[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"safety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:safety":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,46,78,103,132,155,177,199,221,247,277,307,329,350,372,393,417,444,468,495,521,549,580,601,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443",false,"NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","FEMALE","18 Years","50 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[27,28,29,30,31,32],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","NOT_YET_RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":21},"2026-06-15",{"date":41,"type":21},"2027-05-05",{"name":43,"class":44},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100592243","comparison-of-the-analgesic-effect-of-oliceridine-versus-morphine-or-sufentanil-for-postoperative-analgesia-in-lumbar-surgeries-a-randomized-control-trial-100592243","NCT06990893","Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial","Inclusion Criteria:\n\n* Lumbar spine surgery with ASA grades I-III\n* Aged 18-65 years\n* Ethically, the patient voluntarily accepted this trial and signed the informed consent form\n\nExclusion Criteria:\n\n* Severe respiratory and circulatory system diseases\n* Nervous system disease\n* Mental and psychological disorders\n* Abnormal liver and kidney functions\n* Participated in another drug clinical research within the past 30 days","ALL","65 Years",{"count":55,"type":21},90,[57],"NA","Objective: This study aimed to compare the efficacy and safety of oliceridine versus morphine and sufentanil for postoperative analgesia following elective lumbar spine surgery.\n\nMethods: In this randomized, controlled trial, 90 patients scheduled for lumbar spine surgery were allocated in a 1:1:1 ratio to receive postoperative intravenous patient-controlled analgesia (PCIA) with either oliceridine (Group O，1.5mg oliceridine for loading dose， 0.5mg\u002Fkg oliceridine for PICA), morphine (Group M，4mg morphine for loading dose，1.5mg\u002Fkg morphine for PICA), or sufentanil (Group S，4ug sufentanil for loading dose，1.5ug\u002Fkg sufentanil for PICA). The primary outcome was the movement Visual Analogue Scale (VAS) score at 6 hours postoperatively. Secondary outcomes included resting and movement VAS scores, ramsay sation score at 0.5, 2, 6, 12, 24, and 48 hours postoperatively (excluding the motor VAS score at 6 hours postoperatively); number of PCIA demands and rescue analgesic requirements within 48 hours; hemodynamic parameters at 5, 10, 15, 30, and 60 minutes after administration of the initial loading dose. The incidence of adverse events within 48 hours postoperatively, such as nausea and vomiting, somnolence, respiratory depression, or pruritus.",[60,61,62,29,63],"Sufentanil","Morphine","Validity","Oliceridine",[60,29,61,65],"oliceridine","RECRUITING","2026-05-28",{"date":69,"type":37},"2026-06-01",{"date":71,"type":37},"2025-06-01",{"date":73,"type":21},"2026-10-01",{"name":75,"class":76},"Anqing Municipal Hospital","OTHER",1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100636958","the-relationship-between-nurses-perception-of-safety-culture-and-patients-sense-of-safety-100636958","NCT07572448","The Relationship Between Nurses' Perception Of Safety Culture And Patients' Sense Of Safety","An Investigation Of The Relationship Between Day Surgery Nurses' Perception Of Safety Culture And Patients' Level Of Feeling Safe During Surgery","Inclusion Criteria:\n\n* Currently working as a healthcare professional in an outpatient surgical unit,\n* No visual, auditory, or psychological impairments that would prevent them from completing the questionnaires and scales,\n* At least a graduate of a vocational high school for healthcare professions,\n* Patients scheduled for elective surgery under local anesthesia,\n* Patients and nurses who voluntarily agreed to participate in the study.\n\nExclusion Criteria:\n\n* Refusal to voluntarily participate in the study,\n* Presence of any visual, auditory, or psychological impairments that would prevent the completion of questionnaires and scales,\n* Individuals who are not healthcare professionals.\n* Patients undergoing emergency surgical procedures or those under general anesthesia.",{"count":86,"type":21},206,"OBSERVATIONAL","This study will be conducted to determine the relationship between the perception of safety culture among healthcare professionals working in an outpatient surgical unit and the level of safety patients feel during surgery performed under local anesthesia.\n\nThe study population consists of healthcare professionals (N = 140) working in the Day Surgery Unit of Bursa Uludağ University Faculty of Medicine Hospital and patients undergoing procedures. The sample size calculation for the healthcare professionals to be included in the study was determined using the known population sampling method. Using the Raosoft sampling method, with a 5% margin of error and a 95% confidence interval, the minimum required sample size (n) was calculated to be 103. It was decided that the study would include healthcare professionals and patients in a 1:1 ratio. Therefore, the total sample size was calculated to be 206.\n\nData will be collected using the Hospital Survey on Patient Safety Culture (Version 2.0) and the Feeling Safe During Surgery Scale.",[90,29],"Nursing Personnel",[92,93],"Safety culture","Feeling safe","2026-05-06",{"date":96,"type":37},"2026-05-07",{"date":98,"type":21},"2026-05-01",{"date":100,"type":21},"2027-05-01",{"name":102,"class":76},"Uludag University",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100637979","short-term-safety-and-performance-of-two-wound-dressings-evaluation-100637979","NCT07576322","Short-Term Safety and Performance of Two Wound Dressings Evaluation","A Post-Market Clinical Follow-Up Study to Evaluate Short-Term Safety and Performance of POLTX_Fiber Compared With Suprasorb Liquacel Pro in Chronic Wounds","POLTX_Fiber","Inclusion Criteria:\n\nAge ≥ 18 years Chronic wound of 4 weeks to 2 years in duration Moderate to highly exuding wound (clinician-assessed) Wound area 2-50 cm² after debridement Able and willing to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\nKnown hypersensitivity to study or comparator dressing components Clinically infected wound requiring systemic antibiotics at baseline Necrotic wound (\\>25% necrotic tissue) or malignant wound Severe arterial insufficiency (ABI \\\u003C 0.5) Pregnant or breastfeeding Severe comorbid condition likely to interfere with wound healing or safety evaluation (e.g., end-stage renal disease, active cancer on chemotherapy, immunosuppression) Participation in another interventional study within 30 days Use of investigational wound products within 30 days Cognitive or psychiatric condition limiting consent or compliance Unable to attend follow-up visits or likely to relocate during the study period Any condition that, in the investigator's judgment, may compromise safety or study integrity",{"count":112,"type":21},60,[57],"Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, are defined as wounds that fail to heal within 4-8 weeks despite appropriate care. They represent a significant health burden due to prolonged healing, risk of infection, recurrence, and impact on quality of life and healthcare costs. Their development is multifactorial and often linked to vascular impairments, which reduce oxygen and nutrient supply. This leads to impaired tissue repair, persistent inflammation, and increased susceptibility to infection.\n\nStandard treatment includes wound debridement, infection control, maintaining a moist environment, and managing pain and exudate. POLTX\\_Fiber is an absorbent gelling fiber dressing designed to improve moisture balance, manage exudate, and reduce bacterial load, with established safety and CE marking.\n\nA post-market clinical follow-up study will compare POLTX\\_Fiber with Suprasorb® Liquacel Pro over a 30-day period in an outpatient setting. The study evaluates wound healing, infection status, usability, pain, and patient satisfaction. It is conducted in accordance with EU and Swiss regulations, ensures qualified investigators, and considers sex and gender differences in the analysis.",[116,117,29],"Chronic Wound Care","Local Infection",[119,120,121,122],"chronic wound","local infection prevention","wound exudate","safety","2026-05-04",{"date":125,"type":37},"2026-05-08",{"date":39,"type":21},{"date":128,"type":21},"2027-09-30",{"name":130,"class":76},"Sebastian Probst",3,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":151,"leadSponsor":153,"locationsCount":77},"100633086","evaluating-a-shared-decision-making-intervention-for-families-about-firearm-storage-100633086","NCT07522112","Evaluating a Shared Decision-making Intervention for Families About Firearm Storage","Randomized Trial of a Shared Decision-making Intervention for Families About Firearm Storage","Inclusion Criteria:\n\n* Parent or guardian of child aged 17 or younger\n* At least two adults living in the home\n* Firearms in household\n* Unsafe storage practices\n\nExclusion Criteria:\n\n* Not a parent or guardian\n* Child is age 18 or older\n* No other adults living in the home\n* No firearms in household Safe storage practices",true,{"count":141,"type":21},548,[57],"Investigators will conduct a randomized controlled trial assessing effectiveness of the Family Safety Check-In website on firearm storage practices. Prior to conducting the RCT, investigators will engage in a robust, participatory process of language adaptation to ensure the intervention meets the expressed needs of the large and growing proportion of parents in the United States who identify as Hispanic and speak primarily Spanish.",[29],[146],"Firearms","2026-04-13",{"date":149,"type":37},"2026-04-16",{"date":73,"type":21},{"date":152,"type":21},"2030-05-31",{"name":154,"class":76},"Seattle Children's Hospital",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":77},"100594235","phase-1-a-clinical-study-of-gensci134-in-healthy-adults-and-adult-growth-hormone-deficiencyaghd-100594235","NCT07016802","A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)","A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency","Inclusion Criteria:\n\nThe first part in Healthy adult volunteers:\n\n* Healthy adult male subjects（Phase Ia），or Healthy adult subjects（Phase Ib） aged 18-45 years (inclusive of boundary values);\n* Body Mass Index (BMI): 19.0-24.0 kg\u002Fm² (inclusive of boundary values);\n* Good health status;\n* Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.