hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06367088, orgStudyIdInfo id: Sophia, briefTitle: Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients., conditionsModule conditions: Triple-negative Breast Cancer, conditions: Cadonilimab, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, outcomesModule primaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: AE, otherOutcomes measure: Progression-free survival, otherOutcomes measure: Overall survival, otherOutcomes measure: Disease control rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Jie Xiong, role: CONTACT, phone: +8615927611872, email: xxiongjie2000@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
protocolSection identificationModule nctId: NCT06367075, orgStudyIdInfo id: AK104-sarcoma-202401, briefTitle: A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, collaborators name: Sun Yat-sen University, collaborators name: Xiangya Hospital of Central South University, collaborators name: Yunnan Cancer Hospital, collaborators name: The Affiliated Hospital Of Guizhou Medical University, collaborators name: First Affiliated Hospital of Guangxi Medical University, descriptionModule briefSummary: This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin., conditionsModule conditions: Advanced Soft-tissue Sarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: cadonilimab (AK104) with adriamycin, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Adriamycin, outcomesModule primaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Adverse event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06367062, orgStudyIdInfo id: SH9H-2023-T296, briefTitle: General Anesthesia/Surgical Exposure on White Matter Development in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development., conditionsModule conditions: Neurodevelopmental Delay, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: MRI, outcomesModule primaryOutcomes measure: MRI-based assessment of brain development, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06367036, orgStudyIdInfo id: 2021-52, briefTitle: Effect of Hypericum Perforatum Oil on Ecchymosis and Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2022-12-29, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Uskudar University, class: OTHER, descriptionModule briefSummary: Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test., conditionsModule conditions: Pain, conditions: Ecchymosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Two researchers do not know which site was injected., whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Topical hypericum perforatum oil intervention, outcomesModule primaryOutcomes measure: Pain point, primaryOutcomes measure: Ecchymosis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hatice Demirdağ, city: Üsküdar, state: İstanbul, zip: 34672, country: Turkey, geoPoint lat: 41.02252, lon: 29.02369, hasResults: False
protocolSection identificationModule nctId: NCT06367010, orgStudyIdInfo id: MR-36-24-010942, briefTitle: Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jiangxi Provincial Cancer Hospital, class: OTHER, descriptionModule briefSummary: A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy., conditionsModule conditions: Thyroid Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Iodine-125 brachytherapy combine with Anlotinib, outcomesModule primaryOutcomes measure: The CT images were used to measure the change in the maximum diameter of the lesion in millimeters., primaryOutcomes measure: Serological assessment, primaryOutcomes measure: Use the Numerical Rating Scale (NRS) to record patients' pain scores., primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiangxi Cancer Hospital, city: Nanchang, state: Jiangxi, zip: 330029, country: China, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False
protocolSection identificationModule nctId: NCT06366997, orgStudyIdInfo id: CQGOG0207, briefTitle: Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-09, primaryCompletionDateStruct date: 2023-04-18, completionDateStruct date: 2023-05-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chongqing University Cancer Hospital, class: OTHER, collaborators name: Zhejiang Cancer Hospital, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: 3D Medicines Corporation, descriptionModule briefSummary: The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study., conditionsModule conditions: Epithelial Ovarian Cancer, conditions: Adnexal Mass, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1352, type: ACTUAL, outcomesModule primaryOutcomes measure: the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: No.181, Hanyulu Road, Shapingba District, city: Chongqing, state: Chongqing, zip: 400030, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
protocolSection identificationModule nctId: NCT06366984, orgStudyIdInfo id: Adeel4, briefTitle: Outcome of Plastibell Circumcision Versus Open Method Circumcision, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-11, primaryCompletionDateStruct date: 2022-07-11, completionDateStruct date: 2022-08-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Children Hospital and Institute of Child Health, Lahore, class: OTHER, descriptionModule briefSummary: To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital.Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition)., conditionsModule conditions: Bleeding, conditions: Site Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controll trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: outcome assessor is unaware of group allocated, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 174, type: ACTUAL, armsInterventionsModule interventions name: plastibell, interventions name: open method, outcomesModule primaryOutcomes measure: infection, eligibilityModule sex: MALE, minimumAge: 1 Day, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: The Children Hospital, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06366971, orgStudyIdInfo id: auhucgun01, briefTitle: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD., conditionsModule conditions: Sacroiliac Joint Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: The Patient Education, interventions name: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training, outcomesModule primaryOutcomes measure: The Level of Low Back Pain, primaryOutcomes measure: Mobility, primaryOutcomes measure: Flexibility, primaryOutcomes measure: Lumbar Range of Motion, primaryOutcomes measure: Posture, primaryOutcomes measure: Trunk Muscle Endurance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Atlas University, city: Istanbul, state: Kagıthane, zip: 34408, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06366958, orgStudyIdInfo id: Dorsal wrist ganglion, briefTitle: Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-02-02, completionDateStruct date: 2025-04-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion, conditionsModule conditions: Hand Ganglion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: excision of dorsal wrist ganglion, outcomesModule primaryOutcomes measure: comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion, secondaryOutcomes measure: compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06366945, orgStudyIdInfo id: SYSKY-2024-157-02, briefTitle: Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2029-05-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis, conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, conditions: Head and Neck Cancer, conditions: HNSCC, conditions: Head Cancer Neck, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin, interventions name: Tislelizumab, interventions name: Polymeric Micellar Paclitaxel, interventions name: Surgical Resection of Primary +/- Neck Dissection, interventions name: Post-operative radiation therapy, outcomesModule primaryOutcomes measure: Major pathological response (MPR) rate of metastatic lymph nodes, secondaryOutcomes measure: Major pathological response (MPR) rate of primary tumor, secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Incidence of treatment-related adverse events, secondaryOutcomes measure: EORTC QLQ-C30, secondaryOutcomes measure: pathological downstaging rate, secondaryOutcomes measure: Distant metastasis-free survival(DMFS) rate, secondaryOutcomes measure: logical regional-free survival(LRFS) rate, otherOutcomes measure: Correlation between ctDNA dynamic detection and 1-year and 2-year EFS and OS rate after Neoadjuvant immunochemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False