[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"new-onset\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:new-onset":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100597675","phase-1-a-randomized-phase-12-trial-of-low-dose-anti-thymocyte-globulin-atg-with-subsequent-adalimumab-or-verapamil-in-new-onset-type-1-diabetes-100597675",false,"NCT07061574","A Randomized Phase 1\u002F2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes","WAVE T1D","Key Inclusion Criteria:\n\nRecent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.\n\n* At least one positive T1D auto-antibody.\n* If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.\n* Insulin auto-antibodies are only considered if exogenous insulin use is \\\u003C10 days when blood is drawn.\n* Must have stimulated C-peptide levels ≥0.2 pmol\u002FmL measured during MMTT conducted prior to randomization.\n* Age 9 to \\\u003C21 years at the time of randomization.\n* Body weight \\>30kg.\n* BMI \\\u003C95th percentile for age and gender.\n* Willing to comply with intensive diabetes management.\n* Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.\n* Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral\u002Finjection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.\n* Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.\n* Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.\n* Willing to provide informed consent and child assent as applicable.\n* Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.\n* Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).\n* Must be fully vaccinated for age.\n* Must have been vaccinated for flu (if currently in flu season).\n* Must be willing to not receive live vaccines throughout the treatment period.\n* Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.\n\nKey Exclusion Criteria:\n\n* Prior treatment with ATG or known allergy to ATG or rabbit-derived products.\n* Local lab draw at screening:\n* Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\\\u003C3,000 leukocytes \u002FμL), neutropenia (\\\u003C1,500 neutrophils\u002FμL), lymphopenia (\\\u003C800 lymphocytes\u002FμL).\n* Thrombocytopenia (\\\u003C100,000 platelets\u002FμL) or anemia (hemoglobin \\\u003C 10g\u002FdL).\n* Leukocytosis (\\>14,000\u002FmL)\n* Infections:\n* Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization.\n* Have active signs or symptoms of acute infection at the time of randomization.\n* Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON), or a positive test for latent tuberculosis.\n* Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n* History of serious bacterial, viral, fungal, or other opportunistic infections.\n* Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization.\n* Have positive CMV and\u002For EBV PCR test within 30 days prior to randomization.\n* Have positive COVID-19 self-antigen test within 3 days of randomization.\n* History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology).\n* Blood pressure (either systolic or diastolic) \\\u003C5th percentile for age, gender, and height on two out of three measurements.\n* Pulse \\\u003C2nd percentile for age and gender on two out of three measurements.\n* History of vasovagal syncopal episodes related to hypotension.\n* History of malignancies other than of skin.\n* Use of medications likely to interfere with study results:\n* Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only).\n* Current or previous use of Teplizumab.\n* Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed.\n* Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine.\n* Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization.\n* Any known hypersensitivity reaction to any of the study medications or their components.\n* Unable to swallow pills (tested with an inert imitation tablet in clinic at screening).\n* History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing.\n* Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor).\n* Established history of allergy or severe reaction to adhesive or tape that must be used in the study.\n* Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm.\n* Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:\n* Alcohol or drug abuse\n* Untreated or inadequately treated mental illness\n* Liver disease or LFTs \\>2x ULN.\n* Renal disease or creatinine greater than 1.5x ULN.\n* Other autoimmune diseases except for stable and treated hypothyroidism\n* Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet).\n* Nervous system disorder including but not limited to Guillain-Barre\n* Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy.\n* History of multiple abdominal surgeries and\u002For at increased risk for bowel obstruction.\n* Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease).\n\nAny lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\n\\-","ALL","9 Years","20 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\\u003C21 with recent-onset stage 3 T1D.",[28,29],"Type 1 Diabetes","New Onset",[31],"ATG, Verapamil, Adalimumab","RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-02","ACTUAL",{"date":38,"type":36},"2026-03-10",{"date":40,"type":21},"2031-04-15",{"name":42,"class":43},"City of Hope Medical Center","OTHER",11,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100630043","role-of-dexmedatomidine-drug-in-prevention-of-atrial-fibrillations-post-mitral-valve-surgery-100630043","NCT07482540","Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery","The Prophylactic Role of Dexmedetomidine Drug in Reducing Early Postoperative New Onset Atrial Fibrillation After Mitral Valve Surgery - a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nAdult patients aged 21 years or older. American Society of Anesthesiologists (ASA) physical status II-III. Patients able to provide written informed consent.\n\nExclusion Criteria:\n\nHistory of cardiac arrhythmias: atrial fibrillation or any other clinically significant cardiac tachyarrhythmias.\n\nAny degree of atrioventricular block or presence of permanent pacemaker and bradycardia (heart rate \\\u003C 60 beats\u002Fmin) or hemodynamic instability.\n\nEmergency mitral valve surgery. Left ventricular dysfunction (ejection fraction \\\u003C 55%) Ischemic heart disease patients. Severe hepatic or renal impairment. Known hypersensitivity or contraindication to dexmedetomidine. Chronic use of class I or class III anti-arrhythmic drugs","21 Years",{"count":54,"type":21},140,[56],"NA","Recently, dexmedetomidine has been suggested as an alternative agent for sedation in tachyarrhythmias due to its antiarrhythmic properties through decreased catecholamine release, prolonged refractory period, and increased vagal tone. In addition, dexmedetomidine is a highly selective agonist that does not interact with the gamma-aminobutyric acid (GABA) receptors. Thus, its analgesic properties are opioid sparing, which is unique among traditional ICU sedatives and avoids the issue of respiratory depression with over-sedation.\n\nOur aim: To evaluate the potential prophylactic effect of perioperative dexmedetomidine in reducing the incidence of early postoperative new onset atrial fibrillation following mitral valve surgery.",[29,59],"Atrial Fibrillation","NOT_YET_RECRUITING","2026-03-14",{"date":63,"type":36},"2026-03-19",{"date":65,"type":21},"2026-06-01",{"date":67,"type":21},"2027-12-31",{"name":69,"class":43},"Ain Shams University"]