\n\nThe second part in AGHD patients（Phase Ic）:\n\n* Be able to understand and be willing to sign the written ICF (before any study procedure is performed).\n* Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other specified study procedures.\n* Aged from 20 to 70 years old (inclusive), at the time of signing the ICF.\n* Body mass index (BMI): 18.0-32.0 kg\u002Fm² ((inclusive of boundary values).\n* Meeting any of the following diagnostic criteria for growth hormone deficiency:\n* Adult-onset: Participants with GHD due to hypothalamo-pituitary disorder or relevant treatments (surgery, radiotherapy) or other reasons (infection, traumatic craniocerebral injury, etc.); the participant has no relapse or residual disease is stable for more than 1 year after surgery for pituitary adenoma, surgery for craniopharyngioma or other pituitary gland operation.\n* Childhood-onset: Participants with childhood idiopathic, acquired, congenital GHD or childhood GHD for other reasons.\n* Confirmed diagnosis of AGHD (meeting at least one of the following criteria):\n* Insulin tolerance test: peak GH cut-off point ≤ 5 μg\u002FL.\n* Glucagon challenge test:\n* a) Participants with BMI \\\u003C 25 kg\u002Fm² or high clinical suspicion \\[≥ 3 pituitary hormone deficiencies (PHDs)\\] with BMI 25-30 kg\u002Fm², peak GH ≤ 3 μg\u002FL.\n* b) Participants with BMI \\> 30 kg\u002Fm² or low clinical suspicion (≤ 2 PHDs) with BMI 25-30 kg\u002Fm², peak GH ≤ 1 μg\u002FL.\n* ≥ 3 PHDs and IGF-1 SDS \\\u003C -2.0 at screening.\n* Participants who have not previously received human growth hormone (hGH) therapy or are in the washout period of previous hGH therapy.\n\nExclusion Criteria:\n\nThe first part in Healthy adult volunteers:\n\n* Subjects with significant medical history or clinical manifestations determined by the investigator;\n* History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug;\n* History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction;\n* Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;\n* Subjects with immunodeficiency or immunosuppressive diseases at screening;\n* Subjects who have undergone major surgery within 12 months prior to screening;\n* Subjects with a history of neoplastic diseases;\n* Subjects who have participated in any other clinical trial of drugs or medical devices and have used the investigational medicinal product within 28 days or 5 half-lives (whichever is longer) before dosing.\n\nThe second part in AGHD patients（Phase Ic）:\n\n* Known or suspected hypersensitivity to the investigational medical product and\u002For any of its excipients.\n* Female participants who are pregnant, breast-feeding or intend to become pregnant or are of childbearing potential but not using an effective contraceptive method.\n* Male participants with fertility potential or their partners who do not use an effective contraceptive method.\n* Clinically significant hepatic disease.\n* Clinically significant chronic renal insufficiency.\n* Cardiac failure.\n* Use of any investigational product within 30 days prior to screening or participated in another trial within 30 days prior to dosing.\n* Use of systemic corticosteroids at non-alternative doses within 90 days prior to dosing.\n* Any disorder or treatment which, in the opinion of the investigator, possibly jeopardizes participant's safety or affects his\u002Fher compliance with the protocol.\n* History of diabetes mellitus.\n* History of malignancy or ongoing malignancy.\n* Active Cushing's syndrome within 24 months prior to dosing.\n* Acute severe diseases resulting in weight loss within 180 days prior to dosing.\n* Use of weight-reducing drugs known to affect body weight significantly within 12 months prior to dosing.\n* Presence of a mental or language disorder that impairs the ability to understand or cooperate with the study, unwillingness to participate, or any other condition that, in the opinion of the investigator or treating physician, renders the participant unsuitable for the trial.\n* Anticipated change in lifestyle during the trial.","70 Years",{"count":164,"type":21},64,[24],"To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients.",[29,30,168],"Adult Growth Hormone Deficiency","2026-04-12",{"date":171,"type":37},"2026-04-14",{"date":173,"type":37},"2025-06-09",{"date":175,"type":21},"2026-11-25",{"name":43,"class":44},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":162,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":77},"100579030","phase-1-safety-and-efficacy-of-psilocybin-assisted-psychotherapy-for-demoralization-syndrome-in-patients-diagnosed-with-advanced-stage-cancer-100579030","NCT06818994","Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer","Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer: a Pilot Study","Inclusion Criteria:\n\n* Patients diagnosed with advanced stage cancer (stages 3 and 4)\n* Aged between 18 and 70 years.\n* Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30\n* English proficiency\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.\n\nExclusion Criteria:\n\n* Condition impairing oral intake or digestive absorption.\n* Primary brain tumor.\n* Presence of delirium.\n* Significant suicide risk as defined by suicidal ideation with intent and a plan.\n* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history.\n* Patients with first-degree relatives with schizophrenia or bipolar disorder\n* Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.\n* Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and\u002For principal investigator to be incompatible with establishing rapport or safe exposure to psilocybin.\n* Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:\n\n  * MAO inhibitors\n  * Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit)\n  * Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)\n  * Aldehyde dehydrogenase inhibitors (e.g. disulfiram)\n  * Significant inhibitors of UGT 1A0 or UGT 1A10\n* Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.\n* Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he\u002Fshe takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver dysfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.\n* Women who are pregnant, nursing, or planning a pregnancy.\n* Use of a classic psychedelic or MDMA in the last 12 months",{"count":185,"type":21},15,[24],"Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.",[189,29],"Demoralization","2026-03-16",{"date":192,"type":37},"2026-03-18",{"date":194,"type":21},"2026-04-01",{"date":196,"type":21},"2027-06-01",{"name":198,"class":76},"Gustavo Vazquez",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":139,"sex":52,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":77},"100574509","a-study-to-learn-more-about-prevenar-20-once-it-is-out-in-the-korean-market-100574509","NCT06760208","A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market","Korean Post-marketing Surveillance for Prevenar 20","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Infant, children and adolescents who are aged 6 weeks to under 18 years or adult who are 18 years or older\n2. Subjects who have been prescribed Prevenar 20 by their physician as per approved product label\n3. Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)\u002Flegal guardian, if applicable, have been informed of all pertinent aspects of the study\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be included in the study:\n\n1. Subjects with contraindication according to approved label of Prevernar 20 (Pneumococcal 20-valent conjugate vaccine)\n2. Any subjects (or a legally acceptable representative) who do not agree that Pfizer and companies working with Pfizer use his\u002Fher information","6 Weeks",{"count":208,"type":21},660,"The purpose of this study is to understand the safety of Prevenar 20 (Pneumococcal 20-valent conjugate vaccine) once it is out in the Korean market. Prevenar 20 will be given to participants aged 6 weeks or older in Republic of Korea.\n\nThis study is seeking for participants who are:\n\n* Infant, children and adolescents aged 6 weeks to under 18 years or adult who are 18 years or older\n* Prescribed Prevenar 20 by their physician as per approved product label\n\nAll participants in this study will receive Prevenar 20 vaccine.\n\n1 dose (0.5 mL) of Prevenar 20 will be given into a muscle, preferably to the shoulder muscle.\n\nWe will look at the experiences of people receiving the study medicine. This will help us see if the study medicine is safe.\n\nParticipants will take part in this study for 28 days. During this time, study doctor collects the data of subjects to understand the safety of study medicine. There is no strict fixed visit schedule. If subjects are unable to visit the study clinic 28 days after Prevenar 20 vaccine was given then the safety information will be collected by telephone or e-mail.",[211,29],"Pneumococcal Immunization","2026-03-10",{"date":214,"type":37},"2026-03-12",{"date":216,"type":37},"2025-11-13",{"date":218,"type":21},"2027-03-01",{"name":220,"class":44},"Pfizer",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100628406","phase-1-safety-and-tolerability-of-irl757-in-participants-with-parkinsons-disease-and-apathy-100628406","NCT07461220","Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy","A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants With Parkinson's Disease and Apathy","LIFT-PD","Inclusion Criteria:\n\n1. Male and female participants between 50 and 90 years of age, inclusive, with diagnosed Parkinson's disease according to the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's disease.\n2. Hoehn and Yahr stage ≤ 4 at screening.\n3. MoCA score of 20 or greater at screening and baseline.\n4. Meets the ISCTM definition of apathy (criterion B), defined as exhibiting ≥ 1 symptom in ≥ 2 of the following 3 dimensions, that is persistent or frequently recurrent (ie, ≥ 3 days per week) for ≥ 4 weeks prior to screening:\n\n   * Diminished initiative (less spontaneous and\u002For active than usual self; less likely to initiate usual activities such as hobbies, chores, self-care, conversation, work-related or social activities),\n   * Diminished interest (less enthusiastic about usual activities, less interested in, or less curious about, events in their environment, less interested in activities and plans made by others, less interested in friends and family, less persistence in maintaining or completing tasks or activities), or\n   * Diminished emotional expression\u002Fresponsiveness (less spontaneous emotions, less affectionate compared to their usual self, expresses less emotion in response to positive or negative events, less concerned about the impact of their actions on other people, less empathy).