[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"efficacy-and-safety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:efficacy-and-safety":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,72,108,135,160,184,217,239,268,290,307,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100635832","efficacy-of-thermal-ablation-combined-with-antithyroid-drugs-in-the-treatment-of-primary-hyperthyroidism-100635832",false,"NCT07557810","Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism","Multicenter Study on the Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism","Inclusion Criteria:\n\n* Patients diagnosed with primary hyperthyroidism based on clinical manifestations and laboratory findings;\n* Patients whose basal metabolic rate (BMR) remains within ±20% of the normal reference range, and whose resting heart rate is controlled at ≤90 beats\u002Fmin;\n* Patients with inadequate response to standard antithyroid drug (ATD) therapy, those experiencing severe adverse reactions to ATDs, those unsuitable for or unresponsive to radioactive iodine (RAI) therapy, or those who decline conventional surgical resection and wish to undergo ablation combined with medication to shorten the treatment course and achieve rapid improvement of hyperthyroid symptoms, including patients with mild, moderate, or severe disease;\n* Patients with concomitant moderate-to-severe Graves' ophthalmopathy (GO);\n* Patients with a safe needle trajectory for ablation access;\n* Patients who are able to understand the purpose of the study, voluntarily participate, and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe coagulopathy;\n* Poor general condition, such as concomitant severe cardiac, hepatic, renal, or other major organ dysfunction;\n* Substernal goiter or a thyroid gland largely located in the retrosternal space (relative contraindication; staged treatment may be considered);\n* Patients with malignant exophthalmos in whom the condition may worsen post-procedure;\n* Patients with significant tracheal compression requiring urgent decompression;\n* Unilateral vocal cord dysfunction confirmed by laryngoscopy;\n* Women in the first or third trimester of pregnancy, lactating women, or those planning pregnancy in the near future.","ALL","80 Years",{"count":19,"type":20},454,"ESTIMATED","OBSERVATIONAL","Hyperthyroidism is a clinical syndrome caused by excessive production of thyroid hormones, leading to accelerated metabolism and increased excitability of multiple organ systems. Patients commonly present with polyphagia, weight loss, palpitations, and sweating. Primary hyperthyroidism is a common endocrine disorder traditionally treated with anti-thyroid drugs (ATD), radioactive iodine (¹³¹I), or surgery.\n\nWhile ATD can rapidly inhibit thyroid hormone synthesis and control symptoms, long-term use carries risks of liver damage and bone marrow suppression. Radioactive iodine involves risks of recurrence or permanent hypothyroidism, and thyroidectomy-though effective-is associated with significant trauma, potential complications, and cervical scarring. Given the limitations of these monotherapies, a combined approach leveraging thermal ablation as an adjunct to antithyroid drug therapy has emerged as a promising strategy for both rapid symptom control and long-term management.\n\nWith advances in minimally invasive techniques, thermal ablation combined with pharmacotherapy offers a balanced solution. Thermal ablation-including microwave and radiofrequency ablation-provides high precision, minimal invasiveness, and rapid recovery by directly destroying hyperfunctioning thyroid tissue under ultrasound guidance. When paired with a tailored antithyroid drug regimen, this approach not only secures immediate stabilization of thyroid function but also reduces the required drug dosage and duration, thereby mitigating drug-related adverse effects. This combined strategy maintains the cosmetic and cost-effective advantages of ablation while addressing the need for sustained endocrine control.\n\nStudies have demonstrated that thermal ablation combined with antithyroid drugs effectively normalizes T3 and T4 levels, alleviates hypermetabolic symptoms such as palpitations and sweating, and significantly improves quality of life with a low complication rate. This integrated model is suitable for initial treatment, recurrent or refractory cases, and is particularly advantageous for patients with reduced cardiopulmonary reserve or advanced age.