferrous-fumarate--folic-acid-prolonged-release-capsules-effects-in-adult-patients-with-iron-deficiency-anemia-and-cardiovascular-disease-100650873","NCT07753031","Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease","A Multicenter, Non-Interventional, Prospective Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Diseases in Real-World Clinical Practice","PROMETHEUS","Inclusion Criteria:\n\n* Male or female patients aged 18 years or older.\n* Diagnosis of mild to moderate iron deficiency anemia (IDA), defined as hemoglobin 70-129 g\u002FL in men or 70-119 g\u002FL in women and ferritin \\\u003C30 ng\u002FmL, with laboratory results obtained within 14 days before Visit 0.\n* Presence of at least 1 chronic CVD, defined as coronary artery disease or congestive heart failure with preserved ejection fraction (left ventricular ejection fraction ≥50%; NYHA Functional Class I-II).\n* Ability to understand the study requirements and provide written informed consent to participate in the study, including consent for the use and transfer of health information relevant to the study.\n* The physician has decided to prescribe Ferretab® comp. as IDA treatment of IDA at a dose of 2 capsules per day.\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Hypersensitivity to any component of Ferretab® comp.\n* Any contraindication to the use of Ferretab® comp. as specified in the Summary of Product Characteristics.\n* Use of any other iron-containing medicinal products within 3 months prior to study enrollment (including oral iron preparations, intravenous iron formulations, or mineral\u002Fsupplement products containing a therapeutic dose of iron).\n* Severe anemia (hemoglobin concentration \\\u003C70 g\u002FL).\n* Confirmed or suspected diagnosis of anemia of chronic disease.\n* Pregnancy or breastfeeding.\n* Surgery planned to be performed during the study period.\n* CVD or any other chronic disease in the stage of decompensation.\n* Congestive heart failure with reduced ejection fraction (NYHA Functional Class III-IV (see Appendix 2) and\u002For ejection fraction \\\u003C50%).\n* Severe chronic kidney disease (Stage IV-V chronic kidney disease, or patients receiving hemodialysis or peritoneal dialysis).\n* Severe chronic liver disease (Child-Pugh Class B or C liver cirrhosis, active hepatitis, or ALT\u002FAST \\>3 × the upper limit of normal).\n* Active malignancy (patients receiving chemotherapy, radiotherapy, or immunotherapy).\n* Anemias unrelated to iron deficiency, as well as other chronic hematologic disorders (thalassemia, aplastic anemia, myelodysplastic syndrome, and autoimmune hemolytic anemia).\n* Evidence of anemia of inflamation.\n* Gastrointestinal malabsorption disorders (active celiac disease, small bowel resection, short bowel syndrome, or severe flare of Crohn's disease or ulcerative colitis).\n* Recent bleeding, including gastrointestinal bleeding within 3 months before the study entry, surgery associated with blood loss within 8 weeks before the study entry, hemorrhagic stroke within 3 months before the study entry.\n* Blood transfusion within 3 months before the study entry.\n* Severe psychiatric disorders that impair the patient's ability to comply with the Protocol requirements and\u002For to provide valid informed consent.\n* Planned use, at the time of the study entry, of any medication or procedure listed as prohibited therapy.",{"count":594,"type":21},389,"12 Weeks","The goal of this observational study is to learn how well Ferretab® comp. works and how safe it is for adults with iron deficiency anemia and cardiovascular disease who are receiving treatment as part of their usual medical care. The main questions it aims to answer are:\n\n* Does treatment with Ferretab® comp. improve anemia?\n* Does treatment with Ferretab® comp. improve heart-related symptoms, exercise tolerance, and overall well-being?\n* What side effects do participants have while taking Ferretab® comp.?\n\nThis is a non-interventional study. Participants will receive Ferretab® comp. because their doctor has already decided to prescribe it as part of routine medical care. Ferretab® comp. is an oral medicine that contains iron (as iron fumarate) and folic acid. The study will not change their treatment.\n\nParticipants will:\n\n* Take Ferretab® comp. for 12 weeks as prescribed by their doctor.\n* Attend study visits at the start of treatment, after about 4 weeks, and after about 12 weeks.\n* Have routine blood tests and health assessments during the study.\n* Report any side effects and record information in a patient diary.\n* Answer questions about their symptoms, exercise tolerance, and how easy the treatment is to use.",[598,254,599],"Iron Deficiency Anemia","Heart Failure With Preserved Ejection Fraction (HFPEF)",[601,602,603,604,605,606,607,608],"Ferretab® comp.","Ferrous fumarate","Folic acid","Iron replacement therapy","Oral iron therapy","Exercise tolerance","Sideropenic syndrome","Safety of iron therapy","NOT_YET_RECRUITING","2026-08-04",{"date":467,"type":30},{"date":613,"type":21},"2026-09",{"date":615,"type":21},"2027-05",{"name":617,"class":193},"Alcea",5,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":626,"maxAge":4,"enrollmentInfo":627,"targetDuration":628,"studyType":22,"phases":4,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":639},"100261711","vercise-dbs-dystonia-prospective-study-100261711","NCT02686125","Vercise™ DBS Dystonia Prospective Study","Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia","Inclusion Criteria (IC):\n\n* IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia.\n* IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent.\n\nExclusion Criteria (EC):\n\n* EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.","7 Years",{"count":548,"type":21},"3 Years","To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.",[631],"Dystonia",{"date":532,"type":30},{"date":634,"type":30},"2016-03-07",{"date":636,"type":21},"2030-12",{"name":638,"class":37},"Boston Scientific Corporation",36,""]