[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Texas Tech University Health Sciences Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":378},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,79,106,133,167,195,228,256,279,308,329,352],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100357504","phase-1-protective-effects-of-the-nutritional-supplement-sulforaphane-on-doxorubicin-associated-cardiac-dysfunction-100357504",false,"NCT03934905","Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction","Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026)","Inclusion Criteria:\n\n1. Age 18 to 89 years\n2. No prior diagnosis of coronary artery, carotid artery or peripheral artery disease\n3. Not pregnant or breastfeeding (urine pregnancy test will be done if female of childbearing potential)\n4. Breast cancer requiring treatment with DOX-containing regimen above\n5. Women in child bearing age group (18-50 years) will agree to use birth control for duration of study\n6. Study subjects must be willing and able to swallow caplets, up to 8 daily.\n\nExclusion Criteria:\n\n1. Currently on a research study with an investigational drug, or has been on one in the previous 30 days\n2. Pregnant (by urine pregnancy test)\n3. Baseline ejection fraction of less than 50%, evidence of left ventricular hypertrophy or baseline EKG reported as abnormal per cardiologist.\n4. Inability to provide informed consent.\n5. Prior history of chest radiation therapy\n6. Diabetes or Hypertension or prior Myocardial infarction\n7. Trastuzumab patients\n8. Routinely taking vegetable or fruit-containing supplement pills (antioxidant phytochemicals) (daily vitamin pills ok)\n9. Inability to follow up for safety monitoring\n10. Prisoners\n11. Previous or current use of cocaine or any illicit drug\n12. Unable or unwilling to provide blood samples\n13. Taking medications known to have cardiac effects, such as but not limited to, beta blockers, anti-arrhythmic agents, non dihydropyridine calcium channel blockers, ace inhibitors, NSAIDS, diuretic agents.\n14. Unable to follow the protocol\n15. Inability to receive anthracycline due to any reason (underlying baseline cardiac dysfunction due to other reasons, with an EF under 50%)\n16. Patients already taking SFN OTC","ALL","18 Years","89 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Cardiomyopathy is a major complication of doxorubicin (DOX) chemotherapy, and 10-21% of breast cancer patients receiving DOX experience compromised cardiac function. Recent advancements have increased cancer survivorship but it remains clinically challenging to mitigate the cardiotoxic side effects. Although there are several strategies used to reduce the occurrence and severity of DOX-induced cardiotoxicity, they are not particularly effective. Hence, there is an urgent need to develop new strategies that prevent the cardiotoxic effects of DOX but maintain its potency as a cancer therapy. Because the cellular events responsible for the antitumor activity of DOX and DOX-induced cardiotoxicity are distinctly different, it may be possible to develop therapies that selectively mitigate DOX-induced cardiotoxicity. Thus, the investigators propose to test an adjuvant therapy that combines the phytochemical sulforaphane (SFN) with DOX to attenuate DOX-induced cardiomyopathy. SFN activates the transcription factor Nrf2 and induces defense mechanisms in normal cells. Furthermore, SFN inhibits carcinogenesis and metastases and enhances cancer cell sensitivity to DOX, seemingly through Nrf2-independent mechanisms. SFN has also been tested in several clinical trials, although never together with DOX. Our early animal studies suggest that by activating Nrf2, SFN selectively protects the mouse and rat from DOX cardiotoxicity, enhances survival and enhances the effects of DOX on cancer growth in a rat breast cancer model. The investigators suspect that SFN affects DOX metabolism in cancer cells to enhance tumor regression, or it may synergistically activate other key antitumor mechanisms. Hence, SFN may improve the clinical outcome of cancer therapy by (1) attenuating DOX cardiotoxicity and (2) enhancing the effects of cancer treatment on the tumor. Our hypothesis is that SFN protects the heart from DOX-mediated cardiac injury without altering the antitumor efficacy of DOX. In Aim 1, the investigators will conduct an early-phase clinical trial to determine if SFN is safe to