[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Saudi Arabia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":716},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,253,0,25,[9,47,86,113,139,187,224,253,293,331,352,372,393,416,435,457,478,499,521,545,567,589,618,646,687],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387",false,"NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","ALL","1 Month",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[25],"Perimembranous Ventricular Septal Defect",[27,28,29,30,31,32,33,34],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects","RECRUITING","2026-08-24",{"date":38,"type":39},"2026-08-25","ACTUAL",{"date":41,"type":39},"2025-01-01",{"date":43,"type":21},"2027-06-30",{"name":45,"class":46},"Fondation Hôpital Saint-Joseph","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100622538","the-effect-of-vibration-devices-on-pain-and-discomfort-during-local-anesthesia-administration-in-children-100622538","NCT07384923","The Effect of Vibration Devices on Pain and Discomfort During Local Anesthesia Administration in Children","The Effect of Vibration Devices on Pain and Discomfort During Local Anesthesia Administration in Children: A Randmized Clinical Trial.","Inclusion Criteria:\n\n1. Healthy children\n2. Non-anxious\n3. cooperative\n4. Aged six to 12\n5. No previous dental history or experience.\n\n5- Who required non-urgent dental treatment involving at least one pair of contralateral maxillary molars needing buccal infiltration anesthesia\n\nExclusion Criteria:\n\n1. Children requiring urgent dental treatment\n2. Those with active infections at the injection site\n3. Non-Arabic speakers\n4. Children with high anxiety scores in the ACDAS\n5. Those who were uncooperative during the screening appointment",true,"6 Years","12 Years",{"count":58,"type":21},20,"INTERVENTIONAL",[61],"NA","This split-mouth randomized clinical trial will be conducted at the Department of Pediatric Dentistry, King Abdulaziz University Dental Hospital (KAAUDH). The inclusion criteria will include healthy, non-anxious, cooperative children aged six to 12 who require non-urgent dental treatment involving at least one pair of contralateral maxillary molars needing buccal infiltration anesthesia with no previous dental history or experience.\n\nThe children will be screened for eligibility, and a single trained dental intern will approach the parents or guardians of eligible children. Those who agree to be screened for participation in the study will be asked to sign an Arabic consent form. Before the scheduled screening appointment, children's anxiety levels will be assessed using a high score on the Abeer Children Dental Anxiety Scale (ACDAS) in the waiting area.\n\nDuring the appointment, a single trained dental intern will perform the dental examination and prophylaxis, while two trained and calibrated dental interns will assess children's behavior using the Frankl Behavior Rating Scale.\n\nChildren found to be non-anxious based on their ACDAS score and cooperative or definitely cooperative based on the Frankl Behavior Rating Scale will be considered eligible for the study. Two treatment appointments will be scheduled for them, and consent and assent forms for participation in the study will be obtained.\n\nComputer randomization will be performed to determine the treatment sequence (DentalVibe intraoral vibration device followed by Buzzy Bee® extraoral vibration device, or vice versa) and the site (right or left). Randomization will be performed before the first scheduled treatment appointment.\n\nThe subjects will be seated in the dental chair for five minutes to acclimate to the environment. To measure the physiological changes of the participating subjects, a pulse oximeter device (OxyWatch, ChoiceMMed, Hamburg, Germany) will be applied, and a trained dental intern will record the baseline heart rate (HR). During the treatment, HR will also be recorded.\n\nThe tip of the DentalVibe intraoral vibration device will be gently placed on the mucobuccal fold above the tooth to be anesthetized. In contrast, the Buzzy Bee® extraoral vibration device will be positioned externally above the buccal infiltration site.\n\nDuring maxillary buccal infiltration, all subjects will be videotaped using a high-resolution camera, focusing on the face and body. Later, two trained and calibrated evaluators will independently assess the child's behavior during the procedure using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Immediately after administering anesthesia, the subjects will be positioned upright, and the same trained dental intern will introduce the face version of the Visual Analogue Scale (VAS).\n\nFinally, after completing both procedures, the subjects will be asked about their future preference for the vibration device. Due to the study's design, both the investigator administering the maxillary buccal infiltration and the subjects will not be aware of which group they belong to.",[64,65,66,67,68,69,70],"Children's Anxiety Levels","Children's Behavior","Physiological Changes (Heart Rate)","Obejective Pain and Discomfort","Subjective Pain and Discomfort","Subjects' and Parents' Satisfaction","Subjects' and Parents' Future Preference",[72,73,74,75],"Pain and discomfort","future preferece","satisfaction","Vibration Device","NOT_YET_RECRUITING","2026-08-23",{"date":38,"type":39},{"date":80,"type":21},"2026-09-01",{"date":82,"type":21},"2026-12-30",{"name":84,"class":46},"King Abdulaziz University",1,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":59,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100457328","phase-3-thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma-100457328","NCT05235165","Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","Inclusion Criteria:\n\n* Patients must be \\\u003C 50 years at the time of enrollment.\n* Patients must have =\\\u003C 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \\>= 3 mm and all of which must be =\\\u003C 3 cm size.\n\n  * Note: Patient must have eligibility confirmed by rapid central imaging review.