[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atherosclerotic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atherosclerotic-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100599366","routine-validation-and-reproducibility-testing-of-laboratory-assays-and-research-techniques-used-for-endocrine-cardiometabolic-and-musculoskeletal-disorder-research-vald-100599366",false,"NCT07083557","Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)","VALD","Inclusion Criteria:\n\n* ≥18 and ≤100 years of age\n* body mass index ≥16.0 and ≤60 kg\u002Fm2\n\nExclusion Criteria:\n\n* \\\u003C18 and \\>100 years of age\n* body mass index \\\u003C16.0 or \\>60 kg\u002Fm2\n* allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians\n* use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay\u002Ftechniques being evaluated\n* engaged in regular structured exercise \\>150 min per week unless needed for validation of the assay\u002Ftechnique being evaluated\n* significant organ system dysfunction or diseases, except those that are sought for validation of the assay\u002Ftechnique being evaluated\n* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay\u002Ftechnique being evaluated\n* pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.",true,"ALL","18 Years","100 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Obesity and Obesity-related Medical Conditions","Diabetes","Atherosclerotic Disease","Heart Failure","MASH","Sarcopenia","Osteoporosis","Hyperparathyroidism","Hypoparathyroidism","Ischemic Heart Disease","Cystic Fibrosis (CF)","Chronic Kidney Disease(CKD)","Osteopenia","Cachexia","RECRUITING","2026-05-05",{"date":43,"type":44},"2026-05-07","ACTUAL",{"date":46,"type":22},"2027-01-01",{"date":48,"type":22},"2030-07-01",{"name":50,"class":51},"Bettina Mittendorfer","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":5},"100586033","capture-study-polyglucosamine-for-cardio--atherosclerosis-prevention-and-treatment-via-fat-uptake-reduction-100586033","NCT06910111","CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)","Cardio and Atherosclerosis Prevention and Treatment Via Fat Uptake REduction With a Specified Biopolymer: One Year Randomized Double-blind Placebo-controlled Clinical Investigation to Improve Vascular Health in Patients at Cardiovascular Risk: CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)","CAPTURE","Inclusion Criteria\n\n* Outpatients of both genders, with CIMT \\> 1.00 mm suffering from hypertension and\u002For type II diabetes and\u002For hypercholesterolemia, under stable treatment for these conditions since at least 6 months.\n* Age between 45-65\n* BMI \\> 26 ≤35\n* Total cholesterol ≥ 200 ≤ 240 mg\u002FdL\n* BP mm Hg: Mx ≥ 135 ≤ 160 ; Mn ≥ 75 ≤ 90 the subject must remain 10 min at rest in clinostatic position before measurement\n* Blood glucose Mn ≥ 80 ; Mx ≤ 130 mg\u002FdL\n* The subjects suffering from hypertension, and\u002For diabetes, and\u002For hypercholesterolemia can be admitted provided that the diseases under chronic treatment are mitigated with no more than 2 drugs. By drug we mean any formulation (in tablets, capsules, fluid etc..) containing one or more active ingredients. This therapy has to be administered 4 hours before or after the product under evaluation.\n* ESC score (European Society of Cardiology) \\\u003C 10\n* Informed consent must be obtained prior to participation.\n* Subjects able to communicate adequately with the Investigator and to comply with the requirements for the entire study.\n* Subjects must be willing and able to give informed consent\u002Fassent for participation in the study.\n* Negative pregnancy test for women with childbearing capacity.\n\nExclusion criteria\n\n* Age \\\u003C 45 or \\> 65 years.\n* Pregnancy or breastfeeding. During the study, women of reproductive age will have to use reliable contraceptive methods.\n* Mx BP \\> 160 Mn \\> 90 despite a treatment of 6 months with common antihypertensive\n* Total cholesterol \\> 240 mg\u002FdL despite a treatment of 6 months with the common hypolipemic drugs\n* Morning blood glucose \\> 130 mg\u002FdL despite a treatment of 6 months with common oral hypoglycemic drugs\n* BMI \\> 35\n* ESC score (European Society of Cardiology) ≥ 10\n* Myocardial infarction\n* Neurological disorders\n* Cancer\n* Gout\n* Kidney dysfunction (creatinine \\> 3 mg\u002Fdl)\n* Liver dysfunction (ALT \\> 40 U\u002FL)\n* COPD (FEV \\\u003C 80% of predicted value)\n* Psychiatric diseases\n* IBS\n* Anemia (HB \\\u003C 10 g\u002Fdl)\n* Inability or unreliability of the Food Intake Assessment \\[4\\]\n* Hypersensitivity to polyglucosamine\n* Any medical condition or abnormality of clinical laboratory tests that needs systemic pharmacological treatment besides treatment for hypertension, type II diabetes or hypercholesterolemia. This means that local treatments will be allowed.