[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"State University of New York - Upstate Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":284},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,74,100,127,154,180,211,234,261],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100515206","dynamic-deconstructive-psychotherapy-versus-brief-intervention-and-contact-for-suicidal-adolescents-and-young-adults-100515206",false,"NCT05988489","Dynamic Deconstructive Psychotherapy Versus Brief Intervention and Contact for Suicidal Adolescents and Young Adults","Inclusion Criteria:\n\n* CSSRS suicide ideation of ≥ 2 and PHQ-9 item 9 of ≥ 1\n* Ages 14 through 40 years old of both genders\n* Fluency in English\n* Willingness to enter outpatient treatment as evidenced by psychiatric consultation at the PHRP and attending a first session with their intake therapist\n* Willingness to be video-recorded\n* Completion of baseline outcomes measures\n\nExclusion Criteria:\n\n* Previous or current clinical diagnosis of schizophrenia, schizoaffective disorder or autism spectrum disorder as ascertained by self-report on the PHRP intake packet, or on their electronic medical records, or by psychiatric evaluation at the PHRP\n* BMI \\\u003C 18 for adults ≥ 18 years old, and BMI \\\u003C 17 for adolescents\n* Concurrent use of weekly ECT, ketamine, or esketamine\n* IQ \\\u003C 80 on the Peabody Picture Vocabulary Test\n* Current or previous treatment with Dynamic Deconstructive Psychotherapy","ALL","14 Years","40 Years",{"count":19,"type":20},106,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical trial is to assess whether 6 months of treatment with Dynamic Deconstructive Psychotherapy (DDP) is more effective for reducing thoughts of suicide in suicidal adolescents and young adults than usual care in the community supplemented with Brief Intervention and Contact (BIC). DDP and BIC are two evidence-based practices shown to be more effective than usual care at reducing suicidality. Participants will be randomly assigned to receive DDP treatment with safety planning and optional medication management or BIC treatment with safety planning and optional medication management. Participants in both groups will receive the assigned treatment at SUNY Upstate Medical University's Psychiatry High Risk Program (PHRP). Each participant is anticipated to take part in this trial for up to one year.",[26],"Suicidal Ideation",[28,29,30,31],"Suicide","Psychotherapy","Adolescent","Outpatients","RECRUITING","2026-04-21",{"date":35,"type":36},"2026-04-24","ACTUAL",{"date":38,"type":36},"2023-10-25",{"date":40,"type":20},"2027-09",{"name":42,"class":43},"State University of New York - Upstate Medical University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100621678","early-phase-1-pharmacokinetic-pk-study-of-tafenoquine-in-healthy-adults-100621678","NCT07373743","Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults","Inclusion Criteria:\n\n1. Age 18-65 at the time of consent, weighing between 132 and 250 pounds\n2. Ability and willingness to sign informed consent\n3. Available for the study period\n4. Willing to use contraception for the duration of the study\n5. Agree not to take over the counter antioxidants, vitamin C or vitamin E, 2 weeks prior to dosing and 7 days post dosing\n\nExclusion Criteria:\n\n1. Women: positive urine pregnancy test at screening or day of dosing\n2. Women who are lactating or intend to become pregnant during the study period.\n3. Acute or chronic clinically significant hematologic, pulmonary, cardiovascular, hepatic, or renal functional abnormality as determined by medical history, physical examination or laboratory screening.\n4. History of allergic reaction to tafenoquine or primaquine.\n5. Scheduled receipt of any vaccine 1 week prior to or after 4 weeks tafenoquine dosing. Routine COVID and influenza vaccination will be allowed outside of this timeframe.\n6. Currently taking metformin, dofeltilide or other medication with known multidrug and toxin extrusion enzyme (MATE) metabolism.\n7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy.\n8. Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the participant from participating in the study.\n9. Participants with hemoglobin, Creatinine, BUN, and Albumin of grade 2 or greater. Participants with eGFR \\\u003C90mL\u002Fmin\u002F1.73m2; ALT \\>1.5x ULN, or AST \\>1.5x ULN. Any exclusionary lab abnormality may be repeated once. If a repeat screening blood test is performed, only the result of the second test will be reviewed and used to determine eligibility.\n10. Positive HIV, hepatitis B surface antigen or hepatitis C.\n11. G6PD result not normal or \\\u003C 70% activity\n12. