[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beth Israel Deaconess Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,41,73,104,132,156,183,215,236,258,279,313,342,364,388,411,435,460,484,512,538,566,587,607,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100497191","building-respiratory-support-in-east-africa-through-high-flow-versus-standard-flow-oxygen-evaluation-100497191",false,"NCT05754034","Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation","BREATHE","Inclusion Criteria:\n\n* age\\>=18 years AND\n* admitted to a study site hospital within the 24 hours prior to screening AND\n* SpO2\\\u003C90% at time of first assessment OR\n* receiving oxygen at time of first assessment\n\nExclusion Criteria:\n\n* imminent death (high clinical suspicion of death within 24 hours of admission)\n* patient or caregiver refusal of study participation\n* history of chronic respiratory failure (SpO2\\\u003C90% or oxygen dependence for at least three months)\n* anatomical factors precluding the use of nasal cannula\n* intubation or non-invasive ventilation by the clinical team prior to screening for the trial\n* known hypoxemia at transferring facility for \\>48 hours\n* lack of availability of either SFO or HFO devices or supplies at the time of randomization.","ALL","18 Years",{"count":20,"type":21},1600,"ESTIMATED","INTERVENTIONAL",[24],"NA","Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context.\n\nThe goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are:\n\n1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?\n2. What are the facilitators and barriers to using high flow oxygen in these settings?\n3. Does high flow or standard flow oxygen use more oxygen?\n\nParticipants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other.\n\nThe study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.",[27],"Acute Hypoxemia","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2023-10-11",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Beth Israel Deaconess Medical Center","OTHER",5,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100521200","phase-3-precision-ventilation-vs-standard-care-for-acute-respiratory-distress-syndrome-100521200","NCT06066502","Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome","PREcision VENTilation to Attenuate Ventilator-Induced Lung Injury: A Phase 3 Multicenter Randomized Clinical Trial","PREVENT VILI","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ventilator-dependent ARDS, with all of the following (a-e):\n\n   1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5\n   2. Hypoxemia as characterized by: • If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)\u002FFiO2 ≤ 300 mm Hg, or, • if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2\u002FFiO2 ≤ 316 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart. • If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening:\n\n      Qualifying PaO2\u002FFiO2 or SpO2\u002FFiO2 (as defined above) that was recorded within the 6 hours immediately prior to initiating either of these therapies may be used for eligibility determination. • If PEEP has been increased by \\> 5 cm H2O within the last 12 hours immediately prior to screening:\n\n      Qualifying PaO2\u002FFiO2 or SpO2\u002FFiO2 (as defined above) prior to PEEP increase may be used for eligibility determination if recorded within this 12-hour window.\n   3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules\n   4. Respiratory failure not fully explained by heart failure or fluid overload\n   5. Onset within 1 week of clinical insult or new\u002Fworsening symptoms\n3. Early in ARDS course\n\n   * Full criteria for ARDS (#2 above) first met within previous 3 days\n   * Current invasive ventilation episode not more than 4 days duration\n   * Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration\n\nExclusion Criteria:\n\n1. Esophageal manometry already in use clinically\n2. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia or hemorrhage)\n3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)\n4. Esophageal pathology that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement, including high-risk esophageal varices, recent oropharyngeal or gastroesophageal surgery; or past esophagectomy\n5. Ongoing severe coagulopathy (platelet \\\u003C 5000\u002FμL or INR \\> 4)\n6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)\n7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)\n8. Any of the following severe chronic lung diseases: cystic fibrosis, acute bronchiectasis exacerbation, acute exacerbation of a chronic interstitial lung disease (ILD), chronic pulmonary hypertension (PH) on PH-targeted vasoactive medication, or lung transplant\n9. End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3)\n10. ICU admission for burn injury\n11. Current ICU stay \\> 2 weeks or acute care hospital stay \\> 4 weeks\n12. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed\n13. Current limitation on life-sustaining care (other than do-not-resuscitate), or expectation by clinical team that a limitation on life-sustained care will be adopted within next 24 hours.\n14. Treating clinician refusal or unwilling to use protocol-specified ventilator settings\u002Fmodes\n15. Prisoner\n16. Previous enrollment in this trial",{"count":50,"type":21},1100,[52],"PHASE3","The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.",[55,56],"Acute Respiratory Distress Syndrome","Respiratory Failure",[58,59,60,61,62,63],"critical care","critical illness","esophageal manometry","transpulmonary pressure","mechanical ventilation","lung stress","2026-06-25",{"date":66,"type":32},"2026-06-29",{"date":68,"type":32},"2024-06-24",{"date":70,"type":21},"2030-12-31",{"name":38,"class":39},33,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100641249","phase-2-the-cardioprotect-trial-100641249","NCT07654426","The CARDIOPROTECT Trial","A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial","Inclusion Criteria:\n\n* Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted.\n* Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma.\n* Age ≥18 years. Diffuse large B cell lymphoma is rare in participants \\\u003C18 years of age. The prevalence of HF prior to chemotherapy is also exceedingly rare in participants \\\u003C18 years of age; therefore, participants \\\u003C18 years of age are excluded from this study.\n* Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy\n\n  1. LVEF 30-50% on most recent echocardiogram with or without HF history\n  2. LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF).\n  3. History of anthracycline exposure for different malignancy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because dexrazoxane as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) Class III or IV exertional dyspnea. The symptoms should be attributed to HF and not due to lymphoma, anemia, arthritis or other causes per the assessment of the treating clinician or study investigator. NYHA Class III defined as: \"Marked limitations with less than ordinary activity such as walking short distances or climbing a few stairs\" and NYHA Class IV defined as: \"Inability to carry out any activity without discomfort. Symptoms are present at rest and if any physical activity is undertaken the symptoms are increased.\" (see Appendix A for NYHA Classification).\n* LVEF \\\u003C30% on most recent echocardiogram. Patients with prior LVEF \\\u003C30% with improvement to \\>30% on most recent echocardiogram are eligible.\n* Meeting criteria for frailty according to the simplified geriatric assessment (see Appendix A for the simplified geriatric assessment criteria).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.\n* Presence of central nervous system involvement\n* Presence of concurrent genetic rearrangements of the MYC and BCL2 genes, so called \"double-hit\" large-cell lymphoma who are not deemed eligible for intensified induction chemotherapy such as dose adjusted EPOCH-R by their treating physician can be enrolled\n* Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies\n* Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded\n* There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression.\n* Patients with positive Hepatitis B core antibody can be enrolled if they have negative viral load and can be maintained on antiviral prophylaxis\n* Patients with HIV can be enrolled if they have anti-retroviral therapy options without drug-drug interactions with the cancer treatment, agree to take anti-retroviral therapy and do not have uncontrolled opportunistic infections.