\n\nHowever, current evidence is largely derived from single-center studies, and high-quality multicenter data are needed to validate this combined strategy. This study aims to prospectively collect baseline data from patients undergoing thermal ablation in conjunction with antithyroid drug therapy across multiple centers. The objectives are to evaluate the efficacy and safety of this combined modality, explore the factors influencing the prognosis of ablation in a medicated context, optimize postoperative medication adjustment protocols, and provide high-quality evidence to guide the standardization and clinical dissemination of this synergistic approach.",[24,25,26,27],"Complication Rate","Efficacy and Safety","Hyperthyroidism\u002FThyrotoxicosis","Cure Rate",[29],"Thermal Ablation","RECRUITING","2026-04-25",{"date":33,"type":34},"2026-04-29","ACTUAL",{"date":36,"type":34},"2025-02-13",{"date":38,"type":20},"2029-12-01",{"name":40,"class":41},"Chinese PLA General Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100620828","a-cohort-study-of-the-efficacy-and-safety-of-biologics-in-patients-with-abpa-100620828","NCT07362693","A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA","A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision).\n2. The underlying disease was bronchial asthma, and it was severe bronchial asthma.\n3. Have had an acute asthma attack in the past year. Acute exacerbation of asthma is defined as the sudden onset of wheezing, shortness of breath, cough, chest tightness and other symptoms beyond the definition of uncontrolled asthma, or the aggravation of the original symptoms, and is characterized by decreased expiratory flow, often induced by exposure to allergens, irritants or respiratory tract infection.\n4. Blood eosinophil count ≥150 cells \u002FμL.\n5. Age ≥ 18 years old.\n\nExclusion Criteria:\n\n1. The underlying diseases were chronic obstructive pulmonary disease and bronchiectasis;\n2. Known allergic history to biological agents;\n3. Human immunodeficiency virus infection, active pulmonary tuberculosis or pulmonary malignant tumor;\n4. Complicated with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);\n5. Pregnant or lactating women;\n6. Currently participating in other interventional clinical research;\n7. Any other conditions considered by the investigator to preclude participation in the study (e.g., nonadherence, predicted survival \\\u003C1 year, or severe mental illness that prevented cooperation).","18 Years",{"count":52,"type":20},50,"2 Years","To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.",[56,57,58,59,60,25],"ABPA","Biologics","Allergic Bronchopulmonary Aspergillosis (ABPA)","Cohort Study","Allergic Bronchopulmonary Aspergillosis",[62,60,57],"abpa","2026-04-16",{"date":65,"type":34},"2026-04-17",{"date":67,"type":34},"2025-01-31",{"date":69,"type":20},"2028-12-31",{"name":71,"class":41},"Qianfoshan Hospital",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":42},"100612664","comparative-evaluation-of-finger-splint-paraffin-and-peloidotherapy-interventions-in-the-management-of-trigger-finger-100612664","NCT07256522","Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger","Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger. A Prospective, Randomized, Controlled Study","Inclusion Criteria:\n\n* Being between 18 and 75 years of age and willing to participate in the study\n* Having a diagnosis of idiopathic single trigger finger, Grade 2-3\n\nExclusion Criteria:\n\n* Patients with triggering in more than one finger\n* Patients with triggering at the A3 pulley or with Grade 1 or Grade 4 trigger finger\n* Patients with thumb (pollex) trigger finger\n* Patients who have undergone any injection or interventional procedure (release surgery) for trigger finger within the past 6 months\n* Patients who have received physical therapy for the hand within the past 6 months\n* Patients currently using corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Patients with inflammatory or autoimmune rheumatologic diseases such as rheumatoid arthritis, systemic lupus erythematosus, gout, or psoriatic arthritis\n* Patients with other musculoskeletal disorders (e.g., carpal tunnel syndrome, de Quervain's tenosynovitis, symptomatic hand osteoarthritis, or Dupuytren's contracture) or neurological diseases (e.g., stroke-related hemiparesis, spinal cord injury, brachial plexus injury, multiple sclerosis, or Parkinsonism) affecting the same hand\n* Patients with musculoskeletal disorders causing pain and\u002For limitation in the proximal upper extremity on the affected side (e.g., periarthritis, lateral epicondylitis, mononeuropathy, or radiculopathy)\n* Patients with significant metabolic diseases (e.g., hypothyroidism, Cushing's syndrome, or uncontrolled diabetes)\n* Patients with any condition that may interfere with treatment, such as open wounds, rashes, local