[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rabin Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":563},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,75,97,127,149,174,198,221,246,265,291,317,339,358,387,407,433,455,480,509,537],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100610323","phase-3-comparison-of-weekly-somatrogon-to-daily-genotropin-in-children-born-small-for-gestational-age-or-with-idiopathic-short-stature-100610323",false,"NCT07226089","Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.","Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth Hormone","MISSION","Inclusion Criteria:\n\n1. Diagnosis of SGA or ISS. SGA, defined as born with a birth weight and\u002For length \\\u003C-2 SDS below the mean for gestational age. ISS, defined as height \\\u003C -2 SDS for age and gender without evidence of GHD\n2. Females aged ≥3 years and \\\u003C9 years. Males aged ≥3 years and \\\u003C11 years\n3. Pre-pubertal- Tanner stage 1 for breasts and testes.\n4. A bone age of not more than chronological age recorded in previous 8 weeks.\n5. Current height \\\u003C -2 SDS for age and gender.\n6. Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening\n7. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. History of cancer, radiation therapy or chemotherapy.\n2. History of GHD.\n3. Children who are small due to malnutrition, defined as a Z score of weight for height and\u002For BMI below -2 for age, according to national standards.\n4. History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis.\n5. Microcephaly (Head Circumference \\\u003C -2 SDS)\n6. Any chronic disease or diagnosis, likely to affect growth, including but not limited to gastrointestinal disorder, celiac disease, untreated thyroid disease, diabetes mellitus and metabolic disorders.\n7. Known or suspected skeletal dysplasias\n8. Known or suspected chromosomal abnormalities\n9. IGF-1 \\>2 SDS\n10. Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol\n11. Prior exposure to growth promoting therapy\n12. Current use of any prohibited concomitant medication(s): Any rhGH or growth-promoting therapy, Any therapy that affects appetite or weight, Psychiatric medications associated with weight changes and\u002For diabetes, excluding medications used to treat ADHD, Any androgen or estrogen therapy including over the counter supplements, Systemic corticosteroids (inhaled or oral) exceeding the doses: Inhaled: \\> 400 μg\u002Fday of inhaled budesonide or equivalent. Oral: \\> 8 mg\u002Fm2\u002Fday of oral hydrocortisone or equivalent.\n13. Previous administration with an investigational drug within 90 days.\n14. Fasting blood glucose \\>126 mg\u002FdL\n15. Renal impairment\n16. Hepatic dysfunction.\n17. Pregnancy\n18. Known hypersensitivity to the components of the study intervention","ALL","3 Years","11 Years",{"count":21,"type":22},254,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is a randomized, open-label, active controlled, parallel group study comparing the efficacy and safety of once weekly Somatrogon to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature either born Small for Gestational Age (SGA) or with Idiopathic Short Stature (ISS). The planned study duration is 12 months with a screening period of up to 30 days. The study will consist of two groups: 140 children with SGA who are naïve to GH treatment will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months. A second group will include 114 children with ISS who are naïve to GH treatment who will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months.",[28,29],"ISS","SGA",[31,32],"Growth hormone","Somatrogon","RECRUITING","2026-04-29",{"date":36,"type":37},"2026-04-30","ACTUAL",{"date":39,"type":37},"2026-02-01",{"date":41,"type":22},"2028-01",{"name":43,"class":44},"Rabin Medical Center","OTHER",32,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100320448","amino-acid-metabolism-in-fed-surgical-critically-ill-patients-100320448","NCT03451968","Amino Acid Metabolism in Fed Surgical Critically Ill Patients","Twenty Four Hours Amino Acid Metabolism in Fed Surgical Critically Ill Patients: a Stable Isotope Tracer Study.","Inclusion Criteria:\n\nStudy population:\n\n* 15 ICU critically ill patient hospitalized due to surgical\u002Ftrauma injury.\n* above 18 years old no upper limit.\n* hospitalized at the ICU more than 7 days\n\nControl group:\n\n* 15 Healthy volunteers, over 18 years old no upper limit.\n* the volunteers won't be dependent or subordinated to the research investigators\n\nExclusion Criteria:\n\n1. patients under 18 years old\n2. patients under TPN treatment prior to their admission to ICU\n3. patients with chronic bowel disease (e.g Crohn's, celiac, short bowel)\n4. any relation (e.g family member or assistant) to the study investigators",true,"18 Years",{"count":56,"type":22},30,[58],"NA","Introduction Sarcopenia is defined as progressive generalized loss of skeletal muscle mass, strength and function. Sarcopenia due to lack of physical activity is a known phenomenon and is usually observed as a normal part of aging or in certain diseases and pathogenic processes. Major associated factors causing development of sarcopenia may be summarized as interactions of environmental and hormonal factors, underlying diseases, activation of inflammatory pathways, mitochondrial dysfunction, reduced satellite cell numbers, and loss of neuromuscular junctions.\n\nIntensive care acquired weakness (ICU-AW) known formerly as critical illness polyneuropathy, is a diagnosis that becomes more common as survival rates from long ICU hospitalization are more prevalent. It is characterized by a primary axonal degeneration, without demyelination, that typically affects motor nerves more than sensory nerves.\n\nICU-AW affects the limbs (particularly the lower extremities) in a symmetric pattern. Weakness is most notable in proximal neuromuscular areas (e.g., the shoulders and hip girdle). In addition, involvement of the respiratory muscles can occur and can impede weaning from mechanical ventilation.\n\nThe pathophysiological mechanisms of ICU-acquired weakness are believed to be multifactorial. Some suspected factors include dysfunctional microcirculation and hyperglycemia. It has been shown that tight glucose control in ICU patients reduces the risk for ICU-AW (although it has been associated with other adverse events). Sodium channels channelopathy is also a researched cause for ICU-AW. Muscle loss in the ICU are usually related to bedridden condition and lack of mobility, increase in ubiquitination and inadequate protein administration associated with large negative nitrogen balance. In addition mechanical ventilation contributes greatly to this problem. This has been particularly relevant in post trauma\u002Fsurgical long stayer patients.