administer to breast cancer patients undergoing DOX chemotherapy. In Aim 2, the investigators will determine if SFN decreases DOX-induced inflammatory responses and enhances Nrf2- and SIRT1-target gene expression in breast cancer patients. Notably, transcript and protein signatures in peripheral blood mononuclear cells (PBMCs) can predict cardiac function in patients undergoing DOX chemotherapy for breast cancer. The investigators will also determine if SFN\u002FDOX treatment activates Nrf2- and SIRT1-dependent gene expression, alters the levels of biomarkers for presymptomatic DOX-cardiotoxicity and mitigates the generation of cardiotoxic metabolites in PBMCs and plasma. These studies will facilitate the development of SFN co-treatment as a strategy to enhance the efficacy and safety of DOX cancer therapy.",[28],"Anthracycline Related Cardiotoxicity in Breast Cancer",[30,31,32,33,34],"doxorubicin","sulforaphane","cardiotoxicity","nrf2","heart","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2022-06-01",{"date":43,"type":21},"2029-06-01",{"name":45,"class":46},"Texas Tech University Health Sciences Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":47},"100624268","eeg-guided-binaural-beat-audio-to-reduce-performance-related-stress-and-improve-cognition-100624268","NCT07407426","EEG-Guided Binaural Beat Audio to Reduce Performance-Related Stress and Improve Cognition","Effects of EEG-guided Binaural Beat Audio Intervention on Brain Reactivity Associated With Performance-related Stress and Cognition Among Professional Musicians: A Randomized, Double-blinded, Sham-controlled Functional Neuroimaging Trial","Inclusion Criteria:\n\n* Adults (18+ years) enrolled as undergraduate music majors at Texas Tech University\n* Currently preparing for an upcoming concert performance within the next 3 months\n* Able to read standard musical notation\n\nExclusion Criteria:\n\n* Subjects with contraindications to undergo MRI after being screened by the TTNI safety screening sheet - specifically, Subjects with implanted devices that are not compatible with MRI including, but not limited to cardiac pacemakers, cardiac defibrillators, aneurysm clips, carotid artery vascular clamps, implanted nerve stimulators (neuron-stimulators also called TENS or wires), bone growth or bone fusion stimulators, cochlear implants, vagus nerve stimulators, filters for blood clots (Umbrella, Greenfield, bird's nest), embolization coils (e.g. Gianturco) in the brain, ocular implants, vascular stents, medication pumps, medication patches delivering medications, implanted limbs, ventricular shunts, metal joints, rods, plates, pins, screws, nails, or clips, penile implants, or contraceptives devices including IUDs, cervical pessaries and diaphragms Subjects who have undergone cataract surgery Subjects who have shrapnel or metal in the head, eyes or skin Subjects with a history of working with metal fragments ( or have had metal removed from eyes Subjects with gunshot wounds or BB gun injury Subjects with permanent metal body piercings or jewelry that cannot be removed Subjects who use hearing aids or have braces \u002F permanent retainers that cannot be removed temporarily for the MRI scans Subjects with large tattoos in the head and neck area Subjects with claustrophobia Subjects who are currently pregnant or suspected to be pregnant\n* Physical, medical, neurological or psychiatric impairments (including substance abuse)\n* Current use of medications that could affect cognitive performance (including beta-blockers, stimulants, anxiolytics, antidepressants, or antipsychotics)\n* History of head injury resulting in loss of consciousness\u002Fhistory of brain surgery\n* History of diagnosed hearing impairment or use of hearing aids\n* Current or past diagnosis of epilepsy or seizure disorders\n* Unwillingness or inability to refrain from alcohol consumption 48 hours prior to the study visit\n* Unwillingness or inability to refrain from caffeine consumption 12 hours prior to the study visit\n* Current\u002Fpast history of substance abuse\n* Pregnancy or possibility of pregnancy\n* Unwillingness or inability to follow written, on-screen, and verbal instructions given by the study team",true,{"count":57,"type":21},32,[59],"NA","Performance-related stress can impair sustained attention, inhibitory control, and memory. This randomized, double-blinded, sham-controlled parallel-arm trial evaluates whether a 30-minute EEG-guided binaural beat audio intervention reduces subjective stress\u002Fperformance anxiety and improves cognition, and whether it changes task-related brain reactivity measured by fMRI. The intervention uses real-time single-electrode EEG recorded over the left prefrontal cortex to dynamically adjust binaural beat frequencies to guide the brain toward a target state; the sham condition uses non-binaural music delivered through identical headphones.