\n* Vulnerable subjects: incapacitated, immunocompromised, or other conditions which may bring to a condition of vulnerability.\n* Subjects under emergency circumstances\n* Treatment with orally applicable drugs exceeding application in the morning and in the late evening\n* Current treatment with GLP-1 agonists, fosinopril, acarbose.\n* In the case of treatment with food supplements the subject can be enrolled after 1 month of product withdrawal.\n* Known allergy to crustaceans or one of the ingredients\n* Chronic constipation\n* Intestinal obstruction\n* Intake of long-term medications that significantly slow down intestinal activity\n* Current participation in any other investigational trials","45 Years","65 Years",{"count":64,"type":22},240,"INTERVENTIONAL",[67],"NA","This clinical investigation is intended to confirm the application of a new intended purpose and a new indication for an already certified medical device. Therefore, it is a pivotal clinical investigation with a confirmatory type of design.",[28],[71],"CAPTURE formoline AtheroGuard","NOT_YET_RECRUITING","2025-03-27",{"date":75,"type":44},"2025-04-04",{"date":77,"type":22},"2025-04-01",{"date":79,"type":22},"2027-03",{"name":81,"class":82},"Certmedica International GmbH","INDUSTRY",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":65,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":52},"100322642","phase-3-alirocumab-in-patients-on-a-stable-dialysis-regimen-100322642","NCT03480568","Alirocumab in Patients on a Stable Dialysis Regimen","A Phase III Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen: The Alidial Study","Inclusion Criteria:\n\n1. Male or female patients, ages 18 to 80 years.\n2. Written informed consent will be obtained before any study assessment is performed.\n3. Diagnosis of end-stage renal disease, maintained on dialysis, without dialysis complications, for at least 3 months.\n4. Patients may or may not have a diagnosis of atherosclerotic disease, such as a history of myocardial infarction (MI), cardiac percutaneous coronary intervention (PCI), coronary artery bypass (CABG) surgery, atherosclerotic transient ischemic attack (TIA) or cerebrovascular attack (CVA), or peripheral arterial disease (PAD).\n5. A total of 20 patients will be enrolled, 10 patients on hemodialysis and 10 patients on peritoneal dialysis.\n\nExclusion Criteria:\n\n1. LDL-cholesterol level of \\\u003C 70 mg\u002FdL.\n2. Any contraindication to subcutaneous injections.\n3. Patients on statin and\u002For ezetimibe therapy will have their cholesterol-lowering therapy continued as is without change during the time of the study.\n4. History of any allergy or intolerance to the study drug or drugs of the same class.\n5. A history of MI, PCI, CABG surgery, TIA, CVA, or PAD events within 3 months of enrollment.\n6. History of malignant cancer within the past 3 years, excepting basal cell skin cancer or cervical cancer in situ.\n7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of the drug and for 2 weeks after the last injection of the drug. Highly effective methods of contraception include:\n\n   1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n   2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.\n   3. Male sterilization (at least 6 months prior to enrollment). For female patients in the study, the vasectomized male partner should be the sole partner for that patient.\n   4. Use of oral (estrogen and\u002For progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception.\n   5. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   6. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before enrollment.\n8. Pregnant or lactating women.\n9. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug, at investigator's discretion.\n10. History or evidence of drug or alcohol abuse within the last 12 months.\n11. Patients considered unsuitable for the study, including patients with psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.","80 Years",{"count":92,"type":22},20,[94],"PHASE3","12-week study of the efficacy and safety of alirocumab in patients maintained stably on hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9 levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.",[97,98,99,28],"Hemodialysis","Peritoneal Dialysis","Hypercholesterolemia",[101],"Alirocumab","2020-02-10",{"date":104,"type":44},"2020-02-12",{"date":106,"type":44},"2018-05-01",{"date":108,"type":22},"2020-12-31",{"name":110,"class":51},"Baylor Research Institute"]