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact participant safety, including BMI \\> 35kg\u002Fm2\n13. Participation (active or follow-up phase) or planned participation in another vaccine, or drug, in the 4 weeks prior to or during the trial\n14. Beliefs that bar the administration of blood products or transfusions\n15. Clinician discretion",true,"18 Years","65 Years",{"count":55,"type":20},20,[57],"EARLY_PHASE1","The goal of this clinical trial is to learn how people's different genetic makeups affects how their bodies convert the FDA approved drug ARAKODA (tafenoquine) to its active form. Tafenoquine is a drug that is taken to prevent malaria for people traveling to areas where there is malaria. This trial will be in healthy participants age 18-65.",[60],"Pharmacokinetic in Normal Population",[62,63,64],"Tafenoquine","CYP2D6","Pharmacokinetic","NOT_YET_RECRUITING","2026-03-18",{"date":68,"type":36},"2026-03-20",{"date":70,"type":20},"2026-05",{"date":72,"type":20},"2027-03",{"name":42,"class":43},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100563049","early-phase-1-ceftriaxone-pulse-dose-for-post-treatment-lyme-disease-100563049","NCT06611111","Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease","Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease","Inclusion Criteria:\n\n1. Age 18 to 75 at the time of consent\n2. Ability and willingness to sign informed consent\n3. Available for the study period\n4. Must have met the definition of a prior well-defined or probable Lyme disease infection, AND meet the definition of PTLDS\n5. Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit\n6. Have a level of fatigue that interferes with their ability to function in their job, schooling, or other social\u002Fpersonal activities (FSS score of 4 or higher)\n7. Subjects will need to have been off of antibiotics (those standard antibiotics used to target Lyme disease to include doxycycline, amoxicillin, cefuroxime, azithromycin, ceftriaxone or penicillin) for at least 6 weeks prior to study enrollment and be willing to remain off of any outside antibiotics during the duration of the treatment component of the study.\n\nExclusion Criteria:\n\n1. Female: pregnant or lactating\n2. Women who intend to become pregnant during the treatment study period (approximately 45 days)\n3. Patients with a diagnosis of Lyme disease based on only a positive Lyme IgM immunoblot\n4. A history of cephalosporin allergy or significant intolerance\n5. Lyme related symptoms that have been present for greater than 10 years\n6. Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus.\n\n   Note: Subjects who have well controlled HIV, who are on ART with a CD4 count greater than 200 will be allowed to participate.\n7. Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition (to include any finding of increased suicide risk as identified by a rating of moderate or high risk on the CSSRS assessment), which in the opinion of the investigator prevents the subject from participating in the study\n8. Known concurrent rheumatologic or similar disease thought to interfere with study participation or confound results at the discretion of the investigator. These may include but are not limited to rheumatoid arthritis, systemic lupus erythematous, Sjogren's syndrome, scleroderma, psoriasis, fibromyalgia, chronic fatigue syndrome\u002Fmyalgic encephalomyelitis, or obstructive sleep apnea\n9. Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous treatment with a cephalosporin antibiotic, or severe allergic reaction to penicillins (e.g. anaphylaxis or severe rash with Stevens Johnson syndrome or similar)\n10. Planned travel during the study period that would interfere with the ability to complete all study visits (this can be a temporary exclusion with plan to schedule enrollment during a window of time during which they could attend their study visits)\n11. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety\n12. 12\\. Participation (active or follow-up phase) or planned participation in another vaccine, drug, or medical device in the 4 weeks prior to this trial, within 5 times the elimination half-life, whichever is longer, or during the trial\n13. Prior history of Clostridium difficile infection\n14. Currently taking warfarin (Coumadin)\n15. Unable to comply with study requirements\n16. Clinician discretion","75 Years",{"count":83,"type":20},44,[57],"The goal of this clinical trial is to learn if an FDA approved drug, Ceftriaxone, given intermittently, can treat people between 18 and 75 years old with a history of Lyme disease, who are still experiencing persistent or returning symptoms after they have completed treatment. The main questions it aims to answer are:\n\n* Will giving Ceftriaxone approximately every 5 days for 6 weeks be safe and well tolerated when compared to a group that receives placebo (a look-alike substance that contains no drug)?\n* Will giving Ceftriaxone improve symptoms?\n\nParticipants will be asked to do the following:\n\n* Come to the clinic approximately every 5-6 days to receive an IV infusion of either the Ceftriaxone or placebo.