\n* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.\n* Patients must have a histological diagnosis of osteosarcoma.\n* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.\n* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.\n* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n\nExclusion Criteria:\n\n* Patients with unresectable primary tumor.\n* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as \"central\" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).\n* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.\n* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.\n* Patients with evidence of extrapulmonary metastatic disease.\n* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.","50 Years",{"count":95,"type":21},62,[97],"PHASE3","This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.",[100,101,102],"Metastatic Malignant Neoplasm in the Lung","Metastatic Osteosarcoma","Osteosarcoma","2026-08-21",{"date":38,"type":39},{"date":106,"type":39},"2022-04-01",{"date":108,"type":21},"2031-03-31",{"name":110,"class":111},"Children's Oncology Group","NETWORK",233,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":59,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100387252","phase-2-a-study-of-combination-chemotherapy-for-patients-with-newly-diagnosed-dawt-and-relapsed-fhwt-100387252","NCT04322318","A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT","Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)","Inclusion Criteria:\n\n* Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.\n* Patients must be =\\\u003C 30 years old at study enrollment\n* Patients with the following diagnoses are eligible for this study:\n\n  * Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review\n  * Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:\n\n    * Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine\n    * High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan\n    * Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations\n* Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required\n\n  * Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy\n* Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery\u002Fbiopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy\n* Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have a life expectancy of \\>= 8 weeks\n* Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:\n\n  * Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy\n  * Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the initial stratum assignment on APEC14B1-REN\n  * Treatment consisting of vincristine\u002Fdoxorubicin\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing as described\n  * Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible\n* Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study\n  * Radiation therapy (RT): \\>= 2 weeks (wks) must have elapsed for local palliative RT (small port); \\>= 6 months must have elapsed if prior craniospinal RT or if \\>= 50% radiation of pelvis; \\>= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria\n* Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (performed within 7 days prior to enrollment)\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (performed within 7 days prior to enrollment)\n* Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (performed within 7 days prior to enrollment)\n* Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE\u002FCyclo\u002FTopo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:\n\n  * Creatinine clearance or radioisotope GFR \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (performed within 7 days prior to enrollment)\n* Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR \\>= 60 mL\u002Fmin\u002F1.73 m\\^2), or an adequate serum creatinine as per the following table:\n\n  * Age: Maximum Serum Creatinine (mg\u002FdL)\n  * 1 month to \\\u003C 6 months: 0.4 (male and female)\n  * 6 months to \\\u003C 1 year: 0.5 (male and female)\n  * 1 to \\\u003C 2 years: 0.6 (male and female)\n  * 2 to \\\u003C 6 years: 0.8 (male and female)\n  * 6 to \\\u003C 10 years: 1 (male and female)\n  * 10 to \\\u003C 13 years: 1.2 (male and female)\n  * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n  * \\>= 16 years: 1.7 (male), 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age or direct bilirubin =\\\u003C ULN for patients whose total bilirubin \\> 1.5 x ULN (performed within 7 days prior to enrollment)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\\u003C 2.5 x upper limit of normal (ULN) for age or =\\\u003C 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)\n\nExclusion Criteria:\n\n* Patients with a history of bilateral Wilms tumor (synchronous or metachronous)\n* Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0)\n* Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy\n* For patients with high-risk or very high-risk relapsed FHWT:\n\n  * Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate \\\u003C 16 mmol\u002FL and serum phosphate =\\\u003C 2 mg\u002FdL (or \\\u003C 0.8 mmol\u002FL) without supplementation\n* For stages 2-4 DAWT and standard-risk relapsed FHWT patients:\n\n  * Chronic inflammatory bowel disease and\u002For bowel obstruction\n  * Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","30 Years",{"count":122,"type":21},256,[124],"PHASE2","This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE\u002FCyclo\u002FTopo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and\u002For bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE\u002FCyclo\u002FTopo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).",[127,128,129,130,131],"Anaplastic Kidney Wilms Tumor","Recurrent Kidney Wilms Tumor","Stage II Kidney Wilms Tumor","Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor",{"date":38,"type":39},{"date":134,"type":39},"2020-10-19",{"date":136,"type":21},"2027-07-01",{"name":110,"class":111},205,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":59,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":185,"locationsCount":186},"100290931","phase-3-active-surveillance-bleomycin-etoposide-carboplatin-or-cisplatin-in-treating-pediatric-and-adult-patients-with-germ-cell-tumors-100290931","NCT03067181","Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors","A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors","Inclusion Criteria:\n\n* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \\[all sites\\])\n* Standard risk 1: Patients must be \\\u003C 11 years of age at enrollment\n* Standard risk 2: Patients must be \\>= 11 and \\\u003C 25 years of age at enrollment\n* Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).