\n\n   The symptoms must represent a significant change from the participant's usual behaviour and cause significant impairment in personal, social, or occupational functioning. Finally, the symptoms must not be due to psychiatric illness, intellectual disability, physical\u002Fmotor disabilities, or changes in level of consciousness or the effects of substances.\n5. Participants with moderate to severe apathy based on a score of at least -16 on the LARS at screening and baseline.\n6. Availability of the primary caregiver, any adult who spends greater than 10 hours a week with the participant and supervises his or her care, to accompany the participant to trial visits and to participate in the trial.\n7. Treatment with anti-Parkinson drugs, antidepressants (except for those listed as prohibited medications in the protocol), and Choline esterase inhibitors is permitted if doses are stable for 1 month before randomization and remain stable during the trial.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following exclusion criteria when assessed:\n\n1. Any active, current psychiatric comorbidity (such as major depressive disorder, obsessive-compulsive disorder, etc)\n\n   1. as assessed by the MINI at screening,\n   2. as assessed by the MADRS at the baseline visit with a score \\> 18.\n2. Score of \\> 2 in the MDS-UPDRS Part 1, Question 1.2 (hallucinations and psychosis).\n3. Need for acute psychiatric hospitalization.\n4. Participants who:\n\n   1. Answer \"Yes\" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) within the last 6 months prior to screening or the baseline visit, OR\n   2. Answer \"Yes\" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) within the last 6 months prior to screening or at the baseline visit, OR\n   3. Answer \"Yes\" on any of the 5 C-SSRS Suicidal Behaviour Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behaviour) within 2 years prior to screening or at the baseline visit, OR\n   4. In the opinion of the investigator, present a serious risk of suicide.\n5. Subthalamic stimulation of less than 1 year from screening.\n6. Subthalamic stimulation without stable parameters for 3 months from screening.\n7. Clinically significant impulse control disorders (ICDs) as assessed by the QUIP RS (score \\> 6).\n8. Renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 30 mL\u002Fmin\u002F1.73m2 calculated based on cystatin C).\n9. Moderately impaired hepatic function or advanced hepatic dysfunction as assessed by a Child Pugh score B or C.\n10. Significant communicative impairments that prohibit meaningful participation in the trial assessments.\n11. Central nervous system abnormalities (eg, cerebral aneurysm) and\u002For other vascular abnormalities such as vasculitis or pre-existing stroke, motor tics, or family history or diagnosis of Tourette's syndrome, seizures (convulsions, epilepsy), or historical clinically significant abnormal electroencephalograms (EEGs).\n12. History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non metastatic prostate cancer, or in situ cervical cancer. The cancer must not be active or currently under treatment except for potentially long-term stable medications.\n13. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of IMP.\n14. Any planned major surgery within the duration of the trial.\n15. Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.\n16. Any vital signs values outside of the following ranges after 10 minutes of supine rest at the time of screening:\n\n    1. Systolic blood pressure (SBP) \\> 150 mmHg\n    2. Diastolic blood pressure (DBP) \\> 90 mmHg\n    3. Heart rate \\\u003C 50 or \\> 100 beats per minute.\n17. Participants with a history of hypertension must have stable blood pressure for the 3 months prior to the trial, defined as blood pressure \\\u003C 150\u002F90 mmHg. If this criterion is not met the participant is not eligible for the trial.\n18. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 450 msec for male participants or \\> 470 msec for female participants, cardiac arrhythmias, or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.\n19. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL757.\n20. Current nicotine use; irregular nicotine use less than 3 times per week is allowed before the screening visit.\n21. Positive screen for illicit drugs (including cannabinoids) and\u002For abuse or positive screen for alcohol at screening or on Day 1 prior to administration of the IMP.\n22. Use of anabolic steroids.\n23. Use of antipsychotics.\n24. The participant is unwilling or unable to discontinue taking alpha-2 adrenergic receptor antagonists and\u002For cytochrome P450 (CYP) inhibitor or substrate drugs at least 14 days or 5 times the half-life of the drug (whichever is longer) before randomization.\n25. Excessive or variable daily caffeine consumption (ie, exceeding 3 cups per day) for the 2 weeks prior to screening.\n26. Plasma donation within 1 month of screening or any blood donation\u002Fblood loss \\> 450 mL during the 3 months prior to screening.\n27. Participants who are breastfeeding.\n28. Participants who have a positive pregnancy test result prior to receiving IMP.\n29. Heterosexually active participants of reproductive potential (PORP) \u002F POCBP who do not agree to use a highly effective method of birth control or remain fully abstinent from sexual activity with the potential for conception. Female participants of nonchildbearing potential (permanently sterilized \\[ie, hysterectomy, bilateral oophorectomy\\], postmenopausal for at least 12 months, or otherwise incapable of pregnancy) and male participants who have had a bilateral orchiectomy are eligible for enrolment.\n30. Participants who do not agree to refrain from donating sperm or eggs from trial screening through 90 days (for sperm) and 30 days (for eggs) after the last dose of IMP.\n31. Participants who have participated in a clinical trial involving an investigational drug or device within the last 90 days or who participated in more than 2 clinical trials involving an investigational drug or device within the past year.\n32. The investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.\n33. Any condition that, in the opinion of the investigator, makes it medically inappropriate or risky for the participant to enrol in the trial.","90 Years",{"count":231,"type":21},75,[24,233],"PHASE2","This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug).\n\nParticipants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.",[236,237,29],"PARKINSON DISEASE (Disorder)","Apathy","2026-03-04",{"date":212,"type":37},{"date":241,"type":37},"2026-02-18",{"date":243,"type":21},"2027-05",{"name":245,"class":44},"Integrative Research Laboratories AB",13,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":259,"conditions":260,"keywords":266,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":77},"100407991","early-phase-1-human-amniotic-derived-mesenchymal-stem-cell-therapy-for-calciphylaxis-100407991","NCT04592640","Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis","Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study","Inclusion Criteria:\n\n1. 18-75 years old.\n2. Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).\n3. All subjects signed informed consent.\n\nExclusion criteria:\n\n1. Patients who refuse to sign informed consent.\n2. Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months.\n3. Pregnant or lactating women of childbearing age.\n4. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.","75 Years",{"count":256,"type":21},9,[258],"EARLY_PHASE1","Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells",[261,262,263,264,29,265],"Chronic Kidney Diseases","Calciphylaxis","Calcific Uremic Arteriolopathy","Treatment","Efficacy",[261,262,263,267,268,29,265],"Human Amniotic-derived Mesenchymal Stem Cells","Rare disease (ORPHA280062)","2026-03-02",{"date":238,"type":37},{"date":272,"type":37},"2018-09-17",{"date":274,"type":21},"2028-09-17",{"name":276,"class":76},"The First Affiliated Hospital with Nanjing Medical University",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":139,"sex":52,"minAge":284,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":287,"conditions":288,"keywords":292,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100626378","evaluation-of-a-sexual-violence-and-intimate-partner-violence-primary-prevention-program-implemented-in-drinking-establishments-100626378","NCT07434856","Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments","The Safe Night Out Evaluation Study: Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments","Inclusion Criteria:\n\n* Aged 21 years or older (as required per California law for alcohol servers)\n* Employed and working as a bar owner, manager, or staff member of the drinking establishment that has been recruited for the study (for staff participants)\n* A customer or patron in the past month at the drinking establishment that has been recruited for the study (for patron participants)\n* Ability to speak and understand English\n\nExclusion Criteria:\n\n* Aged 20 years and under\n* Inability to speak and understand English\n* No current employment at a drinking establishment recruited for the study (for staff participants)\n* No history of visiting the drinking establishment in the past month (for patron participants)","21 Years",{"count":286,"type":21},650,"The goal of this project is to evaluate the effectiveness of Safe Night Out, a community-level primary violence prevention program offered in drinking establishments in the Sacramento region of California. The main questions this project aims to answer are: 1) Does the Safe Night Out program reduce incidents of sexual violence and intimate partner violence among patrons? 