\n* Answer questions about their level of tiredness, body pain, general health and physical ability, sleep, anxiety, depression and any suicidal thoughts.\n* Give blood so we can make sure your body is handling the drug okay or to help us learn more about how the drug is affecting the persistent Lyme disease symptoms.",[87],"Post-Treatment Lyme Disease",[89,90,91,92],"Pulse Dose","Ceftriaxone","PTLDS","Chronic Lyme Disease",{"date":94,"type":36},"2026-03-19",{"date":96,"type":36},"2025-02-03",{"date":98,"type":20},"2026-12",{"name":42,"class":43},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100622233","mirror-therapy-as-an-adjunct-to-rehabilitation-following-total-knee-arthroplasty-100622233","NCT07380958","Mirror Therapy as an Adjunct to Rehabilitation Following Total Knee Arthroplasty","Inclusion Criteria:\n\n1. Candidates that have been screened and deemed eligible for a TKA and received a TKA 14 days or less post operation.\n2. English speaking\n3. Able to understand and follow instructions\n4. Has at least 5 degrees of knee extension to 100 degrees of knee flexion AROM on the contralateral knee\n5. Able to perform unilateral stance on contralateral side for at least 5 seconds (balance assistance allowed)\n6. Able to perform exercises\n\nExclusion Criteria:\n\n1. Post-surgical complications (DVT, infection, nerve injury, vascular injury)\n2. Pain rating on NPRS no more than a 4\u002F10 on the contralateral LE\n3. Significant scar or deformity of the contralateral LE\n4. Visual impairments causing an inability to see the reflection in a mirror",{"count":107,"type":20},30,[23],"The investigators are looking to see if using a mirror during knee exercises after a knee replacement helps participants with less pain and\u002For better knee range of motion.",[111],"Total Knee Arthroplasty Recovery",[113,114,115,116,117,118],"Total knee replacement","pain","mirror therapy","range of motion","joint replacement","rehabilitation following a knee replacement","2026-01-24",{"date":121,"type":36},"2026-02-02",{"date":123,"type":20},"2026-02",{"date":125,"type":20},"2026-10",{"name":42,"class":43},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":51,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":44},"100609857","effect-of-activated-charcoal-on-serum-osmolality-osmolal-gap-and-enzymatic-ethylene-glycol-assay-100609857","NCT07220031","Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay","Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* Any medical comorbidities\n* Recent illness\n* Pregnancy\n* Prisoners\n* Non-English speaking\n* Weight \\> 100 kg",{"count":134,"type":20},8,"OBSERVATIONAL","The goal of this observational study is to determine whether a clinically relevant dose of activated charcoal raises the serum osmolality and osmolal gap in a population of healthy volunteers. Secondarily to determine whether the same dose creates a false positive result using an enzymatic assay.\n\n1. Does a clinically relevant dose of commercially available activated charcoal raise the osmolal gap above the baseline of a healthy volunteer?\n2. Does the same dose of charcoal cause a false positive enzymatic assay for ethylene glycol?\n\nParticipants will be asked to consume a dose of activated charcoal and have serial blood draws for laboratory measurements.",[138,139],"Osmolality Disturbance","Lab Interference",[141,142,143,144,145],"activated charcoal","serum osmolality","osmolal gap","ethylene glycol","glycerol dehydrogenase","2025-10-21",{"date":148,"type":36},"2025-10-23",{"date":150,"type":20},"2025-11-15",{"date":152,"type":20},"2026-05-01",{"name":42,"class":43},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":15,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100516601","integrated-platform-for-measuring-and-reducing-symptoms-of-autism-spectrum-disorder-100516601","NCT06006637","Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder","IPMR ASD","Inclusion Criteria:\n\n* Ages 2 - 8\n* Autism spectrum disorder diagnosis\n* CARS-2 score of 30 - 45\n\nExclusion Criteria:\n\n* CARS scores less than 30 or over 45.\n* Taking psychotropic medications.