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MRT SHIP-START-3 Rheuma

- 2021-07-03 - 1 Formulär, 1 Item-grupp, 1 Dataelement, 2 Språk
Item-grupp: Rheuma
Rheuma form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MRT.MRTASS.MRTRHEUMA. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

Eligibility Knee Osteoarthritis (OA) NCT00536302

- 2017-03-06 - 1 Formulär, 2 Item-grupper, 15 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT00536302

Eligibility Soft Tissue Volume Augmentation DRKS00003586 NCT02356770 DRKS00003586 - Eligibility Soft Tissue Volume Augmentation NCT02356770 DRKS00003586

- 2017-07-04 - 1 Formulär, 2 Item-grupper, 19 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Responsible Party: Geistlich Pharma AG ClinicalTrials.gov Identifier: NCT02356770 History of Changes Other Study ID Numbers: 10860 DRKS00003586 ( Registry Identifier: Deutsches Register Klinischer Studien ) CIV-11-12-003323 ( Other Identifier: EUDAMED ) Study First Received: December 18, 2014 Last Updated: February 2, 2015 A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02356770

SÜP - FV2 Diagnosen (Rheuma, Diabetes, Tumor, HIV)

- 2024-11-07 - 22 Formulär, 10 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: Rheumatologische/immunologische Erkrankung, Rheumatologische/immunologische Erkrankung, Diabetes mellitus , 2.1. Erstdiagnose, Diabetes mellitus - Typ, Solide Tumorerkrankung, Onkologische Erkrankungen, Hämatoonkologische Erkrankung , Hämatoonkologische Erkrankung , Erstdiagnose
SÜP Study

ICHOM Inflammatory Arthritis - Baseline and 6-monthly/annually Clinical Form

- 2020-04-30 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: Administrative Data, Treatment-Specific
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 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. Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Clinical Variables to be administered at baseline visit and every 6 months if the disease is active or annually if the disease is in remission. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported for the Inflammatory Arthritis Standard Set by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset, and Sheba Academic Medical Center Hospital. Publication: Oude Voshaar MAH, Das Gupta Z, Bijlsma JWJ, et al. International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group. Arthritis Care Res (Hoboken). 2019;71(12):1556‐1565. doi:10.1002/acr.23799 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Inflammatory Arthritis - Baseline and Annual Clinical Form

- 2020-04-30 - 1 Formulär, 3 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Administrative Data, Baseline Condition Factors, Treatment-Specific
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 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. Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Clinical Variables to be administered at baseline visit and (a large number of the variables) annually. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported for the Inflammatory Arthritis Standard Set by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset and Sheba Academic Medical Center Hospital. Publication: Oude Voshaar MAH, Das Gupta Z, Bijlsma JWJ, et al. International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group. Arthritis Care Res (Hoboken). 2019;71(12):1556‐1565. doi:10.1002/acr.23799 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Inflammatory Arthritis - Patient-reported Form

- 2020-04-30 - 1 Formulär, 2 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Administrative Data, Patient-Reported Health and Wellbeing
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 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. Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Patient-reported Variables to be administered at baseline visit and annually. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported for the Inflammatory Arthritis Standard Set by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset and Sheba Academic Medical Center Hospital. Publication: Oude Voshaar MAH, Das Gupta Z, Bijlsma JWJ, et al. International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group. Arthritis Care Res (Hoboken). 2019;71(12):1556‐1565. doi:10.1002/acr.23799 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Rheumatoid Arthritis NCT01166620

- 2021-06-23 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics; ODM derived from: https://clinicaltrials.gov/show/NCT01166620

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - End of Double Blind - Administrative; Subject Continuation; Phase Conclusion

- 2020-03-24 - 1 Formulär, 3 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: Administrative, Subject Continuation, Phase Conclusion
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

FOLLOW UP EBMT JUVENILE IDIOPATHIC ARTHRITIS (JIA)

- 2016-10-02 - 1 Formulär, 8 Item-grupper, 96 Dataelement, 1 Språk
Item-grupper: JUVENILE IDIOPATHIC ARTHRITIS (JIA) FOLLOW UP, GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT, OTHER COMPLICATIONS SINCE LAST REPORT, DATE(S) AND RESULTS OF ALL TESTS DONE FOR ALL DONORS, ADDITIONAL THERAPIES SINCE LAST FOLLOW UP, FIRST EVIDENCE OF RELAPSE OR PROGRESSION SINCE LAST HSCT, ADDITIONAL NOTES IF APPLICABLE, APPENDIX B AUTOIMMUNE DISEASES
ODM derived from 20pp EBMT Arthritis 14JIA forms on http://www.ebmt.org/

dbGaP phs000737 NIDDK Genetics of Metabolic Syndrome in an Island Population - Eligibility

- 2022-12-28 - 6 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Ranjan Deka, PhD, University of Cincinnati, Cincinnati, OH, USA MeSH: Metabolic Syndrome X,Diabetes mellitus type 2,Hypertension, Essential,Dyslipidemia,Coronary Heart Disease,Gout https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000737 The major objective of this study was to conduct a systematic genetic study of metabolic traits involved in metabolic syndrome through collection and analysis of epidemiological, demographic, environmental, and relevant biological and clinical data from a relatively isolated island population of the eastern Adriatic coast of Croatia. The population was chosen for the following reasons: 1) in spite of practicing a largely traditional life style and dietary habits, high rates of obesity, arterial hypertension, dyslipidemia and related metabolic abnormalities were found in previous studies; 2) the population was established by a relatively small number of founders, predominantly of Slavic descent from the mainland during 15th to 18th century AD, a genetically homogeneous population living in a homogeneous environment; 3) sharing a common European ancestry, a relevant population for study in the context of the general US population; 4) Croatian collaborators have been conducting anthropological and genetic studies in these communities for over three decades. There were two major aims of the study: 1) to recruit ~1200 adult participants and collect blood samples together with demographic, anthropometric, environmental and clinical data from the island of Hvar; to perform biochemical tests to measure glucose, insulin, uric acid and lipid levels; 2) conduct a genome-wide association analysis of metabolic traits and phenotypes using genome-wide SNP arrays (Affymetrix Genome-Wide Human SNP Array 5.0).

pht004443.v1.p1

1 Item-grupp 4 Dataelement

pht004444.v1.p1

1 Item-grupp 5 Dataelement

pht004445.v1.p1

1 Item-grupp 7 Dataelement

pht004446.v1.p1

1 Item-grupp 52 Dataelement

pht004447.v1.p1

1 Item-grupp 6 Dataelement

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Status of Treatment Blind; Pregnancy Information; Pharmacogenetic Research Withdrawal of Consent; Study Conclusion; Infusion

- 2020-03-31 - 1 Formulär, 5 Item-grupper, 15 Dataelement, 1 Språk
Item-grupper: Status of Treatment Blind, Pregnancy Information, Pharmacogenetic Research Withdrawal of Consent, Study Conclusion, Infusion
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

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