[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rambam Health Care Campus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":485},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,45,68,96,119,146,175,202,231,253,275,296,323,345,367,386,405,426,443,464],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622468","study-protocol-impact-of-metamizole-optalgin-on-anti-xa-concentrations-in-oncology-patients-receiving-doacs-100622468",false,"NCT07384013","Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs","Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs","Inclusion Criteria:\n\n* Adult oncology patients (≥18 years old).\n* Receiving apixaban or rivaroxaban for anticoagulation.\n* New\u002Fcurrent metamizole users taking at least 1g TID for pain management.\n* Platelets ≥100×10⁹\u002FL\n* ECOG PS\\\u003C3\n* Provided informed consent\n\nExclusion Criteria:\n\n* History of allergic reaction to metamizole or DOACs.\n* Individuals with significant gastrointestinal disorders that may affect absorption, including (but not limited to) diagnosed bowel obstruction, persistent diarrhea, or the presence of a nasogastric tube (NGT\u002Fzonda)","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)",[26,27,28],"Oncologic Diseases","Coagulation Defect","Pain Management",[30,31],"Direct Oral Anticoagulants (DOACs)","Optalgin","RECRUITING","2026-01-26",{"date":35,"type":36},"2026-02-03","ACTUAL",{"date":38,"type":36},"2025-11-01",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"Rambam Health Care Campus","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100618183","delayed-surveillance-colonoscopy-following-piecemeal-emr-100618183","NCT07328308","Delayed Surveillance Colonoscopy Following Piecemeal EMR","Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Undergoing pEMR of LNPCPs\n* Able to provide informed consent and comply with follow-up requirements\n\nExclusion Criteria:\n\n* Patients with invasive cancer identified during the index procedure\n* en bloc resection\n* Patients unable to attend follow-up colonoscopies due to comorbid conditions\n* Patients who require additional surgery for polyp removal or other complications",{"count":53,"type":20},760,[23],"This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard intensive surveillance. Approximately 760 adults undergoing complete pEMR with margin ablation will be randomized 1:1 into:\n\nStandard Surveillance: Colonoscopy at 6, 18, and 48 months\n\nRelaxed Surveillance: Colonoscopy at 12 and 48 months\n\nAll colonoscopies will be performed using high definition white light and narrow band imaging, with biopsies obtained only if recurrence is suspected. The investigators hypothesize that a relaxed surveillance strategy will be non inferior to the current standard intensive surveillance. If non inferiority is demonstrated, the study may support guideline changes toward reduced surveillance frequency after pEMR with margin ablation, potentially decreasing patient burden and healthcare costs.",[57,58],"Colon Cancer Prevention","Polyp Colorectal","NOT_YET_RECRUITING","2026-01-03",{"date":62,"type":36},"2026-01-09",{"date":64,"type":20},"2026-01",{"date":66,"type":20},"2031-01",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":44},"100563956","influence-of-flow-rate-change-on-co2-levels-during-high-flow-nasal-ventilation-hfnv-in-preterm-infants-100563956","NCT06622902","Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.","Inclusion criteria:\n\n* Gestational age 240 to 336.\n* At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).\n* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.\n* At least 6 hours from surfactant administration.\n* Parental consent\n\nExclusion criteria:\n\n* If flow is \\<3 and tcCO2 related pCO2 is\\<40mmHg.\n* If Flow is ≥5 bpm and tcCO2 related pCO2 is\\>60mmHg.\n* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.",{"count":75,"type":20},45,[23],"Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding.\n\nAim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants.\n\nMethods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours.\n\nOutcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics.\n\nStatistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.",[79,80,81],"Respiratory Distress Syndrome","Prematurity","Non Invasive Ventilation",[83,84,85,86,87],"Respiratory distress syndrome","prematurity","HIGH FLOW","CO2","VENTILATION","2025-11-26",{"date":90,"type":36},"2025-11-28",{"date":92,"type":36},"2023-08-16",{"date":94,"type":20},"2026-12-31",{"name":42,"class":43},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":44},"100503277","feasibility-of-integrating-homeopathic-approach-in-a-comprehensive-cancer-center-100503277","NCT05833165","Feasibility of Integrating Homeopathic Approach in a Comprehensive Cancer Center","Inclusion Criteria:\n\n* • 18 years of age or older\n\n  * Ability to read, write, and understand the Hebrew language\n  * Patients treated at the Division of Oncology in Rambam Health Campus.\n  * Performance status of ECOG 0-2.\n  * Consent to participate in the study.\n\nExclusion Criteria:\n\n* • Inability to understand the intent of the study and follow the instructions\n\n  * Diagnosis of active psychosis, altered mental state or severe cognitive impairment confirmed by the patient's attending physician.\n  * Frailty, ECOG worse than 2, or other unstable medical conditions as confirmed by the patient's attending physician including acute illness, fever, unclear rash or medical conditions that would preclude participation in an interview session lasting 15-30 minutes",{"count":103,"type":20},250,"OBSERVATIONAL","Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer. Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. In many countries, homeopathy is being one the CIM methods integrated with a general sense that this treatment is beneficial to the well-being and quality of life (QoL) of cancer patients. In this observational study we will evaluate the feasibility of integrating homeopathic approach in patients attending the complementary and integrative oncology service at the division of oncology in Rambam Health Campus in Haifa, Israel, a major referral comprehensive cancer center.\n\nThis observational study will evaluate three main ingredients of acceptance:\n\n* Obtaining the reasons that patients willing to integrate this supportive approach\n* Patient acceptance of this supportive approach as well as compliance with the homeopathic approach\n* Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters.",[107,108,109,110],"Cancer","Quality of Life","Complementary Medicine","Integrative Medicine","2025-08-03",{"date":113,"type":36},"2025-08-07",{"date":115,"type":36},"2023-01-01",{"date":117,"type":20},"2028-01-01",{"name":42,"class":43},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100510106","phase-4-cefiderocol-and-ampicillin-sulbactam-vs-colistin---meropenem-for-carbapenem-resistant-a-baumannii-100510106","NCT05922124","Cefiderocol and Ampicillin-sulbactam vs. Colistin +\u002F- Meropenem for Carbapenem Resistant A. Baumannii","Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)","CASCADE","Inclusion Criteria:\n\nAdults \\>18 years with bacteremia or hospital-acquired pneumonia (HAP)\u002F ventilator-associated pneumonia (VAP) (Table 3) caused by carbapenem-resistant A. baumannii (CRAB) (meropenem and\u002F or imipenem minimal inhibitory concentration (MIC) \\>8 μg\u002FmL) susceptible to cefiderocol (disc zone diameter \\>=17 mm, corresponding to an MIC \\\u003C2 μg\u002FmL). We will include CRAB regardless of colistin, ampicillin-sulbactam, minocycline, tigecycline, trimethoprim\u002Fsulfamethoxazole and\u002For aminoglycoside susceptibility of the isolate. Attribution of the HAP\u002F VAP to CRAB will be allowed with isolation of CRAB from any respiratory sample within 7 days prior to the clinical diagnosis of pneumonia.\n\nExclusion Criteria:\n\n* More than 72 hours of therapy with in-vitro coverage against the CRAB within 96 hours of enrolment\n* Polymicrobial carbapenem-susceptible infections: growth of other pathogens susceptible to carbapenems, or another beta-lactam, deemed clinically-significant by the treating physicians in blood or sputum (with HAP\u002F VAP). We will allow recruitment of patients with other carbapenem-resistant Gram-negative bacteria\n* CRAB susceptible any beta-lactam other than cefiderocol\n* Coronavirus 2019 (COVID-19) co-infection\n* Immediate-type hypersensitivity to penicillin\n* Pregnant women\n* Previous participation in the trial\n* Lack of informed consent, considering the procedures acceptable to ethics committees per locale, including deferred consent\n* Infection requiring treatment for over 14 days, at the discretion of the investigators\n* Life expectancy less than 24 hours or expected futility of antibiotic treatment","16 Years",{"count":129,"type":20},734,[131],"PHASE4","Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.",[134,135,136],"Carbapenem Resistant Bacterial Infection","Acinetobacter Bacteremia","Acinetobacter Pneumonia","2025-07-29",{"date":139,"type":36},"2025-08-01",{"date":141,"type":36},"2024-09-01",{"date":143,"type":20},"2026-09",{"name":42,"class":43},3,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100337324","phase-4-piperacillin-tazobactam-versus-meropenem-for-treatment-of-bloodstream-infections-caused-by-cephalosporin-resistant-enterobacteriaceae-peterpen-100337324","NCT03671967","PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)","Piperacillin Tazobactam Versus Meropenem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae- a Non-inferiority Randomized Controlled Trial","PETERPEN","Inclusion Criteria:\n\n1. Adults (age ≥ 18 years)\n2. New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection.\n3. The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods).\n4. Both community and hospital-acquired bacteremias will be included.\n5. We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants.\n\nExclusion Criteria:\n\n1. More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).\n2. Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode.\n3. Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.\n4. Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \\\u003C 90 mmHg and\u002For use of vasopressors (dopamine\\>15μg\u002Fkg\u002Fmin, adrenalin\\>0.1μg\u002Fkg\u002Fmin, noradrenalin\\>0.1μg\u002Fkg\u002Fmin, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure \\\u003C90 would need to represent a deviation for the patient's known normal blood pressure.\n5. BSI due to specific infections known at the time of randomization:\n\n   1. Endocarditis \u002F endovascular infections\n   2. Osteomyelitis (not resected)\n   3. Central nervous system infections\n6. Allergy to any of the study drugs confirmed by history taken by the investigator\n7. Previous enrollment in this trial\n8. Concurrent participation in another interventional clinical trial\n9. Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)",{"count":155,"type":20},1084,[131],"Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.",[159,160,161],"Beta Lactam Resistant Bacterial Infection","Enterobacteriaceae Infections","Bacteremia",[163,164,165,166,167],"bacteremia","enterobacteriaceae","extended spectrum beta-lactamase","meropenem","piperacillin tazobactam",{"date":139,"type":36},{"date":170,"type":36},"2019-05-01",{"date":172,"type":20},"2027-04-01",{"name":42,"class":43},14,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":182,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":44},"100588863","phase-2-biosignature-of-the-response-to-treatment-with-cannabis-oil-in-individuals-with-fibromyalgia-100588863","NCT06946940","Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia","CAN-RCT","Inclusion Criteria:\n\n* Adult men and women aged 30 years and over.\n* Diagnosis of fibromyalgia confirmed according to the 2016 diagnostic criteria by a pain specialist, with relevant symptoms lasting 12 months or more.\n* An average reported pain ≥ 6 during the preceding week.\n* Eligible for cannabis at the discretion of the treating physician.\n* Has remained symptomatic despite receiving standard care for fibromyalgia including analgesics, anti-depressants (tricyclic and SNRI) and anti-epileptic agents.\n\nExclusion Criteria:\n\n* Patients who have used cannabis during the preceding month.\n* Any significant comorbid condition at the discretion of the PI (e.g. inflammatory arthritis, inflammatory bowel disease, cancer).\n* Personal or family history of psychotic disorders.\n* Current or past anxiety disorder.\n* Any uncontrolled psychiatric pathology.\n* Current or history of substance addiction or abuse.\n* Diagnosed dementia or cognitive impairment.\n* Personal history of cardiovascular disease.\n* Pregnancy, lactation or intention to conceive.\n* Known allergy to any of the cannabis oil ingredients.\n* Patients with a history of seizure disorder (excluding childhood febrile convulsions) or epilepsy.\n* Active liver disease.\n* Any contraindication to the use of MC.\n* Inflammatory Bowel Disease (IBD).","30 Years",{"count":184,"type":20},150,[186],"PHASE2","Fibromyalgia is a chronic condition that causes widespread pain, fatigue, and other symptoms, significantly affecting quality of life. Unfortunately, there are few effective treatments available. Recently, medical cannabis has gained attention as a potential treatment, leading many countries to approve its use for fibromyalgia. However, its success is limited-only about 25% of patients experience meaningful pain relief, and side effects like dizziness or fatigue are common. Not everyone responds to medical cannabis the same way, and researchers think this variability may partly be explained by differences in the gut microbiome-the community of bacteria and other microorganisms living in our digestive system. These microbes are known to influence various aspects of health, including pain and how the body processes medications. Our research focuses on understanding the link between the gut microbiome and fibromyalgia. We propose a study where 150 fibromyalgia patients will be treated with either cannabis oil or a placebo in a double-blind trial. By analyzing their symptoms and gut microbiome, we hope to identify patterns that could predict who will benefit most from cannabis treatment. If successful, this research could lead to more personalized and effective treatment options for fibromyalgia.",[189],"Fibromyalgia",[189,191,192,193],"Microbiome","Cannabis","Chronic Pain","2025-04-19",{"date":196,"type":36},"2025-04-27",{"date":198,"type":36},"2024-05-30",{"date":200,"type":20},"2027-05",{"name":42,"class":43},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":230},"100485305","phase-2-pre-treatment-with-azithromycin-to-reduce-immunogenicity-to-to-anti-tnf-agents-in-patients-with-crohns-disease-100485305","NCT05599347","Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease","Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Crohn's Disease","AZITRATIM","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period.\n* Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent.\n* Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.\n* Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs).\n* Thiopurine and corticosteroid co-therapy will be permitted.\n\nExclusion Criteria:\n\n* Inclusion in another interventional study\n* Patients who cannot provide informed consent and do not have a legal guardian\n* Patients with perianal involvement who are expected to require antibiotic therapy for their disease\n* Patients on chronic antibiotic therapy due to any cause\n* Patients with ongoing fluid collection\u002Fabscess either internal or perianal\n* Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device\n* Prolonged QTc interval or conditions leading to additional risk for QT prolongation\n* Chronic kidney disease stage 5 (GFR \\\u003C 10)\n* Crohn's Disease complication requiring surgical treatment\n* Planned\u002Fongoing methotrexate co-therapy\n* Fecal microbiota transplantation within 8 weeks prior to randomization\n* Participant has any disorder that, in the opinion of the investigator, may compromise the ability to participate in the study\n* Pregnancy\n* Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy)\n* Patients who