infections, or active malignant disease of the hand\n* Patients with a history of hand trauma (chronic or repetitive)\n* Patients unwilling to complete the self-assessment questionnaires either independently or with assistance\n* Pregnant women","75 Years",{"count":81,"type":20},60,"INTERVENTIONAL",[84],"NA","Patients aged 18-75 years who present with trigger finger to a tertiary rehabilitation hospital and agree to participate will be included in the study. Participants will be randomly allocated into three groups using block randomization. The first group will use a static finger splint that blocks the proximal interphalangeal joint for 6 weeks, along with a home exercise program. The second group will receive paraffin bath therapy, and the third group will receive peloidotherapy, both in combination with home exercises.\n\nAll patients will receive education about the disease and activity modification. The finger joint-restricting splint and exercises will be applied for 6 weeks. Evaluations will be conducted at baseline, at the end of the 3rd week, and at the end of the 6th week by a blinded assessor. No analgesic or anti-inflammatory medication will be permitted during the study, and patients will be instructed to avoid using analgesics within 24 hours prior to each assessment.",[87,88,89,90,25,91],"Trigger Finger","Splint Therapy","Paraffin Bath","Peloidotherapy","Randomised Clinical Trial",[93,94,95,96,97],"trigger finger","splint therapy","paraffin bath","peloidotherapy","Randomised Controlled Study","2026-03-17",{"date":100,"type":34},"2026-03-19",{"date":102,"type":34},"2025-12-15",{"date":104,"type":20},"2027-02-15",{"name":106,"class":107},"Konya Beyhekim Training and Research Hospital","OTHER_GOV",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":82,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100572373","clinical-study-of-fospropofol-disodium-for-injection-in-the-painless-endoscopic-diagnosis-and-treatment-100572373","NCT06732427","Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment","Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Age 50-65 years, weight 40-65kg, male or female;\n2. Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;\n3. American Society of Anesthesia (ASA) grades I-II;\n4. Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -\n\nExclusion Criteria:\n\n1. Patients with simple and painless gastroscopy\n2. Allergy to this study drug and any ingredients;\n3. Patients with pathological obesity \u002F obstructive sleep apnea, patients with difficult respiratory tract management;\n4. Acute upper respiratory tract infection and asthma attacks;\n5. Liver and kidney insufficiency, abnormal heart function;\n6. History of mental disorders, long-term use of analgesics; history of drug addiction and drug use;\n7. Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-","50 Years","65 Years",{"count":118,"type":20},426,[84],"This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete.\n\nThis is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.",[25],[123,124],"Painless gastrointestinal endoscopy","fospropofol disodium for injection","2025-09-25",{"date":127,"type":34},"2025-09-30",{"date":129,"type":34},"2025-08-12",{"date":131,"type":20},"2026-12-31",{"name":133,"class":41},"Affiliated Hospital of Nantong University",5,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":82,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100602678","a-study-on-the-short-course-treatment-regimen-containing-pretomanid-for-drug-resistant-tuberculosis-100602678","NCT07126639","A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis","BPaLM","Inclusion Criteria:\n\nhe research participants themselves voluntarily signed the informed consent form before being enrolled; for those without full capacity for civil conduct, the consent form was signed by their legal guardians.\n\nThe research participants (and their guardians) indicated their willingness to complete all steps and intervention periods of the study.\n\nMale or female, aged 12 years or older, weighing 30 kilograms or more. Confirmed cases of pulmonary tuberculosis pathogen, with molecular or phenotypic drug sensitivity results within the past 3 months confirming resistance to rifampicin, and confirmed by the pathogen culture results of sputum collected at the time of enrollment.\n\nFertile women not in pregnancy, voluntarily undergoing pregnancy tests, with negative results, and willing to use highly effective contraceptive measures from the time of signing the informed consent until 3 months after the end of the study treatment.\n\nFor fertile men, use condoms or other methods to ensure effective contraception for their sexual partners.