2) Does the Safe Night Out program increase incidents of safety checks of patrons by staff participants? To address these questions, we will enroll 150 staff participants and 500 patron participants from 25 drinking establishments that have implemented the Safe Night Out program (\\~3 staff participants and 10 patron participants per drinking establishment) and 25 drinking establishments that have not implemented the Safe Night Out program (\\~3 staff participants and 10 patron participants per drinking establishment). Participants will complete a baseline and three 6-month follow-up assessments, until 18 month-follow-up.",[289,290,291,29],"Intimate Partner Violence (IPV)","Sexual Violence","Alcohol",[293,294,295,296,297],"sexual violence","intimate partner violence","alcohol","bars","clubs","2026-02-19",{"date":300,"type":37},"2026-02-27",{"date":302,"type":21},"2026-06",{"date":304,"type":21},"2028-12",{"name":306,"class":76},"University of California, San Diego",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":77},"100614981","phase-1-a-study-of-genssci098-in-subjects-with-graves-disease-100614981","NCT07286656","A Study of GensSci098 in Subjects With Graves' Disease","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Dose of GenSci098 in Patients With Graves' Disease","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Voluntary signed informed consent.\n* Confirmed diagnosis of diffuse toxic goiter (Graves' disease).\n* Abnormal thyroid function tests (e.g., elevated T4, and suppressed TSH).\n* No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).\n* Female participants must be postmenopausal, surgically sterile, or using a highly effective method of contraception.\n* Male participants must agree to practice abstinence, use a highly effective method of contraception， or have undergone vasectomy.\n* Ability to comply with the follow-up schedule and understand and adhere to the study requirements.\n\nExclusion Criteria:\n\n* Non-diffuse toxic goiter-induced hyperthyroidism.\n* Previous radioactive iodine treatment or thyroid surgery.\n* History or risk of thyroid storm.\n* Use of thyroid hormone medications within the past 6 weeks.\n* accompanied by active thyroid eye disease.\n* Thyroid eye disease treated with radiation\u002Fsurgery,or need for urgent surgery surgical or medical intervention.\n* Optic nerve lesions or corneal damage.\n* Use of steroids or immunosuppressants within the past 3 months,or those who have used biologics within 6 months\n* Inability to quit smoking during the study.\n* Allergy to the study drug or monoclonal antibodies.\n* Participation in another clinical trial within the past 3 months.\n* Abnormal electrocardiogram.\n* Significant hepatic or renal dysfunction.\n* Pregnancy,breastfeeding,or positive pregnancy test.\n* Positive for HIV,syphilis,hepatitis B,or hepatitis C.\n* History of drug or substance abuse.\n* Other autoimmune diseases requiring treatment.\n* History of malignant tumors.\n* Splenectomy or major surgery within the past 6 months.\n* Severe cardiovascular,pulmonary,hepatic,renal,neurological,or hematological diseases.\n* Other conditions deemed unsuitable by investigators.",{"count":315,"type":21},24,[24],"To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease",[29,30,319,320],"GenSci098","Graves Disease","2026-02-13",{"date":323,"type":37},"2026-02-17",{"date":325,"type":37},"2025-11-21",{"date":327,"type":21},"2027-03-18",{"name":43,"class":44},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":254,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":77},"100559870","phase-1-a-study-of-gensci098-in-subjects-with-active-thyroid-eye-disease-100559870","NCT06569758","A Study of GenSci098 in Subjects With Active Thyroid Eye Disease","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients","Inclusion Criteria:\n\n1. At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).\n2. Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline.\n3. Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit.\n4. Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.\n5. Moderate to severe TED (impacting the quality of life, requiring intervention but not threatening vision), usually with at least 2 of the following manifestations: (1) eyelid retraction width ≥ 2 mm, (2) moderate or severe soft tissue involvement, (3) proptosis ≥ 3 mm above normal for race and gender, (4) inconstant or constant diplopia.\n6. Participants must be euthyroid with the underlying disease under control, or have mild hypo- or hyperthyroidism at screening. (Only applicable to Part 1)\n7. Participants must have normal thyroid function or hyperthyroidism due to GD at screening. (Only applicable to Part 2)\n8. No prior treatment with antithyroid medications and\u002For thyroid hormone replacement therapy, or having taken antithyroid medications and\u002For thyroid hormone replacement therapy on a stable dose, or having not been treated with antithyroid medications and\u002For thyroid hormone replacement therapy due to intolerable side effects.\n9. Anyone who will not be required to need or receive any immediate or planned surgical ophthalmological intervention, corrective surgery or orbital irradiation during the study.\n10. Female participants must meet one of the following conditions to be eligible for the study:\n\n    1. Infertile, defined as surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or bilateral oophorectomy) at least 6 weeks prior to administration or menopausal (spontaneous amenorrhea ≥ 12 months which is not caused by underlying diseases and confirmed by serum follicle stimulating hormone \\[FSH\\] level ≥ 40 mIU\u002FmL).\n    2. Fertile female participants agree, from the start of the screening visit until 300 day after the last dose, to consistently and correctly use one of the following acceptable methods of effective contraception:\n\n       1. Complete abstinence (based on the participant's preference and usual lifestyle).\n       2. Use of oral contraceptives (estrogen and progesterone), and being on a stable dose of the same contraceptive medication for at least 3 months prior to study treatment.\n       3. Injectable or implantable hormonal contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar efficacy (failure rate \\\u003C 1%), such as a hormonal vaginal ring or transdermal hormonal contraception. 4) Vasectomized partner, with the procedure performed at least 6 months ago.\n11. Male participants must meet one of the following criteria to be eligible for the study:\n\n1\\) agree to use a condom plus an effective method of contraception (i.e., hormonal contraception initiated at least 30 days prior to administration; or placement of an IUD or IUS) when engaging in sexual activity with a female partner of childbearing potential from the start of the screening visit until 24 weeks after the last dose and refrain from donating sperm during this period.\n\n2\\) agree to practice abstinence from the start of the screening visit until 24 weeks after the last dose.\n\n3\\) have had a vasectomy at least 6 months prior to study treatment. 12. Voluntarily sign the ICF and be able to understand and comply with the study's treatment regimen and assessments until the end of the study\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.\n2. Corneal injury not relieved by medical management.\n3. Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.\n4. Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.\n5. Previous orbital irradiation or surgery for TED.\n6. Use of any steroid (either intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for TED within 4 weeks prior to screening (discontinued steroid eye drops arepermitted).\n7. Use of steroids for conditions other than TED within 4 weeks prior to screening (topical steroids for dermatological conditions and inhaled steroids are permitted).\n8. Drug therapy with biologics or peptides, including teprotumumab, rituximab, or tocilizumab, within 6 months or 5 half-lives of the drug (whichever is longer) prior to screening.\n9. Use of any non-steroidal immunosuppressive agents within the 3 months prior to screening.\n10. Pre-existing ophthalmic disease or autoimmune disease (other than TED) that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results.\n11. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and\u002For current or previous history of thyroid storm. (Only applicable to Part 2)\n12. History of radioiodine treatment or thyroidectomy within 6 months prior to first dose. (Only applicable to Part 2)\n13. Individuals who cannot abstain from smoking\u002Ftobacco products from the screening period to the end of the study.\n14. Any known allergy to the components of the investigational product or analogues or previous allergic reactions to monoclonal antibodies.\n15. Known history \u002Fdiagnosis of malignancy.\n16. Acute\u002Fchronic infection within 2 weeks prior to screening.\n17. Participation in another clinical trial within 3 months before screening (except those who did not receive any intervention), or within 5 half-lives of the study drug in other clinical trials (whichever is longer), or concurrent enrollment in another clinical trial.\n18. Those with prolonged QTcF interval in 12-lead ECG results (\\> 450 ms for males, \\> 460 ms for females) or clinically significant abnormalities in other 12-lead ECG parameters at screening that, in the investigator's judgment, may affect trial participation;\n19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 3 times the ULN, or total bilirubin (TBIL) or alkaline phosphatase (ALP) \\> 2 × ULN, blood creatinine (Cr) ≥ 1.5 times the ULN at screening.\n20. Positive blood pregnancy test, or lactating women at the time of screening.\n21. Positive for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), Treponema pallidum particle agglutination (TPPA) test, or hepatitis B surface antigen (HbsAg) at screening.\n22. History of recreational drug use or substance abuse or positive drug screening results at screening.