\n\nAdult music majors preparing for an upcoming concert will complete pre- and post-intervention fMRI sessions during cognitive\u002Fmusic tasks (Stop Signal Reaction Task, Music Reading Task, Music Memory Retrieval Task) and complete visual analog scales (VAS) assessing performance anxiety, stress, and related subjective states. The primary outcomes include fMRI task-related activity in stress-regulation regions (dlPFC, amygdala, hippocampus), behavioral inhibition indices from the stop-signal task, music memory retrieval accuracy, and VAS-reported stress\u002Fperformance anxiety.",[62,63,64,65],"Cognitive Abilities","Performance","Stress","Cognitive Performance",[67,68,69],"neurofeedback","cognitive performance","stress","NOT_YET_RECRUITING","2026-04-06",{"date":73,"type":39},"2026-04-13",{"date":75,"type":21},"2026-04-07",{"date":77,"type":21},"2026-08-30",{"name":45,"class":46},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"100616766","effect-of-ultrasound-guided-dry-needling-targeting-rectus-capitus-posterior-major-on-individuals-with-headaches-100616766","NCT07309874","Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches","Inclusion Criteria:\n\n* Reports of a headache within the last 6 months (no minimum or maximum frequency or duration)\n* Current reports of headache\n* Tenderness to palpation of suboccipital muscles with Numeric Pain Rating Scale score ≥ 2\u002F10\n* No history of cervical spine surgery or neurological disorders\n\nExclusion Criteria:\n\n* History of cervical spine trauma or surgery\n* Diagnosed bleeding disorder\n* Currently using anticoagulant medications\n* Currently using anti-platelet medications\n* Diagnosed systemic joint diseases such as rheumatoid arthritis\n* Active infection\n* Diabetes\n* Cancer\n* Fibromyalgia\n* Cervical radiculopathy\n* Inability to tolerate prone positioning for the duration of the procedure.","65 Years",{"count":87,"type":21},50,[59],"Headaches such as tension-type, migraine, and cervicogenic (neck-related) headaches are among the most common and disabling conditions worldwide. and are often associated with tight or sensitive muscles at the base of the skull, which can contribute to headaches. Dry needling involves inserting a very thin, sterile needle into tight muscle areas known as trigger points to relieve pain and muscle tension. When applied to the deep neck muscles, including those beneath the skull, dry needling may reduce headache symptoms. The suboccipital region contains important structures such as the vertebral artery, greater occipital nerve, and spinal cord, which requires precise needle placement to maintain safety. Many needling techniques used in this region have not been validated for accuracy or safety in living subjects. This study will use real-time ultrasound imaging to guide dry needling of the rectus capitis posterior major muscle and directly visualize nearby structures to minimize risk.\n\nThe main goals of this research are to examine the effects of a single session of ultrasound-guided dry needling on headache symptoms and to confirm the safety, accuracy, and consistency of the proposed needling technique using ultrasound imaging.",[91,92],"Headache Disorders, Primary","Headache, Cervicogenic",[94,95,96,97],"Headache","cervical spine","suboccipital muscles","needle placement","2026-03-31",{"date":100,"type":39},"2026-04-01",{"date":102,"type":39},"2026-03-01",{"date":104,"type":21},"2026-06-01",{"name":45,"class":46},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":47},"100619729","phase-1-snacks-and-brain-health-100619729","NCT07348406","Snacks and Brain Health","Effects of Pecans on Brain Health in Older Americans With Mild Cognitive Impairment: Gut-brain Axis","Inclusion Criteria:\n\n* men and women \\> 50 years-old\n* self-reported IQCODE (informant questionnaire on cognitive decline in the elderly) average score \\\u003C 4.5\n* self-reported significant functional impairment (related to cognitive impairment) in basic or advanced activities of daily living as evidenced by the Activities of Daily Living (ADLs) questionnaire. If answers to at least one endorsement in the \"NO, dependence due to memory concerns\".