linjc16/ctgov huggingface dataset:
Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

Study Overview
=================
Brief Summary
-----------------
Narrowing of the main valve which controls blood leaving the heart leads to a marked increase in death. To overcome this narrowing the heart muscle thickens abnormally and contracts more vigorously. However, in doing so, blood flow patterns to the heart muscle change through mechanisms which are incompletely understood. New technology allows such heart valve blockages to be fixed using balloons and metal stents inserted through tubes placed in arteries in the leg. Using sensors placed in these tubes it is possible to make detailed measurements of coronary flow and pressure, and apply new mathematical techniques to allow a better understanding of the detrimental effects that aortic stenosis has on coronary flow, before and after valve surgery.

Official Title
-----------------
Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe Aortic Stenosis undergoing TAVI Normal coronary arteries Normal left ventricular function No other valvular pathology Exclusion Criteria: Unable to consent Left ventricular impairment Left ventricular regional wall motion abnormality Other valve abnormality

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Stenosis, Coronary Flow, Wave Intensity Analysis
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract

Study Overview
=================
Brief Summary
-----------------
This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.

Detailed Description
-----------------
This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.

Official Title
-----------------
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract

Conditions
-----------------
Congenital Cataract

Intervention / Treatment
-----------------
* Device: Acrysof Toric IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children less than 14 years Congenital cataract at initial visit Symmetrical keratometric astigmatism more than 2.0 D Exclusion Criteria: Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age) Corneal pathology Keratoconus Irregular astigmatism

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acrysof toric IOL<br>Acrysof Toric intraocular lens in congenital cataract | Device: Acrysof Toric IOL<br>* Lens implantation following cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in astigmatism after cataract surgery at 24 months | Measurement of refraction after cataract surgery was performed. | preop, 3,6,12,24 month postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in quality of vision after cataract surgery at 24 months. | Measurement of visual acuity after cataract surgery was performed. | preop, 3,6,12,24 months postop |
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to determine whether the American Heart Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis patients. The secondary objective is to test the effects of fish oil supplementation on inflammatory and cardiovascular markers.

Official Title
-----------------
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Conditions
-----------------
End-Stage Renal Disease Patients on Hemodialysis

Intervention / Treatment
-----------------
* Drug: Fish oil capsules
* Drug: matched placebo capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Age <18 Pregnant individuals Fish oil or omega-3 supplementation in past 6 months Fish, corn, soybean, gelatin, or vanilla allergies Currently enrolled in a dietary or investigational drug study Life expectancy < 3 months Ongoing active illness requiring hospitalization Malabsorption syndromes Chronic heparin or coumadin anticoagulation (??) Active bleeding issues

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fish oil capsules|nan|
|Drug: matched placebo capsules|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether AHA-recommended fish oil therapy beneficially affects the pro-inflammatory/anti-inflammatory blood fatty acid balance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the safety and tolerability of fish oil therapy in hemodialysis patients |  |  | 
| To measure the effects of fish oil treatment on cardiovascular and inflammatory risk factors |  |  |
Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula MDRD, CKD-EPI or Cockroft-Gault?

Study Overview
=================
Brief Summary
-----------------
The study included 300 patients who are post-kidney transplantation (> 3 months and <10 years). An analysis of body composition using bioelectrical impedance, calculated BMI and serum creatinine was determined. Glomerular filtration rate (GFR) was calculated using the formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.

Official Title
-----------------
Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula Modification of Diet in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockroft-Gault?

Conditions
-----------------
Renal Function Disorder

Intervention / Treatment
-----------------
* Other: Estimating of formula MDRD, CKD-EPI, Cockroft-Gault,
* Device: Tanita BC 418- Bioelectrical impedance analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: give voluntary consent to participate in the study functioning graft longer than 3 months to 10 years no clinical cardiovascular disease during the 6 months preceding entry stable graft function- glomerular filtration rate > 30 ml/min/1.73 m2, creatinine concentration <2.5 mg/dl Exclusion Criteria: not meet the above criteria episode of illness (for example: infection) pregnancy

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 |
| --- | --- |
| Patients After Kidney Transplantation<br>A total of 300 consecutive patients admitted to routine visit in Transplant Centre with functioning graft longer than 3 months to 10 years | Other: Estimating of formula MDRD, CKD-EPI, Cockroft-Gault,<br> <br> Device: Tanita BC 418- Bioelectrical impedance analysis<br>* The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in estimating GFR using formula MDRD, CKD-EPI and Cockroft-Gault in short and long-term postoperative period. |  | 1 day |
Hepatectomy for Early-stage HCC Patients With CSPH

Study Overview
=================
Brief Summary
-----------------
Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered.