\n\nIn the past years great progress was made in the investigation of protein balance, breakdown and synthesis using stable isotope tracers in various medical conditions. In a research performed in PICU (1-5) and ICU (6, 7) regarding the measurement of plasma amino acid during critical illness, stable phenylalanine, tyrosine leucine, arginine and citrulline isotope were used intravenously without any safety issue problem. Another study was performed on adults suffering from COPD with matched healthy adults, using stable isotopes of phenylalanine, tyrosine leucine, isoleucine and valine (8). During the study the isotopes were given parenterally as well as enterally. The study showed significant change in splanchnic extraction of various amino acids and higher turnover of BCAA in COPD patients. Using the theory that supplemental milk can compensate for the elevated turnover of BCAA in COPD patients, using the isotope analysis demonstrated that this theory was proven wrong and the conclusion was that alterations are present in BCAA metabolism despite normal plasma levels in normal weight COPD. Further research is needed to find a way to compensate for it. These studies and other recent studies (9-19) show us the safety regarding the use of stable isotope tracers whether IV or PO, while giving us the opportunity to assess the metabolism of amino acid in all sorts of pathological states.\n\nHypothesis \\& Aim of the study We think that based on current literature, there are important differences between critically ill patients and healthy population in the amino acid profile and distribution in the body as well as synthesis and breakdown.\n\nThe aim of the study is to measure these differences in long ICU stayers (above 7 days) admitted in the ICU after surgical\u002Ftrauma injury, and to try and help aiming future treatment and research in this field.",[61],"Metabolism and Nutrition Disorder",[63,64,65],"amino acid","stable isotope","critical care","2026-04-21",{"date":68,"type":37},"2026-04-22",{"date":70,"type":37},"2018-12-02",{"date":72,"type":22},"2028-01-30",{"name":43,"class":44},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":74},"100580485","transversus-abdominis-plane-block-versus-wound-infiltration-for-pulmonary-function-preservation-following-laparoscopic-living-donor-nephrectomy-100580485","NCT06837909","Transversus Abdominis Plane Block Versus Wound Infiltration for Pulmonary Function Preservation Following Laparoscopic Living Donor Nephrectomy","Transversus Abdominis Plane Block Versus Wound Infiltration for Pulmonary Function Preservation Following Laparoscopic Living Donor Nephrectomy (The TAPWIN Trial): A Double-Blind Randomized Controlled Trial","TAPWIN","Inclusion Criteria:\n\n* Patients who are scheduled to undergo elective LLDN.\n* Age above 18 years.\n* Body Mass Index (BMI) above 20 and below 40 kg m-2.\n* Eligible to sign informed consent.\n\nExclusion Criteria:\n\n* Open or hand-assisted surgery.\n* Known cardiac or pulmonary disease.\n* Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).\n* Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).\n* Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).\n* Preexisting severe pulmonary disease (i.e., an obstructive lung disease with a forced expiratory volume in the first second \\[FEV1\\] below 49%, restrictive lung disease with a forced vital capacity \\[FVC\\] below 49%, pulmonary hypertension).\n\nDiscontinuing criteria:\n\nParticipants will be excluded from the analysis if they:\n\n* Experience intraoperative bleeding requiring transfusion of more than three units of blood products.\n* Experience hemodynamic instability requiring postoperative vasopressor or inotropic support.\n* Require conversion to open surgery.\n* Require mechanical ventilation after being transferred from the OR to the PACU.",{"count":84,"type":22},80,[58],"This study compares two pain control techniques in patients undergoing laparoscopic kidney donation surgery: transversus abdominis plane (TAP) block versus wound infiltration with local anesthetic.\n\nPostoperative pain can impair breathing by causing patients to take shallow breaths to avoid discomfort. This study will evaluate which technique better preserves lung function, specifically peak expiratory flow (PEF), after surgery.\n\nEighty patients will be randomly assigned to receive either a TAP block (injection of local anesthetic into the abdominal wall muscles before surgery) or wound infiltration (injection of local anesthetic at the incision sites at the end of surgery). Both patients and the staff measuring outcomes will be blinded to group assignment.\n\nThe primary outcome is the percentage change in PEF from before surgery to discharge from the recovery room. Secondary outcomes include pain scores, opioid use, breathing complications, and length of hospital stay.",[88],"Postoperative Pain","2026-01-05",{"date":91,"type":37},"2026-01-07",{"date":93,"type":37},"2026-01-01",{"date":95,"type":22},"2027-02-01",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":104,"minAge":54,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":74},"100608952","phase-1-tb-psma-it-radionuclide-before-radical-prostatectomy-in-patients-with-locally-advanced-prostate-cancer---tbeforeprost-trial-100608952","NCT07208240","Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.","Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.","Inclusion Criteria:\n\n* Male aged 18 years and older.\n* Patients with high-risk localized prostate cancer (cT3\u002F4 and\u002For Gleason score ≥ eight and\u002For prostate biopsy or PSA ≥ 20 ng\u002Fdl)\n* High PSMA expression was confirmed according to PROMISE V2 8\n* Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of \\> 10 years.\n\nExclusion Criteria:\n\n* Platelet count lower than 150×103\u002Fµl\n* white blood cell count lower than 4×103\u002Fµl,\n* haemoglobin concentration lower than 12mg\u002Fdl.\n* albumin concentration lower than 3.5 g\u002Fdl.\n* glomerular filtration rate (GFR) lower than 40 mL\u002Fmin.\n* usage of nephrotoxic drugs\n* distant metastatic disease","MALE",{"count":106,"type":22},20,[108,109],"PHASE1","PHASE2","This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.",[112],"High Risk Prostate Cancer",[114,115,116,117,118],"High risk Prostate cancer","Radical Prostatectomy","PSMA","Theranostics","radionuclide therapy","2025-09-26",{"date":121,"type":37},"2025-10-06",{"date":123,"type":37},"2025-08-12",{"date":125,"type":22},"2028-08-12",{"name":43,"class":44},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":74},"100572148","pictorial-fit-frail-scale-in-adults-admitted-to-the-icu-in-a-tertiary-center--an-observational-prospective-study-100572148","NCT06729502","Pictorial Fit-Frail Scale in Adults Admitted to the ICU in a Tertiary Center- an Observational Prospective Study","Pictorial Fit-Frail Scale in Adults Admitted to the Intensive Care Unit in a Tertiary Center- an Observational Prospective Study","Inclusion Criteria:\n\n* Older adults (age ≥ 60 years) who were admitted to the ICU for more than 24 hours at the participating centers\n\nExclusion Criteria:\n\n* Prior recent admission to an ICU (within 30 days)\n* Admissions for brain death evaluation.\n* Planned admissions to the ICU (i.e for percutaneous tracheostomy, for specific treatment under sedation).","60 Years",{"count":136,"type":22},1350,"OBSERVATIONAL","Understanding the frailty levels of critically ill patients using the PFFS at time of admission to ICU.