[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"safety-and-efficacy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:safety-and-efficacy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,72,99,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100630532","phase-1-rig-101-trial-in-healthy-adults-and-adults-with-asthma-100630532",false,"NCT07488897","RIG 101 Trial in Healthy Adults and Adults With Asthma","A Two-part Randomized, Double-blind Placebo Controlled Trial to Assess the Safety and Tolerability of Single and Repeat Ascending Intranasal Doses of RIG-101 in Healthy Participants Followed by Repeat Daily Administration in Adult Participants With Asthma [Part A] Followed by a Randomized Double-blind Placebo Controlled Part to Assess the Efficacy and Safety of RIG-101 in Adult Participants With Asthma Before and After Viral Challenge With Human Rhinovirus RV-A16 [Part B].","Inclusion Criteria:\n\nParticipants must meet all the following inclusion criteria to be eligible to participate in the trial.\n\n* Participants must have a written informed consent obtained prior to any trial related procedure\n* Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent.\n* Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.\n\nAdditional Inclusion Criteria for Healthy Participants\n\n\\- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1 \u002F FVC ratio of \\>70% absolute at screening.\n\nAdditional Inclusion Criteria for Participants with Asthma\n\n* Participants must have a clinical diagnosis of asthma.\n* Participants must have either a positive skin prick test with a wheal diameter of ≥3mm greater than control test at 15 minutes, and\u002For a blood eosinophil count of \\> 200 cells \u002F µL and\u002For a FeNO level of \\> 25 ppb at screening.\n* Participants must have a pre-bronchodilator FEV1 ≥65% predicted at screening\n* Participants must be using SABA alone or inhaled corticosteroids (ICS) with SABA or ICS with formoterol as reliever therapy, AND\u002FOR regular use of low to mid-dose ICS with or without LABA at a stable dose for at least 3 months prior to randomization to control their asthma.\n\nPart B only\n\n* Participants must have an ACQ-6 score of \\> 0.75 at screening.\n* Participants must have a history of asthma worsening in the previous 2 years, in response to a cold or respiratory infection, as confirmed by the participant.\n* Participants must demonstrate seronegativity to RV-A16\n\nExclusion Criteria:\n\nExclusion Criteria for all Participants\n\n* History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical trial, expose the participant to undue risk or interfere with the participants ability to successfully conduct the trial, as judged by the Investigator.\n* Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the trial at time of screening.\n* Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first administration of IMP and\u002For history of being hospitalized due to epistaxis on any previous occasion.\n* Any nasal or sinus surgery within 3 months of the first administration of IMP\n* Any signs of upper respiratory tract infection within 6 weeks of screening or prior to first administration of IMP\n* Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months prior to screening.\n* Smoking history of \\> 5 pack years.\n\nAdditional Exclusion Criteria for Participants with Asthma\n\n* Any asthma exacerbation on their current asthma controller medication requiring oral\u002Fsystemic corticosteroids within 8 weeks of randomization, or that resulted in overnight hospitalization requiring additional treatment for asthma within 3 months of randomization.\n* Difficult-to-treat or severe asthma requiring the maintenance use of add-on biologic Type 2 targeted treatments including anti-Immunoglobulin E, anti-IL4 receptor, anti-IL5, anti-IL5 receptor, and anti-Thymic Stromal Lymphopoietin\n* History of life-threatening asthma, defined as any asthma episode that required admission to a high-dependency or intensive therapy unit.\n* Individuals with close contact to at risk patient groups",true,"ALL","18 Years","65 Years",{"count":21,"type":22},82,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy",[29,30,31],"Healthy Adult Participants","Asthma Exacerbation","Safety and Efficacy","RECRUITING","2026-03-18",{"date":35,"type":36},"2026-03-23","ACTUAL",{"date":38,"type":36},"2026-02-09",{"date":40,"type":22},"2027-02",{"name":42,"class":43},"RIGImmune Inc.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100573834","phase-1-evaluation-of-clinical-perceived-and-instrumental-efficacy-of-a-scar-gel-in-preventing-hypertrophic-scars-100573834","NCT06751433","Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars","Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance","Inclusion Criteria:\n\n1. Participants of both sexes aged between 18 and 70 years;\n2. Participants with recent scars (\\\u003C30 days);\n3. Participants with phototypes III to VI according to the Fitzpatrick scale;\n4. Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;\n5. Understand, agree to and sign the free and informed consent form.\n6. Types of scars: cesarean section, breast implant or blunt cut injury.