Official Title
-----------------
Clinically Significant Portal Hypertension (CSPH) on Early-stage HCC Following Hepatectomy: What's the Impact?

Conditions
-----------------
HCC, Portal Hypertension

Intervention / Treatment
-----------------
* Procedure: hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCC was diagnosed by two experienced pathologists in Child-Pugh grade A/B negative resection margin Initial diagnosis of HCC in the patients Exclusion Criteria: Distant transfer Not HCC
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-CSPH<br>BCLC stage A patients who underwent hepatectomy in the group without clinically significant portal hypertension (Non-CSPH) | Procedure: hepatectomy<br>* Liver resection<br>|
| CSPH<br>BCLC stage A patients who underwent hepatectomy in the group with clinically significant portal hypertension (CSPH) | Procedure: hepatectomy<br>* Liver resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | Patient survival time after surgery | 2009--2025 | 
| recurrence | Patient recurrence time after surgery | 2009--2025 |
Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Study Overview
=================
Brief Summary
-----------------
This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.

Official Title
-----------------
Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers

Conditions
-----------------
Obesity, Fungal Infection

Intervention / Treatment
-----------------
* Drug: Caspofungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate. Exclusion Criteria: Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, so that the pregnancy and post-partum state would be a confounding variable. Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal. History of allergies to echinocandins. Echinocandins are contraindicated for any reason. Volunteers unwilling to comply with study procedures. Suspected or documented systemic fungal infection. Concomitant use of rifamycins, tacrolimus, or cyclosporine

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsofungin<br>Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2. | Drug: Caspofungin<br>* Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)<br>* Other names: Cancidas;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Clearance of Caspofungin |  | 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Echinocandin, Obesity, Pharmacokinetics, Pharmacodynamics, Fungal infection
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis. This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.

Conditions
-----------------
Mitral Valve or Aortic Valve Replacement

Intervention / Treatment
-----------------
* Device: Perimount 2900/6900 Heart Valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China The patients agree to join the study and sign the ICF Exclusion Criteria: No specific exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects implanted with Perimount Heart Valve<br>Only one group was set for this study, including all enrolled subjects who implanted with Perimount Heart Valve during 2001 to 2007 | Device: Perimount 2900/6900 Heart Valve<br>* This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography | 7-15 years after heart valve replacement surgery (during 2001-2007) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perimount 2900, Heart Valve Replacement, China, Perimount 6900P
The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.

Study Overview
=================
Brief Summary
-----------------
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.

Detailed Description
-----------------
All the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. Investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.

Official Title
-----------------
Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Device: PHENIX4-8-8 PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe pelvic organ prolapse(POP-Q:3/4 stage) accept pelvic reconstructive surgery Exclusion Criteria: Dominant stress urinary incontinence Serious medical problems mental disease infectious disease
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS | Device: PHENIX4-8-8 PLUS<br>* transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS<br>|
| No Intervention: The observational group<br>routine nursing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of urinary retention | urinary residual volume | three days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of urinary incontinence | according to the 1-h pad test | three days; seven days; one month; three months; six months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcutaneous electrical nerve stimulation;
Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).

Detailed Description
-----------------
3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.

Official Title
-----------------
Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Device: Bilevel
* Device: PEP mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CF older than 18 years FEV1 between 20% and 69% of predictive. No acute exacerbation. No Burkhordelia Cepacia/MRSA colonization. Exclusion Criteria: Children under 18 year acute exacerbation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilevel<br>Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment. | Device: Bilevel<br>* 3 months<br>|
| Active Comparator: PEP mask<br>PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment. | Device: PEP mask<br>* 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Function: Lung Clearance Index | Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa). | After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung function