linjc16/ctgov huggingface dataset:
Sleep Timing and Insulin Resistance in Adolescents With Obesity

Study Overview
=================
Brief Summary
-----------------
This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.

Official Title
-----------------
Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High school students between the ages of 15-19 BMI > 90th percentile Tanner stage 2 or greater Exclusion Criteria: Any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics) Regular use of melatonin or sleep aids A prior diagnosis of obstructive sleep apnea, diabetes (HbA1c > 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding IQ < 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes) Not enrolled in a traditional high school academic program (e.g., home school students) Night shift employment Travel across more than 2 time zones in the month prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dim Light Melatonin Onset and Offset |  1mL saliva was collected at 30- to 60- minute intervals in dim light (<5 lux in the angle of gaze, approximately the light level of candlelight or civil twilight) from approximately 5pm until noon the next day. Dim light melatonin onset (DLMOn) was defined as the linear interpolated clock time at which evening salivary melatonin concentrations increased and remained above a threshold of 3pg/mL. Melatonin offset (DLMOff) was the linear interpolated clock time at which salivary melatonin concentrations fell below this threshold. Later DLMOn and DLMOff are indicative of a later circadian rhythm. | 1 day | 
| Insulin Sensitivity | After an overnight fast, participants completed an oral glucose tolerance test (OGTT) in the morning. Participants consumed a 75g dextrose drink and serum for glucose and insulin concentrations were collected at baseline and every 30 minutes for 3 hours. The homeostatic model assessment for insulin resistance (HOMA-IR) was calculated as [fasting insulin (μU/ml) x fasting glucose (mmol/l)] / 22.5); lower HOMA-IR indicates better insulin sensitivity. The Matsuda Index was calculated as √10,000 / [[fasting insulin (μU/ml) x fasting glucose (mmol/l)] x [mean OSTT insulin (μU/ml) x mean OSTT glucose (mmol/l)]]; high Matsuda Index indicates better insulin sensitivity. | 3 hours |
Trends in Volume-Outcome Relationship in Surgery

Study Overview
=================
Brief Summary
-----------------
The explanatory mechanism of the relationship between the volume of surgical procedures performed by individual hospitals and the occurrence of serious adverse events is not clear. Based on the  practice makes perfect  dogma, we will explore whether a learning effect can explain the volume-outcome relationship for complex surgical procedures using a nationwide dataset. Especially, we assume that increasing volume of procedures over time may be associated with improved outcomes.

Official Title
-----------------
Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals

Conditions
-----------------
Surgical Procedures

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults hospitalized to have one of the following major surgery: resection of oeso-gastric, intestinal and pancreatic cancer, treatment of intra-abdominal aortic aneurysm, coronary artery bypass graft, endarterectomy, hip fracture prosthesis Exclusion Criteria: Hospitalization <24 hours Absence of surgical procedure Ambulatory care Palliative care Organ transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitals with increasing activity<br>Hospitals experiencing an increase in the volume of surgical procedures over the study period | Other: No intervention<br> <br> |
| Hospitals with decreasing activity<br>Hospitals experiencing a decrease in the volume of surgical procedures over the study period | Other: No intervention<br> <br> |
| Hospitals with stable activity<br>Hospitals experiencing no change in the volume of surgical procedures over the study period | Other: No intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient mortality |  | Within 30 days of surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation occurence |  | Within 30 days of surgical procedure | 
| Occurence of intensive or critical care unit stay |  | Within 30 days of surgical procedure | 
| Occurence of postoperative complication | Postoperative complication includes sepsis, pulmonary embolism or deep vein thrombosis and cardiac arrest | Within 30 days of surgical procedure | 
| Occurence of unplanned hospital readmission |  | Within 30 days of hospital discharge related to index stay |
Objective Functional Outcome Measures in Orthopedic Surgery Using Advanced Tracking Technologies

Study Overview
=================
Brief Summary
-----------------
The proposed project will address the measurement and ramifications of out-of-home mobility problems in various orthopedic disorders in an innovative way, using advanced tracking technologies.

Official Title
-----------------
Objective Functional Outcome Measures in Orthopedic Surgery Using Advanced Tracking Technologies

Conditions
-----------------
Orthopedic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unwillingness to sign informed consent. Exclusion Criteria: Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |
| 2<br> | |
| 3<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedic Surgical Procedures
Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

Study Overview
=================
Brief Summary
-----------------
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy

Detailed Description
-----------------
This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.

Official Title
-----------------
Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Drug: Aspirin 81Mg Non-enteric coated Tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <16 weeks' gestational age Singleton pregnancy Plan to take 81mg aspirin due to high risk history (below), but not yet initiated ≥1 risk factor: Chronic hypertension Type I or II diabetes Previous preeclampsia Renal disease Autoimmune disease (SLE) OR ≥2 risk factor: Nulliparity IVF pregnancy Black race or socioeconomic disadvantaged BMI>30 Prior adverse pregnancy outcome Exclusion Criteria: Contraindication to aspirin Current or planned use of any other anticoagulation Current need for dialysis Use of aspirin therapy prior to enrollment in the current pregnancy Thrombocytopenia (<150) Other known platelet disorder/thrombophilia at enrollment

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: One arm PK/PD study of aspirin in pregnancy1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aspirin<br>81mg aspirin daily | Drug: Aspirin 81Mg Non-enteric coated Tab<br>* one tab daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salicylic acid level | time/concentration profile | 24 hour | 
| serum thromboxane | ELISA based quantification of serum thromboxane B2 | 4 week post initiation | 
| PFA-100 | PFA-100 epi closure time (Siemens) | 4 week post initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary thromboxane | ELISA based quantification of urindary dehydrothromboxane B2 | 4 week post initiation |
Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.

