[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Cleveland Clinic\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":637},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,104,0,25,[9,42,76,104,130,162,190,210,232,251,272,299,327,351,377,407,430,450,473,493,527,546,566,595,620],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100301805","leucine-enriched-essential-amino-acid-mixture-to-reverse-muscle-loss-in-cirrhosis-100301805",false,"NCT03208868","Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis","Inclusion Criteria:\n\n* Cirrhotic patients:\n* Cirrhosis diagnosed by liver biopsy and\u002For clinical, biochemical and imaging evidence of cirrhosis.\n* Abstinence from alcohol and\u002For other recreational drugs for at least 6 months\n* Child's Pugh score 5-9 (inclusive).\n\nExclusion\n\n* Cirrhotic patients:\n* Child's score \\>9\n* Pedal edema above the ankle\n* Presence of concurrent illnesses (renal, cardiac, pulmonary, cerebrovascular, malignancy) or medication (anabolic steroids, corticosteroids) intake that affect skeletal muscle mass.\n* Diabetes mellitus\n* Active gastrointestinal bleeding\n* Sepsis, encephalopathy\n* Renal failure\n* Hepatocellular carcinoma outside of Milan criteria\n* Unwilling to sign informed consent or follow research procedures\n* Does not meet inclusion criteria",true,"ALL","18 Years","70 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"NA","Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. Based on compelling preliminary studies and those of the co investigator, investigators hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in reduced protein synthesis and increased autophagy. Investigators further postulate that leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy will result in an increase in skeletal muscle mass. Investigators will test these hypotheses by quantifying the response to acute and long term (3 month) administration of leucine enriched essential amino acid (EAA\u002FLEU) compared with an isonitrogenous isocaloric non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will be quantified in the acute and long term protocols. Tracer studies using L-\\[D5\\]-phenylalanine (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1) with and L \\[ring-D2\\] tyrosine, forearm plethysmography, and sequential skeletal muscle biopsies (total of 3 per study subject) will be used to quantify these outcomes. Anthropometric, clinical and body composition measures will be additional outcome measures for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1 (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase), phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux will be measured by quantifying expression of the autophagosome proteins.",[28],"Cirrhosis, Liver","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2013-08-05",{"date":37,"type":22},"2028-12-31",{"name":39,"class":40},"The Cleveland Clinic","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":41},"100505998","efficacy-of-low-intensity-shockwave-vs-radial-wave-for-treatment-of-erectile-dysfunction-and-pelvic-pain-100505998","NCT05868668","Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain","Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Focused Shockwave and Sham Therapy for Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer","Shockwave","Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)\n\n1. Cis-gendered heterosexual adult males18 years old\n2. Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration.\n3. Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months\n4. If ED responsive or partially responsive to current use of PDE5I, participant must be willing to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for the duration of the study. Partially responsive ED is defined as inadequate response for desired sexual activity, or poorly maintained erection despite initially good response.\n5. Agreeable to attempt sexual intercourse at least 4 times per month for duration of study without being under the influence of alcohol or recreational drugs\n6. Morning total testosterone level over 300ng\u002FdL\n\nExclusion Criteria (ED):\n\n1. Nerve-injury related ED (\u002Fspinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (e.g, multiple sclerosis, alzheimer's disease, parkinsons disease, amyotrophic lateral sclerosis)\n2. Untreated hypogonadism (morning total testosterone \\\u003C300 ng\u002FdL) or on androgen deprivation therapy in the last 12 months\n3. Predominately psychogenic ED based upon expert clinician opinion\n4. Peyronie's disease, palpable plaque or curvature\u002Fpenile anatomic abnormality that affects penetrative intercourse to any degree\n5. History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting)\n6. History of penile injury or trauma (e.g, priapism, penile fracture)\n7. Use of intracavernosal injection for ED within the last year\n8. If diabetic, HbA1c 8% or higher within the past 12 months\n9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound\n10. Current tobacco smoker, or has smoked in the past year\n11. Poorly controlled hyperlipidemia\n12. Poorly controlled hypertension\n13. Severe cardiac disease or history of myocardial infarction\n14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression\n15. Patients currently using SSRI or psychotropic medication\n16. Severe ED based on IIEF-EF (score 10 or below)\n17. Current acute prostatitis\n\nChronic Pelvic Pain Syndrome Group:\n\nInclusion Criteria (CPPS): (all of the following)\n\n1. Adult males ≥18 years old\n2. Chronic pelvic pain not explained by concurrent urinary tract infections. urine)\n3. Willing to do PFPT\n\nExclusion criteria (CPPS):\n\n1. Nerve-injury related pelvic pain (history of \u002Fspinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting pain in the pelvic region(Multiple sclerosis, Alzheimer's, Parkinsons disease)\n2. Acute prostatitis or any acute infection of the pelvic region\n3. History of pelvic trauma","MALE","40 Years",{"count":53,"type":22},186,[25],"The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.",[57,58,59,60,61,62,63],"Erectile Dysfunction Due to Arterial Insufficiency","Erectile Dysfunction","Erectile Dysfunction Due to Arterial Disease","Chronic Pelvic Pain Syndrome","Chronic Prostatitis","Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction Following Radiation Therapy",[65,66,67],"shockwave","radial wave","pelvic floor physical therapy","2026-08-18",{"date":70,"type":33},"2026-08-19",{"date":72,"type":33},"2023-09-19",{"date":74,"type":22},"2027-06",{"name":39,"class":40},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100652155","negative-pressure-wound-therapy-devices-in-total-knee-arthroplasty-100652155","NCT07770633","Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty","Randomized Controlled Clinical Trial for Closed Incision Negative Pressure Wound Therapy (NPWT) Devices in Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n* Age 18 years or older\n* Undergoing primary total knee arthroplasty\n* Able to understand the study, provide informed consent, and participate in study procedures\n\nMeet at least one of the following co-morbidities:\n\n* BMI ≥35\n* Diabetes\n* Prior surgical incision(s) in the operative area\n* Chronic kidney disease\n\nExclusion Criteria:\n\n* Prisoners\n* Pregnant women\n* Patients who indicate they may not comply with post-operative instructions\n* Patients with active bleeding",{"count":84,"type":22},300,[25],"This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications.\n\nA total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery.\n\nThe primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance.\n\nResearch-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and\u002For dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation.