linjc16/ctgov huggingface dataset:
Fiber Intake in an End Stage Renal Disease (ESRD) Population Followed Over 2 Years

Study Overview
=================
Brief Summary
-----------------
Our research involves the detailed description of the content of the diet of x dialysis patients. For our purpose we used a newly developed food frequency questionnaire. This is the first validated questionnaire specific for dialysis patients and we were the first to use it. Our special focus was the fiber content in the diet of our patient. Our thesis that they are way below the recommended guidelines for fiber intake was verified. Our follow will evaluate the effect of such at diet, mosTLy cardiovascular.

Official Title
-----------------
Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.

Conditions
-----------------
Cardiovascular Outcome, Kalemia Control, Lipid Profile

Intervention / Treatment
-----------------
* Other: Increasing total fiber intake in patient's diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with end stage renal disease on hemodialysis Patients who are able to give informed consent Exclusion Criteria: Pregnant women. Cognitively impaired patients PEG feeding
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>First describe the diet of a cohort of dialysis patients with focus on fiber content. | Other: Increasing total fiber intake in patient's diet<br>* Second counsel patients biweekly about their compliance with a high fiber diet, target being 25 to 30 gm of fiber a day.Follow them for a period of 2 years and assess if their is any significant decrease in their cardiovascular events and profile, in addition to assessing the effect of high fiber on kalemia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular event |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiber, Dialysis, Renal Replacement Therapy, Food Frequency Questionnaire, FFQ, Dietary counseling
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

Study Overview
=================
Brief Summary
-----------------
Short-term outcomes of laparoscopic liver resection is better than those of open liver resection Laparoscopic liver resection is better than open resection in immunological aspects

Detailed Description
-----------------
Advantages and disadvantages of the laparoscopic compared with the open approach for liver resections Advantages 1) Less postoperative ascites production 2) Reduced postoperative pain 3) Feasible in selected cirrhotics who have contraindications to open surgery 4) Less intra-abdominal adhesions (easier salvage transplantation) 5) Shorter recovery time 6) Shorter length of stay 7) Reduced financial cost Disadvantages 1) No manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) High demand in surgical skill (especially major resections)

Official Title
-----------------
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiologically diagnosed hepatocellular carcinoma Child classification A or B Aged 20 to 80 Informed consent taken Exclusion Criteria: Child classification C Extrahepatic metastasis Tumor located in central area or adjacent to middle hepatic vein Recurred hepatocellular carcinoma Critically ill patient Patient with psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: laparoscopic liver resection<br>Patients who underwent laparoscopic liver resection for HCC | Procedure: Liver resection<br>* Laparoscopic or Open hepatectomy<br>|
| Active Comparator: open liver resection<br>Patients who underwent open liver resection for HCC | Procedure: Liver resection<br>* Laparoscopic or Open hepatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 2 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrence, Survival, Immunology, Laparoscopy
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.

Official Title
-----------------
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Conditions
-----------------
Postoperative Supraventricular Tachyarrythmia

Intervention / Treatment
-----------------
* Drug: ONO-1101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-80 years old Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher) Within 7 days postoperatively Other inclusion criteria as specified in the protocol Exclusion Criteria: Acute myocardial infarction (within 1 month after onset) Severe heart failure (New York Heart Association functional class III or higher) Atrioventricular block (grade II or higher),or sick sinus syndrome Other exclusion criteria as specified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 79 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: ONO-1101|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving 20% reduction in heart rate at each dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate, Blood pressure and 12-lead ECG |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia
Study of Glycogen Storage Disease and Associated Disorders

Study Overview
=================
Brief Summary
-----------------
Glycogen, is the storage form of glucose. It is usually formed from sugar and stored in the liver. When tissues, such as muscle, need glucose for fuel the stored glycogen is converted into glucose with the help of enzymes produced in the body. Glycogen storage disease (GSD) refers to a group of conditions characterized by abnormal storage of glycogen due to the absence of particular enzymes needed in the process of storing and using glycogen. This study addresses the related metabolic abnormalities of glycogen storage disease (GSD). As patients with disorders of glycogen metabolism are followed it becomes apparent that the condition is much more complex than initially thought. Researchers believe that patients suffering from glycogen storage disorders should be followed and monitored for other heritable metabolic disorders. This study will attempt to determine the frequency of associated disorders in patients with GSD. In addition, the study will look at the current management of these patients to see if the prognosis and course of the disease is changed.

Detailed Description
-----------------
This study addresses the related metabolic abnormalities of the glycogeneses. As more older individuals with glycogen storage disease are followed and studied, it becomes apparent that when individuals with glycogenosis are viewed from a longitudinal perspective, the condition is much more complex and diverse in its related conditions than one would have reason to believe, even in hindsight. It is relevant to follow these individuals, searching for abnormalities not only with glycogen storage disease in mind, but also because other heritable metabolic disorders, including cystinosis and cystic fibrosis, reflect the accumulation of associated disorders with age which often have no apparent direct association with GSD.