\n\nWomen in lactation, willing to stop breastfeeding from the time of signing the informed consent until 3 months after the end of the study treatment.\n\nVoluntary to undergo HIV testing. If the result is positive, voluntarily accept antiretroviral therapy.\n\nExclusion Criteria:\n\nHad a known hypersensitivity reaction to any drug in the protocol. Was participating in any clinical trial of other drugs. At the screening stage, had cardiovascular disease risk: QTcF interval over 480 milliseconds; within 60 days before enrollment, had a history of clinically significant arrhythmia that the investigator considered could be clinically significant, and the investigator considered that participating in the study might increase the risk; decompensated heart failure; grade 3 hypertension and not reaching the control target; thyroid dysfunction; abnormal serum calcium, magnesium or potassium levels.\n\nHad a history of optic nerve or peripheral nerve lesion, and the investigator considered that it might progress\u002Fdeteriorate during the study or was not suitable for participating in this study.\n\nAt the screening stage, had the following liver disease manifestations: active viral hepatitis; decompensated stage of liver cirrhosis.\n\nAt the screening stage, had the following kidney disease history or kidney-related manifestations: unstable or rapidly progressive kidney disease history; moderate\u002Fsevere renal function impairment or end-stage renal disease; male serum creatinine ≥ 133 μmol\u002FL, female serum creatinine ≥ 124 μmol\u002FL.\n\nOther laboratory test abnormalities: hemoglobin level \\\u003C 8.0 g\u002FdL; platelet count \\\u003C 75,000\u002Fmm³; absolute neutrophil count \\\u003C 1000\u002Fmm³; aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 3×ULN; total bilirubin \\> 2×ULN, or \\> 1.5×ULN, combined with other liver enzyme abnormalities; albumin \\\u003C 30 g\u002FL.\n\nThe investigator considered that the study participants could not complete the study process, or participating in the study was unsafe for the study participants.","12 Years",{"count":144,"type":20},200,[84],"Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, high incidence of adverse reactions and long treatment course, which leads to poor patient compliance. There is an urgent need for new, effective and safe short-course regimens for drug-resistant tuberculosis. A 6-month short-course oral regimen containing pretomanid was introduced in 2020. However, as pretomanid is not yet available in China, it has not been verified and promoted in China. Pretomanid is expected to be launched in China in 2025, and it is urgent to evaluate the application of the new short-course regimen containing pretomanid in the Chinese population. This study is a prospective, randomized, controlled clinical trial. It plans to include RR-TB patients aged ≥12 years in multiple domestic centers. Under the guidance of rapid molecular drug susceptibility test results, the experimental group will be treated with bedaquiline, pretomanid, linezolid and moxifloxacin for 6 months, while the control group will be treated with bedaquiline, delamanid, linezolid and levofloxacin or bedaquiline, delamanid, linezolid and clofazimine for 6 months, depending on the susceptibility to fluoroquinolones. For patients with unknown susceptibility to fluoroquinolones, bedaquiline, delamanid, linezolid, levofloxacin and clofazimine will be used for 6 months. The efficacy and safety will be evaluated to provide a basis for the introduction and implementation of new short-course regimens for RR-TB in China.",[25],[140,149],"short-course treatment regiment","NOT_YET_RECRUITING","2025-08-10",{"date":153,"type":34},"2025-08-17",{"date":155,"type":20},"2025-09-01",{"date":157,"type":20},"2028-09-30",{"name":159,"class":41},"Wuhan Pulmonary Hospital",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":79,"enrollmentInfo":167,"targetDuration":4,"studyType":82,"phases":168,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":42},"100597645","phase-4-fengliao-changweikang-for-diarrhea-predominant-irritable-bowel-syndrome-n-of-1-trial-100597645","NCT07061184","Fengliao Changweikang for Diarrhea-predominant Irritable Bowel Syndrome: N-of-1 Trial","The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial","Inclusion Criteria:\n\n1. Aged between 18 and 75 years.\n2. Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points\\[14\\].\n3. Ability to complete questionnaires and provide written informed consent.\n4. Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.\n5. Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.\n\nExclusion Criteria:\n\n1. History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.