\n* Pregnant women are excluded from this study because dexrazoxane and liposomal doxorubicin are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dexrazoxane and liposomal doxorubicin, breastfeeding should be discontinued if the mother is treated with dexrazoxane and liposomal doxorubicin. These potential risks may also apply to other agents used in this study.\n* Eligibility for observational arm of the study. The above inclusion and exclusion criteria are for the randomized trial. Patients who meet the inclusion criteria but have one or more exclusion criterion are eligible to participate in the observational arm of the study. In addition, patients who meet all eligibility criteria for the randomized trial but decline participation in the randomized trial are also eligible to participate in the observational arm of the study.",{"count":81,"type":21},60,[83],"PHASE2","This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.\n\nThe names of the study drugs involved in this study are:\n\n* Dexrazoxane (a type of Topoisomerase II Inhibitor)\n* Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor)\n* Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)\n* Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab",[86,87,88],"Diffuse Large B-cell Lymphoma (DLBCL)","Cardiotoxicity","Lymphoma",[86,90,87,88,91,92,93],"High Risk for Heart Failure Events","Stage B Heart Failure","Stage C Heart Failure","Left ventricular ejection fraction (LVEF) decline","NOT_YET_RECRUITING","2026-06-12",{"date":97,"type":32},"2026-06-17",{"date":99,"type":21},"2026-10-02",{"date":101,"type":21},"2035-12-31",{"name":38,"class":39},1,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100629165","sleep-light-circadian-central-oxidative-stress-100629165","NCT07471126","Sleep, Light, Circadian, Central Oxidative Stress","Role of Ambien Lighting in Circadian Misalignment in a Chronic Variable Sleep Deficiency Paradigm: Impact on Sleep, Cognition, and Central Oxidative Stress","Inclusion Criteria:\n\n* Healthy participants 18-40 years old.\n\nExclusion Criteria:\n\n1. Volunteers must be drug-free (including caffeine, nicotine, and alcohol) for the entire duration of the study, with no history of drug or alcohol dependency.\n2. Subjects must be free from any significant impairments of the visual system, including color blindness.\n3. Subjects must be ambulatory, have no major visual or auditory handicaps, and be free from any major acute, chronic or debilitating medical conditions.\n4. history of psychiatric illnesses or psychiatric disorders\n5. History of consistent work during the overnight hours for the one year prior to study.\n6. History of transmeridian travel \\>2 times zones, will require a 1 week wash out per hour of time difference from the Eastern Standard\u002FDaylight Time zone.",true,"40 Years",{"count":114,"type":21},40,[24],"Irregular sleep timing and sleep deficiency are pervasive in society despite evidence that sleep deficiency impairs cognition and is linked to neurodegenerative disease. Potential pathways underlying the adverse cognitive function and brain health associated with irregular insufficient sleep include misalignment of sleep from the internal \\~24-hour body clock and brain oxidative stress. This research will investigate these putative pathways and inform future interventions to mitigate the impact of sleep loss on cognition and brain health.",[118,119],"Non-visual Effects of Light","Chronic Variable Sleep Deficiency",[121,122,123,124],"Sleep","Circadian","Light exposure","Oxidative Stress","2026-06-09",{"date":127,"type":32},"2026-06-11",{"date":31,"type":21},{"date":130,"type":21},"2029-06-30",{"name":38,"class":39},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":103},"100477031","physiological-assessment-of-severe-coronary-stenosis-for-informing-planned-pci-100477031","NCT05491668","Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI","Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)","REFINE PCI","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* Patient provides written informed consent\n* Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI))\n* Scheduled for clinically indicated cardiac catheterization\n* At least one lesion with angiographic severity visually estimated to be \\>\u002F= 70% diameter stenosis that is deemed suitable for PCI\n* The operator plans to perform PCI on an ad hoc or planned basis\n* The target lesion is not planned for assessment by invasive physiology\n\nExclusion Criteria:\n\n* Failure to provide signed informed consent\n* Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI)\n* Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)\n* Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus\n* Chronic total occlusion (CTO) in the target vessel\n* Target vessel is supplied by major collaterals or supplies major collaterals to a CTO\n* Target lesion involves the left main coronary artery\n* Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded\n* Previously known untreated severe valvular heart disease\n* Previously known left ventricular ejection fraction \\\u003C30%\n* Sustained ventricular arrhythmias\n* Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol)",{"count":141,"type":21},107,"OBSERVATIONAL","Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized.\n\nThe purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement\u002FPCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.",[145],"Coronary Artery Disease",[147,148,149],"Invasive physiology","Angiography","Percutaneous coronary intervention",{"date":127,"type":32},{"date":152,"type":32},"2022-10-11",{"date":154,"type":21},"2027-06",{"name":38,"class":39},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":103},"100637468","perioperative-high-flow-nasal-oxygen-in-patients-undergoing-robotic-surgery-100637468","NCT07591610","Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery","Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery: A Randomized Trial","Periop HFNO","Inclusion Criteria:\n\n* Age \\>= 18\n* Undergoing non-emergent, non-cardiac, intra-abdominal, intra-thoracic or pelvic robot-assisted surgery with an expected duration of at least 2 hours under general anesthesia with planned extubation at the end of the procedure\n\nExclusion Criteria:\n\n* Known pregnancy\n* Preoperative intubation or tracheostomy\n* Anatomical or clinical conditions precluding the use of high-flow nasal oxygen (severe midface trauma, recent nasal surgery, severe nasal septum deviation, severe nasal deformation)\n* Contraindications to electrical impedance tomography (EIT), including inability to place the EIT belt or presence of active implantable electronic devices (e.g., pacemaker or implantable cardioverter-defibrillator)\n* Planned postoperative admission to the intensive care unit",{"count":165,"type":21},190,[24],"The aim of the study is to assess whether perioperative use of high-flow nasal oxygen (HFNO) during the period from induction of anesthesia until discharge from the post-anesthesia care unit in patients undergoing robotic-assisted surgery reduces perioperative oxygen desaturation and postoperative pulmonary complications.",[169],"Robotic Surgery",[171,172,173,174],"Electric Impedance Tomography (EIT)","High-flow nasal oxygenation","Perioperative oxygenation","Robotic surgery","2026-06-01",{"date":177,"type":32},"2026-06-02",{"date":179,"type":21},"2026-08-01",{"date":181,"type":21},"2029-10-31",{"name":38,"class":39},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100640252","effect-of-a-brief-daily-digital-meditation-on-well-being-in-us-young-adults-begin-ii-100640252","NCT07607782","Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)","BEGIN II","Inclusion Criteria:\n\n* Individuals between the ages of 18-40 years\n* Currently residing in the USA\n* Individuals who are English speaking\n* Willing and able to download an application on iOS\u002FAndroid\n\nExclusion Criteria:\n\n* Individuals who are non-English speaking\n* Unable to access an iOS\u002FAndroid smartphone\n* Individuals who regularly practice any form of meditation \\>4 times per week\n* Individuals scoring 9-12 on the PHQ-4, or ≥3 on either the PHQ-2 or GAD-2 subscale",{"count":191,"type":21},354,[24],"This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives.\n\nWe will invite about 354 adults between 18 and 40 years old who live in the United States to join.\n\nEveryone who joins will be randomly placed into one of three groups for 4 weeks: Intervention group will do a 7-minute Miracle of Mind meditation each day using a phone app. Active comparator group will listen to a neutral 7-minute audio lesson each day. Control group will continue their usual daily routine without adding anything new.\n\nAll participants will answer short online surveys at the start and several times during the 4 weeks, sharing how they feel about their mood, stress, anxiety, overall well-being, and mindfulness.\n\nParticipants who already wear a smartwatch (like a Fitbit or Apple Watch) can choose to share their heart rate-related data so we can see whether the meditation might also affect physical signs of stress.\n\nInvestigators will compare how participants in the three groups change over time to see if the daily 7-minute meditation helps young adults feel better, less stressed, and more emotionally resilient.",[195],"Mental Health and General Well-being",[197,198,199,200,201,202,203,204,205,206,207],"Digital meditation","App-based guided meditation","Miracle of Mind meditation","Young adults mental health","Stress and anxiety reduction","Emotional well-being","Mindfulness","Randomized controlled trial","Active and passive control groups","Well-being questionnaires","Physiological stress indicator","2026-05-21",{"date":210,"type":32},"2026-05-26",{"date":175,"type":21},{"date":213,"type":21},"2028-12-31",{"name":38,"class":39},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100634053","primed-to-thrive-investigating-the-combined-impact-of-mindfulness-education-and-meditation-practice-on-psychological-and-workplace-outcomes-100634053","NCT07534683","Primed to Thrive: Investigating the Combined Impact of Mindfulness Education and Meditation Practice on Psychological and Workplace Outcomes","Primed to Thrive: Investigating the Combined Impact of Mindfulness Education and Meditation Practice on Psychological and Workplace Outcomes (BEGIN III)","BEGIN III","Inclusion Criteria:\n\n* Individuals aged 18 years or older.\n* Current employee of the participating company who expresses interest in participating in the study.\n* Subjects will be required to be able to understand study instructions and materials and provide informed consent.\n* Willing and able to download and use a smartphone application compatible with iOS or Android platforms.\n\nExclusion Criteria:\n\n* Insufficient proficiency in English to comprehend study materials and instructions.\n* Presence of a diagnosed mental health condition that may interfere with the capacity to engage in or benefit from meditation practices, as determined by self-report or clinical history.",{"count":224,"type":21},134,[24],"Employees commonly experience stress and reduced well-being that can affect workplace functioning. This interventional study will evaluate whether combining mindfulness-related educational materials with a brief daily guided meditation practice delivered through a smartphone application improves psychological well-being and workplace outcomes compared with educational materials alone. Adult employees will be randomized to receive the meditation plus educational materials during the initial intervention period or after a waitlist period, with assessments completed at multiple time points over approximately 12 weeks. The primary outcome will evaluate change in work engagement using the Utrecht Work Engagement Scale (UWES-9).",[228],"Workplace Wellbeing","2026-05-12",{"date":231,"type":32},"2026-05-14",{"date":175,"type":21},{"date":234,"type":21},"2027-12-31",{"name":38,"class":39},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":244,"minAge":112,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":103},"100534428","study-on-allopregnanolone-and-depression-in-women-across-the-menopause-transition-100534428","NCT06238700","Study on Allopregnanolone and Depression in Women Across the Menopause Transition","Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition","SADIE-P","Inclusion Criteria:\n\n* Healthy women ages 40 to 60 years in the menopause transition\n* Depressive symptoms\n* Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study\n* Able to read Arabic numerals and perform simple arithmetic\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Systemic hormone therapy\n* Contraindicated medications with pregnenolone\n* Systemic corticosteroid\n* Other psychiatric illnesses that are considered to be primary\n* Current suicidal ideation\n* Active substance use disorders\n* Unstable medical conditions\n* Obstructive sleep apnea or other primary sleep disorders\n* Abnormal hepatic and renal function\n* Known allergy to progesterone, exogenous allopregnanolone, or pregnenolone\n* History of head injury resulting in loss of consciousness \\> 20 min\n* Inability to comply with barrier contraceptive methods\n* Known intellectual disability\n* Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition\n* Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data\n* Inability to comply with study procedures","FEMALE","60 Years",{"count":247,"type":21},80,[24],"This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.",[251],"Depression",{"date":231,"type":32},{"date":254,"type":32},"2024-05-14",{"date":256,"type":21},"2027-08-31",{"name":38,"class":39},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":103},"100408801","prevalence-and-impact-of-obstructive-sleep-apnea-in-multiple-sclerosis-100408801","NCT04603196","Prevalence and Impact of Obstructive Sleep Apnea in Multiple Sclerosis","SOMNUS","Inclusion Criteria:\n\n* Written consent\n* Over age 18\n* Confirmed diagnosis of multiple sclerosis\n\nExclusion Criteria:\n\n* cannot provide informed consent",{"count":266,"type":21},800,"This study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.",[269,270],"Multiple Sclerosis","Obstructive Sleep Apnea","2026-05-06",{"date":273,"type":32},"2026-05-11",{"date":275,"type":32},"2019-06-20",{"date":277,"type":21},"2030-06-20",{"name":38,"class":39},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":111,"sex":17,"minAge":286,"maxAge":18,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":295,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":4},"100606288","transforming-adolescent-perception-and-mental-health-through-meditation-and-cognitive-reappraisal-a-mixed-method-study-100606288","NCT07173608","Transforming Adolescent Perception and Mental Health Through Meditation and Cognitive Reappraisal A Mixed Method Study","THRIVE","Inclusion Criteria:\n\n* Individuals between15-18 years of age\n* Ability to understand study instructions and provide informed consent\u002Fassent. (parental consent for minors)\n* Access to internet and a device to complete online study activities\n* Currently residing in the United States\n* Willing and able to travel to the hospital location in Boston for study procedures.\n\nExclusion Criteria:\n\n* Non-English speaking (Justification: the intervention and assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)\n* Practicing meditation regularly in the past 6 months (4 or more times per week for 4 weeks or more in the past 6 months)\n* History of psychiatric illness such as severe anxiety, severe depression, posttraumatic stress disorder (PTSD), Schizophrenia or bipolar disorder\n* Current use of cognition enhancing drugs\n* Current management for chronic pain\n* History (within past 5 years) of seizure, brain surgery or any condition causing cognitive decline.\n* Active history (within the last 5 years) of alcohol or drug abuse.\n* Current pregnancy or planning to become pregnant in the next 6 months\n* Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI\n* Significant visual impairment\n* Subject has previously learned the intervention.\n* Subject has contraindications for MRI (Detailed in the eligibility screening questions)","15 Years",{"count":288,"type":21},96,[24],"This study will evaluate how a comprehensive meditation-based program, Inner Engineering, supports teens ages 15-18 in becoming more joyful, focused, resilient, and better equipped to manage stress and thrive. Through this study, researchers will examine whether practices like meditation, yoga, and cognitive reframing can help adolescents view and respond to challenges with greater clarity and balance. The study will assess mental and physical impacts through self-report, physiological, and neuroimaging methods.",[292,293,294],"Meditation","Cognitive Reappraisal","Emotional Regulation",[296,297,298,299,300,301,302,203,303,304],"meditation","Inner Engineering","Shambhavi Mahamudra Kriya","EEG","Functional MRI","MRI","Cognition","Mental Health","Adolescent","2026-04-22",{"date":307,"type":32},"2026-04-23",{"date":309,"type":21},"2026-05",{"date":311,"type":21},"2028-03",{"name":38,"class":39},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":103},"100439733","pancreatic-cancer-screening-for-at-risk-individuals-100439733","NCT05006131","Pancreatic Cancer Screening for At-risk Individuals","Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)","PancreasScan","Inclusion Criteria:\n\n* Inclusion criteria 1-3 are indications for pancreatic cancer screening as defined by the CAPS3 guidelines or updated national pancreatic cancer screening guidelines. Patients who do not meet these guidelines but are undergoing pancreatic cancer screening at the discretion of their treating physician at participating study centers will also be included in the study. Based upon the indication for screening, patients will be categorized as either meeting CAPS3 screening criteria, or not meeting CAPS3 screening criteria.