linjc16/ctgov huggingface dataset:
Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures

Detailed Description
-----------------
In the management of drug-resistant epilepsy, many strategies have been examined. The Ketogenic Diet, high in fats and low in all other nutrients was observed to be of benefit. However, due to its complexedness and unpalatability, this diet is rarely used in the adult population. A recent small study showed seizure reduction with the Atkins Diet. In this study, patients will be randomized into one of 2 groups- group 1 receiving limited dietary instruction for the Atkins Diet and group 2- receiving detailed dietary instruction. A seizure severity-matched control group will also take part. We will follow these patients over a period of 2 years looking at seizure frequency, weight, sustainability of the diet, effect on anti-epilepsy medication dosage, effect in cognition, quality of life and financial impact of the diet. Patients will come to clinic to see the dietitian at specific intervals. cognitive testing will also be done at the beginning of the study and every 6 months thereafter. Patients will keep food charts, ketosis charts and seizure diaries.

Official Title
-----------------
Efficacy, Tolerability and Long-Term Adherence of a Modified Ketogenic Diet (Atkins) in the Management of Pharmacoresistant Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Behavioral: atkins diet
* Behavioral: ability to follow low carbohydrate diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food - Exclusion Criteria: Low BMI

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: atkins diet|nan|
|Behavioral: ability to follow low carbohydrate diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, atkins diet
Very Low Calorie Diet for Diabetic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.

Conditions
-----------------
Diabetic Kidney Disease

Intervention / Treatment
-----------------
* Other: very low calorie diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Age > 18 Body mass index ≥ 30 Presumed or biopsy-proven diabetic nephropathy Estimated GFR < 40 ml/min/1.73 meters squared Proteinuria > 0.5 gm/day Motivated to lose weight Stable medical co-morbidities Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated) Exclusion Criteria: Inability to sign informed consent Life expectancy of < 1 year Expected need for initiation of dialysis within 9 months Type 1 Diabetes Recent myocardial infarction or stroke (past 3 months) Unstable angina Active cancer Pregnancy/lactation Serious psychiatric diseases Substance abuse Uncontrolled hypertension (> 180/110) Ineligible for VLCD based on laboratory data

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: very low calorie diet<br> | Other: very low calorie diet<br>* medically supervised diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary albumin excretion |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
determine effects of diet on renal and other parameters
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

Study Overview
=================
Brief Summary
-----------------
Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.

Official Title
-----------------
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results

Conditions
-----------------
Dilated Cardiomyopathy

Intervention / Treatment
-----------------
* Procedure: intramyocardial bone marrow stem cells implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram age below 60 years absence of neoplasm absence of hematologic disease or systemic disease no previous cardiac intervention Exclusion Criteria: episodes of tachycardia or ventricular fibrillation severe or moderated mitral insufficiency any other valvulopathies

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intramyocardial bone marrow stem cells implantation|Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety: morbidity/mortality |  | eighteen months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiomyopathy, stem cell, cardiac failure
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

Detailed Description
-----------------
The duration of treatment is 26 weeks.

Official Title
-----------------
A 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 2)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib
* Drug: Comparator: celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee or hip which requires treatment with medication for pain relief Exclusion Criteria: Any known allergies to the study drugs

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib|nan|
|Drug: Comparator: celecoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. To evaluate the safety / tolerability over a 12-wk and 6-mo treatment period. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis

Detailed Description
-----------------
Diagnosed EKC patients will be devided into two groups,first group will undergo povidone-iodine 2% eye drop four times a day and the control group will be treated only by artificial tear drops,they will be examined 3 months later and evaluations and data collections for the final comparison will be done.

Official Title
-----------------
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis

Conditions
-----------------
Adenoviral Keratoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Povidone Ophthalmic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected for viral conjunctivitis Exclusion Criteria: Allergic to iodized materials Age under 17

Ages Eligible for Study
-----------------
Minimum Age: 17 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: EKC patients<br>Povidone-iodine 2% eye drop will be prescribed four times a day All patients will learn how to improve the hygiene level in order to reduce transmission | Drug: Povidone Ophthalmic<br>* Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis<br>* Other names: Povidone-iodine 2%;|
| No Intervention: Control group<br>All patients will undergo observational treatments including artificial tear drop and improving hygiene level | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis | Decreased patient's symptoms | 3 months | 
| Povidone-iodine 2% eye drop | Decreased viral load based on PCR results | 3 months |
A Late Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: KCT-0809 ophthalmic solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal and conjunctival damage Insufficiency of lacrimal secretion Ocular symptom Exclusion Criteria: Severe ophthalmic disorder Punctual plugs or surgery for occlusion of the lacrimal puncta

