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Table of contents
  1. 1. Ensayo clínico
  2. 2. Documentación de rutina
  3. 3. Estudio de registro / cohorte
  4. 4. Seguro de calidad
  5. 5. Estándar de datos
  6. 6. Resultado reportado por el paciente
  7. 7. Especialidad médica
    1. 7.1. Anestesiología
    1. 7.2. Dermatología
    1. 7.3. ENT
    1. 7.4. Geriatría
    1. 7.5. Ginecología / Obstetricia
    1. 7.6. Medicina Interna
      1. Hematología
      1. Enfermedades infecciosas
      1. Cardiología / Angiología
      1. Neumología
      1. Gastroenterología
      1. Nefrología
      1. Endocrinología / Enfermedades metabólicas
      1. Reumatología
    1. 7.7. Neurología
    1. 7.8. Oftalmología
    1. 7.9. Cuidados paliativos
    1. 7.10. Patología / Forense
    1. 7.11. Pediatría
    1. 7.12. Psiquiatría / Psicosomática
    1. 7.13. Radiología
    1. 7.14. Cirugía
      1. Cirugía General / Visceral
      1. Neurocirugía
      1. Cirugía plástica
      1. Cirugía Torácica
      1. Traumatología / Ortopedia
      1. Cirugía vascular
    1. 7.15. Urología
    1. 7.16. Odontología / OMS
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Lung cancer Nontarget Lesions Supplemental Form (ECOG 4599)

- 16/12/14 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: General information, Lesion
ECOG 4599 Nontarget Lesions Supplemental Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A13424B4-AED3-672E-E034-080020C9C0E0

Lung Cancer NCT01336894 Transmittal - ACOSOG-Z4099 Imaging Report Submission Form - 3220472v1.0 - ACOSOG-Z4099 Imaging Report Submission Form

- 9/1/15 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Header Module, Visit, Report submission
ACOSOG-Z4099 Imaging Report Submission Form Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A01C569D-F032-05E1-E040-BB89AD4349E3

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Independent Response Evaluation Joint Assessment and Consensus Criteria

- 18/8/18 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Independent Response Evaluation, Consensus Criteria, Administrative
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Independent Response Evaluation Radiologist's Assessment and Consensus Criteria

- 18/8/18 - 1 form, 5 itemgroups, 16 items, 1 language
Itemgroups: Lesion Measurements, Sum; Multiplicative Product, Post- Treatment Response, Consensus Criteria, Administrative
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664 - Independent Response Evaluation, Radiologist's Assessment

- 25/5/18 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Radiologist's Assessment, Consensus Criteria
https://clinicaltrials.gov/show/NCT00989664 Independent Response Evaluation, Radiologist's Assessment Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/9/16 - 1 form, 16 itemgroups, 104 items, 1 language
Itemgroups: Medical and Surgical History, Significant Medical and Surgical History, NSCLC Diagnosis, NSCLC-related Surgery, Tobacco/Nicotine History at Randomization, Prior Adjuvant Chemotherapy, Prior Adjuvant Chemotherapy for NSCLC, Optional Research Blood Sample, Radiology, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Study Drug Dispensed, Investigator's Signature
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc ( OSI Pharmaceuticals ) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Baseline Assessments

On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/9/16 - 1 form, 10 itemgroups, 40 items, 1 language
Itemgroups: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: On-Treatment Assessments

Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/9/16 - 1 form, 11 itemgroups, 42 items, 1 language
Itemgroups: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed Applicable, Study Drug Dispensed
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Unscheduled Visit

Eligibility Diagnostic Imaging NCT01089998

- 28/11/19 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations; ODM derived from: https://clinicaltrials.gov/show/NCT01089998

MRT-Referenzbefund OPAL-Studie DRKS00004421 NCT01619124 ALL - MRT-Referenzbefund OPAL-Studie

- 24/6/13 - 1 form, 12 itemgroups, 42 items, 2 languages
Itemgroups: Allgemeine Angaben, Hüftgelenk rechts, Hüftgelenk links, Kniegelenk rechts, Kniegelenk links, oberes Sprunggelenk rechts, oberes Sprunggelenk links, unteres Sprunggelenk rechts, unteres Sprunggelenk links, Beteiligung der Metaphyse rechts, Beteiligung der Metaphyse links, 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

Eligibility Coronary Angiography NCT00468195

- 17/7/17 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography; ODM derived from: https://clinicaltrials.gov/show/NCT00468195

Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 1/8/16 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Follow-Up Assessment, Radiology, Adverse Events, Long-Term Follow-Up Adverse Events
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Long-Term Follow-Up Assessment

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