linjc16/ctgov huggingface dataset:
Age-related Prevalence of Sleep Respiratory Disturbances

Study Overview
=================
Brief Summary
-----------------
To determine the prevalence and longitudinal course of sleep apnea among men and women and to examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and other biomedical correlates.

Detailed Description
-----------------
BACKGROUND: Sleep apnea is characterized by repetitive cessations of respiration during sleep with consequent decreases in arterial oxygen saturation. Sleep apnea can be caused by upper airway obstruction or by central nervous system failure to sufficiently excite the diaphragm and accessory respiratory muscles. However, in most cases, both processes are involved. Hypopneas, in which airflow is significantly compromised without complete cessations of respiratory flow, and snoring are often found in association with apneas. Both apneas and hypopneas cause repetitive disruptions of sleep, consequent daytime somnolence, and complex cardio-respiratory disturbances. DESIGN NARRATIVE: The study was longitudinal in design. A stratified random sample of adults in San Diego was used to examine risk factors in the prevalence of sleep respiratory disturbances. A structured random sample was selected by random digit telephone dialing. Subjects were studied in their homes. Some were followed yearly during the project. Each volunteer gave a brief sleep history and medical review, including blood pressure measurement, the National Interview Survey, And Quality of Well-being Scale. Blood oxygen saturation, pulse rate, snoring, and sleep duration were recorded for three nights. State-of-the-art computerized pulse oximeters and microprocessor-based activity/light monitors were used. Subjects found to have the most severe sleep respiratory disturbances underwent laboratory polysomnograms to add descriptive data and to validate the survey methodology. The prevalence of respiratory disturbances in sleep was analyzed as a function of age and sex. Associations with several aspects of morbidity were determined. The longitudinal course of respiratory disturbances in sleep were examined. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Heart Diseases, Hypertension, Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common. The aim of the study is to retrospectively determine the value of postoperative CT after LSG as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.

Official Title
-----------------
Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

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

Intervention / Treatment
-----------------
* Diagnostic Test: CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult obese patients with LSG BMI ≥ 40 kg/m2 or BMI between 35 and 40 kg/m2 evidence of obesity related comorbidity availability of upper abdomen CT scan with IV and oral contrast medium within 72 hours of surgery Exclusion Criteria: Pregnant women allergy to contract medium lack of venous access patients who did not have a post-surgical upper abdomen CT

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 |
| --- |
|Diagnostic Test: CT scan|Post surgical standard CT Scan as predictor of complication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of Post surgery CT in identifying risks for subsequent development of gastric fistula | Measurements of: presence or abscence of fistula and site; presence/abscence of hematoma and site; presence/abscence of gastric torsion; Stapler to pylorus distance and stapler length | 72 hours post LSG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post surgery risk | Risk stratification based on the correlation of the measurements obtained from the primary objective on outcome (complication vs non complication). | 72 hours post LSG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT Scan
Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effect of two surgical techniques (open vs robotic assisted) on plasma levels of NGAL (neutrophil gelatinase-associated lipocalin) after radical prostatectomy.

Detailed Description
-----------------
Patients undergoing radical prostatectomy are at increased risk of acute kidney injury (AKI) because of intraoperative bleeding, obstructive uropathy and older age. In particular robot-assisted laparoscopic radical prostatectomy (RALP) which is in increasing demand as an alternative surgical option for retropubic radical prostatectomy (RRP) is associated with postoperative renal dysfunction because pneumoperitoneum during RALP can decrease cardiac output and renal perfusion. NGAL may become important for diagnosis of postoperative AKI after urogenital oncosurgery.

Official Title
-----------------
Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels After Robot-assisted Laparoscopic Versus Retropubic Radical Prostatectomy

Conditions
-----------------
Prostatectomy

Intervention / Treatment
-----------------
* Procedure: NGAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who undergo prostatectomy American Society of Anesthesiology (ASA) I-III Exclusion Criteria: preexisting renal disease emergency surgery heart failure peripheral vascular disease

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 |
| --- | --- |
| NGAL - retropubic radical prostatectomy<br>Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia | Procedure: NGAL<br> <br> |
| NGAL - robotic radical prostatectomy<br>Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia | Procedure: NGAL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma NGAL | Plasma NGAL was determined at baseline, 6 hours and 12 hours after surgery, ng/ml | 0 hours, 6 hours and 12 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NGAL, Acute kidney injury, Prostatectomy
Clinical Test Report for Blood Pressure Meter of CH-658

Study Overview
=================
Brief Summary
-----------------
Blood pressure meter model CH-658 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 96 subjects with a wide range of blood pressure were selected. Exclusion Criteria: Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 62 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 |
| --- | --- | --- |
| Measure accuracy of blood pressure meter CH-658 | Measure the accuracy of blood pressure meter model CH-658 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10 | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure
Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.

Official Title
-----------------
Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Biological: Blood Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complicated hepatitis C by HCC Complicated hepatitis C by liver cirrhosis Complicated hepatitis C by steatohepatitis uncomplicated hepatitis C Exclusion Criteria: pre-portal fibrosis secondary to previous bilharzial disease pre-portal fibrosis secondary to alcoholic fatty liver The presence of hepatic malignancy other than HCC decompensated cirrhosis hepatorenal failure hepatic manifestations of congestive heart failure.

