hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06385795, orgStudyIdInfo id: NOE-PMM-201, briefTitle: A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Noema Pharma AG, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women., conditionsModule conditions: Menopause Syndrome, conditions: Menopause, conditions: Hot Flashes, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: NOE-115, outcomesModule primaryOutcomes measure: Withdrawals Due to Adverse Events While on NOE-115 for Any Reason, secondaryOutcomes measure: Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs), secondaryOutcomes measure: Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4, secondaryOutcomes measure: Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4, secondaryOutcomes measure: Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06385782, orgStudyIdInfo id: 20dz1207200, briefTitle: Exploring HRV in Antarctic Overwintering Members of Asia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-01, primaryCompletionDateStruct date: 2022-04-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ya-Wei Xu, class: OTHER, descriptionModule briefSummary: Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters., conditionsModule conditions: Heart Rate Variability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Antarctic environment, outcomesModule primaryOutcomes measure: changes in HRV, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Tenth People's Hospital, city: Shanghai, state: Shanghai, zip: 200079, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06385769, orgStudyIdInfo id: PamukkaleU.ftr-NYıldız-3, briefTitle: Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.The main questions aimed to be answered are:What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week)., conditionsModule conditions: Urinary Bladder, Overactive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous tibial nerve stimulation (TTNS), interventions name: Sham Transcutaneous tibial nerve stimulation (TTNS), outcomesModule primaryOutcomes measure: Decreased frequency of increased voiding, secondaryOutcomes measure: Frequency of voiding, secondaryOutcomes measure: The Quality of Life, secondaryOutcomes measure: Barthel Index for Activities of Daily Living (ADL), secondaryOutcomes measure: The Overactive Bladder Symptom Score (OABSS), secondaryOutcomes measure: Treatment Satisfaction Level, secondaryOutcomes measure: Cystometric value, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, city: Denizli, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False
protocolSection identificationModule nctId: NCT06385756, orgStudyIdInfo id: TJ-IRB202403020, briefTitle: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.The main questions it aims to answer are:* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.Participants will:* Induction of anesthesia with the experimental drug or placebo；* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded., conditionsModule conditions: Amobarbital Sodium, conditions: Hemodynamics Instability, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Amobarbital, interventions name: Propofol, outcomesModule primaryOutcomes measure: Mean arterial pressure (MAP) during Induction of anesthesia, secondaryOutcomes measure: MAP at different time points, secondaryOutcomes measure: Incidence of postoperative nausea and vomiting (ponv), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06385743, orgStudyIdInfo id: yeditepe15, briefTitle: The Effectiveness of Neuromuscular Training-Based Exercise Program, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Yeditepe University, class: OTHER, descriptionModule briefSummary: This randomised controlled study aimed to investigate the effectiveness of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain.The main hypothesis is;H0: There is no difference between the "Thrower's Ten" exercise program and the neuromuscular training-based exercise program applied to overhead athletes with shoulder pain, on pain, function, risk factors specific to shoulder injuries, and performance.H1: The effects of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain are superior to the effects of "Thrower's Ten" exercise program, conditionsModule conditions: Pain, Shoulder, conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Neuromuscular Training-based Exercise Program, interventions name: ''Thrower's Ten'' Exercise Program, outcomesModule primaryOutcomes measure: Pain Assessment, primaryOutcomes measure: Disabilities of the Arm, Shoulder and Hand (DASH), secondaryOutcomes measure: Tampa Kinesiophobia Scale, secondaryOutcomes measure: Hylyght Injury Prevention and Return to the Sports Screening Program (, secondaryOutcomes measure: Y Balance Test- Upper Quarter, secondaryOutcomes measure: Closed Kinetic Chain Extremity Stability Test, secondaryOutcomes measure: Single Arm Seated Shot Put Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yeditepe University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06385730, orgStudyIdInfo id: SCE2401, briefTitle: Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS), acronym: BLESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Chest