linjc16/ctgov huggingface dataset:
B-vitamins Treatment for Improvement of Cognitive Function

Study Overview
=================
Brief Summary
-----------------
Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.

Detailed Description
-----------------
We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.

Official Title
-----------------
Effect of B-Vitamins on Cognitive Function in Elderly People

Conditions
-----------------
Cognitive Function, Metabolic Improvements

Intervention / Treatment
-----------------
* Drug: B-vitamin complex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 65 years and glomerular filtration rate (GFR) > 35 ml/min Exclusion Criteria: acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study. furthermore, people who had dementia (mini-mental state-examination scores MMSE < 15) those treated with B-vitamins those with renal insufficiency those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B-Vitamins<br>folic acid, cobalamin, vitamin B6 | Drug: B-vitamin complex<br>* 5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily<br>* Other names: no other names;|
| Placebo Comparator: placebo<br>none of the vitamins (99.5% mannitol) | Drug: B-vitamin complex<br>* 5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily<br>* Other names: no other names;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function |  | baseline and 45 days later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
folic acid, homocysteine, MMSE scores, methyl malonic acid, betaine
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

Official Title
-----------------
The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: Arzoxifene
* Drug: Raloxifene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have osteoporosis Must be between 50 and 75 years old and be able to walk Have at least two of your back bones that can be x-rayed Have not had a period in at least two years Be willing to have blood tests Exclusion Criteria: Have a bone disease other than osteoporosis History of estrogen dependent cancer History of stroke or certain heart problems Possibly have an allergy to raloxifene or arzoxifene Have certain abnormal lab values History of seizure disorder Have unexplained vaginal bleeding or an abnormal pap smear

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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: 1<br> | Drug: Arzoxifene<br>* 20 mg, oral, tablet, once a day for 52 weeks<br>* Other names: LY353381;|
| Active Comparator: 2<br> | Drug: Raloxifene<br>* 60 mg, oral, tablet, once a day for 52 weeks<br>* Other names: Evista;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Lumbar Spine BMD |  | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary BMD measures of total hip and femoral neck |  | at 6 and 12 months | 
| Biochemical markers of bone metabolism assessed |  | baseline, 3, 6, and 12 months | 
| Assessment of coagulation parameters |  | baseline, 3, 6, and 12 months | 
| Breast Density by mammogram |  | screening and 12 months |
Interstage Assessment of Remnant Liver Function in ALPPS

Study Overview
=================
Brief Summary
-----------------
Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons. When size of the future liver remnant (FLR) is regarded to be not sufficient to sustain post-hepatectomy liver function, techniques as preoperative portal vein embolization or two-stage hepatectomy/associating liver partition and portal vein ligation (ALPPS) can be performed. ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ liver splitting. To date, feasibility of the second stage of ALPPS has been assessed only on the basis of standardized future liver remnant or future liver remnant on body weight. However, decrease of liver function between stages, measured by means of laboratory parameters, has been demonstrated to be associated with higher 90-day mortality, regardless of FLR volume. In other words, this volumetric increase may not reflect the increase of liver function.

Detailed Description
-----------------
The aim of this study is to determine the predictive value of hepatobiliary scintigraphy with 99mTc-mebrofenin between stages in ALPPS, in assessing risk of postoperative liver failure and liver failure-related mortality after completion of stage 2.

Official Title
-----------------
Interstage Assessment of Remnant Liver Function in ALPPS: Can SPECT Hepatobiliary Scintigraphy Provide Any Additional Value in Predicting Risk of Posthepatectomy Liver Failure?

Conditions
-----------------
Liver Failure

Intervention / Treatment
-----------------
* Procedure: hepatobiliary scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery Aged ≥18 Exclusion Criteria: Known allergy to Hida derivatives

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 |
| --- |
|Procedure: hepatobiliary scintigraphy|99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography (SPECT)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| posthepatectomy liver failure |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posthepatectomy liver failure, ALPPS, hepatobiliary scintigraphy, SPECT, mebrofenin
Brief Intervention for Justice-Involved Substance Users

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.

Official Title
-----------------
Brief Intervention for Justice-Involved Substance Users: Moderators and Mechanisms of Change

Conditions
-----------------
Substance Use, Violence

Intervention / Treatment
-----------------
* Behavioral: BMI
* Behavioral: Stadard Care (SC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In Monroe County Pretrial Services Program 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Motivational Intervention (BMI)<br> | Behavioral: BMI<br>* Four 45-minute, brief motivational sessions for substance use<br>Behavioral: Stadard Care (SC)<br>* Standard procedures at pretrial program + assessement<br>|
| Active Comparator: Standard Care (SC)<br> | Behavioral: Stadard Care (SC)<br>* Standard procedures at pretrial program + assessement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Days Abstinent | Percent Days not using alcohol or drugs | 6 months | 
| Substance Use Consequences | Short Inventory of Problems with Alcohol or Drugs (SIP-AD) will be used to determine extent of drug use consequences. 15 items (0-15) - higher = more problems | 6 months | 
| Violent Charges | Number of violent charges during follow-up from Statewide Database | 2 years |
3D Cine Cardiovascular Magnetic Resonance