\n\nExploring any associations between frailty, other prognostic factors, and patient outcomes.",[140],"Frail","2025-07-22",{"date":143,"type":37},"2025-07-23",{"date":145,"type":37},"2025-01-26",{"date":147,"type":22},"2027-03",{"name":43,"class":44},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100515504","tandem-polyurethane-stents-compared-to-single-silicone-stent-for-malignant-ureteral-obstruction-100515504","NCT05992363","Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction","TSTENT","Inclusion Criteria:\n\n* patient with malignant ureteral obstruction\n\nExclusion Criteria:\n\n* ureteral obstruction of other causes\n* Language comprehension or other limitation in giving informed consent",{"count":157,"type":22},106,[58],"Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The secondary endpoints are patient comfort, quality of life and overall survival.",[161,162,163,164,165],"Hydronephrosis; Obstruction, Ureter","Renal Failure","Malignancy","Ureter Obstruction","Ureter Stricture",{"date":167,"type":37},"2025-07-24",{"date":169,"type":37},"2023-12-20",{"date":171,"type":22},"2027-12",{"name":43,"class":44},2,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":74},"100589206","phase-2-tracking-t-cell-responses-to-evaluate-pembrolizumab-effectiveness-in-advanced-non-small-cell-lung-cancer-100589206","NCT06951399","Tracking T-Cell Responses to Evaluate Pembrolizumab Effectiveness in Advanced Non-Small Cell Lung Cancer","T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-Small Lung Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of NSCLC adenocarcinoma stage IV or unresectable stage III.\n* Have measurable disease based on RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Aberration in one or more of molecular drivers.\n* Has received prior systemic anti-cancer therapy prior to allocation.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* Known additional malignancy.",{"count":56,"type":22},[109],"This study includes patients with advanced non-small cell lung cancer (NSCLC) - either unresectable stage III or stage IV adenocarcinoma without actionable driver mutations - who are treated with pembrolizumab in combination with platinum-based doublet chemotherapy, irrespective of PD-L1 expression levels.\n\nThe primary objective is to assess treatment response through integration of serial T-cell receptor (TCR) repertoire sequencing (Rep-seq), capturing longitudinal changes in T-cell clonality and diversity. These immune dynamics will be correlated with radiographic response assessed by RECIST 1.1, with the aim of improving the accuracy of response classification, including differentiation between progression, pseudo-progression, and hyperprogression.\n\nAdditionally, circulating tumor DNA (ctDNA) levels will be measured longitudinally (pre-treatment and during treatment) to evaluate their potential as a complementary biomarker of disease burden and treatment efficacy in the context of chemo-immunotherapy.",[185,186,187],"NSCLC (Advanced Non-small Cell Lung Cancer)","NSCLC Stage IV Without EGFR\u002FALK Mutation","NSCLC Adenocarcinoma",[189],"metastatic NSCLC adenocarcinoma first-line pembrolizumab","NOT_YET_RECRUITING","2025-07-21",{"date":141,"type":37},{"date":194,"type":22},"2025-09-01",{"date":196,"type":22},"2028-04-30",{"name":43,"class":44},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":54,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":220,"locationsCount":74},"100591377","assessing-the-safety-performance-and-user-experience-of-the-tandem-mobi-automated-insulin-delivery-system-among-young-competitive-athletes-in-real-world-settings-100591377","NCT06979635","Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.","Captain MOBI","Inclusion Criteria:\n\n* Type 1 diabetes (T1D) for at least 6 months\n* 11≤Age≤18 years\n* HbA1c \\\u003C10.0%\n* Current treatment with automated insulin delivery system (AID) or insulin pump for at least 1 month\n* Willing to switch to Tandem Mobi Pump System and Dexcom CGM for the study duration\n* Competitive-level athletes\n\nExclusion Criteria:\n\n* Concomitant disease that influences metabolic control or HbA1c interpretation\n* Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)\n* Use of antidiabetic agents other than insulin\n* Two or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous 6 months\n* One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening\n* Individual has a positive pregnancy screening test",{"count":206,"type":22},12,[58],"A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.",[210],"Type 1 Diabetes",[210,212,213],"Competitive athletes","Hybrid Closed Loop System","2025-05-21",{"date":216,"type":37},"2025-05-25",{"date":218,"type":22},"2025-06",{"date":218,"type":22},{"name":43,"class":44},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":228,"maxAge":54,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":74},"100568915","carb-counting-vs-simplified-qualitative-meal-size-estimation-100568915","NCT06687434","Carb Counting vs. Simplified Qualitative Meal-Size Estimation","Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial","Inclusion Criteria:\n\n1. T1D- diagnosed\n2. Age 6-18 years\n3. Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems\n\nExclusion Criteria:\n\n1. Non-T1D\n2. Unstable medical conditions (other than diabetes) that may impact weight or diabetes management (as severe psychiatric disorders, various syndromes)\n3. Use of medications that may impact weight or diabetes management (as use of steroids for an extended period of time. use of GLP-1)\n4. Inability to understand the information, material and questionnaires of the study -","6 Years",{"count":230,"type":22},120,[58],"The goal of this study is to compare qualitative meal-size estimation to accurate carb counting in adolescents with Type One Diabetes using all available AID (Automated Insulin Delivery) systems. We will compare glucose control parameters and patient related outcome measures between the groups. 120 children and adolescents with type 1 Diabetes who begin using AID system will be randomly assigned to one of two groups: simplified qualitative meal size estimation or accurate carb counting. The study will last 6 months, with an additional optional follow up points at 12 and 24 months.\n\nIn the first visit all patients will receive nutrition guidance from the dietitian. In the accurate carb counting group, participants will use precise carb counting to manage their meals. In the simplified qualitative meal-size estimation group, participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian's assessment. During the study, the dietitian will evaluate the insulin-to-carb ratio and meal estimation at least once in the first two weeks.\n\nFollow-up visits will be scheduled at 4-6 weeks, 3, and 6 months after the study's initiation. At each visit participants will upload their data from their AID systems. Evaluation of their diabetes control will be made and an assessment regarding the carbohydrates calculation method. Digital questionnaires assessing diabetes distress, disordered eating behaviors, dietary regimen, and eating patterns will be provided at the beginning of the study and after 6 months, with an additional optional follow-up points that will be held at 12 and 24 months after the study's initiation.",[234],"Type 1 Diabetes Mellitus",[236,237],"Automated insulin delivery system","carb counting","2025-05-15",{"date":240,"type":37},"2025-05-20",{"date":242,"type":37},"2024-12-15",{"date":244,"type":22},"2027-12-15",{"name":43,"class":44},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":53,"sex":17,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":74},"100567255","a-national-screening-program-for-islet-autoantibodies-among-first-degree-relatives-of-t1d-patients-100567255","NCT06665815","A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients","ADIR Families","Inclusion Criteria:\n\n* Age 2-45 years\n* First-degree relatives of Type 1 Diabetes probands\n* Signing an informed consent\n\nExclusion Criteria:\n\n* Known diabetes of any kind (type 1, type 2, MODY)\n* Have a previous history of being treated with insulin or oral diabetes medications.