\n\nThis study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.",[88,89,90,91,92],"Wound Surgical","Diabetes","Obesity","Chronic Kidney Diseases","Smoking",[94,95],"Total Knee Arthroplasty","Total Knee Replacement","NOT_YET_RECRUITING","2026-08-17",{"date":68,"type":33},{"date":100,"type":22},"2026-09-01",{"date":102,"type":22},"2030-12",{"name":39,"class":40},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":41},"100438503","phase-3-bone-marrow-aspirate-concentrate-versus-triamcinolone-injection-for-hip-osteoarthritis-100438503","NCT04990128","Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis","Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis","Inclusion:\n\n1. Provision of signed and dated consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged between 18 - 75 years old\n4. WOMAC Pain Subscale Total Score of 5 or higher in the Likert Scale (total score is 20)\n5. Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays\n6. Body Mass Index ≤ 35 kg\u002Fm\\^2\n7. Unilateral or Bilateral Hip Osteoarthritis\n8. Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program\n9. Agreement to adhere to Lifestyle Considerations\n10. Discontinuation of pain\u002Fanti-inflammatory medications 2 week prior to baseline measurements\n11. Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy\u002Fradiation therapy such as breast cancer, colon cancer, or skin cancer, and others could participate when deemed in remission for 1 year. Written approval from oncologist will be necessary prior to enrollment\n12. Negative gram stain result\n\nExclusion:\n\n1. Prior corticosteroid injection to the hip\n2. History of hip replacement(s)\n3. Noncompliance to preventive screening tests for cancer indicated by age\n4. Active autoimmune disease\n5. Current use of oral corticosteroid\n6. Use of immunosuppressive medications, or who are known to me immunocompromised\n7. Inability to be weaned of oral anti-inflammatory medications\n8. History of Diabetes or HbA1c ≥ 6.5%\n9. Uncontrolled Thyroid Dysfunction: 0.450 uIU\u002FmL ≥ TSH levels ≥ 4.500 uIU\u002FmL\n10. Vitamin D Level \\\u003C 30 ng\u002Fml\n11. Anemia (Hgb \\\u003C 11.7 g\u002FdL for Women; Hgb \\\u003C 13 g\u002FdL for men)\n12. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2\n13. Thrombocytopenia with platelet count less than 150,000 x 10\\^9 L\n14. Patients with coagulopathies based on known clotting disorder\n15. Patients currently on anti-coagulation therapies\n16. Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C\n17. Moving over the next year\n18. Inability to consent to the research study\n19. Inability to complete forms electronically\n20. Subjects in any other clinical trials\n21. History of allergic reaction to lidocaine\n22. Pregnancy or planning to be pregnant during trial\n23. Breastfeeding","75 Years",{"count":113,"type":22},100,[115],"PHASE3","This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows:\n\nSpecific Aim 1: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months).\n\nHypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection.\n\nSpecific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months).\n\nHypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time.\n\nSpecific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score.\n\nHypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected.\n\nThe investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient.\n\nPatients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.",[118],"Hip Osteoarthritis",[120,121],"bone marrow aspirate concentrate","triamcinolone","2026-08-11",{"date":124,"type":33},"2026-08-12",{"date":126,"type":22},"2026-09-30",{"date":128,"type":22},"2027-12",{"name":39,"class":40},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":41},"100650541","decoding-the-neural-mechanisms-underlying-postural-instability-and-gait-dysfunction-in-parkinsons-disease-100650541","NCT07748962","Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease","Inclusion Criteria:\n\n* You have been diagnosed with Parkinson's disease\n* You already have a deep brain stimulation (DBS) device implanted as part of your medical care - specifically, the Medtronic Percept DBS device\n* Your DBS settings have been stable for at least 3 months\n* You experience freezing of gait (sudden inability to move your feet when trying to walk)\n* You are able to walk on your own for at least 10 minutes without assistance\n* You are willing to temporarily stop your Parkinson's medications and have your DBS settings adjusted for study testing\n* You are able to understand the study and provide consent to participate\n\nExclusion Criteria:\n\n* You have a neurological condition other than Parkinson's disease (such as stroke or multiple sclerosis)\n* You have been diagnosed with dementia or have difficulty understanding the study or giving consent\n* You currently have alcohol or substance abuse problems\n* You have hearing or vision problems that would make it difficult to use a virtual reality headset\n* You have any medical or mental health condition that, in the opinion of the study doctor, would make it unsafe or difficult for you to participate",{"count":137,"type":22},5,[25],"The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.",[141,142],"Parkinson Disease","Freezing of Gait",[144,145,146,147,148,149,150,151,152,153],"Deep brain stimulation","Balance","Postural instability","Gait dysfunction","Virtual reality","Mixed reality","Percept","Falls","Parkinson's disease","DBS","2026-07-31",{"date":156,"type":33},"2026-08-06",{"date":158,"type":22},"2026-09-18",{"date":160,"type":22},"2027-04-18",{"name":39,"class":40},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":41},"100650354","phase-2-glp-1-agonists-for-lung-function-improvement-and-muscle-restoration-in-copd-100650354","NCT07747805","GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD","GLIMR COPD: GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD","GLIMR COPD","Inclusion Criteria:\n\n* Age 40-80 years\n* Diagnosis of chronic obstructive pulmonary disease (COPD) with post-bronchodilator FEV₁\u002FFVC \\\u003C 0.70\n* GOLD stage 1-3 COPD (FEV₁ \\>30% predicted)\n* Former smoker with a smoking history of at least 10 pack-years\n* Body mass index (BMI) ≥27 kg\u002Fm² with at least one weight-related comorbidity (e.g., prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) or BMI 30-40 kg\u002Fm²\n* Able and willing to provide written informed consent\n* Able to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Type 2 diabetes mellitus (HbA1c \\> 6.5%)\n* Pregnancy or breastfeeding\n* Coagulopathy, defined as INR \\> 1.4 or platelet count \\\u003C80,000\u002FμL\n* Active malignancy, including lung cancer\n* Use of medications known to significantly alter muscle protein metabolism within 6 weeks of enrollment (e.g., oral corticosteroids, tamoxifen, high-dose estrogen, testosterone)\n* Personal or family history of medullary thyroid carcinoma\n* Multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Known hypersensitivity or contraindication to tirzepatide or its components\n* History of pancreatitis\n* Severe gastrointestinal disease that, in the opinion of the investigator, would increase risk from study participation\n* Significant diabetic retinopathy\n* Clinically significant renal impairment\n* Clinically significant gallbladder disease\n* Current treatment with a DPP-4 inhibitor\n* COPD exacerbation within 60 days prior to enrollment\n* Participation in pulmonary rehabilitation within 2 weeks prior to enrollment\n* Any medical, psychiatric, or social condition that, in the opinion of the investigators, may interfere with study participation, adherence to study procedures, or participant safety","80 Years",{"count":172,"type":22},30,[174],"PHASE2","Chronic obstructive pulmonary disease (COPD) is associated with systemic inflammation, obesity-related metabolic dysfunction, skeletal muscle impairment, and progressive decline in lung function. While obesity has historically been viewed as protective in COPD, emerging evidence suggests that excess adiposity and adipokine dysregulation, particularly elevated leptin levels, contribute to chronic inflammation, impaired muscle function, and worse clinical outcomes. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated anti-inflammatory, metabolic, and potential muscle-preserving effects beyond weight loss, making them promising therapeutic candidates for COPD.