\n\n  * Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:\n\n    * Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \\> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided\n    * Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \\[AFP- ≥ 500 ng\u002FmL or HCG ≥ 500 IU\u002FL) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently\n* Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \\[\\\u003C 3 mm\\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\\\u003C 1,000 ng\u002FmL, beta-HCG institutional normal; all ages\n* Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages\n* Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature\u002Fmature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages\n* Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \\[IGCCC\\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\\u003C 11\n* Standard risk 2 (SR2)\n\n  * Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\>= 11 and \\\u003C 25\n  * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \\\u003C 1,000 ng\u002FmL, beta-HCG \\\u003C 5,000 IU\u002FmL and lactate dehydrogenase (LDH) \\\u003C 3.0 x normal; age (years) \\>= 11 and \\\u003C 25\n* Notes:\n\n  * IGCCC criteria only apply to SR2 patients with a testicular primary tumor\n  * Use post-op tumor marker levels to determine IGCCC risk group\n  * Pure seminoma patients are not eligible for the standard risk arms of the study\n  * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a \"microscopic component\" of yolk sac tumor\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)\n* Adequate renal function defined as:\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to enrollment) OR\n* A serum creatinine based on age\u002Fsex as follows (within 7 days prior to enrollment): (mg\u002FdL)\n\n  * 1 month to \\\u003C 6 months male: 0.4 female: 0.4\n  * 6 months to \\\u003C 1 year male: 0.5 female: 0.5\n  * 1 to \\\u003C 2 years male: 0.6 female: 0.6\n  * 2 to \\\u003C 6 years male: 0.8 female: 0.8\n  * 6 to \\\u003C 10 years male: 1 female: 1\n  * 10 to \\\u003C 13 years male: 1.2 female: 1.2\n  * 13 to \\\u003C 16 years: male: 1.5 female: 1.4\n  * \\>= 16 years male: 1.7 female: 1.4\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (within 7 days prior to enrollment) AND\n* Platelet count \\>= 75,000\u002Fmm\\^3 (within 7 days prior to enrollment)\n* Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment\n* Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \\[PROs\\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate\n* \\>= 11 and \\\u003C 25 years old at enrollment\n* Able to fluently speak and read English\n* Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor\n* Followed for cancer or survivorship care at one of the following institutions:\n\n  * Baylor College of Medicine\u002FDan L Duncan Comprehensive Cancer Center\n  * Dana Farber\u002FHarvard Cancer Center\n  * Hospital for Sick Children\n  * Children's Hospital of Eastern Ontario\n  * Oregon Health and Science University\n  * Seattle Children's Hospital\n  * Yale University\n\nExclusion Criteria:\n\n* Patients with any diagnoses not listed including:\n\n  * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)\n  * Pure ovarian or extragonadal dysgerminoma\u002Fseminoma\n  * Pure mature teratoma\n  * Pure immature teratoma with alpha-fetoprotein (AFP) \\>= 1000 ng\u002FmL\n  * \"Poor risk\" GCT (age \\>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or\n  * Primary central nervous system (CNS) germ cell tumor\n  * Germ cell tumor with somatic malignant transformation\n  * Spermatocytic seminoma\n* Patients must have had no prior systemic therapy for the current cancer diagnosis\n* Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \\[stage IV disease\\] would be considered poor risk and therefore not eligible for this trial)\n* Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])",{"count":147,"type":21},1780,[97],"This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.",[151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180],"Childhood Extracranial Germ Cell Tumor","Extragonadal Embryonal Carcinoma","Germ Cell Tumor","Malignant Germ Cell Tumor","Malignant Ovarian Teratoma","Stage I Ovarian Choriocarcinoma","Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage I Testicular Choriocarcinoma AJCC v6 and v7","Stage I Testicular Embryonal Carcinoma AJCC v6 and v7","Stage I Testicular Seminoma AJCC v6 and v7","Stage I Testicular Yolk Sac Tumor AJCC v6 and v7","Stage II Ovarian Choriocarcinoma","Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage II Testicular Choriocarcinoma AJCC v6 and v7","Stage II Testicular Embryonal Carcinoma AJCC v6 and v7","Stage II Testicular Yolk Sac Tumor AJCC v6 and v7","Stage III Ovarian Choriocarcinoma","Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage III Testicular Choriocarcinoma AJCC v6 and v7","Stage III Testicular Embryonal Carcinoma AJCC v6 and v7","Stage III Testicular Yolk Sac Tumor AJCC v6 and v7","Stage IV Ovarian Choriocarcinoma","Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7","Testicular Mixed Choriocarcinoma and Embryonal Carcinoma","Testicular Mixed Choriocarcinoma and Teratoma","Testicular Mixed Choriocarcinoma and Yolk Sac Tumor",{"date":38,"type":39},{"date":183,"type":39},"2017-05-25",{"date":43,"type":21},{"name":110,"class":111},629,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100239986","project-every-child-for-younger-patients-with-cancer-100239986","NCT02402244","Project: Every Child for Younger Patients With Cancer","The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study","Inclusion