linjc16/ctgov huggingface dataset:
Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the changes in cardiac performance before and after milrinone administration in order to find out whether milrinone improves LV performance in patients undergoing coronary artery bypass surgery.

Official Title
-----------------
Milrinone on Cardiac Performance in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Drug: Milrinone Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient agree and provide written informed consent. patient undergoing elective coronary artery bypass graft surgery preoperative LV EF>50% (TTE) Exclusion Criteria: preoperative cardiac dysrhythmia preoperative IABP use of other inotropic agents

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| TMAD<br>Tissue motion annular displacement (TMAD) of tricuspid valve annulus transesophageal echocardiography | Drug: Milrinone Injection<br>* giving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/min IV<br>* Other names: Milrinone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMAD of ticuspid annulus during early relaxation |  | 15 mini after milrinone administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global longitudinal strain of the right ventricle |  | 15 mini after milrinone administration | 
| left ventricular ejection fraction |  | 15 min after milline administration | 
| global longitudinal strain of the left ventricle |  | 15 min after milline administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Milrinone, diastolic function
Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to prove if there is any difference in the nerve fiber layer between patients with normal- and high-tension-glaucoma with similar structural optic nerve head parameters.

Detailed Description
-----------------
It is till now not definitely clear whether normal- and high-tension glaucoma are different forms of the same disease and whether they have similar pathogenetic mechanisms. Spectral domain optical coherence tomography (SD-OCT) is supposed to objectively evaluate retinal nerve fiber layer (RNFL) thickness. The investigators propose a study to compare the RNFL in patients with normal- and high-tension-glaucoma. In order to exclude other possible differences,which could influence the results, only patients with similar structural optic nerve head damage in both groups will be compared.

Official Title
-----------------
Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma With Similar Structural Optic Nerve Damage

Conditions
-----------------
Normal Tension Glaucoma, High Tension Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons over 18 years men or women with normal- and high-tension glaucoma Exclusion Criteria: cataract cloudy cornea and other conditions with bad visualisation quality of optic nerve head optic nerve atrophy except glaucomatous

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-tension glaucoma<br>subjects with IOP>22 mmHg without eyedrops and signs of glaucomatous optic nerve damage | |
| low-tension glaucoma<br>subjects with IOP<22 mmHg without eyedrops and signs of glaucomatous optic nerve damage | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNFL in different segments | RNFL in upper, lower, temporal and nasal segments | up to 9 Months |
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients. We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.

Detailed Description
-----------------
Double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients Treatment Group Propantheline Bromide: 15mg, three times daily for 08 weeks. Control Group Placebo 03 times daily Case definition Clinically defined OAB patients (ICS criteria), infected by HTLV-1. Frequency was defined as more than 08 daytime voids. Nocturia was defined as more than 02 voids after sleeping. Inclusion criteria More than 18 year. HTLV-1 infected patients with overactive bladder. Negative culture of urine. Without neurological impairment. Exclusion criteria Persistently positive urine culture History of: Allergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.

Official Title
-----------------
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder

Conditions
-----------------
Overactive Bladder Associated With HTLV-1

Intervention / Treatment
-----------------
* Drug: Propantheline Bromide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HTLV-1 infection More than 18 years Negative urine culture No neurological damage Exclusion Criteria: Diabetes Persistently positive urine culture Pelvic, head, urological or gynecological surgery Stroke

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propantheline<br> | Drug: Propantheline Bromide<br>* 15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve in Overactive bladder symptoms score |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in nocturia and urgency |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overactive bladder, HTLV-1, Propantheline, anticholinergic
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.

Official Title
-----------------
Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.

Conditions
-----------------
Abdominal Neoplasms

Intervention / Treatment
-----------------
* Drug: enoxaparin
* Other: Physical prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more. Exclusion Criteria: surgery under laparoscope and other endoscopic operations clinical signs of deep vein thrombosis use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration severe hepatic disease or renal disease women of childbearing potential, pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Enoxaparin | Drug: enoxaparin<br>* 20 mg twice a day<br>|
| Other: 2<br>Intermittent Pneumatic Compression (IPC) | Other: Physical prophylaxis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism incidence |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, venous thromboembolism, curative surgery
A Trial to Assess the Antipsychotic Efficacy of ITI-007

