linjc16/ctgov huggingface dataset:
Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)

Study Overview
=================
Brief Summary
-----------------
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.

Official Title
-----------------
Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Anplag(Sarpogrelate)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person who signed on ICF Type 2 diabetic patient who have microalbuminuria or overt proteinuria In case of hypertension patients, who keep the same medication steadily over last 4 weeks Exclusion Criteria: patients who have hypersensitivity on sarpogrelate or other salicylic acid patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease patients who took other anticoagulant agent within 1 month patient who take ACEI OR ARB but not controlled(over 150/100mmHg) Type 1 diabetes patients Patient who have cardiac or liver problem Cr: >1.8mg/dl or GFR: <40ml/min malignant tumor patients

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Sarpogrelate<br> | Drug: Anplag(Sarpogrelate)<br>* Sarpogrelate 100mg 2 tablets, bid, 400mg/day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo 100mg 2 tablets, bid, 400mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR(Urine Albumin/Creatinine ratio) | change of percentage | treatment period(24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR(Urine Albumin/Creatinine ratio) | improvement efficiency rate of ACR comparing to baseline Definition of improvement efficiency : ACR become normal(<20mg/g Cr) or ACR is decreased more than 50% comparing to data before taking IP(Investigators' product) | Treatment period(24 weeks) | 
| urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen | changes comparing to baseline data | treatment period(24 weeks) | 
| ACR(Urine Albumin/Creatinine ratio) | improved amount comparing to baseline data | treatment period(24 weeks) | 
| ACR(Urine Albumin/Creatinine ratio) | rate of normalized ACR | treatment period(24 weeks) | 
| Creatinine | improved amount of Creatinine | treatment period(24 weeks) | 
| PCR(Protein to Creatinine ratio in Urine) | improved rate comparing to baseline data | treatment period(24 weeks) |
Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.

Study Overview
=================
Brief Summary
-----------------
During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed and replaced by a bone graft. These patients form the population of this study. The goal of this study is to evaluate their current medical condition and to determine the clinical outcome. The clinical result will be stipulated by means of standardized questionnaires (VAS-score, Oswestry low Back Pain Questionnaire and SF-36)

Official Title
-----------------
Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.

Conditions
-----------------
Anterior Lumbar Interbody Fusion Procedure

Intervention / Treatment
-----------------
* Procedure: Anterior Lumbar Interbody Fusion procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005 Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior Lumbar Interbody Fusion procedure<br> | Procedure: Anterior Lumbar Interbody Fusion procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure. | The clinical result will be stipulated by means of standardized questionnaires. | Baseline | 
| A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure. | The clinical result will be stipulated by means of standardized questionnaires. | 5 years after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union of the vertebrae. | Standard post operative X-ray. | 1 day (At the standard follow up consultation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior lumbar interbody fusion
Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery

Study Overview
=================
Brief Summary
-----------------
In neurosurgery, brain tumor patients show increased levels of lactate at the beginning of surgery. This has been related to malignancy. Ki-67 is a cell proliferation index used as a marker of tumor mitotic activity. This research aims to describe the correlation between lactate levels and the Ki-67 index in patients with brain tumor.

Detailed Description
-----------------
Lactate levels are used in the evaluation of perfusion status in critical care. Increases not related to a hypoperfusion state are observed in the patient with brain tumors. These increases have been related to type and tumor grade. This observation does not fully explain the variation within the same tumor grade. Ki-67 label index is a marker of mitotic activity that can be used as proliferation index. It has been associated with histologic grade and survival rate. Provides a quantitative measure of the tumor proliferation status. The investigators will perform a retrospective analysis of the clinical charts of patients after brain tumor resection. The study will address the relationship between baseline lactate levels and the proliferation index found in tissues biopsies.

Official Title
-----------------
Lactate Levels at Beginning of Surgery Correlates With Ki-67 Labeling Index in Brain Tumors

Conditions
-----------------
Brain Tumor, Anesthesia

Intervention / Treatment
-----------------
* Other: Data correlation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurosurgical craniectomy cases June 2017 - February 2018 Valid lactate information after anesthesia induction Ki-67 label index informed in biopsies Tumor type information confirmed in biopsies Exclusion Criteria: Incomplete lactate or Ki-67 index information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactate and Ki 67 levels<br>Neurosurgical patients between June 2017 and February 2018 for tumoral and non-tumoral craniectomy with lactate levels at the beginning of surgery and Ki-67 index in biopsies. | Other: Data correlation<br>* Correlation between lactate levels and Ki-67 index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the correlation between Lactate levels and Ki-67 Index | Levels of lactate in first blood analysis after anesthesia induction and proliferation index in biopsy results | Within 1 week after data acquisition | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactate, Ki-67, Mitotic index, Brain tumor
Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.

