[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Duke University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":658},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,249,0,25,[9,51,97,124,146,181,203,234,257,282,302,326,348,378,413,435,455,476,501,521,549,571,594,617,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100636600","gbpdc-gut-brain-in-pd-consortium-master-protocol-100636600",false,"NCT07567794","GBPDC: Gut-Brain in PD Consortium Master Protocol","Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol","GBPDC","Inclusion Criteria (All PD Cohorts)\n\n1. Aged ≥21 years old and ≤80 years old\n2. Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n3. Adequate visual, hearing, cognitive, and physical ability\n4. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a \"best estimate\" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee\n\nInclusion Criteria Controls\n\n1. Aged ≥21 years old and ≤80 years old\n2. No known or diagnosed neurodegenerative disease\n3. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n4. Resides within the same household as person with PD\n\nInclusion Criteria Prodromal Cohort\n\n1. Aged ≥21 years old and ≤80 years old\n2. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.\n\nExclusion Criteria (All Cohorts)\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Laboratory Values:\n\n   1. Hemoglobin (Hgb) \\\u003C10\n   2. Platelets \\\u003C70,000\n   3. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN)\n   4. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002FBSA \\[body surface area\\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \\[ALP\\] \\>2.0 times the ULN and\u002For total bilirubin \\>2.0 times the ULN)\n   5. Significantly above the normal range for PT\u002FINR\u002FPTT\n3. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure\n4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \\\u003C22\n5. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed\u002Ftreated vitamin B12 deficiency, or other screening laboratory abnormalities\n6. Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide\n7. Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated\u002Fremoved cutaneous carcinomas are not excluded.)\n8. Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study\n9. Body mass index (BMI) \\>35 kg\u002Fm2 or body weight \\\u003C50 kg\n10. Participant is currently pregnant, breastfeeding, and\u002For lactating\n11. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n12. History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n13. Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment\n14. Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.\n15. History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n16. Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n17. Has a history of Crohn's disease, ulcerative colitis, and\u002For other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and\u002For, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.",true,"ALL","21 Years","80 Years",{"count":23,"type":24},250,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.\n\nDuring this study, specific groups of participants, also known as \"cohorts\", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.\n\nParticipants in this study will:\n\n* meet with a medical provider\n* answer questionnaires\n* give samples of blood, stool, and saliva\n* have X-rays taken while swallowing different foods (swallowing study)\n* have X-rays taken to see how long it takes markers to move through their colon (colon transit study)\n* have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)\n* have samples taken of their skin\n* have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.\n\nParticipation in the study will last up to 24 months (2 years).",[28,29,30,31,32],"Parkinson Disease (PD)","PARKINSON DISEASE (Disorder)","Gut Microbiome","Gut Microbiota","Prodromal Parkinsons Disease",[34,35,36,37],"gut brain","Parkinson's disease","Prodromal Parkinson's disease","healthy control","RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":42},"2026-07-03",{"date":46,"type":24},"2028-12-31",{"name":48,"class":49},"Duke University","OTHER",7,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":18,"sex":19,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","0 Years","20 Years",{"count":62,"type":24},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome",{"date":41,"type":42},{"date":92,"type":42},"2020-03-05",{"date":94,"type":24},"2026-12",{"name":48,"class":49},52,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":103,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100647780","effect-of-periumbilical-vibration-on-pain-perception-during-intrauterine-device-insertion-a-randomized-controlled-trial-100647780","NCT07714590","Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Capable of providing informed consent\n* Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic\n* English-speaking\n\nExclusion Criteria:\n\n* Currently pregnant\n* Planned use of IV sedation during IUD placement\n* Inability to provide informed consent due to disability or language barrier","FEMALE","18 Years",{"count":106,"type":24},114,"INTERVENTIONAL",[109],"NA","The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine device (IUD) decreases perceived pain during the procedure. The main question it aims to answer is: Does applying a vibrating device to the umbilicus during IUD insertion significantly reduce perceived pain compared to standard of care?\n\nResearchers will compare pain scores during IUD insertion among patients who received the vibrating device at the umbilicus and those who did not.\n\nParticipants will be randomly assigned to receive a vibrating device placed on the umbilicus during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device. Participants will complete a pre-procedure survey and will report their pain on a scale of 1-100 at various points during the IUD insertion procedure. Participants who received the vibrating device will also complete a post-procedure survey.",[112],"Intrauterine Device Placement",[114],"intrauterine device","NOT_YET_RECRUITING","2026-08-19",{"date":39,"type":42},{"date":119,"type":24},"2026-09-01",{"date":121,"type":24},"2027-07-01",{"name":48,"class":49},1,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":103,"minAge":104,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":107,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100601272","provider-and-patient-rct-promote-100601272","NCT07108335","Provider and Patient RCT PROMOTE","Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)","Inclusion Criteria - Participants:\n\n* Pregnant patients who are 24 - 32 weeks gestation\n* Employed or unemployed and seeking paid employment\n\nInclusion Criteria - Providers:\n\n* Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)\n\nExclusion Criteria - Participants:\n\n* Non- English language fluency\n* Unemployed with no desire to seek paid employment\n\nExclusion Criteria - Providers:\n\n* Not a clinical team member","65 Years",{"count":133,"type":24},404,[109],"Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. Investigators will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. The investigators will compare the frequency of EHR documented work- related counseling and adherence to employer documentation recommendations between the two study arms.