\n* Stable medications (≥ 12-week unchanged dose before baseline) with no planned changes during trial.\n* habitually consume less than two servings (2 ozs = 1\u002F4 cup) of nuts or nut spreads per week\n* willing to accept randomization\n\nExclusion Criteria:\n\n* reported nut allergy or intolerance\n* self-reported untreated hypothyroidism, severe liver disease, or end-stage chronic kidney disease\n* heavy alcohol drinker: in the past 3 months: men ≥14 drinks\u002Fweek or women ≥7 drinks\u002Fweek\n* recent (\\\u003C1 month) appearance of diarrhea or hematochezia before study intervention begins. Rationale: A one-month waiting period after diarrhea or hematochezia (blood in stool) is recommended for a gut microbiome test to ensure the results accurately reflect the state and microbial composition, since diarrhea and hematochezia can significantly alter the gut environment and skew test results.\n* recent (\\\u003C1 month) exposure to antibiotics before study intervention begins. Rationale: A one-month waiting period after antibiotics is recommended for a gut microbiome test because it allows the microbial community time to recover and reach a more stable state, ensuring a more accurate and representative snapshot of the gut microbiome composition, since antibiotic usage can significantly reduce microbial diversity.\n* Self-reported unstable GI disorder\n* likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times","50 Years",{"count":115,"type":21},60,[24,25],"This project will investigate whether daily snack consumption can improve memory, mood, and overall brain function in people with cognitive impairment. Sixty participants, aged 50 and older, with cognitive impairment, will be randomly assigned to eat snacks, either pecans or pretzels, for three months. Researchers will also study how snacks (pecans and pretzels) may influence the body, including changes in gut bacteria, blood markers of inflammation, and signals that connect the gut and the brain.",[119,120,121],"Cognitive Assessment","Psychological Function","GI Health",[123,124,125],"neuroinflammation","gut microbiome","fMRI","2026-03-30",{"date":100,"type":39},{"date":129,"type":21},"2026-05-15",{"date":131,"type":21},"2028-09-30",{"name":45,"class":46},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":151,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100585550","phase-4-ketamine-for-pain-opioid-use-and-mental-health-in-orthopedic-trauma-patients-100585550","NCT06903819","Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients","Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)","Inclusion Criteria:\n\n* Adults aged 18-65\n* Undergoing acute operative fixation for musculoskeletal trauma\n* Injury Severity Score (ISS) greater than 15\n* Ability to provide informed consent (or consent provided by a legally authorized representative)\n\nExclusion Criteria:\n\n* Age under 18 or over 65\n* Use of ketamine for preoperative or postoperative sedation\n* Known allergy or contraindication to ketamine\n* Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD\n* Severe psychiatric conditions or psychotic features\n* History of dementia or glaucoma\n* Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months",{"count":141,"type":21},90,[143],"PHASE4","The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD).\n\nThe main questions it aims to answer are:\n\nDoes ketamine reduce pain after surgery compared to standard anesthesia?\n\nDoes ketamine reduce the amount of opioids patients need for pain control?\n\nDoes ketamine improve symptoms of depression and PTSD after orthopedic trauma?\n\nResearchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery.\n\nParticipants will:\n\nBe randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery.\n\nReport their pain using a simple pain scale (Visual Analog Scale, VAS).\n\nComplete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery.\n\nAllow the research team to review their electronic medical records to measure opioid prescriptions during recovery.