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Inhaltsverzeichnis
  1. 1. Klinische Studie
    1. 1.1. Ein-/Ausschluss
    1. 1.2. Anamnese
    1. 1.3. Körperliche Untersuchung
    1. 1.4. Score
    1. 1.5. Apparative Diagnostik
    1. 1.6. Labor
    1. 1.7. Pathologie/Histologie
    1. 1.8. Aufklärung/Einverständis
    1. 1.9. Therapie
    1. 1.10. Operationsbericht
    1. 1.11. Unerwünschtes Ereignis
    1. 1.12. Follow-Up
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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Vital Signs Anal Cancer NCT00324415

- 31.07.15 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Header module, Vital Signs, Comments
Anal Cancer NCT00324415 On-Study - AMC-045 Vital Signs Form (F20) - 2937179v1.0 Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7285E88F-E0EF-C8EB-E040-BB89AD437ABB

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Subsequent Cycle) - Radium 223 Dichloride (Alpharadin) - Subsequent Cycle

- 16.02.22 - 1 Formular, 8 Itemgruppen, 57 Datenelemente, 1 Sprache
Itemgruppen: Subject Visit, Assessment of Disease Progression, Vital Signs, BPI-SF, ECOG Performance Status, Hematology (with DBC), General Chemistry - Serum, Skeletal Related Events
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

On-Study - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients - 2019420v3.0 - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients

- 27.09.21 - 1 Formular, 4 Itemgruppen, 33 Datenelemente, 1 Sprache
Itemgruppen: CRF Header, AML/MDS: Form Administration, AML/MDS: Disease Description, Comments
Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B24E8B9-F86C-508D-E044-0003BA3F9857

On-Study - Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients - 2019404v4.0 - Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients

- 27.09.21 - 1 Formular, 4 Itemgruppen, 32 Datenelemente, 1 Sprache
Itemgruppen: CRF Header, AML: Form Administration, AML: Disease Description, Comments
Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D071CA6-C045-F391-E040-BB89AD4376C0

Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0 - CALGB: 10201On-Study Form

- 27.09.21 - 1 Formular, 6 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: CALGB Form, Patient Description, Organ Involvement, Current Symptoms, Lab data at Study Entry, CCRR MODULE
CALGB: 10201On-Study Form Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Lung Cancer NCT00113386 On-Study - RTOG-0412 I1: Initial Evaluation Form - 2288131v3.0 - RTOG-0412 I1: Initial Evaluation Form

- 27.09.21 - 1 Formular, 3 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: MODULE 1, PRE-TREATMENT CHACTERISTICS, LYMPH NODE ASSESSMENT
RTOG-0412 I1: Initial Evaluation Form Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E489FECB-49D8-0477-E034-0003BA3F9857

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Holter ECG Results

- 20.09.21 - 1 Formular, 1 Itemgruppe, 79 Datenelemente, 1 Sprache
Itemgruppe: Holter ECG Results
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Holter ECG Results

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Repeat Telemetry Abnormalities

- 20.09.21 - 1 Formular, 1 Itemgruppe, 78 Datenelemente, 1 Sprache
Itemgruppe: Repeat Telemetry Abnormalities
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Repeat Telemetry Abnormalities

RTOG-0412 I1 Rev1: Initial Evaluation Form NCT00113386

- 20.09.21 - 1 Formular, 4 Itemgruppen, 44 Datenelemente, 1 Sprache
Itemgruppen: Header, PRE-TREATMENT CHACTERISTICS, LYMPH NODE ASSESSMENT, Comments
RTOG-0412 I1 Rev1: Initial Evaluation Form NCT00113386 Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ED65A888-399B-7059-E034-0003BA3F9857

Neoplasms, Breast DRKS00003651 NCT00490139 On-Study - BIG 2-06 / NCCTG N063D / EGF106708 - Screening - 2646496v1.0 - BIG 2-06 / NCCTG N063D / EGF106708 - Screening

- 20.09.21 - 1 Formular, 22 Itemgruppen, 159 Datenelemente, 1 Sprache
Itemgruppen: Header Module, Eligibility Screening Form, Randomization, Informed Consent, Header, Vital signs and physical measurements, ECG, LVEF, HER2/neu status (local lab), Central Laboratory, Hormonal receptor status, History of primary breast cancer, Hematology and Biochemistry, History of primary cancer (continued), Sentinel nodes sampling, Primary breast cancer surgery, Axillary node dissection, Prior neo-/adjuvant chemotherapy for primary breast cancer, Previous or current cardiovascular disease, Previous or current diseases other than primary breast and cardiovascular diseases, Radiological examination, Translational Research (Appendix 5)
BIG 2-06 / NCCTG N063D / EGF106708 - Screening ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=320F58CD-66A7-57B6-E044-0003BA3F9857

RTOG-1005 I1: Radiation Therapy Oncology Group Phase III Whole Breast Irradiation for Early Stage Breast Cancer - Initial Evaluation Form NCT01349322

- 20.09.21 - 1 Formular, 10 Itemgruppen, 93 Datenelemente, 1 Sprache
Itemgruppen: RTOG clinical trial administrative data, Patient status, Tumor Involvement, pStage I, II breast cancer AND at least one of the following (see below and code all), Tumor Information, Study Cancer, Baseline Labs, Examinations/Consultations, General Conditions, Footer Module
RTOG-1005 I1: Radiation Therapy Oncology Group Phase III Whole Breast Irradiation for Early Stage Breast Cancer - Initial Evaluation Form NCT01349322 Higher-Dose Radiation Therapy or Standard Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9C06B696-F1B0-F7B4-E040-BB89AD434CCB

E1105 On-Study Form NCT00520975

- 20.09.21 - 1 Formular, 7 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Header, Patient demographics, Data amendment, Pre-Registration Evaluation, Prior Treatment for this Disease, Disease Description, Footer Module
E1105 On-Study Form NCT00520975 First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=171FAB32-7984-3641-E044-0003BA3F9857

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