\n\n  1. Familial Pancreatic cancer kindred. This is defined as family history of pancreas cancer that meet the criteria listed below.\n\n     1. If at least two affected relatives who are First degree relatives (FDR) to each other, of whom at least one is an FDR to the individual considered for surveillance\n     2. If at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance\n     3. If at least two affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance Screening is usually initialed at age 50 years or 10 years younger than the youngest family member with pancreatic cancer\n  2. Patients with genetic susceptibility to pancreas cancer\n\n     1. Patients with Peutz-Jeghers syndrome diagnosed with using clinical criteria or with a deleterious mutation in liver kinase B1\u002FSerine\u002Fthreonine kinase 11 (LKB1\u002FSTK11). Screening is usually initiated at age 40 years or later.\n     2. Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM syndrome), diagnosed using clinical criteria or CDKN2A p16 mutation.\n\nScreening is usually initiated at age 45 years or 10 years younger than the youngest family member with pancreatic cancer.\n\n1. Hereditary Breast and Ovarian Cancer syndrome: diagnosed using clinical criteria or deleterious Breast Cancer gene 1 (BRCA1), Breast Cancer gene 2 (BRCA2), Partner and Localizer of BRCA2 (PALB2). The usual indication for screening is:\n\n   * BRCA1 mutation and at least one affected first-degree relative with pancreatic cancer\n   * BRCA 2 mutation and at least one affected first-degree relative, or at least two relatives of any degree with pancreatic cancer\n   * PALB2 mutation and at least one affected first-degree relative with pancreatic cancer Screening is usually initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer; or per updated national screening guidelines\n2. Lynch syndrome or Ataxia Telangiectasia Mutated (ATM) mutations with at least one affected first-degree relative (FDR). Lynch syndrome could be diagnosed either by using clinical criteria or Mutator L homolog 1 (MLH1), Mutator S homolog 2 (MSH2), Mutator S homolog 6 (MSH6), Postmeiotic Segregation Increased, S. Cerevisiae, 2 (PMS2) or EPCAM mutation.\n\n   Screening to be initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer.\n3. Patients with hereditary pancreatitis diagnosed using clinical criteria or deleterious Serine Protease 1 (PRSS1) mutation. Screening is usually initiated at age 40 years or 10 years younger than the youngest family member with pancreatic cancer 3. New-onset diabetes, age \\> 50 years with weight loss. 4. Patients who do not meet these CAPS screening criteria but are determined by the site principal investigator to be high-risk for pancreatic cancer based upon family history or other risk factors, and are undergoing pancreatic cancer screening will also be included in the study. Indication for pancreatic cancer screening and age at which screening was initiated will be recorded.\n\nExclusion Criteria:\n\n* Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging","90 Years",{"count":323,"type":21},1395,"The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.",[326],"Pancreatic Cancer, Adult",[328,329,330,331,332,333,334,301],"Pancreatic cancer screening","Early detection of pancreatic cancer","Genetic susceptibility to pancreatic cancer","BRCA 1","BRCA 2","familial pancreatic cancer","Endoscopic Ultrasound","2026-04-21",{"date":307,"type":32},{"date":338,"type":32},"2020-07-10",{"date":340,"type":21},"2032-12-31",{"name":38,"class":39},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":350,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":103},"100357616","phase-3-statins-in-intracerbral-hemorrhage-100357616","NCT03936361","Statins In Intracerbral Hemorrhage","STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS","SATURN","Inclusion Criteria:\n\n1. Age ≥ 50 years.\n2. Spontaneous lobar ICH confirmed by CT or MRI scan\n3. Patient was taking a statin drug at the onset of the qualifying\u002Findex ICH\n4. Randomization can be carried out within 7 days of the onset of the qualifying ICH\n5. Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation\n\nExclusion Criteria:\n\n1. Suspected secondary cause for the qualifying ICH, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.\n2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months\n3. Diabetic patients with history of myocardial infarction or coronary revascularization\n4. History of familial hypercholesterolemia\n5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors\n6. Known diagnosis of severe dementia\n7. Inability to obtain informed consent\n8. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits\u002Fassessments.\n9. Life expectancy of less than 24 months due to co-morbid terminal conditions.\n10. Pre-morbid mRS \\>3\n11. ICH score \\>3 upon presentation.\n12. Contraindications to continuation\u002Fresumption of statin therapy, such as significant elevations of serum creatinine kinase and\u002For liver transaminases, and rhabdomyolysis\n13. Woman of childbearing potential\n14. Concurrent participation in another research protocol for investigation of experimental therapy.\n15. Indication that withdrawal of care will be implemented for the qualifying ICH.","50 Years",{"count":352,"type":21},1456,[52],"The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue\u002Fdiscontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype.\n\nAn MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence\u002Fburden of hemorrhagic markers (i.e. cerebral microbleeds and\u002For cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on\u002Foff statin therapy.",[356],"Intracerebral Hemorrhage","2026-04-19",{"date":335,"type":32},{"date":360,"type":32},"2020-06-10",{"date":362,"type":21},"2029-12",{"name":38,"class":39},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":385,"leadSponsor":387,"locationsCount":4},"100605277","phase-2-study-of-protection-and-repair-of-endothelial-glycocalyx-in-sepsis-spares-100605277","NCT07160426","Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)","Pilot Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)","SPARES","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed or suspected infection (pathogen detected or antimicrobial administered)\n* SOFA score ≥2\n* ICU patient or ED patient with anticipated ICU admission\n\nExclusion Criteria:\n\n* Unable to randomize within 24h of meeting inclusion criteria\n* Current hospitalization \\>2 days\n* Decision to withhold life-sustaining treatment (exception for DNR only)\n* Moribund; not expected to survive 24h\n* Life expectancy \\\u003C28 days from non-sepsis condition\n* Any condition where participation isn't in the patient's best interest or limits assessments\n* Prisoner\n* Pregnancy\n* Concurrent interventional trial with overlapping treatments\u002Foutcomes\n* Inability to obtain patient\u002FLAR consent\n* History of Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Circulatory Overload (TACO)\n* End Stage Renal Disease\n* Chronic tracheostomy with ventilator use",{"count":373,"type":21},45,[83],"Sepsis damages the blood vessel lining and its protective \"glycocalyx,\" contributing to organ failure and death. This pilot, randomized, blinded study will test whether giving fresh frozen plasma (FFP)-either as intermittent boluses or as a continuous infusion-protects or repairs the glycocalyx compared with look-alike placebo fluid (lactated Ringer's with multivitamins), and whether this leads to better clinical outcomes. We will measure blood and urine biomarkers of glycocalyx injury and track organ support needs, ICU\u002Fhospital-free days, and survival through 28-90 days.",[377],"Sepsis",[377,379,380,381],"Fresh