received any antibiotic treatment within 4 weeks prior to randomization\n* Re-induction of the same anti-TNF medication\n* Patients who are on chronic therapy which cannot be withheld in one of these medications: colchicine, phenytoin, and digoxin",{"count":211,"type":20},180,[186],"This is a randomized placebo-controlled trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity",[215,216],"Crohn's Disease Relapse","Biological Substance; Adverse Effect",[218,219,220,221,222],"Crohn's disease","infliximab","adalimumab","azithromycin","immunogenicity","2025-04-02",{"date":225,"type":36},"2025-04-04",{"date":227,"type":36},"2023-04-24",{"date":94,"type":20},{"name":42,"class":43},9,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":237,"sex":238,"minAge":17,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":252},"100534201","administration-of-calcium-gluconate-for-the-reduction-of-blood-loss-during-elective-cesarean-delivery-100534201","NCT06235749","Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery","Inclusion Criteria:\n\n\\- Elective Cesarean Delivery, at Gestational age of 35 weeks or more.\n\nExclusion Criteria:\n\n* Age younger than 18 years old.\n* Patients treated with calcium channel blockers.\n* Chronic renal failure and hyperphosphatemia.\n* Sarcoidosis.\n* Hypocalcemia (ionized Ca\\\u003C1 mmol\u002FL) or hypercalcemia (ionized Ca\\> 1.3 mmol\u002FL) before the surgery.\n* Any QT abnormalities as evident by ECG before Calcium Gluconate administrations or any known conduction abnormality.",true,"FEMALE",{"count":240,"type":20},1180,[23],"Postpartum hemorrhage (PPH) is the leading cause of death related to pregnancy. PPH can lead to blood transfusion, disseminated intravascular coagulation (DIC), hysterectomy, or death. The prophylactic administration of uterotonic agents as part of an active management of the third stage of labor has been proven to reduce rates of PPH. However, even with these treatments, PPH rate is still relatively high, and puts women at risk of heavy bleeding and death.\n\nCalcium is a key component in the coagulation cascade and known as factor IV. It has a role in platelet activation, and it is an important co-factor for the activation of factors II and There is a concentration-dependent effect of hypocalcemia on in vitro clot strength in patients at risk of bleeding. Calcium gluconate is the calcium salt of gluconic acid, and it has a relatively strong safety profile.\n\nHypocalcemia is a poor prognostic factor in actively bleeding patients. Calcium has a positive inotropic effect both on skeletal muscle and smooth muscle. The inotropic effect doesn't skip the myometrium, and it is well-established that hypocalcemia can impair myometrial contractility. As so, calcium channel blockers are prescribed as a tocolytic drug and calcium gluconate should be considered as adjuvant therapy for treating PPH duo to atony, in case of prolonged tocolytic or magnesium sulfate use prior to delivery. Studies have already shown an association between low ionized calcium levels and the risk for severe bleeding. In a pilot randomized controlled trial of patients with risk factors for uterine atony, calcium was shown to reduce uterine atony compared to placebo. However, current studies have small sample size and are limited to a high-risk population. There are no recommendations in current guidelines for monitoring calcium levels or prescribing calcium as a prophylactic measure for the third stage of labor, despite atony and coagulopathy being significant causes of PPH.\n\nHYPOTHESIS: Administration of Calcium Gluconate at the third stage of elective Cesarean delivery will decrease the rates of blood loss during and after the surgery by reducing the rates of uterine atony and development of coagulopathy, thus has the potential of reducing the incidence of PPH and its complications without severe side effects.",[244],"Elective Cesarean Delivery","2025-01-27",{"date":247,"type":36},"2025-01-28",{"date":249,"type":36},"2023-11-14",{"date":94,"type":20},{"name":42,"class":43},4,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":44},"100568977","phase-4-intravenous-human-igg1-fc-fragment-efgartigimod-in-myasthenic-crisis-100568977","NCT06688253","Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis","Inclusion Criteria:\n\n* -Age \\> 18\n* MG diagnosis\n* A confirmed diagnosis of Myasthenia Gravis (MG) with generalized muscle weakness, classified as MGFA class II, III, IVa, or IVb and V.\n* Positive AchR or MuSK antibodies (max three patients of the total cohort) this will be tested in our center for all patients.\n* Myasthenic crisis: Worsening of \\> 3 or an increase \\>1 MG-ADL points of a sub score of any individual MG-ADL item other than double vision or eyelid droop and its clinically significant by the investigator. Alternatively, weakness related to MG that is severe enough to necessitate intubation or delay Ex-tubation following surgery.\n* Willingness to provide informed consent.\n\nExclusion Criteria:-Contraindications to Efgartigimod.\n\n* Other significant medical conditions that may interfere with study participation.\n* Prior exposure to Efgartigimod.\n* Male patients who do not intend to use effective contraception during trail or within last dosing\n* Pateints with worsening muscle weekness due to concurrent infection or medications known to exacerbate MG.\n* Patients with known or active seropositive HBV,HCV, HIV.