\n23. Any medical (including other clinically significant abnormal laboratory test parameters) or other conditions that the investigator believes might affect the conduct of the clinical trial.",{"count":337,"type":21},76,[24],"To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)",[29,30,319,341],"Thyroid Eye Disease (TED)","2026-02-09",{"date":344,"type":37},"2026-02-11",{"date":346,"type":37},"2024-09-24",{"date":348,"type":21},"2027-12-13",{"name":43,"class":44},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100534786","phase-1-phase-12-study-of-hyp-2090ptsa-in-patients-with-advanced-solid-tumors-harboring-kras-mutation-100534786","NCT06243354","Phase 1\u002F2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation","An Open-label, Multi-center, Multi-cohort, Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation","Inclusion Criteria:\n\n* A written informed consent should be signed by a subject or his\u002Fher legal representative before any study-related procedures are performed;\n* 18 Years and older;\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;\n* Subjects must have at least one measurable lesion as defined by RECIST v1.1;\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;\n* Expected survival ≥ 3 months;\n* Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\nExclusion Criteria:\n\n* Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;\n* Patients who have received live vaccines within 4 weeks prior to the first dose;\n* Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;\n* Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism\u002Fhemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;\n* Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;\n* Patients who have previously received allogeneic tissue\u002Fsolid organ transplantation;\n* Patients with active infection;\n* Patients who are positive for human immunodeficiency virus (HIV) (HIV1\u002F2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \\> 500 IU\u002FmL) or active hepatitis C (HCV antibody positive and HCV-RNA \\> lower limit of detection by the research center);\n* Female subjects who are lactating or have a positive blood\u002Furine pregnancy result during the screening period;\n* Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.",{"count":358,"type":21},257,[24,233],"This is a multicenter, open-label phase 1\u002F2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.",[29,30,265],"2026-01-27",{"date":364,"type":37},"2026-01-29",{"date":366,"type":37},"2024-02-04",{"date":368,"type":21},"2026-12",{"name":370,"class":44},"Sichuan Huiyu Pharmaceutical Co., Ltd",6,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":77},"100565213","phase-1-phase-12-clinical-study-of-hy07121-powder-for-solution-for-infusion-in-patients-with-advanced-solid-tumors-100565213","NCT06639256","Phase 1\u002F2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","An Open-label, Multiple-center, Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Written informed consent;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;\n* Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Within the defined washout periods for prior anti-cancer treatments;\n* Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.\n* Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).\n* Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;\n* Major surgery within 4 weeks of receiving the first dose of study treatment;\n* Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment;\n* Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;\n* Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension;\n* Known Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS);\n* Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;\n* Active known or suspected autoimmune disease.\n* History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;\n* History of severe allergy;\n* History of allogeneic organ transplantation or graft-versus-host disease;\n* Have received live\u002Fattenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live\u002Fattenuated vaccines and mRNA vaccines during the study period;\n* Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment;\n* Known psychiatric disorder or drug abuse that would interfere the trial requirements;\n* Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage;\n* In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.);\n* Participants considered unsuitable for participation in this study by the investigators.","80 Years",{"count":381,"type":21},258,[24,233],"This is a multi-center, open-label, phase 1\u002F2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)\u002Fpharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.",[29,30,265],"2026-01-26",{"date":387,"type":37},"2026-01-28",{"date":389,"type":37},"2024-10-24",{"date":391,"type":21},"2026-10",{"name":370,"class":44},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":139,"sex":52,"minAge":400,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":77},"100498780","phase-1-curcumin-and-retinal-study-100498780","NCT05774704","Curcumin and Retinal Study","Curcumin and Retinal Amyloid-beta Pilot Study","Inclusion:\n\n* Both male and female, age 40 - 89 years.\n* Diagnosed with Aβ deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aβ deposits in retina within 6 months before the consent session, we will use this diagnosis\u002Fdocumentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study.\n* No pre-existing liver or kidney diseases by self-report.\n\nExclusion:\n\n* Patients with ocular diseases (macular degeneration, severe diabetes retinopathy)\n* Had used systemic antibiotics within 1 month prior to the start of the study intervention\n* Had taken any turmeric or curcumin products within 2 weeks prior to the start of the study intervention\n* Had a known allergy to black pepper\n* Women that are pregnant or breastfeeding","40 Years","89 Years",{"count":112,"type":21},[24,233],"To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance\u002Fcomposition of gut microbiota.",[406,407,29],"Bioavailability","Gut Microbiome","2026-01-12",{"date":410,"type":37},"2026-01-13",{"date":412,"type":37},"2023-08-21",{"date":414,"type":21},"2026-12-31",{"name":416,"class":76},"Texas Tech University Health Sciences Center",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":427,"conditions":428,"keywords":433,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":4},"100615893","phase-4-safety-exploration-and-evaluation-of-dexmedetomidine-hydrochloride-nasal-spray-for-pre-anesthesia-sedation-in-low-monitoring-settings-100615893","NCT07298525","Safety Exploration and Evaluation of Dexmedetomidine Hydrochloride Nasal Spray for Pre-anesthesia Sedation in Low-Monitoring Settings","Inclusion Criteria:\n\n* be 18 years of age or older, including the age of 18; no gender limitation;\n* American Society of Anesthesiologists (ASA) grade I to III;\n* Require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure;\n* Provide informed consent for participation in this study prior to the commencement of the trial and execute a written document of informed consent willingly.\n\nExclusion Criteria:\n\n* Individuals with a known hypersensitivity to dexmedetomidine hydrochloride or any excipient; patients with a documented allergy to any tranquilizers, opioids, or other substances employed in the trial;\n* Individuals with airway hyperactivity, such as those suffering from chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea, who are determined by the researchers to have experienced or are experiencing safety concerns related to these conditions;\n* Patients with a history of nasal disorders, previous surgical procedures, or allergic reactions deemed clinically significant by the research team, which could significantly impact drug absorption (e.g., chronic nasal congestion, rhinorrhea, nosebleeds, and other symptoms, as well as anatomical or mucosal abnormalities in the nose that may affect drug uptake);\n* A blood oxygen saturation (SpO2) level of less than or equal to 92% in a non-oxygenated state during the screening period;\n* patients with current psychiatric disorders (like schizophrenia or depression) or cognitive impairment; those with a history of epilepsy; or individuals with a past record of psychotropic or narcotic substance abuse;\n* A history of myocardial infarction or unstable angina pectoris within the past six months prior to the screening phase;\n* A heart rate or pulse rate of less than or equal to 50 beats per minute during the screening period, the presence of clinically significant heart functional abnormalities as determined by the investigators, or the presence of grade II or higher atrioventricular block (excluding patients with implanted pacemakers) along with other severe arrhythmias;\n* Patients with inadequately controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg during the screening period) or hypotension (systolic blood pressure ≤90 mmHg and\u002For diastolic blood pressure ≤ mmHg during the screening period);\n* Participants who have already engaged in other clinical trials and have taken the investigational drug within the three months preceding the screening period;\n* Pregnant or lactating women expected to undergo a cesarean section during labor and delivery;\n* The investigator concludes that the patient possesses other conditions rendering them ineligible for trial participation.",{"count":424,"type":21},564,[426],"PHASE4","The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication. This study aims to investigate the following aspects: the incidence of adverse respiratory and circulatory events requiring medical intervention following the administration of dexmedetomidine nasal spray for pre-anesthetic sedation, its sedative efficacy and onset time, and its impact on the quality of post-anesthesia recovery and the occurrence of postoperative delirium. Researchers will compare dexmedetomidine hydrochloride nasal spray to a placebo (a look-alike substance that contains no drug) to see the incidence and severity of adverse events following administration. Participants will receive either dexmedetomidine nasal spray or a placebo 45 minutes before anesthesia induction. The blinded assessor will continuously monitor and record vital signs, adverse events, and the level of sedation. More importantly, observations and records should be made for respiratory and circulatory events that require medical intervention. A follow-up assessment will be conducted within three days after the operation to evaluate the incidence of postoperative delirium and patient satisfaction.",[429,430,29,431,432],"Dexmedetomidine","Sedation","Preanesthetic Medication","Monitored Anaesthesia Care",[429,430,29,431,432,434],"Adverse Events of Respiratory Circulation","2025-12-22",{"date":437,"type":37},"2025-12-23",{"date":439,"type":21},"2026-01-10",{"date":441,"type":21},"2026-12-30",{"name":443,"class":76},"Sichuan Provincial People's Hospital",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":466,"locationsCount":4},"100614928","phase-1-a-first-in-human-sad-and-mad-study-in-healthy-participants-to-evaluate-oral-yr011-tablet-100614928","NCT07285967","A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet","A First-in-Human, Randomized, Double-Blinded, Placebo Controlled, SAD and MAD Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR011 Following Oral Administration.","Inclusion Criteria:\n\n* Participants who meet all the following criteria could be enrolled in this study:\n\n  1. Written informed consent obtained from the participant in compliance with all local legal requirements.