\n* Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)","2 Years","45 Years",{"count":256,"type":22},20000,"A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 \\& 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA.\n\nA confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA.\n\nParticipants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.",[210,259],"Autoantibodies Screening",{"date":240,"type":37},{"date":242,"type":37},{"date":263,"type":22},"2028-02-15",{"name":43,"class":44},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":228,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":173},"100590362","prospective-evaluation-of-a-dose-guidance-system-for-people-with-diabetes-initiating-basal-insulin-or-using-insulin-injections-100590362","NCT06966427","Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections","DGS","Inclusion Criteria:\n\n* Documented T1D or T2D, for at least 6 months\n* Aged ≥ 6 years ≤ 75 years\n* HbA1c ≤ 11%\n* For Segment 1: Using basal-bolus MDI therapy, i.e. basal insulin and a bolus that is either:\n\n  1. Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)\n  2. Fix dose for meal \u002F meal estimation with CF\n* For Segment 2: Using or prescribed basal insulin\n* Participants using the following type of insulin as directed in the instructions for use:\n\n  1. Basal insulin: Glargine (including Rezvoglar, Semglee, Toujeo, Soliqua), Degludec (including Tresiba U-100, Tresiba U-200, Xultophy), Determir\n  2. Bolus insulin: regular insulin, rapid analogues (Insulin Aspart, Insulin Glulisine, Insulin Lispro) or ultra-rapid analogues (Fiasp, Lyumjev)\n* Participants willing to use FreesStyle Libre CGM according to manufacturer instructions, document insulin delivery, meals, and daily activities.\n* Participants have a smartphone compatible with study requirements.\n* Participants are willing and able to sign a written informed consent form to use their data.\n* Participants are willing to use the bolus calculator for insulin dosing (only for segment 1)\n\nExclusion Criteria:\n\n1. Concomitant diseases\u002Ftreatment that influence metabolic control or any significant diseases\u002Fconditions including psychiatric disorders and substance abuse or drug or alcohol abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety.\n2. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:\n\n   1. Subject has unstable or rapidly progressive renal disease or has eGFR \\\u003C 45 or is receiving dialysis\n   2. Subject has active proliferative retinopathy\n   3. Active gastroparesis\n3. Participation in any other interventional study\n4. Female participant who is pregnant or planning to become pregnant within the planned study duration\n5. Individuals who are using one of the following types of insulin:\n\n   1. Intermediate-acting insulin (NPH)\n   2. Mixed insulin like:\n\n   i. Premix NPH\u002F Regular (e.g. Humalin 70\u002F30, Novolog 70\u002F30) ii. Premix analogs (e.g, Novolog mix 70\u002F30, Hu,alog mix 75, 25, Humalog Mix 50\u002F50) c. Inhale insulin (e.g. Afrezza)\n6. Hypoglycemia unawareness\n7. Individuals who are treated with intravenous (IV) insulin injections, or a combination of insulin injections and\u002For IV insulin and insulin pump therapy.\n8. Individuals who have extensive skin changes\u002Fdiseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.\n9. An episode of diabetic keto-acidosis within the month prior to study entry and\u002For severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.","75 Years",{"count":274,"type":22},45,[58],"A prospective, randomized, single blind, two-arms, multicenter study. The study aims to assess the safety of a dosing-guided system (DGS) that provides direct advice on insulin dosing recommendations and diabetes management to individuals with diabetes using insulin or starting basal insulin therapy, guided by their continuous glucose monitoring (CGM).\n\nThe study population will include up to 45 individuals with diabetes, distributed as follows: 15 with Type 1 diabetes (T1D) and 15 with Type 2 diabetes (T2D), both on MDI therapy and 15 with T2D using or starting to use basal insulin.\n\nThe study will include a 2- to 4-week run-in period followed by a 6-week intervention period.",[210,278],"Type 2 Diabetes",[280,281,282],"Type 1 diabetes","Type 2 diabetes","Dose guidance system","2025-05-07",{"date":285,"type":37},"2025-05-11",{"date":287,"type":22},"2025-05-08",{"date":289,"type":22},"2026-05-25",{"name":43,"class":44},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":74},"100588357","phase-1-interventional-study-to-evaluate-the-combination-of-palbociclib--sunitinib-as-a-treatment-for-advanced-solid-tumors-100588357","NCT06940349","Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors","A Phase 1b\u002F2 Open Label, Dose Escalating, Single Center Study to Evaluate the Safety, Tolerability and Initial Efficacy of Palbociclib + Sunitinib Oral Kinase Inhibitor Combination as a Treatment for Advanced Solid Tumors","COPS-01","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with Stage IV incurable\u002Frefractory metastatic solid tumors or locally advanced incurable\u002Frefractory tumor, who have one of the following tumor types:\n\n  (1) Gastric adenocarcinoma, (2) Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal cancer (FIGO classification), (3) Breast cancer, (4) NSCLC, (5) Colorectal cancer, (6) Cholangiocarcinoma, (7) Pancreatic cancer, (8) Carcinosarcoma (any tissue origin), (9) High grade Neuroendocrine Carcinoma, from any tissue origin, (10) Sarcoma, all histological types, (11) Any other solid tumor.\n* Patients who have failed all other appropriate lines of therapy or who have refused treatment(s) of choice\n* Life expectancy of greater than 8 weeks\n* Clinical performance status of ECOG 0-2\n* Able to understand and sign the Informed Consent Form\n* Must be able to adhere to the study visit schedule and other protocol requirements.\n\nHematology criteria:\n\nAbsolute neutrophils count greater than 1000\u002Fmm3 without support of filgrastim Normal WBC (\\>3000\u002Fmm3). Hemoglobin greater than 8.0 g\u002FdL Platelet count greater than 80,000\u002Fmm3\n\n* Serology:\n* Seronegative for HIV antibody\n* Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test\n* Patients with active HBV must have:\n* HBV DNA \\\u003C 500 IU\u002FmL obtained within 28 days prior to initiation of study treatment\n* received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study\n* Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV\n* Chemistry:\n* Serum ALT\u002FAST less than three times the upper limit of normal (ULN)\u002F less than five times ULN if liver metastasis present\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg\u002FdL.