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Anamnese und klinische Untersuchung OPAL-Studie DRKS00004421 NCT01619124 ALL - Anamnese und klinische Untersuchung OPAL-Studie

- 20/9/21 - 1 formulario, 13 itemgroups, 72 items, 2 idiomas

Itemgroups: Allgemeine Angaben, Tägliche Aktivitäten, Gehen, Gelenkinspektion, Bewegungsumfang (in °) Hüftgelenk, Bewegungsumfang (in °) Kniegelenk, Bewegungsumfang (in °) Sprunggelenk, Muskelbefund Oberschenkel, Muskelbefund Unterschenkel, Therapiekomplikationen, Begleitmedikation, Spez. Intervention gegen Osteonekrosen, Bemerkungen

Osteonekrosen bei pädiatrischen Patienten mit ALL

Ankle-Arm Index CARLA

- 17/9/21 - 1 formulario, 11 itemgroups, 42 items, 2 idiomas

Itemgroups: General information, Circumference measurement, BP measurement I, BP measurement II, BP measurement II: No. 1, BP measurement II: No. 2, BP measurement III, BP measurement III: No. 1, BP measurement III: No. 2, Further information, Data entry

Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Blood pressure measurement CARLA Follow-up

- 17/9/21 - 1 formulario, 5 itemgroups, 30 items, 2 idiomas

Itemgroups: General information, After 5 min. (Measurement I), After 3 min. (Measurement II), After 3 min. (Measurement III), Data entry

Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Blood pressure measurement CARLA - Blood pressure measurement CARLA

- 17/9/21 - 1 formulario, 5 itemgroups, 26 items, 2 idiomas

Itemgroups: General information, After 5 min. (Measurement I), After 3 min. (Measurement II), After 3 min. (Measurement III), Data entry

Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Ankle-Arm Index CARLA Follow-up

- 17/9/21 - 1 formulario, 12 itemgroups, 44 items, 2 idiomas

Itemgroups: General information, Circumference measurement, Pulse of anterior tibial artery, BP measurement I, BP measurement II, BP measurement II: No. 1, BP measurement II: No. 2, BP measurement III, BP measurement III: No. 1, BP measurement III: No. 2, Further information, Data entry

Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Significant Medical/ Surgical History And Physical Examination, Prior Medication

- 17/9/21 - 1 formulario, 3 itemgroups, 15 items, 1 idioma

Itemgroups: Administrative Data, Medical history, physical examination, Prior Medication

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Significant Medical/ Surgical History And Physical Examination and the Prior Medication form. It has to be filled in for screening.

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021 - General Medical History and Physical Examination

- 24/8/21 - 1 formulario, 3 itemgroups, 7 items, 1 idioma

Itemgroups: Administrative, General Medical History | Physical Examination, General Medical History | Physical Examination

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. The 'General Medical History and Physical Examination' form should be filled in at Visit 2 (0-28 days after Visit 1). Please report medication(s) as specified in the protocol and fill in the medical section. Please note that informed consent has to be obtained prior to any study procedure.

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393 - Medical History and Physical Examination

- 21/7/21 - 1 formulario, 3 itemgroups, 7 items, 1 idioma

Itemgroups: Administrative, General Medical History | Physical Examination, General Medical History | Physical Examination

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). General medical history / physical examination should be documented / performed on visit 2 before administering the first dose of the vaccine. Please report medication(s) as specified in the protocol and fill in the Medication section. Note that informed consent has to be obtained prior to any study procedure.

medical examination SHIP-START-3 somatometry

- 3/7/21 - 1 formulario, 1 itemgroup, 14 items, 3 idiomas

Itemgroup: somatometry

somatometry form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MEX.PHYSEXAM.SOMATOM. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840 - Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration

- 29/5/21 - 1 formulario, 6 itemgroups, 22 items, 1 idioma

Itemgroups: Administrative, General Medical History/ Physical Examination, General Medical History/ Physical Examination , Laboratory Tests, Vaccine Administration, Vaccine Administration

Study ID: 108708 Clinical Study ID: 108708 Study Title: A phase IIb, controlled, randomized, multicentre, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years previously vaccinated in FLU-LD-002 clinical trial Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00385840 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 17/4/21 - 1 formulario, 9 itemgroups, 20 items, 1 idioma

Itemgroups: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response

- 1/4/21 - 1 formulario, 16 itemgroups, 59 items, 1 idioma

Itemgroups: Administrative, Physical Examination (Follow-Up), Physical Examination (Follow-Up), Laboratory Results - Hematology/ Chemistry (Follow-Up), Laboratory Results (Follow-Up) - Hematology, Laboratory Results (Follow-Up) - Hematology, Laboratory Results (Follow-Up) - Chemistry, Laboratory Results (Follow-Up) - Chemistry, Post-Treatment Response (Follow -Up), Post-Treatment Response (Follow-Up) - CT or other Radiological Imaging Results, Post-Treatment Response (Follow-Up) - Bone Marrow Biopsy, Post-Treatment Response (Follow-Up) - Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Response, Signature of Investigator

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

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