[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Paraguay\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":397},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,48,97,123,147,175,196,218,241,265,290,313,336,370],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100478314","lumbar-operatively-inserted-perqdisc-artificial-implant-following-nulcectomy-lopain2-100478314",false,"NCT05508360","\"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy\" (LOPAIN2)","LOPAIN2","Inclusion Criteria:\n\n* Patient is skeletally mature aged 22-70.\n* Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.\n* Patient has adequate disc height (6mm) at the level to be treated\n* Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).\n* Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40\u002F100)\n* Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)\n* Patient has signed the approved Informed Consent Form.\n* All surgeries must be approved by the Medical Advisory Board (MAB)\n\nExclusion Criteria:\n\n* Patient has less than 6 mm of disc height.\n* Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).\n* Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.\n* Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.\n* Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.\n* Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).\n* Patient has any known active malignancy.\n* Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.\n* Patient has active or local systemic infection.\n* Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV.\n* Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.\n* Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.\n* Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.\n* Patient has a known allergy to silicone or barium sulfate.\n* Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.\n* Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).\n* Patient has motion of less than 3 degrees on pre-operative lateral flexion\u002Fextension radiographs.\n* Patient belongs to a vulnerable population or has a condition such that his\u002Fher ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally, disabled, prisoner, chronic alcohol\u002F substance abuser)\n\nIntraoperative Exclusion Criteria:\n\n* Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.\n* Patient has a violated endplate as determined by imaging balloons during fluoroscopy.\n* Patient has a disc space that is too narrow for implantation. MIPL Specific\n* Poor radiological visualization of Kambin's triangle.\n* Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite or repositioning instruments.","ALL","22 Years",{"count":19,"type":20},72,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.",[26,27],"Degenerative Disc Disease","Chronic Low-back Pain",[26,29,30,31,32,33,34],"DDD","Chronic Low Back Pain","cLBP","Disc Herniation","Nucleus Replacement","Low Back Pain","RECRUITING","2026-07-24",{"date":38,"type":39},"2026-07-27","ACTUAL",{"date":41,"type":39},"2022-08-22",{"date":43,"type":20},"2030-08-22",{"name":45,"class":46},"Spinal Stabilization Technologies","INDUSTRY",11,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100638557","phase-4-efficacy-safety-and-tolerability-of-tirzepatide-in-real-world-conditions-in-paraguay-100638557","NCT07588438","Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.","Prospective Cohort Study to Evaluate the Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Persons With Obesity Without Diabetes and Type 2 Diabetes Mellitus With or Without Obesity in Paraguay.","REAL-TIRZEPY","Inclusion Criteria:\n\n* Age between 18 and 70 years at the time of informed consent.\n* Stable residence in Paraguay for at least 12 months prior to screening.\n* Ability to provide written informed consent and comply with all study procedures.\n* Sufficient proficiency in the Spanish language to complete questionnaires and follow study instructions.\n* Clinical stability, defined as the absence of hospitalization related to diabetes or obesity complications within 3 months prior to screening.\n* Adequate renal function, defined as an estimated glomerular filtration rate (eGFR) ≥45 mL\u002Fmin\u002F1.73m² calculated using the CKD-EPI equation.\n* For participants enrolled in the obesity cohort: clinical diagnosis of obesity with BMI ≥30 kg\u002Fm², no prior diagnosis of diabetes mellitus (HbA1c \\\u003C6.5%), and at least one documented unsuccessful attempt at dietary weight-loss intervention within the previous 12 months.\n* For participants enrolled in the type 2 diabetes mellitus (T2DM) cohort: established diagnosis of T2DM for at least 6 months prior to screening according to ADA 2025 criteria, HbA1c between 7.0% and 9.5% at screening confirmed at baseline, BMI ≥24 kg\u002Fm², and stable treatment on monotherapy or dual therapy with metformin, sulfonylureas, DPP-4 inhibitors, or SGLT-2 inhibitors for at least 3 months prior to screening.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus or secondary causes of diabetes.\n* History of diabetic ketoacidosis within 12 months prior to screening.\n* Current or recent use (within 3 months prior to screening) of GLP-1 receptor agonists or dual GIP\u002FGLP-1 receptor agonists.\n* Current or prior use of insulin therapy for the management of diabetes.\n* Clinically significant untreated thyroid dysfunction, including hypothyroidism or hyperthyroidism.\n* Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.\n* Major adverse cardiovascular event (MACE), including acute myocardial infarction, stroke, or hospitalization for heart failure within 6 months prior to screening.\n* Heart failure classified as New York Heart Association (NYHA) Functional Class III or IV.