\n* Patients with documented lack of clinical response to Flax.\n* Use of any investigational drug within 3 month or 5 helf -lives prior to screening.\n* Avidance of significant disease ,recent major surgery or renal\u002F hepatic function who can put patient at undue risk.\n* Previous participation in clinic trail involving ARGX-113\n* Vaccination recived whitin 4 weeks prior screening using live or attenuated vaccinations.\n* Patient Calssified MGFA Class 1\n\n  1. Pregnant and lactating women","99 Years",{"count":261,"type":20},16,[131],"Efgartigimod in Myasthenic Crisis Background Myasthenia gravis (MG) is a prevalent autoimmune disorder affecting neuromuscular junctions, characterized by weakness in skeletal muscles. It is associated with the production of autoantibodies, primarily targeting acetylcholine receptors (AchR), and is often complicated by myasthenic crisis, which can lead to severe respiratory failure. Current treatments primarily involve non-specific immunosuppression, which may not provide rapid relief.\n\nAim This study investigates the therapeutic impact of efgartigimod, an FcRn-targeting Fc fragment, on patients experiencing a myasthenic crisis. We hypothesize that efgartigimod is non-inferior to conventional treatments like intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) in terms of clinical efficacy and safety.\n\nStudy Rationale Efgartigimod aims to reduce pathogenic IgG autoantibodies implicated in MG by accelerating their degradation. This targeted approach could provide faster symptom relief during acute exacerbations compared to existing therapies.\n\nObjectives Primary Objective: To assess the non-inferiority of efgartigimod compared to PLEX and IVIG based on MG-ADL improvements.\n\nSecondary Objectives: Evaluate safety, tolerability, length of hospital stay, respiratory parameters, need for additional therapies, and one-year outcomes.\n\nPrimary Endpoint MG-ADL Improvement: Defined as a ≥3-point improvement post-treatment. The comparison will be made using one-month post-treatment assessments, with follow-ups every three months.\n\nSecondary Endpoints Safety and tolerability Length of hospital stay Changes in respiratory function Need for rescue therapy in case of clinical deterioration Sample Size The study will recruit 32 patients (16 historical group and 16 interventional group), calculated to detect significant differences in MG-ADL improvements with a significance level of 0.05 and power of 0.80.\n\nPatient Recruitment Patients with a confirmed diagnosis of MG who present to the neurology department will be recruited and randomly assigned to either the efgartigimod treatment group or the historical control group receiving standard care (IVIG\u002FPLEX).\n\nInclusion Criteria Adults \\> 18 years Confirmed MG diagnosis with generalized weakness (MGFA class II-V) Positive AchR or MuSK antibodies Evidence of myasthenic crisis Informed consent Exclusion Criteria Contraindications to efgartigimod Significant comorbidities affecting study participation Prior exposure to efgartigimod Ongoing infections or conditions exacerbating MG symptoms Recent major surgery or significant renal\u002Fhepatic dysfunction Planned Protocol Administer efgartigimod intravenously at 10 mg\u002Fkg weekly for four weeks. Total trial duration: 12 months for enrollment and treatment, followed by a 14-month follow-up.",[265],"Myasthenia Gravis Crisis",[265],"2024-11-13",{"date":269,"type":36},"2024-11-14",{"date":271,"type":20},"2024-11-15",{"date":273,"type":20},"2025-03-30",{"name":42,"class":43},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":237,"sex":238,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100544717","oxytocin-in-multiparous-women-100544717","NCT06372522","Oxytocin in Multiparous Women","Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women","Inclusion Criteria:\n\n* multiparous women (women who have given birth one or more times in the past) with a singleton pregnancy that are admitted for induction of labor.\n* Women at gestational age of 370\u002F7 or more.\n* Vertex presentation.\n\nExclusion Criteria:\n\n* Age 18 and under.\n* High order gestation.\n* Women with contraindication for vaginal delivery.\n* Previous cesarean delivery.\n* Active labor.\n* Documented fetal anomalies.",{"count":283,"type":20},166,[23],"This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion.",[287],"Pregnancy Related","2024-04-17",{"date":290,"type":36},"2024-04-18",{"date":292,"type":20},"2024-04",{"date":294,"type":20},"2027-04",{"name":42,"class":43},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":312,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":322,"locationsCount":261},"100492962","low-dose-antenatal-corticosteroids-for-late-preterm-delivery-100492962","NCT05698966","Low Dose Antenatal Corticosteroids for Late Preterm Delivery","Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)","LoDAC","Inclusion Criteria:- - Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at risk for \u002F high probability of delivery in the late preterm period (34+0-36+5 weeks of gestation).\n\nCriteria for determination of late preterm delivery risk:\n\n1. Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement\n2. Spontaneous rupture of the membranes\n3. Expected preterm delivery for any other indication via induction or cesarean between 24 hours to 7 days after the planned randomization, as determined by the obstetric provider.