[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":680},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,97785,0,25,[9,40,76,97,127,162,190,216,237,263,285,316,348,378,407,432,454,480,508,531,550,571,601,623,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100652978","bicarbonate-hd-study-100652978",false,"NCT07779200","Bicarbonate HD Study","Factors Affecting Bicarbonate Levels In Patients On Haemodialysis","Inclusion Criteria:\n\n* Age 18 years and above.\n* Ability to give informed consent.\n* End Stage Renal Disease established on maintenance dialysis for at least 3 months.\n* Patients on dialysis 3 times a week\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patients with acute kidney injury\n* Patients with severe COPD","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The primary goal of this single centre observational study is to look at factors that affect serum bicarbonate levels in patients on maintenance dialysis. This will be done by collecting demographic information, relevant medical history, dialysis history, potential renal acid load from diet by recording different foods consumed over 2 days in a food diary and bicarbonate levels at 3 intervals, pre and post dialysis session 1 and pre dialysis session 2.\n\nBicarbonate levels are of significant interest as an indicator of metabolic acidosis in CKD dialysis patients. This study will allow us to understand the efficacy of different dialysis modalities in controlling bicarbonate levels. It will also enable us to understand the idea of individualizing dialysis for patients in terms of not using a standard concentration of dialysate for all patient undergoing dialysis in this center.",[25,26],"Metabolic Acidosis","CKD on Hemodialysis Patients","RECRUITING","2026-08-20",{"date":30,"type":31},"2026-08-21","ACTUAL",{"date":33,"type":31},"2026-05-12",{"date":35,"type":21},"2026-08",{"name":37,"class":38},"East and North Hertfordshire NHS Trust","OTHER_GOV",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":39},"100652976","ai-generated-personalized-story-book-to-improve-patient-behaviour-100652976","NCT07778134","AI-Generated Personalized Story Book to Improve Patient Behaviour","The Effectiveness of an Artificial Intelligence-Generated, Patient-Specific Storybook for Behaviour Guidance: A Randomized Controlled Trial","AI-STORY","Inclusion Criteria:\n\n* Participants classified as Frankl II (Negative) or Frankl III (Positive) according to the Frankl Behavior Rating Scale.\n* Systemically healthy participants classified as American Society of Anesthesiologists (ASA) Physical Status I.\n* Participants with at least two primary molars requiring Class I occlusal restorations for superficial carious lesions that do not require local anesthesia.\n* Parents or legal guardians who voluntarily provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Participants younger than 4 years or older than 7 years of age.\n* Participants with systemic diseases or developmental delay.\n* Participants with a current psychiatric disorder or who have been under psychiatric follow-up within the previous 6 months.\n* Participants receiving psychotropic medication.\n* Participants diagnosed with neurodevelopmental disorders (e.g., autism spectrum disorder or moderate-to-severe attention-deficit\u002Fhyperactivity disorder).\n* Participants with communication or developmental impairments that may interfere with the reliable administration of the study assessment scales.\n* Children with special health care needs.\n* Participants with general or dental developmental anomalies (e.g., amelogenesis imperfecta, cleft lip and\u002For palate, osteogenesis imperfecta).\n* Participants classified as Frankl I (Definitely Negative) or Frankl IV (Definitely Positive) according to the Frankl Behavior Rating Scale.\n* Participants with a history of spontaneous dental pain or symptomatic teeth requiring emergency treatment.\n* Participants whose parent or legal guardian does not provide written informed consent.",true,"4 Years","7 Years",{"count":52,"type":21},69,"INTERVENTIONAL",[55],"NA","Dental anxiety and uncooperative behavior frequently interfere with the successful delivery of dental treatment in children and may increase the need for pharmacological behavior management. Storytelling is a widely used non-pharmacological behavior guidance technique that can improve participants' familiarity with the dental environment and enhance cooperation. Recent advances in artificial intelligence (AI) enable the development of personalized storybooks tailored to each participant's individual characteristics and preferences, which may improve engagement with behavior guidance interventions.\n\nThis randomized controlled trial aims to compare the effectiveness of three behavior guidance approaches in pediatric participants receiving dental treatment: (1) an AI-generated personalized dental storybook, (2) a standard dental storybook, and (3) standard behavior guidance alone. Eligible participants will be randomly allocated to one of the three study groups. The AI-generated storybook will be individually designed according to each participant's characteristics and interests, whereas the standard storybook will contain the same dental theme without personalization. Participants in the control group will receive routine non-pharmacological behavior guidance used in pediatric dental practice. Behavioral cooperation, dental anxiety, treatment acceptance, and other prespecified outcomes will be assessed using validated measurement tools before and during dental treatment.",[58,59,60],"Dental Anxiety in Children","Behavior Management","Pediatric Dental Anxiety",[62,63,64,65,66,67],"pediatric dentistry","dental anxiety","behavior management","artificial intelligence","personalized storytelling","randomized controlled trial",{"date":30,"type":31},{"date":70,"type":31},"2026-06-08",{"date":72,"type":21},"2027-11-12",{"name":74,"class":75},"Eskisehir Osmangazi University","OTHER",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":53,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":39},"100652971","three-dimensional-molds-based-on-radiological-images-in-patients-with-cancer-the-direct-trial-100652971","NCT07778173","Three-Dimensional Molds Based on Radiological imagEs in Patients With Cancer: the DIRECT Trial","DIRECT","Inclusion Criteria:\n\nTo be eligible for the study, the study candidate must:\n\n* be willing and able to give informed consent and give their written consent for the participation in the study (in case of a child (\\\u003C15-year-old), the consent is collected in an age-appropriate manner from the study candidate and their legal guardian(s))\n* have a malignant or likely malignant tumor\u002Ftumors and undergo a surgical operation.\n\nExclusion Criteria:\n\nTo be eligible for the study, the study candidate cannot:\n\n* lack the capacity to provide informed consent (if a legal guardian objects to the participation of their child (\\\u003C15-year-old), the child is not eligible);\n* be at risk of having their standard of care treatment jeopardized by the study, in the opinion of their physician.",{"count":84,"type":21},30,[55],"Determination of the sites from which the histopathological samples in surgically removed lesions are collected is still done by eye by a pathologist. As radiological determination of regions of interest has already proven useful in in vivo use cases, the implementation of sampling of ex vivo lesions with the help of radiological imaging suggests great potential. By developing and implementing mold printing processes, these molds have the potential to vastly improve the accuracy and consistency of histopathological sampling and collection of tissue samples from different regions of tumor, leading to improved characterization, more individualized treatments, and eventually better survival.",[88,89],"Cancer","Tumor",{"date":30,"type":31},{"date":92,"type":31},"2024-05-31",{"date":94,"type":21},"2033-12-15",{"name":96,"class":75},"Tampere University Hospital",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":105,"studyType":22,"phases":4,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":39},"100652970","internal-jugular-vein-respiratory-variability-as-a-marker-of-disease-severity-in-infant-bronchiolitis-100652970","NCT07778225","Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis","Respiratory Variation of Internal Jugular Vein Diameter as a Novel Ultrasonographic Marker of Disease Severity in Infants With Acute Bronchiolitis: A Prospective Observational Cohort Study","IJV-BRONCH","Inclusion Criteria:\n\n* Infants aged 1-23 months\n* Clinical diagnosis of acute bronchiolitis per AAP (2014) criteria (first wheezing episode following an upper respiratory infection prodrome, with tachypnea, retractions, and\u002For crackles)\n* Written informed consent obtained from parent\u002Flegal guardian\n* Evaluable within the first 6 hours of emergency department presentation\n\nExclusion Criteria:\n\n* Underlying congenital heart disease\n* Chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis)\n* Prior history of recurrent wheezing\u002Fsuspected asthma\n* Anatomical abnormality of the neck or prior history of central venous catheterization or jugular vein thrombosis\n* Hemodynamic instability\u002Fshock\n* Immediate need for intubation\u002Fmechanical ventilation precluding ultrasound assessment\n* Parent\u002Flegal guardian declines consent","1 Month","23 