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KCT-0809 Lower Dose<br> | Drug: KCT-0809 ophthalmic solution<br> <br> |
| Experimental: KCT-0809 Higher Dose<br> | Drug: KCT-0809 ophthalmic solution<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Corneal conjunctival staining |  | 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Adverse Events |  | 8weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndromes, Corneal diseases, Conjunctival diseases
The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
In the previous cohort studies focused on diabetes in China, there were few studies on elderly patients with diabetes. The aim of this prospective cohort study was to investigate the prevalence, management and nutritional status of elderly diabetic patients aged ≥65 years in Shanghai and Suzhou communities, and record the occurrence of endpoint events.

Detailed Description
-----------------
This is a multicenter, observational, prospective cohort study.We plan to collect the baseline information in three years, and follow up every two years for at least 10 years. The study will enroll 5000 elderly diabetic patients aged ≥65 years and be conducted in Shanghai and Suzhou. The primary outcomes include MACE(major adverse cardiovascular events) , all-cause mortality, and chronic complications of diabetes and so on.

Official Title
-----------------
The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study

Conditions
-----------------
Diabetes Mellitus, Cardiovascular Diseases, Complication Diabetic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged 65-100 years old; Patients who had been diagnosed with diabetes mellitus. Exclusion Criteria: Patients with psychiatric disorders or impaired cognitive function; Patients who cannot or reject to sign the consent form.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| MACE | major adverse cardiovascular events,including the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke. | Up to 10 years | 
| all-cause mortality | All-cause mortality was confrmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Xiangcheng Center for Disease Control and Prevention. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic complications of diabetes |  | Up to 10 years |
An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.

Official Title
-----------------
GERMAN TARCEVA NON-INTERVENTIONAL STUDY in 1st Line Treatment of NSCLC EGFR Mutation Positive Patients

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines Exclusion Criteria: N/A

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at 18 months |  | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (complete response/partial response) by type of mutation |  | 3.5 years | 
| Percentage of patients with remission |  | 3.5 years | 
| Progression-free survival (overall/stratified) |  | 3.5 years | 
| Overall survival (overall/stratified) |  | 3.5 years | 
| Tolerability: Incidence of fatigue, rash, diarrhea |  | 3.5 years | 
| Safety: Incidence of serious adverse events |  | 3.5 years | 
| Dose modifications/withdrawals |  | 3.5 years | 
| Symptom control (cough, dyspnea) |  | 3.5 years |
3-dimensional Sensor Technology to Quantify Leg-edema

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is two-fold: to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema. to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.

Detailed Description
-----------------
Leg-edema are common in patients with worsening heart failure. Apart from using a measuring tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart failure early detection of leg-edema is quite difficult. From earlier pacemaker-studies it has been shown that an increase of afterload changes ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring blood-pressure affect QRS-morphology in patients with heart failure.

Official Title
-----------------
Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure

Conditions
-----------------
ADHF

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalization for worsening heart failure age greater than 18 years ability to stand without help from others informed consent Exclusion Criteria: leg-edema of non-cardiac origin (venous, lymphatic) dialysis shunt

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 with leg-edema<br>patients with decompensated heart failure presenting with leg-edema | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of 3-dimensional measurements | the 3-D camera will record changes in leg-shape around the ankles that result from reabsorption of fluid. These changes will be compared with changes in leg-circumference using a measuring tape | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute heart failure
An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine

Study Overview
=================
Brief Summary
-----------------
To facilitate provision of atovaquone (566C80) to patients who have severe Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.

Official Title
-----------------
An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Atovaquone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Clinical diagnosis of acute severe Pneumocystis carinii pneumonia (PCP). Dose-limiting intolerance to TMP / SMX and parenteral pentamidine. Willingness and ability to give informed consent. Exclusion Criteria Co-existing Condition: Excluded: Patients with a history of intolerance to 566C80. Patients with the following prior conditions are excluded: History of serious dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug. Required: Trimethoprim / sulfamethoxazole (TMP/SMX); pentamidine.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atovaquone|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
-----------------
Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone