Search results - Portal of Medical Data Models (MDM-Portal)

Itemgroups: Administrative documentation, Blood Pressure, Exercise, Information, Pharmaceutical Preparations, Subject Diary, Alcohol consumption, Subject Diary, Caffeine Use, Subject Diary, Tobacco Use, Subject Diary

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

ICHOM Depression and Anxiety - Baseline - Patient-reported Form

- 9/20/21 - 1 form, 8 itemgroups, 70 items, 1 language

Itemgroups: Administrative Data, Demographic factors, Health status, Prior Treatment, Symptom Burden, Functioning, Recovery Speed and Health Sustainability, Other

ICHOM Depression and Anxiety data collection Version 2.3.2 Revised: August 10th, 2018 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 Depression and Anxiety, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. This document contains the Baseline - Patient-reported Form. It has to be filled in at Baseline(Treatment begin). Condition: Depression: Major Depressive Disorder | Dysthymia | Depressive Adaptive/Adjustment Disorder | Depressive Disorder - NOS Anxiety: Generalized Anxiety Disorder | Phobic Disorder | Agoraphobia | Post-Traumatic Stress Disorder | Panic Disorder | Obsessive-Compulsive Disorder Treatment Approaches : Psychopharmacotherapy | Psychotherapy | Lifestyle Interventions | Self-Guided Help | Other Forms of Therapy Collecting Clinician and Patient-Reported Outcome Measures: PHQ-9 (Patient Health Questionnaire). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. GAD-7 (Generalized Anxiety Disorder). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. (and all other GAD or PHQ screeners); Pfizer owner, authors: Drs. Spitzer, Williams and Kroenke SPIN (Social Phobia Inventory ), MIA (Mobility Inventory for Agoraphobia), IES-R (Impact of Event Scale - Revised for Post-traumatic Stress Disorder), PDSS-SR (Panic Disorder Severity Scale), OCI-R (Obsessive-Compulsive Inventory). As permission for use has to be obtained for all of these questionnaires from the copyright holder, only the total score will be included in this version of the standard set. WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0). As there is a license needed for use of this questionnaire, only the total score will be included in this version oft he standard set. MOS-SSS (Medical Outcomes Study: Social Support Survey). There is no license or permission needed for use. https://www.rand.org/health-care/surveys_tools/mos/social-support.html This Standard set of ICHOM was supported by the Douglas mental health university institute, Charité Universitätsmedizin Berlin, Stichting benchmark GGC. Publication: Obbarius A, van Maasakkers L, Baer L, et al. Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group. Qual Life Res. 2017;26(12):3211–3225. doi:10.1007/s11136-017-1659-5 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Baseline

- 9/20/21 - 1 form, 8 itemgroups, 32 items, 1 language

Itemgroups: Administrative documentation, Eligibility Determination, Vital signs, Concomitant Agent, Medical procedure, Signs and Symptoms, Employment status, Baseline, Randomization, Dispensing medication

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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

- 9/20/21 - 1 form, 9 itemgroups, 56 items, 1 language

Itemgroups: 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

- 9/20/21 - 1 form, 8 itemgroups, 33 items, 1 language

Itemgroups: 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.

Baseline Lymphoma Disease Activity and Assessment

- 9/20/21 - 1 form, 1 itemgroup, 20 items, 1 language

Itemgroup: Lymphoma disease activity

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

- 9/20/21 - 1 form, 47 itemgroups, 279 items, 2 languages

Itemgroups: 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

Breast Cancer ALTTO Study BIG 2-06/N063D NCT00490139 - Outcome of Pregnancy Breast Cancer NCT00490139

- 9/20/21 - 1 form, 44 itemgroups, 314 items, 2 languages

Itemgroups: Header Module, Registration Header, Submission Details, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynecological status, 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, Hormone therapy, Concomitant Treatment, Administration of Study Drug, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, 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 Outcome of Pregnancy - 2764926v1.0 NCT00490139

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

- 9/20/21 - 1 form, 16 itemgroups, 106 items, 2 languages

Itemgroups: 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

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