Official Title
-----------------
A Study of Collateral Disorders of Glycogen Storage Disease

Conditions
-----------------
Glycogen Storage Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients age 20 or older, male or female.
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
-----------------
Electrooculography, Electroretinogram, Fluorescein Angiogram, Glycogen Storage Disease
Vaginal DHEA for Women After Breast Cancer

Study Overview
=================
Brief Summary
-----------------
There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.

Official Title
-----------------
Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy

Conditions
-----------------
Vaginal Dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction

Intervention / Treatment
-----------------
* Drug: Vaginal DHEA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed. Exclusion Criteria: women using products to alleviate vaginal dryness. women taking medication for urinary incontinence women not sexually active, for other reasons.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal DHEA<br>Vaginal DHEA 0.5%(6.5mg)inserted nightly | Drug: Vaginal DHEA<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in vaginal dryness |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in urinary incontinence |  | 12 weeks | 
| improvement in sexual satisfaction |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexual Satisfaction, Vaginal dryness, Breast Cancer, Urinary Incontinence, Quality of Life
Prevalence of Diabetes Mellitus Among Patients Treated With Atypical and Conventional Antipsychotics

Study Overview
=================
Brief Summary
-----------------
This pilot study hypothesizes that diagnosed and undiagnosed prevalence of diabetes mellitus may differ across antipsychotioc medications in a community mental health center. The study further hypothesizes that control of diabetes among diagnosed cases may be suboptimal.

Detailed Description
-----------------
Study of longitudinal incidence proved impractical within the limitations of the project.

Official Title
-----------------
Prevalence and Incidence of Diabetes Mellitus Among Patients Treated With Atypical and Conventional Antipsychotics

Conditions
-----------------
Schizophrenia, Bipolar Disorder, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with antipsychotic medication at a community mental health center Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.

Official Title
-----------------
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)

Conditions
-----------------
Biliary Concentration of Tacrolimus

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years) of both sexes, Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease, Not having expressed their opposition to participation in the study Exclusion Criteria: Bilio-enteric anastomosis, Associated transplantation of another organ Contraindications to TCR administration Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.

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: Tacrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC |  | during the first 7 days after its initiation |
Endothelial Cell Loss After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.

Official Title
-----------------
Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Procedure: Standard phacoemulsification
* Procedure: Reduced ultrasound phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visually significant moderate density cataract Exclusion Criteria: Corneal or retinal pathology limiting visual potential to worse than 20/40 Lens pathology including pseudoexfoliation or lens dislocation Prior intraocular surgery Age less than 40

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound phacoemulsification<br>Cataract nucleus is removed using standard amounts of ultrasound energy. | Procedure: Standard phacoemulsification<br>* Cataract nucleus removal using standard amounts of ultrasound energy<br>|
| Active Comparator: Reduced ultrasound phacoemulsification<br>Cataract nucleus removal using less ultrasound energy and more mechanical energy. | Procedure: Reduced ultrasound phacoemulsification<br>* Cataract nucleus removal using less ultrasound energy and more mechanical energy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cell loss by specular microscopy after cataract surgery |  | 3 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Corneal endothelial cell loss, Ultrasound power, Corneal endothelium
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years

Official Title
-----------------
The Post Marketing Surveillance Study Conducted With a Continuous Enrollment Method to Assess Serious Adverse Events, Adverse Events, Safety, Efficacy of Micardis Tablet (Telmisartan 20, 40, 80mg p.o. Once Daily Over 2 Weeks)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients diagnosed with essential hypertension Patients without prior experience with Micardis tablet Exclusion Criteria: Known hypersensitivity to Micardis tablet Pregnancy or breastfeeding Biliary atresia Severe hepatic failure patients Severe renal failure patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with essential hypertension<br> | Drug: Telmisartan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure reduction |  | Up to 6 years | 
| Final assessment of efficacy on a 3-point scale |  | Up to 6 years | 
| Assessment of efficacy based on subject's demographics on a two-point scale |  | Up to 6 years | 
| Number of patients with adverse events |  | Up to 6 years | 
| Incidence rate of adverse events | based on demographic factors | Up to 6 years | 
| Assessment of safety on a 4-point scale | based on adverse events and changes in abnormality of clinical laboratory tests | Up to 6 years |
Phase II Trial of RAD001 in Refractory Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Single center open-label study of an oral agent (RAD001) in subjects with metastatic colorectal cancer refractory to at least 2 standard chemo/biologic regimens.

Detailed Description
-----------------
Study is completed and closed.

Official Title
-----------------
Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: RAD001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal cancer refractory to at least 2 chemo/biologic regimens Measurable disease ECOG 0-2 Exclusion Criteria: CNS disease Chemotherapy or radiotherapy < 4 weeks prior Active bleeding diathesis

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: RAD001|nan|

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
-----------------
Metastatic, Refractory