Months",{"count":108,"type":21},120,"This prospective observational cohort study evaluates whether respiratory-cycle variation in internal jugular vein (IJV) diameter, measured by point-of-care ultrasound, correlates with clinical disease severity in infants 1-23 months of age presenting with acute bronchiolitis. Using a standardized M-mode protocol, the IJV Variability Index (\\[IJVmax-IJVmin\\]\u002FIJVmax x 100) will be calculated and compared with the Wang Bronchiolitis Severity Score, four additional validated clinical severity instruments (Modified Tal Score, Respiratory Distress Assessment Instrument, Kristjansson Respiratory Score, Respiratory Assessment Change Score), oxygen saturation, respiratory rate, need for high-flow nasal cannula or supplemental oxygen, pediatric intensive care unit admission, and length of hospital stay. Concurrent lung and diaphragm point-of-care ultrasound will be performed to build a multimodal ultrasound severity model. No intervention is assigned; all ultrasound assessments are performed in addition to standard clinical care and do not alter treatment decisions.",[111,112,113],"Acute Bronchiolitis","Viral Bronchiolitis","Respiratory Syncytial Virus Infections",[115,116,117,118,119],"bronchiolitis","point-of-care ultrasound","internal jugular vein","lung ultrasound","pediatric emergency medicine","NOT_YET_RECRUITING",{"date":30,"type":31},{"date":123,"type":21},"2026-09-01",{"date":125,"type":21},"2027-08-31",{"name":74,"class":75},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":53,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":39},"100652959","screening-for-obstructive-sleep-apnea-in-high-risk-patients-in-a-danish-rural-population-a-pilot-feasibility-study-100652959","NCT07778121","Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study","Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population","Inclusion Criteria:\n\n* Age 18 years or above\n* Diagnosed with type 2 diabetes mellitus\n* Resident in Region Zealand, Denmark\n* Understand and speak Danish\n\nExclusion Criteria:\n\n* Previously undergone surgery for OSA\n* Currently or within the last month used treatment for OSA such as CPAP, sleep position trainer, mandibular advancement devices etc.\n* Having an Implanted Cardioverter Defibrillator (ICD)\n* Clinically suspected of a sleep disorder other than OSA that might compromise the intended purpose of the devices",{"count":135,"type":21},40,[55],"Background:\n\nObstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent collapse of the upper airway during sleep, resulting in intermittent hypoxia and fragmented sleep. The condition is more prevalent among individuals with hypertension, atrial fibrillation, type 2 diabetes, and other chronic diseases compared with the general population. Evidence indicates that untreated OSA is associated with adverse health outcomes, whereas treatment of OSA provides significant clinical benefits. However, a substantial proportion of individuals with OSA remain undiagnosed, highlighting the need to improve detection and reduce underdiagnosis.\n\nDevices currently used to diagnose OSA are not suitable for screening; however, newer alternatives may be appropriate.\n\nThe study:\n\nThis study is a pilot feasibility study. All participants will undergo an interview and examination at a baseline visit and will subsequently use OSA testing devices at home for three consecutive nights. The study includes a questionnaire assessing participants' experience with the devices and technology in general. The objective of this study is to test the feasibility of conducting a study in which adult participants with type 2 diabetes undergo three different home sleep apnea tests over three nights, including issues to be optimized in a subsequent main\u002Fdefinitive study.\n\nThe main study aims to assess the diagnostic agreement between the devices and will be registered independently.",[139,140],"Type 2 Diabetes","Obstructive Sleep Apnea (OSA)",[142,143,144,145,146,147,139,148,149,150,151,152,153,154],"Home Sleep Apnea Test","HSAT","NightOwl","SleepImage","OSA","Obstructive Sleep Apnea","Peripheral Arterial Tonometry","Cardiopulmonary coupling","Screening","Feasibility","Pilot","Nox T3","Cardiorespiratory Monitor",{"date":30,"type":31},{"date":157,"type":31},"2025-10-20",{"date":159,"type":21},"2026-10-01",{"name":161,"class":75},"Zealand University Hospital",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":53,"phases":173,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":189},"100652949","phase-3-phase-3-trial-of-tarlatamab-sc-vs-iv-in-extensive-stage-small-cell-lung-cancer-after-platinum-based-first-line-chemotherapy-es-sclc-100652949","NCT07778316","Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)","A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)","DeLLphi-315","Inclusion Criteria:\n\n* Participant has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.\n* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.\n* Participants who progressed or recurred following 1 platinum-based regimen.\n* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate organ function.\n* History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.\n\nExclusion Criteria:\n\nDisease Related\n\n\\- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.\n\nOther Medical Conditions\n\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment.\n* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.\n* Current evidence or history of non-infectious pneumonitis\u002FILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.\n* History of other malignancy within the past 2 years, with exceptions defined in the protocol.\n* Presence or history of viral infection based on criteria per protocol.\n* History of solid organ transplantation.\n* Symptoms and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.\n* Known sensitivity or a contraindication to any of the products or components.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n\nPrior\u002FConcomitant Therapy\n\n* Prior systemic anticancer therapy within 30 days of enrolment\n* Prior history of severe or life-threatening events from any immune-mediated therapy.\n* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.\n* Live and live-attenuated vaccines within 28 days prior to the start of study treatment.\n* Receiving another anticancer therapy for a malignancy other than SCLC.\n* More than 1 prior line of anticancer therapy for SCLC.\n* Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.\n* Treatment in an alternative investigational trial within 28 days prior to enrolment.\n* History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.\n\nOther Exclusions\n\n* Participants unable to have SC injections administered in the abdomen or thigh.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.\n* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.","99 Years",{"count":172,"type":21},400,[174],"PHASE3","The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.",[177],"Small Cell Lung Cancer",[179,180],"Tarlatamab","ES-SCLC",{"date":30,"type":31},{"date":183,"type":21},"2026-08-31",{"date":185,"type":21},"2030-07-30",{"name":187,"class":188},"Amgen","INDUSTRY",2,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":198,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":39},"100652905","effect-of-aromatherapy-on-the-management-of-chemotherapy-induced-neuropathy-cin-100652905","NCT07779135","Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN)","Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN) in Patients Receiving Taxane Therapy for Breast Cancer.","AROMA NEUROTAX","Inclusion Criteria:\n\n* Female patients with breast cancer\n* who have painful or bothersome CIN\n* occurring in the context of paclitaxel treatment (during or after treatment)\n* for whom conventional drug treatments provide insufficient relief (or are poorly tolerated or refused).\n* Age ≥ 18 years\n* Who, after receiving information, do not object to the use of their data for the purposes of this research\n\nExclusion Criteria:\n\n* Pre-existing neuropathy (e.g., due to diabetes)\n* Known allergy to an essential oil or a component of essential oils (e.g., linalool)\n* Presence of wounds on the affected areas\n* Refusal to use aromatherapy\n* Inability to complete the questionnaires","FEMALE",{"count":200,"type":21},80,"The main objective of this study is to describe the effect of an essential oil-based blend applied topically in the management of painful symptoms, sensory disturbances, or functional impairment caused by Chemotherapy-Induced Neuropathy (CIN) in breast cancer patients who have undergone paclitaxel treatment.",[203,204],"Breast Cancer","Neuropathic Pain in Cancer",[206,207,208],"Chemotherapy-Induced Neuropathy","Breast cancer","Aromatherapy",{"date":30,"type":31},{"date":211,"type":31},"2026-07-15",{"date":213,"type":21},"2027-09-15",{"name":215,"class":75},"Centre Hospitalier de Colmar",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100652900","factors-affectng-enteral-feedng-intolerance-n-intensve-care-unt-patents-100652900","NCT07780734","FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS","FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS: A PROSPECTİVE OBSERVATİONAL STUDY","EFI-ICU","Inclusion Criteria:\n\n* Age ≥18 years\n* Admission to the Anesthesia Intensive Care Unit\n* Enteral nutrition planned or initiated during intensive care unit admission\n* Expected to require enteral nutrition during intensive care unit follow-up\n* Availability of sufficient clinical and nutritional data for study evaluation\n* Patient or legally authorized representative provides informed consent when required by the ethics protocol\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patients receiving only parenteral nutrition\n* Patients in whom enteral nutrition is contraindicated throughout the observation period\n* Patients with insufficient data for evaluation of enteral feeding tolerance\n* Patients transferred to another intensive care unit before adequate study assessment\n* Patients who decline participation or whose legally authorized representative declines participation when consent is required",{"count":225,"type":21},102,"Enteral nutrition is the first-line nutritional support method in critically ill patients because it helps preserve gastrointestinal system integrity, reduce the risk of infection, and meet metabolic requirements. However, gastrointestinal motility is frequently impaired in critically ill patients due to physiological stress, hemodynamic instability, sedative and vasopressor medications, mechanical ventilation, and underlying diseases. This may result in enteral feeding intolerance (EFI), which complicates nutritional management.