hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06388785, orgStudyIdInfo id: TAK-003-5001, briefTitle: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia, acronym: PRIME-Q, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate., conditionsModule conditions: Dengue Fever, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP), eligibilityModule sex: ALL, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universiti Putra Malaysia, city: Serdang, state: Selangor, zip: 43400, country: Malaysia, contacts name: Study Contact, role: CONTACT, phone: +603-9769 1000, email: zamberi@upm.edu.my, contacts name: Zamberi Sekawi, Dr, role: PRINCIPAL_INVESTIGATOR, locations facility: Universiti Malaya, city: Kuala Lumpur, state: Wilayah Persekutuan Kuala Lumpur, zip: 50603, country: Malaysia, contacts name: Study Contact, role: CONTACT, phone: +60379493641, email: sfaridah@ummc.edu.my, contacts name: Sharifah Faridah binti Syed Omar, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False
protocolSection identificationModule nctId: NCT06388772, orgStudyIdInfo id: HJG-CZQH-QHRD106, briefTitle: Study to Assess PK, Safety and Tolerability Early in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-05, primaryCompletionDateStruct date: 2022-07-22, completionDateStruct date: 2023-01-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Changzhou Qianhong Bio-pharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: QHRD106 Injection, interventions name: placebo, outcomesModule primaryOutcomes measure: Safety as assessed by incidence, severity, and causality of adverse events, primaryOutcomes measure: Plasma measurements of QHRD106, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nanjing Drum Tower Hospital, city: Nanjing, state: Jiangsu, zip: 210008, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06388759, orgStudyIdInfo id: TQ05105-Ib-03, briefTitle: TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis., conditionsModule conditions: Myelofibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ACTUAL, armsInterventionsModule interventions name: TQ05105 Tablets, outcomesModule primaryOutcomes measure: Spleen volume reduction (SVR35)≥35% from baseline, secondaryOutcomes measure: Optimum effective rate, secondaryOutcomes measure: Onset time of splenic response, secondaryOutcomes measure: Duration of maintenance of spleen response (DoMSR) ≥35% reduction, secondaryOutcomes measure: Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline, secondaryOutcomes measure: The total symptom score of MPN-SAF TSS decreased compared with baseline, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Leukemia free survival (LFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Severity of AEs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230001, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The First Affiliated Hospital of Wannan Medical College, city: Wuhu, state: Anhui, zip: 241001, country: China, geoPoint lat: 31.33728, lon: 118.37351, locations facility: Union Hospital Tongji College Huazhong University of Science And Technology, city: Wuhan, state: Hubei, zip: 430071, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Affiliated Hospital of Xuzhou Medical University, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130021, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Shanghai Sixth People's Hospital, city: Shanghai, state: Shanghai, zip: 200233, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06388746, orgStudyIdInfo id: NKUA, briefTitle: Arresting Carious Lesions With Minimal Intervention Techniques, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, descriptionModule briefSummary: A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars., conditionsModule conditions: Caries,Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: BRIX3000®, interventions name: Riva Star Aqua, SDI Limited, Australia, outcomesModule primaryOutcomes measure: clinical success, primaryOutcomes measure: radiographic success, secondaryOutcomes measure: Longevity and the quality of the final restoration, secondaryOutcomes measure: Patient's acceptance, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388720, orgStudyIdInfo id: NCC2024-0026, briefTitle: The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy, acronym: IMGeS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National Cancer Center, Korea, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml, outcomesModule primaryOutcomes measure: Recurrent free survival in sequential treatment group., secondaryOutcomes measure: Progression free survival in sequential treatment group., secondaryOutcomes measure: Cystectomy free survival in sequential treatment group., secondaryOutcomes measure: cancer specific survival in sequential treatment group., secondaryOutcomes measure: Overall survival in sequential treatment group., secondaryOutcomes measure: Safety of sequential treatment., eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, status: RECRUITING, city: Goyang-si, country: Korea, Republic of, contacts name: Ho Kyung Seo, role: CONTACT, phone: 82-31-920-1678, email: seohk@ncc.re.kr, contacts name: Ho Kyung Seo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eui Hyun Jung, Ph.D, role: SUB_INVESTIGATOR, geoPoint lat: 37.65639, lon: 126.835, hasResults: False
protocolSection identificationModule nctId: NCT06388707, orgStudyIdInfo id: NF-2022-01, briefTitle: A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NaviFUS Corporation, class: INDUSTRY, collaborators name: NaviFUS US LLC, descriptionModule briefSummary: This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE)., conditionsModule conditions: Drug Resistant Epilepsy, conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: NaviFUS System, outcomesModule primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Change from baseline in seizure frequency, secondaryOutcomes measure: Change from baseline in electroencephalography (EEG) epileptiform discharges, secondaryOutcomes measure: Days of seizure-free, secondaryOutcomes measure: Changes from baseline in Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Changes from baseline in Beck Depression Inventory (BDI-II), secondaryOutcomes measure: Changes from baseline in Personal Impact of Epilepsy Scale (PIES), otherOutcomes measure: Change from baseline in subjective seizure strength, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University School of Medicine, city: Palo Alto, state: California, zip: 94305, country: United States, contacts name: Robert Fisher, M.D., Ph.D., role: CONTACT, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Ellen Bubrick, M.D., role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Virginia School of Medicine, city: Charlottesville, state: Virginia, zip: 22903, country: United States, contacts name: Nathan Fountain, M.D., role: CONTACT, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False