\n\nThe GLIMR COPD study is a prospective, randomized, controlled pilot trial designed to evaluate the effects of tirzepatide on lung function, skeletal muscle health, inflammation, and body composition in overweight and obese adults with COPD. Thirty participants will be enrolled at the Cleveland Clinic COPD Center, including 20 participants receiving tirzepatide and 10 age- and sex-matched control participants. Study participants will be followed for 12 months with assessments performed at screening, baseline, 6 months, and 12 months. Tirzepatide-treated participants will undergo standard dose escalation to a maintenance dose of 2.4 mg weekly.\n\nThe primary objective is to determine the effect of GLP-1 receptor agonist therapy on skeletal muscle function and physiology over 12 months. Secondary objectives include evaluating changes in body composition, systemic inflammation, adipokine signaling, immune function, pulmonary physiology, physical performance, and treatment tolerability.\n\nThe study is built around three mechanistic aims. First, we will characterize the effects of GLP-1 therapy on systemic inflammation and immune dysregulation using longitudinal blood-based proteomic analyses and adipokine measurements, including leptin and adiponectin. Second, we will investigate the impact of GLP-1 therapy on skeletal muscle mitochondrial function and fatty acid oxidation using muscle biopsies obtained at baseline and 12 months, combined with high-resolution respirometry, transcriptomics, metabolomics, and proteomics. Third, we will assess changes in clinical outcomes including lung function, body composition, muscle strength, and physical performance.\n\nParticipants will undergo comprehensive phenotyping that includes spirometry, respiratory muscle strength testing, six-minute walk testing, handgrip strength, sit-to-stand testing, body composition assessment, diaphragm ultrasound, and non-contrast CT imaging of the lungs and thighs. Blood samples will be collected for biomarker, proteomic, metabolomic, genomic, and immunologic analyses. Vastus lateralis muscle biopsies will be performed at baseline and study completion to evaluate mitochondrial bioenergetics and molecular pathways associated with muscle remodeling.\n\nEligible participants will be adults aged 40-80 years with COPD, a smoking history of at least 10 pack-years, and overweight or obesity. Individuals with diabetes, active malignancy, recent COPD exacerbations, contraindications to tirzepatide, or conditions that could interfere with study participation will be excluded.\n\nThis pilot study is designed to generate critical mechanistic and clinical data regarding the role of GLP-1 receptor agonists in COPD. Findings will help define the relationships among obesity, adipokine signaling, systemic inflammation, skeletal muscle dysfunction, and lung disease progression, while providing preliminary efficacy estimates to support the design of a future multicenter randomized clinical trial evaluating GLP-1 therapy as a novel treatment strategy for COPD.",[177,178,179],"COPD","Obesity & Overweight","Sarcopenia",[177,181,182],"sarcopenia","obesity",{"date":184,"type":33},"2026-08-05",{"date":186,"type":22},"2026-08-28",{"date":188,"type":22},"2029-08-15",{"name":39,"class":40},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":196,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100642531","early-phase-1-self-start-triage-model-for-post-botox-lower-urinary-tract-symptoms-100642531","NCT07648290","Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms","Inclusion Criteria:\n\n* Female patients of all races and ethnicities aged 18 years and older.\n* Diagnosis of Overactive Bladder (OAB) and\u002For Urge Urinary Incontinence (UUI).\n* Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management.\n* Has decision making capacity to provide informed consent and comply with and follow study protocols.\n* Ability to navigate a computer system independently\n* Access to MyChart and email account\n\nExclusion Criteria:\n\n* Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter.\n* History of Severe Renal Impairment Cr\u002FCl - \\\u003C60 ml\u002Fmin 1.73m2\n* History of recurrent UTIs (defined as \\>3x symptomatic UTIs in 12 months).\n* Post-Void Residual (PVR) volume \\>150 mL.\n* Active UTI at the time of procedure (procedure cancellation criteria).\n* Patients currently on prophylactic antibiotics.\n* Inability to provide informed consent.","FEMALE",{"count":198,"type":22},260,[200],"EARLY_PHASE1","The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in\u002Furgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the \"self-start\" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.",[203],"Overactive Bladder",{"date":205,"type":33},"2026-08-03",{"date":154,"type":33},{"date":208,"type":22},"2028-03-31",{"name":39,"class":40},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":16,"sex":196,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":41},"100634312","single-visit-clinical-validation-of-screenfire-a-low-cost-hpv-test-efficacy-and-cost-effectiveness-phase-2-100634312","NCT07538050","Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)","Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)","SCALE AIM 2","Inclusion Criteria:\n\n* Women between 30-59 years of age\n* Willing to conduct HPV self-sampling\n\nExclusion Criteria:\n\n* Prior hysterectomy\n* HPV testing in at least 5 years\n* Previous diagnosis or treatment of invasive cancer","30 Years","59 Years",{"count":221,"type":22},1000,[25],"In high-income countries, prevention strategies have led to declines in cervical cancer rates by more than 75% in high-income countries. In contrast, low- and middle-income countries (LMICs) carry the global burden of cervical cancer with about 85% of new cases and 90% mortality. Screening is an essential component of effective prevention to reduce this disease burden. The World Health Organization recommends human papillomavirus (HPV) testing as the most effective screening method. However, HPV testing can be expensive and complex to implement. Most tests require central laboratory processing, which means women must come back for a different visit to obtain results and potential treatment. In LMICs, this often results in high loss to follow up because many women face transportation and other challenges. The development of new, low-cost HPV tests that can be processed locally as the potential to improve adherence in screening programs. In this study, the research team will assess the feasibility of a same-day screen-and-treat approach compared to the standard two-visit regime in the context of the cervical cancer prevention program in El Salvador. This will be a cross-sectional study that will enroll 1,000 women in remote areas of the country over 10-15 weeks. The hypothesis is that at least 10% fewer women lost to follow-up at six months using the single visit approach compared to the \\>20% historical loss to follow-up using the standard two-visit approach.",[225],"Cervical Cancer Screening",{"date":205,"type":33},{"date":228,"type":33},"2026-04-16",{"date":230,"type":22},"2027-12-31",{"name":39,"class":40},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":41},"100629191","centered-surgery---preoperative-counseling-and-patient-satisfaction-100629191","NCT07471464","Centered Surgery - Preoperative Counseling and Patient Satisfaction","Inclusion Criteria:\n\n* Age \\>18y\n* Has decision-making capacity and able to provide informed consent for research participation\n* For patients undergoing SMA: Has active MyChart\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Unable to consent",{"count":239,"type":22},106,"OBSERVATIONAL","This study is a prospective cohort study which aims to assess patient satisfaction and preparedness for surgery through two methods of preoperative counseling: standard individual phone calls versus virtual group sessions called Shared Medical Appointments (SMAs). The study will focus on patients undergoing urogynecology prolapse surgeries at Cleveland Clinic. Researchers hypothesize that virtual group counseling will improve patient satisfaction and preparedness compared to individual phone calls. Additionally, the study will evaluate healthcare resource utilization as a secondary outcome.