\n\nHypothesis: Patients receiving care by a provider randomized to PROMOTE will have higher rates of documented counseling about work and pregnancy.\n\nResearch Aim 2: Determine the effectiveness of PROMOTE vs. usual care to reduce undesired wage or advancement reduction, increase accommodation requests granted, and improve maternal-infant health. The investigators will recruit a racially and socioeconomically diverse cohort of 304 pregnant patients and compare responses to surveys and qualitative interviews about work experiences and EHR-documented maternal-infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.\n\nHypothesis: Compared to patients receiving care by providers randomized to usual care, participants receiving care by providers randomized to PROMOTE will have less undesired loss of wages and advancement, increased accommodation request granted, and improved maternal-infant health during pregnancy.",[137,138,139],"Maternal Health","Pregnancy","Employment",{"date":39,"type":42},{"date":142,"type":24},"2026-10-01",{"date":144,"type":24},"2029-08",{"name":48,"class":49},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":107,"phases":155,"briefSummary":156,"conditions":157,"keywords":165,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":180,"locationsCount":123},"100583352","visual-restoration-using-focused-ultrasound-stimulation-and-immersive-virtual-reality-after-stroke-100583352","NCT06875206","Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke","LIFU-IVR","Inclusion Criteria:\n\n* ≥ 18 years old of any gender and race\n* Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred \\>= 6-24 months ago\n* Partial or complete homonymous hemianopsia on clinical exam\n\nExclusion Criteria:\n\n* Documented history of severe dementia with or without medication before stroke that affect subject's ability to participate in and be compliant to study protocol\n* Significant upper motor deficits and the subject cannot do IVR sessions at the baseline\n* History of seizures\n* Inability to get a new MRI\n* Presence of any ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of ultrasonic stimulation on the fetus is unknown); preexisting scalp lesion or wound or bone defect or hemicraniectomy.\n* Patients will be excluded if they have a previous diagnosis of hemianopsia, a new diagnosis of central retinal ischemic injury, or visual blindness or a history of any other ocular disease.\n* Concerns about the inability to complete study visits\u002Fprocedures by the PI.",{"count":154,"type":24},28,[109],"This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Before this therapy, the participants will get structural brain imaging. Functional brain imaging will be performed before and after the study's completion to measure brain activity response to therapy.\n\nThe purpose of this research study is to evaluate patients who have had a stroke between 6 and 24 months ago with a visual field impairment. The duration of active participation in the study is 1.5 months.",[158,159,160,161,162,163,164],"Stroke","Visual Field Defect","Visual Field Defect Following Cerebrovascular Accident","Hemianopia","Quadrantanopia","Occipital Lobe Infarct","Visual Fields Hemianopsia",[166,167,168,169,170,171,172,173,174],"virtual reality","stroke","visual deficit","chronic stroke","ultrasound stimulation","neuromodulation","stroke recovery","visual field defect","funcational imaging","2026-08-18",{"date":39,"type":42},{"date":119,"type":24},{"date":179,"type":24},"2028-10-31",{"name":48,"class":49},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":107,"phases":191,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100578871","phase-2-trial-of-glioblastoma-immunotherapy-advancement-with-nivolumab-and-relatlimab-100578871","NCT06816927","Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab","A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab (GIANT)","GIANT","Inclusion Criteria:\n\n1. Signed informed consent approved by the IRB\n2. Adults ≥ 18 years of age\n3. Patients with either:\n\n   * A newly suspected diagnosis of GBM based on MRI\n   * A previous diagnosis of GBM and who have not received prior RT or systemic therapy for their brain tumor\n4. Patients who in the opinion of the treating neurosurgeon require resection\n5. Patient is willing to undergo planned surgical procedures\n6. Patient agrees to make biospecimens that will be prospectively collected (after date of consent) available for research\n7. Patients who have undergone a diagnostic biopsy or open surgical procedure prior to enrolling in this study:\n\n   * If adequate archival tissue, defined as at least 3 blocks, is readily available, there is clear documentation of its availability, and the patient must consents to provide that tissue, the patient does not need to undergo another biopsy prior to, or on study, in order to be eligible for this trial\n   * If archival tissue is sufficient as described above, patient must have either residual enhancing disease requiring resection, or molecularly confirmed GBM with a clear clinical indication for additional resection, as determined by the country PI (or delegate) and the designated trial surgeon.\n   * If archival tissue is insufficient, or if the patient previously underwent a needle biopsy and there is no clear documentation of tissue availability, and the patient wishes to enroll, the patient must agree to undergo a repeat biopsy as part of this study prior to Screening.\n8. Hematological function as follows:\n\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Haemoglobin \\> 90 g\u002FL\n   * Prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.5 x upper limit of normal (ULN)\n9. Renal function as follows:\n\n   • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 ml\u002Fmin using the Cockcroft-Gault formula (Appendix 1)\n10. Hepatic function as follows:\n\n    * Total bilirubin ≤ 1.5 x ULN (Exception: Patient has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable)\n    * Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n    * Serum albumin ≥ 25 g\u002FL\n11. Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 (Appendix 2)\n12. Life expectancy of at least 12 months\n13. Negative human immunodeficiency virus (HIV) test at Screening\n14. Negative hepatitis B surface antigen (HbsAg) test at Screening or positive test followed by a negative hepatitis B virus (HBV) DNA test at Screening\n15. Negative hepatitis C antibody (anti-HCV) test at Screening or positive test followed by a negative HCV RNA test at Screening\n16. Able to undergo brain MRI with and without contrast\n17. People of childbearing potential must agree to use a highly effective contraceptive method (with a failure rate of \\\u003C 1%) during study treatment and for at least 6 months following the last dose of study drug and agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Acceptable methods of contraception are:\n\n    * Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n    * Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n    * Intrauterine device: Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomised partner\n    * Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence needs will be evaluated in relation to the duration of the study and to the usual lifestyle of the patient Note: People are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the person has been confirmed by follow-up hormone level assessment are they considered not of childbearing potential.