\n* Uncontrolled hypertension, defined as systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite optimal antihypertensive therapy.\n* History of acute or chronic pancreatitis.\n* Active inflammatory bowel disease or prior bariatric surgery.\n* Clinically significant diabetic gastroparesis or other gastrointestinal motility disorders that may interfere with the absorption of concomitant oral medications.\n* Use of systemic corticosteroids for more than 14 consecutive days within 3 months prior to screening.\n* Treatment with oral anti-obesity medications (including orlistat, phentermine, naltrexone\u002Fbupropion, or topiramate) within 3 months prior to screening.\n* Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening.\n* Moderate to advanced chronic kidney disease defined as eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² or requirement for dialysis.\n* Active liver disease or transaminase levels (ALT\u002FAST) greater than 3 times the upper limit of normal.\n* Active malignancy or history of cancer within the previous 5 years, except for completely resected basal cell or squamous cell skin carcinoma.\n* Uncontrolled major psychiatric disorders or history of suicide attempt within the previous 2 years.\n* Confirmed or suspected pregnancy, including positive serum beta-hCG test at screening, or active breastfeeding.\n* Intention to become pregnant during the study period.\n* Women of childbearing potential unwilling to use effective contraceptive methods (hormonal, intrauterine, or dual-barrier) throughout the study and for 3 months after the final dose.","18 Years","70 Years",{"count":59,"type":20},160,[61],"PHASE4","This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population. The study includes two cohorts: Cohort 1 consists of adults with obesity (BMI ≥30 kg\u002Fm²) without type 2 diabetes mellitus (T2DM), and Cohort 2 consists of adults with T2DM with or without obesity. Each cohort will enroll 80 participants (160 total). All participants will receive tirzepatide as part of their standard clinical care and will be followed for 52 weeks with visits approximately every 6 weeks. Primary outcomes include percentage change in body weight from baseline at week 52 (Cohort 1) and change in HbA1c and body weight at week 52 (Cohort 2). Safety outcomes include adverse event rates. The study is conducted at Las Rias Medical Center, Asuncion, Paraguay, and has been approved by the CEI-INCAN Ethics Committee and authorized by DINAVISA.",[64,65],"Obesity","Diabetes Mellitus, Type 2",[67,68,69,70,71,64,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86],"Tirzepatide","GIP Receptor Agonist","GLP-1 Receptor Agonist","Incretin-based Therapy","Dual Agonist","Overweight","Type 2 Diabetes Mellitus","Metabolic Syndrome","Weight Loss","Real-World Evidence (RWE)","Real-World Data","Prospective Cohort Study","Post-Marketing Surveillance","Observational Study","Paraguay","Latin America","South American Population","Body Composition","HbA1c Reduction","Adverse Events Monitoring","2026-05-17",{"date":89,"type":39},"2026-05-19",{"date":38,"type":20},{"date":92,"type":20},"2027-08-10",{"name":94,"class":95},"Las Rías Medical Center","OTHER",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":96},"100635671","stargraft-10401-pilot-100635671","NCT07555717","STARgraft (10401) Pilot","STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot","Inclusion Criteria:\n\n1. Adult patients, 18 years or older.\n2. Patient has given informed consent to participate in the trial.\n3. Stated willingness to comply with all trial procedures and availability for the duration of the trial.\n4. Able to effectively communicate with trial personnel.\n5. Indicated patient population (end stage renal disease).\n6. Candidate for a new AV graft placed in the upper arm and judged to need dialysis within 2 months. Patient may have a failed access at a different anatomical location.\n7. Life expectancy judged to be at least 2 years with consideration of patient frailty.\n8. Axillary vein approximately 7 mm in diameter or greater.\n9. Brachial artery approximately 4 mm in diameter or greater.\n10. Acceptable cardiac risk level (cardiac output ≥ 3.5 l\u002Fmin, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%).\n11. Systolic blood pressure equal to or greater than 120 mmHg.\n12. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and\u002For venogram.\n\nExclusion Criteria:\n\n1. Unable or unlikely to comply with trial protocol and\u002For follow-up.\n2. Pregnancy.\n3. Previous history of Peritoneal Dialysis treatment within the last 2 months\n4. Central venous catheter located on same side as intended implant location.\n5. Clinical morbid obesity (BMI \\> 40).\n6. Anatomical limitations, including issues discovered intraoperatively during vessel exposure.\n7. Immunodeficiency syndrome.\n8. History of hypercoagulation or bleeding disorders.\n9. Elevated platelet count \\> 1 million per microliter of blood.\n10. History of heparin-induced thrombocytopenia syndrome\n11. Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.\n12. Inadequate arterial flow or pressure proximal to the implant site.\n13. Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.\n14. Fever greater than 38°C.\n15. Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials.\n16. Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.\n17. Uncontrolled or poorly controlled diabetes.\n18. History or evidence of severe cardiac disease.\n19. Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.",{"count":105,"type":20},20,[23],"This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.