linjc16/ctgov huggingface dataset:
Long-Term Study of Cerebral Glucose Metabolism in Huntington's Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Correlate clinical outcome with cerebral glucose metabolism in patients with Huntington's disease (HD) and their at-risk relatives. II. Evaluate the efficacy of cerebral glucose metabolism in observing the pathophysiologic development of HD, monitoring responses to experimental therapy, and predicting HD genotype. III. Identify, define, and describe the natural history of pathophysiologic lesions in HD. IV. Characterize the genotypic and phenotypic expression of the HD gene.

Detailed Description
-----------------
PROTOCOL OUTLINE: Participants are screened for Huntington's disease, including cerebral glucose metabolism assessment and genetic testing. Studies include a detailed family history and neurologic, psychometric, and neurobehavioral evaluations. Imaging includes positron emission tomography with fluorodeoxyglucose and brain magnetic resonance imaging. A genotype assessment is performed; genetic results are not disclosed to patients or relatives.

Conditions
-----------------
Huntington's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented family history of Huntington's disease (HD) Symptomatic HD: chorea required At-risk for HD: no detectable systemic or oculomotor abnormality Age-matched control subjects No history of inherited neurological disease No general or neurologic abnormality --Prior/Concurrent Therapy-- At least 4 weeks since other HD treatment, e.g.: Haloperidol Benzodiazepine Other tranquilizers or neuroleptics --Patient Characteristics-- No pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Huntington's disease, neurologic and psychiatric disorders, rare disease
To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

Detailed Description
-----------------
The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.

Official Title
-----------------
Safety and Tolerability Study of Sublingual Lobeline

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lobeline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals with a body mass index between 18 and 30. Willing and able to give written consent. Must have a negative drug test Females must have a negative pregnancy test prior to study drug administration Must have no medical contraindications as determined by routine testing Exclusion Criteria: Please contact the site for more information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lobeline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.

Official Title
-----------------
Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Dietary Supplement: Leucine supplements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: compensated liver cirrhosis. Exclusion Criteria: hepatocellular carcinoma, active alcoholism (less than 1 year), decompensated cirrhosis, variceal bleeding less than 3 months, contraindication for exercise.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise + Leucine<br>Patients will receive leucine 10 g/d po + exercise for 3 months | Dietary Supplement: Leucine supplements<br>* leucine supplements<br>* Other names: No other names;|
| Active Comparator: Leucine without exercise<br>patients will receive leucine 10 g/d po | Dietary Supplement: Leucine supplements<br>* leucine supplements<br>* Other names: No other names;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glutamine synthetase activity |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhosis, exercise, leucin, glutamine synthetase
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Detailed Description
-----------------
This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.

Official Title
-----------------
Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Drug: 3 cycles chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System. Received enucleation in the study eye. Monocular retinoblastoma. Exclusion Criteria: Any previous disease in the study eye. Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals). History of chemical intervention for retinoblastoma in the study eye.
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: 3 cycles chemotherapy<br>Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months. | Drug: 3 cycles chemotherapy<br>* Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.<br>* Other names: vincristine, carboplatin, etoposide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | measure the disease-free survival rate at five years | five years |
Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports have shown that metformin can induce TSH suppression without change in T3 and T4 concentration. The purpose of this study was to prescribe metformin as additional drug to levothyroxin in order to decrease levothyroxine dosage.

Conditions
-----------------
Malignant Neoplasm of Thyroid Stage I, Malignant Neoplasm of Thyroid Stage II

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: papillary or follicular thyroid cancer stage 1 or 2 according to TNM system version 6 surgery and radioiodine treatment levothyroxine suppression treatment Exclusion Criteria: cardiopulmonary failure liver failure renal failure pregnancy drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin<br>patients who receive metformin in addition to levothyroxine | Drug: Metformin<br>* in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.<br>|
| Placebo Comparator: levothyroxine<br>patients who receive only levothyroxine | Drug: Metformin<br>* in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSH |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freeT3,freeT4 |  | 3months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
differentiated thyroid cancer, THS suppression, metformin
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

Study Overview
=================
Brief Summary
-----------------
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.