\n18. Sexually active patients that are able to produce a sperm, must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 3 months after the last dose of treatment\n19. People of childbearing potential must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) at the time of screening and within 48 hours of starting the study drug(s)\n20. Ability to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria:\n\n1. Tumors where a gross total resection is not considered feasible by the treating neurosurgeon\n2. Tumor involves cerebellum, brainstem, or deep basal ganglia\n3. Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon\n4. Patients with contraindications to MRI or unwilling to undergo MRI\n5. History of CNS bleeding as defined by stroke within 6 months prior to registration\n6. Contraindication to surgery\n7. Treatment with immunosuppressive medications Note: Low-dose corticosteroids (≤ 2 mg\u002Fday dexamethasone or equivalent) for tumor-associated edema is permitted. Patients who require corticosteroids \\> 2mg\u002Fday dexamethasone (or equivalent) for acute emergencies during the screening window will be eligible, if the corticosteroid dosing reduces to ≤ 2 mg\u002Fday dexamethasone (or equivalent) at least one day prior to the initial trial-mandated biopsy.\n8. Active autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis\n9. Active tuberculosis\n10. Patient has had a previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms must have resolved and based on treating physician's assessment, there are no sequelae that would place the patient at a higher risk of receiving trial treatment\n11. Evidence of acute intracranial\u002Fintra-tumoral hemorrhage, which requires urgent intervention\n12. Severe infection within 4 weeks prior to registration\n13. Treatment with a live, attenuated vaccine within 4 weeks prior to registration, or anticipation of need for such a vaccine during study or within 5 months after final dose of nivolumab and relatlimab\n14. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more\n15. Major surgical procedure, other than for diagnosis, within 4 weeks prior to registration\n16. History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n17. Patient is pregnant or breastfeeding\u002Fchestfeeding\n18. Prior allogeneic stem cell or solid organ transplantation\n19. Known allergy or sensitivity nivolumab, relatlimab, temozolomide or their excipients\n20. Patient has any kind of disorder that, in the opinion of the site PI, may compromise the ability of the patient to give written informed consent and\u002For to comply with all required study procedures\n21. Patients with a history of myocarditis\n22. Patient has troponin T (TnT) or I (TnI) \\> 2 × ULN Note: Patients with TnT or TnI levels between \\> 1 × to 2 × ULN will be eligible if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \\> 1 × to 2 × ULN within 24 hours, the patient must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the patient must be evaluated by a cardiologist. After cardiologist evaluation, the patient may be eligible if the site PI assesses a favorable benefit\u002Frisk\n23. Left ventricular ejection fraction (LVEF) \\\u003C 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 6 months prior to registration\n24. History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the site PI would pose a risk to patient safety or interfere with the study evaluation, procedures or completion",{"count":190,"type":24},92,[192],"PHASE2","GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).",[195],"Newly Diagnosed Glioblastoma",{"date":116,"type":42},{"date":198,"type":42},"2025-11-28",{"date":200,"type":24},"2031-06-01",{"name":48,"class":49},3,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":107,"phases":213,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},"100585991","phase-4-inclisiran-versus-placebo-for-the-prevention-of-major-adverse-cardiovascular-and-limb-events-in-patients-undergoing-percutaneous-coronary-intervention-or-peripheral-endovascular-intervention-100585991","NCT06909565","Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention","Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)","V-INTERVENTION","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Males or females ≥ 18 years of age\n* Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD\n* Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention\n\nExclusion Criteria:\n\n* Planned future PCI or PVI\n* Current or planned use of an open-label PCSK9 inhibitor during the study\n* Any prior treatment with inclisiran\n* Active or planned participation in another clinical study involving investigational drugs or devices during the study\n* Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results\n* Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities\n* Patients taking prohibited therapies as listed in Section 6.6.3\n* Pregnant or breast-feeding women",{"count":212,"type":24},6000,[214],"PHASE4","V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.",[217,218],"Percutaneous Coronary Intervention","Peripheral Endovascular Intervention",[220,221,222,223,224,217,225],"inclisiran","Coronary Artery Disease","hypercholesterolemia","Cardiovascular Disease","Percutaneous Endovascular Intervention","PCSK9","2026-08-14",{"date":175,"type":42},{"date":229,"type":42},"2025-07-23",{"date":231,"type":24},"2029-12",{"name":48,"class":49},133,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":107,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":123},"100551283","intervention-to-improve-communication-and-medication-adherence-in-lupus-100551283","NCT06458075","Intervention to Improve Communication and Medication Adherence in Lupus","Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)","CO-LEAD","Clinician Inclusion Criteria:\n\n1. Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions\n2. Clinicians who have ambulatory rheumatology care at least ½ day per week\n\nClinician Exclusion Criteria:\n\n1. Clinicians at Duke University who were involved in the investigators' pilot work\n2. Clinicians with an anticipated departure from the institution in the 12 months following enrollment\n\nPatient Inclusion Criteria:\n\n1. 18 years or older\n2. English-speaking, able to provide consent\n3. Diagnosed with SLE and receiving care with enrolled clinicians\n4. Prescribed at least one SLE medication, and filling their SLE mediations at a pharmacy linked to Surescripts reporting visible in Epic EMR.\n\nPatient Exclusion Criteria:\n\n1. Non-English speakers\n2. Patients who are prescribed only corticosteroids for SLE\n3. Patients who are accompanied by third-party member that is not willing or able to remain in the waiting room during the patient's visit and\n\n   * Does not wish to be audio recorded\n   * A minor without a parental\u002Flegal guardian and\u002For\n   * Unable to give consent","90 Years",{"count":244,"type":24},480,[109],"CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE).\n\nThe purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following:\n\n1. clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers.\n2. use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.",[248],"Systemic Lupus Erythematosus","2026-08-13",{"date":251,"type":42},"2026-08-17",{"date":253,"type":42},"2024-07-01",{"date":255,"type":24},"2028-12",{"name":48,"class":49},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":103,"minAge":104,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":107,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},"100625770","weight-management-after-cancer-for-survivors-in-rural-communities-100625770","NCT07426952","Weight Management After Cancer for Survivors in Rural Communities","Development and Pilot Testing of a Novel Intervention to Reduce Cardiovascular Disease Risk Among Breast Cancer Survivors Living in Rural, Medically Underserved Communities","WeCan-Rural","Inclusion Criteria:\n\n* aged 18 years or older\n* female (biological sex)\n* diagnosis of stage I-III breast cancer\n* completed treatments with curative intent (with the exception of hormonal treatments) in the last 5 years\n* body mass index \\>30\n* healthy enough to participate in home-based physical activity\n* able to speak\u002Fread English\n* reports rating of ≥4 (i.e., moderate or more severe) out of 10 for one or more of the following symptoms at its worst in the last month (per the MD Anderson Symptom Inventory): pain, fatigue, sadness, and\u002For distress\n\nExclusion Criteria:\n\n* visual, hearing or cognitive impairment or severe mental illness interfering with participation",{"count":266,"type":24},40,[109],"This study is testing a new program called WeCan-Rural, designed to help breast cancer survivors manage symptoms and build healthy habits like eating well, staying active, and managing their weight. These changes may help lower the risk of heart disease after cancer treatment.\n\nThe study will answer two main questions:\n\n* Can study team successfully recruit and keep participants in the study, and will the participants find the program helpful and easy to follow?\n* Will participants who join the program see better results in areas like weight, symptoms, diet, physical activity, and confidence in managing the participant's health compared to those who receive standard care?\n\nHere's what participants will do:\n\n* Visit the participant's clinic twice (about 12 weeks apart) to be weighed, have the blood pressure checked, give a blood sample, and complete a short walking test\n* Fill out online surveys about the participant's health, diet, physical activity, symptoms, and confidence in managing the participant's health\n* Be randomly assigned (like flipping a coin) to either receive the WeCan-Rural program or standard health information\n* If assigned to the program, attend 12 weekly one-hour video sessions on Zoom with a trained therapist",[270,271,272,273],"Breast Cancer Survivorship","Weight Management","Cardiovascular (CV) Risk","Breast Cancer","2026-08-11",{"date":249,"type":42},{"date":277,"type":24},"2026-08",{"date":279,"type":24},"2026-12-31",{"name":48,"class":49},5,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":18,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":107,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":123},"100504457","msaada-a-mobile-health-tool-100504457","NCT05848557","mSaada: A Mobile Health Tool","mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya","R21\n\nAim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials\n\nInclusion Criteria:\n\n* 18 years or older\n* be employed by a government clinic\n* be working in cervical cancer screening\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nWomen\n\nInclusion Criteria:\n\n\\- between 30 and 65 years old\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nAim 2 Community health volunteers (CHVs)\n\nInclusion Criteria:\n\n* 18 years or older\n* be employed by a government clinic\n* be working in cervical cancer screening\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nWomen\n\nInclusion Criteria:\n\n* between 30 and 65 years old\n* intact cervix and uterus\n* able to provide informed consent.\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nR33\n\nWomen (knowledge and risk perception surveys) We plan to enroll approximately 600 women (50 per health facility) to complete a survey about cervical cancer and HPV knowledge, risk perception and screening awareness, acceptability and self-efficacy.\\\\\n\nEligibility criteria for women participants include:\n\n* Reside within Siaya County, in one of the study communities\n* Eligible for cervical cancer screening per the Kenya Ministry of Health guidelines and\n* Ability to provide informed consent.\n\nCHPs in both arms will be asked to complete a survey about their self-efficacy, knowledge of HPV and cervical cancer, and the usability of the mSaada app (CHPs in the intervention arm only).\n\nInclusion:\n\n* CHV participants must be employed by government clinics in Siaya County, and\n* be able to provide informed consent.\n\nExclusion:\n\n* Does not understand the study purpose and details\n* Is not willing to sign an informed consent",{"count":212,"type":24},[109],"In the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness.\n\nIn the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.",[293,294,295],"Cervical Cancer","HPV","mHealth",{"date":249,"type":42},{"date":298,"type":42},"2024-02-19",{"date":300,"type":24},"2027-06-30",{"name":48,"class":49},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":107,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":4},"100651890","temporal-interference-brain-stimulation-for-adults-with-drug-resistant-epilepsy-undergoing-stereo-eeg-monitoring-100651890","NCT07764718","Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring","Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy","Inclusion Criteria:\n\n* Adult patients with focal DRE who will undergo presurgical evaluation with sEEG\n* Availability of at least one sEEG electrode inserted into the thalamus for clinical purposes\n* sEEG performed with the indication to identify one single epileptic focus\n* Ability to provide written informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n\\- Remote resective\u002Fablative brain surgery",{"count":310,"type":24},30,[109],"This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep. Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation. Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison. The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits.",[314],"Drug-Resistant Focal Epilepsy",[316,317,318],"Drug-Resistant Epilepsy","Temporal Interference Stimulation","Stereo-EEG","2026-08-10",{"date":226,"type":42},{"date":322,"type":24},"2026-08-15",{"date":324,"type":24},"2031-08-14",{"name":48,"class":49},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":18,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":107,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":123},"100472923","prototyping-a-device-for-automating-stool-and-urine-output-tracking-100472923","NCT05438199","Prototyping a Device for Automating Stool and Urine Output Tracking","Inclusion Criteria:\n\n* people who are able to use the private bathroom at no risk to themselves in the CIEMAS building (B508) or the bathroom located in room 4002, 4th floor of MSRB3.\n* students or employees at Duke University since card access is required for our MSRB3 bathroom.\n* people who spend most of their time in these buildings so we can assure the use of the toilet.\n* If the recruitment number is slow, enrollment will include people from the closest buildings.