hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06301022, orgStudyIdInfo id: WXZ-Finerenone, briefTitle: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Harbin Medical University, class: OTHER, descriptionModule briefSummary: Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.Methods:Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, outcomesModule primaryOutcomes measure: 24 hours urinary total protein, primaryOutcomes measure: estimate Gromerular filtration rate, primaryOutcomes measure: serum potassium, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Aaffiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, zip: 150001, country: China, contacts name: XINGZHI WANG, PHD.,MD, role: CONTACT, phone: +8613904506176, email: WANG.XINGZHI@HRBMU.EDU.CN, geoPoint lat: 45.75, lon: 126.65, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-15, uploadDate: 2024-02-26T03:42, filename: Prot_SAP_000.pdf, size: 207441, hasResults: False
protocolSection identificationModule nctId: NCT06301009, orgStudyIdInfo id: AI-CAC-PVS, briefTitle: The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray, acronym: AI-CAC-PVS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, class: OTHER, collaborators name: Compagnia di San Paolo, descriptionModule briefSummary: The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing., conditionsModule conditions: Cardiovascular Diseases, conditions: Atherosclerosis, conditions: Coronary Artery Calcification, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: AI-CAC score, outcomesModule primaryOutcomes measure: Diagnostic accuracy of the AI-CAC score to identify the presence of subclinical atherosclerosis on chest x-ray, secondaryOutcomes measure: Percentage of individuals with a therapeutic management change by the attending physician based on the CAC score, with concordant AI-CAC., secondaryOutcomes measure: Comparison of ASCVD events occurring in patients without (AI-CAC=0) vs. with subclinical atherosclerosis (AI-CAC >0) based on the AI-CAC score, as assessed by Kaplan Meier estimates of ASCVD events occurring until study completion., eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06300983, orgStudyIdInfo id: PR(AG)398/2022, briefTitle: Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being, acronym: HRQoL, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-15, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2022-10-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups., conditionsModule conditions: Quality of Life, conditions: Myositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Psychoeducative, interventions name: Placebo, outcomesModule primaryOutcomes measure: Health related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona, city: Barcelona, zip: 08035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06300970, orgStudyIdInfo id: 0900f3eb81e634a9, briefTitle: Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-09, primaryCompletionDateStruct date: 2023-08-16, completionDateStruct date: 2023-08-16, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Centers for Disease Control and Prevention, class: FED, collaborators name: Ministry of Health, Liberia, descriptionModule briefSummary: To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia., conditionsModule conditions: Plasmodium Falciparum, conditions: Malaria, conditions: Uncomplicated Malaria, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 352, type: ACTUAL, armsInterventionsModule interventions name: Amodiaquine-artesunate (ASAQ), interventions name: Artemether+Lumefantrine (AL), outcomesModule primaryOutcomes measure: Number of Participants with Early Treatment Failure (ETF), primaryOutcomes measure: Number of Participants with Late Treatment Failure (LTF), primaryOutcomes measure: Number of Participants with Adequate Clinical and Parasitological Response (APCR), secondaryOutcomes measure: Number of Patients with Adverse Events, otherOutcomes measure: Number of samples with confirmed Histidine-rich protein 2/3 (HRP2/3) gene deletions, otherOutcomes measure: Number of samples with molecular markers of anti-malarial resistance, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County, city: Sinje, state: Grand Cape Mount County, country: Liberia, locations facility: Saclepea-Mahn Comprehensive Health Center Saclepea-Mahn District, Nimba County, city: Saclepea, state: Nimba County, country: Liberia, geoPoint lat: 6.9625, lon: -8.84056, hasResults: False
protocolSection identificationModule nctId: NCT06300944, orgStudyIdInfo id: Ran Gao-2023-12, briefTitle: The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: General Hospital of Ningxia Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel assignment, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: saline, interventions name: Esketamine, outcomesModule primaryOutcomes measure: Moderate to severe pain, primaryOutcomes measure: Incidence of adverse reactions including nausea, vomiting and dizziness, primaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Remifentanil dosage, secondaryOutcomes measure: Additional post-operative analgesics, secondaryOutcomes measure: Postoperative exhaust time of patients, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Hospital of Ningxia Medical University, status: RECRUITING, city: Yinchuan, state: Ningxia, country: China, contacts name: Ma Hanxiang, role: CONTACT, phone: 86-13519591508, email: mahanxiang@hotmail.com, geoPoint lat: 38.46806, lon: 106.27306, hasResults: False
