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Personal Health Record

- 27.09.21 - 1 Formular, 15 Itemgruppen, 269 Datenelemente, 2 Sprachen
Itemgruppen: General Information, PATIENT REGISTRATION, SERVICE PROVIDER INFORMATION, MEDICAL HISTORY, PATIENT’S IMMUNIZATION RECORD, CLINICAL MEASUREMENTS, EXAM FINDINGS, LABORATORY/OTHER TESTS, DIAGNOSTICS, SUMMARY FINDINGS, TREATMENT RECOMMENDATION, TRAVEL RECOMMENDATION, POST-ARRIVAL RECOMMENDATION, TREATMENT ADMINISTRATION, VACCINE ADMINISTRATION
Personal Health Record السجل الصحي الشخ ي ص

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - T3-Diaries

- 20.09.21 - 1 Formular, 10 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Date of visit; Assessment Date, Migraine Disorder, Subject Diary, Experimental drug, Migraine Disorder, Subject Diary, Experimental drug, Dosage, Concomitant Agent, Concomitant Agent, Clinic, Experimental drug, Status, Concomitant Agent, Home environment, Travel
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - T2-Diaries

- 20.09.21 - 1 Formular, 10 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Date of visit; Assessment Date, Migraine Disorder, Subject Diary, Experimental drug, Migraine Disorder, Subject Diary, Experimental drug, Dosage, Concomitant Agent, Concomitant Agent, Clinic, Experimental drug, Status, Concomitant Agent, Home environment, Travel
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - T1-Diaries

- 20.09.21 - 1 Formular, 10 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Date of visit; Assessment Date, Migraine Disorder, Subject Diary, Experimental drug, Migraine Disorder, Subject Diary, Experimental drug, Dosage, Concomitant Agent, Concomitant Agent, Clinic, Experimental drug, Status, Concomitant Agent, Home environment, Travel
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393 - Absences from Study Area

- 10.08.21 - 1 Formular, 3 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Absences from Clinical Trial Area Duration, Absences from Clinical Trial Area Duration
Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Absences from the study area for more than one week during the clinical trial period should be documented on an ongoing basis. A separate form needs to be filled in for the double-blind phase (covers period from day 0 to month 6 1/2) and the single-blind phase (covers period from month 7 to month 14). Note that informed consent has to be obtained prior to any study procedure.

International Travel History Protocol PhenX Toolkit

- 27.09.17 - 1 Formular, 4 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: PhenX - international travel history protocol, Trips, History of previous travel, Diagnoses
From the Global Surveillance Network of the International Society of Travel Medicine (ISTM) and the Centers for Disease Control and Prevention (CDC), The GeoSentinel protocol is a self-reported questionnaire that collects information on a respondent’s recent (within the last 6 months) and previous (within the last 5 years) travel history. It also provides a template for the clinician to use in assessing the exposure details. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

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