\n2. Scores of IBS-SSS \\> 300 points or IBS-SSS \\\u003C 75 points.\n3. History of severe heart, kidney or liver diseases.\n4. Pregnant or breastfeeding.\n5. Current alcohol or drug abuse.",{"count":52,"type":20},[169],"PHASE4","Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development.\n\nThis study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients.\n\nAfter 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.",[172,173,174,25],"Irritable Bowel Syndrome - Diarrhoea","Traditional Chinese Medicine (TCM)","N of 1 Study Design","2025-07-02",{"date":177,"type":34},"2025-07-11",{"date":179,"type":20},"2025-11",{"date":181,"type":20},"2028-05",{"name":183,"class":41},"Peking Union Medical College Hospital",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":192,"targetDuration":194,"studyType":21,"phases":4,"briefSummary":195,"conditions":196,"keywords":201,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":42},"100579637","safety-and-efficacy-of-impt-or-imrt-for-breast-cancer-100579637","NCT06826885","Safety and Efficacy of IMPT or IMRT for Breast Cancer","The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study","SEPPT-BC","Inclusion Criteria\n\n* Aged ≥18 years old\n* Karnofsky Performance Status (KPS) score ≥70\n* Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.\n* ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.\n* Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.\n* Ability to understand and willingness to participate in the research and sign the informed consent form.\n\nExclusion Criteria\n\n* Pregnant or lactating women.\n* Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.\n* Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.\n* Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.",{"count":193,"type":20},500,"5 Years","The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and\u002For regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.",[197,198,199,25,200],"Breast Cancer","Proton Therapy","Intensity Modulated Radiation Therapy","Radiotherapy, Adjuvant",[202,203,204,205,206,207,208],"postoperative radiotherapy","preoperative radiotherapy","IMPT","IMRT","breast cancer","efficacy","toxicity",{"date":210,"type":34},"2025-02-14",{"date":212,"type":34},"2024-12-01",{"date":214,"type":20},"2029-11-30",{"name":216,"class":41},"Ruijin Hospital",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":82,"phases":226,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":237,"locationsCount":42},"100354923","phase-1-msc-intratissular-injection-in-crohn-disease-patients-100354923","NCT03901235","MSC Intratissular Injection in Crohn Disease Patients","Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells","MSC","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Signing the informed consent\n* Diagnosis of Crohn Disease for more than 6 months\n* Presence of at least one Crohn Disease lesion refractory to conventional therapies (azathioprine, 6-mercaptopurine or methotrexate) and to biologic treatments (anti-Tumor Necrosis Factor therapies, vedolizumab, or ustekinumab).\n* Refractory lesion defined by (1) a stricture with a length of 2 to 5cm of the colon or the ileum accessible by ileocolonoscopy (i.e. a lesion identified during a colonoscopy with a lumen narrowing non passable by the colonoscope), (2) unhealed deep ulcer of the colon or the ileum accessible to ileocolonoscopy, or (3) actively draining perianal fistula(s).\n* Twenty patients with stricture(s), 20 patients with unhealed deep ulcer(s), and 20 patients with an actively draining perianal fistula(s) will be included\n\nExclusion Criteria:\n\n* Indication for immediate luminal surgery\n* Intestinal obstruction\n* Intra-abdominal fistulas or abscess\n* Intestinal\u002Fcolonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy\n* Undrained peri-anal abscess\n* Pregnant women or planning pregnancy within one year\n* Positive stool culture\u002Ftoxin for clostridium difficile pathogen or other pathogens\n* Renal failure (anuria, serious fluid overload, Glomerular Filtration Rate \\\u003C 30 ml\u002Fmin, dialysis) or hepatic failure (Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \\>3 mg\u002FdL)\n* documented human immunodeficiency virus infection; active hepatitis B, C, or tuberculosis\n* an opportunistic infection within 6 months before screening or a serious infection in the previous 3 months\n* malignancy within the past 5 years; or a history of lymphoproliferative disease",{"count":81,"type":20},[227,228],"PHASE1","PHASE2","The main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.",[25],"2024-12-06",{"date":233,"type":34},"2024-12-12",{"date":235,"type":34},"2018-01-15",{"date":131,"type":20},{"name":238,"class":41},"University