protocolSection identificationModule nctId: NCT06300931, orgStudyIdInfo id: KAPSDFE0948, briefTitle: KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention., conditionsModule conditions: SDF, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: OTHER, enrollmentInfo count: 449, type: ESTIMATED, armsInterventionsModule interventions name: educational lecture, outcomesModule primaryOutcomes measure: Assessment of knowledge levels and attitude regarding SDF use before educational intervention, secondaryOutcomes measure: Assessment of knowledge levels and attitude regarding SDF use after educational intervention Correlation between demographic data and use of SDF., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06300918, orgStudyIdInfo id: 2024-KY76, briefTitle: A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Jie Li, class: OTHER, descriptionModule briefSummary: The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points., conditionsModule conditions: The Condition of Fundus Neovascularization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Time, outcomesModule primaryOutcomes measure: The number of fundus neovascularization seen in FFA., primaryOutcomes measure: The area of fundus neovascularization seen in FFA (using PD size as measurement)., primaryOutcomes measure: The intensity of neovascularization fluorescein leakage, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial, status: RECRUITING, city: Chendu, state: Sichuan, zip: 610014, country: China, contacts name: Jie Li, doctor, role: CONTACT, phone: +86 13908094675, email: lijieyk@med.uestc.edu.cn, hasResults: False
protocolSection identificationModule nctId: NCT06300905, orgStudyIdInfo id: CRO-2023-05-OMO-SNA-YPZ, briefTitle: Clinical Study on Malodor, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-07-02, completionDateStruct date: 2023-07-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Colgate Palmolive, class: INDUSTRY, descriptionModule briefSummary: This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use., conditionsModule conditions: Oral Malodor, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: test product, interventions name: Control product, outcomesModule primaryOutcomes measure: Organoleptic Oral Malodor Evaluations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Dental Institute of Chengdu, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06300892, orgStudyIdInfo id: SURG-2023-31841, briefTitle: Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.* Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.* Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation., conditionsModule conditions: Open GI Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: alpha diversity composition, primaryOutcomes measure: microbial community composition, primaryOutcomes measure: pathogenic strain of bacteria, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06300866, orgStudyIdInfo id: CRO-2020-04-PGN-LLU-YPZ, briefTitle: Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-18, primaryCompletionDateStruct date: 2021-03-08, completionDateStruct date: 2021-03-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Colgate Palmolive, class: INDUSTRY, descriptionModule briefSummary: The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use., conditionsModule conditions: Gingivitis, conditions: Plaque, Dental, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Test, interventions name: Control, outcomesModule primaryOutcomes measure: Whole-Mouth Gingivitis Measurement, primaryOutcomes measure: Whole-Mouth Dental Plaque Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loma Linda University School of Dentistry, city: Loma Linda, state: California, zip: 92350, country: United States, geoPoint lat: 34.04835, lon: -117.26115, hasResults: False
protocolSection identificationModule nctId: NCT06300814, orgStudyIdInfo id: ERU-HEM-EU-01, briefTitle: The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: This study was planned as a randomized controlled experimental study with a pretest-posttest design to determine the effect of parental supervision and video-guided progressive relaxation exercise (PRE) and music recital on sleep, quality of life and emotional states in children with epilepsy aged 9-16 years. The main questions it aims to answer are as follows:According to the evaluation of children with epilepsy, does the progressive relaxation exercise applied to children have an effect on sleep, quality of life and emotional states? According to the evaluation of children with epilepsy, does music recital applied to children have an effect on sleep quality of life and emotional states? The study consisted of 45 children (15 children in the progressive relaxation exercise group, 15 children in the music recital group and 15 children in the control group). Ethics committee approval, permission from the institutions and informed consent of the children were obtained for the conduct of the study. A value of p\<0.05 was considered statistically significant in data analysis., conditionsModule conditions: Epilepsy in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Progressive relaxation exercise group, interventions name: Music recital group, outcomesModule primaryOutcomes measure: The Children's Sleep Habits Questionnaire (CSHQ), secondaryOutcomes measure: The Pediatric Quality of Life Inventory (PedsQL), secondaryOutcomes measure: The Me and My School Questionnaire (M&MS), eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Erciyes University, status: RECRUITING, city: Kayseri, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False