\n\nParticipants will complete surveys before and after surgery to measure satisfaction and preparedness using validated tools. The study will enroll patients aged 18 and older who can provide informed consent and are scheduled for specific prolapse surgeries. Findings may help improve preoperative counseling practices and enhance patient-centered care.",[243],"Pelvic Organ Prolapse",[245],"surgical counseling",{"date":205,"type":33},{"date":248,"type":33},"2026-06-11",{"date":230,"type":22},{"name":39,"class":40},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":196,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":41},"100620878","nifedipine-and-enalapril-vs-nifedipine-and-labetalol-for-the-treatment-of-postpartum-hypertension-study-100620878","NCT07363343","Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study","Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study (NEPHRON)","NEPHRON","Inclusion Criteria:\n\n* Postpartum women aged 18 years or older\n* Clinical diagnosis of hypertensive disorder in pregnancy (gestational hypertension, chronic hypertension, preeclampsia with or without severe features)\n* Taking Nifedipine 60 mg every 12 hours for blood pressure control\n* Persistently elevated blood pressure at\u002Fabove 140\u002F90 mmHg in a 24-hour time period or have one or more severe range blood pressure at\u002Fabove 160\u002F110 mmHg requiring a second antihypertensive medication\n* English speaking\n\nExclusion Criteria:\n\n* Taking ≥2 antihypertensive agents during pregnancy\n* Heart block\n* Heart rate \\\u003C60 or \\>120 beats per minute\n* Heart failure\n* Creatinine \\>1.5 mg\u002FdL\n* Renal artery stenosis\n* Active connective tissue disease\n* Cerebrovascular accident\n* Failed treatment or contraindications to nifedipine, enalapril or labetalol",{"count":260,"type":22},200,[25],"To determine if nifedipine and enalapril will have better blood pressure control in the postpartum setting compared to nifedipine and labetalol.",[264,265],"Hypertension","Postpartum Preeclampsia",{"date":205,"type":33},{"date":268,"type":33},"2026-03-10",{"date":270,"type":22},"2029-12-31",{"name":39,"class":40},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":196,"minAge":18,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100545494","engaging-patients-in-prenatal-genetic-testing-decisions-as-a-pathway-to-improve-obstetric-outcomes-100545494","NCT06382636","Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes","OPUS","Inclusion Criteria:\n\n* Able to read and speak English\n* Able to provide consent to participate in the study\n* Offered routine aneuploidy screening and diagnostic testing\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Not currently pregnant or an intrauterine pregnancy has not yet been established\n* Unable to provide informed consent for research participation\n* Unable to read and speak English","50 Years",{"count":281,"type":22},600,[25],"The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \\& Diagnostic Testing (PS\\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\\&D and decreases decisional conflict associated with those decisions.\n\nUsing data from NEST (Ensuring Patients Informed Access to NIPT \\[non-invasive prenatal testing\\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\\&D options, and resources to learn about insurance coverage for PS\\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer.",[285],"Prenatal Disorder",[287,288,289,290,291],"Prenatal Genetic Screening","Prenatal Diagnostic Testing","Shared Decision Making","Informed Choice","Decisional Regret",{"date":205,"type":33},{"date":294,"type":33},"2024-05-06",{"date":296,"type":22},"2027-02-28",{"name":39,"class":40},3,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":306,"conditions":307,"keywords":318,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":41},"100599224","longitudinal-validation-of-circ-technologies-100599224","NCT07081711","Longitudinal Validation of CIRC Technologies","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Vulnerable populations will be excluded from this study including Prisoners\n* Other contraindications to CMR imaging to be determined by standard MRI protocols\n* Decisionally impaired (e.g., dementia or cognitive disability)",{"count":221,"type":22},"Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases.\n\nThe study team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.",[308,309,310,311,312,313,314,315,316,317],"Cardiovascular Diseases","Heart Failure","Ischemic Heart Disease","Non-ischemic Cardiomyopathy","Valvular Heart Disease","Metabolic Cardiomyopathy","Congenital Heart Disease","Aortic Diseases","Atrial Fibrillation","Ventricular Fibrillation",[319],"MRI","2026-07-29",{"date":154,"type":33},{"date":323,"type":33},"2026-05-06",{"date":325,"type":22},"2037-08",{"name":39,"class":40},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":349,"locationsCount":350},"100544898","phase-4-fibrosis-lessens-after-metabolic-surgery-100544898","NCT06374875","Fibrosis Lessens After Metabolic Surgery","A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis","FLAMES","Inclusion Criteria\n\nEntry into the study would require that the patient:\n\n1. Is a candidate for general anesthesia\n2. Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS\u002FIFSO 2022 guidelines\n3. Has insurance coverage for metabolic surgery (the requirements may vary in each country)\n4. Is ≥18 and ≤75 years old at the time of signing the informed consent\n5. Has a BMI ≥35 and ≤70 kg\u002Fm2 at the time of first study visit\n6. FIB-4 ≥ 1.3\n7. At least one of the following 5 criteria suggesting presence of advanced fibrosis:\n\n   * LSM ≥ 12 kPa by VCTE using FibroScan®\n   * LSM ≥ 12 kPa by SWE\n   * LSM ≥ 1.7 m\u002Fs by ARFI\n   * LSM ≥ 3.63 kPa MRE\n   * ELF score ≥ 9.8\n8. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide or liraglutide) for at least 3 months prior to entry, with glycated hemoglobin (HbA1c) ≤12%.\n9. Self-reported stable weight in 6 months before the first study visit (no weight loss \\>10% within 6 months prior to the first study visit)\n\n   a. In patients with a historical noninvasive tests or liver biopsy, weight loss of no more than 10% is allowed from 6 months prior to the historical tests until the first study visit\n10. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study\n11. Can understand the options and comply with the requirements of each arm, including one liver biopsy performed during the screening period (if no adequate biopsy within 12 months before screening is available) and one liver biopsy after 2-years\n12. Has a negative urine pregnancy test at the first and at the randomization visits for women of childbearing potential.\n13. Women of childbearing age must agree to use reliable method of contraception for 2 years\n\n8.2 Exclusion Criteria\n\nPatients who meet the following criteria will be excluded from the study:\n\n1. Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):\n\n   * Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)\n   * Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)\n   * Autoimmune liver disease as diagnosed by antibodies or compatible liver histology\n   * Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)\n   * Primary sclerosing cholangitis\n   * Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology\n   * Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology\n   * Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy\n   * Drug-induced liver disease diagnosed by medical history\n   * Known bile duct obstruction\n   * Suspected or proven liver cancer\n2. Weight change \\>10% within 6 months prior to the first study visit or prior to the historical liver biopsy\n3. Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) \\\u003C90 days before the first study visit.\n\n   • However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.\n4. Type 1 diabetes or autoimmune diabetes\n5. Known cases of human immunodeficiency virus infection\n6. Prior bariatric and metabolic surgery of any kind\n\n   • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.\n7. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery\n8. Any surgery requiring general anesthesia within 1 month prior to signing the consent\n9. History of solid organ transplant\n10. Severe pulmonary disease defined as FEV1 \\\u003C 50% of predicted value\n11. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)\n12. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V\n13. Classified as New York Heart Association Class IV\n14. Left ventricular ejection fraction \\\u003C25% at the time of screening\n15. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months\n16. Chronic renal insufficiency with eGFR below 30 mL\u002Fmin\u002F1.73 m2, or being on dialysis\n17. Presence of large hiatal hernia (\\>7 cm)\n18. Presence of Crohn's disease\n19. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery\n20. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures\n21. Breastfeeding\n22. Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)\n23. Anemia defined as hemoglobin less than 9 g\u002FdL\n24. On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)\n25. Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis\n26. Clinical judgment that life expectancy is less than 3 years\n27. Use of investigational therapy within 3 months prior to signing the consent\n28. History of pancreatic carcinoma\n29. Acute pancreatitis \\\u003C 180 days before screening\n30. History or presence of chronic pancreatitis\n31. Presence of concerning thyroid nodule\n32. Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) \\> 6.0 mIU\u002FL or \\\u003C 0.1 mIU\u002FL before the first study visit\n\n    * Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.\n    * Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.\n33. A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n34. Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment\n\n    • Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.\n35. Evidence or history of hepatic encephalopathy\n36. Evidence or history of variceal bleeding\n37. Evidence or history of portosplenic vein thrombosis\n38. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.\n\n    • Defined as more than 14 units\u002Fweek for females (\\>1 drink per day) and more than 21 units\u002Fweek for males (\\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.\n39. Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids \\[oral or intravenous\\], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).\n40. ALT or AST or Alkaline phosphatase \\>200 U\u002FL\n41. Recurrent major hypoglycemia or hypoglycemic unawareness\n42. Inability to safely obtain a liver biopsy\n43. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study\n44. Unable to understand the risks, benefits, and compliance requirements of study\n45. Lack capacity to give informed consent\n46. Plans to move outside the primary location of study (country) within the next 24 months\n47. Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products\n48. Previous participation in this trial and got randomized to one of the study groups but did not proceed.\n49. Hospitalization due to COVID-19 within 2 months prior to screening.\n50. Platelet count \\\u003C80,000\n51. International Normalized Ratio (INR) \\>1.7\n52. Child-Pugh score B or C\n53. MELD score ≥15\n54. Upper endoscopy showing gastroesophageal varices\n55. Upper endoscopy showing more than mild portal hypertensive gastropathy\n56. Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (\\>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.\n\n    Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.\n    * Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count \\\u003C150,000 per μL or with a (historical) liver biopsy showing cirrhosis.\n    * A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:\n\n      * liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is \\>150,000 per μL, or\n      * a (historical) liver biopsy showing absence of cirrhosis, or\n      * a (historical) HVPG \\\u003C 5 mmHg\n57. Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites\n\n    • Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.\n58. HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)\n59. Liver biopsy characteristics:\n\n    * F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.\n    * F0 and F1 in historical liver biopsy\n    * Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inﬂammation) in patients with F1, F2, and F3\n    * Absence of steatosis (\\\u003C5%) in patients with F4\n    * Diagnosis other than MASH",{"count":336,"type":22},120,[338],"PHASE4","Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.\n\nPatients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.",[341,342,343,344,90],"Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Non-Alcoholic Fatty Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":154,"type":33},{"date":347,"type":33},"2024-07-11",{"date":270,"type":22},{"name":39,"class":40},22,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},"100588152","randomized-trial-of-cold-emr-compared-to-hybrid-cold-emr-100588152","NCT06937671","Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.","Inclusion Criteria:\n\n* Adult patient (age 18 years or older)\n* Polyp size of at least 20 mm\n* \\- Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)\n\nExclusion Criteria:\n\n* Polyps with previous failed resection attempts or polyp recurrence\n* Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)\n* Polyps with nodules too large (\\>1-1.5cm) for the use of a cold snare\n* Inflammatory bowel disease",{"count":358,"type":22},194,[25],"The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps.\n\nParticipants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.",[362,363],"Polyp of Colon","Endoscopic Mucosal Resection",[365,366,367,368],"EMR","Cold EMR","Hybrid EMR","Endoscopic mucosal resection","2026-07-28",{"date":320,"type":33},{"date":372,"type":33},"2025-05-01",{"date":374,"type":22},"2026-12",{"name":39,"class":40},2,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":41},"100626985","phase-2-neural-mechanisms-of-aerobic-exercise-benefits-in-pd-with-dbs-100626985","NCT07442747","Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS","Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n* Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD\n* Clinically optimized DBS parameters for one month prior to enrollment\n* Ability to ambulate with or without an assistive device for 5 continuous minutes\n* Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments\n\nExclusion Criteria:\n\n* Neurocognitive impairment that compromises the ability to provide informed consent\n* Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)\n* Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:\n\n  1. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation.\n  2. Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible.\n* A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise\n* Current cardiac arrhythmia",{"count":385,"type":22},36,[174],"This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.",[389,390],"Parkinson's Disease","Deep Brain Stimulation",[392,390,152,393,153,394,395,396,397,398,150,399,400],"Parkinson","Deep Brain Stimulation Surgery","Exercise","exercise training","Parkinson disease","Parkinson's","Parkinson's Disease with Deep Brain Stimulation","Cycling","Aerobic","2026-07-27",{"date":369,"type":33},{"date":404,"type":33},"2026-07-08",{"date":270,"type":22},{"name":39,"class":40},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":422,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":41},"100391014","phase-4-dextenza-in-the-post-op-management-of-vitreoretinal-surgeries-100391014","NCT04371445","Dextenza in the Post-op Management of Vitreoretinal Surgeries","Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery","Inclusion Criteria:\n\n* Men and women \\>18 years old\n* Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.\n\nExclusion Criteria:\n\n* Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and\u002For implant of a drug delivery system\n* History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye\n* Structural lid abnormalities such as ectropion or entropion in surgical eye\n* Ongoing use of systemic narcotic pain relievers\n* Presence of any intraocular inflammation (cells and flare) in the study eye at screening\u002Fbaseline\n* Pain score greater than \"0\" on the ocular pain assessment in the study eye at screening\u002Fbaseline\n* Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes\n* Other ocular surgeries or procedures during the study period and\u002For 6 months prior\n* Intraoperative complications\n* Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.