\n\nThis prospective observational study aims to determine the demographic, clinical, laboratory, and treatment-related factors associated with enteral feeding intolerance in adult intensive care unit patients and to evaluate the association between enteral feeding intolerance and morbidity and mortality.\n\nAdult patients who are started on enteral nutrition in the Anesthesiology and Reanimation Intensive Care Unit will be prospectively followed. No additional intervention will be performed. Patients will be monitored according to routine intensive care and enteral nutrition protocols. Enteral feeding intolerance and potentially associated factors will be recorded prospectively.\n\nThe study is planned to include 102 patients.",[228],"Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study",[230],"Enteral Nutrition, Enteral Feeding Intolerance, Intensive Care Unit,",{"date":30,"type":31},{"date":35,"type":21},{"date":234,"type":21},"2026-09-15",{"name":236,"class":38},"Eda Cirit Bardakçi",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":53,"phases":247,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":39},"100652863","phase-2-study-of-adebrelimab-combined-with-thymalfasin-and-chemotherapy-for-neoadjuvant-treatment-of-esophageal-cancer-100652863","NCT07780721","Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer","Exploratory, Single-Arm, Multicenter Clinical Study of Adebrelimab Combined With Thymalfasin and Chemotherapy as Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Has signed the written informed consent form and voluntarily participates in this study;\n* Aged 18-80 years, male or female;\n* Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;\n* Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;\n* Has at least one measurable lesion (per RECIST Version 1.1: the measurable lesion has a longest diameter ≥10 mm on spiral CT scan, or a malignant lymph node with short-axis diameter ≥15 mm);\n* Expected to achieve R0 resection;\n* ECOG Performance Status (PS) 0-1 (see Appendix 1);\n* Has not received any prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;\n* Plans to receive surgical resection after completion of neoadjuvant therapy;\n* No contraindications to surgery.\n* Adequate organ function as specified below:\n\n  1. Hematology laboratory values (No blood products, hematopoietic growth factors, leukopoietic agents, thrombopoietic agents or anti-anemia medications are permitted within 14 days prior to the first study drug administration):\n\n     White blood cell count ≥ 3.0 × 10⁹\u002FL Absolute neutrophil count ≥ 1.0 × 10⁹\u002FL Platelet count ≥ 80 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n  2. Serum chemistry:\n\n     Total bilirubin ≤ 1.5 × ULN Alanine transaminase (ALT) ≤ 2.5 × ULN; Aspartate transaminase (AST) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula, see Appendix 2)\n  3. Coagulation function:\n\nInternational normalized ratio (INR) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n\n* Female subjects of reproductive potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug, and must use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for at least 3 months after the last dose of study drug. Male subjects with female partners of reproductive potential must use effective contraception throughout the study and for 3 months after the last dose.\n* Subjects with good compliance and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n* Tumor invades adjacent organs of the esophageal lesion (major arteries or trachea);\n* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n* Poor nutritional status with BMI \\\u003C 18.5 kg\u002Fm². Subjects whose nutritional status is corrected by symptomatic nutritional support prior to enrollment may be considered for inclusion upon assessment by the principal investigator;\n* History of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents;\n* Previously received or currently receiving any of the following treatments:\n\n  1. Any anti-tumor radiotherapy, chemotherapy, immunotherapy, targeted therapy or other anti-neoplastic agents;\n  2. Immunosuppressive agents or systemic corticosteroids administered for immunosuppressive purposes (prednisone \\>10 mg\u002Fday or equivalent dose) within 2 weeks prior to the first study drug administration. Inhaled or topical steroids, and corticosteroid replacement therapy (prednisone \\>10 mg\u002Fday or equivalent dose) are permitted in the absence of active autoimmune disease;\n  3. Live attenuated vaccines administered within 4 weeks prior to the first study drug administration;\n  4. Major surgery or severe trauma within 4 weeks prior to the first study drug administration.\n* Active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects receiving hormone replacement therapy may be enrolled). Subjects with psoriasis or childhood asthma\u002Fallergies completely resolved without any intervention in adulthood can be considered eligible; patients requiring medical intervention with bronchodilators are excluded.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, history of solid organ transplantation or allogeneic bone marrow transplantation;\n* Poorly controlled cardiac signs or diseases, including but not limited to: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after intervention.\n* Severe infection (CTCAE Grade \\>2) within 4 weeks before the first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Active pulmonary inflammation indicated by baseline chest imaging; subjects presenting with signs and symptoms of infection within 14 days before first dosing or requiring oral\u002Fintravenous antibiotics, except for prophylactic antibiotic use.\n* Active pulmonary tuberculosis confirmed by medical history or CT scan; history of active pulmonary tuberculosis within 1 year before enrollment; or history of active pulmonary tuberculosis more than 1 year previously without standardized treatment.\n* Hereditary bleeding diathesis or coagulation disorders. Clinically significant bleeding events or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++.\n* Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival rate \\>90%). Fully treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of cervix, etc., may be considered for enrollment.\n* Pregnant or breastfeeding women.\n* Any other conditions judged by the investigator that may force premature study discontinuation, such as other severe diseases (including psychiatric disorders) requiring combined medication, alcohol abuse, drug abuse, family or social factors that may affect subject safety or compliance.","80 Years",{"count":246,"type":21},31,[248],"PHASE2","This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.",[251],"Esophageal Cancer",[253,254,255,251],"Chemotherapy","Adebrelimab","neoadjuvant treatment",{"date":30,"type":31},{"date":258,"type":21},"2026-08-30",{"date":260,"type":21},"2029-02-01",{"name":262,"class":75},"The Affiliated Hospital of Putian University",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":270,"maxAge":18,"enrollmentInfo":271,"targetDuration":4,"studyType":53,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":282,"leadSponsor":283,"locationsCount":39},"100652843","supervised-vs-home-schroth-exercise-in-ais-100652843","NCT07779070","Supervised vs. Home Schroth Exercise in AIS","Comparative Effectiveness of Supervised vs. Home-Based Schroth Exercises in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosis of Adolescent Idiopathic Scoliosis (idiopathic etiology)\n* Age between 10 and 18 years\n* Cobb angle between 10° and 45°\n* Able to participate in a 5-day\u002Fweek exercise program (supervised or home-based)\n* Patient and parent\u002Fguardian provide written informed consent\n* Sufficient cooperation to comply with the study protocol and complete assessments\n\nExclusion Criteria:\n\n* Non-idiopathic scoliosis (neuromuscular, congenital, functional, etc.)