\n\n   \\-\n\n   Exclusion Criteria: They had already received a full course of betamethasone.\n   * Expected delivery in less than 12 hours, irrespective of cause including: 1)ruptured membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 centimeters or more unless oxytocin was withheld for at least 12 hours (although other induction agents were allowed), 2) chorioamnionitis, 3) cervical dilation of 8 cm or more, and 4) evidence of non-reassuring fetal status requiring immediate delivery.\n   * Prior ACS treatment\n   * Current known or suspected infection ( viral, bacterial or other)\n   * Pre-gestational diabetes mellitus.\n   * Any infection that required antibiotics or hospitalization in the month prior to study allocation - Poor understanding of the inform consent language","45 Years",{"count":306,"type":20},1510,[23],"This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.",[310,311],"Respiratory Morbidity","Preterm Labor",[313,314,315],"corticosteroids","low dose","late prerterm","2024-04-09",{"date":318,"type":36},"2024-04-10",{"date":320,"type":36},"2022-01-01",{"date":117,"type":20},{"name":42,"class":43},{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":238,"minAge":17,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":44},"100531161","prognostic-value-of-conization-and-negative-hpv-after-conization-in-ais-and-early-stage-cervical-cancer-100531161","NCT06196190","Prognostic Value of Conization and Negative HPV After Conization in AIS and Early Stage Cervical Cancer","The Prognostic Value of Conization and Negative HPV Typing After Conization Prior to Surgical Intervention in Adenocarcinoma in Situ and Early Stage Cervical Cancer","Inclusion Criteria:\n\nAge Range: 18-85 years old Cervical cancer stage I B 2(Tumor up to 4 cm FIGO 2018) AIS HPV types before and after conization\n\nExclusion Criteria:\n\nPregnant women under 18 years old. Women who refused to continue to be in study. Women that data about HPV types , final pathology or complication are missing.","85 Years",{"count":332,"type":20},200,"In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma,\n\nAdeno-squamous carcinoma or AIS we want to examine prospectively:\n\n1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumor in the final pathology.\n2. To examine if conization in women with cervical tumor up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.",[335,336],"Cervix Cancer","HPV-Related Malignancy","2024-01-08",{"date":339,"type":36},"2024-01-09",{"date":341,"type":36},"2023-07-26",{"date":343,"type":20},"2028-07-01",{"name":42,"class":43},{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":237,"sex":238,"minAge":17,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":44},"100530024","time-of-oxytocin-initiation-at-2nd-stage-of-labor-and-adverse-outcomes-100530024","NCT06181396","Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes","Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes","Inclusion Criteria:\n\n1. Singleton pregnancy\n2. Maternal age ≥ 18 years' old\n3. Oxytocin administration initiated or renewed during second stage of labor\n\nExclusion Criteria:\n\n1. Maternal age \\\u003C 18 years' old\n2. Multiple gestation pregnancy\n3. Known fetal malformations\n4. Uterine scar",{"count":353,"type":20},120,[23],"Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.",[357,358],"Delivery Complication","Cesarean Delivery Affecting Fetus","2023-12-22",{"date":361,"type":36},"2023-12-26",{"date":363,"type":36},"2023-10-01",{"date":365,"type":20},"2026-10",{"name":42,"class":43},{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100314710","cva-in-patients-suffering-from-decreased-consciousness-confusion-or-headaches-to-an-emergency-room-100314710","NCT03377062","CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room","Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room","Inclusion Criteria:\n\nPatients arriving to the emergency room with decreased consciousness, severe headaches or dizziness\n\nExclusion Criteria:\n\nPregnant women",{"count":353,"type":20},"A CVA occurs when there is a sudden interruption of blood supply to the brain. Fast identification of CVA is crucial in order to refer the patient to an appropriate medical center as well as to direct him\u002Fher to a suitable treatment upon arrival to the Medical Center, in order to minimize the permanent damage to the brain. In this study, we are evaluating a tool for detecting CVA based on EEG (electroencephalograph) data analysis using innovative algorithm. The system is comprised of four electrodes, reference electrode and earphones for auditory stimulation. In the study, 120 patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness will be monitored for five-minute each, with EEG accompanied with auditory stimulation. The EEG analysis will be performed based on the synchronization of the front and back hemispheres. During CVA, specific hemisphere is damaged, therefore desynchronization is expected. The purpose of this study is to develop a tool for identifying CVA in patients who have no clear CVA related signs.",[377],"CVA","2023-12-07",{"date":380,"type":36},"2023-12-08",{"date":382,"type":20},"2024-06-01",{"date":384,"type":20},"2026-12",{"name":42,"class":43},{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":330,"enrollmentInfo":393,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":44},"100526600","the-correlation-between-microbiome-of-esophageal-cancer-patients-and-post-esophagectomy-anastomotic-leaks-100526600","NCT06136845","The Correlation Between Microbiome of Esophageal Cancer Patients and Post Esophagectomy Anastomotic Leaks","microbiome","Inclusion Criteria:\n\n* Cancer patients who have a surgery sample at Rambam Pathology Department\n* Given written informed consent to Rambam BioBank or Midgam for collection, storage, collection of information and use for future research\n* Patients with non-metastatic esophageal cancer (mid\u002FSiewert 1\u002FSiewert 2) who developed esophageal leak\n* Patients with non-metastatic esophageal cancer (mid\u002FSiewert 1\u002FSiewert 2) who had no post-op complication.