hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06295120, orgStudyIdInfo id: 362-1, briefTitle: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D), acronym: CAP-D, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Research Unit for General Practice in Aalborg, class: OTHER, descriptionModule briefSummary: The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily., conditionsModule conditions: Community-acquired Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Phenoxymethylpenicillin 1.2 MIE 4 times daily, outcomesModule primaryOutcomes measure: Treatment failure at day 30, secondaryOutcomes measure: Clinical recovery at day 8, secondaryOutcomes measure: The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score, secondaryOutcomes measure: Prolonged antibiotic treatment, secondaryOutcomes measure: Change in type of antibiotic, secondaryOutcomes measure: Relapse of acute Lower Respiratory Tract Infection (LRTI), secondaryOutcomes measure: Reconsultation, secondaryOutcomes measure: New prescriptions within 30 days, secondaryOutcomes measure: Hospitalisation, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Treatment adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Research Unit for General Practice Aalborg, status: RECRUITING, city: Gistrup, zip: 9260, country: Denmark, contacts name: Line Maj Jensen, role: CONTACT, phone: +45 25 69 99 33, email: lmj@dcm.aau.dk, geoPoint lat: 56.9943, lon: 9.99085, hasResults: False
protocolSection identificationModule nctId: NCT06295107, orgStudyIdInfo id: 2023-00195-01, briefTitle: Reliability of Range of Movement Measurements in Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability., conditionsModule conditions: Cerebral Palsy, conditions: Movement Disorders in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Ankle Passive Range of Movement (pROM), interventions name: Knee Passive Range of Movement (pROM), outcomesModule primaryOutcomes measure: Ankle range of motion, primaryOutcomes measure: Knee range of motion, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children Habilitation Unit, status: RECRUITING, city: Lund, state: Skane, zip: 22241, country: Sweden, contacts name: Olof Linden, MD, role: CONTACT, phone: 0046708475690, email: olof.linden@skane.se, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False
protocolSection identificationModule nctId: NCT06295094, orgStudyIdInfo id: PIPAC-OPC6, briefTitle: The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients., acronym: EPICURE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment., conditionsModule conditions: Gastric Cancer, conditions: Chemotherapy, Adjuvant, conditions: Peritoneal Metastases, conditions: Minimally Invasive Surgical Procedures, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatin, interventions name: Doxorubicin, outcomesModule primaryOutcomes measure: Peritoneal disease-free survival, secondaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Postoperative toxicity, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Postoperative mortality, secondaryOutcomes measure: Rate of positive peritoneal lavage, secondaryOutcomes measure: Patient-reported Quality of life, secondaryOutcomes measure: Patient-reported Quality of life, secondaryOutcomes measure: Number of patients not receiving adjuvant chemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Yanghee Woo, PhD, role: CONTACT, email: yhwoo@coh.org, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Odense University Hospital, city: Odense C, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: University Hospital Lille, city: Lille, country: France, contacts name: Clarisse Eveno, PhD, role: CONTACT, email: clarisse.eveno@gmail.com, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Charité, University of Berlin, city: Berlin, country: Germany, contacts name: Beate Rau, PhD, role: CONTACT, email: beate.rau@charite.de, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Karolinska University Hospital, city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
protocolSection identificationModule nctId: NCT06295068, orgStudyIdInfo id: PRT-1400-11, briefTitle: Evaluation of ARi With OpSens SavvyWire, acronym: ARi, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Opsens, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography., conditionsModule conditions: Aortic Valve Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Transcatheter Aortic Valve Replacement (TAVR), interventions name: Balloon Aortic Valvuloplasty (BAV), outcomesModule primaryOutcomes measure: Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography, secondaryOutcomes measure: Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography, secondaryOutcomes measure: Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AHS Morristown Medical Center, status: RECRUITING, city: Morristown, state: New Jersey, zip: 07960, country: United States, contacts name: Christine Ciprich, role: CONTACT, phone: 973-971-7541, email: christine.ciprich@atlantichealth.org, contacts name: Philippe Généreux, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.79677, lon: -74.48154, hasResults: False
protocolSection identificationModule nctId: NCT06295055, orgStudyIdInfo id: Dentistry Prince of Songkla, briefTitle: Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA), acronym: SSBS for ABA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-04, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement., conditionsModule conditions: Guided Bone Regeneration, conditions: Bone Formation, conditions: Bone Volume, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Before- after augmentation in patients with alveolar bone defects, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Ridge augmentation with semi-rigid shell barrier system, outcomesModule primaryOutcomes measure: Bone gain evaluation, primaryOutcomes measure: Biocompatibility evaluation, secondaryOutcomes measure: Ridge volume change of alveolar ridge evaluation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Songkla, status: RECRUITING, city: Songkhla, state: Hatyai, zip: 90110, country: Thailand, contacts name: panisa tantiwongs, role: CONTACT, phone: 0824864497, email: k-kampt@hotmail.com, geoPoint lat: 7.19882, lon: 100.5951, hasResults: False
protocolSection identificationModule nctId: NCT06295042, orgStudyIdInfo id: 32-235 ex 19/20, briefTitle: Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-10, primaryCompletionDateStruct date: 2023-11-28, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction., conditionsModule conditions: Complications, Postoperative/Perioperative, conditions: Quality of Life, conditions: Satisfaction, Patient, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 162, type: ACTUAL, armsInterventionsModule interventions name: BREAST-Q Questionnaire, outcomesModule primaryOutcomes measure: Complications, secondaryOutcomes measure: Health-related quality of life and satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, city: Graz, zip: 8036, country: Austria, geoPoint lat: 47.06667, lon: 15.45, hasResults: False
protocolSection identificationModule nctId: NCT06295029, orgStudyIdInfo id: CPA-Z05-ZC-2023-002, briefTitle: Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: Progression-free survival (PFS), primaryOutcomes measure: Overall adverse event rate, primaryOutcomes measure: Incidence of grade III and above adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06295003, orgStudyIdInfo id: CEFA-COVID, briefTitle: Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-30, primaryCompletionDateStruct date: 2022-05-30, completionDateStruct date: 2022-05-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020)., conditionsModule conditions: COVID-19, conditions: Headache Disorders, conditions: Emergency Service, Hospital, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 700, type: ACTUAL, outcomesModule primaryOutcomes measure: During the study period, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years)., secondaryOutcomes measure: Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06294990, orgStudyIdInfo id: 2023-505854-16-00, briefTitle: Klinefelter Syndrome and Testosterone Treatment in Puberty, acronym: TiPY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Lise Aksglæde, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.Participants will be randomized to two years treatment with testosterone or placebo., conditionsModule conditions: Klinefelter Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center, national, randomized, double-blind, placebo-controlled intervention study, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Testosterone gel, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in body fat mass, secondaryOutcomes measure: Pubertal development and virilization, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Bone mineralization, secondaryOutcomes measure: Neuropsychological evaluation, secondaryOutcomes measure: Neuropsychological evaluation,, eligibilityModule sex: MALE, minimumAge: 10 Years, maximumAge: 14 Years, stdAges: CHILD, hasResults: False
protocolSection identificationModule nctId: NCT06294977, orgStudyIdInfo id: CRISI-COVID, briefTitle: Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-30, primaryCompletionDateStruct date: 2022-12-30, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)., conditionsModule conditions: Epilepsy, conditions: Emergency Services, Hospital, conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ACTUAL, outcomesModule primaryOutcomes measure: During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward, secondaryOutcomes measure: Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False