\n* Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.\n* Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.\n* Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.\n* Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure\n* Are pregnant or nursing\u002Flactating\n* Participation as a subject in any clinical study within the 30 days prior to randomization.\n* Surgeries using 20 gauge or 23 gauge instruments.",{"count":172,"type":22},[338],"This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group.\n\nPatients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.",[418,419,420,421],"Vitreoretinal Surgery","Ocular Inflammation","Post-operative Pain","Post-Operative Inflammation",[423,419,421,420],"dexamethasone insert",{"date":320,"type":33},{"date":426,"type":33},"2020-06-01",{"date":428,"type":22},"2027-12-01",{"name":39,"class":40},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100645678","personalized-approach-to-celiac-disease-diagnosis-100645678","NCT07701655","Personalized Approach to Celiac Disease Diagnosis","PACkeD","For Aim 1:\n\nInclusion Criteria:\n\n* Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of celiac disease undergoing biopsy and TTG-IgA antibody testing for follow-up care\n* Children and vulnerable populations (e.g. pregnant women or prisoners)\n* Patients with IgA deficiency\n* Patients already following a gluten-free diet\n\nFor Aim 2:\n\nInclusion Criteria:\n\n* Physicians (primary care or subspeciality) who test or evaluate patients for celiac disease\n* Patients already diagnosed with celiac disease or undergoing evaluation for celiac disease\n\nExclusion Criteria:\n\n\\- Children and vulnerable populations (e.g. pregnant women or prisoners)\n\nFor Aim 3:\n\nInclusion Criteria:\n\n* Patients ≥18 with a standard-of-care celiac disease evaluation (both TTG-IgA antibody and upper endoscopy with duodenal biopsy)\n* Willing to participate and able to provide informed consent\n\nExclusion Criteria:\n\n\\- Children and vulnerable populations (e.g. pregnant women or prisoners)",{"count":438,"type":22},15500,"The goal of this observational study is to learn about an adult's chance of having celiac disease based on blood testing and symptoms. The main question it aims to answer is:\n\nCan a blood test and symptom information separate patients into 3 groups of low, intermediate, and high risk for celiac disease?\n\nParticipants already being evaluated for celiac disease as part of regular medical care will answer online survey questions about symptoms and have laboratory data collected from charts.\n\nThe investigators hypothesize that a clinical prediction model integrating clinical data with TTG-IgA antibody levels can accurately identify patients with celiac disease offering a personalized approach. The investigators anticipate this prediction model would classify patients into 3 risk groups for celiac disease: 1) Low likelihood (no further testing required), 2) Intermediate likelihood (biopsy required for confirmation), and 3) High likelihood (biopsy can be avoided based on the model's accuracy) thereby reserving endoscopy and biopsies for cases of intermediate probability to improve diagnosis, reduce invasive testing, increase patient focus, and decrease costs.",[441],"Celiac Disease","2026-07-17",{"date":444,"type":33},"2026-07-20",{"date":446,"type":22},"2026-08",{"date":448,"type":22},"2031-04-30",{"name":39,"class":40},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":457,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":472,"locationsCount":41},"100596709","phase-1-deep-brain-stimulation-of-the-deep-cerebellar-nuclei-for-refractory-tremor-100596709","NCT07049003","Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor","rT DBS","Inclusion Criteria:\n\n* Age 21 years and older;\n* Ability to give informed consent;\n* Diagnosis of ET, cerebellar tremor, or MS-related tremor with a failed a prior intervention (VIM DBS or HIFU thalamotomy) or determined to not be suitable candidates for VIM DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor.\n* Tremor history of at least three years;\n* Tremor that is refractory to medical management;\n* A score of ≥24 on the Mini Mental State Examination;\n* Inability to successfully perform ADLs without assistance or has lost interest in social, professional, or personal activities due to tremor\n\nExclusion Criteria:\n\n* Any other neurological condition that could reduce the safety of study participation including central nervous system vasculitis and intracranial malignancy\n* A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome;\n* A diagnosis of dementia;\n* Tremors due to other neurological conditions such as Parkinson's disease, dystonia, or other conditions not consistent with ET, cerebellar outflow tremor, or MS-related tremor.\n* Diagnosis of epilepsy;\n* Major active and untreated psychiatric illness that may interfere with study, such as psychotic disorders or severe personality disorders;\n* Untreated or inadequately treated depression defined by a score of 20 or greater on the Beck Depression Inventory-II at the time of enrollment;\n* At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS);\n* Pregnancy;\n* Unable to communicate with investigators or staff;\n* Surgical contraindications to DN DBS;\n* Contraindication to magnetic resonance (MRI) imaging, e.g., weight incompatible with scanner, implanted metallic devices or electrical devices (pacemaker, defibrillator, spinal cord stimulator, prior DBS) or intolerance to MRI contrast agent;\n* Enrolled in another device, biologic or pharmaceutical study within 30 days of consent in the current study, (i.e., patient cannot be enrolled if participation in another study was not completed at least 30 days prior to consent.);\n* Evidence of behavior(s) consistent with alcohol or substance abuse\u002Fdependence as defined by the criteria outlined in the DSM-V within the preceding six months;\n* Injection of botulinum toxins into the arm, neck or face within six months prior to baseline;","21 Years",{"count":459,"type":22},12,[461],"PHASE1","This objective of this study is to document the safety and feasibility of electrical stimulation of the deep cerebellar nuclei for refractory tremor using the Medtronic Percept RC Deep Brain Stimulation System. The population will consist of patients that have either failed a prior intervention (Vim DBS or HIFU thalamotomy) or determined to not be suitable candidates for Vim DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor. Those patients with a previous intervention, must have a prior diagnosis of ET, cerebellar outflow tremor, or MS-related tremor. Subjects without a previous intervention must have a diagnosis of cerebellar outflow tremor or MS-related tremor.",[464,465],"Tremor","Essential Tremor","2026-07-09",{"date":468,"type":33},"2026-07-10",{"date":470,"type":33},"2026-01-15",{"date":270,"type":22},{"name":39,"class":40},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":480,"maxAge":111,"enrollmentInfo":481,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":41},"100646038","imaging-in-semaglutide-study-100646038","NCT07695454","Imaging in Semaglutide Study","31P-MRS and MRI Imaging in Semaglutide Study","Inclusion Criteria:\n\n1. Gender: men and women\n2. Ethnicity: all ethnic groups\n3. Age between 45 and 75 years\n4. BMI ≥ 30 kg\u002Fm2 and BMI \\\u003C 45 kg\u002Fm2\n5. Diagnosis of Type 2 Diabetes (T2D) with HbA1c levels between 7% and 10.5%.\n6. Starting subcutaneous semaglutide for clinically indicated T2D management.\n7. Ability and willingness to participate in the study for its full duration.\n8. Provision of informed consent for participation in research.\n\nExclusion Criteria:\n\n1. Previous intolerance or allergy to any semaglutide-based therapy.