\n\nThe study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft (10401) compared to the ePTFE controls in a prior study (NCT03916731) and to published results, over a period of 6 months. Additional data out to 36 months post-implantation may be captured.",[109],"End Stage Kidney Disease (ESRD)",[111,112,113],"Hemodialysis","Vascular Access","Arterio-venous Grafts (AVG)","2026-04-21",{"date":116,"type":39},"2026-04-29",{"date":118,"type":39},"2026-01-29",{"date":120,"type":20},"2028-12",{"name":122,"class":46},"Healionics Corporation",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":16,"minAge":56,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":96},"100584962","effect-of-ilex-paraguariensis-harvest-time-and-consumption-method-of-processed-yerba-mate-on-the-lipid-profile-100584962","NCT06896175","Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile","Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile of Consumes in the Department of Caaguazu, Paraguay","Inclusion Criteria:\n\n1. Individuals of both sexes, between 18 and 60 years of age, residing in the country, who consume prepared yerba mate.\n2. Consumers of mate or tereré and mate\u002Fterere who agree to consume the yerba mate samples provided by the research team, which will be masked from laboratory analysis.\n3. Two weeks of abstinence from consuming prepared yerba mate, either as mate or tereré, prior to randomization for the trial.\n4. Consume exclusively prepared yerba mate in the prescribed manner (quantity of yerba, frequency of consumption, and sips), either in its mate or tereré form independently, and for those who consume both forms daily.\n5. Do not change the yerba mate consumer's usual diet or regular physical activity during the trial period.\n6. Agree to know the laboratory results of the lipid profile only at the end of the trial (180 days after the start).\n\nExclusion Criteria:\n\n1. Individuals receiving lipid-lowering treatment at the start of the trial.\n2. Consuming any other type of yerba mate not provided by the principal investigator.\n3. Individuals requiring vitamins as a nutritional supplement.\n4. Individuals taking thermogenic supplements.\n5. Individuals consuming cooked mate.\n6. Addiction to medicinal plants or herbs, both mate and tereré.\n7. Individuals with a personal history of coronary artery disease.",true,"60 Years",{"count":133,"type":20},198,[23],"Introduction: This project studies the impact of Ilex paraguariensis harvest time, commonly known as yerba mate, and its consumption mode (mate, tereré, and mate\u002Fterere) on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Yerba mate is rich in bioactive compounds such as polyphenols, xanthines, and saponins. There are no clinical trials conducted in Paraguay with our Ilex paraguariensis plantations that have analyzed the influence of harvest time on the yerba mate production process and the infusion mode, in relation to its effect on dyslipidemias. General Objective: To establish the effectiveness of Ilex paraguariensis harvest time and the mode of consumption of the produced yerba mate on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Methodology: The research approach will be quantitative, using a triple-blind randomized clinical trial design. Participants will be regular consumers of yerba mate, divided into groups based on harvest time (beginning or end of the harvest) and consumption mode (mate, tereré, or both). Lipid profile measurements will be taken at baseline and at 30, 90, and 180 days after consumption. Yerba mate samples will be analyzed and classified according to their bioactive properties before being blinded to the researchers and participants. Expected results: a report on the social, cultural, and anthropometric characterization of regular consumers of mate and tereré, and a report on the concentrations of the bioactive properties of yerba mate; polyphenols, xanthines, saponins from Ilex paraguariensis harvested at the beginning and end of the harvest and the database of patients with baseline lipid profile results, at 30, 90, and 180 days of mate and tereré consumers with yerba mate prepared randomly according to the harvest time of the Ip (beginning or end of harvest) analyzed.",[137],"Lipid Metabolism Disorders","2026-04-15",{"date":140,"type":39},"2026-04-16",{"date":142,"type":39},"2026-02-01",{"date":144,"type":20},"2026-10-01",{"name":146,"class":95},"Universidad Nacional de Caaguazu",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":155,"minAge":56,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":96},"100632958","prevention-and-mass-screening-of-tb-in-prisons-in-paraguay-100632958","NCT07520448","Prevention and Mass Screening of TB in Prisons in Paraguay","Prevention and Mass Screening of TB in Prisons in Paraguay (PRESMAP-TB)","PRESMAP-TB","Inclusion Criteria:\n\n1. Be a person deprived of liberty (PDL) residing in one of the participating penitentiary centers during the study period.\n2. Be 18 years of age or older at the time of enrollment.\n3. Be present in the penitentiary facility at the time of a screening round or enter the facility during the study period.\n4. Provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Are currently undergoing treatment for active tuberculosis at the time of the screening round.\n2. Have a medical condition that, in the opinion of the clinical staff, prevents the safe performance of the planned diagnostic procedures.","MALE","65 Years",{"count":158,"type":20},4500,[23],"The goal of this interventional study is to evaluate three tuberculosis (TB) screening and prevention strategies in prisons in Paraguay. The main questions it aims to answer are:\n\n* Which strategy is more effective for reducing the incidence rate of active TB?\n* Which strategy is more effective for reducing the TB infection rate?\n* Are these strategies safe, feasible, and cost-effective in prison settings?