Criteria:\n\n* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem\n* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority\n* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:\n\n  * All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one \"1\" (borderline), two \"2\" (carcinoma in situ) or three \"3\" (malignant)\n  * All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant\n  * All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant\n  * The following other benign\u002Fborderline conditions:\n\n    * Mesoblastic nephroma\n    * Teratomas (mature and immature types)\n    * Myeloproliferative diseases including transient myeloproliferative disease\n    * Langerhans cell histiocytosis\n    * Lymphoproliferative diseases\n    * Desmoid tumors\n    * Gonadal stromal cell tumors\n    * Neuroendocrine tumors including pheochromocytoma\n    * Melanocytic tumors, except clearly benign nevi\n    * Ganglioneuromas\n* Subjects must be =\\\u003C 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \\[NCTN\\]) therapeutic study, for which there is a higher upper age limit\n* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission\n\n  * If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1","25 Years",{"count":196,"type":21},75000,"This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.",[199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216],"Adrenal Gland Pheochromocytoma","Carcinoma In Situ","Central Nervous System Neoplasm","Childhood Immature Teratoma","Childhood Kidney Neoplasm","Childhood Langerhans Cell Histiocytosis","Childhood Mature Teratoma","Congenital Mesoblastic Nephroma","Desmoid Fibromatosis","Ganglioneuroma","Lymphoproliferative Disorder","Malignant Neoplasm","Malignant Solid Neoplasm","Melanocytic Neoplasm","Myeloproliferative Neoplasm","Neoplasm of Uncertain Malignant Potential","Neuroendocrine Neoplasm","Stromal Neoplasm",{"date":38,"type":39},{"date":219,"type":39},"2015-11-03",{"date":221,"type":21},"2030-12-31",{"name":110,"class":111},279,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":59,"phases":235,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":252},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n    1. Basal or squamous cell carcinoma of the skin;\n    2. Carcinoma in situ of the cervix;\n    3. Carcinoma in situ of the breast; and\u002For\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.","18 Years",{"count":234,"type":21},324,[97],"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[238,239],"Myelofibrosis","Anemia",[241,242],"TAK-226","Drug therapy","2026-08-20",{"date":36,"type":39},{"date":246,"type":21},"2026-09-02",{"date":248,"type":21},"2034-03-30",{"name":250,"class":251},"Takeda","INDUSTRY",195,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":59,"phases":264,"briefSummary":265,"conditions":266,"keywords":283,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100637347","phase-3-a-study-of-orforglipron-ly3502970-in-participants-with-type-2-diabetes-who-observe-ramadan-fasting-100637347","NCT07613307","A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting","A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)","ACHIEVE-RAM","Inclusion Criteria:\n\n* Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.\n* Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol\u002Fmol)) to less than 9.5% (91 mmol\u002Fmol) at screening.\n* Intend to be compliant with the fast during the Ramadan period.\n* Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.\n* Have body mass index (BMI) of 25 kilograms per meter square (kg\u002Fm2) or higher at screening.\n\nExclusion Criteria:\n\n* Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes\n* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* Have a history of chronic or acute pancreatitis any time prior to screening\n* Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.\n* Have a history of cholecystectomy (surgically removed gallbladder)\n* Have New York Heart Association Functional Classification IV congestive heart-failure.","65 Years",{"count":263,"type":21},130,[97],"The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.",[267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282],"Diabetes Mellitus, Type 2","Diabetes Melletus","Glucose Metabolism Disorders","Metabolic Disorders","Nutritional and Metabolic Diseases","Endocrine System Diseases","Feeding Behavior","Behavior","Fasting","Glucagon-Like Peptide-1 Receptor","Glucagon-Like Peptide Receptors","Receptors, G-Protein-Coupled","Receptors, Cell Surface","Membrane Proteins","Proteins","Receptors, Peptide",[284,275],"Ramadan",{"date":103,"type":39},{"date":287,"type":39},"2026-07-15",{"date":289,"type":21},"2027-05",{"name":291,"class":251},"Eli Lilly and Company",40,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":301,"targetDuration":303,"studyType":22,"phases":4,"briefSummary":304,"conditions":305,"keywords":310,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100609370","inrad-observational-study-100609370","NCT07213700","InRAD Observational Study","The International Registry for Alzheimer's Disease and Other Dementias (InRAD): An International Registry Observational Study Dedicated to Evaluating Outcomes Data in Alzheimer's Disease","InRAD","Inclusion Criteria:\n\n* Be undergoing diagnostic work-up for Alzheimer's disease (AD), OR\n* Have a confirmed diagnosis of AD (whether currently treated with an AD-specific treatment, or untreated),\n* Be attending an InRAD Center,\n* Have provided informed consent for long-term follow-up\n\nExclusion Criteria:\n\n-Any patient or legal representative who is unable or unwilling to provide a signed informed consent form",{"count":302,"type":21},50000,"10 Years","The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers.\n\nThe InRAD Registry Observational Study has several aims:\n\n* To collect medical information for many years from a large group of people with Alzheimer's disease. This will be used for research, which will support improved understanding about the disease.\n* To enable researchers to look at the effectiveness, usefulness and safety of treatments for Alzheimer's disease.