linjc16/ctgov huggingface dataset:
A Clinical Study to Assess the Efficacy and Safety of DA-3002

Study Overview
=================
Brief Summary
-----------------
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Official Title
-----------------
Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome

Conditions
-----------------
Turner's Syndrome

Intervention / Treatment
-----------------
* Drug: DA-3002
* Drug: Genotropin®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Turner's Syndrome through chromosome analysis The chronological age: 2≤AGE≤12 The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates Before the adolescence, Tuner stage I (breast) Normal thyroid function Exclusion Criteria: Growth hormone was administered for 12 months or longer in the past Treated with estrogen or adrenal androgens for 12 months or longer in the past Malignancy, CNS Trauma, Psychiatric Disorder

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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 |
| --- | --- |
| Experimental: DA-3002<br>0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas | Drug: DA-3002<br> <br> |
| Active Comparator: Genotropin®<br>0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas | Drug: Genotropin®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized height velocity(cm/year) after 52 weeks | Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in height standard deviation score after 52 weeks |  | 52 weeks | 
| Changes in bone maturation(changes in bone ages/changes in chronological age) |  | 52 weeks | 
| Changes in IGF-1 |  | 52 weeks | 
| Changes in IGFBP-3 |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turner's Syndrome, Short Stature, Dwarfism
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps

Study Overview
=================
Brief Summary
-----------------
Neurologically-impaired individuals may have significant neurologic morbidity related to epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and potentially reversing the epileptogenic process, is of paramount importance in improving the lives of those with epilepsy.

Official Title
-----------------
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps

Conditions
-----------------
Seizures, Epilepsy

Intervention / Treatment
-----------------
* Other: Music Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Thad E. Saleeby Center Epilepsy or seizure disorder At least one year of detailed seizure reporting prior to study starting date Exclusion Criteria: Severe hearing impairment

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 90 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 |
| --- | --- |
| No Intervention: Control group - No Music Exposure<br>Subjects that were assigned to the control group of the study were not exposed to music. | |
| Experimental: Music Exposure<br>The treatment subjects were randomly assigned to receive nightly exposure to music at periodic intervals between the hours of 9:00 PM and 8:00 AM. | Other: Music Exposure<br>* Twenty-seven subjects were randomly assigned to receive nightly exposure to music at periodic intervals between the hours of 9:00 PM and 8:00 AM.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure rates | Main Outcome Measure: The effect of exposure to the auditory stimulus on seizure frequency. Changes in seizure rates from baseline to treatment years were determined and statistically compared within the treatment and control groups, as well as between the groups to assess efficacy of treatment. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizures, Epilepsy, Auditory Stimulation, Music
Assessment of the Disease Severity and Treatment Patterns of Rheumatoid Arthritis in Eastern Europe, Middle East and North African Countries (P08167)

Study Overview
=================
Brief Summary
-----------------
The study will assess the disease severity and treatment patterns of rheumatoid arthritis in Eastern European, Middle Eastern, and North African countries.

Official Title
-----------------
Cross-sectional Study of Disease Severity and Treatment Patterns of Rheumatoid Arthritis, in Eastern Europe Middle East and North Africa

Conditions
-----------------
Arthritis, Rheumatoid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Confirmed diagnosis of rheumatoid arthritis, preferably based upon criteria established by the American College of Rheumatology (ACR) 1987 clinical signs & symptoms data obtained from previous laboratory and instrumental examination, which may include but is not limited to: Radiography, Blood tests Written informed consent, signed before participation in the study. Exclusion Criteria : Refusal to participate in the study Age under 18 years

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 |
| --- | --- |
| All Participants<br>Adults with a confirmed diagnosis of rheumatoid arthritis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with low, moderate, or high disease activity as assessed by the Disease Activity Score using 28 joint counts (DAS28) |  | Day of enrollment (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with rheumatoid arthritis visiting participating sites in the course of one year |  | One year | 
| Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ). |  | Day of enrollment (Day 0) | 
| Number of participants treated with non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDS), corticosteroids, and/or biologics |  | Day of enrollment (Day 0) |
Differential Diagnosis of STA-PSV in Thyrotoxicosis