\n\nExclusion Criteria:\n\n• Patients who had complete response are excluded due to lack of tumoral tissue in the specimen for analysis",{"count":394,"type":20},300,"Esophageal cancer continues to be one of the most challenging topics and the subjects of numerous studies. Surgery is the mainstay for curative treatment and the need to improve all aspects of perioperative management in order to reduce morbidity and mortality, continues to be of immense importance.\n\nCited as the sixth most common cause of cancer-related death worldwide, esophageal cancer has a distinct geographic distribution known as the esophageal cancer belt: north central China through the central Asian republics to northern Iran, and from eastern to southern Africa.\n\nSquamous-cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer, in a geographic differentiation as well, with squamous-cell carcinoma as the most common esophageal cancer subtype worldwide. Though adenocarcinoma is at a considerable rise in Western populations and has become the predominant subtype North America, Australia and Europe.\n\nAlthough an ongoing improvement has been marked in the long-term survival after esophagectomy, it is still a highly invasive procedure with serious post-operative complications and entails a high morbidity and mortality rates.\n\nRates of mortality and morbidity range vastly in the literature with 30-day mortality reaching 11-22%. Complication rates up to 50%, with anastomotic leaks as the main complication ranging widely 0-35%.\n\nVarious risk factors have been proposed as contributors to mortality and morbidity in general and to anastomotic leaks in particular. These include both patient and tumoral characteristics such as premedical history and perioperative factors as tumor location, surgical technique and perioperative treatment.\n\nThe microbiome as a contributor to a patients' disease progression and management is of great interest in the understanding and better management of cancer patients as a whole and of the gastrointestinal tract in specific.\n\nThe contribution of the microbiome of a patient to colorectal cancer progression and to anastomotic leaks in the post-operative period has been addressed vastly in the literature in recent years, showing a distinct correlation to specific microbiota profile. Shogan et al. depicted a potential molecular mechanism of bacterial-driven anastomotic leak. It was shown that strains of the commensal organism Enterococcus faecalis could cause anastomotic leakage by causing direct collagen degradation at the site of a freshly constructed anastomosis, and indirectly by bacterial-induced over activation of host matrix metalloproteinase 9 (MMP9).\n\nA geographic differentiation in microbiota of Colorectal Cancer (CRC) was also shown by comparing tumor tissue and adjacent tissue of Colorectal Cancer patients from the US and Spain, elaborating yet another aspect of the importance of microbiome of cancer patients.\n\nOropharyngeal microbiome profiling has been proven as a possible predictor for post esophagectomy pneumonia projecting on overall survival as well.\n\nA recent study by Rishindra et al from the university of Michigan shows a strong correlation of post esophagectomy anastomotic leaks and increased bacterial variance in preoperative oral and gastric flora.\n\nWe hypothesize that a correlation exists between microbiome of esophageal cancer patients and post esophagectomy anastomotic leaks.\n\nAccording to former evidence microbiota are integrated into the tumor and therefore the microbial profile of the host (patient) may be represented by tumor microbiota.\n\nIn this proposed study, we intend to characterize retrospectively the microbial signature of esophageal tumors and to study whether there is a correlation between differential microbial signature and risk of post esophagectomy anastomotic leaks.",[397],"Esophageal Tumors","2023-11-13",{"date":400,"type":36},"2023-11-18",{"date":402,"type":36},"2020-01-13",{"date":40,"type":20},{"name":42,"class":43},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":237,"sex":238,"minAge":17,"maxAge":304,"enrollmentInfo":412,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":4},"100510105","cervical-ripening-balloon-for-12-hours-vs-1-hour-100510105","NCT05922111","Cervical Ripening Balloon for 12 Hours vs. 1 Hour.","Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Nulliparous or multiparous gravidas\n2. Gestational age ≥ 370\u002F7 to 416\u002F7 gestational weeks\n3. Age 18-45\n4. Signed informed consent\n\nExclusion Criteria:\n\n1. Contraindications for vaginal delivery\n2. Multifetal gestation\n3. Rupture of membranes\n4. Bishop score \\> 6\n5. The cervix is dilated to more than 2 cm\n6. Previous caesarean delivery",{"count":413,"type":20},164,[23],"The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.