\n* Non-pregnant (via negative pregnancy test)\u002Fnon-breast-feeding women and women with no intention to become pregnant\u002Fto breast-feed during the term of the trial and for at least three months after cessation of the P+S treatment\n* More than 14 days must have elapsed since any prior systemic therapy before day 1, and patients' toxicities must have recovered to a Grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures, local radiotherapy with the past two weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria:\n\n* Inclusion Criteria:\n\n  * Age ≥18 years\n  * Patients with Stage IV incurable\u002Frefractory metastatic solid tumors or locally advanced incurable\u002Frefractory tumor, who have one of the following tumor types:\n\n    (1) Gastric adenocarcinoma, (2) Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal cancer (FIGO classification), (3) Breast cancer, (4) NSCLC, (5) Colorectal cancer, (6) Cholangiocarcinoma, (7) Pancreatic cancer, (8) Carcinosarcoma (any tissue origin), (9) High grade Neuroendocrine Carcinoma, from any tissue origin, (10) Sarcoma, all histological types, (11) Any other solid tumor.\n  * Patients who have failed all other appropriate lines of therapy or who have refused treatment(s) of choice\n  * Life expectancy of greater than 8 weeks\n  * Clinical performance status of ECOG 0-2\n  * Able to understand and sign the Informed Consent Form\n  * Must be able to adhere to the study visit schedule and other protocol requirements\n  * Hematology:\n* Absolute neutrophils count greater than 1000\u002Fmm3 without support of filgrastim\n* Normal WBC (\\>3000\u002Fmm3).\n* Hemoglobin greater than 8.0 g\u002FdL\n* Platelet count greater than 80,000\u002Fmm3\n\n  • Serology:\n* Seronegative for HIV antibody\n* Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test\n* Patients with active HBV must have:\n* HBV DNA \\\u003C 500 IU\u002FmL obtained within 28 days prior to initiation of study treatment\n* received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study\n* Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV\n\n  • Chemistry:\n* Serum ALT\u002FAST less than three times the upper limit of normal (ULN)\u002F less than five times ULN if liver metastasis present\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg\u002FdL.\n\n  * Non-pregnant (via negative pregnancy test)\u002Fnon-breast-feeding women and women with no intention to become pregnant\u002Fto breast-feed during the term of the trial and for at least three months after cessation of the P+S treatment\n  * More than 14 days must have elapsed since any prior systemic therapy before day 1, and patients' toxicities must have recovered to a Grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures, local radiotherapy with the past two weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria:\n\n* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 1 week of day 1\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study\n* Uncontrolled hypertension\n* Proteinuria \\>3 grams per day\n* Subjects who have received any investigational drug or used investigational device within two weeks preceding screening\n* Active consumption of illicit drugs within one month preceding screening\n* Serious psychiatric or psychological disorders\n* Patients with significant cardiac, respiratory or active malignancy disease comorbidities.\n* Women of child-bearing potential who intend to become pregnant or breast-feed or who are pregnant or breastfeeding",{"count":300,"type":22},100,[108,109],"The goal of this clinical trial is to learn if a combination of Palbociclib and Sunitinib is safe and effective in various solid tumors.\n\nThe main questions it aims to answer are:\n\n* Is the drugs combination safe for the participants?\n* Is the drug combination effective in all solid malignancies? It is a single arm study, phase 1b\u002F2, dose escalation and expansion, to determine the safety, tolerability and initial efficacy of this combination.\n\nParticipants will:\n\n* Take the drugs combination every day for 5 executive days, and 2 days of, in a 28 days cycle, for up to a year.\n* Visit the clinic once every 2 weeks for checkups and tests",[304],"Solid Tumors Refractory to Standard Therapy",[306,307,308],"COPS study","phase 1\u002Fphase 2 study","combination Palbociclib and Sutent","2025-04-15",{"date":311,"type":37},"2025-04-23",{"date":313,"type":37},"2021-10-21",{"date":315,"type":22},"2028-01-01",{"name":43,"class":44},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100587648","phase-1-aprepitant-in-the-management-of-immune-checkpoint-inhibitors-pruritus-in-solid-cancer-patients-100587648","NCT06931119","Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus in Solid Cancer Patients","Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus: Pilot Study in Solid Cancer Patients","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed solid tumor (e.g., melanoma, RCC, NSCLC).\n* Currently receiving ICIs (such as but not limited to nivolumab, pembrolizumab, ipilimumab)\n* Pruritus that is either:\n* Refractory: Persistent pruritus despite standard treatment (e.g., antihistamines, corticosteroids).\n* New-onset: Developing after initiation of ICIs or targeted therapies.\n* ECOG performance status 0-2.\n* Willingness to comply with study procedures and provide informed consent.\n\nExclusion Criteria:\n\n* History of severe allergic reactions to Aprepitant.\n* Uncontrolled or severe dermatologic conditions unrelated to cancer therapy.\n* Use of NK1R antagonists within 4 weeks before study entry.\n* Concurrent use of medications that strongly interact with Aprepitant.\n* Concurrent use of medications that may influence pruritus manifestation (e.g steroids or antihistamines) . Note, Regular treatment with such medications prior to the appearance of pruritus, and or pruritus appearing despite such regular treatment, will not disqualify you from participating in the study\n* Uncontrolled infection or significant comorbidities.\n* Pregnant or breastfeeding women.",{"count":56,"type":22},[108],"Pruritus, commonly known as itching, is an unpleasant sensation that triggers the urge to scratch, which may provide temporary relief. Pruritus can be intermittent or persistent, localized or widespread, and may be associated with medication use. Chronic pruritus, defined as lasting more than six weeks, can significantly affect sleep and quality of life.\n\nDermatologic toxicities are among the most common immune-related adverse events (irAEs), reported in 43-45% of patients receiving ipilimumab and approximately 34% of those treated with nivolumab or pembrolizumab. Combination therapies (ipilimumab+ nivolumab or pembrolizumab) tend to elevate the incidence of potential irAEs to 41%. These toxicities typically emerge within the first few weeks of treatment, though delayed-onset cases have been documented. Cutaneous irAEs occur more rapidly in patients receiving combination therapy compared to anti-PD1 monotherapy.