\n* To enable researchers to answer similar research questions and compare results in many different areas of the world.\n\nPeople with Alzheimer's disease who meet the eligibility criteria and agree to participate in the Study will be asked to visit their doctor (e.g. psychiatrist, geriatrician, or neurologist) at least once a year, or as frequently as is needed for their care. During or after their appointments they may be offered assessments, tests, medications, and treatments as determined by their doctor and their team. This is an observational data collection.",[306,307,308,309],"Alzheimer's Disease(AD)","Mild Cognitive Impairment (MCI)","Subjective Cognitive Decline (SCD)","Non-Alzheimer Degenerative Dementia",[311,312,313,314,315,316,317,318,319,320,321,322],"Alzheimer's disease (AD)","Dementia","Observational study","Real-world data (RWD)","International registry","Cognitive decline","Lecanemab","InRAD Registry","InRAD Foundation","Cognitive screening (MoCA, MMSE)","AD-specific therapies","Clinical staging",{"date":103,"type":39},{"date":325,"type":39},"2026-03-30",{"date":327,"type":21},"2036-01",{"name":329,"class":46},"Stichting International Registry for Alzheimer's Disease and other Dementias Foundation",12,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":59,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100587975","phase-3-a-study-to-test-whether-vicadrostat-bi-690517-in-combination-with-empagliflozin-helps-people-with-heart-failure-and-a-weak-pumping-function-of-the-left-side-of-the-heart-100587975","NCT06935370","A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) \u003C 40%","Inclusion criteria:\n\n1. At least 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 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per 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 and instructions on the duration of their use is provided in the protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\\u003C 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local\u002Finternational guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.\n2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.\n3. Receiving the following treatments:\n\n   * A direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)\n5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.",{"count":339,"type":21},4200,[97],"This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat\u002Fempagliflozin tablets, and the other group takes placebo\u002Fempagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[343],"Heart Failure",{"date":103,"type":39},{"date":346,"type":39},"2025-05-20",{"date":348,"type":21},"2029-02-22",{"name":350,"class":251},"Boehringer Ingelheim",589,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":59,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":371},"100564690","liverage---cirrhosis-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-cirrhosis-100564690","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",{"count":360,"type":21},1590,[97],"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.",[364],"Metabolic Dysfunction Associated Steatohepatitis",{"date":103,"type":39},{"date":367,"type":39},"2024-11-12",{"date":369,"type":21},"2029-06-05",{"name":350,"class":251},445,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":59,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},"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":380,"type":21},1800,[97],"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.",[384,385],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":103,"type":39},{"date":388,"type":39},"2024-10-14",{"date":390,"type":21},"2031-12-27",{"name":350,"class":251},528,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":400,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":59,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100549191","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100549191","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).","16 Years","80 Years",{"count":403,"type":21},1200,[97],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[407],"Crohn's Disease",{"date":103,"type":39},{"date":410,"type":39},"2024-06-05",{"date":412,"type":21},"2029-11-12",{"name":414,"class":251},"Merck Sharp & Dohme LLC",499,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":59,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100548691","phase-3-a-study-to-test-whether-vicadrostat-in-combination-with-empagliflozin-helps-people-with-heart-failure-100548691","NCT06424288","A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure","EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%","Inclusion criteria:\n\n1. At least 18 years old and at least of 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. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on 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 and instructions on the duration of their use is provided in the participant information\n4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2\n5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2\n6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:\n\n   1. in participants with body mass index (BMI) \\\u003C27 kg\u002Fm²: ≥300 pg\u002FmL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   2. in participants with BMI ≥27 kg\u002Fm² to \\\u003C35 kg\u002Fm²: ≥220 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   3. in participants with BMI ≥35 kg\u002Fm²: ≥125 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n7. At least one of the following:\n\n   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1\n   * Documented hospitalisation for HF within 6 months prior to Visit 1\n   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1\n\n     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg\u002FmL\n     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg\u002FmL\n   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg\u002Fg, analysed at the central laboratory at Visit 1\n8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local\u002Finternational guidelines and judgment of the investigator Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study\n2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator\n3. Receiving the following treatments:\n\n   * a direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery\u002FCABG)\n5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2\n9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.",{"count":424,"type":21},6000,[97],"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.