\n\nResearchers will compare three cluster-based, non-randomized programmatic strategies implemented in three prisons. These strategies differ in the frequency of screening, the diagnostic methods used, and the approach to tuberculosis preventive therapy (TPT).\n\nParticipants will:\n\n* undergo informed consent and clinical evaluation\n* receive TB screening through symptom assessment, chest digital X-ray with CAD, and rapid molecular testing, depending on site strategy\n* undergo IGRA testing and preventive therapy assessment, depending on the assigned strategy\n* be followed for 18 months, with screening rounds every 6 months or annually depending on the prison",[162,163,164,165],"Tuberculosis (TB)","TB Infection","Prisoners","Epidemiology","NOT_YET_RECRUITING","2026-04-08",{"date":169,"type":39},"2026-04-14",{"date":171,"type":20},"2026-08-01",{"date":173,"type":20},"2028-12-31",{"name":146,"class":95},{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":130,"sex":16,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":96},"100633625","effect-of-consuming-a-mango-and-chia-based-beverage-on-modulating-the-intestinal-microbiota-in-obese-children-100633625","NCT07529119","Effect of Consuming a Mango and Chia-based Beverage on Modulating the Intestinal Microbiota in Obese Children","Inclusion Criteria:\n\n100 children aged 8-16 years from Paraguay, stratified by BMI (with\u002Fwithout excess weight).\n\nExclusion Criteria:\n\nAllergyc to mango or chia","8 Years","16 Years",{"count":184,"type":20},100,[23],"This randomized clinical trial evaluates the effect of a mango and chia-based beverage on gut microbiota modulation in 100 Paraguayan children aged 8-16 years with obesity. Participants will consume the intervention beverage for 6 weeks. Fecal samples will be collected before and after each intervention to analyze microbiota composition using 16S rRNA sequencing. This study aims to characterize the gut microbiota of Paraguayan children for the first time and assess whether this functional beverage can positively modulate intestinal bacteria as a potential strategy to address childhood obesity, which affects 1 in 3 school-age children in Paraguay.",[188],"Microbiota","2026-04-07",{"date":169,"type":39},{"date":192,"type":39},"2026-02-09",{"date":194,"type":20},"2026-07",{"name":146,"class":95},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":96},"100630814","safety-and-effectiveness-of-tirzepatide-in-patients-with-obesity-at-hospital-de-clnicas-paraguay-100630814","NCT07492563","Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay","Effectiveness and Safety of Tirzepatide (t.g.) in Patients Treated at the Obesity Unit of the Department of Endocrinology of the Hospital de Clínicas, Faculty of Medical Sciences, UNA: Phase 4 Study","Inclusion Criteria:\n\n* Age ≥18 years\n* BMI ≥27 kg\u002Fm² with weight-related comorbidities OR BMI ≥35 kg\u002Fm²\n* Clinical indication for tirzepatide per treating physician\n* Paraguayan citizenship or permanent residence\n* Residence in Asunción or Metropolitan Area or possibility to assist to regular visits\n* Ability to attend visits for 12 months\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes or secondary diabetes\n* Known hypersensitivity to tirzepatide\n* Personal or family history of medullary thyroid carcinoma or MEN 2 syndrome\n* Acute pancreatitis in last 12 months or chronic pancreatitis\n* Severe gastrointestinal disease\n* Bariatric surgery in last 12 months\n* Pregnancy or breastfeeding\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic impairment (Child-Pugh B or C)\n* Unstable cardiovascular disease\n* Active cancer (except non-melanoma skin cancer completely resected)\n* Current use of other GLP-1 receptor agonists\n* Participation in another interventional trial within 30 days",{"count":204,"type":20},300,"OBSERVATIONAL","This is a Phase 4 observational study evaluating the safety and effectiveness of tirzepatide (T.G.) manufactured by INDUFAR S.A. in 300 patients with obesity treated at the Obesity Unit of Hospital de Clínicas in Paraguay over 12 months. The primary objective is to assess the safety profile through monitoring adverse events. Secondary objectives include evaluating weight loss, metabolic parameters improvement, and treatment satisfaction in real-world clinical practice.",[64,73,208],"Overweight With Comorbidities","2026-03-19",{"date":211,"type":39},"2026-03-25",{"date":213,"type":20},"2026-03",{"date":215,"type":20},"2027-10",{"name":217,"class":46},"LABORATORIOS INDUFAR",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100519076","feasibility-study-of-the-tioga-tmvr-system-100519076","NCT06038838","Feasibility Study of the Tioga TMVR System","Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation","Inclusion Criteria:\n\n* Age 18 years or older\n* Symptomatic, moderate to severe (3+) or severe (4+) MR\n* NYHA Functional Classification ≥ II\n* Heart team concurs that the subject is non-ideal for surgical intervention or other available treatment options (e.g., TEER)\n* The subject or the subject's legal representative has been informed of the nature of the study, has agreed to return for post-procedure follow-up visits, and has provided informed consent\n\nExclusion Criteria:\n\n* LVEF \\\u003C 30%\n* LVEDD \\> 70 mm\n* Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, MAC) unsuitable for the Tioga TMVR System\n* Severe aortic valve stenosis or regurgitation\n* Severe right ventricular dysfunction or severe tricuspid valve disease\n* Evidence of intracardiac thrombus, vegetation, or mass\n* Prior mitral valve intervention\n* Prior prosthetic heart valve in any position\n* Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to enrollment\n* Any carotid surgery within 30 days prior to enrollment\n* Any open cardiac or vascular surgery (other than carotid surgery) within 90 days prior to enrolment\n* Myocardial infarction within 30 days prior to enrollment\n* Cardiac resynchronization therapy (CRT) device implanted within 30 days of enrollment\n* History of endocarditis within 6 months prior to enrollment or evidence of active systemic infection or sepsis.