Frozen Plasma","Endothelium","glycocalyx","2026-04-18",{"date":305,"type":32},{"date":31,"type":21},{"date":386,"type":21},"2028-12-01",{"name":38,"class":39},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100553872","eim-via-the-myolex-mscan-as-an-als-biomarker-100553872","NCT06491732","EIM Via the Myolex mScan as an ALS Biomarker","Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker","ElectricALS","Inclusion Criteria:\n\n* Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria\n* Capable of providing informed consent and complying with study procedures in the investigator's opinion\n* Time since ALS symptom onset ≤36 months\n* Vital Capacity of ≥40% of predicted capacity as measured by forced vital capacity or slow vital capacity\n* Must have a study partner for home visits\n* Access to the internet for data upload\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Clinically significant unstable medical condition (other than ALS) that would affect the participant's ability to participate, according to the investigator's judgment\n* Patient with pure upper motor neuron disease (PLS)\n* Known history of unstable psychiatric disease, cognitive impairment, dementia, or active substance abuse\n* Significant pitting edema (2+ or more) that would interfere with EIM measures\n* Active cancer or history of cancer treated with chemotherapy and\u002For radiation\n* BMI \\>35",{"count":247,"type":21},"Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimately approved for slowing disease progression. Many pharmaceutical companies continue to seek new therapeutic approaches. One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy. Tools to track ALS progression must be convenient, objective, require minimal training, be easily standardized, cost-efficient, and have the potential to be applied effectively at home. There has been a push to identify accurate, objective biomarkers of ALS progression. In this study, the investigators propose to use Electrical impedance myography (EIM) to evaluate the progression of the disease. Work has shown that the EIM 50 kilohertz (kHz) phase value from one or more muscles, followed sequentially, can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person.",[399],"Amyotrophic Lateral Sclerosis",[399,401,402],"Electrical Impedance Myography","Biomarker","2026-04-17",{"date":305,"type":32},{"date":406,"type":32},"2025-03-01",{"date":408,"type":21},"2027-05-30",{"name":38,"class":39},6,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":428,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":103},"100489655","phase-2-y-90-with-durvalumabgemcis-in-intrahepatic-cholangio-100489655","NCT05655949","Y-90 With Durvalumab\u002FGem\u002FCis in Intrahepatic Cholangio","A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine\u002FCisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study\n* Male and female participants at least 18 years of age at the time of signing the ICF\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma; at least one intrahepatic lesion must be present\n* Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria\n* ECOG performance status ≤1\n* Body weight \\>30 kg\n* Must have a life expectancy of at least 12 weeks\n* Participants must have adequate marrow function as defined below:\n\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL\n  * Platelet count ≥75 × 109\u002FL\n* Participants must have adequate renal function as defined below:\n\n  * Serum creatinine ≤ 1.5 mg\u002FdL OR\n  * Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance\n* Participants must have adequate hepatic function as defined below:\n\n  * Bilirubin ≤1.5 x ULN\n  * ALT ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n  * AST ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n  * This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician\n  * No known history of active HBV or HCV infection.\n\n    * Note: Participants with Hepatitis C who have been clinically cured, defined as persistent absence of Hepatitis C RNA detected by polymerase chain reaction (PCR) test in serum 12 weeks after completing antiviral treatment, are eligible for this study\n    * Note: Participants with a history of Hepatitis B infection that are currently on viral suppressive therapy are eligible for enrollment\n* Adequate coagulation studies as demonstrated by prothrombin (PT) and partial thromboplastin (PTT) time within normal limits (\\\u003C\u002F= 1.5 x ULN) in the absence of anticoagulation medication. Participants receiving anticoagulation may be approved by sponsor\n* Participants with known human immunodeficiency virus (HIV) on effective highly-active antiretroviral therapy (HAART) with undetectable viral load within 6 months are eligible for this trial, so long as the following criteria are met:\n\n  * HAART does not interact with or have overlapping toxicities with study medication, per discretion of the treating provider\n  * CD4 count is ≥350 cells\u002FuL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications\n  * Probable long-term survival with HIV if cancer were not present\n  * Stable on a HAART regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study\n  * HIV is not multi-drug resistant\n  * Taking medication and\u002For receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication\n\nExclusion Criteria:\n\n* Surgically resectable disease at enrollment\n* Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma or mixed adenocarcinoma\u002Fhepatocellular carcinoma\n* Received prior systemic chemotherapy and\u002For radiotherapy for intrahepatic cholangiocarcinoma. Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since last dose of treatment, and if the tumor is amenable to Y-90 SIRT\n* Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or checkpoint pathways\n* Any of the following within 6 months of screening:\n\n  * New York Heart Association (NYHA) Class III or IV heart failure\n  * Myocardial infarction, unstable angina pectoris, or symptomatic coronary artery disease\n  * Unstable arrhythmia\n  * Stroke to transient ischemic attack\n* Previous malignancies, except for adequately treated non-melanoma skin cancer, in-situ cancer, or any other cancer from which the subject has been disease-free for at least 3 years\n* Severe chronic obstructive or other pulmonary disease with chronic baseline hypoxemia due to potential for gemcitabine-induced bronchospasm and\u002For durvalumab-induced pneumonitis\n* Major surgery (other than diagnostic) within 4 weeks of study treatment day 1\n* Active, uncontrolled or untreated bacterial, viral, or fungal infection that requires systemic therapy\n* Active, untreated HIV, HBV, or HCV\n* Subjects who have participated in another investigational drug or device study within 4 weeks prior to study registration.\n\nPregnant women are excluded from this study because cisplatin is a class D agent with the potential for teratogenic or abortifacient effects. Because cisplatin is present in breast milk and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin, breastfeeding should be discontinued prior to entry into the study. Subjects and their sexual partners entered into the study must agree to contraception. The following restrictions apply while the patient is receiving study treatment and for the specified times before and after:\n\n* Female patients of child-bearing potential Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception (Table 2) from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy). Non-sterilised male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female patients should also refrain from breastfeeding throughout this period.\n* Male patients with a female partner of childbearing potential Non-sterilized male patients who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy). However, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male patients should refrain from sperm donation throughout this period.\n\nFemale partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period (Table 2).\n\nFemales of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.\n\nWomen will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n* Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.\n* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n\nHighly effective methods of contraception, defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly are described in Table 2. Note that some contraception methods are not considered highly effective (e.g. male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action \\[excluding Cerazette\u002Fdesogestrel which is considered highly effective\\]; and triphasic combined oral contraceptive pills).