\n\nExclusion Criteria:\n\n* People who use wheelchairs or other mobility devices won't be able to enroll, since at this moment the bathroom is not compliant with the requirements on The Americans with Disabilities Act (ADA) of 1990.",{"count":333,"type":24},48,[109],"The purpose of this study is to test an electronic apparatus for measuring stool and urine output in an accurate and easy way. Participants will have one in-person or virtual visit with the study team prior to starting the study events. Participants that enroll in this study will have the freedom to choose when to begin and stop using the toilet apparatus when it is available for human testing. This apparatus will be located in a private bathroom in either the CIEMAS building or MSRB III Building.",[337],"Waste Output",[339,340],"urine output","stool output",{"date":342,"type":42},"2026-08-12",{"date":344,"type":42},"2022-11-14",{"date":346,"type":24},"2027-07",{"name":48,"class":49},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":356,"targetDuration":358,"studyType":25,"phases":4,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":377},"100202723","idiopathic-pulmonary-fibrosis-and-interstitial-lung-disease-prospective-outcomes-registry-100202723","NCT01915511","Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry","Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Interstitial Lung Disease Prospective Outcomes (IPF-PRO\u002FILD-PRO) Registry","IPF\u002FILD-PRO","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Established a new diagnosis (within 12 months) of IPF by the enrolling center.\n* Age 21 years or older, or\n* Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype during the last 24 months by the enrolling center that meets the following criteria:\n\n  * Chronic fibrosing ILD as defined by reticular abnormality with traction bronchiectasis with or without honeycombing confirmed by chest HRCT scan and\u002For lung biopsy.\n  * Progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs (8):\n\n    * decline in FVC % predicted (% pred) based on ≥10% relative decline\n    * decline in FVC % pred based on ≥5 - \\\u003C10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator\n    * decline in FVC % pred based on ≥5 - \\\u003C10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator\n    * decline in DLCO % pred based on≥ 10% relative decline\n    * worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change.\n\nThe relative decline for FVC % predicted is calculated using the formula:\n\nRelative Decline= (FVC % Pred (Reference)-FVC % Pred (Screening))\u002F(FVC % Pred (Reference))×100%, where FVC % Pred (Reference) is the greatest measurement of FVC % predicted in the 24 months prior to screening and FVC % Pred (Screening) is the measurement of FVC % predicted at screening.\n\nThe relative decline for DLCO % predicted is calculated using the formula:\n\nRelative Decline= (DLCO % Pred (Reference)-DLCO % Pred (Screening))\u002F(DLCO % Pred (Reference))×100%, Where DLCO % Pred (Reference) is the greatest measurement of DLCO % Pred in the 24 months prior to screening and DLCO % Pred (Screening) is the measurement of DLCO % Pred at screening\n\nExclusion Criteria:\n\n* Malignancy, treated or untreated, other than skin or early -stage prostate cancer, within the past 5 years\n* Currently listed for lung transplantation at the time of enrollment\n* Currently enrolled in an interventional clinical trial at the time of enrollment in this registry\n* For the additional IPF cohort of 1000 individuals, previous enrollment in this registry.",{"count":357,"type":24},3000,"5 Years","The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects.",[361],"Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease",[363,364,365,366,367,368,369,370],"Idiopathic pulmonary fibrosis","Pulmonary fibrosis","IPF","Registry","1199.174","Interstitial Lung Disease","ILD","Interstitial Lung Disease with Progressive Phenotype",{"date":342,"type":42},{"date":373,"type":42},"2014-06",{"date":375,"type":24},"2031-01",{"name":48,"class":49},47,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":19,"minAge":386,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":107,"phases":390,"briefSummary":392,"conditions":393,"keywords":398,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":412},"100610783","phase-3-pre-empt-prospective-randomized-evaluation-and-management-of-premature-atherosclerosis-100610783","NCT07232069","PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","PRE-EMPT","Inclusion Criteria:\n\n1. Women aged 40-60 years; Men aged 30-50 years\n2. Willing and able to provide informed consent and comply with study procedures\n3. Smart phone user\n4. Use of highly effective contraception by females with reproductive potential.\n5. CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\\\u003C100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)\n6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab\n\nExclusion Criteria:\n\n1. Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)\n2. Current symptoms thought to be from CAD\n3. PREVENT ASCVD 10-year risk ≥5% (if known)\n4. Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)\n5. LDL-C ≥190mg\u002FdL (most recent, if known)\n6. HIV (if known)\n7. Severe liver disease or untreated Hepatitis C infection (if known)\n8. Pregnancy, lactation or intending to become pregnant during the study period of 2 years\n9. eGFR \\\u003C45mL\u002Fmin\u002F1.73m2 (if known)\n10. AST or ALT \\>1.5x the upper limit of normal (if known)\n11. BMI\\>40kg\u002Fm2 or unable to have a CCTA scan for any reason\n12. Allergy to iodinated intravenous contrast or other contraindication to CCTA\n13. Current or previous use of lipid lowering therapy or colchicine\n14. Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.\n15. Systemic cancer undergoing active treatment\n16. PREVENT ASCVD 10-year risk ≥5%\n17. eGFR \\\u003C45 ml\u002Fmin\u002F1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)\n18. Hemoglobin A1c ≥6.5% per baseline labs\n19. LDL-C ≥190mg\u002FdL per baseline labs\n20. Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)\n21. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)\n22. Individuals who are excluded based on any of these factors will be notified as to the reason for exclusion and encouraged to follow-up locally to address this medical issue with their treating physician.","30 Years","60 Years",{"count":389,"type":24},1500,[391],"PHASE3","Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.\n\nPRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called \"plaque\", in their heart arteries. It consists of two phases:\n\n1. A Screening Study - Participants will be assessed for plaque by one or both of these scans.\n\n   * Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries.\n   * Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque.\n2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos.\n\n   * Rosuvastatin 20 mg: a cholesterol-lowering medicine\n   * Colchicine 0.5 mg: a medication that lowers inflammation\n\nEveryone in the trial will be given information and advice on heart-healthy diet and lifestyle.