Official Title
-----------------
Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

Conditions
-----------------
Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Other: sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vitreous haemorrhage tractional retinal detachment active proliferative diabetic retinopathy. Exclusion Criteria: neovascular glaucoma cataract combined traction and rhegmatogenous RD
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7 days<br> | Drug: Bevacizumab<br> <br> |
| Active Comparator: 20 days<br> | Drug: Bevacizumab<br> <br> |
| Sham Comparator: sham<br> | Other: sham<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Blood Biomarker of Alzheimer's Disease (AD)

Study Overview
=================
Brief Summary
-----------------
Currently, no cures or disease modifying therapies exist for Alzheimer's disease (AD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for stratification of Alzheimer's disease patients and healthy volunteers. This study may lead to future blood tests that may help earlier diagnosis of Alzheimer's disease and detect the disease progression.

Official Title
-----------------
mtDNA Damage in Alzheimer's Disease (AD)

Conditions
-----------------
Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's Disease Patients: 50 years and older AD patient who is seen at the Memory Disorders Clinic AD diagnosis Non smoking No cancer treatment in the last 5 years Informed consent from the patient or the patient's legally authorized representative (LAR) Patient and/or LAR able to read and speak English Healthy Control Participants: 50 years and older Non smoking No cancer treatment in the last 5 years Age matched to AD subject Able to read and speak English Exclusion Criteria: Alzheimer's Disease Patients: Known additional neurological disease Healthy Control Participants: Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alzheimer's Patients<br> | |
| Healthy Volunteers<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological marker of Alzheimer's disease | Test for blood biological marker of Alzheimer's disease, mtDNA damage | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood, Alzheimer's Disease, biomarkers
The Role of Mind Body Therapy in Geriatric Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Background: The main goal of geriatric rehabilitation reconditioning following an acute illness is rapid restoration of normal activity. Key elements are pain control, restoration of bowel functions, sleep, appetite and general well-being, along side the physical activity. Objective: To assess the effect of mind-body intervention as an adjunct to medical and physical rehabilitation in geriatric patients. Design: Prospective study Setting: University affiliated large city general hospital

Conditions
-----------------
Elderly, Treatment

Intervention / Treatment
-----------------
* Other: mind-body intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suitable candidates had to be aged 18 years or older treated in the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) and were willing and able to complete the study protocol. Exclusion Criteria: severe unstable chronic illness (e.g., congestive heart failure, chronic renal failure, cancer).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>control group - receiving standard treatment | Other: mind-body intervention<br>* multi-disciplinary mind-body intervention including: breathing techniques, guided imagery, meditation, touch therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being: Short Form-36 (SF-36), Geriatric Depression Scale (GDS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients in a sub-acute geriatric rehabilitation department
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

Detailed Description
-----------------
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.

Official Title
-----------------
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Spectacle lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 6 and 12 years Myopia between -1.00 and -4.00 D Exclusion Criteria: Participating in any clinical or other research study Contact lens wearer

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens Design 1<br>Spectacle lenses design 1, fitted into spectacle frames | Device: Spectacle lenses<br>* Spectacle lenses with clear central apertures<br>|
| Experimental: Lens Design 2<br>Spectacle lenses design 2, fitted into spectacle frames | Device: Spectacle lenses<br>* Spectacle lenses with clear central apertures<br>|
| Experimental: Lens Design 3<br>Spectacle lenses design 3, fitted into spectacle frames | Device: Spectacle lenses<br>* Spectacle lenses with clear central apertures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | Measurement of best corrected distance visual acuity | 2 weeks | 
| Contrast Sensitivity | Measurement of contrast sensitivity | 2 weeks | 
| Subjective Responses | Assessment of subject responses related to wear time of spectacles | 2 weeks |
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.

Official Title
-----------------
Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy

Conditions
-----------------
Prostatic Neoplasms, Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
-----------------
* Diagnostic Test: Doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with prostate cancer who underwent laparoscopic radical prostatectomy Exclusion Criteria: Patients who were not interested in their sexual function and refused to perform this study Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group #1<br>Patients with prostate cancer who will undergo radical prostatectomy | Diagnostic Test: Doppler ultrasound<br>* Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left and right Cavernous artery diameter | mm | 1 year | 
| Left and right Systolic velocity cavernous artery | cm/s | 1 year | 
| Left and right Diastolyc velocity cavernous artery | cm/s | 1 year |
Sleep Impairment and Coping Style in Diabetes

Study Overview
=================
Brief Summary
-----------------
To examine the effect of sleep impairment on coping style of patients with diabetes

Detailed Description
-----------------
Abstract Objective: To examine the effect of sleep impairment on coping style of patients with diabetes Research Design and Methods: A total of 105 patients (40 male, 65 female) with diabetes mellitus were recruited from outpatient diabetic clinics in 2011 February. All patients were asked to fill the sociodemographic inquiry, Epworth Sleepiness Scale and Coping Style Inventory.

Official Title
-----------------
Sleep Impairment Can Influence The Coping Style Of Patients With Diabetes

Conditions
-----------------
Obesity, Sleep Disorders, Coping Skills

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with diabetes longer than 6 months Exclusion Criteria: - Complications as a congestive heart failure, chronic renal failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Diabetes<br>Patients with diabetes suffer from sleep impairment or not | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coping style of Patients with Diabetes suffer from Sleep Disorder | Patients with diabetes had filled the Epworth Sleepiness Scale and Coping styles ınventory | Up to 1 week (Patients at follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep impairment, Coping Style, Diabetes Mellitus