\n\n* Copper T intrauterine device\n* Levonorgestrel-releasing intrauterine system (e.g., Mirena®)a\n* Implants: Etonogestrel-releasing implants: e.g. Implanon® or Norplant®\n* Intravaginal: Ethinylestradiol\u002Fetonogestrel-releasing intravaginal devices: e.g. NuvaRing®\n* Injection: Medroxyprogesterone injection: e.g. Depo-Provera®\n* Combined Pill: Normal and low dose combined oral contraceptive pill\n* Patch: Norelgestromin\u002Fethinylestradiol-releasing transdermal system: e.g. Ortho Evra® Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette® is currently the only highly effective progesterone-based\n\n  * Any concomitant disease or condition that could interfere with the conduct of the study, or that would in the option of the investigator pose an unacceptable risk to the subject in the study\n  * Contraindications to Y-90 SIRT per assessment by treating Interventional Radiologist (eg significant vascular drainage of the tumor to the lung that increases the potential for pulmonary toxicity)\n  * Unwillingness or inability to comply with the study protocol\n  * History of allogenic organ transplantation.\n  * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    * Patients with vitiligo or alopecia\n    * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    * Any chronic skin condition that does not require systemic therapy\n    * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n    * Patients with celiac disease controlled by diet alone\n  * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n  * History of active primary immunodeficiency\n  * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice\n  * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n  * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n  * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",{"count":419,"type":21},30,[83],"This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery.\n\nThe specific names of the interventions that will be used are:\n\n* Y-90 (a type of radiation microsphere bead)\n* Durvalumab (a type of immunotherapy)\n* Gemcitabine (a type of chemotherapy)\n* Cisplatin (a type of chemotherapy)",[423,424,425,426,427],"Bile Duct Cancer","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Metastatic","Metastatic Intrahepatic Cholangiocarcinoma",[423,424,425,426,427],{"date":305,"type":32},{"date":431,"type":32},"2024-02-13",{"date":433,"type":21},"2027-12-01",{"name":38,"class":39},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":103},"100624080","phase-2-reversal-of-spinal-anesthesia-residual-motor-block-via-intrathecal-catheter-100624080","NCT07404982","Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter","Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study","IT-Cath","Inclusion Criteria:\n\n1. Patients having elective lower extremity joint replacement surgery\n2. Patients \\>18 years\n\nExclusion Criteria:\n\n1. Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities)\n2. Patient on anticoagulation not withheld\n3. Patient receiving re-operation on the same joint\n4. Prior intra-cranial bleeding\n5. Patient's ASA status \\>3\n6. Non-English speaking",{"count":444,"type":21},20,[83],"The purpose of this study is to determine the feasibility of administering a predetermined amount of normal saline into the intrathecal or subarachnoid space via a small spinal catheter to reduce or eliminate the effects of previously injected spinal anesthetic following lower extremity orthopedic surgery.",[448],"Joint Replacement Surgery",[450,451],"Joint Replacement","Knee Replacement","2026-04-16",{"date":454,"type":32},"2026-04-20",{"date":456,"type":32},"2026-03-19",{"date":458,"type":21},"2027-12",{"name":38,"class":39},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":476,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":482,"leadSponsor":483,"locationsCount":103},"100582750","reducing-psychological-distress-to-optimize-recovery-of-elderly-icu-survivors-and-caregivers-restore-icu-100582750","NCT06867367","REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU)","REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU): A Pilot Feasibility Study","RESTORE-ICU","Patient Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.\n2. Elderly ICU survivors aged over 60 years who have experienced long ICU stays of more than five days.\n3. Caregivers who either live in the same household as the survivor or visit more than three times a week.\n\nExclusion Criteria:\n\nCo-enrollment in other interventional studies will not be allowed.\n\n1. Age \\>=85 years (Justification: Assessment instruments not validated in this age group and patients in extremes of age may have limited proficiency to engage in proposed meditative practices)\n2. Non-English speaking\u002FLow-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)\n3. Non-US resident\n4. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint).\n5. Individuals discharged to a non-home location, such as a rehabilitation center, nursing home, or long-term acute care facility.\n6. Individuals with limited internet access, which would prevent access to online guided meditation\n7. Prisoners.\n8. Individuals who refuse to participate in the study.\n9. Not on vasopressor or inotropic support at the time of enrollment.\n10. Not on non-invasive ventilation, high-flow nasal cannula (HFNC), or mechanically ventilated.\n11. Not on continuous renal replacement therapy (CRRT).\n12. Failure to pass Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) screening (\\>3.6; Justification: Cognitive decline would limit the ability to engage with and complete the study interventions and assessments).\n13. Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels.\n14. Known diagnosis of moderate or severe dementia.\n15. Neurological injury.\n16. Residing in a medical institution before admission.\n17. Patient on hospice at or before the time of enrollment.\n18. Mechanical ventilation at baseline or solely for airway protection.\n19. Patient not expected to go home (e.g., transfer to a facility).\n20. Patient not expected to survive two months or expected to transition to hospice.\n21. Patient died in hospital before enrollment.\n22. Attending physician declined enrollment.\n23. Patient discharged before being approached for consent.\n24. Either the patient or caregiver in the dyad declined participation (based on IQCODE or consent).\n\nCaregiver Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.\n2. Caregivers who either live in the same household as the survivor or visit more than three times a week.\n3. Age ≥18 years old.\n\nExclusion Criteria:\n\n1. Non-English speaking\u002FLow-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)\n2. Non-US resident\n3. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint).\n4. Individuals with limited internet access, which would prevent access to online guided meditation\n5. Prisoners.\n6. Individuals who refuse to participate in the study.\n7. Diagnosed with severe psychiatric disorders, such as schizophrenia, bipolar disorder, or ongoing substance abuse, that could interfere with participation.\n8. Individuals actively receiving treatment for recent trauma\n9. Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels.\n10. severe or acute medical illness","85 Years",{"count":470,"type":21},14,[24],"This research study aims to explore whether a set of simple breathing techniques and guided meditations can improve the psychological well-being and recovery of ICU survivors and their caregivers.\n\nICU survivors and their caregivers often experience high levels of stress, anxiety, and depression after discharge. This study investigates whether practicing Isha Kriya, a guided meditation, and Nadi Shuddhi, a breathing technique, can support their mental health and relationship quality. These practices are delivered through a mobile app or in a group setting.\n\nParticipants enroll as a caregiver-patient dyad and will engage in these techniques throughout the study. In addition to the practices, brain activity will be recorded using a safe, non-invasive EEG device. The EEG, a lightweight cap with small sensors, measures brainwaves to assess potential changes in brain function and connection. EEG recordings will take place in the hospital during two sessions, each lasting approximately 40 minutes.\n\nParticipants will also complete short surveys at five time points throughout the study, assessing mood, stress, and relationship quality. Baseline demographic information will be collected, and at the conclusion of the study, a brief interview will be conducted to gather feedback on the experience.