\n* Prior or planned spinal surgery\n* Neurological, rheumatological, metabolic, or cardiopulmonary disease that would interfere with participation\n* Brace treatment within the last 6 months or planned during the study\n* Regular scoliosis-specific exercise (more than 2 days\u002Fweek) within the last 6 months","10 Years",{"count":272,"type":21},62,[55],"This study aims to compare the effectiveness of supervised Schroth exercises versus a home-based exercise program in adolescents with Adolescent Idiopathic Scoliosis (AIS).",[276],"Adolescent Idiopathic Scoliosis (AIS)",[278,279],"Adolescent Idiopathic Scoliosis","Schroth Exercise",{"date":30,"type":31},{"date":183,"type":21},{"date":125,"type":21},{"name":284,"class":75},"Bitlis Eren University",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":53,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100652841","nrp--ex-situ-hmpo2-vs-nrp-alone-in-dcd-kidney-transplantation-100652841","NCT07779187","NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation","Oxygenated Perfusion for Enhanced Renal Function in Donation After Circulatory Death (DCD) Kidney Transplants (OxyPERF) - A National Swedish Randomized Controlled Trial","OxyPerf","Inclusion Criteria:\n\nDonor kidneys:\n\n1. All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.\n2. Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)\n\nRecipients:\n\n1. All adult patients (\\>18 yrs old) eligible for renal transplantation during study duration.\n2. Recipient consented for surgery, matched to a DCD kidney.\n\nExclusion Criteria:\n\nDonor kidneys:\n\n1\\. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules.\n\nRecipients:\n\n1. Paediatric patients (\\\u003C18 yrs old).\n2. Participation in other clinical drug or medical devices trials.\n3. Patient subject to combined transplant of kidney + other organ.",{"count":294,"type":21},214,[55],"The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:\n\n* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone.\n* Are the postoperative complications and outcomes different between the two groups?\n* Is the quality of life of recipients different between the two groups?\n* Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.\n\nParticipants will:\n\n* Receive a kidney treated with one of the two strategies.\n* Visit the clinic as per usual clinical practice for checkups and tests\n* Report on their quality of life pre and post transplant\n* Undergo a kidney biopsy at one year to forecast long term transplant function",[298,299],"Kidney Transplant","DCD Kidney",[301,302,303,304,305,306,307],"DCD kidneys","Normothermic Regional Perfusion (NRP)","Hypothermic oxygenated perfusion","Patient reported outcomes","Kidney transplants","Randomised Control Trial","Health economic analysis",{"date":30,"type":31},{"date":310,"type":21},"2027-01-01",{"date":312,"type":21},"2030-12-31",{"name":314,"class":75},"Karolinska University Hospital",3,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":53,"phases":326,"briefSummary":327,"conditions":328,"keywords":331,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":344,"leadSponsor":346,"locationsCount":39},"100652839","impact-of-appointment-reminder-strategies-on-smoking-cessation-clinic-attendance-100652839","NCT07779161","Impact of Appointment Reminder Strategies on Smoking Cessation Clinic Attendance","Effect of Reminder Strategies on No-Show Rates in a Nicotine Cessation Clinic: A Randomized Controlled Trial","NO-SHOW-NCC","Inclusion Criteria:\n\n* Age ≥ 18 years. Confirmed diagnosis of nicotine dependence (F17 according to the International Classification of Diseases, 10th Revision \\[ICD-10\\]) and active patient status at the Smoking Cessation Clinic.\n* Provision of voluntary, written, informed consent to participate in the study and to be contacted by telephone or short text message.\n* Ability to independently provide information and operate a mobile phone.\n* At the time of study enrollment, attendance at an initial visit at the clinic.\n\nExclusion Criteria\n\n* Age \\\u003C 18 years.\n* Lack of written, informed consent to participate in the study.\n* Inability to independently understand the study procedures or provide responses (e.g., due to dementia or a language barrier).",{"count":325,"type":21},300,[55],"The goal of this clinical trial is to learn whether different appointment reminder methods can improve attendance at an anti-smoking (smoking cessation) clinic among adult smokers.\n\nThe main question it aims to answer is:\n\n\"Which reminder method helps participants come to their scheduled smoking cessation clinic appointments most often?\" Researchers will compare different appointment reminder methods with standard appointment scheduling to see if they help participants attend their clinic visits more often.\n\nParticipants will:\n\n* Receive appointment reminders using different methods\n* Come to their scheduled visits at a smoking cessation (anti-nicotine) clinic",[329,330],"Behavioral Intervention","Nicotine Addiction",[332,333,334,335,336,337,338,339,340,341],"nicotine cessation clinic","nicotine","smoking cessation","clinic attendance","anti-nicotine clinic","adult smokers","behavioral intervention","patient engagement","reminder systems","healthcare attendance",{"date":30,"type":31},{"date":35,"type":21},{"date":345,"type":21},"2027-04",{"name":347,"class":75},"Medical University of Gdansk",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":355,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":53,"phases":359,"briefSummary":360,"conditions":361,"keywords":365,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":39},"100652831","passive-fit-of-implant-supported-frameworks-digital-vs-conventional-impressions-100652831","NCT07778199","Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions","Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study","Inclusion Criteria:\n\n* Completely edentulous patients requiring full-arch implant-supported fixed prosthesis\n* Age 35-70 years\n* Adequate mandibular bone to place at least four implants without major grafting\n* Ability to undergo digital scanning and radiographic evaluation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Systemic conditions affecting healing (uncontrolled diabetes, immunosuppression)\n* History of head\u002Fneck radiotherapy or bisphosphonate therapy\n* Active oral infection or severe bruxism\n* Strong gag reflex preventing accurate scanning\n* Poor compliance or unwillingness to attend follow-up visits","35 Years","70 Years",{"count":358,"type":21},8,[55],"This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional splinted open-tray impression technique. Eight completely edentulous patients each receiving four mandibular implants will be included. Passivity of fit will be evaluated clinically using the Sheffield one-screw test and radiographically using intraoral periapical radiographs obtained with the parallel technique.",[362,363,364],"Dental Implants","Edentulous Jaw","Passive Fit",[366,367,368,369,370],"Passive fit","Implant-supported framework","Digital impression","Full-arch implant prosthesis","Crossover study",{"date":30,"type":31},{"date":373,"type":31},"2026-01-25",{"date":375,"type":21},"2027-01-25",{"name":377,"class":75},"Mansoura University",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":53,"phases":386,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":315},"100652819","early-phase-1-safety-and-feasibility-of-first-line-avutometinib-and-defactinib-in-patients-with-newly-diagnosed-high-grade-gliomas-100652819","NCT07778602","Safety and Feasibility of First-line Avutometinib and Defactinib in Patients With Newly Diagnosed High-grade Gliomas","Inclusion Criteria:\n\n* Patient must be able to provide written informed consent.\n* ≥ 18 years of age\n* Likely high-grade glioma based on frozen pathology in patients with no prior diagnosis of a glioma or astrocytoma.\n* Patient appropriate for standard therapy for high-grade glioma that includes 6 weeks of radiation.\n* Patient is not deemed at a high risk of symptomatic progression within 4 weeks by the treating physician and investigator team.\n* Karnofsky Performance Scale (KPS) ≥ 70%.\n* Post-operative MRI completed with 72 hours of surgery that includes FLAIR sequences\n* Measurable disease per RANO 2.0 enhancing criteria. Leptomeningeal disease not allowed.\n* Patient is on a tapering dose of steroids anticipated to be on a total daily dose of dexamethasone \\\u003C 2 mg for at least 5 days by start of study intervention.\n* Willing to submit archival tumor sample if available\n* Adequate organ and marrow function defined as:\n* Ability to swallow and retain orally administered medications (no liquid suspensions available).\n* Female participants of childbearing potential must have a negative serum pregnancy test prior to study start.\n* Male participants must also be documented to be surgically sterile or agree to use adequate contraception and not to donate sperm\n* Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with other malignancies must be disease-free for \\> 2 years.\n* Patients with human immunodeficiency virus (HIV) who are on effective antiretroviral therapy are eligible if the viral load was assessed as undetectable within 6 months prior to baseline.\n\nExclusion Criteria:\n\n* Any prior glioma or astrocytoma, or any prior cancer diagnosis resulting in irradiation of the skull or scalp\n* Significant bi-hemispheric disease or midline shift observed on post-operative MRI likely to result in rapid clinical deterioration\n* Those who have undergone diagnostic biopsy only for suspected primary brain cancer.