\n\nParticipants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.",[394,395,396,397],"Coronary Artery Disease Risk Factors Multiple","Coronary Artery Disease Progression","Prevention & Control","Premature Atherosclerosis",[399,400,401,402,403,404],"Prevention","Heart Disease Prevention","Family History of Heart Disease","At risk for heart disease","coronary artery calcium","non-calcified coronary plaque","2026-08-07",{"date":274,"type":42},{"date":408,"type":42},"2026-07-21",{"date":410,"type":24},"2031-07",{"name":48,"class":49},23,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":18,"sex":19,"minAge":420,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":107,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":123},"100563687","amd-and-validation-rod-meditated-dark-adaptation-with-everyday-task-performance-100563687","NCT06619405","AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance","AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance","Inclusion Criteria:\n\n* Capable and willing to provide consent\n* Has been diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy or has a healthy macular for controls\n* At least 50 years of age\n\nExclusion Criteria:\n\n* Unable or unwilling to give consent or unable to read consent since the study involves testing which requires reading\n* Under 50 years of age\n* Presence of dense cataracts in the study eye (s) that can affect visual function tests\n* Presence of glaucoma requiring treatment during the study and\u002For visual field defects\n* Previous retinal laser or surgical therapy in the study eye(s)\n* Previous retinal laser or surgical therapy in the study eye(s)\n* Any other ocular condition requiring long-term therapy or surgery during the study\n* The participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing\n* Diagnosis of nystagmus that will interfere with testing\n* High myopia -8 Diopters or more severe\n* The participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.","50 Years","89 Years",{"count":423,"type":24},100,[109],"The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.",[427],"Age-Related Macular Degeneration","2026-08-06",{"date":319,"type":42},{"date":431,"type":42},"2025-08-15",{"date":433,"type":24},"2028-01-31",{"name":48,"class":49},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":21,"enrollmentInfo":441,"targetDuration":4,"studyType":107,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":123},"100479235","testing-a-device-for-automatically-tracking-urine-and-stool-in-an-inpatient-hct-setting-project-trust-100479235","NCT05520346","Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)","Inclusion Criteria:\n\n1. Scheduled to undergo an allogeneic or autologous hematopoietic stem cell transplant for any cancer or non-cancer illness through the Duke ABMT clinic OR currently undergoing treatment for HF in the Duke Cardiology Clinic with order of strict I\u002FO monitoring\n2. Age 18-80 years\n3. Karnofsky Performance Scale (KPS) ≥ 70 if a BMT patient\n4. Able to read\u002Fwrite English\n\nExclusion Criteria:\n\n1. Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter.\n2. Physician recommendation that patient does not use standard urine\u002Fstool collection hat during days 1-2 of HCT conditioning OR during HF treatment.\n3. Women who are pregnant\n4. Patient height \\\u003C 5'3\" if they are a patient within the Duke Cardiology Clinic\n5. Disabled individuals using wheelchairs or transfer devices to use bathroom",{"count":442,"type":24},54,[109],"The purpose of this study is to determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets.\n\nIn this study, participants' hospital rooms will be outfitted with the prototype toilet device. Participants will use the toilet as usual throughout the duration of their inpatient stay. Sometimes output will be measured by the device, and other times output will be measured manually by nurses.",[446],"Fluid Output",[448],"toilet device",{"date":319,"type":42},{"date":451,"type":42},"2023-09-13",{"date":453,"type":24},"2028-08",{"name":48,"class":49},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":19,"minAge":462,"maxAge":104,"enrollmentInfo":463,"targetDuration":4,"studyType":107,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":123},"100393485","a-study-of-facilitators-and-barriers-to-improve-acute-kidney-injury-in-children-through-mobile-health-intervention-100393485","NCT04403633","A Study of Facilitators and Barriers to Improve Acute Kidney Injury in Children Through Mobile Health Intervention","Improving Patient-Centered Care in Pediatric Acute Kidney Injury (Change Peds AKI)","Inclusion Criteria:\n\n* age 1 to 18 years\n* patients with diagnosis of AKI while hospitalized\n\nExclusion Criteria:\n\n* legal blindness of deafness\n* cognitive impairment that limits ability to consent\n* non-English speaking\n* patient age greater than age 18 years, 11 months","1 Year",{"count":7,"type":24},[109],"The purpose of this study is to improve patient-centered care for acute kidney injury (AKI) in order to decrease the adverse health outcomes associated with this common condition.",[467],"Acute Kidney Injury",[469,470,467],"AKI","Pediatric AKI",{"date":405,"type":42},{"date":473,"type":42},"2020-06-01",{"date":94,"type":24},{"name":48,"class":49},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":484,"minAge":104,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":107,"phases":486,"briefSummary":487,"conditions":488,"keywords":492,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":499,"leadSponsor":500,"locationsCount":123},"100646916","rehabilitation-and-sex-therapy-to-optimize-recovery-after-prostate-cancer-treatment-100646916","NCT07685249","Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment","RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial","RESTORE-PC","Inclusion Criteria\n\n* Age 18 years or older.\n* Biopsy-confirmed localized prostate adenocarcinoma.\n* Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.\n* Initiating pelvic floor physical therapy as part of routine clinical care.\n* Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.\n* Able to read and understand English to complete patient-reported outcome measures.\n* Ability to provide informed consent.\n\nExclusion Criteria\n\n* Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.\n* Recieved non-nerve-sparing treatment (when applicable).\n* Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.\n* Need for additional or secondary prostate cancer treatment during the intervention period.\n* Documented cognitive impairment or impairment that would interfere with participation.\n* Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment.\n* Inability to complete study video visits or questionnaires.\n* History of prior local or systemic treatment for prostate cancer","MALE",{"count":310,"type":24},[109],"This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.\n\nAll participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.