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Years 6-9 Medical & Personal History Cardiovascular Health Study (CHS)

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 314 Dataelement, 1 Språk

Item-grupp: medical history

Documentation part: Record 59 Years 6-9 Medical & Personal History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

PROGNOSTIC FACTORS Roche H0650g Breast Cancer - PROGNOSTIC FACTORS

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 26 Dataelement, 1 Språk

Item-grupp: Prognostic factors

Study part: Prognostic factors. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

New Cohort Personal History Cardiovascular Health Study (CHS)

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 124 Dataelement, 1 Språk

Item-grupper: New Cohort Personal History, siblings

Documentation part: Record 58 New Cohort Perosnal History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Treatment - Prior Therapy Supplement - 3279607v1.0 - Prior Therapy Supplement

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 10 Dataelement, 1 Språk

Item-grupp: Prior Therapy Supplement

Details of prior therapies related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study as indicated on the Prior Treatment Summary case report form. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD0FD25D-D2EF-6C5F-E040-BB89AD431DAE

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

- 2021-09-20 - 1 Formulär, 13 Item-grupper, 72 Dataelement, 2 Språk

Item-grupper: 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

Years 10-11 Medical & Personal History Cardiovascular Health Study (CHS)

- 2021-09-17 - 1 Formulär, 1 Item-grupp, 352 Dataelement, 1 Språk

Item-grupp: medical history

Documentation part: Record 59 Years 10-11 Medical & Personal History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Studie NNH Nase - Medical history (Anamnese)

- 2021-09-17 - 1 Formulär, 10 Item-grupper, 49 Dataelement, 1 Språk

Item-grupper: Administrative Data, Basic information, Symptoms, History of nasal sinus surgery, Hypersensitivity, Other comorbidities, Obstructive sleep apnea, History of malignant diseases, Multiresistant germs and antibiotic intake, Asthma

Medical history form of the ENT department University Hospital Muenster. It contains items about hypersensitivity originating from: Top 15 DEGS Bundesgesundheitsbl 2013 · 56:687–697

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

- 2021-09-17 - 1 Formulär, 3 Item-grupper, 15 Dataelement, 1 Språk

Item-grupper: 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

- 2021-08-24 - 1 Formulär, 3 Item-grupper, 7 Dataelement, 1 Språk

Item-grupper: 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

- 2021-07-21 - 1 Formulär, 3 Item-grupper, 7 Dataelement, 1 Språk

Item-grupper: 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.

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

- 2021-05-29 - 1 Formulär, 6 Item-grupper, 22 Dataelement, 1 Språk

Item-grupper: 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

- 2021-04-17 - 1 Formulär, 9 Item-grupper, 20 Dataelement, 1 Språk

Item-grupper: 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

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