\n\nParticipants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:\n\n* Vicadrostat\u002Fempagliflozin group: participants take vicadrostat\u002Fempagliflozin as tablets once a day.\n* Placebo\u002Fempagliflozin group: participants take placebo\u002Fempagliflozin as tablets once a day.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.\n\nThe study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.",[343],{"date":103,"type":39},{"date":430,"type":39},"2024-06-17",{"date":432,"type":21},"2028-05-22",{"name":350,"class":251},652,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":442,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":59,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},"100494123","efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100494123","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":445,"type":21},342,[124,97],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[343,449],"Left Ventricular Systolic Dysfunction",{"date":103,"type":39},{"date":452,"type":39},"2023-05-31",{"date":454,"type":21},"2032-04-15",{"name":414,"class":251},108,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":59,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":477},"100609861","phase-3-a-study-to-find-out-if-bi-764198-helps-adults-and-adolescents-with-a-kidney-condition-called-focal-segmental-glomerulosclerosis-fsgs-100609861","NCT07220083","A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)","A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants","Inclusion criteria:\n\n1. Male or female participants ≥12 years old on the day of signing informed consent\u002Fassent (Visit 1)\n2. Weight of ≥40 kg at the screening visit (Visit 1)\n3. Body mass index (BMI) of ≤40 kg\u002Fm² at the screening visit (Visit 1)\n4. Participants with a diagnosis prior to the screening visit (Visit 1) of either:\n\n   * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR\n   * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)\n5. Urine protein-creatinine ratio (UPCR) ≥1500 mg\u002Fg based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)\n6. Estimated glomerular filtration rate (eGFR)\n\n   * For adult participants (≥18 years): ≥25 mL\u002Fmin\u002F1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)\n   * For adolescent participants (12 to \\\u003C18 years): ≥25 mL\u002Fmin\u002F1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)\n2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)\n3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)\n4. A history of organ transplantation or planned organ transplantation during the course of the trial\n5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.",{"count":465,"type":21},286,[97],"PODOMOUNT-pFSGS\n\nThis study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS.\n\nParticipants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine.\n\nParticipants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS.\n\nParticipants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[469],"Focal Segmental Glomerulosclerosis","2026-08-19",{"date":243,"type":39},{"date":473,"type":39},"2026-02-16",{"date":475,"type":21},"2029-01-24",{"name":350,"class":251},306,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":59,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100597898","phase-3-easi-protkt---a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease-100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":486,"type":21},11800,[97],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[267,490,491],"Hypertension","Cardiovascular Diseases",{"date":243,"type":39},{"date":494,"type":39},"2025-07-22",{"date":496,"type":21},"2029-12-21",{"name":350,"class":251},1147,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":59,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.",{"count":508,"type":21},1700,[97],"This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[512,513],"Idiopathic Pulmonary Fibrosis","Progressive Pulmonary Fibrosis",{"date":243,"type":39},{"date":516,"type":39},"2024-05-06",{"date":518,"type":21},"2027-05-05",{"name":350,"class":251},373,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":528,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":59,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":85},"100652632","effect-of-high-intensity-interval-training-versus-home-based-rehabilitation-program-on-patients-underwent-coronary-artery-bypass-graft-surgery-100652632","NCT07775742","Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program On Patients Underwent Coronary Artery Bypass Graft Surgery","Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program on Peak Metabolic Equivalents On Patients Underwent Coronary Artery Bypass Graft Surgery","Inclusion Criteria:\n\n1. Participants will be eligible if they are clinically stable as defined by the American College of Cardiology\u002FAmerican Heart Association.\n2. Only Participants will be stratified as low to moderate risk as identified by the American College of Sport Medicine\u002F\n3. Mean age ± standard deviation, 55 ± 3 years.\n4. All patients underwent coronary artery bypass graft surgery, rested at home for at least one month, and then returned to the center for a cardiac rehabilitation program\n\nExclusion Criteria:\n\n1. Patients will be excluded from this study if they had an ejection fraction of less than 40% at rest (high risk as defined by American Association of Cardiovascular and Pulmonary Rehabilitation Stratification).\n2. Mental health disorders (such an anxiety or depression).\n3. Any vision or hearing defects or any neurological, respiratory, or musculoskeletal conditions that have an impact on ambulation.