\n\nThe study spans approximately seven weeks, with the overall goal of determining whether these breathing and meditation practices can provide accessible and scalable mental health support for ICU survivors and their caregivers.",[474,475],"Relationship, Family","Well-Being, Psychological",[477,478,479],"mental health","relationship quality","ICU recovery",{"date":454,"type":32},{"date":309,"type":21},{"date":458,"type":21},{"name":38,"class":39},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":511},"100250950","biomarkers-in-infection-100250950","NCT02545478","Biomarkers in Infection","Early Detection of Inflammatory Biomarkers in Infection","Inclusion Criteria for Infected subjects:\n\n* Age 18 years of age or older\n* Confirmed or suspected infection\n\nInclusion Criteria for Control Subjects:\n\n* Age 18 years of age or older\n* A non-infectious clinical presentation to include\n* Normal white blood cell count ( \\> 4,000 and\u002For \\\u003C 12,000)\n* Normothermia ( \\> 96.5 and\u002For less 100.4)\n* Absence of the following clinical complaints: productive cough, fever, pyuria, rash\n* No evidence of acute coronary syndrome\n\nExclusion Criteria for Control Subjects:\n\n\\- Suspected infection",{"count":492,"type":21},4200,"The purpose of this investigation is to evaluate how early biomarkers of infection and inflammation perform in identifying patients at risk for poor outcome in sepsis and septic shock.",[377,495,496],"Infection","Inflammation",[498,499,500,501,502],"septic shock","infection","inflammation","pathologic process","biomarkers","2026-04-13",{"date":505,"type":32},"2026-04-15",{"date":507,"type":4},"2006-04",{"date":509,"type":21},"2031-12",{"name":38,"class":39},2,{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":245,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":526,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100571558","phase-3-the-scope-trial-sleep-cognition-and-pain-bundle-vs-eras-cardiac-for-postoperative-delirium-100571558","NCT06721819","The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium","SCOPE","Inclusion Criteria:\n\n* Planned cardiac surgery \\[CABG with or without valve, isolated valve surgery\\] requiring median sternotomy and full CPB at least 10 days in the future.\n\n  * 60 years of age.\n\nWillingness to use a provided tablet and wearable devices and commit at least 1 hour amount of time per day before surgery to complete interventions (psCBT\u002Fcognitive activity\u002Fexercise) if randomized to experimental group.\n\nExclusion Criteria:\n\n* Pre-operative left ventricular ejection fraction (LVEF) \\\u003C than 30%\n\nEmergent procedures\n\nIsolated aortic surgery\n\nLiver dysfunction (ALT or AST \\> 4 times the upper limit of local normal; all patients will have a baseline liver function test information or history and exam suggestive of jaundice or both)\n\nKnown hypersensitivity to the study drugs\n\nActive (in the past year) history of alcohol abuse (≥ 5 drinks\u002Fday for men or ≥ 4 drinks\u002Fday for women) Any history of alcohol withdrawal or delirium tremens\n\nDelirium at baseline\n\nEnglish language Limitations\n\nPhysician refusal\n\nChronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)\n\nSignificant visual impairment\n\nPrisoner\n\nSevere OSA in the past year (AHI is greater than 30 (more than 30 episodes per hour)) or ESS of 18 or more\n\nCo-enrollment with non-approved interventional trial\n\nSevere cognitive impairment (MOCA \\\u003C 10) or medications for cognitive decline\n\nRecent treatment for insomnia with CBT-I within the last 6 months",{"count":520,"type":21},406,[52],"Sleep disturbances, cognitive reserve, and continuing pain and inflammation are other risk factors contributing to delirium (confusion and agitation) and neurocognitive decline (in the long term) following heart surgery. Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with intravenous acetaminophen combined with enhanced recovery after surgery protocols (SCOPE bundle). SCOPE will fill significant gaps in evidence by testing the value of a patient and care-provider-focused intervention that can potentially minimize POD and improve outcomes (cognitive \\& physical function, sleep quality, pain, depression or anxiety, and survival) important to patients and families.\n\nThe SCOPE trial will address many heart surgery outcome-related questions commonly asked by patients:\n\nWhat can I do to reduce my chances of developing confusion, hallucinations, or delirium after surgery? How can I best prepare before surgery to improve my long-term health and avoid disability? Are there exercises I can participate in that improve my sleep, pain, and mood after surgery? Intellectual pursuits, physical activity, and social interactions support cognitive reserve, while poor health, poor sleep hygiene, poor nutrition, and mental health disease can diminish reserve. Various interventions with different intensities and timing to augment cognitive reserve have been associated with positive outcomes on neuropsychological testing. Adaptive video gaming for as little as 10 hours leads to the maintenance of independence in activities of daily living and sustained improvements in speed of processing, attention, and working memory in older people. Likely through the increased cognitive reserve, perioperative brain exercise aims to protect against morbid cognitive recovery after surgery.\n\nSleep is vital for memory and cognitive function. Poor sleep traits in older adults that are potentially modifiable, including short\u002Flong duration, daytime napping, and associated sleepiness, led to an almost 2-fold increase in delirium risk. Patients will complete an evidence-based course on healthy sleep habits and will complete guided exercises designed to restructure behaviors and thinking. They are encouraged to follow a set of recommendations to improve their sleep (e.g., optimal sleep duration, advice for habits such as daytime napping, maintaining a regular sleep schedule, avoiding caffeine, regular daylight exposure, dimming lights or electronics and relaxation and thought exercises for optimal sleep); many of these sleep behaviors have been strongly linked to increased risk for cognitive decline. Investigators propose that sleep optimization before AND after (an established best practice sleep bundle) surgical insult will contribute to cognitive reserve leading to decreased delirium risk and key patient-centered outcomes (postoperative sleep, pain, cognition, mood, and survival).\n\nInadequate pain relief and opioids are both risk factors for delirium. Surgery on the chest is a significant pain source. Approximately 30-75% of patients suffer from moderate to severe pain in the postoperative period. Almost half of the patients have severe pain at rest, and three-quarters have severe pain during coughing and movement. Pain and inflammation are closely biochemically linked.\n\nSleep, brain exercise, and adequate pain control with opioid-sparing can be additive or synergistic interventions to prevent delirium following heart surgery.\n\nInvestigators propose three specific aims by conducting a 1:1 randomized controlled trial in 406 heart surgery patients 60 or older undergoing heart surgery. They will be administered perioperative sleep optimization, brain exercise training, and intravenous acetaminophen over 48 hours. A trained expert will administer the sleep and cognitive exercise protocols at least two weeks before surgery. This expert will handhold the patients for two weeks until the surgery. Thus, the gains made before surgery with better sleep quality and improved brain reserve will be sustained with postoperative pain control to lower the ongoing inflammation. Through this trial, investigators will evaluate if the SCOPE bundle can reduce 1) in-hospital delirium, 2) long-term (one, six, and twelve months) cognitive, physical, and self-care function, and 3) barriers to implementation of this bundle.