hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06313281, orgStudyIdInfo id: E-18-3331, briefTitle: Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2021-09-30, completionDateStruct date: 2021-09-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: King Saud University, class: OTHER, descriptionModule briefSummary: Objective: Transnasal skull-base surgery is a complex and invasive procedure that involves the use of preoperative antiseptic preparations. However, evidence supporting their use in preventing postoperative infectious complications is limited. The aim of this study is to assess the efficacy of preoperative antiseptic techniques in reducing postoperative infectious complications within 30 days of surgery.Methods: A multicenter, prospective, randomized, single-blind, three-arm trial was conducted from February 2019 to October 2021. Participants were randomized to either of three antiseptic preparation techniques: external 0.9%NaCl nasal preparation, external 0.05% chlorhexidine gluconate, or intranasal irrigation with 80 mg of gentamicin added to 1000 ml of 0.9%NaCl plus external nasal preparation with chlorhexidine gluconate 0.05%. A total of 130 adults with skull-base pathologies were randomized, 12 were excluded before randomization for failure to meet inclusion criteria (n=9) or refusal to participate (n=3). The investigators excluded patients with evidence of infection adjacent to the surgical site, allergies to preparation methods, those who underwent craniotomy during the same admission, and pediatric patients., conditionsModule conditions: Meningitis and Sinusitis in Transnasal Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: Preoperative Antiseptic preparation prior to transnasal skull base surgery, outcomesModule primaryOutcomes measure: the difference in the incidence of postoperative infections within 30 days of surgery between the three interventional groups, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Saud University, city: Riyadh, zip: 12394, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, hasResults: False
protocolSection identificationModule nctId: NCT06313268, orgStudyIdInfo id: LT-02-20, briefTitle: Safety of Effivia®, a Bevacizumab Biosimilar, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-21, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Laboratorios Liomont, class: INDUSTRY, collaborators name: Servicios Especializados en Ensayos Clínicos, S.C., descriptionModule briefSummary: This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer., conditionsModule conditions: Metastatic Colorectal Cancer, conditions: Metastatic Cervical Cancer, conditions: Non Squamous Non Small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab Biosimilar MB02, outcomesModule primaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UMAE Hospital de Especialidades No. 1, status: RECRUITING, city: León, state: Guanajuato, zip: 37320, country: Mexico, contacts name: David Suárez García, M.D., role: CONTACT, phone: +524777174000, contacts name: David Suárez García, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.12908, lon: -101.67374, locations facility: Hospital de Gineco-Obstetricia No. 3, status: RECRUITING, city: Azcapotzalco, state: Mexico City, zip: 02990, country: Mexico, contacts name: Eliseo Neftalí de la Cruz Escobar, M.D., role: CONTACT, phone: +525557821088, contacts name: Eliseo Neftalí de la Cruz Escobar, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.48698, lon: -99.18594, locations facility: Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI, status: RECRUITING, city: Cuauhtémoc, state: Mexico City, zip: 06720, country: Mexico, contacts name: Alberto Alfonso Pimentel Rentería, M.D., role: CONTACT, phone: +525556276900, contacts name: Alberto Alfonso Pimentel Rentería, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.44506, lon: -99.14612, locations facility: Instituto Nacional de Cancerología, status: RECRUITING, city: Tlalpan, state: Mexico City, zip: 14080, country: Mexico, contacts name: David Francisco Cantú de León, M.D., Ph.D., role: CONTACT, phone: +525556280400, contacts name: David Francisco Cantú de León, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.29513, lon: -99.16206, locations facility: Hospital de Oncología IMSS Puebla, status: RECRUITING, city: Puebla, zip: 07200, country: Mexico, contacts name: José Gustavo Núñez Cerrillo, M.D., role: CONTACT, phone: +522222230690, contacts name: José Gustavo Núñez Cerrillo, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.03793, lon: -98.20346, hasResults: False
protocolSection identificationModule nctId: NCT06313255, orgStudyIdInfo id: KYLL-202301-008-1, briefTitle: A Retrospective Observational Study on the Effects of Prebiotics on HBsAg Clearance, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-09, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The goal of this retrospective observational study is to find out the effects of prebiotics on HBV clearance. The main question it aims to answer is:Are the prebiotics have an effect in promoting HBV clearance? The participants will observe the HBV clearance rate in chronic hepatitis B patients receive prebiotics in addition to the routine antiviral therapy.Researchers will compare the HBV clearance rate in chronic hepatitis B patients receive prebiotics and antiviral therapy with those receiving solely antiviral therapy., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PegIFNα2b, interventions name: PegIFNα2b+prebiotics, interventions name: Nucleoside analog, interventions name: Nucleoside analog+prebiotics, outcomesModule primaryOutcomes measure: HBsAg clearance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Yu-Chen Fan, role: CONTACT, phone: 0086+053182169596, email: fanyuchen@sdu.edu.cn, contacts name: Yu-Chen Fan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06313242, orgStudyIdInfo id: 202403, briefTitle: Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens., conditionsModule conditions: Magnetically Controlled Capsule Endoscopy, conditions: Bowel Preparation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: Polyethylene Glycol Electrolytes Powder (II), interventions name: Low residue diet, interventions name: Normal diet, outcomesModule primaryOutcomes measure: Image quality of small intestine, secondaryOutcomes measure: Rate of completion of inspections, secondaryOutcomes measure: Small intestine transit time, secondaryOutcomes measure: Lesion detection rate, secondaryOutcomes measure: Patient tolerance, secondaryOutcomes measure: Rate of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, country: China, contacts name: Feixue Chen, role: CONTACT, phone: +8618560086108, email: chenfeixue@email.sdu.edu.cn, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06313229, orgStudyIdInfo id: KFSIRB200-195, briefTitle: Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-03-25, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement., conditionsModule conditions: Alveolar Bone Loss, conditions: Dental Implant Failed, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The present clinical trial was single-blinded one as the evaluator and the statistician were both blinded. While both the implantologist or the participant were not blinded as the interventions were dissimilar., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: implant placement 6 months after ridge augmentation, interventions name: implant placement Simultaneously with ridge augmentation, outcomesModule primaryOutcomes measure: Stability Quotient of Implants (SQI), primaryOutcomes measure: Horizontal bone dimensions (HBDs), primaryOutcomes measure: Peri-implant Bone Density (PBD), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of dentistry, kafrelsheikh University, status: RECRUITING, city: Kafr Ash Shaykh, state: Kafrelsheikh, zip: 214312, country: Egypt, contacts name: Walid elamrousy, PhD, role: CONTACT, phone: +201091444946, email: perioking1@gmail.com, contacts name: Dalia Rasheed Issa, PhD, role: CONTACT, email: dalia_rasheed@hotmail.com, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
protocolSection identificationModule nctId: NCT06313190, orgStudyIdInfo id: SL-B2024-061, briefTitle: Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402), acronym: HSBRT2402, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, collaborators name: Fifth Affiliated Hospital, Sun Yat-Sen University, collaborators name: Ningbo Medical Center Lihuili Eastern Hospital, descriptionModule briefSummary: For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic body radiotherapy, interventions name: Sintilimab, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Local control rate (DCR), secondaryOutcomes measure: Treatment-related adverse events, otherOutcomes measure: Correlation between serum cytokines and overall survival and immune-related adverse events, otherOutcomes measure: Correlation between ctDNA and overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Mian Xi, MD, role: CONTACT, phone: +862087343385, email: ximian@sysucc.org.cn, contacts name: Mian Xi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Qi Zeng, MD, role: SUB_INVESTIGATOR, contacts name: Yi Lu, MD, role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06313151, orgStudyIdInfo id: Soh-Med-24-02-02MD, briefTitle: The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate if the 2019 EULAR/ACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus (SLE) and as predictor for prognosis ., conditionsModule conditions: SLE, and Organ Damage Index, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria., eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Sohag University, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: alyaa A mohamed, role: CONTACT, phone: 01007218644, email: aliaa.abdelhameed@med.sohag.edu.eg, contacts name: mahmoud S allam, role: CONTACT, phone: 01091103331, email: m.sobhy.allam@gmail.com, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
protocolSection identificationModule nctId: NCT06313099, orgStudyIdInfo id: SakaryaAppliedSciencesUPNSC, briefTitle: Parameters of the General Health Status of Prison Officers, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2021-02-15, completionDateStruct date: 2021-03-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Pakize Nurgul Sen, class: OTHER, descriptionModule briefSummary: Introduction The working conditions of prison officers are very stressful. Today, it is known that stress affects the health status of individuals in many ways. In this study, it was aimed to evaluate the musculoskeletal system problems, fatigue severity, depression levels, and quality of life of prison officers and to examine the relationship between these parameters and the socio-demographic characteristics of the participants.Method The study included a total of 141 volunteers. The musculoskeletal problems of the participants were evaluated with the Cornell Musculoskeletal Disorders Questionnaire, fatigue levels were evaluated with the Fatigue Severity Scale, depression levels were evaluated with the Beck Depression Inventory, and quality of life was evaluated with the Nottingham Health Profile., conditionsModule conditions: Musculoskeletal Pain, conditions: Fatigue, conditions: Depression, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 141, type: ACTUAL, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Cornell Musculoskeletal Disorders Questionnaire, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Sleep Quality: Virtual Analog Scala: VAS, secondaryOutcomes measure: Beck Depression Inventory, secondaryOutcomes measure: Nottingham Health Profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Muğla E Type Closed Prison, city: Muğla, state: Menteşe, zip: 48000, country: Turkey, geoPoint lat: 37.21807, lon: 28.3665, hasResults: False
protocolSection identificationModule nctId: NCT06313086, orgStudyIdInfo id: SYSA1501-009, secondaryIdInfos id: CTR20240245, type: REGISTRY, domain: NMPA, briefTitle: DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer, conditionsModule conditions: HER2-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 442, type: ESTIMATED, armsInterventionsModule interventions name: DP303c, interventions name: trastuzumab emtansine, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) by BIRC, secondaryOutcomes measure: Progression-free survival (PFS) by investigator, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), 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: NCT06313073, orgStudyIdInfo id: CHFL-BC-01, briefTitle: Neoadjuvant Radiotherapy for Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-15, completionDateStruct date: 2026-02-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer.The main questions it aims to answer are:* The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens.* Evaluate the acute and late toxicity of preoperative radiotherapy Participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group., conditionsModule conditions: Neoadjuvant Radiotherapy, conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Neoadjuvant radiotherapy, interventions name: adjuvant radiotherapy, outcomesModule primaryOutcomes measure: pCR, secondaryOutcomes measure: RCB, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Huojun Zhang, M.D., role: CONTACT, phone: +8613311732399, email: chyyzhj@163.com, contacts name: Huojun Zhang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False