hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06266923, orgStudyIdInfo id: SPH6516-101, briefTitle: A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-20, primaryCompletionDateStruct date: 2023-04-20, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Shanghai Pharmaceuticals Holding Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: SPH6516 tablets, outcomesModule primaryOutcomes measure: MTD（Maximum tolerated dose）, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Peak Plasma Concentration (Cmax）, secondaryOutcomes measure: Peak time（Tmax）, secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: half-life（T1/2）, secondaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: Progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06266910, orgStudyIdInfo id: 2023KYPJ320, briefTitle: Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Zhongshan Ophthalmic Center, Sun Yat-sen University, class: OTHER, collaborators name: South China University of Technology, descriptionModule briefSummary: This study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: By employing a single simulation technology for blinding, both the 2D group and the 3D group share identical training equipment and a consistent video background. The only distinction lies in the subtle variation in the configuration of training markers. It is difficult for participants to differentiate their respective groups., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Visual training video, outcomesModule primaryOutcomes measure: Accommodative facility, primaryOutcomes measure: Vergence facility, secondaryOutcomes measure: Negative and positive fusional vergence, secondaryOutcomes measure: Accommodative response, secondaryOutcomes measure: negative and positive relative accommodation, secondaryOutcomes measure: Near point of convergence, secondaryOutcomes measure: Accommodation amplitude, secondaryOutcomes measure: Electroencephalogram (EEG) node efficiency, secondaryOutcomes measure: Functional near-infrared spectroscopy (fNIRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhongshan Opthalmic Center, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Yehong Zhuo, role: CONTACT, phone: 13352828998, email: zhuoyh@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06266897, orgStudyIdInfo id: ZhujiangEM, briefTitle: A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-18, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: Endometriosis (EM) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. Here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. The investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments., conditionsModule conditions: Endometriosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 52 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhujiang Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, contacts name: Ying Ma, role: CONTACT, phone: +8613113361169, email: mayingwuzhuoyi@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06266884, orgStudyIdInfo id: AgriIbrahimCecen, briefTitle: The Effect of Kangaroo Care on Father-Baby Attachment, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-11-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Agri Ibrahim Cecen University, class: OTHER, collaborators name: Kahramanmaras Sutcu Imam University, descriptionModule briefSummary: The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared., conditionsModule conditions: Kangaroo Care, conditions: Attachment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Kangaroo care, outcomesModule primaryOutcomes measure: Fathers' Attachment Level, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Agri Ibrahim Cecen University, city: Agri, country: Turkey, geoPoint lat: 39.71944, lon: 43.05139, hasResults: False
protocolSection identificationModule nctId: NCT06266871, orgStudyIdInfo id: WCH-2023-1625, briefTitle: SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-07-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: SOX+Tislelizumab+LDRT, outcomesModule primaryOutcomes measure: pCR rate, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: MPR rate, secondaryOutcomes measure: ORR, secondaryOutcomes measure: 2-year disease-free survival (DFS) rate, secondaryOutcomes measure: 2-year OS rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06266858, orgStudyIdInfo id: SYSKY-2022-407-02, briefTitle: Multimodality Imaging Assessment of the Severity of Mitral Regurgitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To investigate to assess the severity of mitral regurgitation by multimodality imaging., conditionsModule conditions: Mitral Regurgitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: rehydration, interventions name: UCG, interventions name: CMR, interventions name: fasting, outcomesModule primaryOutcomes measure: effective regurgitant orifice area (EROA), primaryOutcomes measure: mitral regurgitant volume (RVol), primaryOutcomes measure: mitral regurgitant fraction (RF), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Maohuan Lin, PhD, role: CONTACT, phone: 13580575861, email: maohuan_lin@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06266832, orgStudyIdInfo id: 20230727, briefTitle: The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sir Run Run Shaw Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma., conditionsModule conditions: Rectal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, interventions name: Oxaliplatin, interventions name: Capecitabine, interventions name: Short-course Radiation, interventions name: Biopsy, outcomesModule primaryOutcomes measure: Organ retention rate, secondaryOutcomes measure: Total mesorectal excision rate, secondaryOutcomes measure: Total mesorectal excision rate after recurrence, secondaryOutcomes measure: Tumor regression grade, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: TRAEs, secondaryOutcomes measure: QoL, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Xiujun Cai, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06266819, orgStudyIdInfo id: OU-HEM-LE-01, briefTitle: The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: T.C. ORDU ÜNİVERSİTESİ, class: OTHER, descriptionModule briefSummary: In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women., conditionsModule conditions: Hyperemesis Gravidarum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups with chewing mint gum experimental group and a control group, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The study protocol in the research will be created using SPIRIT as a guide. Reporting of the trial will be structured according to the CONSORT checklist. Random distribution of pregnant women included in the study to the intervention and control groups will be made at www.randomizer.org. Which group will be the intervention or control group will be determined by drawing lots at the beginning of the study. Pregnant women in the intervention group will be given the practice of chewing mint-flavored gum.Since the researcher knows which group the pregnant women are included in, the data collection phase of the study is single blind. To avoid selection bias in this study, pregnant women will be randomly assigned to the intervention and control groups by randomization method. To prevent reporting bias, the analysis of the research data will be carried out by an expert statistician., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: chewing gum, outcomesModule primaryOutcomes measure: Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24), primaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Stress Coping Styles Scale (SCSS), secondaryOutcomes measure: State-Trait Anxiety Inventory (STAI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Özel Şar Hospital, status: RECRUITING, city: Rize, zip: 53100, country: Turkey, contacts name: M.Akif KUMBUZOĞLU, Uzm. Dr., role: CONTACT, phone: +90 464 212 11 03, email: info@sarhospital.com.tr, geoPoint lat: 41.02083, lon: 40.52194, hasResults: False
protocolSection identificationModule nctId: NCT06266793, orgStudyIdInfo id: 2072488-2, briefTitle: Comparison of Holmium Laser and Thulium Laser for Mini PCNL, acronym: HOTLaser, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: MaineHealth, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting., conditionsModule conditions: Nephrolithiasis, conditions: Percutaneous Nephrolithotomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Holmium Laser, interventions name: Thulium Laser, outcomesModule primaryOutcomes measure: Laser Treatment Time, secondaryOutcomes measure: Retreatment rate, secondaryOutcomes measure: Total Operative Time, secondaryOutcomes measure: Stone-Free Rate, otherOutcomes measure: Length of stay, otherOutcomes measure: Safety Profile and Adverse Events, otherOutcomes measure: Subjective pain scores, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maine Medical Center, city: Portland, state: Maine, zip: 04102, country: United States, contacts name: Danielle Landry, RN, role: CONTACT, phone: 207-662-0111, email: danielle.landry@mainehealth.org, geoPoint lat: 43.66147, lon: -70.25533, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-05, uploadDate: 2024-02-05T13:32, filename: Prot_SAP_000.pdf, size: 799007, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-05, uploadDate: 2024-02-05T13:23, filename: ICF_001.pdf, size: 397260, hasResults: False
protocolSection identificationModule nctId: NCT06266754, orgStudyIdInfo id: OPV-IMMUNO-ADULT, briefTitle: The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Bandim Health Project, class: OTHER, collaborators name: Radboud University Medical Center, descriptionModule briefSummary: OPV is the live attenuated vaccine against polio virus. OPV has been key in almost eradicating polio infection. Intriguingly, OPV has been associated with lower all-cause mortality and morbidity. These beneficial OPV effects were seen in contexts with no circulating polio virus and thus have nothing to do with the specific effects of OPV against polio infection. They have been coined "non-specific effects" (NSEs). Such NSEs have also been observed for other live attenuated vaccines such as BCG vaccine and measles vaccine. The underlying immunological mechanisms are unknown. Other live vaccines with beneficial NSEs have been shown to induce epigenetic changes leading to "trained immunity". They have also been associated with decreased inflammation. In the present study it will be investigates whether OPV can induce trained immunity, reduce inflammation, and induce epigenetic modifications of the innate immune cells in senior citizens in Guinea-Bissau., conditionsModule conditions: Vaccine Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised trial, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: A placebo will be used., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Oral polio vaccine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Levels of in vitro proinflammatory cytokines such as IL1-beta, TNF-alfa and IFN-gamma after stimulation of peripheral blood mononuclear cells with non-OPV antigens and mitogens, primaryOutcomes measure: Levels of plasma markers of systemic inflammation such as TNF ligand superfamily member 12 (TWEAK) and sirtuin 2 (SIRT2), primaryOutcomes measure: Amount of pseudo-bulk ATACseq and RNAseq - indicating chromatin accessibility of interferon-stimulated genes associated with the interferon response pathway in PBMCs., primaryOutcomes measure: Proportions of immune cell subsets, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bandim Health Project, Apartado 861, city: Bissau, country: Guinea-Bissau, geoPoint lat: 11.86357, lon: -15.59767, hasResults: False