\n4. Irreversible heart failure.\n5. Myocardial Infarction (MI) over the past month.\n6. Persistent ventricular arrhythmias or unstable angina.\n7. Any exercise restrictions.","55 Years","58 Years",{"count":531,"type":21},84,[61],"1. To assess the effect of high-intensity interval training on peak metabolic equivalents in patients with coronary heart disease after the coronary artery bypass grafting surgery.\n2. To assess the effect of a home-based cardiac rehabilitation program on peak metabolic equivalents in patients with coronary heart disease after coronary artery bypass grafting surgery.\n3. To compare functional outcomes between the different treatment approaches.",[535,536],"Coronary Artery Disease","Coronary Graft Stenosis","2026-08-18",{"date":243,"type":39},{"date":540,"type":39},"2026-07-01",{"date":542,"type":21},"2027-02-01",{"name":544,"class":46},"Kafrelsheikh University",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":566},"100609545","a-real-world-study-to-evaluate-luspatercept-in-adults-with-transfusion-dependent-beta-thalassemia-in-the-middle-east-100609545","NCT07215975","A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East","REal-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE): A Non-interventional Retrospective and Prospective Observational Study","Inclusion Criteria:\n\n* Male or female participants of any race aged at least 18 years at time of initiation of luspatercept treatment\n* Participants with documented diagnosis of transfusion-dependent β-thalassemia (TDT).\n* Participants who have been initiated on treatment with luspatercept as per the product's Summary of Product Characteristics (SmPC) no longer than 12 months prior to informed consent signature, and for whom therapy is ongoing.\n* Participants for whom the decision to prescribe luspatercept treatment is clearly separated from the physician's decision to include the participant in the current study.\n* Participants who have provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study\n\nExclusion Criteria:\n\n* Participants that meet any of the contraindications to the administration of luspatercept as outlined in the latest version of the locally approved SmPC.\n* Participants who are currently receiving or are planned to receive treatment with any investigational drug\u002Fdevice\u002Fintervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to luspatercept therapy initiation.\n* Participants who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.\n* Participants who have not provided signed informed consent for participating in the study and for collecting and analysing medical data pertinent to the objectives of this study.",{"count":553,"type":21},200,"The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East",[556],"β-thalassemia",[558],"Transfusion-dependent β-thalassemia",{"date":470,"type":39},{"date":561,"type":39},"2026-06-26",{"date":563,"type":21},"2031-04-17",{"name":565,"class":251},"Bristol-Myers Squibb",13,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":54,"sex":17,"minAge":574,"maxAge":232,"enrollmentInfo":575,"targetDuration":4,"studyType":59,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":588},"100595901","early-detection-of-type-1-diabetes-in-first-degree-relatives-of-type-1-diabetes-patients-detect-t1d-gulf-100595901","NCT07038473","Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)","Islet Autoantibody Early Detection in At-risk Children\u002FAdolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries","Inclusion Criteria:\n\n* Children and adolescents, age 1.5 years to 18 years\n* First degree relatives of T1D probands\n* Parent or legal guardian signing an informed consent\n\nExclusion Criteria:\n\n* Already developed clinical overt T1D\n* Known diabetes of any kind (type 1, type 2, Maturity Onset Diabetes of the Young - MODY)\n* Have a previous history of being treated with insulin\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","18 Months",{"count":576,"type":21},3500,[61],"The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).",[580],"Type 1 Diabetes",{"date":470,"type":39},{"date":583,"type":39},"2025-12-17",{"date":585,"type":21},"2026-12-25",{"name":587,"class":251},"Sanofi",7,{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":59,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":617},"100551997","phase-3-phase-3-study-of-t-dxd-and-rilvegostomig-versus-soc-in-advanced-her2-expressing-biliary-tract-cancer-100551997","NCT06467357","Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer","DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer","DESTINY-BTC01","Key Inclusion Criteria:\n\n* Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.\n* Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and\u002For adjuvant setting is permissible provided there is \\> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.\n* Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.\n* Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.\n* Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)\n* WHO\u002FECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n* Adequate organ and bone marrow function within 14 days before randomization.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.\n* Minimum life expectancy of 12 weeks.\n\nKey Exclusion Criteria:\n\n* Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.\n* Histologically confirmed ampullary carcinoma.\n* Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.\n* Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Medical history of myocardial infarction within 6 months before randomization\u002Fenrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\\\u003C 6 months) cardiovascular event including stroke.\n* Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.\n* Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening triplicate 12-lead ECG.\n* History of (non-infectious) ILD\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc).\n* Prior pneumonectomy (complete).\n* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis\u002Fbiliary tract infections\u002Fbiliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.