hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06383949, orgStudyIdInfo id: CP 21-001-IRE01, briefTitle: Real World Data Collection on the Synergy Disc, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2028-02-23, completionDateStruct date: 2033-02-23, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Synergy Spine Solutions, class: INDUSTRY, collaborators name: MCRA, descriptionModule briefSummary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease., conditionsModule conditions: Cervical Degenerative Disc Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Synergy Cervical Disc system, outcomesModule primaryOutcomes measure: Neck Disability Index (NDI), primaryOutcomes measure: Device Related or Device Procedure Related Adverse Events, secondaryOutcomes measure: Neck and Arm Pain Measurement, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Motor and Sensory Function in the Arm, secondaryOutcomes measure: Nurick's Criteria, secondaryOutcomes measure: Odom's criteria, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mater Misericordiae University Hospital, status: RECRUITING, city: Dublin, country: Ireland, contacts name: Jake McDonnell, MD, role: CONTACT, email: jackmcdonnell@rcsi.ie, contacts name: Joseph Butler, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Stacy Darwish, MD, role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False
protocolSection identificationModule nctId: NCT06383936, orgStudyIdInfo id: FAST-K II, briefTitle: FAldini Sport Total Joint Arthroplasty-Knee II, acronym: FAST-K II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: The majority of patients undergoing total knee arthroplasty are elderly individuals with low functional demands, aiming to alleviate pain. However, there exists a subgroup of younger patients, under the age of 65, with higher functional demands. The purpose of this study is to evaluate the return to sports activities in this patient group following a non-cemented total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators expect that with the use of non-cemented prostheses and a specific rehabilitation protocol, many of these patients will safely resume sports activities., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: intensive rehabilitation after uncemented TKA, outcomesModule primaryOutcomes measure: number of patients returning to sports activities assessed by questionnaire, primaryOutcomes measure: clinical and functional outcomes measured as the variation in the Knee Society Score, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06383923, orgStudyIdInfo id: BYSYDL2022015, briefTitle: Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: 1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;3. Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease., conditionsModule conditions: Placenta Accreta Spectrum, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Placenta Accreta Spectrum, secondaryOutcomes measure: Amount of bleeding, secondaryOutcomes measure: Hemostatic measures, secondaryOutcomes measure: hysterectomy, secondaryOutcomes measure: blood transfusion volume, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Wang Yan, M.D.Ph.D., role: CONTACT, phone: 13501282029, email: wjgqhn@263.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06383910, orgStudyIdInfo id: 10.185.1.58, briefTitle: The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-12, primaryCompletionDateStruct date: 2023-12-27, completionDateStruct date: 2024-01-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Square Stepping Exercise, outcomesModule primaryOutcomes measure: Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks, primaryOutcomes measure: Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks, primaryOutcomes measure: Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks, primaryOutcomes measure: Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, city: Denizli, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False
protocolSection identificationModule nctId: NCT06383897, orgStudyIdInfo id: HS-10398-101, briefTitle: Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: HS-10398, interventions name: HS-10398 Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AEs), primaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Observed maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to reach maximum plasma concentration (Tmax), secondaryOutcomes measure: Elimination Halflife (T1/2), secondaryOutcomes measure: Apparent clearance（CL/F）, secondaryOutcomes measure: Apparent Volume of Distribution（Vd/F）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Affiliated Hospital of Qingdao University, city: Qingdao, country: China, contacts name: Xiaolei Zhang, role: CONTACT, phone: 0532-82912611, email: qingyilunli@126.com, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