\n* Planned cardiovascular procedure within 30 days of enrolment\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days of enrollment\n* Active peptic ulcer or active GI bleeding within 90 days of enrollment\n* Cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical heart assistance\n* Pulmonary arterial hypertension with fixed PASP \\> 70mmHg or PVR \\> 5WU that cannot be reduced to less than 5WU with vasodilator therapy\n* Severe chronic obstructive pulmonary Disease (COPD) or airways disease requiring continuous home oxygen\n* Renal insufficiency (eGFR \\\u003C20 mL\u002Fmin) or ESRD on dialysis\n* Life expectancy \\\u003C 12 months\n* Subject is on the waiting list for a transplant or has had a prior heart transplant\n* Child class C cirrhosis\n* Blood dycrasias as defined by acute anemia with Hb \\\u003C 9, platelets \\\u003C 75K, WBC \\\u003C 0.5\n* Female subjects who is breast feeding or pregnant or planning to become pregnant within the study period.\n* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution) or hypersensitivity to nickel or titanium\n* Inability to tolerate anticoagulation or antiplatelet therapies",{"count":226,"type":20},30,[23],"The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\\>=3+)",[230],"Mitral Regurgitation","2025-11-07",{"date":233,"type":39},"2025-11-12",{"date":235,"type":39},"2024-04-01",{"date":237,"type":20},"2028-07-01",{"name":239,"class":46},"Tioga Cardiovascular, Inc.",5,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":96},"100574714","early-phase-1-assessment-of-osa-in-latin-american-and-response-to-neuromod-therapy-100574714","NCT06762873","Assessment of OSA in Latin American and Response to Neuromod Therapy","Assessment of Obstructive Sleep Apnea in the Latin American Population and Response to Neuromodulation Therapy to Treat Obstructive Sleep Apnea","Trans-Q DISE","Inclusion Criteria:\n\n1. Subject is aged ≥ 18 years old\n2. Subject is willing and able to provide informed consent\n3. Subject is geographically stable\n4. Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and\u002For behavioral treatments)\n5. Subject has an Apnea-Hypopnea Index (AHI) score ≥15 \\\u003C 100 events per hour on Screening PSGs (under AASM 4%) based on in-lab polysomnography studies\n\nExclusion Criteria:\n\n1. Subject is currently implanted with another active implantable device.\n2. Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing.\n3. Subject is considered vulnerable such as incarcerated or cognitively impaired.\n4. Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that in the opinion of the investigator may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n5. Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study ((e.g. uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD, major depression, Parkinson's disease, epilepsy)\n6. Subject has previous upper respiratory tract (URT) surgery (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n7. Subject has a need for chronic supplemental oxygen therapy for any reason or a PaO2 \\\u003C70 mm Hg\n8. Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness and\u002For overnight PSG Study outcomes (e.g. Narcolepsy with cataplexy, idiopathic hypersomnolence, insomnia, REM sleep behavior disorder, or sleep movement disorders, such as restless leg syndrome or periodic limb movement, producing sleep disturbances unrelated to OSA.)\n9. Subject has severe chronic kidney disease (GFR \\\u003C 30)\n10. Subject has currently excessive use of alcohol, tobacco, caffeine, or recreational drugs.\n11. Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.\n12. Subject has a BMI \\> 40 kg\u002Fm2\n13. Subject has an active systemic infection\n14. If female, subject is pregnant at the time of enrollment or planning to become pregnant during the study time period (must have a negative serum or urine pregnancy test within 14 days prior to enrollment)\n15. Subject has a tonsil size 3 or 4 based on the tonsil grading system\n16. Subject has documented history of Phrenic nerve palsy or asymmetry of the diaphragm\n17. Subject has any trauma to the upper airway that interferes with limited tongue movement or inability to move the tongue, tongue dysfunction, atrophy, hypertrophy, fasciculation, or problems swallowing or speaking\n18. Subject has severe mandibular deficiency\u002Fretrognathia or syndromic craniofacial abnormalities.\n19. Subject has previous surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.\n20. Subject has an oxygen saturation (SaO2) \\>10% falls index \\> 15 events per hour on Screening PSGs\n21. Subject has \\>25% central apnea events as a proportion of the sum of apnea and hypopnea events per hour on Screening PSGs (up to 3 patients with CAI+MAI ≥ 25% may be included)\n22. Subject has sleep Efficiency \\\u003C 80%",{"count":250,"type":20},50,[252],"EARLY_PHASE1","The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate\u002Fsevere obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.",[255],"Obstructive Sleep Apnea","2025-09-02",{"date":258,"type":39},"2025-09-03",{"date":260,"type":39},"2024-11-21",{"date":262,"type":20},"2025-12-31",{"name":264,"class":46},"Lunair Medical",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":96},"100603749","safety-and-feasibility-study-transcatheter-valve-repair-in-severe-symptomatic-functional-tricuspid-regurgitation-100603749","NCT07140562","Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation","Prospective, Multi-Center, Single-Arm Study: Safety and Technical Feasibility of the Tangent Tricuspid Annular Therapy System for Transcatheter Valve Repair in Patients With Severe, Symptomatic Functional Tricuspid Regurgitation","Inclusion Criteria:\n\n1. 18-90 years old at the time of consent\n2. Symptomatic functional tricuspid regurgitation (without co-existing degenerative disease) despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the study consent\n3. Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and\u002For transthoracic echocardiogram (TTE) using the 5-grade classification\n4. TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance\n5. The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair\n6. Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Estimated life expectancy of less than 12 months\n2. Systolic pulmonary artery pressure (sPAP) \\>70 mmHg as assessed by TTE or right heart catheterization\n3. Acutely decompensated, defined as hypotension with SBP \\\u003C90 mmHg, use of hemodynamic support devices or inotropes or uncontrolled arterial hypertension with SBP \\>180 mmHg within 30 days of the study procedure\n4. Severe COPD dependent on home oxygen or chronic home oxygen use\n5. Echocardiographic evidence of severe right ventricular dysfunction\n6. Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)\n7. Any condition that would interfere with the procedure, such as prior tricuspid valve repair, tricuspid valve leaflet anatomy which may preclude device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle)\n8. Tricuspid valve stenosis defined as a tricuspid valve orifice of ≤1.0 cm2 and\u002For mean gradient of ≥5 mmHg\n9. New or untreated right heart chamber and\u002For superior vena cava intracardiac mass, thrombus, or vegetation\n10. Degenerative tricuspid or rheumatic tricuspid valve disease\n11. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure\n12. Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure\n13. Known need for emergent, urgent, or planned surgery or intervention within 30 days following the study procedure, or planned or scheduled cardiac surgery within 12 months following the study procedure\n14. Stroke or other major cerebrovascular event within 90 days prior to the study procedure\n15. Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction\n16. Active or recent GI bleed within 30 days prior to the study procedure, or patients contraindicated for oral anticoagulation therapy\n17. Bleeding disorders including thrombocytopenia (platelet count \\\u003C70,000 mm3) or thrombocytosis (platelet count \\>700,000 mm3)\n18. Transfusion-dependent chronic anemia with Hb \\\u003C9\u002FdL\n19. Current or planned pregnancy within 12 months of the study procedure for women of childbearing potential\n20. Active or recent endocarditis within 90 days of the study procedure, or sepsis\u002Fother systemic infection requiring oral or intravenous antibiotics within 30 days of the study procedure\n21. Prior tricuspid repair or tricuspid replacement or prosthetic implant that would interfere with successful deployment or functioning of the Tangent Implant\n22. Participation in another pre-market investigational device study or investigational drug study (for a cardiac-related drug)\n23. Presence of other anatomic or co-morbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's availability to participate in the clinical investigation or to comply with follow-up requirements\n24. Any patient considered to be vulnerable\n25. Left ventricular ejection fraction (LVEF) \\\u003C30%\n26. Deep vein thrombosis or pulmonary embolism within 6 months of the study procedure\n27. Child-Pugh C cirrhosis","90 Years",{"count":274,"type":20},25,[23],"The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.",[278,279,280],"Tricuspid Regurgitation Functional","Tricuspid Regurgitation (TR)","Tricuspid Regurgitation","2025-08-18",{"date":283,"type":39},"2025-08-24",{"date":285,"type":39},"2025-07-15",{"date":287,"type":20},"2026-12",{"name":289,"class":46},"Tangent Cardiovascular Inc.",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":96},"100595564","path-03-paraguay-feasibility-study-100595564","NCT07034092","PATH-03 Paraguay Feasibility Study","Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation","Inclusion Criteria:\n\n1. Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and\u002For clinical judgement of the investigator\n2. Adults (age \\>18 years old)\n3. Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients)\n4. Target vein diameter of ≥2.0 mm\n5. Target artery diameter of ≥2.0 mm\n6. Both radial and ulnar artery flow to the hand, confirmed with Duplex Ultrasound and\u002For Allen's test (i.e. palmar arch)\n7. Able to provide informed consent\n8. Able to comply with follow-up visit assessment requirements\n9. Patient is free from clinically significant conditions or illnesses that might compromise the procedure or the AVF\n\nExclusion Criteria:\n\n1. Significant central venous stenosis or narrowing that exceeds 50% based on imaging\n2. Hypercoagulable state or known bleeding diathesis\n3. NHYA Class III or IV heart failure\n4. Estimated life-expectancy of \\\u003C1 year based on the physician's opinion\n5. Oedema of extremities\n6. Current diagnosis of carcinoma\n7. Pregnant or breastfeeding women\n8. Diagnosed or suspected skin disease at the access site\n9. Immunosuppression or otherwise immunocompromised patients\n10. Currently being treated with another investigational device or medication\n11. Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials\n12. Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity\n13. Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required",{"count":105,"type":20},[23],"The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.",[301],"Kidney Disease, End-Stage",[303,304],"fistula, AVF, endoAVF, hemodialysis, vascular access","endovascular AVF",{"date":306,"type":39},"2025-07-17",{"date":308,"type":20},"2025-10",{"date":310,"type":20},"2026-10",{"name":312,"class":46},"Pathfinder Medical",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":96},"100583998","neurostimulation-for-sleep-disordered-breathing-100583998","NCT06883617","Neurostimulation for Sleep Disordered Breathing","The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing","ECLIPSE 1","Inclusion Criteria:\n\n* Subject does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments\n* Subject has moderate to severe sleep disordered breathing as diagnosed by PSG\n\nExclusion Criteria:\n\n* Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n* Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate\n* Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n* Subject has a need for chronic supplemental oxygen therapy for any reason\n* Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness\n* Subject has severe chronic kidney disease\n* Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study.\n* Subject conducts work or regular activities requiring vigilance\n* Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.\n* Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices\n* Subject has an active systemic infection at time of implant.\n* Subject has clinical evidence of immunodeficiency.\n* Any condition likely to require future MRI or diathermy\n* Subject is pregnant\n* Subject has a severe nasal obstruction that could restrict airflow\n* Subject has any trauma to the upper airway\n* Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.",{"count":322,"type":20},45,[23],"This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.",[326,327],"Sleep Disordered Breathing (SDB)","Sleep Apnea","2025-03-19",{"date":330,"type":39},"2025-03-20",{"date":332,"type":39},"2025-01-13",{"date":334,"type":20},"2027-12-15",{"name":264,"class":46},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":344,"maxAge":56,"enrollmentInfo":345,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100552877","phase-2-early-resuscitation-in-paediatric-sepsis-using-inotropes-100552877","NCT06478797","Early Resuscitation in Paediatric Sepsis Using Inotropes","Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)","ANDES-CHILD","Inclusion Criteria:\n\n* 28 days and \\\u003C18 years\n* Treated for sepsis\n* Received at least 20 ml\u002Fkg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock\n* Parental\u002Fcaregiver consent prior to or after enrolment\n\nExclusion Criteria:\n\n* Preterm babies born \\\u003C34 weeks gestation that have a corrected age of \\\u003C28 days\n* Received ≥ 40 mL\u002Fkg of fluid boluses during the 4 h pre-enrolment\n* Inotrope infusion commenced pre-enrolment\n* Lack of access (intraosseous, central venous or peripheral) to administer fluids and\u002For inotropes after 60min of enrolment\n* Cardiomyopathy or chronic cardiac failure\n* Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment\n* Known chronic renal failure (defined as requiring renal replacement therapy)\n* Known chronic hepatic failure\n* Palliative care patient\u002Fpatient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)\n* Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of \\>2min duration, or death is deemed to be imminent or inevitable during this admission.\n* Major bleeding with haemorrhagic shock\n* Sepsis is not likely to be the cause of shock\n* Previous enrollment in ANDES-CHILD","28 Days",{"count":346,"type":20},40,[348],"PHASE2","Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL\u002Fkg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)",[351],"Sepsis",[353,354,355,356,357,358,359],"pediatric sepsis","septic shock","inotropes","adrenaline","emergency department","fluid","child","2024-06-24",{"date":362,"type":39},"2024-06-27",{"date":364,"type":20},"2024-07",{"date":366,"type":20},"2025-12",{"name":368,"class":95},"NATALIA LOPERA MUNERA",4,{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":378,"maxAge":156,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":380,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100467208","phase-1-arterial-ablation-for-the-treatment-of-type-2-diabetes-mellitus-and-its-comorbidities-100467208","NCT05363761","Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities","Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities (NECTAR III Trial)","NECTAR III","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for participation in the study:\n\n1. Age ≥ 21 and ≤ 65 years at time of enrollment.\n2. Disease diagnosed\n\n   2.1 Diagnosed with T2DM with baseline:\n   1. Fasting plasma glucose ≥ 140 mg\u002Fdl (7.8 mmol\u002Fl) and ≤ 270 mg\u002FdL (15 mmol\u002FL)\n   2. HbA1c levels ≥ 7.0% and ≤ 9.0% (53-75 mmol\u002Fmol)\n   3. Triglyceride level \\\u003C 400 mg\u002FdL (4.52 mmol\u002FL)\n   4. On oral anti-hyperglycemic drug regimen of metformin. Subjects may be on additional oral anti-hyperglycemic drug of a different drug class\n   5. Years of T2DM ≤ 10 years\n\n   And \u002F Or\n\n   2.2 Diagnosed hypertension with baseline:\n   1. Office blood pressure of SBP of ≥ 140 mmHg and ≤ 180 mmHg and DBP ≥ 90 mmHg\n   2. Mean 24-hour ambulatory SBP of ≥ 130 mmHg and ≤ 170 mmHg with ≥ 75% valid readings\n   3. On stable oral anti-hypertension drug regimen consisting of up to a maximum of three drugs\n3. BMI between 27.5 and 40 kg\u002Fm2\n4. C-peptide testing: non-fasting random or stimulated C-peptide ≥ 2 ng\u002FmL (660 pmol\u002FL)\n5. Vessel diameter of 3 mm to 7 mm with a minimum arterial treatable length of 20 mm in one or more of the following arteries:\n\n   * Renal\n   * Hepatic\n\nExclusion Criteria:\n\n1. T1DM or poorly controlled T2DM (defined as HbA1c \\> 9.0% or use insulin as medication to control glucose level).