\n\nPruritus is one of the most frequently observed cutaneous irAEs. Current treatments for pruritus are often inadequate, leaving many patients suffering from persistent and debilitating symptoms. Despite available therapies, a significant number of individuals continue to experience chronic itch that negatively impacts their quality of life. Substance P (SP) functions as a neurotransmitter and neuromodulator in the central and peripheral nervous systems of mammals. It is produced by both neuronal and non-neuronal cells and plays a role in various physiological responses, including nausea, depression, vomiting, pain, neurogenic inflammation, and, more recently, pruritus. SP exerts its biological effects primarily through neurokinin receptors (NKRs), also known as tachykinin receptors. When SP binds to NK1R in the skin, it triggers mast cell degranulation, leading to the release of pruritogenic and proinflammatory mediators such as histamine, interferon-γ, leukotriene B4, vascular endothelial growth factor (VEGF), and nerve growth factor (NGF). This results in vasodilation and neurogenic inflammation, manifesting clinically as pruritus, erythema, and edema. NK1R antagonists are a class of drugs with antiemetic, antidepressant, anxiolytic, and antipruritic properties, though they have not been effective as analgesics in humans. These drugs act centrally by crossing the blood-brain barrier and selectively blocking NK1R activation by SP in the central nervous system, particularly in vomiting centers. Aprepitant has also demonstrated efficacy in treating pruritus induced by anticancer therapies.\n\nThis study is a pilot, single-center open label study evaluating the safety and efficacy of single course of EMEND® (aprepitant) capsules (80mg +125mg) in treating pruritus (new onset and\u002For refractory) induced by immune checkpoint inhibitors in patients with solid tumors.",[328],"Pruritus",[330],"pruritus, immune checkpoint inhibitors","2025-04-08",{"date":333,"type":37},"2025-04-17",{"date":335,"type":22},"2025-05-30",{"date":337,"type":22},"2026-12-30",{"name":43,"class":44},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":272,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":357,"locationsCount":74},"100515780","deep-brain-stimulation-surgery-for-the-treatment-of-refractory-obsessive-compulsive-disorder-100515780","NCT05995951","Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder","Inclusion Criteria:\n\n* Patients with a diagnosis of obsessive-compulsive disorder according to DSM 5 criteria, diagnosed by three independent psychiatrists not routinely involved with the patients' treatment.\n* Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 25.\n* Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.\n* Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.\n* Having failed to improve despite adequate psychotherapy.\n* Meet established criteria for implantation of a deep brain stimulation system.\n* Patients between ages 18 and 75.\n* Ability to understand and sign written informed consent by the patient.\n\nExclusion Criteria:\n\n* Diagnosis of severe major depression disorder (MDD) with psychotic features.\n* Significant suicidal risk \\[Hamilton Depression scale item 3 (suicide) \\>2\\].\n* Comorbidity with any primary Psychotic Disorder, Bipolar Disorder, Post-Traumatic Stress Disorder (PTSD), Eating Disorder, Autistics Spectrum Disorder.\n* History of substance or alcohol dependence or abuse in the preceding 12 months.\n* Significant cognitive decline, measured by Mini-Mental State Examination (MMSE \\\u003C26) and Montreal Cognitive Assessment (MoCA; \\\u003C24).\n* Any other current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder.\n* Any clinically significant abnormality on preoperative MRI.\n* Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other significant medical risk factors for surgery.\n* Pregnancy.",{"count":346,"type":22},10,[58],"This study will include two parts. The first part will include two patients in a non-blinded, non-randomized, open trial. They will undergo Deep Bran Stimulation (DBS) for OCD (targeting the amSTN), as clinically accepted and approved in Israel (by the MOH) and in other countries in Europe and the US. The second part will include eight patients. This part will be an interventional, randomized, double-blinded clinical trial (patient and psychiatrist; the neurosurgeon will activate stimulation during the randomization period and will not be blinded). All subjects will undergo standard pre-operative psychiatric and neurosurgical assessment. Around 4-6 weeks later subjects will undergo implantation of Medtronic implantable DBS system (bilateral brain leads model 3389, lead extenders and PERCEPT pulse generator). Intraoperative recordings will include single unit and local field potentials (LFP) for target identification and validation, as accepted for clinical use. In the second part of the study, blinded randomization for treatment or sham-control arms (1:1 ratio) will be held two weeks post-operation. Treatment and sham-control arms will continue for four months. At the end of four months treatment, the groups will be crossed-over for another four months. Thus, the sham-control group will start treatment (using pre-defined stimulation parameters) and the treatment group will start sham stimulation. Four months later (six and a half months from surgery), randomization will be over, and both arms will get open-label active treatment. Psychiatric assessments post-operation will take place after two weeks, one month, and then once every six weeks, in the first year for all study patients. Chronic recordings will take place using the clinically used and approved PERCEPT DBS pulse generator during the first year after surgery.",[350],"Obsessive-Compulsive Disorder","2025-04-03",{"date":353,"type":37},"2025-04-04",{"date":355,"type":37},"2021-10-12",{"date":194,"type":22},{"name":43,"class":44},{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":374,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":74},"100584991","phase-1-single-center-trial-on-ketogenic-diet-and-immunotherapy-in-advanced-cancer-this-study-evaluates-the-safety-and-effects-of-a-ketogenic-diet-kd-combined-with-immunotherapy-in-adults-with-advanced-melanoma-cscc-or-rcc-100584991","NCT06896552","Single-Center Trial on Ketogenic Diet and Immunotherapy in Advanced Cancer This Study Evaluates the Safety and Effects of a Ketogenic Diet (KD) Combined With Immunotherapy in Adults With Advanced Melanoma, cSCC, or RCC.","Investigating the Effect of Ketogenic Diet on Immunological Parameters in Advanced Cancer Patients Undergoing Immunotherapy","Inclusion Criteria:\n\n* • Males and females, age \\>= 18 years\n\n  * Patients with a histologically confirmed melanoma or cSCC or RCC receiving first line treatment with combination nivolumab and ipilimumab \u002Frelatlimab or single agent ipilimumab, nivolumab, pembrolizumab, Cemiplimab.\n  * Able to read, understand, and provide written informed consent\n  * Willing and able to complete all study-specific procedures and visits\n  * Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n  * Blood tests:\n\n    * Creatinine (Cr) \\\u003C 1.5 mg\u002FdL.\n    * Magnesium normal range ( 1.5 -2,6 mg\u002FdL)\n    * Liver function tests (LFTs) 2.5x upper limit of normal (ULN).\n    * Neutrophils ≥ 1,000\u002Fmm3, platelets ≥ 50,000\u002Fmm3, Hb\\>8 g\u002FdL\n    * Women of childbearing potential must have a negative β-HCG pregnancy test documented within 1 week of registration.