\n\nCurrently, no options are routinely available to patients to optimize their sleep and cognition before cardiac surgery. The proposed research is significant because it will be the first to test the bundled behavioral intervention approach (sleep optimization, brain exercise) before surgery with extended, scheduled pain management with non-opioids following surgery. The SCOPE trial will yield relevant and immediately actionable data to improve care for over 900,000 adults in the U.S. each year.",[524,525],"Delirium, Postoperative","Delirium in Old Age",[527,528,529],"Delirium","PostOperative","Cardiac Surgery","2026-04-10",{"date":505,"type":32},{"date":533,"type":32},"2025-06-06",{"date":535,"type":21},"2030-03-31",{"name":38,"class":39},3,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":552,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":103},"100469516","the-effect-of-sleep-loss-on-emotion-regulation-100469516","NCT05393830","The Effect of Sleep Loss on Emotion Regulation","The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation","Inclusion Criteria:\n\n* willing and able to follow the protocol\n* willing and able to meet inclusion criteria for fMRI scanning\n* willing to refrain from alcohol and recreational drugs for the duration of the protocol\n* normal or corrected to normal vision is required\n\nExclusion Criteria:\n\n* left-handedness or ambidexterity\n* the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)",{"count":546,"type":21},90,[24],"The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions.\n\n(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.",[121,550,551],"Insomnia","Sleep Deprivation",[553,554,555,121,556,557],"Emotion","Sleep Restriction","Insomnia Disorder","Emotion Regulation","functional Magnetic Resonance Imaging (fMRI)","2026-04-09",{"date":560,"type":32},"2026-04-14",{"date":562,"type":32},"2023-05-11",{"date":564,"type":21},"2027-07-31",{"name":38,"class":39},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":350,"maxAge":573,"enrollmentInfo":574,"targetDuration":576,"studyType":142,"phases":4,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":103},"100510375","cognitive-neurology-unit-clinical-registry-100510375","NCT05925621","Cognitive Neurology Unit Clinical Registry","Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry","Inclusion Criteria:\n\n* o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease\n\n  * Patient has evidence of cognitive impairment on neuropsychological testing\n  * Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement\n  * Amyloid PET imaging and\u002For CSF analysis consistent with Alzheimer's disease\n  * Amyloid PET imaging positive\n  * CSF p-Tau\u002FAbeta42 ration \\>0.023 and ABeta42 \\\u003C 1027\\*\\*\n  * 3T MRI in past 6 months\n  * Patient has a care partner\n  * Patient under the care of an appropriate BI-Lahey amyloid clinic\n  * Patient is on a stable medication regimen\n\nExclusion Criteria:\n\n* o Recent stroke or suspected TIA in the past year\n\n  * Pregnancy\n  * Active autoimmune or immunological disease\n  * Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives\n  * Bleeding disorder with Plts \\\u003C 50,000 or INR \\> 1.5\n  * On warfarin, heparin, or DOAC\n  * On dual antiplatelet therapy\n  * Non Alzheimer disease cause of dementia\u002FMCI\n  * ApoE e4 homozygote","95 Years",{"count":575,"type":21},500,"30 Months","A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease",[579],"Alzheimer Disease","2026-04-08",{"date":503,"type":32},{"date":583,"type":32},"2023-07-16",{"date":585,"type":21},"2028-06",{"name":38,"class":39},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":596,"studyType":142,"phases":4,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":103},"100551716","general-pre-trial-screening-protocol-for-infectious-diseases-research-100551716","NCT06463704","General Pre-Trial Screening Protocol for Infectious Diseases Research","General Pre-Trial Screening Protocol for Enrollment of Volunteers Into Infectious Diseases Research Protocols","Inclusion Criteria:\n\n* 18 years of age or older at time of consent\n* Available to participate for the planned duration of the clinical trials for which screening is being done\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n• A condition, based on clinical judgement, which requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being",{"count":595,"type":21},250,"1 Year","The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) or Division of Infectious Diseases at Beth Israel Deaconess Medical Center. This general screening protocol will help to determine the eligibility of potential volunteers for any vaccine or therapeutic trials open for recruitment or soon to be opened.",[599],"Healthy Volunteers","2026-04-07",{"date":580,"type":32},{"date":603,"type":32},"2024-06-21",{"date":605,"type":21},"2034-06",{"name":38,"class":39},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":614,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":626,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":103},"100460869","avecure-flexible-microwave-ablation-probe-for-lung-nodules-100460869","NCT05281237","Avecure Flexible Microwave Ablation Probe For Lung Nodules","Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule","Inclusion Criteria:\n\n* Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.\n* Pathological proof of target nodule\u002Ftumor type and malignancy with specimen considered adequate per institutional laboratory standards\n* Target nodule\u002Ftumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively\n* Resection\u002Fsurgical candidate (lobectomy or greater)\n* Participants must be at least 22 years old and able to provide consent\n\nExclusion Criteria:\n\n* Subjects in whom flexible bronchoscopy is contraindicated\n* Target nodule \\\u003C 1.0 cm\n* Prior radiation or neo adjuvant chemotherapy of the target nodule\u002Ftumor\n* Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives\n* Pacemaker, implantable cardioverter, or another electronic implantable device\n* Patient cannot tolerate bronchoscopy\n* Patients with coagulopathy\n* Patients in other therapeutic lung cancer studies\n* Subject is pregnant or breastfeeding\n* COVID-19 positive patient at the time of procedure.","22 Years",{"count":616,"type":21},10,[24],"This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.\n\nThis research study involves microwave ablation (MWA)",[620,621,622,623,624,625],"Stage I - II Primary Lung Cancer","Stage I Lung Cancer","Stage II Lung Cancer","Lung Cancer Stage I","Lung Cancer Stage II","Lung Cancer",[627,621,622,623,624,625],"Stage I - II primary lung cancer",{"date":580,"type":32},{"date":630,"type":32},"2022-06-01",{"date":632,"type":21},"2027-06-30",{"name":38,"class":39},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":112,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":648,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":103},"100459058","inter-lobar-fissure-completion-in-patients-with-failed-bronchoscopic-lung-volume-reduction-100459058","NCT05257681","Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction","Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction","SAVED-1","Inclusion Criteria:\n\n* Age 40 to 75 years.\n* Stable with less than 10mg prednisone (or equivalent) daily.\n* Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.\n* Current pneumococcus vaccination.\n* Current influenza vaccination.\n* Target lung volume reduction \\\u003C350ml after bronchoscopic lung volume reduction (BLVR).\n* Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction (BLVR).\n* Endobronchial valves (EBV) are still in place.\n* Willing and able to complete protocol required study follow-up assessments and procedures.\n\nExclusion Criteria:\n\n* Clinically significant (greater than 4 tablespoons per day) mucus production.\n* Myocardial infarction within 6 months of screening.\n* Decompensated heart failure.\n* Three or more pneumonia episodes in last year.\n* Three or more COPD exacerbation episodes in the last year.\n* Prior lung transplant, LVRS, bullectomy, or lobectomy.\n* Clinically significant bronchiectasis.\n* Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.\n* Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \\>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).\n* Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).\n* Resting bradycardia (\\\u003C50 bpm), Complex ventricular arrhythmia, sustained SVT.\n* PaCO2 greater than 50mmHg on room air at screening.\n* PaO2 less than 45mmHg on room air at screening.","75 Years",{"count":444,"type":21},[24],"The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema\u002FCOPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema\u002FCOPD.",[647],"Emphysema or COPD",[649,650,651,652,653],"COPD","Chronic Obstructive Lung Disease","Chronic Obstructive Pulmonary Disease","Emphysema","Video-assisted thoracic surgery",{"date":503,"type":32},{"date":656,"type":32},"2022-05-24",{"date":658,"type":21},"2026-05-24",{"name":38,"class":39},""]