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  2. 2. Routine Documentation
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Eligibility NCT00322621 Diabetic Neuropathies - Eligibility

- 8/11/14 - 1 form, 2 itemgroups, 9 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00322621

LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 6/28/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration,LASER ADMINISTRATION STUDY EYE
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

dbGaP phs000090 The Atherosclerosis Risk in Communities (ARIC) Study - pht000114.v1.p1

- 5/23/22 - 3 forms, 1 itemgroup, 362 items, 1 language
Itemgroup: pht000114.v1.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000090 The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective epidemiologic study conducted in four U.S. communities. The four communities are Forsyth County, NC; Jackson, MS; the northwest suburbs of Minneapolis, MN; and Washington County, MD. ARIC is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date. ARIC includes two parts: the Cohort Component and the Community Surveillance Component. The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. In the Community Surveillance Component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. Hospitalized stroke is investigated in cohort participants only. Starting in 2006, the study conducts community surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) for heart failure events beginning in 2005. ARIC is currently funded through January 31, 2012. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to atherosclerosis and cardiovascular disease through large-scale genome-wide association studies of well-characterized cohorts of adults in four defined populations. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht001035.v1.p1

1 itemgroup 4 items

pht001036.v1.p1

1 itemgroup 4 items

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

- 6/11/17 - 1 form, 3 itemgroups, 12 items, 1 language
Itemgroups: Patient administration,CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12),Procedure
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Patient administration,SUBJECT ELIGIBILITY,Eligibility Criteria Not Met
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Visit 3 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/19/22 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Date of Visit,Orthostatic Vital Signs,12 Lead ECG,Weight
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 3

Visit 10 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/16/22 - 1 form, 4 itemgroups, 13 items, 1 language
Itemgroups: Date of Visit,Orthostatic Vital Signs,Weight,Waist and Hip Circumference
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study

Eligibility Diabetes NCT01028404

- 9/27/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01028404

Eligibility Diabetes Mellitus NCT02310555

- 9/27/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS); ODM derived from: https://clinicaltrials.gov/show/NCT02310555

Eligibility Diabetes Mellitus NCT01796834

- 9/27/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Managing Diabetes Mindfully Study; ODM derived from: https://clinicaltrials.gov/show/NCT01796834

Eligibility Obstructive Sleep Apnea and Diabetes Mellitus NCT01136785

- 9/27/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Effects of Continuous Positive Airway Pressure (CPAP)Treatment on Glucose Control; ODM derived from: https://clinicaltrials.gov/show/NCT01136785

Eligibility New Onset Diabetes Mellitus After Renal Transplantation NCT01268995

- 9/23/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01268995

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