Hospital, class: OTHER, descriptionModule briefSummary: The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC)., conditionsModule conditions: Esophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: neoadjuvant anti-PD-1, interventions name: neoadjuvant anti-PD-1 with LDRT, outcomesModule primaryOutcomes measure: MPR rate, secondaryOutcomes measure: pCR rate, secondaryOutcomes measure: Adverse events and treatment-related adverse events, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Objective Response rate, secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Correlation between potential biomarkers and tumor response, eligibilityModule sex: ALL, minimumAge: 76 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, city: Shanghai, state: Shanghai, zip: 200030, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06385717, orgStudyIdInfo id: ZhejiangU, briefTitle: Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer, acronym: ESCORT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2029-01-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection., conditionsModule conditions: Esophagus Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: chemo-radiation, outcomesModule primaryOutcomes measure: Incidence of toxic events, secondaryOutcomes measure: 3-year overall survival, secondaryOutcomes measure: 3-year local-regional recurrence free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Jing Xu, MD, role: CONTACT, phone: 0086-0571-87783521, email: jing_xu@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University, School of Medicine, status: NOT_YET_RECRUITING, city: Hangzhou, country: China, contacts name: Jing Xu, role: CONTACT, phone: 0086-0571-87783521, email: jing_xu@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06385704, orgStudyIdInfo id: DMRIBFGM0420, briefTitle: Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR), acronym: DMR-IBF-GM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wang Siqi, class: OTHER, collaborators name: China-Japan Friendship Hospital, descriptionModule briefSummary: The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: DMR Procedure, outcomesModule primaryOutcomes measure: Microbiome Analysis, primaryOutcomes measure: High Performance Liquid Chromatography, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06385678, orgStudyIdInfo id: HRS-4642-201, briefTitle: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation., conditionsModule conditions: Advanced KRAS G12D Mutant Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: HRS-4642, interventions name: Adebrelimab, interventions name: SHR-A1921, interventions name: Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection, outcomesModule primaryOutcomes measure: Phase IB: Safety endpoints: adverse events (AEs)., primaryOutcomes measure: Phase IB： Maximum tolerated dose (MTD), primaryOutcomes measure: Phase IB：Recommended phase 2 dose (RP2D), primaryOutcomes measure: Phase II: Overall response rate (ORR)., secondaryOutcomes measure: Efficacy endpoints: Overall response rate (ORR)., secondaryOutcomes measure: Efficacy endpoints: Duration of response (DoR)., secondaryOutcomes measure: Efficacy endpoints: Disease control rate (DCR)., secondaryOutcomes measure: Efficacy endpoints: Progression free survival (PFS)., secondaryOutcomes measure: Efficacy endpoints: overall survival (OS)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai East Hospital, city: Shanghai, state: Shanghai, zip: 200120, country: China, contacts name: Caicun Zhou, Doctor, role: CONTACT, phone: 13301825532, email: caicunzhoudr@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06385665, orgStudyIdInfo id: Xin Peng, briefTitle: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-04-22, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Xin Peng, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:1. Patients with advanced breast cancer need family companionship2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Graded companionship, outcomesModule primaryOutcomes measure: Change from Baseline meatal state on GAD-7 at Week 48., primaryOutcomes measure: Change from Baseline physical state on kps at Week 48., eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, zip: 430022, country: China, contacts name: Peng Xin, postgraduate, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
protocolSection identificationModule nctId: NCT06385639, orgStudyIdInfo id: WK2024005, briefTitle: Efficacy and Safety of Probiotic Products for Digestive Health, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-05-25, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wecare Probiotics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota., conditionsModule conditions: Healthy Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Intestinal health, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Danang@Equilab-Int.Com, status: RECRUITING, city: Jakarta, state: Pusat, zip: 10430, country: Indonesia, contacts name: Danang A. Yunaidi, MD, role: CONTACT, phone: 217515932, phoneExt: +62, email: danang@equilab-int.com, geoPoint lat: -6.21462, lon: 106.84513, hasResults: False