\n\nExclusion Criteria:\n\n1. Pregnancy or risk of pregnancy;\n2. History of atopic or allergic reactions to cosmetic products;\n3. Participants who are using topical antibiotics or other skin products on the same area being evaluated;\n4. Immunosuppression due to drugs or active diseases;\n5. Decompensated endocrine diseases;\n6. Relevant clinical history or current evidence of alcohol or other drug abuse;\n7. Known history or suspected intolerance to products in the same category;\n8. Intense sun exposure up to 15 days before the evaluation;\n9. Patients who are using topical antibiotics or other skin products on the same area being evaluated.","70 Years",{"count":54,"type":22},80,[25,26],"Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.",[58,59,31,60,61,62],"Acceptability Study","Real-use Conditions","Topical Administration","Hypertrophic Scars","Keloid Scars","2025-09-09",{"date":65,"type":36},"2025-09-11",{"date":67,"type":36},"2025-04-03",{"date":69,"type":22},"2025-12",{"name":71,"class":43},"Herbarium Laboratorio Botanico Ltda",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100534877","study-on-the-safety-and-efficacy-of-mr-linac-technique-in-patients-with-unresectable-locally-advanced-colon-cancer-100534877","NCT06244537","Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer","UNLACC","Inclusion criteria:\n\n1. Patients over 18 years old\n2. Patients can remain in a stationary position on the treatment bed for 1-1.5 hours\n3. ECOG score 0-1\n4. Pathological diagnosis of colon adenocarcinoma, clinical stage cT4N0-2M0\n5. Organ function is normal, and the following conditions are required: white blood cell count ≥3.5×10\\^9\u002FL; platelet count ≥100×10\\^9\u002FL; hemoglobin ≥90g\u002FL. Total bilirubin level ≤1.5× upper limit of normal (ULN); AST and ALT levels ≤2.5 × ULN; endogenous creatinine clearance rate: 56-122ml\u002Fmin; serum creatinine \\\u003C1.0× ULN; serum albumin ≥30g\u002FL.\n6. Able to adhere to the study protocol during the research period\n7. Signed written informed consent\n\nExclusion Criteria:\n\n1. Patients with dMMR or MSI-H\n2. Presence of other types of tumors in addition to colon adenocarcinoma\n3. Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons\n4. Distant metastasis (M1)\n5. Pregnant or lactating women\n6. Previous anti-tumor treatment\n7. Concurrent use of prohibited drugs for treatment\n8. Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome.\n9. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina pectoris, congestive heart failure (≥New York Heart Association class II) or severe arrhythmia requiring medication treatment\n10. Individuals with uncontrolled epilepsy, central nervous system disorders or a history of mental illness, whose clinical severity may hinder signing informed consent or affect patient compliance with oral medication according to the investigator's judgement\n11. Organ transplant surgery requiring immunosuppressive therapy\n12. Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities",{"count":80,"type":22},20,[82],"NA","In this phase I single-arm clinical study, 20 patients with T4 unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy\u002F5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. The study will assess patients' surgical R0 resection rate, pCR or cCR rate, PFS, OS, and related adverse effects of treatment, aiming to explore the feasibility, safety, and efficacy of MR-Linac in the treatment of unresectable locally advanced colon cancer.",[31],[86,87,88],"MR-Linac","unresectable locally advanced colorectal cancer","neoadjuvant radiotherapy","2025-09-02",{"date":63,"type":36},{"date":92,"type":36},"2024-04-01",{"date":94,"type":22},"2027-12-31",{"name":96,"class":97},"Sichuan Cancer Hospital and Research Institute","OTHER",1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":98},"100599492","early-phase-1-a-clinical-study-of-the-safety-and-efficacy-of-chemogenetics-therapy-in-the-treatment-of-parkinsons-disease-100599492","NCT07085195","A Clinical Study of the Safety and Efficacy of Chemogenetics Therapy in the Treatment of Parkinson's Disease","Inclusion criteria\n\nParticipants who meet all the following criteria can be included in this clinical study:\n\n1. Clinically diagnosed with idiopathic Parkinson's Disease \\[in accordance with the Diagnostic Criteria for Parkinson's Disease in China published in 2016, or in accordance with the Diagnostic Criteria for Primary PD of the International Parkinson's and Movement Disorders Society (MDS) in 2015\\];\n2. Subjects aged 40-65 years old (including the boundary value), regardless of gender;\n3. Medical history of disease ≥5 years;\n4. Hoehn-Yahr staging scale for \"off\" period is 2.5-4;\n5. Regular use of dopaminergic drugs before the screening period, including taking levodopa for at least 4 weeks;\n6. MDS-UPDRS III score \\>35 in the \"off\" period, and the improvement rate of acute levodopa stress test ≥30%;\n7. AAV neutralizing antibody titer ≤1:2000;\n8. The subject agrees to postpone other neurosurgery during the main study phase (including deep brain stimulation, except for sudden life-threatening conditions requiring neurosurgery during the trial);\n9. No acute adverse reactions to the scheduled therapeutic dose of clozapine (1-month observation period);\n10. The subject agrees not to participate in other therapeutic intervention studies during the trial;\n11. The subject agrees not to be vaccinated during the study phase;\n12. Use reliable contraceptive methods from the screening period to at least 8 weeks after drug infusion;\n13. The subject has good compliance and can follow up regularly. During the follow-up period, the PD patient diary can be accurately completed. Family members, guardians, or caregivers can help the subject fill in the patient diary;\n14. The subject fully understands the nature, purpose, methods, and possible adverse reactions of this clinical trial, voluntarily participates as a subject, and signs the informed consent form; if the subject is unable to read, the legal agent or impartial witness can read the informed consent form and other written materials and witness the informed consent.