linjc16/ctgov huggingface dataset:
Metabolism of Omega-3 and Omega-6 During Healthy Aging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and 13C-arachidonic acid (AA) in young and older participants

Official Title
-----------------
Metabolism of Uniformly Labelled 13C Eicosapentaenoic Acid and 13C Arachidonic Acid During Healthy Aging

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: 13C eicosapentaenoic acid and 13C arachidonic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: six young (18-30 y old) and six older (≥ 70 y old) healthy non medicated participants. Exclusion Criteria: Tobacco, malnutrition (assessed from blood albumin, haemoglobin and lipids), - participants taking an EPA+DHA supplements or consuming more than 2 fish meals per week, severe gastro-intestinal problems, medication for diabetes, thyroid disease, renal failure, cancer, psychiatric difficulties or depression, cardiovascular disease, glucose intolerance (>8 mmol/L in fasted samples) chronic immune condition or inflammation (CRP > 10 mg/l, white cell count), recent major surgery or cardiac event, dementia, ongoing or past severe drug or alcohol abuse, ongoing or past intensive physical training.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young<br>Six young (18-30 yrs old) healthy participants were recruited. The study had three blocks of one month: 13C-EPA follow-up, wash-out and 13C-AA follow-up. Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA. | Other: 13C eicosapentaenoic acid and 13C arachidonic acid<br>* Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA.<br>|
| Elderly<br>Six older (≥ 70 yrs old) healthy participants were recruited. The study had three blocks of one month: 13C-EPA follow-up, wash-out and 13C-AA follow-up. Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA. | Other: 13C eicosapentaenoic acid and 13C arachidonic acid<br>* Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of 13C-EPA and 13C-AA |  | Plasma incorporation of 13C-EPA or 13C-AA was measured from the area under the curve in young and older participants over 28 days post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eicosapentaenoic acid, Arachidonic acid, Metabolism, Healthy aging
ACS-NSQIP Calculator for Liver Surgery

Study Overview
=================
Brief Summary
-----------------
The American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP) calculator has been endorsed by the surgeons' community to counsel patients and relatives regarding estimated postoperative complications. However, it does not include organ-specific risks. The aim of this study was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay (LOS) in patients undergoing hepatectomy for liver tumors

Detailed Description
-----------------
This is an observational retrospective study conducted in a tertiary-referral university hospital. An established classification of complications, including post-hepatectomy insufficiency and bile leak, was adopted. The endpoint was the rate of complications, mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after surgery.

Official Title
-----------------
Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors

Conditions
-----------------
Liver Surgery, Hepatectomy, Outcome After Hepatectomy

Intervention / Treatment
-----------------
* Procedure: Liver resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who underwent surgery for a liver tumor at our Institution between the defined period of time Exclusion Criteria: Any patient with missing data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Liver resection|Surgery for the liver|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACS-NSQIP calculator's ability | The primary study endpoint was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay in patients undergoing hepatectomy for liver tumors | From the date of surgery up to three months from the date of surgery |
Patient Registry of Blind Subjects With Sleep-related Problems

Study Overview
=================
Brief Summary
-----------------
Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. This is a research protocol to develop a patient registry of subjects who may suffer from Non-24 and who are blind. Subjects participate in the study through a phone survey. This registry will be used to better understand, sleep related problems in blind individuals, including the investigation of a potential treatment, recruitment for future clinical studies, and to provide a forum for raising awareness about Non-24. The survey consists of questions regarding the degree of vision impairment and sleep problems that the subjects may be experiencing.

Official Title
-----------------
Development of a Patient Registry of Blind Subjects With Sleep-related Problems

Conditions
-----------------
Sleep-wake Disorder in Blind Individuals

Intervention / Treatment
-----------------
* Other: Data collection on blindness and sleep problems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects or legal guardians must be at least 18 years of age to participate in the telephone survey. Parents or legal guardians may represent children from 0 through 17 years who meet the following criteria. Subjects must be blind. Subjects must have some self-described problem with sleep or daytime sleepiness.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blind with sleep problems<br>Blind individuals with no light perception and with sleep-related problems who may suffer from Non-24 | Other: Data collection on blindness and sleep problems<br>* Data related to degree of vision impairment and sleep problems is collected through a phone or web survey<br>* Other names: Data Collection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blind participants |  | ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep/wake disruptions |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-24, N24HSWD, Blindness, Sleep, Wake, Circadian Rhythm, Nap
Saccadic Eye Movements Are Impaired In Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether rapid eye movements called saccades are impaired in glaucoma, a neurodegenerative disease of visual pathways.

Detailed Description
-----------------
Eye movements that quickly scan a visual scene are critical to a number of daily activities including driving. It is not known whether rapid eye movement called saccades, are altered in glaucoma.