Study Overview
=================
Brief Summary
-----------------
The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: ITI-007
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia experiencing an acute exacerbation of psychosis Exclusion Criteria: any subject unable to provide informed consent any female subject who is pregnant or breast-feeding any subject judged to be medically inappropriate for study participation

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40 mg ITI-007<br>40 mg ITI-007 administered orally as formulated capsules once daily for 28 days | Drug: ITI-007<br> <br> |
| Experimental: 60 mg ITI-007<br>60 mg ITI-007 administered orally as formulated capsules once daily for 28 days | Drug: ITI-007<br> <br> |
| Placebo Comparator: Placebo<br>Placebo administered orally as formulated capsules once daily for 28 days | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale Total Score |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale Subscales |  | 28 days |
Effect of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).

Study Overview
=================
Brief Summary
-----------------
This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide.

Official Title
-----------------
A Multi-center, Prospective, Observational Study to Assess the Effect of Patient Education Related to CV Risk Factors in Type 2 Diabetes Mellitus

Conditions
-----------------
Glycemia, Hypertension, Hyperlipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had been diagnosed with type II diabetes mellitus Patients with hypertension and / or hyperlipidemia Patients who had agreed to Informed Exclusion Criteria: Patients who had been diagnosed with type I diabetes mellitus Patients with neither hypertension and hyperlipidemia

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 |
| --- | --- |
| 1<br>Type II DM and Hypertension and/or Hyperlipidemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline |  | At baseline and Endpiont (after 2months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The treatment goal of risk factors is based on ADA guideline. |  | At baseline and Endpiont (after 2months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Type II DM, Hyperlipidemia, Glycemia, ADA 2008 guideline, Patient Consultation
Relationship Between Folic Acid and Warfarin Metabolism and Effect

Study Overview
=================
Brief Summary
-----------------
Folic acid supplementation has been shown previously to be associated with enhanced formation of p-HPPH from phenytoin, a metabolic pathway which is predominantly mediated through the activity of CYP2C9. The metabolism of S warfarin, the more active enantiomer of warfarin, is also mediated predominantly through the activity of CYP2C9. The purpose of the present study was to examine the relationship between folic acid concentration and warfarin pharmacokinetic as well as warfarin dose requirement among patients treated by warfarin. In addition the effect of folic acid supplementation (5 mg/d) for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in the second part of the study.

Official Title
-----------------
The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.

Conditions
-----------------
Folic Acid Deficiency

Intervention / Treatment
-----------------
* Drug: Folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on chronic warfarin therapy Exclusion Criteria: Refusal to participate in the study

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Folic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warfarin pharmacokinetic prior to and following administration of folic acid |  |  | 
| Warfarin dose requirement prior to and following the administration of folic acid. |  |  |
Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?

Study Overview
=================
Brief Summary
-----------------
Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Detailed Description
-----------------
Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function. Healthy women at 12 weeks' gestation and over from four different areas in Zhejiang province were enrolled to participate this program from May 2007 to May 2010. Women consented to provide urine samples and salt samples during pregnancy (12, 16, 24 weeks' gestation and before delivery), and give permission to access their newborn's TSH value. Urinary iodine concentration (UIC) was determined by ammonium persulfate digestion microplate method, and TSH was determined by a time resolved fluoro-immunoassay (TRFIA). The diagnostic standard for congenital hypothyroidism was: TSH ≥ 20 mU/L and declined FT4 levels. Compare the correlation to effects with different level of iodine content in salt, maternal UIC and neonatal TSH. Investigate the optimal level of iodine content in salt in different areas in ZheJiang province.

Conditions
-----------------
Congenital Hypothyroidism, Pregnancy, Iodine Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women in Zhejiang province (and their newborns) Exclusion Criteria: Endocrine disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital Hypothyroidism, pregnancy, iodine, deficiency
Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.

Official Title
-----------------
The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients

Conditions
-----------------
Drug-induced Ototoxicity in Peritoneal Dialysis Patients

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End-stage renal disease Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode Exclusion Criteria: Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months Detection of mechanical occlusion of external ear Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry History of a continuous ambulatory peritoneal dialysis related peritonitis

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine<br>N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin | Drug: N-acetylcysteine<br>* N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone<br>|
| No Intervention: Controls<br>Vancomycine and/or amikacin alone | Drug: N-acetylcysteine<br>* N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone<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
-----------------
ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis