linjc16/ctgov huggingface dataset:
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR

Study Overview
=================
Brief Summary
-----------------
The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.

Detailed Description
-----------------
The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.

Official Title
-----------------
Effect of Mild Increase in Folic Acid Intake on the Distribution of Folate Forms in Relation to a Common Polymorphism in One Folate Catabolising Enzyme

Conditions
-----------------
the Effect of MTHFR C677T on Folate Metabolism

Intervention / Treatment
-----------------
* Dietary Supplement: folic acid plus B6 and B12
* Dietary Supplement: folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Age > 65 years. Exclusion Criteria: Renal dysfunction Recent stroke, or coronary event (within the last 3 months) Current cancer treatment Antifolate (e.g. methotrexate) treatment Ileum resection Current B-vitamin supplement Epilepsy medications Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: folic acid plus B6 and B12<br>folic 400 µg plus vitamin B12 plus B6 | Dietary Supplement: folic acid plus B6 and B12<br>* folic acid 400 µg plus vitamin B12 plus B6<br>* Other names: no further names;|
| Placebo Comparator: Folic acid<br>folic acid alone | Dietary Supplement: folic acid<br>* folic acid 400 µg<br>* Other names: folic acid alone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood metabolic markers | we will measure primary folate forms after folic acid supplement | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Folate, MTHFR, Homocysteine
Ultrasound Elastography of Salivary Glands

Study Overview
=================
Brief Summary
-----------------
Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.

Official Title
-----------------
Elastometry of the Salivary Glands in Sicca Syndrome

Conditions
-----------------
sjögren Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female More than 18 years old Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome Consent agreement Exclusion Criteria: No consent agreement No sicca symptoms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| salivary glands elastometry | Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salivary glands, ultrasonography, elastometry, elastography
Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor

Study Overview
=================
Brief Summary
-----------------
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.

Official Title
-----------------
An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 to 75 years (both inclusive) Informed consent obtained after being advised of the nature of the study The subject has Type 1 diabetes (as defined by WHO) for at least 24 months The subject's HbA1c <= 10% Body Mass Index (BMI) <= 35 kg/m2 The subject is treated with continuous subcutaneous insulin infusion for at least 3 month Exclusion Criteria: Subject is actively enrolled in another clinical trial or took part in a study within 30 days Experienced recurrent severe hypoglycaemic unawareness Total daily insulin dose >= 1.4 IU/kg Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration Allergy against insulin Lispro A history of drug or alcohol dependence Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator Uncontrolled hypertension with resting blood pressure over 140/90 mmHg Patient is pregnant, or breast feeding during the period of the study Patient donated blood in the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: algorithm<br> | Procedure: algorithm<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of glucose values obtained every 15 min in predefined glucose ranges |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injected insulin dose |  | 24 hours | 
| Accuracy of the glucose monitoring unit | The absolute and relative difference between glucose monitoring readings and reference values (blood glucose) will be used to determine the accuracy of the monitoring unit | 24 hours |
BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis

Study Overview
=================
Brief Summary
-----------------
Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.

Official Title
-----------------
BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Brush sign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years old hospitalized for cerebral infarction MCA territory MRI within 24hours Sequence of magnetic susceptibility (SWAN) Exclusion Criteria: Incomplete cerebral infarct MRI not possible

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Brush sign|presence of a brush sign in MRI image in acute cerebral ischaemia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autonomy level | measurement of autonomy level by mRS | Month 3 |
Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.

Official Title
-----------------
Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

Conditions
-----------------
Gastreoesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Administration of omeprazole suspension
* Drug: omeprazole administered as a multi-unit-pellet system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children > 15 kg Cerebral palsy and mental retardation with swallowing disorders Presence of gastrostomy tube GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks Informed consent Exclusion Criteria: Treatment with ciclosporine, tacrolimus, mycofenolate Treatment with anticoagulants Infection Recent start of treatment with known inhibitors of the omeprazole-metabolism Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)

Ages Eligible for Study
-----------------
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of omeprazole suspension|nan|
|Drug: omeprazole administered as a multi-unit-pellet system|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (at the end of the treatment period of 14 days) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric pH (at the end of the treatment period of 14 days) |  |  |
Creatine on Bone Mass in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.

Official Title
-----------------
A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopausal Women

Intervention / Treatment
-----------------
* Dietary Supplement: Creatine supplementation
* Dietary Supplement: dextrose (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy postmenopausal women T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD Exclusion Criteria: drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation) low BMI (< 18.5 Kg/m2).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: Creatine supplementation<br> | Dietary Supplement: Creatine supplementation<br>* The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: dextrose (placebo)<br>* The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density (BMD) |  | 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone markers | will include CTX and P1NP | 12 and 24 months | 
| history of falls |  | 24 months | 
| bone microarchitecture |  | 12 and 24 months | 
| muscle function |  | 12 and 24 months | 
| lean mass |  | 12 and 24 months | 
| laboratory parameters |  | 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
creatine supplementation, bone mass, postmenopausal women, muscle function, bone markers
Efficiency of the Super Inductive System in Spasticity Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to see whether a physical therapy program can relieve pain, decrease spasticity and increase muscle contraction force by using the super inductive system (high frequency electromagnetic field). It is a longitudinal, prospective study, of 60 patients with spasticity after stroke. No new treatment method is tested, as the Super inductive system is approved for physical therapy by the Ministry of Health.

