[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Indian Council of Medical Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,80],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100601715","development-validation-and-evaluation-of-a-deprescribing-tool-100601715",false,"NCT07114094","Development, Validation and Evaluation of a Deprescribing Tool","Development and Validation of a Deprescribing Tool Relevant to the Indian Context and Evaluation of Its Effectiveness in Reducing Inappropriate Polypharmacy in the Elderly","Inclusion Criteria:\n\n* Elderly patients (≥ 60 years) of either sex, visiting the General Medicine\u002F Community and Family Medicine OPD of the study sites\n\nExclusion Criteria:\n\n* Patients not willing to participate in the study","ALL","60 Years",{"count":19,"type":20},1650,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn if a deprescribing tool can help in reducing prescriptions with potentially inappropriate medications (PIMs), in the Indian elderly population. The main question it aims to answer is- Can inappropriate polypharmacy in elderly patients be reduced through development and implementation of a deprescribing tool relevant to the Indian context? Researchers will compare control arm outcome parameters to see if there is a reduction in Proportion of prescriptions with at least one PIM ( Primary outcome parameter).\n\nParticipating Prescribers ( Physicians) will be randomized to Control or Intervention arms. Particpating patients will not be randomized, and will receive routine consultation with a Physician who does not use the Deprescribing Tool (Control arm) or a prescriber who uses the Deprescribing tool ( Intervention Arm)",[26],"Elderly",[28,29,26],"Deprescribing Tool","Polypharmacy","RECRUITING","2025-08-09",{"date":33,"type":34},"2025-08-14","ACTUAL",{"date":36,"type":34},"2025-05-01",{"date":38,"type":20},"2026-09",{"name":40,"class":41},"Indian Council of Medical Research","OTHER_GOV",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100545092","phase-3-selective-antibiotics-when-symptoms-develop-versus-universal-antibiotics-for-preterm-neonates-100545092","NCT06377397","Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates","Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates At-risk of Early-onset Bacterial Sepsis: a Multicentric, Randomized, Controlled, Non-inferiority Trial (the SAUNA Trial)","SAUNA","Inclusion criteria:\n\n* Gestational age of 26 to 34 weeks\n* Chronological age 4 hours\n* Have any one or both of the following risk factors of EONS:\n\n  * Prolonged rupture of membranes \\>18 hours\n  * Pre-labour rupture of membranes \\[as all subjects will be preterm, this is effectively pPROM\\]\n* Are either asymptomatic or have no signs attributable to sepsis at 4 hours. This will be defined as absence of the following clinical signs or need for interventions mentioned below:\n\n  1. Apnea (Standard definition) requiring intervention at any time until enrolment.\n  2. Need for a fluid bolus or inotropic support at any time until enrolment.\n  3. Seizures or seizure-like activity at any time until enrolment.\n  4. Upper GI bleed in the absence of a history of ante-partum hemorrhage at any time until enrolment.\n  5. Pus from any site at any time until enrolment.\n  6. Need for CPAP \\>6 cms of water with FiO2 \\>35% at 6-8 hours OR need for CPAP £6 cms and FiO2 £35% but with increasing requirement of support\\*\\*\n  7. Chest Xray (if performed) with radiological features of pneumonia.\n  8. Need for intubation and mechanical ventilation.\n  9. Temperature \\>37.5°C or \\\u003C36°C, unexplained by environmental causes\n  10. Feed intolerance \\[bilious or bloodstained vomiting (or gastric residuals) or visibly distended abdomen or \\>50% of the previous feed volume as gastric residuals\\]\n  11. Lethargy or unarousability\n  12. Sclerema\n\n      Exclusion Criteria:\n\n      Subjects will be excluded if they have any 1 of the following:\n\n  \u003C!-- -->\n\n  1. Life-threatening congenital malformation\n  2. Severe perinatal asphyxia (Apgar score \\\u003C5 at 10 minutes or cord pH \\\u003C7.0)\n  3. Clinical chorioamnionitis# \\[see definition below\\]\n  4. Foul-smelling liquor\n  5. Multiple gestation\n  6. Received a dose of antibiotics\n  7. Positive amniotic fluid culture (if performed and available prior to randomization)\n  8. Treating neonatologist unwilling to enroll the patient in the trial on the grounds that the patient needs antibiotics.