\n\nExclusion criteria\n\nIf any of the following criteria are met, the patient shall be excluded from this study:\n\n1. Atypical or secondary Parkinson's syndrome (such as Parkinson's plus syndrome, hereditary Parkinson's syndrome, drug-induced Parkinson's syndrome);\n2. Contraindications to surgery or previous deep brain stimulation surgery, pallidotomy, extrapyramidal surgery, other brain surgeries, or other neurosurgery that the researcher determines will affect their participation in this trial;\n3. Previous cranial imaging suggests abnormal brain structure, cerebrovascular malformations, intracranial tumors, intracranial hemorrhage risk, brain trauma, and other abnormalities;\n4. Mini-Mental State Examination (MMSE) score \\\u003C24 points;\n5. Montreal Cognitive Assessment (MoCA) score \\\u003C26 points;\n6. Mini-Mental State Questionnaire (PHQ-9) ≥16;\n7. Abnormal liver and kidney function: Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 1.5 times the upper limit of normal value, serum creatinine (Cr) \\>1.5 times the upper limit of normal value;\n8. Abnormal coagulation function or using anticoagulants;\n9. Infectious disease screening: Hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV-DNA) positive, hepatitis C virus RNA (HCV-RNA) positive, human immunodeficiency virus (HIV) positive, or syphilis serum positive;\n10. Undergoing antiviral treatment for hepatitis B and hepatitis C;\n11. Suffering from unstable or severe other systemic diseases: including active tuberculosis, cardiovascular system, respiratory system, Diseases of the digestive system, urinary system, mental and nervous system (such as epilepsy), blood system, immune system, etc., or abnormal laboratory test values, the investigator determines that the patient is not suitable for participating in this trial;\n12. Suffering from malignant tumors or having a history of malignant tumors;\n13. Having had severe allergic reactions, allergic to contrast agents, or being unable to accept surgical anesthesia;\n14. Participating in other clinical trials or having participated in other clinical trials within 3 months before the screening period;\n15. Having received gene therapy before being enrolled into this trial;\n16. Having received stem cell therapy within 6 months before the screening period;\n17. Having used other investigational drugs within 4 weeks before screening or within 5 half-lives of the investigational drug (whichever is longer), or drugs that the investigator determines affect this trial;\n18. Having received live vaccines within 2 months before the screening period or having a history of vaccination within 30 days before the screening period;\n19. Have a history of alcohol dependence or drug addiction and cannot stop drinking as advised by the doctor during the trial;\n20. Female subjects who are pregnant or breastfeeding;\n21. Severe motor complications after anti-PD drug treatment and no suitable alternative treatment options;\n22. Subjects who are assessed by the researchers as unsuitable for inclusion.","40 Years",{"count":107,"type":22},6,[109],"EARLY_PHASE1","The investigators propose a gene therapy strategy using chemical genetic inhibition to intervene in the abnormal activity of the subthalamic nucleus in Parkinson's disease. The investigators design and construct a highly efficient therapeutic injection STP-001 (first drug), through the efficient adeno-associated virus capsid (AAV), neuronal promoter (hSyn), and chemical genetic effector element (hM4Di), and accurately inject the drug into the bilateral subthalamic nucleus, the core pathological nucleus of Parkinson's disease, through stereotactic technology. Combined with a very low dose of clozapine (the second drug), the abnormal activity of the subthalamic nucleus is precisely intervened to improve the core motor symptoms of Parkinson's disease.",[112,113,31,114],"Parkinson Disease (PD)","Gene Therapy","Clozapine","NOT_YET_RECRUITING","2025-07-24",{"date":118,"type":36},"2025-07-25",{"date":120,"type":22},"2025-08-01",{"date":122,"type":22},"2025-12-30",{"name":124,"class":97},"Ruijin Hospital",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":98},"100466117","safety-and-efficacy-of-sbrt-in-the-treatment-of-thoracic-malignant-tumors-at-different-sites-100466117","NCT05349552","Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites","Inclusion Criteria:\n\n* Pathological diagnosis was malignant tumor.\n* The location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm.\n* There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.\n* KPS\\>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.\n\nExclusion Criteria:\n\n* Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.\n* The general condition is poor, and the expected survival time is less than 3 months.\n* Psychiatric patients or poor compliance, unable to cooperate to complete treatment.\n* For other reasons, the researcher believes that it is not suitable to participate in this trial.","80 Years",{"count":133,"type":22},120,"OBSERVATIONAL","SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue \u002F organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis.\n\nHowever, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different.\n\nThis study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure.\n\n48-60Gy \u002F 4-10f (EQD2 = 62.5Gy \\~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.",[137,138,31],"Radiotherapy","Thoracic Cancer","2023-12-22",{"date":141,"type":36},"2023-12-27",{"date":143,"type":36},"2022-05-01",{"date":145,"type":22},"2027-04-30",{"name":147,"class":97},"Peking University Third Hospital"]