\n2. Office diastolic blood pressure \\\u003C 90 mmHg.\n3. Current use of \\> 3 hypertension medications.\n4. Currently on beta blockers.\n5. One or more documented hyperglycemia episodes requiring hospitalization in the 180-day prior to screening date.\n6. Prior evidence of hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months.\n7. BMI \\> 40 kg\u002Fm2.\n8. Diagnosed proliferative retinopathy or evidence of peripheral neuropathy.\n9. Lack of appropriate treatment site or anatomy precluding the intervention of the target arteries (renal and hepatic artery).\n10. History of prior renal or hepatic artery intervention including balloon angioplasty, stenting, etc.\n11. Arterial stenosis \\>50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).\n12. Any abnormality or disease in one or more of the target arteries that, per the physician assessment, precludes the safe insertion of the guiding catheter (including, but not limited to, artery aneurysm, excessive tortuosity, calcification).\n13. Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure.\n14. Known or suspected secondary hypertension, such as Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, history of pre-eclampsia, onset of hypertension prior to the age of 18.\n15. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.\n16. Severe or unstable cardiovascular comorbidities, such as AMI or ACS, cardiac valve stenosis, pulmonary embolism, heart failure with NYHA Class III or IV, chronic atrial fibrillation, primary pulmonary hypertension, COPD.\n17. Renal transplant, history of nephrectomy or single kidney, renal tumor\u002Fcancer, known non-functioning kidney, unequal renal size (\\>2 cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function), chronic renal deficiency with eGFR ≤ 60ml\u002Fmin\u002F1.73m2, or on chronic renal replacement therapy.\n18. Prior liver transplant.\n19. Any organ transplantation procedures are planned in the 365 days following Index Procedure.\n20. Gastrointestinal permanent anatomic alteration surgery.\n21. Any surgical procedure within 30 days prior to Index Procedure.\n22. Currently taking the following medications within 90 days prior to screening and\u002For there is a need or anticipated need for these medications during the study:\n\n    1. Systemic Corticosteroids\n    2. Anticonvulsants\n    3. Centrally acting sympatholytics\n23. Bleeding disorders, such as bleeding diathesis, thrombocytopenia, and severe anemia.\n24. Use of anticoagulation therapy which cannot be discontinued from 7 days before or 14 days after the Index Procedure.\n25. Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the investigator.\n26. Significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to reliably quantify alcohol intake.\n27. Active substance abuse, based on Investigator judgement, including inhaled or injected drugs, within 1 year prior to the initial screening.\n28. Significant weight loss within the last 6 months (e.g., \\> 10% total body weight loss).\n29. Hepatic decompensation defined as the presence of any of the following:\n\n    1. Serum albumin less than 3.5 g\u002FdL\n    2. International normalization ratio (INR) greater than 1.4 (unless due to therapeutic anticoagulants)\n    3. Total bilirubin greater than 2 mg\u002FdL with the exception of Gilbert syndrome\n    4. History of esophageal varices, ascites, or hepatic encephalopathy\n30. ALT or AST greater than 200 U\u002FL.\n31. Diagnosis of liver cirrhosis.\n32. Chronic liver or biliary disease of the following etiology:\n\n    1. History or diagnosis of Hepatitis B\n    2. History or diagnosis of Hepatitis C\n    3. History or diagnosis of current active autoimmune hepatitis\n    4. History or diagnosis of primary biliary cholangitis\n    5. History or diagnosis of primary sclerosing cholangitis\n    6. History or diagnosis of Wilson's disease\n    7. History or diagnosis of alpha-1-antitrypsin deficiency\n    8. History or diagnosis of hemochromatosis\n    9. History or diagnosis of drug-induced liver disease, as defined on the basis of typical exposure and history.\n    10. Known bile duct obstruction.\n    11. Suspected or proven liver cancer\n33. History of acute or chronic pancreatitis.\n34. Human immunodeficiency virus (HIV).\n35. Subjects with a history of adverse reaction to heparin or heparin induced thrombocytopenia (HIT).\n36. Systemic infection that the investigator judges would pose unacceptable procedural risks to the subject.\n37. Known hypersensitivity to contrast media, nickel and ethanol that cannot be adequately pre-medicated.\n38. Subject is depressed or on antidepressants.\n39. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.\n40. Life expectancy of less than 5 years.\n41. Unwilling or unable to comply with the follow-up study requirements.\n42. Subjects or their legally authorized representatives unable to provide informed consent.\n43. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.\n44. Currently participation in another pre-market drug or medical device clinical study.","21 Years",{"count":250,"type":20},[381],"PHASE1","This study is assess the safety and performance of the Neurotronic Infusion catheter for treatment of patients with Type 2 Diabetes (T2DM) and hypertension.",[65,384],"Hypertension",[386],"Diabetes, Hypertension, Ablation, Denervation","2023-03-17",{"date":389,"type":39},"2023-03-21",{"date":391,"type":39},"2022-04-19",{"date":393,"type":20},"2029-01",{"name":395,"class":46},"Neurotronic, Inc.",3,""]