\n* Those who are on other investigational agents at the time of screening and including patients on carmustine and\u002For gamma tiles\n* History of clinically significant ophthalmologic disorders\n* Impairment in gastrointestinal function or disease that may significantly alter the absorption of oral study drug\n* Clinically significant cardiovascular disease\n* History of recent (≤ 90 days) thromboembolic or cerebrovascular event\n* Known history of any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and\u002For detectable virus.\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible.\n* Patients may not take any of the listed contraindicated medications for 7 days prior to the start of study drug, with the exception of dexamethasone; see section 5.6 \"concomitant therapy\":\n\n  1. Warfarin\n  2. Strong CYP2C9 or CYP3A4 inhibitors or inducers\n  3. P-glycoprotein inhibitors or inducers\n* Patients may not be on H2 blocker or PPI (Proton pump inhibitors) for 2 days prior to start of study drug.\n* Subjects with a history of hypersensitivity to any of the active or inactive ingredients (hydroxypropylmethylcellulose, mannitol, magnesium stearate) of the investigational products.\n* Pregnant or breastfeeding\n* Active or past medical history of interstitial lung disease (ILD)\u002Fpneumonitis, including drug-induced or radiation ILD\u002Fpneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS\n* History of medically significant rhabdomyolysis",{"count":385,"type":21},22,[387],"EARLY_PHASE1","This clinical trial is designed with two treatment stages: Stage 1: one cycle of study drug treatment prior to initiation of first-line standard radiation in all study participants. Stage 2: two additional cycles of study drug treatment (8 weeks total) concomitantly with standard of care radiation (\\~6 weeks) for participants with pathology-confirmed MGMT (enzyme O-6-methylguanine-DNA methyltransferase) unmethylated GBM only.\n\nThe co-primary endpoints of the study are 1) feasibility of completing Stage 1 of treatment prior to radiation in all study participants and starting radiation within 6 weeks, and 2) safety of study drug across both treatment parts. The investigators will additionally evaluate the radiographic response rate after the first cycle of drug in all patients based upon RANO 2.0 (Response Assessment in Neuro-Oncology) criteria as well as safety of study drug in all patients (secondary endpoints). Exploratory endpoints will include characterization of ERK (extracellular signal-regulated kinase) and FAK (Focal adhesion kinase) dependence in pre-treatment tissue (by immunohistochemistry and\u002For 'omics) and correlation of expression and co-mutations with response and survival.\n\nA total of up to 22 evaluable patients can be enrolled in this study. Evaluable patients are those who have received at least one dose of study drug treatment. Patients who do not start drug will be replaced, up to a total of 28 patients.",[390,391],"MGMT-unmethylated Glioblastoma (GBM)","IDH Wildtype Glioblastoma",[393,394,395,396,397,398,399],"Glioblastoma","Newly Diagnosed","MGMT unmethylated","neoadjuvant","surgery","IDH Wildtype","WHO Grade 4",{"date":30,"type":31},{"date":402,"type":21},"2026-11-10",{"date":404,"type":21},"2029-12-23",{"name":406,"class":75},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":105,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":53,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":39},"100652813","phase-2-epidiolex-trial-for-presymptomatic-treatment-of-sturge-weber-syndrome-100652813","NCT07778810","Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome","Epidiolex Pilot Trial for Presymptomatic Treatment of Sturge-Weber Syndrome","Epi-Pre","Inclusion Criteria:\n\n* Clinical diagnosis of Sturge-Weber Syndrome.\n* Age 1 to 18 months of age, inclusive.\n* Neuroimaging demonstrating involvement of 3 or more lobes, or bilateral involvement.\n* No history of seizures.\n* Patient's parent or legal guardian provides written informed consent prior to treatment initiation.\n\nExclusion Criteria:\n\nAny severe and\u002For uncontrolled medical conditions at randomization including, but not limited to the following:\n\n* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBVDNA and\u002For positive HbsAg, quantifiable HCV-RNA). Specifically the patient should not have either AST or ALT more than 1.5 times the upper limit of normal. The Child- Pugh Score must be A (mild) which is a score of 5-6 (minimum\u002Fnormal score=5). Child-Turcotte-Pugh (CTP) Calculator - Clinical Calculators - Hepatitis C Online (uw.edu)\n* Uncontrolled diabetes as defined by fasting serum glucose \\> 1.5 ULN\n* Active (acute or chronic) or uncontrolled severe infections\n* Active, bleeding diathesis\n\n  * Any other neurological diagnosis that increases the risk of seizure or neurodevelopmental disability.\n  * Patients who have had a major surgery or significant traumatic injury within 4 weeks of study entry, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.\n  * Prior treatment with any investigational drug or use of any other cannabis product within the preceding 4 weeks prior to study entry.\n  * Use of aspirin.\n  * Allergic reaction\u002Fhypersensitivity to Epidiolex or other forms of cannabidiol.\n  * Concern for non-compliance to medical regimens, or concern that the patient will not be able to complete the entire study, whether due to reliability or logistical barriers. This includes those in foster care, or those unable to keep follow-up appointments, maintain close contact with Principal Investigator, or complete all necessary studies to maintain safety.\n  * Use of any seizure medication (whether for seizures or any other reason) (e.g. valproate, clobazam).\n  * Use of chronic medications other than a multi-vitamin and\u002For vitamin D supplements.","18 Months",{"count":417,"type":21},10,[248],"Patients with Sturge-Weber syndrome (SWS) are frequently affected by seizures, and seizures are associated with poorer neurological outcomes. To date there is no established means of predicting or preventing seizure onset. Cannabidiol (Epidiolex) was well tolerated in an open label study in this population. This trial will evaluate whether Epidiolex in presymptomatic Sturge-Weber patients may delay the onset of seizures and improve neurological outcome.",[421],"Sturge - Weber Syndrome (SWS)",[423,424,425],"Presymptomatic","Open-label","Cannabidiol",{"date":30,"type":31},{"date":35,"type":21},{"date":429,"type":21},"2028-07",{"name":431,"class":75},"Johns Hopkins University",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":48,"sex":17,"minAge":4,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":53,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":4},"100652808","effects-of-goat-milk-formula-on-gastrointestinal-comfort-and-growth-in-infants-100652808","NCT07778927","Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants","A Multicenter, Randomized, Controlled Trial to Evaluate the Effects of Goat Milk Formula on Gastrointestinal Comfort, Behavioral Status, and Early Growth and Development in Infants","Inclusion Criteria:\n\n* Infants aged 0 to 5 months at enrollment\n* Full-term birth (gestational age ≥37 weeks)\n* Birth weight ≥2500 g\n* Infants with symptoms of gastrointestinal discomfort (e.g., abdominal distension, excessive crying, regurgitation, or feeding intolerance)\n* Parents or legal guardians able and willing to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Infants with known or suspected organic gastrointestinal diseases (e.g., congenital malformations, Hirschsprung disease)\n* History of severe perinatal complications or significant systemic diseases\n* Known or suspected cow's milk protein allergy or other food allergies\n* Use of antibiotics, probiotics, or other medications that may affect gastrointestinal function within 2 weeks prior to enrollment\n* Participation in another clinical study within the past 3 months\n* Any condition that, in the investigator's judgment, may interfere with study participation or outcome assessment For the reference cohort: healthy breastfed infants without significant gastrointestinal symptoms","5 Months",{"count":441,"type":21},150,[55],"Infant gastrointestinal discomfort is common in early life and can affect feeding, sleep, and overall well-being. Goat milk formula, due to its unique protein composition and smaller fat globules, may be easier to digest and potentially improve gastrointestinal tolerance in infants.\n\nThis study is a multicenter, randomized, controlled trial designed to evaluate the effects of goat milk formula compared with standard cow milk formula in infants aged 0-5 months with gastrointestinal discomfort. The study will assess improvements in gastrointestinal symptoms, overall comfort, behavioral status, and early growth and development, as well as explore potential changes in gut microbiota and intestinal inflammation.",[445,446],"Functional Gastrointestinal Disorders (FGIDs)","Infant Discomfort",{"date":30,"type":31},{"date":449,"type":21},"2026-08-01",{"date":451,"type":21},"2027-12-31",{"name":453,"class":75},"Ruijin Hospital",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":461,"maxAge":244,"enrollmentInfo":462,"targetDuration":4,"studyType":53,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":39},"100652807","tacs-and-upper-limb-rehabilitation-in-chronic-stroke-100652807","NCT07778342","tACS and Upper Limb Rehabilitation in Chronic Stroke","Pilot Study Investigating the Neuromodulatory Effects of Transcranial Alternating Current Stimulation (tACS) on Upper Limb Motor Rehabilitation in Chronic Stroke Patients","Inclusion Criteria:\n\n1. Age 21-80 years old;\n2. First ever stroke, at least 9 months after stroke onset;\n3. Evidence of corticomotor excitability as manifested by a recordable Motor Evoked Potential from the ipsilesional Motor Cortex (M1) by TMS measurement.