\n\nAttend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery",[146,147,148,149,150],"Orthopedic Trauma Surgery Patients","Postoperative Pain","Opioid Use","Depression","Post-traumatic Stress Disorder (PTSD)",[152,153,147,154,149,155,156,157],"Ketamine","Orthopedic Trauma","Opioid Reduction","PTSD","Musculoskeletal Injury","Trauma Surgery","2026-03-19",{"date":160,"type":39},"2026-03-24",{"date":162,"type":39},"2025-11-06",{"date":164,"type":21},"2028-05",{"name":45,"class":46},2,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100627636","evaluating-the-efficacy-of-blood-flow-restriction-therapy-in-a-randomized-clinical-trial-for-postoperative-rehabilitation-following-ankle-ligament-reconstruction-100627636","NCT07451210","Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction","BFRankle recon","Inclusion Criteria:\n\n1. Age 18-65 years.\n2. Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).\n3. Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.\n\nExclusion Criteria:\n\n1. Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).\n2. Autoimmune disorders.\n3. History of stroke or deep vein thrombosis (DVT).\n4. Bleeding or coagulation disorders.\n5. Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).\n6. Pregnancy (current or planning to become pregnant in the next 4 months)\n7. Malignancy (cancer).\n8. Professional athletes.\n9. Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).\n10. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or\n11. Be deemed unsuitable for inclusion in the study at the discretion of the Investigators\n12. Cognitively not able to consent or participate in research (dementia; severe developmental delay; language\u002Fcommunication limitations; brain injury; etc.)",{"count":175,"type":21},105,[59],"The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention.\n\nFollowing standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups.\n\nOutcome measures of interest include:\n\n* muscle atrophy;\n* ankle function;\n* fatigability\u002Fmanual muscle testing;\n* pain scores;\n* cardiovascular effects (heart rate, blood pressure).",[179,180,181],"Ankle Reconstruction","Blood Flow Restriction Therapy","Physical Therapy",[183,184,185,186],"ankle reconstruction","physical therapy","blood flow restriction therapy","BFR","2026-03-13",{"date":189,"type":39},"2026-03-17",{"date":102,"type":21},{"date":192,"type":21},"2027-12-31",{"name":45,"class":46},5,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":47},"100626341","speech-intervention-via-telepractice-for-children-with-repaired-cleft-palate-100626341","NCT07434375","Speech Intervention Via Telepractice for Children With Repaired Cleft Palate","Speech Intervention Via Telepractice for Children With Repaired Cleft Palate: Randomized Controlled Trial and Assessment of Speech Production and Perception Skills","Inclusion Criteria:\n\n* Within the ages 5;0 and 11;11 (years; months) at enrollment and for enrollment duration\n* Having normal hearing based on a pure-tone hearing screening at 20 dB HL bilaterally at 500, 1000, 2000 and 4000Hz. Children with a history of hearing loss or children who currently are properly equipped with amplification will be included if they pass the hearing screening\n* Having typical nonverbal IQ, language, and socioemotional function as determined by a T-score with no more than -1.5 SD from the mean on Kauffman Brief Intelligence Test-2 (KBIT-2), receptive language of Clinical Evaluation Language Fundamentals-5 (CELF-5 Core Language), and Childhood Autism Rating Scale-2 (CARS-2)\n* Having a speech sound disorder as determined by a score ≤ 30th percentile on the Goldman-Fristoe Test of Articulation-3 (GFTA-3)\n* Demonstrate a cleft-related or a phonological error on at least one phoneme. For the sound, a cleft-related or a phonological error appears at word-initial phoneme on any two of the following tests; single words on GFTA-3, American English Phrase Samples (AEPS) and Sentence Sample (AESS) on the CAPS-A AM\n* Willing to comply with all study procedures and availability for the study duration.\n\nExclusion Criteria:\n\n* Demonstrates a medically diagnosed sensory or neurological disorder based on parents' report\n* Presents with velopharyngeal insufficiency (VPI) due to structural anomalies or an oronasal fistula\n* English is not the primary language spoken at home. Bilingual children will not be excluded.\n* Children who do not demonstrate cleft speech characteristics.","5 Years","11 Years",{"count":205,"type":21},64,[59],"The goal of this interventional study is to see if online speech therapy works just as well as face-to-face speech therapy in children with cleft palate. The main purposes are:\n\nTo compare the speech accuracy of target sounds in words produced by children with cleft palate between online and face-to-face speech therapy.