protocolSection identificationModule nctId: NCT06383871, orgStudyIdInfo id: HRS-7058-101, briefTitle: A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Shandong Suncadia Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058., conditionsModule conditions: Advanced Malignant Tumour, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 151, type: ESTIMATED, armsInterventionsModule interventions name: HRS-7058 capsule/ HRS-7058 tablet, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: maximum tolerated dose (MTD), primaryOutcomes measure: Phase II recommended dose (RP2D), primaryOutcomes measure: Safety endpoints: adverse events (AE), secondaryOutcomes measure: Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06383858, orgStudyIdInfo id: [2023] Ethics Review NO.151, briefTitle: The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated Hospital of Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Preeclampsia is the main cause of illness and death in pregnant women and fetuses. Currently, there is no effective treatment for preeclampsia in clinical practice, and the fundamental treatment is still termination of pregnancy and placental delivery.Therefore, early prediction of preeclampsia and targeted strengthening of high-risk pregnant women supervision, early intervention and diagnosis and treatment can greatly reduce the serious obstetric complications and perinatal maternal and fetal deaths caused by preeclampsia, which has significant social and clinical significance., conditionsModule conditions: Preeclampsia, conditions: Maternal Deaths, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Preeclampsia, secondaryOutcomes measure: Premature birth, secondaryOutcomes measure: Fetal Growth Restriction, secondaryOutcomes measure: Severe complications of preeclampsia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FANG HE, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510150, country: China, contacts name: FANG HE, M.D, role: CONTACT, phone: 13724831279, email: hefangjnu@126.com, contacts name: Qingwen Nie, Master, role: CONTACT, phone: 15622149953, email: qw0621n@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06383845, orgStudyIdInfo id: MAS ESLI, briefTitle: Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery., conditionsModule conditions: Breast Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Erector spinae plane block VS intravenous lidocaine., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Lido-IV, interventions name: ESP Block, outcomesModule primaryOutcomes measure: Item 5 of Brief Pain inventory score (BPI Score), secondaryOutcomes measure: Acute pain assessed by Simple Verbal Scale (SVS), secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: DN4 questionnaire (DN4), secondaryOutcomes measure: The short-form McGill Pain Questionnaire (SFM-PQ), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tunisia, city: Nabeul, zip: 8000, country: Tunisia, geoPoint lat: 36.45606, lon: 10.73763, hasResults: False
protocolSection identificationModule nctId: NCT06383806, orgStudyIdInfo id: STU00219933, secondaryIdInfos id: 315-SR-23, type: OTHER_GRANT, domain: American Academy of Sleep Medicine Foundation, briefTitle: Decreasing Nightmares in Adults With Narcolepsy, acronym: DAWN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment., conditionsModule conditions: Narcolepsy, conditions: Narcolepsy Type 1, conditions: Narcolepsy With Cataplexy, conditions: Narcolepsy Without Cataplexy, conditions: Nightmare, conditions: Nightmare Disorder With Associated Other Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Waitlist control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Imagery Rehearsal Therapy (IRT), outcomesModule primaryOutcomes measure: Disturbing Dream and Nightmare Severity Index (DDNSI), primaryOutcomes measure: Nightmare frequency (sleep diary), secondaryOutcomes measure: PROMIS Anxiety, secondaryOutcomes measure: PROMIS Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06383793, orgStudyIdInfo id: Northjiangsu000, briefTitle: Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northern Jiangsu People's Hospital, class: OTHER, descriptionModule briefSummary: As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: overlap, outcomesModule primaryOutcomes measure: 1 year survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yifan Cheng, status: RECRUITING, city: Yangzhou, state: Jiangsu, zip: 225000, country: China, contacts name: Yifan Cheng, role: CONTACT, phone: 8615267258283, email: cyfchengyifan528@sina.com, geoPoint lat: 32.39722, lon: 119.43583, hasResults: False
protocolSection identificationModule nctId: NCT06383780, orgStudyIdInfo id: SYSKY-2023-901-01, briefTitle: Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: XIANG YANQUN, class: OTHER, descriptionModule briefSummary: This is a prospective, open-label phase III clinical trial evaluating the efficacy and safety of the GP（Gemcitabine combined with cisplatin） regimen in combination with Tislelizumab versus the TPC（cisplatin, nab-paclitaxel and capecitabine）regimen in combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma patients With Bone Metastasis., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Active Comparator:Drug:GP（Gemcitabine combined with cisplatin）regimen combined with Tislelizumab Experimental:Drug：TPC（cisplatin, nab-paclitaxel and capecitabine）regimen combined with Tislelizumab, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: GP combined with Tislelizumab, interventions name: TPC combined with Tislelizumab, outcomesModule primaryOutcomes measure: 1-year progression-free survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: incidence of adverse events, secondaryOutcomes measure: rate of skeletal-related events, secondaryOutcomes measure: Biomarker response (EBV-DNA, bone metabolic markers), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SunYat-senU, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Yanqun Xiang, MD, role: CONTACT, phone: +86-18666096623, email: xiangyq@sysucc.org.cn, contacts name: Weixiong Xia, MD, role: CONTACT, phone: +86-18520415699, email: xiawx@sysucc.org.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False