of Liege",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":246,"minAge":50,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":82,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":42},"100402303","phase-1-fuzuloparib-arsenic-trioxide-platinum-resistance-relapsed-ovarian-cancer-100402303","NCT04518501","Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer","Fuzuloparib Plus Arsenic Trioxide in Patients With Platinum Resistance Relapsed Ovarian Cancer","Inclusion Criteria:\n\n* 18-70years old;\n* High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma;\n* Patients received at least two lines of platinum-containing chemotherapy, with recurrence occurring within six months after the last chemotherapy dose, or were platinum-refractory patients who have undergone at least two cycles of platinum-based chemotherapy;\n* Measurable disease as per RECIST 1.1\n* ECOG 0-2;\n* Life expectancy ≥12 weeks;\n* Confirmation of BRCA1\u002F2 mutation status;\n* PARPi naive;\n* LVEF ≥ 50%;\n* Bone Marrow Function: ANC：≥1.5×109\u002FL； PLT：≥100×109\u002FL；Hb: ≥90g\u002FL;\n* Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \\\u003CULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present;\n* The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating;\n* Signed the informed consent;\n\nExclusion Criteria:\n\n* Prior treatment with PARP inhibitors except under specific conditions: 1. Patients who previously received PARP inhibitor (PARPi) therapy without disease progression during treatment, but discontinued due to reasons such as treatment cost or adherence issues; 2. Patients who received only one prior PARPi therapy (excluding fuzuloparib), with maintenance therapy lasting ≥ 12 months. In both cases, the time since the last PARPi treatment must be \\>6 months prior to study enrollment;\n* Patients who had previously received \\>20% bone marrow radiotherapy in 1 week;\n* Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;\n* Uncontrolled systemic infection requiring anti-infective treatment;\n* Allergies to the Fuzuloparib or Arsenic Trioxide or their excipients or intolerant patients;\n* Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;\n* Researchers think it is not suitable for enrolling.","FEMALE","70 Years",{"count":52,"type":20},[227,228],"Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes.\n\nTo explore the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide therapy in platinum-resistance relapsed Ovarian cancer patients.",[25],[253,254,255,256,257,258],"PARPI","Arsenic Trioxide","High Grade Serous Carcinoma","High Grade Endometria Carcinoma","Platinum-resistant Ovarian Cancer","Fuzuloparib","2024-12-03",{"date":261,"type":34},"2024-12-04",{"date":263,"type":34},"2020-07-01",{"date":265,"type":20},"2025-01-01",{"name":267,"class":41},"Xing Xie",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100570618","thermal-ablation-versus-parathyroidectomy-for-secondary-hyperparathyroidism-100570618","NCT06709586","Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism","Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism: a Multicenter Study","Inclusion Criteria:\n\n* persistent serum iPTH (intact parathyroid hormone) levels \\> 800 pg\u002FmL；\n* resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment；\n* severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life；\n* imaging examinations indicating the presence of at least one enlarged parathyroid gland\n\nExclusion Criteria:\n\n* severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia",{"count":276,"type":20},612,"Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.",[279,25,280,281,282],"Achievement Rate","PTH","Calcium","Clinical Symptoms","2024-11-26",{"date":285,"type":34},"2024-11-29",{"date":283,"type":20},{"date":288,"type":20},"2028-12-30",{"name":40,"class":41},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100570563","thermal-ablation-versus-parathyroidectomy-for-primary-hyperparathyroidism-100570563","NCT06708871","Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism","Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study","Inclusion Criteria:\n\n* Symptomatic patients with primary hyperparathyroidism, such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as muscle weakness, dysfunction, and sleep disorders.\n* Asymptomatic PHPT patients with any of the following conditions:\n\n  ① Serum calcium is higher than the upper limit of the normal value by 1 mg\u002FdL (0.25 mmol\u002FL);\n\n  ② There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level \\> 400 mg\u002FdL) on renal imaging, or impaired renal function (glomerular filtration rate \\\u003C 60 mL\u002Fmin);\n\n  ③ There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and\u002For radiographic evidence of fragility fractures.