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dbGaP phs001270 Sleep and Circadian Disorders Study (SACDS) - pht006249.v1.p1

- 11.11.24 - 6 Formulare, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: pht006249
Principal Investigator: Ying-Hui Fu, PhD, University of California San Francisco, San Francisco, CA, USA MeSH: Sleep Wake Disorders,Short Sleeper Syndrome,Long Sleeper Syndrome,CLOCK Proteins,Circadian Clocks https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001270 Sleep is essential for life. A good night's sleep is pleasurable and sleep deprivation is stressful. Prolonged sleep loss impairs temperature control, metabolism, immunity, and ultimately leads to death. Extensive observational and epidemiological evidence indicates that optimal sleep duration of 8 hours is associated with the maintenance of good health. In our society, however, most people only get 6.5 - 7 hours. Suboptimal sleep duration has a strong association with mortality and morbidity. Lack of sleep has been linked to cardiovascular diseases, obesity, hypertension, type 2 diabetes, and other health/cognition conditions. It is clear that the biological need for sleep varies dramatically among humans. Sleep and circadian disorders can include Familial Advanced Sleep Phase (FASP), Delayed Sleep Phase (DSP), Advanced Sleep Phase (ASP), Natural Short Sleepers (NSS) or Long Sleeping. In example, Natural Short Sleepers (NSS) have a lifelong tendency to sleep only 4 - 6 hours per night and to awaken refreshed and energetic. Natural Long Sleepers biologically require 9 - 10 hours/night to feel well rested. The 'Sleep and Circadian Disorders Study' (SACDS) at the University of California San Francisco, set out to investigate the mechanisms involved in regulating sleep duration, patterns and sleep quality regulation by identifying and characterization of individuals and families with unusual sleep and circadian rhythm behavior patterns. SACDS participants were screened with a "General Sleep Questionnaire" that inquired about multiple aspects of sleep, including habitual work-day versus non-work day sleep-wake schedules, permits calculation of subjective habitual initial sleep onset, final sleep offset, and number of awakenings. There was an additional screening process including demographic data, sleep, mood, behavioral and general medical questionnaires, plus the study consent. After the extensive screening of 117 participants, blood samples were collected from 38 individuals and of those 10 samples were chosen for whole exome sequencing analysis.

pht006250.v1.p1

1 Itemgruppe 5 Datenelemente

pht006251.v1.p1

1 Itemgruppe 5 Datenelemente

pht006252.v1.p1

1 Itemgruppe 5 Datenelemente

pht006253.v1.p1

1 Itemgruppe 7 Datenelemente

F.0

2 Itemgruppen 5 Datenelemente

Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia - Eligibility

- 27.09.21 - 1 Formular, 2 Itemgruppen, 51 Datenelemente, 2 Sprachen
Itemgruppen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00247390

Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

- 20.09.21 - 1 Formular, 2 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia; ODM derived from: https://clinicaltrials.gov/show/NCT00227942

Sleep Apnea - Child Protocol PhenX Toolkit

- 20.09.21 - 1 Formular, 6 Itemgruppen, 106 Datenelemente, 1 Sprache
Itemgruppen: PhenX - respiratory - sleep apnea - child protocol, Long - term medical problem, Medication list, Psychological, psychiatric, emotional, or behavioral problem, Sleep disorders, Sleep or behavior disorders relatives
The Pediatric Sleep Questionnaire (PSQ) protocol is a parent questionnaire for children from 2 through 18 years, and rated on a simple three-point scale ("yes," "no," or "don’t know") for all items except the inattention/hyperactivity items that are rated on a four-point Likert scale. This protocol provides an overall total score and five sleep scales: (1) Sleep-Related Breathing Disorders (SRBD), (2) Snoring, (3) Sleepiness, (4) Behavior, and (5) Periodic Limb Movement Disorder (PLMD). ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

Eligibility Excessive Daytime Sleepiness NCT00642928

- 17.09.21 - 1 Formular, 2 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00642928

Eligibility Sleep Disorders in Pulmonary Arterial Hypertension NCT01371669 - Eligibility Sleep Disorders in Pulmonary Arterial HypertensionNCT01371669

- 28.09.20 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01371669

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Romberg Test and Heel-To-Toe Test

- 15.11.19 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Rhomberg Test and Heel-To-Toe Test
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events

- 15.11.19 - 1 Formular, 18 Itemgruppen, 72 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Concomitant Medications, Concomitant Medications , Non-Serious adverse Events, Non-Serious adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 2 Seriousness, Serious Adverse Event - Section 3 Demography Data, Serious Adverse Event - Section 4, Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s), Serious Adverse Event - Section 6 Relevant medical Conditions, Serious Adverse Event - Section 7 Other relevant Risk Factors, Serious Adverse Event - Section 8 Relevant Concomitant Medications, Serious Adverse Event - Section 9 Details of Investigational Product(s), Serious Adverse Event - Section 10 Details of relevant Assessments, Serious Adverse Event - Section 11 Narrative Remarks, Investigator's signature
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - 12-Lead ECG Abnormalities

- 15.11.19 - 1 Formular, 3 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Administrative, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Eligibility Criteria

- 15.11.19 - 1 Formular, 4 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Eligibility Question, Inclusion Criteria, Exclusion Criteria
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

- 11.11.19 - 1 Formular, 5 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Medical Conditions, Alcohol Intake, Drug and Alcohol Sreen, Serology - HIV Screen, Electronically Transferred Laboratory Data
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter

- 07.11.19 - 1 Formular, 6 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Demography, Vital Signs, Vital Signs, 12-Lead ECG, Summary Holter
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

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