\n\nTo compare the gain in speech accuracy in sentences produced by children with cleft palate between online and face-to-face speech therapy.\n\nTo assess whether changes in speech intelligibility are perceived by parents. To explore what kinds of factors influence speech accuracy. To explore speech training accuracy and speech understandability training accuracy during speech therapy sessions in children with CP\n\nParticipants will participate in 30-minute speech intervention sessions twice a week for 10 weeks, either in-person or online.",[209,210],"Cleft Palate Children","Speech Sound Disorder",[212,213,214,215,216,217,218,219],"non-inferiority","telepractice","speech therapy","intervention","speech perception","speech production","cleft palate","children","2026-02-25",{"date":222,"type":39},"2026-02-27",{"date":224,"type":21},"2026-03-02",{"date":226,"type":21},"2029-01-01",{"name":45,"class":46},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":235,"minAge":4,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":243,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":255,"locationsCount":47},"100607506","l-theanine-and-paraxanthine-for-cognitive-improvement-in-adults-with-adhd-and-asd-100607506","NCT07189442","L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD","Combining L-theanine and Paraxanthine for Transient Improvement of Cognitive Deficits Among Patients With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder: A Series of Translational Pilot Neuroimaging Studies","Inclusion Criteria:\n\nAdults (18+ years) diagnosed by a physician (per self-report) with ADHD or ASD\n\n\\* Participants with a dual diagnosis and ASD and ADHD will be recruited but will only be included in the ASD group - their concurrent ADHD diagnosis will be included as an additional variable in exploratory analyses\n\nExclusion Criteria:\n\n1. Subjects with gross visual or auditory impairments that might limit their ability to perform neuropsychological tasks\n2. Inability to read and follow written instructions\n3. Physical, neurological, intellectual, or psychiatric impairments (except ADHD or ASD) that could affect cognitive and motor functions\n4. Subjects on medications including antidepressants and antipsychotics that may affect performance in the tasks\n5. Subjects on medications that are likely to interact with the administered substances, including regular intake of medication that could alter visual, auditory, cognitive, or motor functions (except stimulants)\n6. History of head injury resulting in loss of consciousness\u002Fhistory of brain surgery\n7. Subjects who have developed adverse effects when caffeine\u002Fparaxanthine \u002FL-theanine\u002Fcorn starch (will be in placebo) containing products were consumed\n8. Subjects who are unwilling or unable to refrain from intake of L-theanine\u002F caffeine\u002F paraxanthine containing food or beverages within the 24 hours prior to each study visit\n9. Intake of drugs containing caffeine, other phosphodiesterase inhibitors, or adenosine receptor blockers within the past 3 months\n10. Intake of medications known to have pharmacological interactions with paraxanthine within the past 3 months\n11. Current\u002Fpast diagnosis of tics or other forms of dyskinesia\n12. History of headache, drowsiness, anxiety, insomnia, or nausea following intake of caffeine or caffeine-containing beverages\n13. Current\u002Fpast history of smoking and\u002For alcohol or drug abuse\n14. Subjects with absolute contraindications to undergo MRI after being screened by the TTNI safety screening sheet (Appendix)\n15. Unwillingness or inability to entirely refrain from the use of electronic devices during study visits\n16. Unwillingness or inability to follow written, on-screen, and verbal instructions given by the study team.","MALE",{"count":237,"type":21},24,[59],"This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.",[241,242],"Attention Deficit Hyperactivity Disorder (ADHD)","Autism Spectrum Disorder (ASD)",[244,245,246,247,248],"ADHD","Attention Deficit Hyperactivity Disorder","ASD","Autism spectrum disorder","Autism","2026-02-04",{"date":251,"type":39},"2026-02-05",{"date":253,"type":39},"2025-10-01",{"date":104,"type":21},{"name":45,"class":46},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":55,"sex":16,"minAge":263,"maxAge":18,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":47},"100498780","phase-1-curcumin-and-retinal-study-100498780","NCT05774704","Curcumin and Retinal Study","Curcumin and Retinal Amyloid-beta Pilot Study","Inclusion:\n\n* Both male and female, age 40 - 89 years.