\n* Active primary immunodeficiency, known uncontrolled active HIV infection or HCV.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.\n* Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).\n* Any concurrent anticancer treatment without an adequate washout period prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.\n* History of organ transplants or allogenic stem cell transplant.","99 Years",{"count":599,"type":21},620,[97],"The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.",[603],"Biliary Tract Cancer",[603,605,606,607,608,609],"HER2","HER2 expressing BTC","Trastuzumab deruxtecan","T-DXd","Rilvegostomig",{"date":470,"type":39},{"date":612,"type":39},"2024-08-12",{"date":614,"type":21},"2029-05-16",{"name":616,"class":251},"AstraZeneca",269,{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":628,"conditions":629,"keywords":633,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":645},"100078039","product-performance-report-evaluate-long-term-reliability--performance-of-medtronic-marketed-cardiac-therapy-products-100078039","NCT00271180","Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products","Medtronic CRDM Product Performance Report","PPR","Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.\n\nInclusion Criteria:\n\n• Subject or appropriate legal guardians provide written informed consent and\u002For authorization for access to and use of health information as required by an institution's IRB\u002FMEC\u002FREB\n\nAND one of the following must also apply:\n\n* Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application\n* Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data\n\nExclusion Criteria:\n\n* Subjects who are, or will be inaccessible for follow-up\n* Subjects with exclusion criteria required by local law (EMEA only)\n* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant\n* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded",{"count":627,"type":21},20000,"The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.",[630,631,343,632],"Arrhythmia","Bradycardia","Sinus Tachycardia",[634,635,636,637],"Cardiac Pacing","Implantable Cardioverter Defibrillator","pacemaker","Sinus Bradycardia",{"date":243,"type":39},{"date":640,"type":39},"1983-01",{"date":642,"type":21},"2040-12",{"name":644,"class":251},"Medtronic",333,{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":653,"targetDuration":303,"studyType":22,"phases":4,"briefSummary":655,"conditions":656,"keywords":665,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":686},"100566711","long-term-characterization-of-gore-tag-conformable-thoracic-stent-graft-with-active-control-system-performance-100566711","NCT06658730","Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance","TGR 23-02TA","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) provides written authorization and\u002For consent per institution and geographical requirements.\n2. Patient has been or is intended to be treated with an eligible registry device.\\*\n3. Patient is age ≥ 18 years at time of informed consent signature.\n\n   * The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable.\n\nExclusion Criteria:\n\n1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.\n2. Patient with exclusion criteria required by local law.\n3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and\u002For investigational device study\\* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.\n\n   * The term \"study\" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).",{"count":654,"type":21},1500,"An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w\u002FAC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.",[657,658,659,660,661,662,663,664],"Vascular Disease","Dissection","Dissection Aortic Aneurysm","Dissection of Aorta","Aneurysm Thoracic","Aneurysm Dissecting","Transection Aorta","Intramural Hematoma",[666,667,668,669,670,671,672,673,674,675,651,676,677],"Endovascular","CTAG","Post-market Registry","Observational","Multi-regional","Real world data","Together Registry","Gore Together Registry","Gore Together Aortic Registry","Conformable Thoracic Stent Graft","TGR23-02TA","GORE TAG","2026-08-17",{"date":470,"type":39},{"date":681,"type":39},"2025-06-19",{"date":683,"type":21},"2038-08",{"name":685,"class":251},"W.L.Gore & Associates",37,{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":59,"phases":696,"briefSummary":697,"conditions":698,"keywords":700,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":708,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":715},"100563385","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986393-versus-standard-regimens-in-adult-participants-with-relapsed-or-refractory-and-lenalidomide-exposed-multiple-myeloma-quintessential-2-100563385","NCT06615479","A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)","A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma","Inclusion Criteria\n\n* Participants must have relapsed or refractory multiple myeloma (RRMM).\n* Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.\n* Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.\n* Participants must have measurable disease during screening.\n* Participants must have adequate organ function.\n* Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.\n\nExclusion Criteria\n\n* Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).\n* Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.\n* Participants must not need urgent treatment due to rapidly progressing MM.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":695,"type":21},440,[97],"The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.",[699],"Relapsed or Refractory Multiple Myeloma (RRMM)",[701,702,703,704,705,706,707],"Relapsed or Refractory Multiple Myeloma","Multiple Myeloma","BMS-986393","Chimeric Antigen Receptor T-cell (CAR T-cell)","CAR T-cell Therapy","Arlocabtagene Autoleucel","Arlo-cel",{"date":537,"type":39},{"date":710,"type":39},"2025-03-12",{"date":712,"type":21},"2032-06-22",{"name":714,"class":251},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",141,""]