hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06350084, orgStudyIdInfo id: 2023/381, briefTitle: Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection., conditionsModule conditions: Pain, Acute, conditions: Newborn, conditions: Crying, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Mother's Touch, interventions name: Nurse's Therapeutic Touch, outcomesModule primaryOutcomes measure: NIPS (Neonatal Infant Pain Scale), secondaryOutcomes measure: Crying times, secondaryOutcomes measure: Processing time, eligibilityModule sex: ALL, minimumAge: 2 Days, maximumAge: 4 Days, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Bucak State Hospital, status: RECRUITING, city: Burdur, state: Bucak, zip: 15030, country: Turkey, contacts name: Selda Ateş Beşirik, PhD., role: CONTACT, phone: +905076228189, email: seldaates07@gmail.com, contacts name: Selda Ateş Beşirik, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Emine Geçkil, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False
protocolSection identificationModule nctId: NCT06350071, orgStudyIdInfo id: 2023/06, briefTitle: Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection., conditionsModule conditions: Pain, Acute, conditions: Newborns, conditions: Crying, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Kangaroo Care, interventions name: Swaddling, outcomesModule primaryOutcomes measure: NIPS (Neonatal Infant Pain Scale), secondaryOutcomes measure: Crying times, secondaryOutcomes measure: Processing time, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 4 Days, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Bucak State Hospital, status: RECRUITING, city: Burdur, state: Bucak, zip: 15030, country: Turkey, contacts name: Selda Ateş Beşirik, PhD., role: CONTACT, phone: +905076228189, email: seldaates07@gmail.com, contacts name: Selda Ateş Beşirik, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Emine Geçkil, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False
protocolSection identificationModule nctId: NCT06350058, orgStudyIdInfo id: 202012005, briefTitle: Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-08-03, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 375, type: ACTUAL, armsInterventionsModule interventions name: Inactivated rotavirus vaccine (low dose), interventions name: Inactivated rotavirus vaccine (high dose), interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence rate of AE, primaryOutcomes measure: Incidence rate of SAE, eligibilityModule sex: ALL, minimumAge: 6 Weeks, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hebei Provincial Center for Disease Control and Prevention, city: Shijiangzhuang, state: Hebei, zip: 050021, country: China, geoPoint lat: 34.61038, lon: 113.58554, hasResults: False
protocolSection identificationModule nctId: NCT06350045, orgStudyIdInfo id: supra 11th puncture PCNL, briefTitle: High Supracostal Versus Subcostal Puncture in Adult PCNL, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one, conditionsModule conditions: Urolithiasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: closed envelop, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 162, type: ACTUAL, armsInterventionsModule interventions name: PCNL, outcomesModule primaryOutcomes measure: Rate of complications, primaryOutcomes measure: Stone free rate, secondaryOutcomes measure: duration of Hospital stay., secondaryOutcomes measure: Operative time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut University Hospital, city: Assiut, zip: 11751, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
protocolSection identificationModule nctId: NCT06350019, orgStudyIdInfo id: 26379996/91, briefTitle: Vascular Effects of Penil revascularızatıon, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-01-01, primaryCompletionDateStruct date: 2014-08-15, completionDateStruct date: 2014-12-25, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated., conditionsModule conditions: Erectile Dysfunction, conditions: Erectile Dysfunction Due to Arterial Disease, conditions: Erectile Dysfunction Due to Venous Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Penile revascularızation, outcomesModule primaryOutcomes measure: The importance of resistive index in evaluating the postoperative success of penile revascularization, eligibilityModule sex: MALE, minimumAge: 23 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06350006, orgStudyIdInfo id: SHR-A1904-301, briefTitle: SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Hengrui Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study consists of two research phases:Phase Ib (includes dose escalation phase and efficacy extension phase): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.Phase III: A randomized, double-blind, multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors., conditionsModule conditions: Cldn18.2-positive Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two phases, IB-A for dose escalation and IB-B for efficacy extension. The Phase III multi-center, randomized controlled, double-blind study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 