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 67 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 |
| --- | --- |
| Complicated HCV<br> | Biological: Blood Sampling<br>* Blood sampling under a complete aseptic conditions<br>|
| Non Complicated HCV<br> | Biological: Blood Sampling<br>* Blood sampling under a complete aseptic conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between MicroRNA and HCV | The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients | 12 months |
Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then measaured the plasma levels of methionine metabolites, such as SAH, SAM, and analyze the association.

Detailed Description
-----------------
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then use HPLC-MS/MS to measaure the plasma levels of methionine metabolites, such as SAH, SAM, and use methylated specifical PCR to detect the promoter DNA methylation of p66shc, and use ELISA kits to measure the plasma ROS levels of CVD patients, such as MDA, 8-iso-prostaglandin F2a, and finally analyze the association between SAH, ROS levels, promoter DNA methylation of p66shc, and flow-mediated dilation.

Official Title
-----------------
Investigation of Association Between Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction in Cardiovascular Disease Patients

Conditions
-----------------
Cardiovascular Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have stable clinical conditions, except for acute coronary syndromes, and the availability of measurement of flow-mediated dilation, or have more than three cardiovascular traditional risk factors, such as smoking, alcohol use, obesity, hypertesion, diabetes, family history, and so on. Exclusion Criteria: critical illness or hemodynamic instability other than acute coronary syndromes, surgery, or trauma within the previous month, known cancer, hepatic failure or hepatitis, or the use of drugs, such as anticancer agents, which would affect plasma tHcy concen-trations.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high cardiovascular risk group<br>no intervention | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | measurement of flow-mediated dilation by B ultrasound | one month after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
S-adenosylhomocysteine, Endothelial function
Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.

Official Title
-----------------
Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Hetrombopag Olamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy. Weight≥50 kg，19≤BMI≤28 kg/m2. Platelet count is within normal range Exclusion Criteria: History of clinically significant illness. History of alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hetrombopag 7.5mg fasted to fed<br>Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11. | Drug: Hetrombopag Olamine<br> <br> |
| Experimental: hetrombopag 7.5mg fed to fasted<br>Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11. | Drug: Hetrombopag Olamine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) of hetrombopag | Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state | 0h-120h | 
| The area under the plasma concentration-time curve (AUC) of hetrombopag | AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state | 0h-120h | 
| The accumulative excretion rate of hetrombopag and its metabolites in urine and feces |  | 0h-120h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of platelet count |  | On day 2, 4, 6, 8,12, 14 and 16 | 
| The number of volunteers with adverse events as a measure of safety and tolerability |  | up to Day 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjects
Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline

Study Overview
=================
Brief Summary
-----------------
In children with cerebral palsy, secondary problems lead to hip dislocation and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip.

Detailed Description
-----------------
Observation cohort study. The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor muscles pressure test and electromyography(EMG test) test of hip adductor and spine muscles

Official Title
-----------------
Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline

Conditions
-----------------
Cerebral Palsy, Spastic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe cerebral palsy patients(GMFCS level 3,4,5) 2 to 10 years old Exclusion Criteria: Those who disagree with the study. other than cerebral palsy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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 |
| --- | --- |
| cerebral palsy<br>They are included in GMFCS level 3, 4, 5. and they have diplegia or quadriplegia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip adductor and spin muscles electromyography(EMG) test | Use EMG to check the activity of the hip adductor and spine muscles of participants. This figures will give investigators a look at the association with a hip dislocation. | once at study, when patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole spine AP and total Hip AP X-ray photograph | Whole spine and total Hip joint are checked with X-ray photograph. and investigators will check the progress of hip dislocation and spinal scoliosis. | once at study, when patient enrolled and after once every six months for three years | 
| hip adductor muscles pressure meter test | Pressures of hip adductors muscles are measured from pressure meter. and This figures will give investigators a look at the association with a hip dislocation. | once at study, when patient enrolled | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip dislocation, GMFCS level 3,4,5, scoliosis
Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.

Detailed Description
-----------------
The goal is to determine if parathyroid tomoscintigraphy on a CZT camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.

Official Title
-----------------
Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera

Conditions
-----------------
Primary Hyperparathyroidism

Intervention / Treatment
-----------------
* Device: Tomoscintigraphic parathyroid imaging on a CZT camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suffering from sporadic primary hyperparathyroidism referred to the Nuclear Medicine Dept for a pre-operative scintigraphy of the parathyroid glands who have given their written consent who benefit from the French Government Medical Insurance Exclusion Criteria: pregnant women ages < 18 or > 80 years hyperparathyroidism recidive after a first surgery secondary or tertiary hyperparathyroidism Multiple endocrine Neoplasia (MEN) type I context or familial history of hyperparathyroidism absence of written consent non-beneficiary of the French Government Medical Insurance

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tomoscintigraphic parathyroid imaging on a CZT camera<br>Tomoscintigraphic parathyroid imaging on a CZT camera | Device: Tomoscintigraphic parathyroid imaging on a CZT camera<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pathologic parathyroid detection performances between planar pinhole on Anger camera and tomoscintigraphy on CZT camera, gold standard being the pathological results after surgery |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CZT camera, pinhole