\n* Having skin lesions on scalp\n* Having history of seizures\n* Having history of abnormal EEG\n* Being a relative of the PI or a researcher\n* Having implanted devices (including cochlear implants).","2 Years","8 Years",{"count":164,"type":20},80,[23],"This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.",[168],"Autism Spectrum Disorder",[170,168],"Transcranial photobiomodulation","2025-10-10",{"date":173,"type":36},"2025-10-14",{"date":175,"type":36},"2023-10-17",{"date":177,"type":20},"2026-08-15",{"name":42,"class":43},2,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":51,"sex":15,"minAge":52,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":44},"100524696","phase-1-repetitive-transcranial-magnetic-stimulation-for-post-concussion-headaches-100524696","NCT06112093","Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches","Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study","Inclusion Criteria:\n\n* 18 - 55 years old\n* mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours\n* diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria\n* headache develops within 7 days after head trauma\n* headache persists for \\>=3 months after head trauma despite receiving standard care\n* average persistent headache intensity is \\>= 3\u002F10 of the numerical rating scale (NRS) on \\>=3days\u002Fweek\n* no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation\n* no evidence of other possible causes of headaches\n\nExclusion Criteria:\n\n* history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI\n* history of other neurologic conditions with medications affecting the central nervous system\n* contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip","55 Years",{"count":189,"type":20},60,[191],"PHASE1","This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.",[194,195,196,197],"Brain Concussion","Mild Traumatic Brain Injury","Headache","Post-Concussion Symptoms",[199,200,201,202,203],"Repetitive transcranial magnetic stimulation","Non-invasive brain stimulation","Neuromodulation","Chronic pain","Biomarkers","2025-10-08",{"date":171,"type":36},{"date":207,"type":36},"2023-10-23",{"date":209,"type":20},"2027-10-23",{"name":42,"class":43},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":51,"sex":15,"minAge":52,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":44},"100105717","evaluation-and-optimization-of-ultrasound-andor-mri-hardware-and-software-100105717","NCT00640107","Evaluation and Optimization of Ultrasound and\u002For MRI Hardware and Software","Evaluation and Optimization of Ultrasound and\u002For MRI Hardware and Software in Existing SUNY Ultrasound and\u002For MRI Units and Newly Installed Commercially Available Units","Inclusion Criteria:\n\n* Able to Understand and Sign Informed Consent Disclosure (ICD)\n* Healthy Volunteers Aged 18-70\n* Healthy Volunteers with No History of Aneurysm Clips, Cardiac Pacemakers, Claustrophobia, Neurostimulators, and Pregnancy.\n\nExclusion Criteria:\n\n* Subjects \\> 300 Pounds\n* Subjects \\\u003C 18 Years Old\n* Subjects \\> 70 Years Old\n* Subjects w\u002F Aneurysm Clips\n* Subjects w\u002F Cardiac Pacemakers\n* Subjects w\u002F Claustrophobia\n* Subjects w\u002F Neurostimulators\n* Subjects w\u002F Pregnancy","70 Years",{"count":107,"type":20},"The purpose of this study is to evaluate and optimize ultrasound and\u002For MRI hardware and software in both existing ultrasound\u002FMRI units as well as in newly installed commercially available ultrasound\u002FMRI units. The study also serves to familiarize the ultrasound\u002FMRI technician staff with how to operate newly installed software sequences or hardware. The information obtained from this study will be utilized to optimize new software sequences and hardware that have been installed on the UMU ultrasound\u002FMRI scanners. This will offer ultrasound\u002FMRI technologists ample time to become familiar with the operation of new equipment. More specifically, the objectives of this study are to maximize contrast to noise (CNR) and signal to noise (SNR) ratios for new imaging sequences and hardware to obtain high quality images, maximize the potential of new machines and associated software\u002Fhardware to obtain the highest quality of images, and obtain the highest quality images in reasonable scan time to minimize patient motion.",[222],"Healthy",[224,225],"Magnetic Resonance Imaging","Ultrasound","2024-06-27",{"date":228,"type":36},"2024-06-28",{"date":230,"type":36},"2007-10",{"date":232,"type":20},"2030-09",{"name":42,"class":43},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100527632","early-phase-1-effect-of-probiotics-on-immunosuppressive-drug-associated-diarrhea-among-renal-transplant-recipients-100527632","NCT06150287","Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients","Inclusion Criteria:\n\n* Received living or deceased donor kidney, subjects will be monitored peri-operatively\n* Presence of mild to severe diarrhea (\\> 3 times loose stools\u002Fday); include type 6 and 7 in the Bristol Stool Chart.\n* Has been on adjusted and\u002For maintenance dose of calcineurin inhibitors, antimetabolites and steroid regimen. Treatment of rejection including administration of steroids, intravenous immunoglobulin\u002Fplasmapheresis, rituximab and anti- thymocytes are also acceptable in this research.\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Has been receiving probiotics treatment\n* Recurrence of gastrointestinal diseases including inflammatory bowel diseases, diverticulosis, irritable bowel syndrome. Had past surgical history of gastric bypass.