Official Title
-----------------
Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Behavioral: Physical activity guidance
* Behavioral: Health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle schools. Exclusion Criteria: Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Physical activity guidance Health education | Behavioral: Physical activity guidance<br>* Physical education class amelioration Additional physical activities for overweight&obese students Family physical activities Parent involvement<br>* Other names: Physical activity programme;Behavioral: Health education<br>* Knowledge of obesity prevention and control<br>|
| No Intervention: Control<br>Receive no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI) |  | Baseline, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in obesity-related anthropometric measurements |  | Baseline, Month 3 | 
| Change in serum lipids and fasting glucose |  | Baseline，Month 3 | 
| Change in dietary and physical activity behaviors |  | Baseline, Month 3 | 
| Change in physical fitness |  | Baseline, Month 3 | 
| Change in percentage of overweight&obesity |  | Baseline, 3 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schoolchildren, Obesity, Physical activity, Intervention Studies
CART-meso Long-term Follow-up

Study Overview
=================
Brief Summary
-----------------
This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-mesothelin scFv Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses are a subfamily of retroviruses. This protocol is designed in adherence with the November 2006 Food and Drug Administration (FDA) Guidance for Industry, Monitoring for Delayed Adverse Events and Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors  and involves up to 15 years of monitoring of subjects who have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry, hematology and tumor markers (as applicable). On annual visits, subjects will further undergo a physical exam and medical history (including concomitant medications and adverse events) with careful attention to features possibly related to retrovirus-induced diseases

Official Title
-----------------
Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-meso Gene Therapy Products in Cancer Studies

Conditions
-----------------
Subjects Who Have Received Lentiviral-based CART-meso Therapy

Intervention / Treatment
-----------------
* Biological: lentiviral-based CART meso therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be enrolled into this destination protocol because they have received CART-meso cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND #15882 and have received CART-meso cells will be asked to participate in this protocol. Subjects 18 years of age and older Subjects who have provided informed consent prior to their study participation. Exclusion Criteria: None

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 |
| --- | --- |
| Subjects who have received lentiviral-based CARTmeso therapy<br> | Biological: lentiviral-based CART meso therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | At each visit until study completion, up to 15 years |
A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group) Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg<br> | Drug: insulin degludec<br>* 0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days<br>|
| Active Comparator: IGlar<br> | Drug: insulin glargine<br>* 0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250) |  | 0-24 hours (derived on treatment day 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NN1250 concentration-time curve during one dosing interval at steady state |  | 0-24 hours (derived on treatment day 6) |
iPod Games in Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
To see if using ipod games can improve mental functioning

Conditions
-----------------
Hepatic Encephalopathy, Cirrhosis

Intervention / Treatment
-----------------
* Behavioral: ipod games


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis proven by biopsy, radiology or endoscopy Age 18-70 Able to give informed consent Cognitive dysfunction defined by impaired performance on standard cognitive tests Exclusion Criteria: Illicit drug or alcohol use within 3 months Trans-jugular intra-hepatic porto-systemic shunt (TIPS) placement Need for psychoactive medications apart from continuous anti-depressants or methadone Any focal neurological deficit or neuro-muscular disease Inability to function with an iPod Inability to understand English For MRI: inability to perform brain MRI is an exclusion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ipod games<br>Administered ipod games with cognitive testing before and after | Behavioral: ipod games<br>* Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in cognitive test performance with iPod games | improvement in cognitive performance on a battery of cognitive tests (Psychometric Hepatic Encephalopathy Score, Inhibitory Control test and Verbal Learning) after iPod tests | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in health-related quality of life | Sickness Impact Profile will be used before and after the treatment | 8 weeks | 
| Improvement in brain MRI parameters | change in detailed imaging parameters related to diffusion tensor imaging, resting state and voxel-based morphometry | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatic encephalopathy, covert hepatic encephalopathy, cirrhosis
Antiepileptic Drugs in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.

Official Title
-----------------
Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients

Conditions
-----------------
Seizure, Epileptic

Intervention / Treatment
-----------------
* Drug: antiepileptic drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥65 years old; Diagnosed with epilepsy; Using antiepileptic drugs for treatment; Exclusion Criteria: Patients who are expected to die within 48 hours; Patients with allergy to antiepileptic drugs; Patients receiving other investigational drugs; Other factors that the researcher considers unsuitable for inclusion.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>The use of antiepileptic drugs depends on the clinical practice. | Drug: antiepileptic drugs<br>* phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The peak plasma drug concentration of antiepileptic drugs. | To detect the peak plasma drug concentration of antiepileptic drugs. | at (0-4) h after oral administration | 
| The random plasma drug concentration of antiepileptic drugs. | To detect the random plasma drug concentration of antiepileptic drugs. | at (4-10) h after oral administration | 
| The trough plasma drug concentration of antiepileptic drugs. | To detect the trough plasma drug concentration of antiepileptic drugs. | at (1-2) h before the next administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reaction |  | Through study completion, an average of 14 days | 
| The frequency of seizures |  | Through study completion, an average of 14 days |
ATTEND-Family-led Rehabilitation After Stroke in India

Study Overview
=================
Brief Summary
-----------------
ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model which proves to offer several advantages in low and mid income countries. The objectives of the pilot stude were to determine that with a randomized blinded outcome assessor, controlled trial, family- led caregiver- delivered home based rehabilitation is better than usual care for those with disabling stroke in India and the feasibility of this model.

Official Title
-----------------
Family-led Rehabilitation After Stroke in India

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Physiotherapy
* Other: Control arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (>18 years) Recent (<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke Residual disability (requiring help from another person for everyday activities) Expected to survive to discharge from hospital with a reasonable expectation of six month survival Able (or by proxy) to provide informed consent Exclusion Criteria: Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care Those unwilling/unable to adhere to follow up.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>Routine hospital based physiotherapy | Other: Control arm<br>* Routine hospital based physiotherapy<br>|
| Other: Physiotherapy intervention arm<br>Caregiver delivered, home based physiotherapy | Other: Physiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in modified Rankin Score |  | 3rd and 6th month |