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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D - study documentation

- 2021-09-20 - 1 Formulär, 47 Item-grupper, 279 Dataelement, 2 Språk

Item-grupper: ChecklistDemographics, Header Module, Registration Header, Registration characteristics, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynaecological examination, Patient Status, ECG, Cardiac Monitoring, Local Her2 Results, Hormonal Receptor Status, History Of Primary Breast Cancer, History Of Primary Cancer (continued), Sentinel Node Sampling, Most Extensive Primary Surgery, Axillary Node Dissection, Chemotherapy, Previous Or Current Cardiovascular Disease, ECG, Translational Research, Central Her2 Testing Form - FISH, Central Her2 Testing Form - IHC, Radiotherapy, Hormonetherapy, Concomitant Treatment, Administration of Study Drug, Post-Event-Treatment, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, On Study - Years 6, 7, 8, 9, and 10, Patient Status, Cardiac Monitoring, Mammogram, Hematoly and Biochemistry, Survival Follow-Up, Treatment Completion, Additional Comments , Death Form

A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

Visit 1 - Baseline Form Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis - Visit 1 - Baseline Form

- 2021-09-20 - 1 Formulär, 9 Item-grupper, 56 Dataelement, 1 Språk

Item-grupper: Header module, Patient demographics, Inclusion criteria, Footer module, Exclusion criteria, Physical Examination, Medication, Laboratory, Rhinosinusitis Disability Index (RSBI)

This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim

ICHOM Older Person - Baseline - Clinician- and Administrative-reported

- 2021-09-20 - 1 Formulär, 8 Item-grupper, 33 Dataelement, 1 Språk

Item-grupper: Administrative Data, Demographic factors, Disutility of care, Symptoms, functioning and quality of life, Frailty, Time spent in hospital, Overall survival, Place of death

ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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. For Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Baseline - Clinician- and Administrative-reported form. It has to be filled in at patient's entry into the set. Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. ASCOT Toolkit. As a license agreement is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Bogen 1 Einschluss Randomisierung DRKS00005243 NCT01657604 Chronic Myeloid Leukemia - Bogen 1 Einschluss Randomisierung

- 2021-09-20 - 1 Formulär, 16 Item-grupper, 106 Dataelement, 2 Språk

Item-grupper: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Randomisierung, Laborwerte, Molekularbiologie, BCR-ABL-Transkripte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Vor- und Begleiterkrankungen, Medikamente, Knochenmarkanalyse, Zytogenetik, Unterschrift

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

CML TIGER inclusion DRKS00005243 NCT01657604 - Bogen 1 Einschluss Randomisierung CML NCT01657604

- 2021-09-20 - 1 Formulär, 16 Item-grupper, 106 Dataelement, 2 Språk

Item-grupper: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Randomisierung, Laborwerte, Molekularbiologie, BCR-ABL-Transkripte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Vor- und Begleiterkrankungen, Medikamente, Knochenmarkanalyse, Zytogenetik, Unterschrift

Bogen 1 Einschluss Randomisierung TIGER Studie Version 22052012 Condition NCT01657604

REGIMS Registry Baseline - Baseline Pregnancy Part 1

- 2021-09-20 - 3 Formulär, 5 Item-grupper, 24 Dataelement, 2 Språk

Item-grupper: Daten der Patientin, Schwangerschaft, Relevante Anamnese (Grunderkrankung, Begleiterkrankungen, Allergien, Risikofaktoren, ...), MS-Medikation, Andere Medikation vor / während der Schwangerschaft

Baseline items for semantic analysis of the Multiple sclerosis immunotherapy registry REGIMS of the Institute of Epidemiology and Social Medicine of the University Hospital Münster provided by Prof. Dr. Klaus Berger and Dr. Maximov Stanislav.

Baseline Pregnancy Part 2

5 Item-grupper 21 Dataelement

Baseline Main Sheet

25 Item-grupper 116 Dataelement

DESCRIBE (DZNE – Clinical Register Study of neurodegenerative Disorders) CRF Baseline Basis Module - DESCRIBE CRF Baseline Basis Module

- 2021-09-20 - 1 Formulär, 23 Item-grupper, 256 Dataelement, 1 Språk

Item-grupper: Date of visit, Demographics, National origin, Mother tongue, Clinical diagnosis, Living situation, Education and profession, Consumption of semiluxury food - nicotine, Consumption of semiluxury food - alcohol, Vital signs, Clinical phenotype - Anamnesis and inspection, Clinical phenotype - Further examination, Umsars I: Questions 9-12, Anamnesis motor skills, Montreal Cognitive Assessment (MoCA), Geriatric depression scale (GDS), Sampling - Blood collection, Sampling according to SOP, Registration of samples, Sampling - Urine sample, Sampling according to SOP (Urine), Results of urine strips, Registration of samples (Urine)

Background and Purpose: The purpose of the DESCRIBE study is to document the natural course of diseases in context of medical care of neurodegenerative disorders as well as cerebrovascular diseases and to perform phenotyping of the test persons. Disease-spanning analyses of the measured clincial data, the results of the imaging processes, results of the analysis of the biometerials including genetic analysis are planed. Principal Investigator: Prof. Klockgether, Dr. Spottke DZNE, Bonn. Source: DESCRIBE-Studie http://www.dzne.de/forschung/forschungsbereiche/klinische-forschung/studien/describe-bn006.html Participating Study Sites: Berlin, Bonn, Göttingen, Dresden, Köln, Magdeburg, München, Rostock/Greifswald, Tübingen

Patient data AML Pazopanib NCT01361334

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 14 Dataelement, 2 Språk

Item-grupper: Patient data, Bisherige Behandlung AML: RQG

Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible (PAZOPANIB-AML) https://clinicaltrials.gov/ct2/show/NCT01361334 Principal Investigator: PD Dr. Torsten Kessler, University Hospital Muenster, Germany

Baseline visit Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Baseline visit]

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 24 Dataelement, 1 Språk

Item-grupp: Baseline Examination

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Ersterhebung OPAL-Studie DRKS00004421 NCT01619124 ALL - Ersterhebung OPAL-Studie

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 60 Dataelement, 2 Språk

Item-grupper: Allgemeine Angaben, Anamnese, Vorerkrankungen, Vorbehandlung (systemisch verabreicht), Befunde bei Diagnose, Bemerkungen

Osteonekrosen bei pädiatrischen Patienten mit ALL Studienleitung: Dr. M. Kuhlen, Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie, Moorenstr. 5, 40225 Düsseldorf, Tel.: 0211 81 17687, Fax: 0211 81 04982, Email: Michaela.Kuhlen@med.uni-duesseldorf.de

Bogen 0 Ersterhebung_Diagnose DRKS00005243 NCT01657604 CML - Bogen 0 Ersterhebung_Diagnose

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 88 Dataelement, 2 Språk

Item-grupper: Allgemeine Angaben, Laborwerte, Klinischer Befund, Molekularbiologie, Knochenmarkanalyse, Zytogenetik

German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

NSCLC (NCT00049543) - Eligibility Checklist and Initial Evaluation NSCLC (NCT00049543)

- 2021-09-20 - 1 Formulär, 10 Item-grupper, 154 Dataelement, 1 Språk

Item-grupper: PATIENT INFORMATION, ELIGIBILITY CHECKLIST, RANDOMIZATION, HISTORY AND PHYSICAL EXAM, INVESTIGATIONS, HEMATOLOGY and BIOCHEMISTRY (baseline), DISEASE HISTORY and PRIOR TREATMENT, Adverse event, CONCOMITANT MEDICATIONS, OTHER MAJOR MEDICAL PROBLEMS

Form 1 - Eligibility Checklist and Initial Evaluation Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed NCT00049543 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

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