924, type: ESTIMATED, armsInterventionsModule interventions name: SHR-A1904; Adebrelimab, interventions name: SHR-A1904; CAPOX; Adebrelimab, outcomesModule primaryOutcomes measure: Incidence and severity of AE, primaryOutcomes measure: Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximal Tolerable Dose (MTD), primaryOutcomes measure: Phase III Recommended Dose (RP3D), primaryOutcomes measure: Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria, secondaryOutcomes measure: SHR-A1904 toxin binding antibody, secondaryOutcomes measure: SHR-A1904 Total antibody, secondaryOutcomes measure: Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb), secondaryOutcomes measure: Expression level of CLDN18.2 in tumor tissues, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence and severity of AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Ruihua Xu, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06349993, orgStudyIdInfo id: pd003, briefTitle: Digital Intervention for Depression and Anxiety in Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Adai Technology (Beijing) Co., Ltd., class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.Participants will be asked to engage with the digital intervention platform for a period of two months., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Digital Intervention, interventions name: Health Education, outcomesModule primaryOutcomes measure: Hamilton Depression Rating Scale, primaryOutcomes measure: Hamilton Anxiety Rating Scale, secondaryOutcomes measure: ADHD(attention deficit hyperactivity disorder) Rating Scale-IV, secondaryOutcomes measure: PHQ-9 (Patient Health Questionnaire-9), secondaryOutcomes measure: GAD-7 (Generalized Anxiety Disorder-7), eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital, status: RECRUITING, city: Chengdu, state: Sichuang, country: China, contacts name: Liqun Zhang, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06349980, orgStudyIdInfo id: HLX53-HCC201, briefTitle: A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2027-02-10, completionDateStruct date: 2027-02-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Shanghai Henlius Biotech, class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients., conditionsModule conditions: Carcinoma, Hepatocellular, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: HLX53 (1000mg), interventions name: HLX53 (2000mg), interventions name: HLX10, interventions name: HLX04, interventions name: Placebo, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: Incidence and severity of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06349967, orgStudyIdInfo id: WCH-2023-1592, briefTitle: Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-05-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 59, type: ESTIMATED, armsInterventionsModule interventions name: Nab-paclitaxel Combined With Cadonilimab (AK104), outcomesModule primaryOutcomes measure: overall response rate (ORR), secondaryOutcomes measure: disease control rate (DCR), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06349954, orgStudyIdInfo id: BFHHZS20240064, briefTitle: Effectiveness and Safety of Single-session Endoscopic Stone Extraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction., conditionsModule conditions: Choledocholithiasis With Acute Cholangitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All patients will be randomly allocated into single-session group or two-session group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: single-session ERCP, interventions name: two-session ERCP, outcomesModule primaryOutcomes measure: Success rate of complete stone removal, primaryOutcomes measure: ERCP-related complication rate, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Hospital expenses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Wei Jiang, role: CONTACT, phone: 18663186116, email: jfw899w@outlook.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06349941, orgStudyIdInfo id: STU-2023-0745, briefTitle: Telemedicine in Rural Patients With Heart Failure, acronym: RURAL-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, descriptionModule briefSummary: We propose a pilot trial examining the effectiveness of a mHealth-based home cardiac rehabilitation program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with heart failure with reduced ejection fraction.(HFrEF). The goal of the pilot trial will be to demonstrate the feasibility of a telemedicine platform for the recruitment and retention of underserved rural patients in clinical trials. Participants will participate in a cardiac rehabilitation program delivered through a smartphone application called Movn. They will be monitored for 14 weeks., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot trial, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Movn app, outcomesModule primaryOutcomes measure: Physical activity levels, primaryOutcomes measure: Quality of life using KCCQ score, secondaryOutcomes measure: Enrollment rate, secondaryOutcomes measure: Loss to follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False