Official Title
-----------------
A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: MnB vaccine rLP8026
* Biological: MnB vaccine rLP8026
* Biological: MnB vaccine rLP8026


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Aged 18- to 36-months Healthy male or female subjects Exclusion Criteria Prior vaccination with a serogroup B meningococcal vaccine Prior history of any invasive meningococcal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

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

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

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 |
| --- | --- |
| Experimental: Cohort 1<br>Experimental (20ug); Active Comparator/Placebo | Biological: MnB vaccine rLP8026<br>* MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)<br>|
| Experimental: Cohort 2<br>Experimental (60ug); Active Comparator/Placebo | Biological: MnB vaccine rLP8026<br>* MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)<br>|
| Experimental: Cohort 3<br>Experimental (200ug); Active Comparator/Placebo | Biological: MnB vaccine rLP8026<br>* MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months |  | Vaccinations at 0,1,6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toddlers, Vaccine, Safety
Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Study Overview
=================
Brief Summary
-----------------
Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Detailed Description
-----------------
Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.

Official Title
-----------------
Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Conditions
-----------------
Catheterization

Intervention / Treatment
-----------------
* Drug: Chlorhexidine gluconate
* Drug: Transparent Adhesive Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or Females over 18 years of age Patients with an existing, or newly inserted, central venous catheter Patients who require the catheter for at least 3 days Exclusion Criteria: Sensitivity to chlorhexidine

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 |
| --- | --- |
| Placebo Comparator: Transparent Adhesive Dressing<br>Standard of Care Non-Antimicrobial Transparent Adhesive Dressing | Drug: Transparent Adhesive Dressing<br>* Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear<br>* Other names: TAD, Polyurethane Dressing, Transparent Membrane Dressing;|
| Experimental: CHG antimicrobial transparent dressing<br>Chlorhexidine gluconate antimicrobial transparent adhesive dressing | Drug: Chlorhexidine gluconate<br>* 2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear<br>* Other names: 3M(TM) Tegaderm(TM) CHG Dressing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Overall Satisfaction With Catheter Securement | Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor | Daily up to 7 Days (average 3-7 days of wear) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Overall Satisfaction With Dressing | Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor | Daily up to 7 Days (average 3-7 days of wear) | 
| Rating of Skin Condition | Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe) | Daily up to 7 Days (average 3-7 days of wear) |
BLYS and IFN in SLE

Study Overview
=================
Brief Summary
-----------------
This protocol tests whether changes in BLyS or IFN can be detected in a normal immune response to a vaccine and, if so, whether the response differs between those with lupus and healthy controls.

Official Title
-----------------
BLyS and IFN Responses to Antigen Challenge in Human SLE

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Biological: fluzone
* Biological: pneumovax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACR lupus criteria 18<age<65 Exclusion Criteria: chronic infection or cancer pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>SLE | Biological: fluzone<br>* once<br>Biological: pneumovax<br>* once<br>|
| 2<br>healthy controls | Biological: fluzone<br>* once<br>Biological: pneumovax<br>* once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in specific antibodies in response to vaccine |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in BLyS after vaccination |  | 2 weeks | 
| change in IFN after vaccination |  | 2 weeks |
A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

Study Overview
=================
Brief Summary
-----------------
This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.

Official Title
-----------------
The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

Conditions
-----------------
Post Operative Sore Throat

Intervention / Treatment
-----------------
* Drug: dexmedetomidine infusion
* Drug: remifentanil infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status classification I and II Undergoing lumbar spine surgery in prone position Exclusion Criteria: Pre-existing sore throat, hoarseness, or upper respiratory tract infection Allergy to the study drugs Anticipated difficult airways More than two attempts at intubation

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine infusion group<br>dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery | Drug: dexmedetomidine infusion<br>* dexmedetomidine as anaesthetic adjuvant<br>|
| Active Comparator: remifentanil infusion group<br>remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery | Drug: remifentanil infusion<br>* remifentanil as anaesthetic adjuvant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative sore throat at rest | 0=none; 1=occur | 1 hour after surgery | 
| incidence of postoperative sore throat at swallowing | 0=none; 1=occur | 1 hour after surgery | 
| severity of postoperative sore throat at rest | 4-point scale (0=none; 1=mild; 2=moderate; 3=severe) | 1 hour after surgery | 
| severity of postoperative sore throat at swallowing | 4-point scale (0=none; 1=mild; 2=moderate; 3=severe) | 1 hour after surgery |