\n\nExclusion Criteria:\n\n* • Individuals \\\u003C 18 years of age\n\n  * Unable or unwilling to provide consent\n  * Other active malignancy (other than adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease free \\>=2 years)\n  * Currently consuming a low-carbohydrate (\\\u003C 130 g\u002Fday) or KD or done so in the last 6-months\n  * Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy.\n  * Active autoimmune diseases requiring active Immune suppressive medications\n  * Systemic steroid therapy, excluding for replacement due to adrenal insufficiency\n  * Major surgery within last 3 months\n  * BMI \\\u003C18 or \\>35\n  * Medical contraindications to the intervention diet as determined by the treating physician.\n  * Self-reported major dietary restrictions related to the intervention such as irritable bowel syndrome (IBS).\n  * Patients with a history or active eating disorder\n  * Uncontrolled Diabetes mellitus or patients receiving insulin\n  * Known diagnosis of HIV\n  * Known active hepatitis B or hepatitis C\n  * Known inborn errors of lipid metabolism\n  * Sever or uncontrolled Hyperlipidemia (total cholesterol over 400 mg \u002F dL, low-density lipoprotein (LDL) above 300 mg \u002F dL, triglycerides over 500 mg \u002F dl.).\n  * Pregnant or lactating.\n  * Patients who have undergone a transplant","100 Years",{"count":367,"type":22},60,[108,109],"This clinical trial aims to evaluate whether a ketogenic diet (KD), when combined with immunotherapy, can improve immune function and treatment outcomes in patients with advanced melanoma, cutaneous squamous cell carcinoma (cSCC), or renal cell carcinoma (RCC).\n\nWhy Is This Study Important? Immunotherapy is a promising cancer treatment, but not all patients respond well. Research suggests that diet, particularly a high-fat, low-carbohydrate ketogenic diet, may help boost the immune system and make treatments more effective.\n\nWhat Will This Study Examine?\n\nResearchers want to understand:\n\nIs the ketogenic diet well-tolerated for cancer patients? Does the diet improve immune responses and treatment effectiveness?\n\nHow Will the Study Work?\n\nParticipants will be placed into one of two groups:\n\nKetogenic Diet (KD) Group: A structured high-fat, low-carb diet (intermittent schedule: 2 weeks on, 1 week off).\n\nStandard Diet (SD) Group: A typical diet with no major changes. Throughout the study, a dietitian will closely support and guide you. Both groups will continue their standard immunotherapy treatment.\n\nWhat Will Participants Do? Write their food intake three times a week to help assess dietary adherence Follow their assigned diet for 10 weeks Have weekly check-ins with a dietitian (in-person at the hospital or via phone) Have weekly blood glucose and ketone level checks using a home device. Provide monthly blood samples to measure immune response during routine immunotherapy infusions Provide stool samples for gut microbiome analysis at the start and end of the study Measure Monthly Weight, body composition, and resting calorie burn Complete quality-of-life questionnaires\n\nWhat Are the Potential Benefits? Improved response to immunotherapy Better understanding of how diet influences cancer treatment Potential for a new supportive strategy for cancer care\n\nThis study may help uncover ways to enhance cancer treatment through personalized nutrition.",[371,372,373],"Cancer","Immunotherapy","Ketogenic Diet",[375,376,373,377,378],"Metastatic Melanoma","Renal Cell Carcinoma","Dietary Intervention and Immunotherapy","Ketogenic diet (KD) and cancer treatment","2025-03-19",{"date":381,"type":37},"2025-03-26",{"date":383,"type":22},"2025-04",{"date":385,"type":22},"2027-04",{"name":43,"class":44},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":74},"100573114","histiocytosis-and-inflammatory-manifestations-in-patients-with-h-syndrome-100573114","NCT06742073","Histiocytosis and Inflammatory Manifestations in Patients with H Syndrome","Histiocytosis and Inflammatory Manifestations in Patients with H Syndrome- a Multinational Collaboration","Inclusion Criteria: Any patient with a genetically confirmed diagnosis of H syndrome -\n\nExclusion Criteria:\n\n\\-",{"count":230,"type":22},"H syndrome is a rare genetic disorder predisposing to histiocytosis. Our knowledge of the clinical spectrum of these patients is based on case reports and small patient series. Patients with H syndrome have been treated with a range of immunomodulatory and chemotherapeutic agents, with limited success. We aim to comprehensively assess the clinical manifestations and patterns of treatment response in a multinational cohort of patients with H syndrome.",[397],"H Syndrome",[399],"SLC29A3",{"date":401,"type":37},"2024-12-19",{"date":403,"type":37},"2024-11-01",{"date":405,"type":22},"2026-08-01",{"name":43,"class":44},{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":74},"100512988","phase-3-intra-wound-vancomycin-powder-for-prevention-of-surgical-site-infection-following-spinal-surgery-100512988","NCT05959603","Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery","Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial","Inclusion Criteria:\n\n* Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center\n* Ability to understand and sign written informed consent by the patient or legal guardian\n\nExclusion Criteria:\n\n* Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment)\n* Receiving ongoing treatment of antibiotics for other infections\n* Sensitivity or allergy to vancomycin or cefazolin\n* Previous spine surgery at the index level within the last 90 days\n* Postoperative radiotherapy of the surgical site required (e.g. for tumor)\n* Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml\u002Fmin or worse\n* Undergoing spinal decompression only\n* Trauma patients\n* Pregnancy","90 Years",{"count":416,"type":22},363,[25],"Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.",[420],"Infection",[422,423,424],"Vancomycin","Infections","Surgical Site","2024-11-24",{"date":427,"type":37},"2024-11-27",{"date":429,"type":37},"2020-05-31",{"date":431,"type":22},"2026-12-01",{"name":43,"class":44},{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":104,"minAge":54,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":74},"100518234","two-fraction-versus-five-fraction-stereotactic-radiotherapy-for-localized-prostate-cancer-100518234","NCT06027892","Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer","Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual","SABR-Dual","Inclusion:\n\n* Male patients ≥18 years\n* Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma\n\n  * T1-T2c\n  * Prostate specific antigen \\\u003C 20\n  * Gleason 6 or 7 (3+4)\n  * Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease\n* Prostate gland \\\u003C 60 cc (can include following cytoreductive androgen deprivation)\n* International Prostate Symptom Score \\\u003C 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)\n\nExclusion:\n\n* Unfavorable intermediate-risk disease and above\n* Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)\n* Chronic immunosuppression\n* Contraindications to hydrogel spacer placement\n* Contraindications to a prostate MRI\n* Any prior prostate cancer treatment\n* Prior pelvic radiotherapy\n* Previous transurethral resection of the prostate (TURP) within 12 months\n* Hip prosthesis\n* Prior use of therapeutic androgen deprivation therapy",{"count":442,"type":22},562,[58],"The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized prostate cancer was given in small treatments over a period of multiple weeks. Recent studies have shown that with newer technologies and better understanding of how prostate cancer responds to radiation, the same effective dose can be given in as few as 5 treatments. This study is comparing this newer standard course of 5 treatments with an even shorter course of just 2 treatments. The dose for the 2 treatments is based on a form of internal radiation called brachytherapy, but in this study, that dose will be given using external radiation, without the need for invasive procedures.