\n  2. Male or female participant aged between 18 and 60 years (extremes included).\n  3. Body mass index (BMI) between 18-32 kg\u002Fm2 (extremes included) and body weight less than 120 kg.\n  4. Males must use a condom or remain abstinent during the trial and for 3 months after their last dose of study medication. And a fertile man's female partner must not try to become pregnant during the study.\n  5. Female participants of childbearing potential must be established on a highly effective method of contraception (The recommended birth control methods are: Implantable (e.g. Implanon(r)), injectable (e.g. Depo-Provera(r)), insertable (e.g. NuvaRing®), Mirena (r) (LNG-IUS)), Combined oral contraceptives pill or progestin-only pill, Evra patch®, Intrauterine device (e.g. ParaGard(r), copper T) or Female sterilization, Male sterilization. The recommended birth control methods must be taken at least 3 weeks prior to screening (i.e., to ensure the contraceptive method has taken effect).) prior to dosing and until 3 months after their last dose in combination with male partner's use of a condom during the trial and for 3 months after the last dose.\n  6. Free from any clinically relevant illness or disease that may adversely affect the safety of the participant, or the integrity of the study as determined by medical history, physical examination, safety laboratory, and other assessments.\n  7. Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Without other intestinal diseases such as irritable bowel syndrome and acute diarrhea due to any infection.\n\nExclusion Criteria:\n\n* If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:\n\n  1. Pregnant or lactating women.\n  2. Participants with dysphagia.\n  3. Severe infections requiring parenteral antibiotics treatment within 4 weeks prior to screening, e.g. sepsis, or severe pneumonia.\n  4. Any clinically relevant conditions e.g. cerebral stroke, myocardial infarction, heart failure, unstable angina, and severe heart rate abnormalities within 6 months before screening.\n  5. History or presence (within 6 months) of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n  6. Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  7. Presence of any renal impairment or dysfunction (i.e. estimated glomerular filtration rate (eGFR)\\\u003C90 mL\u002F min).\n  8. Presence of hepatic impairment: Child-Pugh A, B or C and\u002For transaminase levels that are outside the upper normal limit (i.e., Serum bilirubin ≥1.5× upper limit of normal (ULN), ALT or AST levels \\> ULN).\n  9. diagnosis of diabetes regardless the degree of control at screening visit\n  10. Hyperthyroidism or hypothyroidism.\n  11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.\n  12. Any major surgery within 6 months of screening.\n  13. Participant has a positive test result of HBV (positive HBsAg), HCV (positive anti-HCV), or human immunodeficiency virus I and II (positive anti-HIV I\u002FII), Treponema Pallidum antibody (positive anti-TP) at screening.\n  14. Participants with innate or acquired immune system defects.\n  15. Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  16. Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or a medically qualified sub-investigator.\n  17. Participant has a QT interval with Fridericia's correction method (QTcF) \\>450 ms (males) or\\>470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit; or history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); or the use of concomitant medications that prolong the QT\u002FQTc interval.\n  18. Participant has a history of a major psychiatric illness or currently receiving therapy for a psychiatric condition Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.\n  19. Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal \\[including traditional Chinese medicinal products\\] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration. etc.","60 Years",{"count":164,"type":21},[24],"This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants.\n\nThe trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8.\n\nKey procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.\n\nThe trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.",[29,30,31],[457,458,459,460],"KV1.3","YIRUI pharma","yirui","Healthy Volunteers","2025-12-18",{"date":463,"type":37},"2025-12-26",{"date":194,"type":21},{"date":414,"type":21},{"name":467,"class":44},"Hangzhou Yirui Pharmaceutical Technology Co., Ltd",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":484,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":77},"100572469","phase-1-safety-and-pk-of-ceftibuten-ledaborbactam-etzadroxil-fixed-dose-combination-100572469","NCT06733675","Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination","A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil","Inclusion Criteria:\n\n* Healthy adult male or female, between 18 and 55 years of age\n* Body mass index ≥ 18 and ≤ 32 kg\u002Fm2\n* Laboratory values meeting defined laboratory ranges\n* Males or non-pregnant, non-lactating females\n\nExclusion Criteria:\n\n* History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug\n* Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant\n* Positive alcohol, drug or tobacco use\u002Ftest","55 Years",{"count":477,"type":21},46,[24],"This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.",[481,31,29,482,483],"Healthy Volunteer","Drug-Drug Interaction (DDI)","FDC",[460,485,486],"Ceftibuten","Ledaborbactam etzadroxil","2025-12-17",{"date":461,"type":37},{"date":490,"type":37},"2025-01-07",{"date":492,"type":21},"2026-06-30",{"name":494,"class":44},"Basilea Pharmaceutica",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":77},"100571255","phase-2-long-term-pea-safety-study-100571255","NCT06717867","Long-Term PEA Safety Study","A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.","Inclusion Criteria:\n\n* Adults (18 years and older)\n* Generally healthy\n* Able to provide informed consent\n* BMI 18.5 - 35.0 kg\u002Fm2\n* Agree to not participate in another clinical trial during enrolment period\n\nExclusion Criteria:\n\n* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years\n* Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions\n* Unstable illness (e.g., diabetes and thyroid gland dysfunction)\n* History of renal function impairment\n* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy \\[(excluding low dose aspirin (under 300 mg\u002Fday)\\]\n* Regular consumption (\\>4 times a week) of PEA over the past 2 weeks\n* Substance Abuse (illicit and\u002For prescription) Drug (prescription or illegal substances) abuse\n* Chronic past (within 12-months) and\u002For current alcohol use (\\>14 alcoholic drinks week)\n* Pregnant or lactating women\n* Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula\n* Has a clinically significant abnormal finding on the medical assessment, medical history, or clinical laboratory results at screening.\n* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.",{"count":503,"type":21},200,[233],"The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers.\n\nThe main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation.\n\nParticipants will:\n\n* Have their suitability for the study checked against the full inclusion\u002Fexclusion criteria during the screening process.\n* Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study.\n* Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call.\n* During visits there will be safety assessments performed, blood sampling and questionnaires.\n\nThe trial will include two participation modes:\n\n1. In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility.\n2. Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.",[507,29],"Healthy",[509,510,511,512],"Palmitoylethanolamide","PEA","Levagen","PEA Safety study","2025-12-11",{"date":461,"type":37},{"date":516,"type":37},"2025-01-22",{"date":518,"type":21},"2027-06",{"name":520,"class":44},"RDC Clinical Pty Ltd",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":254,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":548},"100612462","phase-2-efficacy-and-safety-of-ak104-combined-with-chemotherapy-and-cetuximab-or-bevacizumab-100612462","NCT07253896","Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab","Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status","Inclusion Criteria:\n\n* 1\\. Voluntarily sign a written ICF. 2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female. 3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.\n\n  4\\. The expected survival period is ≥ 3 months. 5. Metastatic colorectal adenocarcinoma confirmed by histology or cytology. 6. Microsatellite instability (MSI) status is MSI-L or MSS type human. 7. The metastatic lesion cannot be removed and is not suitable for curative surgical treatment.\n\n  8\\. Previously only received first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX), and other systemic anti-tumor treatments for metastatic colorectal cancer are not allowed. Note: For subjects who have previously received neoadjuvant therapy, adjuvant therapy, or curative radiotherapy and chemotherapy, if disease progression occurs during or within 6 months after treatment, it is considered that they have received first-line treatment.\n\nAccording to RECIST v1.1, subjects must have at least one measurable lesion. For subjects who have previously received radiotherapy, if there are no other lesions that can be selected as target lesions and there is objective evidence of significant progression after radiotherapy, the irradiated lesions can be considered as target lesions.\n\n10\\. The subjects are required to provide 15 recently archived or freshly obtained FFPE pathological sections of tumor tissue.