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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Admission M051 Blood value base and additional blood values Patient MaAN NCT02962726 - Admission M051 - Blood value base and additional blood values MaAN NCT02962726

- 2/20/17 - 1 form, 2 itemgroups, 15 items, 2 languages
Itemgroups: MAN_M051_BLOOD_BASE, MAN_M051_BLOOD_SUPPL
Event: Admission. Blood value base and additional blood values form of the MaAN study (Microbiome Shifts in Adolescent Anorexia Nervosa) NCT02962726. The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design. Publication granted by Prof. Deserno, UK Aachen. Blutwerte Basis und zusätzliche Blutwerte Formular der MaAN Studie (Veränderungen des Mikrobioms bei adoleszenter Anorexia Nervosa) NCT02962726.

Admission M042 Visit basis GI complaints and samples Patient MaAN NCT02962726 - M042 - Visit basis, GI complaints and samples MaAN NCT02962726

- 2/20/17 - 1 form, 3 itemgroups, 26 items, 2 languages
Itemgroups: MAN_M042_BASE_VISIT, MAN_M042_GI_TROUBLE, MAN_M042_SAMPLES
Event: Admission. Visit basis, GI complaints and samples form of the MaAN study (Microbiome Shifts in Adolescent Anorexia Nervosa) NCT02962726. The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design. Publication granted by Prof. Deserno, UK Aachen. Visitenbasis, GI-Beschwerden und Proben Formular der MaAN Studie (Veränderungen des Mikrobioms bei adoleszenter Anorexia Nervosa) NCT02962726.

Admission M031 Past Medication Patient MaAN NCT02962726 - M031 Past Medication MaAN NCT02962726

- 2/20/17 - 1 form, 1 itemgroup, 7 items, 2 languages
Itemgroup: MAN_M031_MEDIC_HIST
Event: Admission. Past Medication form of the MaAN study (Microbiome Shifts in Adolescent Anorexia Nervosa) NCT02962726. The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design. Publication granted by Prof. Deserno, UK Aachen. Medikamente Vergangenheit Formular der MaAN Studie (Veränderungen des Mikrobioms bei adoleszenter Anorexia Nervosa) NCT02962726.

Admission M012 Patient Admission and Nutrition MaAN NCT02962726 - Admission M012 Patient Admission and Nutrition MaAN NCT02962726

- 2/20/17 - 1 form, 2 itemgroups, 5 items, 2 languages
Itemgroups: MAN_M012_AUFNAHME_PAT, MAN_M012_ERNAEHRUNG_PAT
Event: Admission. Patient Admission and Nutrition form of the MaAN study (Microbiome Shifts in Adolescent Anorexia Nervosa) NCT02962726. The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design. Publication granted by Prof. Deserno Patienten Aufnahme & Ernaehrung Formular der MaAN Studie (Veränderungen des Mikrobioms bei adoleszenter Anorexia Nervosa) NCT02962726.

Admission M018 Admission Nutrition Comorbidities GI & Psychology Patient MaAN NCT02962726 - M018 Admission, Nutrition, Comorbidities, GI & Psychology MaAN NCT02962726

- 2/20/17 - 1 form, 4 itemgroups, 45 items, 2 languages
Itemgroups: MAN_M018_AUFNAHME, MAN_M018_ERNAEHRUNG, MAN_M018_KOMORBID_GI, MAN_M018_KOMORBID_PSY
Event: Admission. Admission, Nutrition, Comorbidities, GI & Psychology form of the MaAN study (Microbiome Shifts in Adolescent Anorexia Nervosa) NCT02962726. The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design. Publication granted by Prof. Deserno, UK Aachen. Aufnahme, Ernährung, Komorbiditäten, GI & Psychologie Formular der MaAN Studie (Veränderungen des Mikrobioms bei adoleszenter Anorexia Nervosa) NCT02962726.

WTZ-GIST-09-01 (Imatinib + LBH589) Medical History 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Medical History 2009-011417-24

- 11/23/16 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Medical History
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24

- 11/23/16 - 1 form, 3 itemgroups, 25 items, 1 language
Itemgroups: Demographics, Screening: physical examination, - concomitant therapies, concomitant diseases, Tumor characteristics
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

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

- 9/27/16 - 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

Anamnesis Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 9/25/16 - 1 form, 6 itemgroups, 19 items, 2 languages
Itemgroups: Patient identification, Patient administration, General Anamnesis, Pre-existing illness, ARDS specific anamnesis and physical examination, CT Thorax Findings
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

Baseline study (T0) – Demographics and Medical history VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28 - Baseline study (T0) – Demographics and Medical history

- 9/13/16 - 1 form, 4 itemgroups, 42 items, 1 language
Itemgroups: Demographics, medical history woman, medical history Malignant Neoplasms, laboratory parameters
Study documentation part: Baseline study (T0) – Demographics and Medical history, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

Year 4 Medical & Personal History Cardiovascular Health Study (CHS)

- 9/7/16 - 1 form, 12 itemgroups, 229 items, 1 language
Itemgroups: Medical History, Medical History: Myocardical Infarction, Medical History: Angina, Medical History: Congestive heart failure, Medical History: Intermittent claudication, Medical History: Cerebrovascular accident, Medical History: Transient ischemic attack, Hospitalization, Nursing home admission, Personal History, Personal History: Women only, Date of interview
Documentation part: Record 39 Year 4 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.

Year 3 Medical History Cardiovascular Health Study (CHS)

- 9/4/16 - 1 form, 11 itemgroups, 219 items, 1 language
Itemgroups: Medical History, Medical History: Myocardical Infarction, Medical History: Congestive heart failure, Medical History: Intermittent claudication, Medical History: Angina, Medical History: Cerebrovascular accident, Medical History: Transient ischemic attack, Medical History: Hypertension, Hospitalization, Nursing home admission, Date of interview
Documentation part: Record 37 Year 3 Medical 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.

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