\n\nIn order to make sure that the radiation therapy is given in a way that minimizes the risk of side effects to the surrounding organs, including the rectum and bladder, prior to radiation a hydrogel material will be inserted behind the prostate in order to distance the rectum further from the prostate gland, and small gold markers will be inserted into the prostate to decrease any possible movement during treatment.\n\nThe main questions are whether 2-treatment radiation is tolerated as well and is as effective at treating prostate cancer, compared to the standard 5-treatment course of radiation.",[446],"PROSTATE CANCER","2024-11-13",{"date":449,"type":37},"2024-11-15",{"date":451,"type":37},"2022-12-29",{"date":453,"type":22},"2032-12",{"name":43,"class":44},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":17,"minAge":462,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"100426554","screening-for-islet-autoantibodies-in-the-israeli-paediatric-general-population-for-detection-of-pre-symptomatic-type-1-diabetes-mellitus-100426554","NCT04834518","Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus","ADIR","Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities\n* Children aged 9-months- 5 years at first screening.\n\nExclusion Criteria:\n\n* Known diagnosis of diabetes (Type 1 or other)","9 Months","5 Years",{"count":465,"type":22},50000,"A national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodies.Up to 50,000 Children will be screened by their primary care physician all over Israel. The initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for CBC ) and repeated at ages 2-5 years. Antibodies will be measured in capillary blood samples using the Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. By using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology. In addition, multiple antibodies will be also measured using a radio-binding assay (RBA) of a venous blood sample for investigational purpose only. Children with confirmed multiple antibodies (stage 1 or 2 T1D) will be followed up routinely for the appearance of clinical signs of diabetes (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. This program will include diabetes education emphasizing on DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. The analysis and storage of the samples will be done in a single screening center at Schneider Children's Medical Center of Israel.",[468],"Type1diabetes",[470],"autoantibodies screening","2024-10-15",{"date":473,"type":37},"2024-10-17",{"date":475,"type":37},"2021-04-01",{"date":477,"type":22},"2027-03-31",{"name":43,"class":44},7,{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":17,"minAge":488,"maxAge":54,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":74},"100494707","clabsi-prevention-with-tissue-adhesive-100494707","NCT05721677","CLABSI Prevention With Tissue Adhesive","The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit","Cya-No-CLABSI","Inclusion Criteria:\n\nAll patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):\n\n* young age\\\u003C1y \\& Congenital Heart Surgery Mortality Category (STAT\\\\STS-EACTS) score 2-5\n* Risk Adjustment for Congenital Heart Surgery (RACHS) category ≥3\n* preoperative length-of-stay (LOS) \\>7 days\n* preoperative ventilator support\n* presence of a genetic abnormality\n* extracorporeal membrane oxygenation (ECMO) support\n\nExclusion Criteria:\n\n* Patients with on-going bacteremia\n* patients with pre-existing central-line or peripherally inserted central catheter (PICC)\n* parental refusal to participate.","0 Days",{"count":490,"type":22},600,[58],"Our aim is to test the effect of tissue adhesive application at the Central-line exit-site on CLABSI rates in high-risk pediatric congenital heart disease patients.",[494],"Central-line Associated Blood Stream Infections (CLABSI)",[496,497,498,499,500],"CLABSI","Pediatric","Cardiac intensive care","cyanoacrylate","tissue adhesive","2024-09-30",{"date":503,"type":37},"2024-10-02",{"date":505,"type":37},"2023-03-15",{"date":507,"type":22},"2026-09-15",{"name":43,"class":44},{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":53,"sex":516,"minAge":54,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":74},"100519917","prelabor-visual-biofeedback-by-a-self-operated-ultrasound-device-100519917","NCT06049784","Prelabor Visual Biofeedback by a Self-operated Ultrasound Device","Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device","Inclusion Criteria:\n\n* Nuliparity\n* Singleton pregnancy\n* Planned for vaginal delivery\n* Low risk pregnancy\n* Ability to fulfill a questionnaire\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)\n* High risk pregnancy","FEMALE",{"count":518,"type":22},261,[58],"A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Previously, visual biofeedback has been implemented only in an in-hospital setting and, with one known exception, only during labor. A Mobile Self-Operated Home Ultrasound System has been reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37-39 weeks of gestation): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (2) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.",[522,523],"Obstetric Labor Complications","Obstetric Trauma",[525,526,527,528],"Visual Biofeedback","Self Operated Ultrasound device","Second stage of labor","Trans Perineal Ultrasound","2024-05-02",{"date":531,"type":37},"2024-05-06",{"date":533,"type":37},"2023-12-31",{"date":535,"type":22},"2026-12",{"name":43,"class":44},{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":74},"100445866","phase-2-combined-kidney-and-hematopoietic-stem-cell-transplantation-for-tolerance-induction-100445866","NCT05086003","Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction","Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs","Inclusion Criteria:\n\n* Age older than 18 years\n* Matched siblings\n* No contra-indication to thymoglobuline or total lymphoid irradiation\n\nExclusion Criteria:\n\n* Pregnant women or breast feeding\n* Infection with HIV, HBV or HCV\n* Previous or presnt malignancy","65 Years",{"count":106,"type":22},[109],"Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.",[549],"Renal Transplantation",[551,552,553,554],"Renal transplantation","Bone marrow transplantation","Immune tolerance","Immunosuppression","2021-10-20",{"date":557,"type":37},"2021-10-28",{"date":559,"type":37},"2016-01-19",{"date":561,"type":22},"2026-12-31",{"name":43,"class":44},""]