\n* Diagnosed with Aβ deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aβ deposits in retina within 6 months before the consent session, we will use this diagnosis\u002Fdocumentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study.\n* No pre-existing liver or kidney diseases by self-report.\n\nExclusion:\n\n* Patients with ocular diseases (macular degeneration, severe diabetes retinopathy)\n* Had used systemic antibiotics within 1 month prior to the start of the study intervention\n* Had taken any turmeric or curcumin products within 2 weeks prior to the start of the study intervention\n* Had a known allergy to black pepper\n* Women that are pregnant or breastfeeding","40 Years",{"count":115,"type":21},[24,25],"To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance\u002Fcomposition of gut microbiota.",[268,269,270],"Bioavailability","Gut Microbiome","Safety","2026-01-12",{"date":273,"type":39},"2026-01-13",{"date":275,"type":39},"2023-08-21",{"date":277,"type":21},"2026-12-31",{"name":45,"class":46},{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":55,"sex":287,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":292,"studyType":293,"phases":4,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":47},"100196134","prospective-data-bank-creation-to-study-vaginal-conditions-100196134","NCT01829204","Prospective Data Bank Creation to Study Vaginal Conditions","A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach","CRIPB-13-002","Inclusion Criteria:\n\n* All patients willing to participate, and give informed consent, and\n* Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.\n* Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.\n* Pregnant women ages 21 to 75 years who are both asymptomatic and healthy\n* Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition\n\nExclusion Criteria:\n\n* Asymptomatic patients ages \\\u003C 21 or \\> 75, or symptomatic patients ages \\\u003C 21 or \\> 75 years.\n* Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks\n* Patients unable to follow the protocol or unwilling to participate","FEMALE","21 Years","75 Years",{"count":291,"type":21},550,"12 Months","OBSERVATIONAL","The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.",[296,297,298,299],"Vulvodynia","Mycoses","Bacterial Vaginosis","Preterm Labor","2025-12-10",{"date":302,"type":39},"2025-12-18",{"date":304,"type":4},"2013-04",{"date":306,"type":21},"2027-12",{"name":45,"class":46},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":55,"sex":16,"minAge":263,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":328,"locationsCount":47},"100463263","phase-1-annatto-derived-gg-for-statin-associated-myopathy-100463263","NCT05312424","Annatto-derived GG for Statin-associated Myopathy","Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy","GG-statin","Inclusion Criteria:\n\n* Age ≥40 of either sex\n* Statin-treated patients with muscle pain alone or accompanied by other symptoms.\n* Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase\n\nExclusion Criteria:\n\n* Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse.\n* Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.\n* Had CoQ10 supplement one month before starting the study.\n* Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism\n* Had steroid medication one month before starting the study.",{"count":317,"type":21},95,[24,25],"To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.",[321],"Myopathy; Primary","2025-09-05",{"date":324,"type":39},"2025-09-12",{"date":326,"type":39},"2022-07-15",{"date":192,"type":21},{"name":45,"class":46},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":287,"minAge":17,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":4},"100501217","phase-1-grouping-immune-modulation-with-cryoablation-logic-for-breast-cancers-100501217","NCT05806385","Grouping Immune-modulation With Cryoablation (LOGIC) for Breast Cancers","Local Therapy Optimization by Grouping Immune-modulation With Cryoablation (LOGIC) for High Risk Breast Cancers","LOGIC","Inclusion Criteria:\n\n* Females\n* Stage I\u002FII Cancer\n* Age range 18 - 90 years\n* Diagnoses: Invasive carcinoma, ER -, PR-, HER2- (triple negative)\n* Radiology findings: Unifocal disease visible on ultrasound\n\nExclusion Criteria:\n\n* Additional primary cancer\n* Inflammatory breast cancer\n* History of autoimmune disease\n* History of chronic immunosuppression\n* Prior immunotherapy\n* Recent vaccination (within 4 wks.)