\n* Diagnosed with cancer\n* Presence of infectious diarrhea, fever and high white blood cells (WBC) count. Infectious diarrhea is defined by polymerase chain reaction (PCR) negative for community acquired diarrhea panel \\[positive for Sapo virus, Noro virus, Clostridium difficile (positive for toxin A and B), Yersinia enterocolitica \\[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\\].","80 Years",{"count":242,"type":20},70,[57],"The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are:\n\n1. Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea?\n2. Does probiotics effective in reducing inflammation?\n3. Is there any connection between fecal microbiome and immunological markers?\n\nParticipants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.",[246],"Renal Transplantation",[248,249,246,250,251,252],"Probiotics","Immunosuppressive Drugs","Diarrhea","Living Donor","Deceased Donor","2024-05-10",{"date":255,"type":36},"2024-05-13",{"date":257,"type":20},"2024-12",{"date":259,"type":20},"2027-05",{"name":42,"class":43},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":4},"100419071","phase-2-sirolimus-treatment-of-patients-with-sle-100419071","NCT04736953","Sirolimus Treatment Of Patients With SLE","Sirolimus Treatment of Patients With Systemic Lupus Erythematosus","STOPSLE","Inclusion Criteria:\n\n1. Age \\> 18;\n2. Male or female;\n3. ≥ 4 ACR SLE classification criteria;\n4. Positive ANA at a titer of ≥ 1\u002F80;\n5. Stable immunosuppressants (MMF ≤ 3 g\u002Fday, azathioprine ≤ 100 mg\u002Fday; methotrexate ≤ 15 mg\u002Fday) and\u002For antimalarials (hydroxychloroquine ≤ 400 mg\u002Fday) for 30 days prior to screening; stable oral corticosteroids for 2 weeks prior to screening; ≤ 20 mg\u002Fday prednisone or equivalent; stable belimumab for 90 days prior to screening;\n6. BILAG 2004 index (3) level A disease activity in ≥ 1 organ\u002Fsystem except renal or central nervous system or (ii) BILAG 2004 index level B disease activity in ≥ 2 organs\u002Fsystems if no level A disease activity is present and (iii) SLEDAI ≥ 6;\n7. Enrollment is approved by adjudication committee.\n\nExclusion Criteria:\n\n1. Acute SLE flare threatening vital organs;\n2. Pregnant or lactating;\n3. Female subjects who are planning to become pregnant during the study or within 3 months after last dosing or male subjects who are considering fathering a child within 3 months after last dosing;\n4. Abnormal laboratory test results: hemoglobin ≤ 8 g\u002FL (8 g\u002FdL), platelet count ≤ 70 x 109\u002FL (70,000 cells\u002Fmm³), white blood cell count ≤ 2.0 x 109\u002FL (2,000 cells\u002Fmm³), neutrophils: ≤ 1.5 X 109\u002FL, proteinuria \\> 3 g\u002Fday measured by 24 hour collection or spot urine protein to creatinine ratio of \\>3;\n5. Glomerular filtration rate (GFR) \\\u003C 50 mL\u002Fmin\u002F1.73 m², any other clinically significant abnormal screening laboratory results as evaluated by the Investigator;\n6. Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency) that in investigator's opinion confers high risk for adverse events;\n7. Patients receiving cyclophosphamide within 3 months;\n8. Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patients with oral steroid-dependent asthma;\n9. Infections requiring intravenous antibiotics within a month or oral antibiotics within two weeks of screening;\n10. Patients taking (unwilling or unable to stop) NAC or other antioxidants within 1 month of screening (which is considered sufficient time to revert GSH to pre-treatment levels;\n11. Patients receiving rituximab within 12 months or other biologic therapy within five half lives;\n12. Patients receiving mTOR inhibitors (rapamycin\u002Fsirolimus, everolimus);\n13. Patients enrolled in other interventional trials.",{"count":270,"type":20},220,[272],"PHASE2","Phase II Double-blind, placebo-controlled, randomized treatment trial with two arms: one SIROLIMUS arm with 92 patients and one placebo arm with 92 patients. The safety and therapeutic efficacy of SIROLIMUS will be determined within a dosage range of 1 mg\u002Fday to 4 mg\u002Fday, which will be titrated to tolerance during an initial 3-month open label period, relative to placebo in SLE patients over 12 months followed by a 1-month washout. The proposed study design, known as an enriched enrollment randomized withdrawal (EERW), has major advantages that (1) only people who tolerate SIROLIMUS are randomized, potentially reducing the percentage of dropouts in the randomized phase and (2) it allows participants to use an individualized dosage of study medication, which mimics clinical practice in terms of how SIROLIMUS would be administered. Healthy subjects receive no drugs and serve as controls for in vitro studies.",[275],"Lupus Erythematosus, Systemic","2023-06-02",{"date":278,"type":36},"2023-06-05",{"date":280,"type":20},"2025-01-01",{"date":282,"type":20},"2029-01-01",{"name":42,"class":43},""]