\n\nParticipants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.",[489,490,491],"Prostate Cancer","Urinary Incontinence","Erectile Dysfunction",[493,494,495],"Pelvic Floor Physical Therapy","Sex Therapy","Penile Rehabilitation","2026-08-05",{"date":405,"type":42},{"date":277,"type":24},{"date":453,"type":24},{"name":48,"class":49},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":103,"minAge":104,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":107,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":4},"100591689","patient-navigation-for-her2-metastatic-breast-cancer-patients-treated-with-tucatinib-100591689","NCT06983691","Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib","Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib","Inclusion Criteria:\n\n* female (sex assigned at birth);\n* ≥18 years of age at enrollment;\n* diagnosed with HER2+ metastatic breast cancer (mBC);\n* receiving treatment with tucatinib combined with capecitabine and trastuzumab;\n* able to speak and read English\n\nExclusion Criteria:\n\n* visual or hearing impairment;\n* severe cognitive impairment;\n* severe mental illness interfering with ability to participate",{"count":509,"type":24},26,[109],"The goal of this study is to test a novel nurse-delivered patient navigation program for women with HER2+ metastatic breast cancer (mBC) receiving tucatinib, trastuzumab, and capecitabine. The program will focus on enhancing understanding of the treatment regimen, managing symptoms and adherence, and improving coping and self-management skills. If successful, the program could be integrated into clinical care to better support mBC patients. The main question the study aims to answer is: is the patient navigation program feasible and acceptable for mBC patients?\n\nParticipants will receive patient navigation sessions over about 6 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3 and 6 weeks after enrollment, with the last assessment occurring after completion of the patient navigation program sessions. Participants will also complete a post-program exit interview.",[513],"HER2+ Metastatic Breast Cancer (MBC)",[515],"Patient Navigation",{"date":405,"type":42},{"date":277,"type":24},{"date":519,"type":24},"2027-03",{"name":48,"class":49},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":18,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":107,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":123},"100568899","food-dna-digestion-100568899","NCT06687226","Food DNA Digestion","Digestion and Transit of Food DNA Through the Human Gut","Anna Bauer","Inclusion Criteria:\n\n* Above age 18?\n* Able to provide stool samples at no risk to the participant?\n* Does the participant have card access to the MSRBIII building, and is the participant able to visit this building (at times of the participant's convenience) for the purposes of this study?\n\nExclusion Criteria:\n\n* Already consume camu camu, maqui or kelp in typical diet?\n* Have a history or current diagnosis of irritable bowel syndrome?\n* Have a history or current diagnosis of inflammatory bowel disease?\n* Have a history or current diagnosis of type 2 diabetes?\n* Have a history or current diagnosis of chronic kidney disease with decreased kidney function?\n* Have a history or current diagnosis of intestinal obstruction?\n* Have a history or current diagnosis of untreated colorectal cancer?\n* Has the participant had a colonoscopy within the past month?",{"count":530,"type":24},20,[109],"This pilot study investigates the digestion rate of naturally occurring food DNA through the human digestive tract by detecting residual food DNA in stool samples. The investigators hypothesize that food DNA primarily transits through the digestive system within 24 hours, with maximal detection in stool samples collected the day after ingestion. Previous research has focused on food DNA digestion in human gastric juices, leaving digestion through the entire gut largely unexplored. This study employs a fixed-order within subjects design involving healthy participants. Each participant will submit a baseline stool sample, consume a single dose of a study-specific powdered food (reconstituted in water) differing from their usual diet, and provide the subsequent five stool samples. If five samples are collected in fewer than five days, an additional sample will be obtained on the fifth day post-consumption. The presence and decline of food specific DNA in these samples will be quantified using qPCR, enabling us to determine the digestion rate of food DNA. The study design poses with minimal risk as it non-invasively monitors the natural process of food DNA digestion and transit through stool sample analysis.",[534],"Digestion Rate",[536,537,538,539,540,541,542],"Food","DNA","gut microbiome","transit time","digestion","digestive system","food DNA digestion",{"date":405,"type":42},{"date":545,"type":24},"2027-01-01",{"date":547,"type":24},"2027-12-01",{"name":48,"class":49},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":570},"100546773","prospective-multicenter-research-on-donor-and-recipient-management-strategies-to-improve-lung-transplant-outcomes-100546773","NCT06399302","Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes","Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study","PROMISE","Inclusion Criteria:\n\n1. Able to understand and provide informed consent\n2. ≥ 18 years of age at the time of written informed consent\n3. Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days\n\n   * Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion\u002Fexclusion criteria.\n\nExclusion Criteria:\n\n1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol\n2. Pregnancy or plans to become pregnant\n3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.",{"count":558,"type":24},2600,"This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.",[561,562,563,564],"Lung Transplant; Complications","Lung Transplant; Infection or Inflammation","Lung Transplant Rejection","Lung Transplant Failure",{"date":405,"type":42},{"date":567,"type":42},"2024-09-03",{"date":300,"type":24},{"name":48,"class":49},19,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":103,"minAge":4,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":107,"phases":579,"briefSummary":580,"conditions":581,"keywords":585,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":123},"100640511","pilot-feasibility-study-with-doulas-100640511","NCT07614789","Pilot Feasibility Study With Doulas","A Pilot Feasibility Study to Evaluate a Doula-led Postpartum Prevention Intervention","Inclusion criteria are:\n\n1. Edinburgh Postpartum Depression score of 10 or greater;\n2. currently pregnant or within the first 3 years postpartum.\n\nExclusion criteria includes:\n\n1. high risk of an imminent suicide attempt;\n2. actively psychotic or manic;\n3. current drug or alcohol use disorder;\n4. significant health complications (e.g., cancer).",{"count":266,"type":24},[109],"The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc.",[582,583,584],"Post Partum","Maternal Depression","Maternal Depression and Parent Practices, Postpartum",[582,586],"maternal depression","2026-08-04",{"date":496,"type":42},{"date":590,"type":24},"2026-10",{"date":592,"type":24},"2027-12",{"name":48,"class":49},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":107,"phases":603,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":614,"leadSponsor":616,"locationsCount":4},"100637355","storytelling-for-provider-empathy--patient-trust-in-obstetric-care-100637355","NCT07588308","Storytelling for Provider Empathy & Patient Trust in Obstetric Care","Co-Developing a Nurse-Led, Community-Engaged Intervention to Improve Labor Pain Management and Build Trust in Obstetric Care","Inclusion Criteria\n\nProvider Participants:\n\n* Licensed clinician employed or credentialed at Duke Health Birthing Centers (nurse, anesthesia care provider, obstetrician, or nurse midwife).\n* In clinical practice for at least 6 months post-orientation.\n* Able to read and understand English.\n\nPatient Participants:\n\n* Self-identified non-Hispanic Black American women.\n* Age ≥18 years.\n* Able to read and converse in English.