\n\n  ④ Age \\\u003C 50 years\n\n  ⑤ The patient cannot accept routine follow - up observation.\n* Imaging examination shows that at least one parathyroid gland is enlarged.\n\nExclusion Criteria:\n\n* diagnosis of secondary or tertiary HPT\n* severe coagulation disorder\n* severe cardiopulmonary insufficiency",{"count":298,"type":20},520,"This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). The study will assess the impact of both treatment modalities on serum parathyroid hormone (iPTH) and calcium levels, clinical symptom improvement, bone mineral density enhancement, reduction in the incidence of urinary system stones, and postoperative complication rates. While surgical treatment has been the standard of care for PHPT, offering definitive cure, it carries inherent surgical risks and complications. Ablation therapy, as a minimally invasive approach, presents a novel alternative with reduced trauma and fewer complications. The outcomes of this study will inform clinical decision-making and potentially optimize treatment strategies for patients with PHPT.",[27,24,25],{"date":302,"type":34},"2024-11-27",{"date":283,"type":20},{"date":305,"type":20},"2028-12-26",{"name":40,"class":41},{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":314,"maxAge":17,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100543120","efficacy-and-safety-of-deep-cervical-lymph-node-vein-bypass-surgery-in-als-amyotrophic-lateral-sclerosis-100543120","NCT06351735","Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis","Evaluation of the Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* ①diagnosis of probable, clinically probable, clinically probable laboratory-supported, or clinically definite ALS according to the revised El Escorial World Federation of Neurology criteria; ② aged between 20 and 80 years old (inclusive); ③ ALS patients with King's Stage 3-4; ④ body weight not less than 45 kg and body mass index (BMI) not less than 18.0 kg\u002Fm2; 5) not currently receiving riluzole or receiving a stable dose of riluzole for at least 4 weeks before screening; Subjects who received riluzole were expected to maintain the same dose throughout the study; ⑦ Subjects' FVC≥60% predicted value after adjusting for sex, age, and height.\n\nExclusion Criteria:\n\n* ① Refusal to participate; ② Unable to complete MRI scan; ③ significant cognitive impairment, mental illness, epilepsy or other neurodegenerative diseases, substance abuse; ④ recent severe infection or infectious diseases within 4 weeks; ⑤ complicated with other systemic underlying diseases; Any past stem cell or gene therapy for ALS.","20 Years",{"count":316,"type":20},3,"Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression.",[25],[320],"Amyotrophic Lateral Sclerosis","2024-05-14",{"date":323,"type":34},"2024-05-16",{"date":325,"type":20},"2024-08-01",{"date":327,"type":20},"2027-08-01",{"name":329,"class":41},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":314,"maxAge":79,"enrollmentInfo":337,"targetDuration":4,"studyType":82,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100545528","phase-2-hr070803-in-combination-with-oxaliplatin-s-1-versus-nalirifox-as-adjuvant-therapy-for-pancreatic-cancer-100545528","NCT06383078","HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer","HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study","Inclusion Criteria:\n\n1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).\n2. ECOG performance status 0 or 1.\n3. Life expectancy of greater than or equal to 6 months.\n4. Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.\n5. The number of lymph nodes dissected during resection ≥ 15.\n6. Able and willing to provide a written informed consent.\n\nExclusion Criteria:\n\n1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;\n2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.\n3. CA19-9 exceeding normal value within 14 days prior to enrollment.\n4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.\n5. Severe infection (\\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;\n6. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.",{"count":338,"type":20},120,[228],"The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil\u002Fleucovorin (5FU\u002FLV) treatment as adjuvant therapy in patients with resected pancreatic cancer.",[25],"2024-04-22",{"date":344,"type":34},"2024-04-25",{"date":346,"type":20},"2024-04-20",{"date":348,"type":20},"2027-12-30",{"name":350,"class":41},"The First Affiliated Hospital with Nanjing Medical University"]