\n\nWomen admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.",[417],"Induction of Labor","2023-06-18",{"date":420,"type":36},"2023-06-28",{"date":422,"type":20},"2023-08-01",{"date":424,"type":20},"2026-06-30",{"name":42,"class":43},{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":238,"minAge":17,"maxAge":304,"enrollmentInfo":433,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":442,"locationsCount":4},"100501691","a-novel-device-for-gestational-diabetes-control-100501691","NCT05812547","A Novel Device for Gestational Diabetes Control","A Novel Device for Gestational Diabetes Control, a Randomized Control Trial","Inclusion Criteria:\n\n1. Gravidas aged 18-45 years\n2. Singleton pregnancy\n3. Diagnosed with GDM in current pregnancy\n4. First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation\n5. Not treated with diabetes-related medications\n\nExclusion Criteria:\n\n\\-\n\nMedications:\n\n1. Insulin and medications for glycemic control\n2. Antipsychotics\n3. Diuretics\n4. Corticosteroids\n5. Oncologic treatment\n\nConditions:\n\n1. Previous diagnosis of diabetes\n2. Renal disease\n3. Hepatic disease\n\nPersonal requirements:\n\n1. Inability to read and understand English\n2. Inability to use a smartphone\n3. Any issues arise with using the Lumen device and application\n4. Aerobic exercise \\> 3 times per week",{"count":353,"type":20},[23],"Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in lifestyle or medication. Several studies have demonstrated the effectiveness of mobile apps in improving obstetric outcomes in GDM. In addition, the LUMEN device is a breathing device that produces dietary and exercise recommendations based on CO2 levels and improves metabolic parameters in patients with type 2 diabetes. No work has been done on its effectiveness in treating GDM. Aims of the study: Comparison of metabolic outcomes in women with gestational diabetes, with or without the use of LUMEN app. Design: This will be an open label parallel group 1:1 randomized-controlled trial Methods: the investigators will recruit women diagnosed with GDM. The women will be randomized to the intervention arm that will use the LUMEN device and app or to the control arm that will use a free mobile tracking app. The women will be required to monitor their blood sugar levels daily and to have GDM follow-up in the feto-maternal outpatient clinic, as is customary in GDM. After the birth, the maternal and neonatal outcome will be recorded. Based on past research data, a recruitment of 170 is needed to demonstrate a 16.7% decrease in insulin use to balance diabetes, with α = 0.05 and β = 80.",[437],"Gestational Diabetes Mellitus",{"date":439,"type":36},"2023-06-22",{"date":422,"type":20},{"date":424,"type":20},{"name":42,"class":43},{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":238,"minAge":17,"maxAge":330,"enrollmentInfo":449,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":44},"100497162","early-phase-1-a-pilot-study-of-monitoring-insulin-levels-and-treating-hyperinsulinemia-and-hyperglycemia-with-pioglitazone-in-patients-treated-with-alpelisib-for-metastatic-breast-cancer-100497162","NCT05753657","A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.","Inclusion Criteria:\n\n* Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.\n* Ages 18 - 85\n* ECOG performance status 0, 1 or 2\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib\n* Uncontrolled diabetes mellitus, defined as HbA1c above 8%\n* Diabetes mellitus controlled by insulin\n* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnancy\n* Known allergy to pioglitazone",{"count":19,"type":20},[451],"EARLY_PHASE1","The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.",[454,455,456],"Metastatic Breast Cancer","Hyperinsulinism","Hyperglycemia Drug Induced","2023-02-22",{"date":459,"type":36},"2023-03-03",{"date":461,"type":36},"2022-12-25",{"date":40,"type":20},{"name":42,"class":43},{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":237,"sex":16,"minAge":470,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":44},"100253249","exercise-capacity-in-diseases-and-health-100253249","NCT02575469","Exercise Capacity in Diseases and Health","Inclusion Criteria:\n\n* Ability to complete full exercise evaluation (including cardiopulmonary exercise testing).\n\nExclusion Criteria:\n\n* Acute illness on visit day.\n* for healthy volunteers: chronic disease or use of medications.\n* Professional athletes.","6 Years","90 Years",{"count":473,"type":20},500,"Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g. ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way to measure exercise capacity is to perform a cardiopulmonary exercise testing. Normal\u002Freference values in health and disease relate to specific population and subpopulations. The population in Israel is unique in its diversity.\n\nObjectives: Data collection of exercise capacity assessment in health and illness in the northern of Israel for future local database.\n\nPopulation: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.\n\nStudy design: Prospective observational study. Participants will answer a health related questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a treadmill or a cycle ergometer.",[476],"Exercise Capacity","2017-01-23",{"date":479,"type":20},"2017-01-24",{"date":481,"type":20},"2017-10-01",{"date":483,"type":20},"2036-01-01",{"name":42,"class":43},""]