\n\n11\\. Determine good organ function through the following requirements:\n\na) Hematology (no use of any blood components or cell growth factor branches within 7 days prior to starting treatment)\n\nHolding treatment:\n\ni. Neutrophil absolute value ANC ≥ 1.5 × 109\u002FL (1500\u002Fmm3); Ii. Platelet count ≥ 100 × 109\u002FL (100000\u002Fmm3); Iii. Hemoglobin ≥ 90 g\u002FL. b) Kidney: i. The calculated value of creatinine clearance rate \\* (CrCl) is ≥ 50 mL\u002Fmin\n\n\\*The Cockcroft Fault formula will be used to calculate CrCl (Cockcroft Fault formula) CrCl (mL\u002Fmin)={(140- age) × Weight (kg) × F} \u002F(SCr (mg\u002FdL) × 72) F=1 for males; F=0.85 for women; SCr=serum creatinine. Ii Urinary protein ≤ 1+or 24-hour (h) urinary protein quantification\\\u003C1.0 g. c) Liver: i. Total serum bilirubin (TBil) ≤ 1.5 × ULN; For liver metastasis or evidence to confirm\u002Fsuspect Subjects with Gilbert disease, TBil ≤ 3 × ULN Ii. AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN Iii. Serum albumin (ALB) ≥ 28 g\u002FL d) Coagulation function: i. International Standardization Ratio\n\nExclusion Criteria:\n\n* 1\\. Patients with known MSI-H or dMMR. 2. Patients with BRAF mutations. 3. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).\n\n  4\\. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.\n\n  5\\. Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors.\n\n  6\\. Patients with active autoimmune diseases that require systematic treatment within the past two years (such as using medication to improve the condition, corticosteroids, immunosuppressive agents), and replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) are not considered as systematic treatment.\n\n  7\\. A history of active or previous inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).\n\n  8\\. History of immunodeficiency; HIV antibody test positive individuals; Currently using systemic corticosteroids or other immunosuppressants for a long time.\n\n  9\\. Subjects who are known to have active pulmonary tuberculosis (TB) and suspected to have active TB need to undergo clinical examination to exclude them; Known active syphilis infection.\n\n  10\\. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n\n  11\\. Previous or current non infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid treatment.\n\n  12\\. Severe infections occurring within 4 weeks prior to the first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti infective treatment within two weeks prior to the first administration (excluding antiviral treatment for hepatitis B or C).\n\n  13\\. Subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies\u002Fml (200 IU\u002Fml) or above the lower detection limit, whichever is higher). Note: Non active or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU\u002FmL are eligible for inclusion. Subjects with hepatitis B are required to receive anti hepatitis B virus treatment during the study treatment.\n\n  14\\. Active hepatitis C subjects (HCV antibody positive and HCV RNA levels above the detection limit).\n\n  15\\. Those who have undergone major surgical procedures or experienced severe trauma within 30 days prior to the first administration, or have planned major surgical procedures within 30 days after the first administration (as determined by the investigator); Minor local surgery performed within 3 days prior to initial administration (excluding peripheral venous puncture and central venous catheterization and intravenous infusion port implantation)",{"count":529,"type":21},40,[233],"Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer",[29],[534,535,536,537,538],"colorectal cancer","AK104","chemotherapy","cetuximab","bevacizumab","2025-11-26",{"date":541,"type":37},"2025-11-28",{"date":543,"type":37},"2024-01-03",{"date":545,"type":21},"2027-01-03",{"name":547,"class":76},"Second Affiliated Hospital, School of Medicine, Zhejiang University",2,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":566,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":77},"100591115","phase-1-safety-and-early-efficacy-of-ipsc-derived-motor-neuron-progenitor-cells-xs228-in-subacute-spinal-cord-injury-a-phase-i-trial-100591115","NCT06976229","Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial","A Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury","Inclusion Criteria:\n\nAge: 18 to 65 years (inclusive), regardless of gender.\n\nEtiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.\n\nSeverity:\n\nClassified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.\n\nDisease Stage:\n\nPrimary SCI occurring 14 to 60 days prior to screening (subacute phase).\n\nContraception:\n\nParticipants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.\n\nCompliance:\n\nVoluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.\n\nExclusion Criteria:\n\n* Neurological Inability\n\nPrimary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.\n\nRespiratory\u002FCirculatory Instability\n\nHigh cervical SCI (C1-C3) causing respiratory\u002Fcirculatory compromise requiring endotracheal intubation or tracheostomy.\n\nLife-Threatening Multiorgan Dysfunction\n\nConcurrent severe injuries to other organ systems with life-threatening dysfunction.\n\nUnstable Thoracoabdominal Injuries\n\nInjuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.\n\nPrior Spinal Pathology\n\nHistory of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary\u002Fmetastatic spinal tumors, spinal vascular malformations, syringomyelia).\n\nLocal Infection\u002FIncreased ICP\n\nActive infection at the lumbar puncture site or intracranial hypertension during screening.\n\nSevere Infections\n\nSepsis, septic shock, or severe pneumonia (per IDSA\u002FATS 2007 diagnostic criteria).\n\nConfounding Neurological\u002FPsychiatric Conditions\n\nParkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.\n\nCardiac Abnormalities (any of the following):\n\nCongestive heart failure (NYHA Class III\u002FIV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).\n\nUnstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications\n\nPulmonary hypertension, pulmonary embolism, or suspected embolism during screening.\n\nUncontrolled Hypertension\u002FHypotension\n\nSystolic BP \\>160 mmHg or diastolic BP \\>100 mmHg; or systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg.\n\nActive Autoimmune Diseases\n\nRequiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).\n\nImmunosuppressant Non-Compliance\n\nUnwillingness or inability to use immunosuppressants per protocol.\n\nLaboratory Abnormalities (any of the following):\n\nALT\u002FAST \\>2×ULN or total bilirubin \\>2×ULN. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI 2021 formula). APTT\u002FPT \\>2.5×ULN (without anticoagulants). Platelets \\\u003C100×10⁹\u002FL or hemoglobin \\\u003C90 g\u002FL. Allergy\n\nHistory of severe allergies or hypersensitivity to trial drug\u002Fexcipients (human albumin, lactated Ringer's solution).\n\nInfectious Diseases\n\nHBsAg+ with HBV DNA \\>1000 IU\u002FmL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal\n\nUnwillingness to undergo intrathecal administration procedures. Pregnancy\u002FLactation\n\nFemales who are pregnant or breastfeeding. Malignancy\n\nActive malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation\n\nEnrollment in another drug trial within 3 months prior. Investigator Discretion\n\nAny condition deemed unsuitable for participation by the investigator.",{"count":557,"type":21},12,[24],"This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury",[561,29,562,265,563,564,565],"Spinal Cord Injury","Clinical Trials","Induced Pluripotent Stem Cells","Human Motor Neuron Progenitor","Transplantation",[567,122,568,569,563,570,565],"spinal cord injury","efficacy","clinical trials","Human motor neuron progenitor","2025-11-19",{"date":573,"type":37},"2025-11-25",{"date":575,"type":37},"2025-07-02",{"date":577,"type":21},"2028-05-30",{"name":579,"class":44},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":593,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":77},"100591018","phase-2-efficacy-of-ipsc-derived-motor-neuron-cells-xs228-in-subacute-spinal-cord-injury-a-phase-ii-randomized-controlled-trial-100591018","NCT06974968","Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial","A Phase II Clinical Study Evaluating the Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury","Inclusion Criteria:\n\n* Age: 18 to 65 years (inclusive), regardless of gender.\n\nEtiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.\n\nSeverity:\n\nClassified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.\n\nDisease Stage:\n\nPrimary SCI occurring 14 to 60 days prior to screening (subacute phase).\n\nContraception:\n\nParticipants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.\n\nCompliance:\n\nVoluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.\n\nExclusion Criteria:\n\n* Neurological Inability\n\nPrimary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.\n\nRespiratory\u002FCirculatory Instability\n\nHigh cervical SCI (C1-C3) causing respiratory\u002Fcirculatory compromise requiring endotracheal intubation or tracheostomy.\n\nLife-Threatening Multiorgan Dysfunction\n\nConcurrent severe injuries to other organ systems with life-threatening dysfunction.\n\nUnstable Thoracoabdominal Injuries\n\nInjuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.\n\nPrior Spinal Pathology\n\nHistory of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary\u002Fmetastatic spinal tumors, spinal vascular malformations, syringomyelia).\n\nLocal Infection\u002FIncreased ICP\n\nActive infection at the lumbar puncture site or intracranial hypertension during screening.\n\nSevere Infections\n\nSepsis, septic shock, or severe pneumonia (per IDSA\u002FATS 2007 diagnostic criteria).\n\nConfounding Neurological\u002FPsychiatric Conditions\n\nParkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.\n\nCardiac Abnormalities (any of the following):\n\nCongestive heart failure (NYHA Class III\u002FIV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).\n\nUnstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications\n\nPulmonary hypertension, pulmonary embolism, or suspected embolism during screening.\n\nUncontrolled Hypertension\u002FHypotension\n\nSystolic BP \\>160 mmHg or diastolic BP \\>100 mmHg; or systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg.\n\nActive Autoimmune Diseases\n\nRequiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).\n\nImmunosuppressant Non-Compliance\n\nUnwillingness or inability to use immunosuppressants per protocol.