Study Overview
=================
Brief Summary
-----------------
Conventional CMR is based on breath-hold 2D cine image acquisitions which are sequentially acquired in different imaging planes. The necessity of precisely planning and then acquiring multiple 2D imaging planes during breath-hold is relatively inefficient and leads to CMR exam times of ≤60 minutes. However, some patients are too ill or young to hold their breath. Furthermore, 2D images sometimes fail to provide a complete picture of complex 3D anatomy of patients with complex morphology. To address these limitations, we have recently developed a 3D cine (3 spatial dimensions plus time) CMR technique. Rather than acquiring 2D cine images in multiple orientations during breath-hold, this approach allows one to acquire a free-breathing 3D block of data for each phase of cardiac cycle that can be reformatted offline into the desired views without adding to the exam time. This added efficiency should lead to a reduction in CMR exam time, increasing patient comfort, and making CMR exam easy and available for all. In addition, the 3D nature of the data may yield more complete information about the anatomy and physiology. In this proposal, we will examine the agreement between the 2D cine and 3D cine CMR techniques with regard to left and right ventricular volumes and systemic and pulmonary blood flow circulation. The internal consistency of the measurements between the 2 techniques will be also investigated. This study will focus on children because they may benefit the most from the short, improved efficiency, and free-breathing CMR exams.

Official Title
-----------------
Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Cardiovascular Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are greater than 40 kg and are referred for a clinically indicated 2D CMR exam with a gadolinium-based contrast agent. Informed consent/assent will be obtained. Exclusion Criteria: Patients who are under anesthesia, sedated, or with a contraindication to CMR exams.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with congenital heart disease<br>Patients with congenital heart disease who are greater than 40 kg and are referred for a clinically indicated 2D CMR exam with a gadolinium-based contrast agent. | Other: Cardiovascular Magnetic Resonance Imaging<br>* Cardiovascular Magnetic Resonance Imaging or MRI exam from children's with congenital heart disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-diastolic and end-systolic volumes of right and left ventricles |  | 1 day |
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description
-----------------
A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Official Title
-----------------
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine，Capecitabine
* Drug: Gemcitabine, Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18-70 years old ECOG 0-1 Expected lifetime more than 12 weeks Exclusion Criteria: Pregnancy Brain Metastasis, Severe Infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine，Capecitabine<br>Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14 | Drug: Gemcitabine，Capecitabine<br>* Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14<br>|
| Active Comparator: Gemcitabine, Carboplatin<br>Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8 | Drug: Gemcitabine, Carboplatin<br>* Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RECIST 1.1 |  | -7 days |
Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children. The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.

Official Title
-----------------
Early Use of Insulin Glargine in Diabetic Ketoacidosis

Conditions
-----------------
Diabetic Ketoacidosis

Intervention / Treatment
-----------------
* Drug: glargine
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with: Established history of insulin dependent diabetes AND: Chief c/o hyperglycemia or vomiting Venous pH < 7.24 Serum Bicarbonate < 18 Blood glucose > 150 Urinary Ketones Exclusion Criteria: Age < 6y.o. New onset diabetes Received IV insulin bolus prior to arrival to VCH Emergency Room (ER) Venous pH > 7.24 Serum Bicarbonate > 18 Pregnancy Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glargine<br>0.3u/kg of glargine, subcutaneously, once | Drug: glargine<br>* 0.3u/kg of glargine, subcutaneously, once<br>|
| Placebo Comparator: Placebo<br>0.3u/kg of saline, subcutaneously, once | Drug: saline<br>* 0.3u/kg of saline, subcutaneously, once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Acidosis Correction | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on Insulin Drip | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Minutes | 
| Total Hospital Stay | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, Diabetes, Emergency Care, Endocrinology, Critical Care
Assessment of Developmental Status and Locomotor Balance in Healthy Children.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess developmental milestones and balance in children in Pakistan. We are using Ages and Stages Questionnaire for developmental milestones and Timed up and Go test for balance.

Detailed Description
-----------------
We will visit daycare centers and primary schools to collect data and compare them to cut off values provided in the scale. After scoring each domain, scores will tell whether child needs further investigation or he is healthy.

Official Title
-----------------
Assessment of Developmental Status and Locomotor Balance in Healthy Children. A Normative Study.

Conditions
-----------------
Development, Child

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 months to 5 years of age Families living in urban areas Families with financial stability when the child was growing Exclusion Criteria: Multiple Pregnancies of mother A known history of diabetes of mother Uneducated Mother A known history of psychological problems of parents Impaired Cognition of Children Deafness or Blindness of Children Children with 36 weeks or less gestational periods

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 5 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ages and Stages Questionnaire | It is parent-completed questionnaires for young children. It ranges from age 1 to 60 months and consists of 19 different questionnaires.The questionnaires cover over five different domains: communication, gross motor, fine motor, problem solving and personal social skills.If the child scores below cut off value he needs further medical assessment otherwise he is healthy. Cut off values are different for each domain. | last one week | 
| Timed Up and Go test | Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 2 On the word Go, begin timing. 3 Stop timing after patient sits back down. 4 Record time. Observe the patient's postural stability, gait, stride length, and sway. | last one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balance, developmental milestone, locomotor balance, proprioception, ages and stages questionnaire, timed up and go test