protocolSection identificationModule nctId: NCT06388694, orgStudyIdInfo id: RDO KPNC 24-056, briefTitle: Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kaiser Permanente, class: OTHER, descriptionModule briefSummary: This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience., conditionsModule conditions: Attention-deficit Hyperactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 315, type: ESTIMATED, armsInterventionsModule interventions name: Pharmacist Care, interventions name: Primary Care Physician Care, outcomesModule primaryOutcomes measure: Percentage of participants appropriately referred for a follow-up weight check, secondaryOutcomes measure: Timeliness of care, secondaryOutcomes measure: Parent perception of effectiveness of care, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Kaiser Permanente Northern California, city: Oakland, state: California, zip: 94612, country: United States, geoPoint lat: 37.80437, lon: -122.2708, hasResults: False
protocolSection identificationModule nctId: NCT06388681, orgStudyIdInfo id: HMKU-KMY-SA-02, briefTitle: Stress Ball Use in Patients Undergoing Coronary Angiography, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-06-26, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mustafa Kemal University, class: OTHER, descriptionModule briefSummary: One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography, outcomesModule primaryOutcomes measure: Patient Identifying Information Form, primaryOutcomes measure: Immobilization Comfort Scale, otherOutcomes measure: Visual Benchmarking Scale, otherOutcomes measure: Vital Signs Monitoring Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hatay Mustafa Kemal University, status: RECRUITING, city: Hatay, country: Turkey, contacts name: SÜMEYYE AKÇOBAN, role: CONTACT, geoPoint lat: 38.40227, lon: 27.10486, hasResults: False
protocolSection identificationModule nctId: NCT06388668, orgStudyIdInfo id: ICM 2025-3428, briefTitle: Lipid Testing After Myocardial Infarction at the Montreal Heart Institute, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Montreal Heart Institute, class: OTHER, collaborators name: Novartis Pharmaceuticals, descriptionModule briefSummary: Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization.It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge., conditionsModule conditions: Dyslipidemias, conditions: Lipid Testing, conditions: Myocardial Infarction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Lipid panel, outcomesModule primaryOutcomes measure: Variation in LDL, secondaryOutcomes measure: Variation in non-HDL and apoB, secondaryOutcomes measure: Evaluation of intensification threshold, otherOutcomes measure: Repeat lipid panel after discharge, otherOutcomes measure: Evaluation of intensification threshold after discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montreal Heart Institute, city: Montréal, state: Quebec, zip: H1T 1C8, country: Canada, contacts name: Guillaume Marquis-Gravel, MD, MSc, role: CONTACT, phone: (514) 376-3330, email: guillaume.marquis.gravel@umontreal.ca, contacts name: Guillaume Marquis-Gravel, MD, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Jean Grégoire, MD, role: SUB_INVESTIGATOR, contacts name: François Simard, MD, role: SUB_INVESTIGATOR, contacts name: Rafaël Monet-Alarcia, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
protocolSection identificationModule nctId: NCT06388655, orgStudyIdInfo id: MDCR-19-007, briefTitle: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-10, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Daegu Catholic University Medical Center, class: OTHER, descriptionModule briefSummary: The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations., conditionsModule conditions: Internet Addiction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 61, type: ACTUAL, armsInterventionsModule interventions name: mobile neurofeedback, interventions name: sham mobile neurofeedback, outcomesModule primaryOutcomes measure: Comparisons of the means of children's self-scale variables, secondaryOutcomes measure: Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II), secondaryOutcomes measure: Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV), secondaryOutcomes measure: Comparisons of the means of children's Stroop, secondaryOutcomes measure: Comparisons of the means of children's ATA(Advanced Test of Attention), secondaryOutcomes measure: Comparisons of the means of children's CCTT(Children's Color Trails Test), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Daegu Catholic University Medical Center, city: Daegu, state: Nam-gu, zip: 42471, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, hasResults: False
protocolSection identificationModule nctId: NCT06388642, orgStudyIdInfo id: CUV052, briefTitle: Pharmacokinetics of Afamelanotide in EPP Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Clinuvel Europe Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients., conditionsModule conditions: Erythropoietic Protoporphyria, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Afamelanotide 16mg implant, outcomesModule primaryOutcomes measure: Cmax (maximum Plasma Concentration), primaryOutcomes measure: AUC(0-t) (area under the curve from administration to last observed concentration at time t), secondaryOutcomes measure: AUC(0-∞) (area under the curve extrapolated to infinite time), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, status: RECRUITING, city: Rotterdam, country: Netherlands, contacts name: Erasmus Medical Centre, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False