\n4. Objectively documented motor weakness of the upper extremity as manifested by an Upper Extremity-Fugl-Meyer Assessment score \\\u003C=55\n\nExclusion Criteria:\n\n1. Patients with implants: cardiac, neural or medication implants; any electrically, magnetically or mechanically activated implant; brain medical devices; vascular clips or any other electrically sensitive support system in the brain; other metal implants inside the body that are contraindications of MRI scan;\n2. Pregnancy;\n3. Patients with a history of seizures; Patients with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy;\n4. Patients with serious brain injury;\n5. Patients showing damage of skin at sites of stimulation;\n6. Patients with unstable or non-controlled neuropsychiatric illness;\n7. Patients suffering from severe or frequent headaches;\n8. Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia;\n9. Sensorimotor disturbance due to other causes other than stroke;","21 Years",{"count":463,"type":21},34,[55],"This study tests whether a brain stimulation technique called tACS can help stroke patients recover movement in their affected arm.\n\nPatients receive either real or fake brain stimulation three times a week for about a month (12 sessions total). During each session, they wear a cap with electrodes that deliver mild electrical currents tailored to their individual brain patterns, while researchers monitor their brain activity.\n\nThe study measures progress at three time points: before treatment, right after treatment, and one month later. Researchers use brain stimulation tests to check how well the brain controls muscles, and conduct physical tests to measure arm movement, muscle stiffness, and grip strength.",[467],"Stroke",[469,470,471,472],"transcranial Alternating Current Stimulation","stroke","upper limb","motor recovery",{"date":30,"type":31},{"date":475,"type":21},"2026-12-01",{"date":477,"type":21},"2028-12-31",{"name":479,"class":75},"National University Hospital, Singapore",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":53,"phases":490,"briefSummary":491,"conditions":492,"keywords":495,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100652802","clinical-comparison-of-clear-aligners-and-fixed-appliances-in-dental-anterior-open-bite-100652802","NCT07778108","Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite","Clinical Comparison of Clear Aligners and Fixed Orthodontic Appliances in the Treatment of Dental Anterior Open Bite in Adults: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nAdult patients aged 18 to 30 years with fully erupted permanent dentition. Anterior open bite equal to or greater than 2 mm. Angle Class I malocclusion. Good oral hygiene and healthy periodontal status.\n\n\\-\n\nExclusion Criteria:\n\n* Previous orthodontic treatment. Presence of craniofacial anomalies or cleft lip\u002Fpalate. Active periodontal disease or severe bone loss. History of temporomandibular joint disorders (TMD). Systemic conditions or medications affecting bone metabolism and tooth movement.","30 Years",{"count":489,"type":21},46,[55],"Dental anterior open bite is a challenging orthodontic condition with a high risk of relapse in adults. This randomized controlled clinical trial aims to compare the effectiveness and post-treatment stability of in-house clear aligners versus fixed orthodontic appliances in treating adult patients aged 18-30 years with dental anterior open bite (0 to -4 mm).\n\nA total of 46 eligible participants will be randomly allocated into two equal groups (23 treated with clear aligners and 23 with fixed appliances). Treatment outcomes, vertical dentoalveolar changes, and skeletal changes will be evaluated using digital intraoral scans, virtual model superimposition, and lateral cephalometric analysis. Following active treatment, an 8-month retention phase (bonded lingual retainer combined with a vacuum-formed retainer) and an 8-month post-retention follow-up phase will be implemented to comprehensively evaluate treatment stability and relapse tendency over a total observation period of 16 months.",[493,494],"Open Bite","Malocclusion Class I",[496,497,498,499,500],"Anterior Open Bite","Clear Aligners","Fixed Orthodontic Appliances","Randomized Controlled Clinical Trial","Orthodontic Stability",{"date":30,"type":31},{"date":503,"type":21},"2026-11",{"date":505,"type":21},"2029-07",{"name":507,"class":75},"Sana'a University",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":355,"enrollmentInfo":515,"targetDuration":4,"studyType":53,"phases":517,"briefSummary":518,"conditions":519,"keywords":522,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":530,"locationsCount":4},"100652793","diastema-closure-and-stability-clear-aligners-vs-fixed-appliances-with-laser-frenectomy-100652793","NCT07778095","Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy","Closure and Stability of Diastema Associated With Generalized Interdental Spacing Using Clear Aligners Versus Fixed Appliances With Adjunctive Frenectomy: A 2x2 Factorial RCT","Inclusion Criteria:\n\n* Adult patients aged 18 to 35 years.\n* Presence of maxillary median diastema associated with generalized interdental spacing (width \\>= 3 mm).\n* Fully erupted permanent teeth (excluding third molars).\n* Good periodontal health with probing depths \\\u003C= 3 mm and no bone loss.\n* High motivation and commitment to follow treatment protocols and compliance.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Previous orthodontic treatment.\n* Severe skeletal malocclusion or craniofacial anomalies.\n* Active periodontal disease, poor oral hygiene, or untreated caries.\n* Missing or impacted permanent teeth in the maxillary arch (excluding third molars).\n* Systemic diseases or long-term medication use affecting bone metabolism or tooth movement (e.g., bisphosphonates, systemic corticosteroids).\n* Pregnant or lactating females.\n* Heavy smokers or individuals with severe parafunctional",{"count":516,"type":21},48,[55],"This study is a prospective 2x2 factorial randomized clinical trial designed to evaluate and compare the closure efficiency and post-treatment stability of diastema associated with generalized interdental spacing (width \\>= 3 mm) treated with clear aligners versus fixed orthodontic appliances, with and without adjunctive laser frenectomy. Participants are randomized into four treatment arms to assess the main effects and interaction effects of appliance modality and laser frenectomy. Stability and relapse rates are systematically tracked across active treatment, a 6-month retention period, and post-retention follow-up intervals at 6 and 8 months.",[520,521],"Diastema","Generalized Interdental Spaces",[520,523,497,498,524,525],"Generalized Interdental Spacing","Laser Frenectomy","Treatment Stability",{"date":30,"type":31},{"date":503,"type":21},{"date":529,"type":21},"2029-01",{"name":507,"class":75},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":53,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":548,"locationsCount":189},"100652781","orelabrutinib-combined-with-pola-r-chp-as-first-line-treatment-for-patients-with-intermediate--to-high-risk-dlbcl-100652781","NCT07778212","Orelabrutinib Combined With Pola-R-CHP as First-Line Treatment for Patients With Intermediate- to High-Risk DLBCL","A Translational Study of Orelabrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) as First-Line Treatment for Patients With Intermediate- to High-Risk Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Aged ≥ 18 years;\n2. Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma;\n3. No prior receipt of other anti-tumor treatments;\n4. ECOG performance status 0-2;\n5. IPI score 2-5, and patients with stage III-IV disease;\n6. Life expectancy ≥ 6 months;\n7. Voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Lymphoma involving the central nervous system or leptomeningeal metastasis;\n2. Transformed lymphoma, i.e., transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma;\n3. Primary mediastinal large B-cell lymphoma;\n4. Burkitt lymphoma;\n5. Left ventricular ejection fraction \\\u003C 50%;\n6. Laboratory test values at screening: (unless caused by lymphoma);\n\n   1. Neutrophils \\\u003C 1.5×10⁹\u002FL;\n   2. Platelets \\\u003C 75×10⁹\u002FL;\n   3. ALT or AST higher than 2 times the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal;\n   4. Creatinine level higher than 1.5 times the upper limit of normal;\n7. Patients with psychiatric disorders or other patients who are known or suspected to be unable to fully comply with the study protocol;\n8. Pregnant or lactating women;\n9. Known infection with human immunodeficiency virus (HIV), or active hepatitis B or C virus infection (positive result by polymerase chain reaction \\[PCR\\]). If a patient has a positive HBsAg test result, HBV DNA testing is required. If HBV DNA \\\u003C 10³ IU\u002Fml, the patient can be enrolled. If the HBsAg test result is negative, but the HBcAb test is positive (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \\\u003C 10³ IU\u002Fml, the patient can be enrolled. If a patient is HCV antibody positive, HCV RNA is detected by PCR technology, and a positive result meets the exclusion criterion;\n10. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers;\n11. nability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction;\n12. Other concurrent and uncontrolled medical conditions that the investigator deems will affect the patient's participation in the study.",{"count":84,"type":21},[55],"To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL).",[542,543,544],"DLBCL - Diffuse Large B Cell Lymphoma","Intermediate-High Risk","First-Line",{"date":30,"type":31},{"date":258,"type":21},{"date":477,"type":21},{"name":549,"class":75},"The First Affiliated Hospital of Xiamen University",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":244,"enrollmentInfo":557,"targetDuration":4,"studyType":53,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":39},"100652713","lumbar-fusion-with-nanotube-vs-titanium-cage-100652713","NCT07777718","Lumbar Fusion With Nanotube Versus Titanium Cage","Nanotube Surface Architecture Versus Simple Titanium Coating on PEEK Interbody Cages in Adults Undergoing 1- and 2-Level Transforaminal Lumbar Interbody Fusion: A Randomized Controlled Superiority Trial","Inclusion Criteria:\n\n* Subject is scheduled to undergo 1- or 2-level TLIF with the principal investigator.\n* Subject has failed nonoperative management for a minimum of 3 months prior to enrollment.\n* Diagnosis is degenerative disc disease (DDD), defined as discogenic back pain with disc degeneration confirmed by history and radiographic studies, at 1 or 2 contiguous spinal levels from L2 to S1. Subjects may have up to grade 1-2 spondylolisthesis or retrolisthesis at the index level(s).\n* Subject is able to provide written informed consent.\n* Subject is, in the investigator's opinion, psychosocially, mentally, and physically able to comply with the protocol, required follow-up visits, and completion of required study forms.\n\nExclusion Criteria:\n\n* Prior lumbar arthrodesis surgery at any level.\n* Diagnosis of osteoporosis (T-score = -2.5) or severe osteopenia (T-score = -2.0 with fragility fracture history).\n* Body mass index (BMI) greater than 40 kg\u002Fm².\n* Requirement for additional bone grafting materials beyond milled local autograft bone (e.g., rhBMP-2, iliac crest autograft, allograft structural spacers).\n* Active local or systemic infection.\n* Known metal sensitivity or foreign body reaction to titanium or PEEK.\n* Active malignancy or history of spinal malignancy.\n* Known diabetes mellitus with preoperative HbA1c =8%, confirmed within 90 days of the planned surgery date. Diabetic patients with HbA1c \\\u003C8% are eligible following standard preoperative medical optimization.\n* Condition requiring medications known to interfere with bone healing (chronic oral or parenteral glucocorticoids, immunosuppressives, bisphosphonates initiated within 3 months of surgery, methotrexate, or similar agents).\n* Inadequate tissue coverage over the operative site or open wound at the operative area.\n* Pregnancy or planned pregnancy within the next 12 months, or currently lactating.\n* Current involvement in litigation or receipt of Worker's Compensation related to back or leg pain.\n* Current enrollment in another investigational drug or device study that could confound study data.\n* History (present or past) of substance abuse that, in the investigator's opinion, would interfere with protocol adherence or follow-up completion.\n* Any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude safe participation in the study.\n* Subject is a prisoner.",{"count":558,"type":21},108,[55],"This study is comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other. Adults who are having a 1 or 2 level lumbar fusion surgery will be randomly assigned to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage. Participants will have follow-up visits with imaging and questionnaires to evaluate bone fusion, back and leg pain, physical function, and overall health.",[562,563],"Degenerative Disc Disease","Lumbar Fusion",{"date":30,"type":31},{"date":566,"type":21},"2026-09",{"date":568,"type":21},"2028-04-30",{"name":570,"class":75},"Francis Farhadi",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":578,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":53,"phases":581,"briefSummary":583,"conditions":584,"keywords":590,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":39},"100652704","phase-1-base-edited-hematopoietic-stemprogenitor-cell-gene-therapy-for-treatment-of-cxcr4-whim-100652704","NCT07775313","Base-Edited Hematopoietic Stem\u002FProgenitor Cell Gene Therapy for Treatment of CXCR4-WHIM","Phase 1\u002F2 Base-Edited Hematopoietic Stem\u002FProgenitor Cell Gene Therapy for Treatment of CXCR4-WHIM","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged \\>= 3 years and weighing \\>=15 kg.\n* Confirmed CXCR c.1000C\\>T, pR334X mutation.\n* Ability to undergo apheresis for stem cell collection.\n* Medical lab data (historical) of neutropenia, or B cell dysfunction (low or absent IgG levels, or on IV gamma globulin.\n* Expected survival of at least 120 days.\n* Must be willing to have blood and tissue samples stored.\n* Participants of reproductive potential must agree to consistently use effective contraception from start of busulfan conditioning through at least one-year post-treatment. Acceptable forms of contraception are:\n\n  * Hormonal contraception in continuously effective use.\n  * Male or female condom with spermicide as indicated.\n  * Diaphragm or cervical cap in consistent and effective pattern of use with a spermicide.\n  * Intrauterine device in-situ\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Acute onset infection as indicated by symptoms such as persistent fevers, or imaging (new pneumonia on CT for example), isolated pathogen and requiring medical intervention.\n* Severe liver dysfunction with transaminases \\> 6 fold upper limit will be excluded until approval by hepatology consult who will provide mitigating plans for liver protection.\n* Renal dysfunction-serum creatinine \\>3.0 x ULN.\n* Coagulation dysfunction- Prothrombin INR or Partial thromboplastin time \\>2 x ULN (patients on controlled anticoagulation agents will not be excluded for therapeutic levels).\n* Known hypersensitivity to busulfan or any component of the product.\n* Contraindications for administration of busulfan, including but not limited to: hypersensitivity, chronic lymphocytic leukemia, acute leukemia in blastic crisis, pregnancy, or lactation.\n* Childhood malignancy (occurring before 18 years of age) in the participant or a first degree relative, or previously diagnosed known genotype of the participant conferring a predisposition to cancer unless approved by the with appropriate consultants and approved by the study PI (no DNA or other testing for cancer predisposition genes will be performed as part of the screen for this protocol).\n* Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant, or would preclude the participant from successful study completion.","3 Years","75 Years",{"count":417,"type":21},[582,248],"PHASE1","Background:\n\nWarts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body. WHIMs is caused by a mutation in the CXCR4 gene. Treatment with drugs can help control the infections but does not cure the disorder. Researchers want to try a treatment where they collect stem cells from a person with WHIMS, use base-editing to replace the bad gene with a healthy version, and return the new cells to the person. This could cure WHIMs.\n\nObjective:\n\nTo test a treatment using base-edited stem cells in people with WHIMs.\n\nEligibility:\n\nPeople aged 3 years and older with WHIMs.\n\nDesign:\n\nThe study has 4 stages.\n\nStage 1: Screening. Participants will be screened at 1 or more visits. They will have a physical exam with blood tests. A sample of tissue and fluid (biopsy) will be taken from the bone marrow in the hip.\n\nStage 2: Apheresis. Blood will be taken from the body through a needle; the blood will pass through a machine that separates out the stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will undergo gene editing.\n\nStage 3: Treatment. Participants will stay in the hospital for about 4 weeks. They will receive 3 drugs to prepare their body for the procedure. Then the edited stem cells will be returned to their bloodstream. They will stay in the hospital until they recover.\n\nStage 4: Follow-up. Participants will have 8 follow-up visits over 5 years. Long-term visits will continue for 15 years.",[585,586,587,588,589],"WHIM","Warts","Hypogammaglobulinemia","Immunodeficiency","Myelokathexis",[591,592],"Gene Editing","base editing",{"date":30,"type":31},{"date":595,"type":21},"2026-08-26",{"date":597,"type":21},"2033-12-31",{"name":599,"class":600},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":53,"phases":609,"briefSummary":610,"conditions":611,"keywords":614,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":39},"100652635","phase-3-study-of-d-mapps-ophthalmic-solution-in-adults-with-chronic-ocular-graft-versus-host-disease-ogvhd-100652635","NCT07776210","Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)","A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects With Chronic Ocular Graft-Versus-Host Disease (oGVHD)","Inclusion Criteria:\n\n* Age 18 years or older.\n* Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation.\n* Investigator determines the participant is medically stable and appropriate for study participation.\n* Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline.\n* UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline.\n* Modified Oxford Corneal Staining Score of at least 1 in at least one eye.\n* Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments.\n* Written informed consent obtained before study procedures.\n* Willing and able to comply with study visits, study treatment, and protocol requirements.\n* Background therapies stable for at least 30 days before Baseline.\n\nExclusion Criteria:\n\n* Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment.\n* Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis.\n* Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study.\n* Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline.\n* Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease.\n* Participation in another investigational study within 30 days before Screening or concurrent enrollment.\n* Pregnancy or breastfeeding.",{"count":84,"type":21},[174],"This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.",[612,613],"oGVHD","Ocular Graft Versus Host Disease",[612,615,613],"Ocular Graft-Versus-Host Disease",{"date":30,"type":31},{"date":618,"type":21},"2026-08-19",{"date":620,"type":21},"2027-06-30",{"name":622,"class":188},"Regenerative Ocular Immunobiologics LLC",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":48,"sex":17,"minAge":630,"maxAge":631,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":634,"conditions":635,"keywords":638,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":653,"locationsCount":39},"100652615","physical-profile-of-cervicogenic-headache-comparison-with-neck-pain-and-healthy-controls-100652615","NCT07776275","Physical Profile of Cervicogenic Headache: Comparison With Neck Pain and Healthy Controls","A Multidimensional Physical Profile of Cervicogenic Headache: A Cross-Sectional Comparison With Nonspecific Neck Pain and Healthy Controls","* Inclusion Criteria:\n* Aged 25 to 60 years\n* Able to provide written informed consent\n* Meeting the criteria for one of the following groups:\n* Cervicogenic headache: physician diagnosis according to the International Classification of Headache Disorders, 3rd edition, with symptoms lasting at least 3 months\n* Chronic nonspecific neck pain: neck pain lasting at least 6 months without headache\n* Healthy control: no neck pain or headache\n\nExclusion Criteria:\n\n* Receipt of physiotherapy for headache or neck pain during the previous 6 months\n* Diagnosis of a headache disorder other than cervicogenic headache, including migraine or tension-type headache, or a diagnosis of trigeminal neuralgia\n* History of cervical spine surgery or significant cervical trauma\n* Current or previous diagnosis of a tumor or cancer\n* Serious cardiovascular, cerebrovascular, hematological, metabolic, neurological, or psychiatric disorder\n* Rheumatoid arthritis\n* Congenital cervical abnormality\n* Cervical spondylolisthesis or cervical instability\n* Active infection\n* Temporomandibular joint dysfunction\n* Dizziness or visual disturbance accompanying headache\n* Any clinical red flag suggesting serious cervical pathology\n* Pregnancy or breastfeeding\n* Upper-extremity injury, surgery, or another condition affecting handgrip strength\n* Serious musculoskeletal disorder affecting cervical posture or muscle measurements\n* Inability to complete the questionnaire-based or instrument-based assessments","25 Years","60 Years",{"count":633,"type":21},135,"The goal of this observational study is to compare physical findings across three adult groups. Cervicogenic headache (CGH) is a headache linked to a problem in the neck. Neck pain may affect posture, muscle function, grip strength, and sensitivity to pressure. Researchers do not know whether CGH has a distinct pattern of these findings.\n\nThe main questions are:\n\n* Do posture, grip strength, muscle stiffness, elasticity, and pressure sensitivity differ among the groups?\n* Are any differences more closely associated with CGH than with neck pain?\n\nResearchers will compare adults ages 25 through 60. One group will include people with CGH lasting at least three months. Another group will include people with neck pain lasting at least six months. People in the neck pain group will have no headaches. Healthy participants will have no neck pain or headaches.\n\nResearchers will not provide treatment or change participants' usual care. Each participant will complete one study visit lasting about 15 minutes. Participants will:\n\n* Answer short questions about their health and pain\n* Stand while researchers measure their head and neck posture\n* Squeeze a device that measures grip strength\n* Complete brief tests of neck muscle stiffness and elasticity\n* Tell researchers when applied pressure first becomes painful\n\nResearchers will compare results across the three groups. The findings may guide future CGH assessment and treatment research.",[636,637],"Cervicogenic Headache","Chronic Neck Pain",[639,640,641,642,643,644,645,646,647,648],"physical profile","myotonometry","upper trapezius","muscle stiffness","logarithmic decrement","pressure pain threshold","handgrip strength","craniovertebral angle","tragus to wall distance","cross-sectional study",{"date":30,"type":31},{"date":651,"type":31},"2026-04-21",{"date":159,"type":21},{"name":654,"class":75},"Istanbul Medipol University Hospital",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":662,"maxAge":663,"enrollmentInfo":664,"targetDuration":4,"studyType":53,"phases":666,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":39},"100652408","stn-ttis-with-different-intervention-intervals-versus-standard-medical-treatment-for-parkinsons-disease-100652408","NCT07774312","STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease","STN-targeted Temporal Interference Stimulation With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease: A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n* 1.Aged 50-85 years, male or female.\n* 2.Diagnosed with idiopathic Parkinson disease (PD) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Parkinson's Disease (4th Edition), with a confirmed diagnosis for at least 6 months and a stable condition, defined as no significant deterioration or major medication adjustment within the past month.\n* 3.Receiving stable doses of antiparkinsonian medication (e.g., levodopa or dopamine agonists) and willing to maintain the medication regimen during the study.\n* 4.Hoehn and Yahr stage 1-3 in the medication ON state.\n* 5.Baseline MDS-UPDRS Part III total score ≥20 in the medication ON state.\n* 6.No history of non-invasive neuromodulation therapy, or discontinuation of such therapy for at least 3 months before enrollment if previously received.\n* 7.Normal cognitive function (MoCA score ≥24) and able to cooperate with tTIS intervention, clinical scale assessments, and basic smartphone- and smartwatch-assisted home-based motor self-assessments.\n* 8.Able and willing to provide written informed consent and complete all required study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n* 1.Other neurological disorders that may affect motor or cognitive function.\n* 2.Contraindications to magnetic resonance imaging (MRI), such as claustrophobia.\n* 3.History of taking antipsychotics, antidepressants, or other medications affecting dopamine levels.\n* 4.Psychiatric disorders (e.g., depression or schizophrenia), substance abuse, or alcohol dependence.\n* 5.Implanted medical devices (e.g., pacemaker or defibrillator), metal implants in the cranium or spine, a personal or family history of epilepsy, or severe skull defects.\n* 6.Previous deep brain stimulation (DBS) or other intracranial implantation surgery, or participation in another Parkinson disease clinical trial within the past 3 months.","50 Years","85 Years",{"count":665,"type":21},60,[55],"The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease.\n\nPrevious studies suggest that STN-tTIS may improve motor symptoms in people with Parkinson disease. However, most previous studies evaluated only one stimulation session. It remains unclear how often STN-tTIS should be administered during a repeated treatment course and whether shorter intervention intervals stimulation produces greater or longer-lasting improvement without increasing adverse events.\n\nThe main questions this study aims to answer are:\n\n1. Does STN-tTIS administered five times weekly improve motor symptoms more than standard medication treatment alone at the end of the 2-week treatment period?\n2. Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?\n3. Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?\n4. Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety?\n\nParticipants will be randomly assigned to receive STN-tTIS once weekly, twice weekly, or five times weekly for 2 weeks, or to continue standard antiparkinsonian medication without additional stimulation. All participants will maintain a stable medication regimen during the study. Their motor and non-motor symptoms will be assessed during the treatment period and during a subsequent 2-week follow-up period.",[669],"Parkinson's Disease (PD)",[671,672,673],"Subthalamic nucleus","Transcranial Temporal Interference Stimulation","Intervention Intervals",{"date":30,"type":31},{"date":676,"type":31},"2026-07-27",{"date":678,"type":21},"2027-04-15",{"name":453,"class":75},""]