Detailed Description
-----------------
The 60 patients will be submitted to 2 treatment groups: 30 patients will receive 10 sessions of the superinductive system on the antagonist muscles, and 30 patients will receive 10 sessions the superinductive system on the agonist and antagonist muscles. All patients will also receive the standard kinetotherapy program for spasticity. The patients will be evaluated at the beginning of the treatment, at 10 days and at 30 days by using the functional MAS index and Barthel index.

Official Title
-----------------
Efficiency of the Super Inductive System in Spasticity Treatment

Conditions
-----------------
Spasticity, Muscle

Intervention / Treatment
-----------------
* Other: Super inductive system (high frequency electromagnetic field)
* Other: Physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spasticity after stroke Exclusion Criteria: spasticity of other causes
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
Interventional Model Description: case-control study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spasticity after stroke 1<br>Physical therapy with super inductive system on the agonist and antagonist muscles | Other: Super inductive system (high frequency electromagnetic field)<br>* Super inductive system (high frequency electromagnetic field)<br>Other: Physical therapy<br>* specific for spasticity<br>|
| Active Comparator: Spasticity after stroke 2<br>Physical therapy with super inductive system on the antagonist muscles | Other: Super inductive system (high frequency electromagnetic field)<br>* Super inductive system (high frequency electromagnetic field)<br>Other: Physical therapy<br>* specific for spasticity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in MAS functional index | upper extremity functional index | day 0, day 10, day 30 | 
| change in Barthel index | measurement of activities of daily living | day 0, day 10, day 30 |
Genetic Linkage Study for Hereditary Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish linkage in families with hereditary pancreatitis (HP) to the cationic trypsinogen gene or other, as yet unknown, HP gene(s).

Detailed Description
-----------------
Hereditary Pancreatitis (HP) is an inflammatory condition of the pancreas which is usually recurrent in nature and occurs in blood-related persons over two or more generations. It is an autosomal dominant trait with complete penetrance by variable expression. Symptoms are usually present during childhood and it is the second most common cause of chronic or recurrent pancreatitis in children. HP is a primary disorder and can therefore be differentiated from other inherited disorders that cause secondary pancreatitis. The purpose of this study is to establish linkage in families with HP between the phenotype and a chromosomal locus (loci) which contains the responsible gene. Affected families are recruited to donate a blood sample through referral from their primary physician or self-referral. The potential significance lies in the identification of the genetic defect causing HP and understanding the pathophysiologic mechanism of the disease. Typically families with HP have a high incidence of adenocarcinoma of the pancreas and identification of the cause of this disease may provide critical insights into the cause of pancreatic cancer. Blood samples are collected from patients and family members. DNA is extracted from the blood and used for genotypic analysis and linkage analysis. Patients do not necessarily receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Official Title
-----------------
Molecular Genetics of Hereditary Pancreatitis

Conditions
-----------------
Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pancreatitis at age < 60 OR Diagnosis of pancreatitis at any age and at least one other 1st or 2nd degree relative with a diagnosis of pancreatitis or pancreatic cancer OR Diagnosis of pancreatic cancer and a 1st or 2nd degree relative with pancreatic cancer or pancreatitis OR Diagnosis of pancreatic insufficiency or maldigestion that improves with pancreatic enzyme replacement OR Close family members (parents, grandparents, siblings cousins - anyone related by blood) of subjects who meet criteria 1, 2, or 3 AND Age 3 months up to 100 years Exclusion Criteria: There are no general exclusions.
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 |
| --- | --- | --- |
Validation of an Instrument to Qualitatively and Quantitatively Profile Hospitalist Workflow

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a simple 'pick-list' menu applied to a handheld computer's time-motion program can be used to record reliably what a hospital-based doctor does while working a shift in the hospital. In this study reliability will be measured by comparing the data collected by at least two different observers recording data from the same hospitalist during the same period of time.

Detailed Description
-----------------
We were unable to configure the software to get started on this study.

Official Title
-----------------
Validation of an Instrument to Qualitatively and Quantitatively Profile Hospitalist Workflow

Conditions
-----------------
Physician Workflow

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a practicing hospitalist, defined as a physician working exclusively in a hospital settings Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elapsed time engaged in specific hospital work activities |  | 1 hospital workday |