Sökresultat - Portal för medicinska datamodeller (MDM-portal)

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 2021-09-27 - 1 Formulär, 7 Item-grupper, 29 Dataelement, 1 Språk

Item-grupper: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 2021-09-27 - 1 Formulär, 7 Item-grupper, 29 Dataelement, 1 Språk

Item-grupper: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Swedish Bladder Cancer Registry - Cystectomy - Follow-Up

- 2021-09-27 - 1 Formulär, 5 Item-grupper, 106 Dataelement, 2 Språk

Item-grupper: General Information, Preoperative Data, Perioperative Data, Postoperative Data, Complications and Reoperations

Swedish Bladder Cancer Registry Healthcare Quality http://www.cancercentrum.se/vast/cancerdiagnoser/urinvagar/urinblase--och-urinvagscancer/kvalitetsregister/dokument/ Cystectomy - Follow-Up

German Quality Management KVWL - dataset KVWL

- 2021-09-27 - 1 Formulär, 8 Item-grupper, 98 Dataelement, 2 Språk

Item-grupper: Patient data, Diagnosis, Follow up, Autopsy, Tumor Expansion, Histopathology, Staging, Distant metastasis

quality management dataset German Quality Management Onkologische Qualitätssicherung der Kassenärztlichen Vereinigung Westfalen-Lippe" (OQSWL)

Swedish Heart Failure Registry (RiksSvikt) - SHFR Hospital

- 2021-09-20 - 1 Formulär, 9 Item-grupper, 93 Dataelement, 2 Språk

Item-grupper: Demography and Lifestyle, Patient self rated symptoms, Previous diseases, Performed procedures, Diagnostics, Biometrics and physical signs, Medication treatment, Patient and relative Information, Planned Follow-Up

Swedish Heart Failure Registry (RiksSvikt/SwedeHF) Sweden has a long tradition of measuring results and performance of the given health care. In order to stimulate to achieve better results, we try to find explanations for the discrepancies between different regions/hospitals/primary care units. In recent years, quality registries have become an increasingly important source of Swedish clinical research. SwedeHF (or RiksSvikt) was created in order to give the participating units knowledge, about how they diagnosed and treated their patients. The given information obtains indications where further efforts are needed in order to give patients with heart failure an optimal management. SwedeHF is an Internet-based registry, where participating units register their heart failure patient on-line, using transferred data from standardized forms or from computerized patients records. SHFR Hospital

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Follow-Up Visit und Unscheduled Visit Form

- 2021-09-20 - 1 Formulär, 3 Item-grupper, 34 Dataelement, 1 Språk

Item-grupper: Administrative Data, Vital Signs, Physical Examination

This ODM file contains a form for the documention required at the follow-up and unscheduled visits. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

ICHOM Type 1 and Type 2 Diabetes in Adults - Annual Characteristics, Patient reported Form

- 2021-09-20 - 1 Formulär, 9 Item-grupper, 32 Dataelement, 1 Språk

Item-grupper: Patient ID, Demographic Factors, Lifestyle and Social Factors, Treatment variables, Clinician-reported Outcomes: Chronic Complications, Patient reported Outcomes: Financial Barriers to Care, Patient reported Outcome: Psychological Well-being, Patient-reported outcomes: Diabetes Distress, Patient-reported outcomes: Depression

Type 1 and Type 2 Diabetes in Adults DATA COLLECTION Version 1.0.0 Revised February 28th, 2019 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Type 1 Diabetes | Type 2 Diabetes Excluded Conditions: Diabetes mellitus types other than 1 and 2 | Secondary Diabetes | Gestational Diabetes Population: Adults Aged 18 years and Above Excluded Populations: Children and Young persons below 18 years Treatment Approaches: Non-Pharmacological Therapy | Non-Insulin-based Pharmacological Therapy | Insulin-based Pharmacological Therapy This form is for documentation of characteristics to be reported annually by the patient. If necessary (i.e. information not already on the 6-monthly clinician-reported form) please also fill in the 6-monthly patient-reported form. It is sufficient for the educational status to only be updated every 5 years. Use of the following Scores for this standard set: WHO (Five) Well-Being Index (WHO-5): The WHO-5 is free for all health care organizations, and a license is not needed. There are translations available. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. More information (including the WHO-5 Scoring Guide) may be found at www.who-5.org. Problem Areas in Diabetes Questionnaire (PAID): The PAID, authored by Joslin Diabetes Center (http://www.joslin.org), is the copyright of Joslin Diabetes Center (Copyright ©2000, Joslin Diabetes Center). The PAID, provided under license from Joslin Diabetes Center may not be copied, distributed or used in any way without the prior written consent of Joslin Diabetes Center. Contact Susan D. Sjostrom at Joslin Diabetes Center at: susan.sjostrom@joslin.harvard.edu for licensing details and scoring guide. Patient Health Questionnaire (PHQ-9): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site", please visit http://www.phqscreeners.com/ for more information. For this standard set ICHOM was supported by Imperial College London Diabetes Centre and JDRF. Publication: Nano J, Carinci F, Okunade O, et al. A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach. Diabetic Medicine [Internet]. [cited 2020 Mar 4];n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14286 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Bogen 2 Verlaufsbogen Seite 1 von 2 TIGER Studie Version 23052012 Condition DRKS00005243 - Bogen 2 Verlaufsbogen Seite 1 von 2

- 2021-09-20 - 1 Formulär, 11 Item-grupper, 39 Dataelement, 2 Språk

Item-grupper: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Therapiephase, Bisherige Therapie im Intervall, Nilotinib 2*300 mg, 1. Nilotinib Pause, PEG-IFN, 1. PEG-IFN Pause, weitere Medikation, Unterschrift

NCT01657604

Bogen 2 Verlaufsbogen Seite 1 von 2 DRKS00005243 NCT01657604 Chronic Myeloid Leukemia - Bogen 2 Verlaufsbogen Seite 1 von 2

- 2021-09-20 - 1 Formulär, 11 Item-grupper, 41 Dataelement, 2 Språk

Item-grupper: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Therapiephase, Bisherige Therapie im Intervall, Nilotinib 2*300 mg, 1. Nilotinib Pause, PEG-IFN, 1. PEG-IFN Pause, weitere Medikation, Unterschrift

http://clinicaltrials.gov/ct2/show/NCT01657604

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

- 2021-09-20 - 1 Formulär, 10 Item-grupper, 72 Dataelement, 2 Språk

Item-grupper: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch

Study documentation part: Outpatient Department Visit 1 - 8. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Swedish Stroke Registry RIKSSTROKE - 3-month Follow-up

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 41 Dataelement, 3 Språk

Item-grupper: 3-month Follow-up, General information, RIKSSTROKE – 3-month Follow-Up Questionnaire

Schwedisches Schlaganfallregister RIKSSTROKE Quelle: http://www.riksstroke.org/eng/ Riksstroke – a Swedish national quality register for stroke care primarily aimed at health professionals and decision makers in health care. We collect, analyze and follow-up data on morbidity and hospital stay. 3-month Follow-up

Swedish Stroke Registry RIKSSTROKE - 2-years Follow-up

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 41 Dataelement, 2 Språk

Item-grupp: RIKS-STRROKE - 2 YEARS FOLLOW-UP

Schwedisches Schlaganfallregister RIKSSTROKE Quelle: http://www.riksstroke.org/eng/ Riksstroke – a Swedish national quality register for stroke care primarily aimed at health professionals and decision makers in health care. We collect, analyze and follow-up data on morbidity and hospital stay. 2-years Follow-up

Nyckelord

Innehållsförteckning

Valda datamodeller