hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06274372, orgStudyIdInfo id: FCV,V-2202, briefTitle: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-07, primaryCompletionDateStruct date: 2024-08-06, completionDateStruct date: 2024-08-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Derince Training and Research Hospital, class: OTHER, descriptionModule briefSummary: It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations., conditionsModule conditions: Laparoscopic Surgeries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: flow controlled ventilation, interventions name: volume controlled ventilation, outcomesModule primaryOutcomes measure: effects of flow controlled ventilation on heamodynamic parameters, primaryOutcomes measure: effectcs of flow controlled ventiletion on respiratory parameters, primaryOutcomes measure: effects of flow controlled ventilation on heamodynamic parameters, primaryOutcomes measure: effects of flow controlled ventilation on heamodynamic parameters, primaryOutcomes measure: effectcs of flow controlled ventiletion on respiratory parameters, secondaryOutcomes measure: respiratory related complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli Derince Training and Research Hospital, city: Derince, state: Kocaeli, zip: 41900, country: Turkey, hasResults: False
protocolSection identificationModule nctId: NCT06274359, orgStudyIdInfo id: 21-3985, briefTitle: Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Denver Health and Hospital Authority, class: OTHER, descriptionModule briefSummary: While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases., conditionsModule conditions: Influenza, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Caregivers will be assigned randomly to receive a series of digital stories by text message or to receive usual care., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Digital storytelling, outcomesModule primaryOutcomes measure: Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary), secondaryOutcomes measure: Intervention Feasibility, secondaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Intervention Appropriateness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Denver Health Eastside Clinic, city: Denver, state: Colorado, zip: 80205, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Denver Health Park Hill Clinic, city: Denver, state: Colorado, zip: 80207, country: United States, geoPoint lat: 39.73915, lon: -104.9847, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-26, uploadDate: 2024-01-30T11:52, filename: ICF_000.pdf, size: 298169, hasResults: False
protocolSection identificationModule nctId: NCT06274333, orgStudyIdInfo id: RC.18.1.2024, briefTitle: Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, collaborators name: Benha University, descriptionModule briefSummary: The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia., conditionsModule conditions: Percutaneous Nephrolithotripsy (PCNL), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine 0.5 mic/kg, interventions name: Tramadol 1mg/kg, interventions name: Paracetamol 10mg/kg, outcomesModule primaryOutcomes measure: The incidence of catheter-related bladder discomfort (CRBD), secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Meperidine requirement, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Surgeon satisfaction, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Neveen Kohaf, status: RECRUITING, city: Cairo, zip: 11865, country: Egypt, contacts name: Neveen Kohaf, Ph.D, role: CONTACT, phone: +201069482380, email: nevenabdo@azhar.edu.eg, contacts name: Hany Bauiomy, M.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed M. Abosakaya, M.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06274320, orgStudyIdInfo id: LRP22002 LIPIKAR UREA 30%, briefTitle: Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cosmetique Active International, class: INDUSTRY, descriptionModule briefSummary: This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment., conditionsModule conditions: Actinic Keratoses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Group A: holistic approach, interventions name: Group B: Tolak® Standard of use, outcomesModule primaryOutcomes measure: Change in lesion response rate, secondaryOutcomes measure: Percentage change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CentroDerm GmbH, city: Wuppertal, country: Germany, geoPoint lat: 51.27027, lon: 7.16755, hasResults: False
protocolSection identificationModule nctId: NCT06274294, orgStudyIdInfo id: 2023/12, briefTitle: Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC, acronym: PASSPORT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: CMC Ambroise Paré, class: OTHER, collaborators name: Paris IBD Center, collaborators name: Celltrion HealthCare France, descriptionModule briefSummary: The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: CT-P13, outcomesModule primaryOutcomes measure: Ratio SC/IV, secondaryOutcomes measure: Ctrough at week 24 (non-inferiority), secondaryOutcomes measure: AUC at week 24, secondaryOutcomes measure: Clinical response at week 6 and week 24, secondaryOutcomes measure: IBD disability index at week 6, secondaryOutcomes measure: Fecal calprotectin at week 24, secondaryOutcomes measure: Clinical remission at week 6 and week 24, secondaryOutcomes measure: Presence of antibodies to infliximab at Week 6 and Week 24, secondaryOutcomes measure: Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24), secondaryOutcomes measure: Adverse events, including injection site reactions and hypersensitivity reactions, secondaryOutcomes measure: TSQM collected at Week 6 and Week 24, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06274268, orgStudyIdInfo id: CHMS23006, briefTitle: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments, acronym: SARC-ONCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Metropole Savoie, class: OTHER, collaborators name: Université Savoie Mont Blanc, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.The main question it aims to answer is :Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests., conditionsModule conditions: Sarcopenia, conditions: Oncology, conditions: Physical Inactivity, conditions: Toxicity Due to Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective cohort study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Sarcopenia diagnostic test, outcomesModule primaryOutcomes measure: Event-free survival according to sarcopenic statut, secondaryOutcomes measure: Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment., secondaryOutcomes measure: Progression free-survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate at 6 and 12 months, secondaryOutcomes measure: Number of patients classified as sarcopenic by BIA method and CT method., secondaryOutcomes measure: Exploratory: Event-free survival during PACLITAXEL protocol, secondaryOutcomes measure: Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2)., secondaryOutcomes measure: Exploratory: RCB-based objective response rate at 6 and 12 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06274255, orgStudyIdInfo id: BalikesirU, briefTitle: Serum Magnesium Level and Pediatric Migraine, acronym: Migraine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded., conditionsModule conditions: Migraine, Magnesium, Pediatric, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Serum Magnesium Level and Pediatric Migraine, secondaryOutcomes measure: Serum Magnesium Level and Pediatric Migraine, eligibilityModule sex: ALL, minimumAge: 72 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hilal Aydın, city: Balıkesir, state: Türkiye, zip: 33343, country: Turkey, contacts name: Hilal Aydın, assoc. Dr., role: CONTACT, phone: +902666121461, email: drhilalaydin@gmail.com, contacts name: Hilal Aydın, assoc. Dr., role: CONTACT, phone: +905072607541, email: drhilalaydin@gmail.com, geoPoint lat: 39.64917, lon: 27.88611, locations facility: Aysen Orman, city: Mersin, state: Türkiye, zip: 33343, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, locations facility: MersinU, city: Mersin, state: Türkiye, zip: 33343, country: Turkey, contacts name: Aysen Orman, role: CONTACT, email: ormanaysen709@gmail.com, contacts name: Aysen Orman, role: CONTACT, phone: 3242410000, phoneExt: 2646, email: ormanaysen709@gmail.com, geoPoint lat: 36.79526, lon: 34.61792, locations facility: Aysen Orman, city: Mersin, state: Türkiye, zip: 38000, country: Turkey, contacts name: Aysen Orman, assoc. Dr., role: CONTACT, phone: +903242410000, phoneExt: +903242410000, email: ormanaysen709@gmail.com, contacts name: Aysen Orman, assoc. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
protocolSection identificationModule nctId: NCT06274242, orgStudyIdInfo id: MU-CIRB 2022/300.0711, briefTitle: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2023-07-22, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial., conditionsModule conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 98, type: ACTUAL, armsInterventionsModule interventions name: Haruna, interventions name: Placebo Powder, outcomesModule primaryOutcomes measure: Change in Stool Frequency, primaryOutcomes measure: Change in Fecal Microbiota, secondaryOutcomes measure: Change in Stool consistency, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mahidol University, city: Nakhon Pathom, zip: 73170, country: Thailand, geoPoint lat: 13.8196, lon: 100.04427, hasResults: False
protocolSection identificationModule nctId: NCT06274229, orgStudyIdInfo id: EA4/252/23, briefTitle: DivAirCity Social Health Survey, acronym: DivAirCitySH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, collaborators name: Universitat Politècnica de València, collaborators name: Universitatea din Bucuresti, collaborators name: University of Aarhus, collaborators name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, collaborators name: European Commission, descriptionModule briefSummary: To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site)., conditionsModule conditions: Psychological Stress, conditions: Psychological Well-Being, conditions: Pollution; Exposure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Air pollution and noise reducing installations, outcomesModule primaryOutcomes measure: WHO-5 Well-being Scale, secondaryOutcomes measure: Kessler K6 psychological distress, secondaryOutcomes measure: ASKU questionnaire, otherOutcomes measure: Questionnaire for General Physiological Health, otherOutcomes measure: Questionnaire about feelings of safety and security at the site, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité -- Universitaetsmedizin Berlin, status: RECRUITING, city: Berlin, zip: 14109, country: Germany, contacts name: Farid I Kandil, PhD, role: CONTACT, phone: +491605631744, email: farid-ihab.kandil@charite.de, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False
protocolSection identificationModule nctId: NCT06274203, orgStudyIdInfo id: 10584-2/5-2023, briefTitle: High Dose Vitamin D Supplementation in Children With Sickle Cell Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL., conditionsModule conditions: Sickle Cell Disease, conditions: Vitamin D Deficiency, conditions: Health Related Quality of Life, conditions: Hand Grip Strength, conditions: Bone Mineral Density, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Vitamin D3, outcomesModule primaryOutcomes measure: Serum 25(OH)D level, secondaryOutcomes measure: Bone mineral density (BMD), secondaryOutcomes measure: Maximum handgrip strength (HGS), secondaryOutcomes measure: Health related quality of life (HRQL), secondaryOutcomes measure: Serum concentrations of C reactive protein (CRP), secondaryOutcomes measure: Serum concentrations of Erythrocyte sedimentation rate (ESR), secondaryOutcomes measure: Safety reporting of any adverse events, secondaryOutcomes measure: Safety measurements of serum Ca, secondaryOutcomes measure: childhood health assessment, secondaryOutcomes measure: Safety measurements of serum 25(OH)D levels, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Zagazig university, city: Zagazig, state: Sharkia, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False