\n2. History of prior intolerance to any GLP-1RA or GIP\u002FGLP-1RA.\n3. Unwillingness or uncertainty to commit to the duration of the study.\n4. Contraindication to MRI (e.g. claustrophobia, implanted devices including cardiac pacemaker and cardioverter-defibrillators), circumference of largest calf \\> 17inch\u002F43cm (max size to fit into the MR coil).\n5. History of myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass) within 30 days prior to screening.\n6. History of hospitalization for heart failure within the past 30 days, or NYHA class IV\n7. Current use of glucocorticoid therapy (≥5 mg prednisone or equivalent).\n8. Self-reported weight loss \\> 10 lbs in the 90 days prior to screening.\n9. Use of other mediation, on or off-label, for the primary intent of weight loss within 90 days prior to screening.\n10. Secondary etiologies for sarcopenia (e.g., gastrointestinal malabsorption, myopathies, severe neurological conditions).\n11. Glomerular Filtration Rate (eGFR) within the past 120 days is not available.\n12. Mental incapacity or language barriers preventing informed consent and compliance.\n13. Pregnancy, plans for pregnancy in the next 12 months, or lactating\u002Fnursing females.\n14. History of bariatric or metabolic surgery or related procedures.\n15. Prior participation in the Endocrinology and Metabolism Institute's Integrated Weight Management Program within the past 3 months.\n16. Active smoking.\n17. Excessive alcohol consumption, defined as ≥3 drinks per day.\n18. Uncontrolled lung disease (e.g., severe asthma or COPD).\n19. Uncontrolled thyroid disease.\n20. Personal commitments that may limit optimal participation (e.g., work, travel, caregiving responsibilities).\n21. History of malabsorptive disorders, such as celiac disease or Crohn's disease.\n22. Cholestatic liver disease or inadequate hepatic function (AST\u002FALT \\> 3.0 x ULN).\n23. Liver cirrhosis.\n24. Conductive implanted devices (e.g., cardiac pacemaker, cardioverter-defibrillators).\n25. Major surgical procedures or significant traumatic injury within 30 days prior to the enrollment date.\n26. Any medical or surgical condition that, in the opinion of the principal investigator, may make the participant unfit for the trial (e.g., psychiatric disorders, malignancy).\n27. Any condition, unwillingness, or inability, not otherwise covered by exclusion criteria, which might jeopardize the subject's safety or compliance with the protocol.\n28. Presence of metal in the eye","45 Years",{"count":482,"type":22},10,"In this preliminary observation study, the investigators will assess muscle function in terms of muscle strength and leverage imaging (MRI) and spectroscopy (31P-MRS) based techniques to assess longitudinal changes in muscle volume, quality and metabolic function in patients with T2D and obesity prescribed to semaglutide therapy. The patients will be evaluated at three time points: 1) baseline, 2) 3-month and 3) 6-month after the therapy. These longitudinal changes will then be compared and correlated with changes in physical measurements such as BMI and patient reported outcome measures (PROMs). The primary aim of our study is to investigate the longitudinal effects of semaglutide therapy on patients with T2D and obesity, on skeletal muscle strength, muscle volume, quality and metabolic function.",[485,486],"Type 2 Diabetes","BMI Greater Than 30",{"date":468,"type":33},{"date":489,"type":22},"2026-07-15",{"date":491,"type":22},"2027-06-01",{"name":39,"class":40},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":16,"sex":17,"minAge":500,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":513,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":41},"100636620","neural-correlates-of-suicidal-behavior-in-youth-100636620","NCT07568054","Neural Correlates of Suicidal Behavior in Youth","Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study","Inclusion Criteria:\n\n* Subjects must be 14-24 years old\n* Subjects must be:\n\n  * High Risk Subjects: Psychiatrically admitted due to a suicide attempt or history of 2 previous suicide attempts\n  * Medium Risk Subjects: Suicide ideation for the past year with no suicide attempt\n  * Minimal Risk Subjects: No previous history of suicidal ideation or behavior, not taking any psychiatric history or medication, and no family history of suicide\n* Subjects must have the ability to understand and the willingness to sign a written informed consent\u002Fassent document\n* Subjects must be English speaking\n\nExclusion Criteria:\n\n* Subjects with known history of Autism Spectrum Disorder; non-verbal patients\n* Subjects with moderate or severe intellectual disability (IQ less than 70 and those patients in special education classes full time)\n* Subjects with Schizophrenia or history of any type of psychosis including mood related psychosis and brief reactive psychosis\n* Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (subjects prescribed amphetamines for the management of ADHD will not be excluded)\n* Subjects with a history of moderate or severe substance or alcohol use per DSM-5 criteria in the past 6 months\n* Subjects who are currently pregnant or breastfeeding\n* Subjects in custody of Children's Services\n* Subjects with recent bone, tendon, spine or joint surgery\n* Subjects with recent metallic dental implants\n* Subjects weighing less than 30 kg or more than 200 kg","14 Years","24 Years",{"count":503,"type":22},60,[25],"This study, titled \"Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study,\" aims to better understand the brain mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults (ages 14-24). Suicide is a leading cause of death in this population, and current clinical approaches often fail to accurately predict or prevent suicidal behavior. This study seeks to identify objective neurobiological markers associated with suicide risk and treatment response.\n\nParticipants will be divided into three groups: (1) high-risk individuals recently hospitalized following a suicide attempt, (2) medium-risk individuals with chronic suicidal ideation but no attempts, and (3) low-risk healthy controls. All participants will undergo advanced neuroimaging, including magnetoencephalography (MEG) and magnetic resonance imaging (MRI), along with comprehensive psychiatric assessments.\n\nThe study focuses on brain regions and networks implicated in suicidality, including the anterior cingulate cortex and salience network, as well as neurochemical markers such as glutamate. It also examines electrophysiological activity and functional connectivity patterns associated with suicidal thoughts and behaviors.\n\nHigh-risk participants will receive an evidence-based psychotherapy called the Collaborative Assessment and Management of Suicidality (CAMS). This therapeutic approach emphasizes collaboration between patient and clinician to identify and address the underlying drivers of suicidal thoughts, with a focus on increasing hope and reducing psychological distress. Neuroimaging and clinical assessments will be repeated after completion of CAMS to evaluate treatment-related changes.\n\nThe study's primary goals are to:\n\n* Identify neural and electrophysiological correlates of suicide risk.\n* Distinguish biological differences between individuals with suicidal ideation and those who have attempted suicide.\n* Determine how CAMS therapy affects brain function and neurochemistry.\n\nBy integrating clinical and neurobiological data, this research aims to improve understanding of suicidality, enhance risk prediction, and inform more effective, personalized interventions for at-risk youth.",[507,508,509,510,511,512],"Suicidal Ideation","Suicide Attempt","Suicidal Behavior","Depression \u002F Major Depressive Disorder","Hopelessness","Neurobiological",[514,515,516,517,518,511,519,520],"Suicidal ideation","Suicide attempt","Suicidal behavior","Youth suicide","Depression","CAMS therapy","Neuroimaging",{"date":468,"type":33},{"date":523,"type":22},"2026-06-30",{"date":525,"type":22},"2031-10-01",{"name":39,"class":40},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":41},"100569462","monocytes-in-subjects-with-type-1-diabetes-and-chronic-kidney-disease-100569462","NCT06694558","Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease","Inclusion Criteria:\n\n1. T1D CKD subjects:\n\n   1. Adults, males or females diagnosed with T1D\n   2. Age 18-65 years\n   3. Diagnosed with CKD (eGFR 60-90 ml\u002Fmin\u002F1.73 m2)\n   4. Diagnosed with albuminuria (UACR 30-500 mg\u002Fg)\n   5. On insulin injections or pump\n   6. On CGM\n\n   Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\\\u003C60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\\>70% A1c 5.0-7.0\n2. Controls: T1D subjects without CKD\n\n   1. Adults, males or females diagnosed with T1D\n   2. Age 18-65 years\n   3. No CKD (eGFR \\>90 ml\u002Fmin\u002F1.73 m2)\n   4. No albuminuria (UACR \\\u003C30 mg\u002Fg)\n   5. On insulin injections or pump\n   6. On CGM\n\nBased on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\\\u003C60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\\>70% A1c 5.0-7.0\n\nExclusion Criteria:\n\n1. Hemoglobin \\\u003C9\n2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days\n3. pregnancy or plans to become pregnant\n4. On steroids\n5. Diagnosed with cancer, immunosuppression\u002Fautoimmune conditions\n6. Reported heavy alcohol use or recreational drug use\n7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion","65 Years",{"count":503,"type":22},"This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.",[537,538],"Chronic Kidney Disease(CKD)","Type 1 Diabetes (T1D)","2026-07-06",{"date":404,"type":33},{"date":542,"type":33},"2025-03-01",{"date":544,"type":22},"2027-07-01",{"name":39,"class":40},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":16,"sex":196,"minAge":18,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":41},"100636917","health-related-quality-of-life-and-metabolic-outcomes-in-pcos-100636917","NCT07571915","Health-Related Quality of Life and Metabolic Outcomes in PCOS","Health-Related Quality of Life and Metabolic Outcomes in PCOS: A Feasibility Study of Comprehensive PCOS Education and Lifestyle Modification Support Delivered Via Synchronous Virtual Groups","Inclusion Criteria:\n\n1. Non-pregnant females ages 18-49 years\n2. Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg\u002Fm2) at enrollment\n\nExclusion Criteria:\n\n1. Patients who are pregnant or planning to become pregnant during the study period\n2. Patients currently or with recent participation (\\\u003C 12 months at the time of enrollment) in a PCOS-focused group\n3. Patients with documented monogenic obesity\n4. Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)\n5. Patients on systemic glucocorticoid therapy \\> 7 days at the time of enrollment\n6. Patients with any end-stage organ disease\n7. Patients without access to internet\n8. Patients requiring English language interpretation\n9. Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study","49 Years",{"count":555,"type":22},40,[25],"The primary outcome of interest is change in PCOS health-related quality of life, while the secondary outcome of interest is change in adiposity, cardiometabolic, and inflammation biomarkers.",[559],"PCOS (Polycystic Ovary Syndrome)",{"date":561,"type":33},"2026-07-01",{"date":563,"type":33},"2026-06-01",{"date":230,"type":22},{"name":39,"class":40},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":41},"100645243","ultrasound-guided-versus-standard-margin-selection-in-ileocecal-resection-of-terminal-ileal-cd-100645243","NCT07680283","Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD","Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial","SMILE-CD","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Diagnosis of terminal ileal Crohn's disease with inflammatory or fibrostenotic phenotype localized to terminal ileum\u002Fileocecal region and assessed on either preoperative imaging or during surgical exploration at the time of surgery.\n* Scheduled to undergo primary ileocolic resection.\n\nExclusion Criteria:\n\n* Penetrating disease with abscess or complex fistula requiring complex resection.\n* Prior ileocolic resection.\n* Diagnosis of Crohn's colitis.\n* Pregnancy or inability to provide informed consent.\n* Stoma at or before randomization: Participants in whom a stoma is required before randomization (identified intra-operatively) will not be randomized and will be excluded from the trial. Stoma after randomization: If a stoma is created after randomization-either during the index operation or at re-operation for postoperative complications-the participant remains in the trial. All feasibility, histopathology, operative, and safety outcomes will be collected and analyzed in the assigned arm (ITT). However, these participants will not be evaluable for the endoscopic-recurrence endpoint; they will be listed as \"not assessed for endoscopic recurrence (stoma)\" with reasons documented.\n* Contraindication to IOUS (as determined by the surgeon).",{"count":575,"type":22},44,[25],"This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn's disease. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while surgeons, by the nature of the intervention, cannot be blinded. Randomization will be computer-generated with concealed allocation using permuted blocks to ensure balanced group sizes.",[579],"Crohn's Disease (CD)",[581,582,583,584,585,586],"Ultrasound","ileocecal resection","anastomosis","resection margin","ileocolic resection","Crohn's disease","2026-06-29",{"date":589,"type":33},"2026-07-02",{"date":591,"type":22},"2026-07",{"date":593,"type":22},"2029-01",{"name":39,"class":40},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":41},"100645278","cognitive-and-immunologic-profiles-of-patients-with-olfactory-dysfunction-after-smell-training-100645278","NCT07681973","Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training","CIPOD","Inclusion Criteria:\n\n* Age less than 18 years-old\n* Present to rhinology clinic with CRS with nasal polyps\n* Sense of smell loss for any reason (other than trauma or tumor)\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years of age\n* Individuals with unilateral nasal polyps\n* Autoimmune diseases\n* Ciliary disorders\n* Cystic fibrosis\n* Smell loss due to tumors or trauma",{"count":603,"type":22},52,[25],"A research study to assess the baseline olfactory function, mental health status, clinical severity, and immunological profile in patients with smell loss. The impact of a 3-month olfactory training program on smell function, immunological changes, and mental health in patients with smell loss will be evaluated.\n\nThe primary purpose of this study is to investigate tissue and blood samples to identify molecules that may be related to smell loss, ultimately aiming to develop future treatments for this condition and correlate with cognition.",[607,608],"Smell Loss","Chronic Rhinosinusitis (CRS)",[607,610,611,612],"Chronic Rhinosinusitis","Nasal Polyps","CRSwNP","2026-06-26",{"date":589,"type":33},{"date":616,"type":33},"2025-12-09",{"date":618,"type":22},"2027-03-31",{"name":39,"class":40},{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":636,"locationsCount":41},"100515595","randomized-controlled-trial-of-miniaturized-percutaneous-nephrolithotomy-with-vacuum-assisted-access-sheaths-versus-conventional-sheaths-for-treatment-of-nephrolithiasis-100515595","NCT05993546","Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis","Inclusion Criteria:\n\n* Patients with planned prone mini-PCNL and a preoperative NCCT\n* Primary stone size: 10-25 mm\n* Pre-existing indwelling nephrostomy tube or ureteral stent permitted\n* Age: ≥ 18 years old\n* Gender: all\n* Ethnicity: all\n* Capable of giving informed consent\n* Capable and willing to fulfill requirements of the study\n\nExclusion Criteria:\n\n* Anticoagulated or history of coagulopathy\n* Congenital renal anomalies\n* Prior ipsilateral upper urinary tract reconstructive procedures\n* Conversion to open procedure\n* Multiple access tracts\n* Inability to give informed consent or unable to meet requirements of the study for any reason",{"count":627,"type":22},90,[25],"The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.",[631],"Kidney Stone",{"date":587,"type":33},{"date":634,"type":33},"2023-08-29",{"date":374,"type":22},{"name":39,"class":40},""]