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dbGaP phs000373 Osteoporotic Fractures in Men (MrOS) - Eligibility

- 1/29/25 - 5 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: IG.elig
Principal Investigator: ES Orwoll, MD, Oregon Health and Sciences University, OR, USA MeSH: Osteoporosis,Osteoarthritis,Sleep https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000373 The Osteoporotic Fractures in Men Study (MrOS) is a multi-center prospective, longitudinal, observational study of risk factors for vertebral and all non-vertebral fractures in older men, and of the sequelae of fractures in men. The original specific aims of the study include: (1) to define the skeletal determinants of fracture risk in older men, (2) to define lifestyle and medical factors related to fracture risk, (3) to establish the contribution of fall frequency to fracture risk in older men, (4) to determine to what extent androgen and estrogen concentrations influence fracture risk, (5) to examine the effects of fractures on quality of life, (6) to identify sex differences in the predictors and outcomes of fracture, (7) to collect and store serum, urine and DNA for future analyses as directed by emerging evidence in the fields of aging and skeletal health, and (8) define the extent to which bone mass/fracture risk and prostate diseases are linked. The MrOS study population consists of 5,994 community dwelling, ambulatory men aged 65 years or older from six communities in the United States (Birmingham, AL; Minneapolis, MN; Palo Alto, CA; Monongahela Valley near Pittsburgh, PA; Portland, OR; and San Diego, CA). Inclusion criteria were designed to provide a study cohort that is representative of the broad population of older men. The inclusion criteria were: (1) ability to walk without the assistance of another, (2) absence of bilateral hip replacements, (3) ability to provide self-reported data, (4) residence near a clinical site for the duration of the study, (5) absence of a medical condition that (in the judgment of the investigator) would result in imminent death, and (6) ability to understand and sign an informed consent. To qualify as an enrollee, the participant had to provide written informed consent, complete the self-administered questionnaire (SAQ), attend the clinic visit, and complete at least the anthropometric, DEXA, and vertebral X-ray procedures. There were no other exclusion criteria. The baseline examination was completed over a 25-month period from March 2000 to April 2002. Participants completed questionnaires regarding medical history, medications, physical activity, diet, alcohol intake, and cigarette smoking. Objective measures of anthropometric, neuromuscular, vision, strength, and cognitive variables were obtained at a clinic visit. Skeletal assessments included DEXA, calcaneal ultrasound, and vertebral radiographs. Vertebral and proximal femoral QCT was performed on a subset (65%) of participants. Serum, urine, and whole blood specimens were collected. During the study period, participants complete a tri-annual questionnaire every four months that obtains information concerning the occurrence of incident falls and fractures. Follow-up is over 99% complete. All reported fractures are confirmed using physician review of radiology reports or study radiologist review of x-rays. All deaths are also centrally adjudicated using death certificates and recent hospitalization records. In additional to the baseline study visit and tri-annual questionnaires, all surviving active participants were invited to follow-up visits and questionnaires. A second comprehensive clinic visit was completed between March 2005 and May 2006 or about 4.5 years after baseline. Most baseline measures, including vertebral radiographs, were repeated at the second visit. A third comprehensive clinic visit was completed between March 2007 and March 2009 or about 7.0 years after baseline. Many baseline measures were repeated at the third visit. A measure of energy expenditure was also obtained utilizing an accelerometer based armband device. Surviving participants have also completed two extensive mailed questionnaires designed to updated information obtained at clinic visits. The first questionnaire was mailed between baseline and visit 2 between July 2002 and March 2004. The second questionnaire was mailed after the third questionnaire between March 2009 and February 2011. The MrOS Sleep Study, an ancillary study of the parent MrOS cohort, was conducted between December 2003 and March 2005 and recruited 3,135 MrOS participants for a comprehensive sleep assessment. Men were screened for nightly use of mechanical devices during sleep including pressure mask for sleep apnea (CPAP or BiPAP), mouthpiece for snoring or sleep apnea, or oxygen therapy and were generally excluded. The sleep visit included objective measures of sleep using actigraphy and polysomnography. Other measures at the sleep visit include neuropsychiatric measures, performance measures, health related questionnaires, routine exam measures previously completed at MrOS clinic visits and a urine and serum specimen collection. During the sleep study period, participants complete a tri-annual questionnaire every four months that contains information about incident cardiovascular events. All reported events are centrally adjudicated utilizing hospital records, study ECGs and other supporting documentation. The Hip Osteoarthritis study, another ancillary study of the parent MrOS cohort, was completed at the second clinic visit between March 2005 and May 2006. Participants were asked for consent for a hip x-ray and osteoarthritis measurements were obtained from these x-rays. DNA was extracted from baseline whole blood samples for use in genetic research. Consent for use of DNA was obtained through written consent. Raw GWAS data is housed at the study's coordinating center and not released as part of the dbGAP release. The raw data can be requested from the study's coordinating center. Only QC cleaned Plink files are available on dbGAP.