\n\nLaboratory Abnormalities (any of the following):\n\nALT\u002FAST \\>2×ULN or total bilirubin \\>2×ULN. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI 2021 formula). APTT\u002FPT \\>2.5×ULN (without anticoagulants). Platelets \\\u003C100×10⁹\u002FL or hemoglobin \\\u003C90 g\u002FL. Allergy\n\nHistory of severe allergies or hypersensitivity to trial drug\u002Fexcipients (human albumin, lactated Ringer's solution).\n\nInfectious Diseases\n\nHBsAg+ with HBV DNA \\>1000 IU\u002FmL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal\n\nUnwillingness to undergo intrathecal administration procedures. Pregnancy\u002FLactation\n\nFemales who are pregnant or breastfeeding. Malignancy\n\nActive malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation\n\nEnrollment in another drug trial within 3 months prior. Investigator Discretion\n\nAny condition deemed unsuitable for participation by the investigator",{"count":112,"type":21},[233],"Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries.\n\nStudy Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose.\n\nWho Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C).\n\nStudy Plan:\n\nPhase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio.\n\nFollow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress.\n\nWhat Researchers Are Looking For:\n\nPrimary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months.\n\nSecondary Goals:\n\nImprovement in ASIA Impairment Scale (AIS) grade (e.g., from \"complete\" to \"incomplete\" paralysis).\n\nRecovery of sensation and bladder\u002Fbowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth.\n\nWhy This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.",[561,29,265,591,563,564,565,592],"Clinical Trial","RCT",[561,29,568,594,563,570,565,592],"clinical trial",{"date":573,"type":37},{"date":597,"type":21},"2028-05-25",{"date":599,"type":21},"2031-05-26",{"name":579,"class":44},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":139,"sex":52,"minAge":17,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":77},"100573887","phase-1-safety-tolerability-and-pharmacokinetics-of-rcs-21-in-healthy-volunteers-100573887","NCT06752122","Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.","Safety, Tolerability and Pharmacokinetics of Single-ascending Doses of RCS-21 in Healthy Volunteers. A Double Blind, Randomized, Placebo Controlled Phase I Study.","AMIR-21","Inclusion Criteria:\n\n1. Able and willing to give written informed consent.\n2. Male or female aged 18 to 64 years (inclusive).\n3. Women will be considered for inclusion if they are:\n\n   * Not pregnant, as confirmed by pregnancy test (see assess- ment schedule), and not breastfeeding. AND\n   * WOCBP must use one of the following highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly\n\n     * according to recommendations by the European Heads of Medicines Agencies - from at least 14 days before the first administration of study medication until 30 days after the last administration of study medication:\n\n       * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n         * oral\n         * intravaginal\n         * transdermal\n       * progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n         * oral\n         * injectable\n         * implantable\n       * intrauterine device (IUD)\n       * intrauterine hormone-releasing system (IUS)\n       * bilateral tubal occlusion\n       * vasectomized partner (provided that this partner is the sole sexual partner of the WOCBP participant and that the vasectomized partner has received medical as- sessment of the surgical success)\n       * sexual abstinence (defined as refraining from hetero- sexual intercourse during the entire study period, be- ginning 2 weeks prior to the screening visit) OR\n   * Of non-childbearing potential defined according to the Clinical Trial Facilitation Group (CTFG) document \"Recommendations related to contraception and pregnancy testing in clinical trials\"\n4. Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 30 days after the last administra- tion of study medication:\n\n   * Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator.\n   * Male participants are required to use a condom during treatment and until 30 days after the last administration of study medication.\n   * Female partners of male participants who have not undergone a vasectomy with the absence of sperm confirmed or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until 30 days after the last administration of study medication.\n   * Sperm donation is not allowed during treatment and until 30 days after the last administration of study medication.\n5. Healthy participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead Electrocardiogram (ECG), pulmonary function testing and clinical laboratory tests.\n6. Body Mass Index (BMI) of 18.5 to 31.9 kg\u002Fm2 (inclusive).\n7. Ability to inhale in an appropriate manner (e.g. as confirmed in the inhalation training using the PARI eFlow® device with a pla- cebo medication at the screening visit).\n8. Non-smokers (including e-cigarette) or ex-smokers (with less than 10 pack years and stopped smoking for at least 5 years prior to screening visit).\n9. Normal pulmonary function with Forced Expiratory Volume in the first second (FEV1) ≥ 80 % of predicted normal at screening visit. Calculations will be based on the Global Lung Function Initiative (GLI 2012) formula.\n\nExclusion Criteria:\n\n1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study or may influence the results of the study, or the participant's ability to participate in the study.\n2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, he- patic disease (asymptomatic Gilbert syndrome is allowed), renal disease, hematological disease, neurological disease, endo- crine disease (stable and asymptomatic hypothyroidism with or without Hormone Replacement Therapy (HRT) is allowed) or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).\n3. Having received any vaccination within the last 2 weeks before the first screening visit.\n4. History or current evidence of clinically relevant allergies or idiosyncrasy to any drug or food.\n5. History of allergic reactions to any active or inactive component of the study medication (including medication for bronchoscopy, e.g. salbutamol, lidocaine, midazolam or propofol).\n6. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).\n7. Proneness to orthostatic dysregulation, fainting, or blackouts.\n8. History or presence of any malignancy except for basalioma.\n9. Chronic or acute infections or history of an acute infection during the four weeks before the first screening visit.\n10. Positive results in any of the following virology tests: human im- munodeficiency virus (HIV) antibodies and antigen, Anti-hepati- tis B-core antibody (HBc-Ab), hepatitis B-surface antigen (HBs- Ag) and anti-hepatitis C virus antibody (HCV-Ab).\n11. Positive drug screen (amphetamines, barbiturates, benzodiaze- pines, cannabinoids, cocaine, methadone, methamphetamine, opiates, phencyclidine, or tricyclic antidepressants).\n12. History of previous administration of any registered or investiga- tional oligonucleotide-based drug.\n13. History or presence of alcohol or drug abuse.\n14. Use of any medication (including over-the-counter medication, herbal products) except allowed concomitant medication within 2 weeks (for biologics: 6 months) before administration of IMP or within \\< 10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer.\n15. Positive breath alcohol test.\n16. Planned donation of oocytes, blood, organs, bone marrow dur- ing the course of the study or within 6 months after the last screening visit.\n17. Participation in another clinical study with an investigational drug or device within the last 3 months or during the course of the study. For biologics, the minimum exclusion period is at least 6 months or the time of duration of the pharmacodynamic effect or 10 times the half-life of the respective drug whatever is longer before inclusion in this study.\n18. Blood donation of more than 250 ml within the last 30 days before the first screening visit.\n19. Anticipated non-availability for study visits\u002Fprocedures.\n20. Anticipated lack of willingness or inability to cooperate adequately.\n21. Vulnerable participants, except WOCBP.","64 Years",{"count":315,"type":21},[24],"The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose of RCS-21 and their health status will be constantly monitored.",[460,29,30,31],[615,616,617,618],"RCS-21","Phase I","Healthy volunteers","Inhalation","2025-11-17",{"date":621,"type":37},"2025-11-20",{"date":623,"type":37},"2025-02-18",{"date":625,"type":21},"2026-08",{"name":627,"class":44},"RNATICS GmbH",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":638,"conditions":639,"keywords":642,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":77},"100605030","an-international-survey-on-the-use-of-niv-outside-the-icu-100605030","NCT07157215","An International Survey on the Use of NIV Outside the ICU","An International Survey on the Use of NIV Outside the ICU (NIV-Safety Study)","NIV-SAFETY","Inclusion criteria Physicians, Nursing Officers, and Respiratory therapists dealing with adult patients with acute and chronic respiratory failure.\n\nExclusion Criteria Physicians and Respiratory therapists who refuse to give consent.",{"count":637,"type":21},400,"Non-invasive ventilation (NIV) is a way to support breathing using a mask or helmet instead of a breathing tube, and it is proven to reduce the need for intubation, save lives, shorten hospital stays, and lower costs. While NIV has long been used in intensive care units, it is now increasingly applied in emergency rooms, hospital wards, and long-term care facilities. However, global data on how it is used outside ICUs-such as which patients receive it, how well it works, and what barriers exist-is lacking. The NIV-Safety Study is a worldwide survey of doctors, nurses, and respiratory therapists to understand current practices, outcomes, and challenges of NIV use beyond the ICU. The findings aim to guide safer, more effective, and standardized use of NIV across different healthcare settings.",[640,641,29],"Non-invasive Ventilation","Intensive Care (ICU)",[643,644,645],"NIV","SAFETY","ICU","2025-09-28",{"date":648,"type":37},"2025-09-30",{"date":650,"type":37},"2025-09-16",{"date":652,"type":21},"2026-03-15",{"name":654,"class":655},"Dr. Ram Manohar Lohia Hospital","OTHER_GOV"]