Official Title
-----------------
Novel Vision Testing Paradigms for Patients With Glaucoma

Conditions
-----------------
Glaucoma, Open-Angle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages from 40-80 years. Primary open angle glaucoma is defined by characteristic glaucomatous optic nerve head findings and the presence of corresponding visual field deficits in one or both eyes. All control subjects will be age-matched, with no ocular medical or surgical history, and a completely normal eye examination. Age-matched controls will be recruited from local hospital personnel and accompanying relatives. Exclusion criteria: Any patient with a history of other eye disease, neurological disease or neurodegenerative disorder, or history of incisional ocular surgery within the previous month will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Glaucoma Group<br> | |
| Age-Matched Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in saccades |  | April 2014 |
The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure

Study Overview
=================
Brief Summary
-----------------
In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients with chronic kidney disease.

Detailed Description
-----------------
Endothelial dysfunction (ED) is a key event in the development of atherosclerotic cardiovascular disease observed in patients with chronic kidney disease (CKD). Experimental models have shown that hyperuricemia causes hypertension and renin angiotensin system activation. In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on ED in patients with CKD.

Official Title
-----------------
Prospective Study of Allopurinol Treatment That Improves Endothelial Function by Decreasing Uric Acid Levels of Patients With Chronic Kidney Disease

Conditions
-----------------
Hyperuricemia, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboratory finding of hyperuricemia Patients between ages of 18 and 60 years Non-diabetic patients Creatinine clearance values between 20 and 60 mL/min/1.73 m2 Exclusion Criteria: Low (< 20 ml/min/1.73 m2) creatinine clearance, Patients with diabetes mellitus, ischemic heart disease, acute coronary syndrome, congestive heart failure (CHF) (New York Heart Association class II or greater), valvular heart disease and a history of cerebral infarction or transient ischemic attack. Patients taking urate lowering medication (allopurinol and probenecid)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allopurinol<br>Hyperuricemic (uric acid (UA)>7 mg/dL), nondiabetic CKD patients without any comorbidity, age<60 years with creatinine clearance (CrCl) between 20 and 60ml/min were evaluated. | Drug: allopurinol<br>* 150 mg once a day<br>* Other names: urikoliz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function improvement with uric acid lowering treatment |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allopurinol, chronic kidney disease, endothelial dysfunction, hyperuricemia, uric acid, vascular endothelium, xanthine oxidase inhibitor
Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.

Official Title
-----------------
Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Ketorolac, Nepafenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age scheduled to undergo cataract surgery Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams) Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication to any study medication or any of their components Uncontrolled systemic disease Required use of ocular medications other than the study medications during the study Abnormal pre-operative OCTs if obtainable Diabetic patients Use of oral NSAIDS Patients with ocular disease (macula degeneration, glaucoma, corneal disease) which reduces the potential visual rehabilitation (patients will ocular disease that will no preclude achievement of a 20/20 visual outcome may be included)..

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketorolac, Nepafenac|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.

Official Title
-----------------
Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapeutic need according to the approved specific products characteristics (SPC) Exclusion Criteria: contraindication according to the SPC

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- |
| Somatropin<br>Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization | Drug: Somatropin<br>* Somatropin powder and solvent for solution for injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Zomacton® treatment measured by the increase in body height per annuum |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Zomacton® treatment measured by the increase in body weight per annuum |  | 5 years | 
| Safety of Zomacton® and the application device measured by local adverse reactions to the application device |  | 5 years |
Study of Vitamin D in the Severely Mentally Ill

Study Overview
=================
Brief Summary
-----------------
Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.

Detailed Description
-----------------
Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.

Official Title
-----------------
A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19-70, Schizophrenia or Schizoaffective disorder stabilized but not expecting to be discharged soon capacity to give informed consent Exclusion Criteria: acutely psychotic acutely medically ill renal insufficiency hypercalcemia hyperparathyroidism

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Vitamin D3<br>Will start Vitamin D3 immediately | Dietary Supplement: Vitamin D3<br>* Vitamin D3 50,000 units weekly<br>* Other names: Cholecalciferol;|
| Active Comparator: Three month delay<br>Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately) | Dietary Supplement: Vitamin D3<br>* 50,000 units of Vitamin D3 weekly<br>* Other names: Cholecalciferol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychopathology as measured by the PANSS | PANSS is being done every month | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| movement disorder | AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly. | three months | 
| General Health | Measured by staff observation and reports, Labs for example glucose mg/dL, HgbA1c %A1c, Vitamin D ng/ml, calcium mg/dL, assessed monthly | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Schizophrenia, Severely Mentally Ill
Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.

Official Title
-----------------
A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Endothelin receptor antagonist therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I) Age ≥18 year Not receiving ERA therapy in the 30 days prior to the enrolment visit Signed patient informed consent form Exclusion Criteria: Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device

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

| Intervention/Treatment |
| --- |
|Drug: Endothelin receptor antagonist therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment |  | Baseline to Week 54 | 
| Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation |  | baseline to week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Functional Class |  | Baseline to Week 54 | 
| NT-ProBNP/BNP |  | Baseline to Week 54 | 
| Echocardiography parameters | Tricuspid pressure gradient TAPSE Pulmonary outflow tract acceleration time Right ventricular fractional area change Pericardial effusion | Baseline to Week 54 | 
| Number of hospitalization due to PAH (min. overnight) |  | Baseline to Week 54 | 
| Quality of Life | Minnesota Living with Heart Failure Questionnaire (MLHFQ) | Baseline to Week 54 |