\n* Prior radiation therapy\n* Prior investigational agent therapy within last 1 year\n* Pregnancy at the time of diagnosis and\u002F or treatment\n* Breast feeding","90 Years",{"count":339,"type":21},36,[24,25],"Summary Points:\n\n1. High Risk Breast Cancers: Triple negative cancer is considered high risk due to high rate of local and systemic failure. Newer innovative treatment strategies are needed to improve systemic control of disease and survival.\n2. Immune system modulation: is an emerging modality in cancer treatment. Tumor antigens can stimulate T cells to identify and destroy cancer cells. Cancers express \"altered self\" antigens that tend to induce weaker responses than the \"foreign\" antigens expressed by infectious agents. Thus, immune stimulants and adjuvant approaches have been explored widely. Opportunities to develop effective cancer vaccines may benefit from seminal recent advances in understanding how immunosuppressive barricades are erected by tumors to mediate immune escape. This concept is precisely applicable to triple negative breast cancer due to their antigenicity. Checkpoint inhibitors are an attractive method for treatment of high-risk breast cancers. However, to leverage the efficacy of checkpoint inhibition, approaches are needed to enhance delivery of cancer antigens to the T cells.\n3. Cryoablation: offers an efficacious and safe method to enhance tumor antigen presentation to the immune cells while destroying the primary tumor. This ablation method is superior by virtue of antigen preservation in situ despite toxicity to the tumor cell. Impact of cryoablation in enhancing immunological responses in tumor microenvironment are well established; however, cryoablation can also cause tumor antigen tolerance via non-specific stimulation of T cells.\n4. Rationale for combining cryoablation and checkpoint inhibitors: Since checkpoint inhibitors curtail the tolerance developed by tumor antigens, and cryoablation enhances antigen presentation and T cell recruitment, it is intuitive that combination of these two approaches presents an ideal opportunity to leverage the benefits of both approaches while curtailing the limitations of either. Therefore, the investigators hypothesize in this study that their combination will improve the response rate and the degree of response.",[343],"Triple Negative Breast Cancer","2025-09-02",{"date":346,"type":39},"2025-09-09",{"date":348,"type":21},"2026-03",{"date":350,"type":21},"2029-06",{"name":45,"class":46},{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":47},"100542969","early-phase-1-zynrelef-vs-exparel-the-battle-of-postoperative-pain-control-after-robotic-sleeve-gastrectomy-100542969","NCT06349772","Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy","Inclusion Criteria:\n\n1. Age range: 18-65 years old\n2. Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.\n3. Is able to provide written informed consent.\n4. Is able to adhere to the study visit schedule and complete all study assessments.\n\nExclusion Criteria:\n\n1. Positive urine drug screen prior to surgery\n2. History of substance abuse in the past year-by self report\n3. Patient with ongoing daily narcotic use at the time of surgery-by self report\n4. Inability to understand informed consent or read English\u002FSpanish\n5. Pregnant or lactating patients\n6. Prisoners\n7. Patients with renal or hepatic failure\n8. Bupivacaine use within 96 hours of operation\n9. Patient intolerant of opiates, nonsteroidal anti-inflammatory drug s, acetaminophen, or Zynrelef and Exparel. Subjects in all cohorts must not have any contraindications to any of the protocol-specified drugs\n10. Patient with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients",{"count":359,"type":21},130,[361],"EARLY_PHASE1","The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.",[364],"Post Operative Pain",[366,367,368,369],"robotic surgery","sleeve gastrectomy","zynrelef","exparel","2025-03-18",{"date":372,"type":39},"2025-03-21",{"date":374,"type":39},"2024-11-01",{"date":376,"type":21},"2025-12-01",{"name":45,"class":46},""]