pht007128.v1.p1

1 itemgroup 5 items

pht007127.v1.p1

1 itemgroup 4 items

pht007129.v1.p1

1 itemgroup 120 items

pht007130.v1.p1

1 itemgroup 5 items

Study SHIP-TREND_TREND0_SLP - t0.slp_usslp_us

- 10/26/24 - 9 forms, 1 itemgroup, 192 items, 2 languages
Itemgroup: t0.slp_usslp_us
SHIP Study https://doi.org/10.1093/ije/dyac034

t0.slp_us_re

1 itemgroup 54 items

t0.slp_psqi

1 itemgroup 25 items

t0.slp_rls

1 itemgroup 10 items

t0.slp_ess

1 itemgroup 8 items

t0.slp_isi

1 itemgroup 7 items

t0.slp_np_bioeich

1 itemgroup 14 items

Study SHIP-NEXT_metadata_20240913_NEXT|NEXT0|SLP - x0.slp_rls

- 10/8/24 - 10 forms, 1 itemgroup, 6 items, 2 languages
Itemgroup: x0.slp_rls
Item catalog SHIP-NEXT part 10

x0.slpintro

1 itemgroup 16 items

x0.slp_psqi

1 itemgroup 28 items

x0.slp_ess

1 itemgroup 8 items

x0.slpmeas

1 itemgroup 75 items

x0.slpread

1 itemgroup 10 items

x0.slp_isi

1 itemgroup 7 items

dbGaP phs000510 Study of Osteoporotic Fractures (SOF) - Eligibility

- 10/19/22 - 5 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Steven R. Cummings, MD, San Francisco Coordinating Center, California Pacific Medical Center, Research Institute, CA, USA MeSH: Osteoporosis,Osteoarthritis,Sleep https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000510 *The Study of Osteoporotic Fractures (SOF)* is a prospective multicenter study of risk factors for vertebral and non vertebral fractures. The cohort is comprised of 9704 community-dwelling women 65 years old or older recruited from populations-based listings in four U.S. areas: Baltimore, Maryland; Minneapolis, Minnesota; Portland, Oregon; and the Monongahela Valley, Pennsylvania. Women enrolled in the study were 99% Caucasian with African American women initially excluded from the study due to their low incidence of hip fractures. (A cohort of AA women was recruited at the 6th Visit.) The SOF participants were followed up every four months by postcard or telephone to ascertain the occurrence of falls, fractures and changes in address. To date, follow-up rates have exceeded 95% for vital status and fractures. All fractures are validated by x-ray reports or in the case of most hip fractures, a review of pre-operative radiographs. Blood samples were collected in 6795 women at their Year 2 exam (Visit 2) and with written consent for use of DNA in genetic studies. Of these, we have GWAS data on 3625 Caucasian participants. As a separate study, the SOF Osteoarthritis Project was funded separately to collect data about risk factors for osteoarthritis (OA) and analyze baseline hip and hand films for the presence and severity of OA. Raw GWAS data is housed at the study's coordinating center and not released as part of the dbGaP release. The raw data can be requested from the study's coordinating center. Only QC cleaned PLINK files are available at dbGaP. Auxiliary files are also available for duplicates and HapMap participants.

pht010696.v1.p1

1 itemgroup 2 items

pht010695.v1.p1

1 itemgroup 4 items

pht010697.v1.p1

1 itemgroup 110 items

pht010698.v1.p1

1 itemgroup 4 items

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Visit Maintenance 1 +2; Early Withdrawal; Follow up; Optional Visit; Unscheduled - PR/Conmeds; SOOS; Vitals

- 3/15/21 - 1 form, 8 itemgroups, 54 items, 1 language
Itemgroups: Administrative, Prior/ Current Concomitant Medications, Prior/ current non-drug therapies, Non-drug therapies, Sudden Onset of Sleep Questionnaire, Vital Signs - Semi supine , Vital Signs - Standing , Physical Exam
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

- 3/15/21 - 1 form, 6 itemgroups, 39 items, 1 language
Itemgroups: Administrative, Prior/ Current Concomitant Medications, Prior/ current non-drug therapies, Non-drug therapies, Pregnancy, Sudden Onset of Sleep Questionnaire
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Eligibility Sleep NCT00724087

- 10/29/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.; ODM derived from: https://clinicaltrials.gov/show/NCT00724087

Eligibility Sleep NCT00721019

- 10/29/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Sleep Loss and Glucose Metabolism in People With Family History of Type 2 Diabetes.; ODM derived from: https://clinicaltrials.gov/show/NCT00721019

Eligibility Sleep NCT00720889

- 10/29/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Glucose Metabolism and Sleep in People With Family History of Type 2 Diabetes.; ODM derived from: https://clinicaltrials.gov/show/NCT00720889

Eligibility Sleep NCT00721084

- 10/29/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Fitness and Sleep in People With Family History of Type 2 Diabetes.; ODM derived from: https://clinicaltrials.gov/show/NCT00721084

MRT SHIP-Trend-0 MRT Sleep Related Breathing Disorders

- 11/28/17 - 1 form, 1 itemgroup, 11 items, 2 languages
Itemgroup: MRT Sleep Related Breathing Disorders
MRT Sleep Related Breathing Disorders form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MRT.MRTASS.MRTMSA. 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

Sleep and Asthma Questionnaire Cardiovascular Health Study (CHS)

- 2/27/17 - 1 form, 1 itemgroup, 93 items, 1 language
Itemgroup: Sleep and Asthma Questionnaire
Documentation part: Record 56 Sleep and Asthma Questionnaire 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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