\n* Receiving obstetric care from a provider who is already enrolled in the study.\n\nExclusion Criteria\n\nProvider Participants:\n\n* Providers in training or with \\\u003C6 months independent clinical practice.\n* Providers unwilling or unable to give informed consent.\n\nPatient Participants:\n\n* Under 18 years of age.\n* Non-English speakers (due to study survey language limitations).\n* Unable or unwilling to provide informed consent.",{"count":602,"type":24},120,[109],"Aim 3 is a provider-focused pilot randomized controlled trial evaluating a digital storytelling intervention to increase obstetric care providers' empathy and to examine associations with postpartum patient trust. Providers randomized to the intervention view a video of Black women's labor pain and care experiences and complete a brief reflection; control providers receive general culturally sensitive care materials. Outcomes include change in provider empathy (primary) and patient trust among Black postpartum patients under those providers' care (secondary). Risks are minimal and mitigated via consent, voluntary participation, the option to skip questions, and secure data practices.",[138,606],"Labor Pain",[608,609,610,611],"Empathy","Cultural Competency","Provider-Patient Relations","Trust",{"date":428,"type":42},{"date":277,"type":24},{"date":615,"type":24},"2027-08-31",{"name":48,"class":49},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":19,"minAge":104,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":107,"phases":626,"briefSummary":627,"conditions":628,"keywords":631,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":637,"leadSponsor":638,"locationsCount":123},"100610469","cognitive-rehabilitation-for-treatment-of-anger-in-veterans-with-tbi-and-ptsd-100610469","NCT07227987","Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD","Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI (Traumatic Brain Injury) and PTSD (Post-traumatic Stress Disorder)","CALM","Inclusion Criteria:\n\nInclusion Criteria for Veterans\n\n* U.S. Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since 9\u002F11\u002F01\n* Meets criteria for TBI\n* Meets criteria for PTSD or subthreshold PTSD\n* Reports anger problems began after their head injury\n* Reports current problems with cognitive function\n* At least 18 years old\n* Fluent and literate in English\n* Able to provide voluntary, informed consent to participate.\n* Smartphone Use: Has an iPhone (iPhone 11 or higher with iOS 17 or higher) or Android (Android 8.0 or higher) smartphone.\n\nInclusion Criteria for Family members or Friends:\n\n* Over age 18;\n* Family member\u002Ffriend of Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, National Guard) post-9\u002F11 and who meets TBI and PTSD inclusion criteria. (Veterans select this trusted family member or friend to serve as a support person for the study).\n* Fluent and literate in English\n* Able to provide voluntary, informed consent to participate.\n\nExclusion Criteria:\n\n-Does not have a trusted support person, e.g., spouse, family member, or friend for enrollment.",{"count":423,"type":24},[109],"This randomized clinical trial will enroll 100 Veteran-family\u002Ffriend dyads to test the efficacy of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomized to the CALM group will demonstrate:\n\n* Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction.\n* Significantly larger improvements in social and adaptive functioning including less aggression.\n* Significantly larger reduction in PTSD symptoms and suicidal ideation.\n\nThe study targets Veterans who experience difficulties with anger and impulsivity due to TBI and PTSD. These issues are common, with up to 38% of Veterans with TBI also having PTSD. These conditions often make it challenging for Veterans to control their emotions and interact successfully in social and work settings. Our research will test the CALM (Cognitive Applications for Life Management) mobile app, which helps Veterans manage their goals, remember important tasks, and improve their attention. Initial tests of CALM have shown it can reduce levels of anger and related issues in Veterans. The investigators will conduct a study with 100 pairings of Veterans and a family member or friend. These pairs will be randomly assigned to one of two groups: one using the CALM mobile platform and the other receiving brain health education. Both groups will use their assigned intervention for three months and will receive support through videoconference calls at the beginning, middle, and end of the program.",[629,630],"Traumatic Brain Injury (TBI)","Posttraumatic Stress Disorder (PTSD)",[629,632,633,634],"Posttraumatic stress Disorder (PTSD)","Mobile app","Veterans",{"date":428,"type":42},{"date":587,"type":42},{"date":46,"type":24},{"name":48,"class":49},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":484,"minAge":646,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":123},"100604031","validation-of-a-platelet-proteomic-assay-for-diagnosing-and-monitoring-prostate-cancer-100604031","NCT07144228","Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer","Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.","Eligibility criteria\n\n* Patients ≥ 40 years of age\n* All patients with suspicion of PCa\n\nMen ≥ 40 years of age attending Duke Health\u002FUrology with suspicion of prostate cancer (Primary disease) will be approached to consent for the study. Upon consent, samples will be obtained alone, during repeat PSA\u002Fother biomarkers testing, or during imaging at Duke Lab.\n\nExclusion criteria\n\n* Men who have previously undergone treatment for prostate cancer.\n* Men with prior diagnosis of prostate cancer.\n* Men with severe, irreversible coagulopathy.\n* Men on anticoagulant therapies or those who have taken antiplatelet agents such as aspirin, NSAIDs (ibuprofen, entrophen, naproxen, diclofenac etc), clopidrogel, prasugrel, ticagrelor, or dipyridamole in the 7 days preceding blood collection.","40 Years",{"count":648,"type":24},300,"This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease. Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation. Researchers are trying to see if HeLP™ can be a safe and accurate alternative.\n\nThe study is inviting men who are being seen for suspicion of prostate cancer (based on symptoms or previous lab results). If they agree to be in the study, the research team will take a sample of their blood at the time they are getting a repeat PSA test or having Imaging. The research test does not affect the care they are already receiving and takes 3 extra tubes of blood (\\~3 tbsp).\n\nThe research team is aiming to include 300 participants total. They believe 278 people are needed to confidently compare results between people with and without prostate cancer.\n\nThey will do an interim analysis halfway through the study, once samples from 150 subjects have been collected.\n\nThe research is considered low risk-no more uncomfortable or dangerous than a blood draw. There is a risk of loss of privacy, but researchers are taking strong steps to protect privileged information. That includes proper data handling, secure, storage, and making sure the study team is trained in research ethics.",[651],"Prostate Cancer (Diagnosis)",{"date":428,"type":42},{"date":654,"type":42},"2026-03-11",{"date":656,"type":24},"2028-09-30",{"name":48,"class":49},""]