\n\n     \\-","0 Hours","4 Hours",{"count":54,"type":20},1500,[56],"PHASE3","Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.\n\nThe goal of this research study is to find out:\n\n1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.\n2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.\n3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under \"Outcomes\").",[59,60,61,62,63],"Sepsis","PROM, Preterm (Pregnancy)","Early-Onset Neonatal Sepsis","Preterm Premature Rupture of Membrane","Preterm Birth",[65,66,67,68,69],"Prolonged rupture of membranes","Preterm premature rupture of membranes","Early-onset neonatal sepsis","Selective antibiotics","Non-inferiority trial","NOT_YET_RECRUITING","2024-04-17",{"date":73,"type":34},"2024-04-22",{"date":75,"type":20},"2024-04-15",{"date":77,"type":20},"2028-04-14",{"name":40,"class":41},1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":79},"100509738","phase-3-intensified-short-course-regimen-for-tbm-in-adults-100509738","NCT05917340","Intensified Short Course Regimen for TBM in Adults","Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis : an Open-label Randomized Controlled Trial","INSHORT","Inclusion Criteria:\n\nA patient will be eligible for entry to the trial if ALL of the following conditions are satisfied\n\n1. Adults (\\> 18 years) with or without HIV infection\n2. Possible, probable or definite TBM according to Lancet consensus diagnostic criteria\n3. Willing to give written informed consent\n4. Is willing to have an HIV test.\n5. Residing within 100 km of the study sites\n6. Express willingness to attend the treatment centre for supervised treatment\n7. Express willingness to adhere to the trial procedures and follow-up schedule.\n8. Agrees to use effective barrier contraception during the period of the treatment in case of female participants\n\nExclusion Criteria:\n\nPatients will not be eligible for the trial if they meet ANY of the following criteria\n\n1. Known current\u002Fprevious drug resistance to ATT (Rifampicin, INH, FQ)\\*\\*\n2. Concurrent or known diagnosis any other meningitis such as bacterial, viral, and fungal.\n3. Currently having an uncontrolled cardiac arrhythmia or ECG abnormalities which are contradiction for the administration of moxifloxacin including prolonged QTc. QTc value define as \\>450 ms in males and \\>460 ms in females measured in lead II or V5 on a standard 12-lead ECG.\n4. Has clinical icterus or hepatic impairment characterized by serum bilirubin level above the normal laboratory reference range with abnormal liver enzymes, or isolated alanine aminotransferase (ALT) and\u002F or aspartate aminotransferase (AST) levels above 5 times the upper limit of the normal laboratory reference range\n5. Previous history of anti-TB treatment, If any, should not exceed one month in the past and not more than 7 days in the preceding one month.\n6. pregnant or lactating women\n7. rapid clinical deterioration or very sick and moribund during the screening process, renal failure, liver disease or any condition (social or medical) that in the opinion of the investigator would make trial participation unreliable or unsafe.\n8. Has a known allergy to any of the drugs proposed to be used in the trial regimen\n\n   * All participants with Rifampicin resistance will be excluded at baseline from the study. Participants with H, FQ and Z resistance identified from MGIT results done at baseline will be referred back to NTEP for appropriate management and their numbers will be compensated.","18 Years",{"count":90,"type":20},372,[56],"Tuberculous meningitis (TBM) is the most lethal form of extra pulmonary tuberculosis. This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors. TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice. High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades. However, evidence from such clinical trials is lacking in TBM and the treatment remains uncertain. There is a significant variation in the choice, dose and duration of drugs between countries, institutions and clinicians. Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin, and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids. Controls will receive standard treatment as per national guidelines for TBM. The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT (Rifampicin, INH, Moxifloxacin and Pyrazinamide) in CSF between the two groups",[94],"Tuberculous Meningitis","2023-12-20",{"date":97,"type":34},"2023-12-21",{"date":99,"type":20},"2024-03",{"date":101,"type":20},"2027-09",{"name":40,"class":41},""]