Study Overview
=================
Brief Summary
-----------------
Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake is limited for its availability in china and easily influenced by medicine or food contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily varied by operator subjective judgement. This study is focus on the role of peak systolic velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods: Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below the low value of normal range. Graves disease is defined as the typical symptoms of graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver operator curve(ROC) to evaluate its diagnosis value

Official Title
-----------------
Differential Diagnosis Value of Peak Systolic Velocity of Thyroid Superior Artery Using Color Flow Doppler Sonography in Transient Thyrotoxicosis Caused by Thyroiditis and Graves Disease

Conditions
-----------------
Thyrotoxicosis, Peak Systolic Velocity of Superior Thyroid Artery, Thyroiditis, Graves Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range is willing to be enrolled Exclusion Criteria: unwilling taking antithyroid drug or beta receptor blocker taking foods or medicine rich in iodine in 8 weeks women with pregnant or lactation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| mean STA-PSV | the mean STA-PSV | 2014-04-07 | 
| uptake of iodine |  | December 1, 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSV |  | December 1, 2013 |
Immune Suppression Of Infants Treated With Steroids

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas.

Detailed Description
-----------------
Infants with large or complicated hemangiomas are often treated systemically with oral steroids. The side effects of the drug on young infants has not been studied. The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas. Prednisone will be started according to established standard of care. Visits will occur every four weeks for follow-up. There will be six blood draws from baseline to completion of study. Approximately up to 1 ½ teaspoons per blood sample will be drawn to test the strength of the infant's immune system. Participation in this study will last up to 14 months or until stabilization of the hemangioma. Evaluation will occur 12 weeks after discontinuing the steroid for its long-term effects on the immune system.

Official Title
-----------------
Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study

Conditions
-----------------
Hemangioma

Intervention / Treatment
-----------------
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants < 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids Infant must be enrolled prior to initiation of steroid therapy Exclusion Criteria: Infants > 6 months of age Infants already receiving oral corticosteroid treatment prior to the start of this study Infants with know immunodeficiencies Infants receiving other oral medications for the treatment of hemangiomas

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infantile Hemangioma Patients<br>Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions. | Drug: Prednisolone<br>* Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.<br>* Other names: steroid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) | Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemangioma, Corticosteroid, Prednisone
5HT3 Antagonism and Auditory Gating in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The target groups in this study are brain waves and neurotransmitters (chemical messengers) in the brain. Subjects with diagnosed with schizophrenia will be studied. The study will help understand more about normal brain functioning and how that functioning differs in people with schizophrenia. Another purpose of this study is to determine how the altered brain functioning in schizophrenia contributes the symptoms found in the illness.

Official Title
-----------------
5HT3 Antagonism and Auditory Gating in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: ondansetron
* Behavioral: neuropsychological testing
* Drug: nicotine
* Drug: haloperidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with diagnosed with schizophrenia will be studied.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Intervention/Treatment |
| --- |
|Drug: ondansetron|nan|
|Behavioral: neuropsychological testing|nan|
|Drug: nicotine|nan|
|Drug: haloperidol|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
-----------------
schizophrenia, ondansetron, nicotine, haloperidol
Study of the Expression of Heat Shock Proteins in Populations of B Lymphocytes in Human Tonsils

Study Overview
=================
Brief Summary
-----------------
It has recently been shown that various HSPs are strongly expressed in B lymphomas. Indeed, HSP90 stabilizes the protein Bcl-6 in diffuse large-cell B lymphomas. Pharmacological inhibition of HSP90 in vitro induced apoptosis in lymphoma cells (Cerchietti et al. Nat. Medicine, 2009, 1369-1376). In addition, HSP110 is strongly expressed in non-Hodgkin lymphomas, and targeting this HSP at the cell surface using specific antibodies could constitute a future therapy (Zappasodi et al. Blood, 2011, 4421-4430). Despite the importance of these proteins in the development of lymphomas, their expression and their role in the activation of normal B lymphocytes and the normal development of germinal centres is not known. The expression of Heat shock proteins should vary among the different B lymphocyte populations present in the tonsils (naïve B cells, memory B cells, germinal centre B cells). The aim of this study is to establish an expression profile for heat shock proteins in populations of B lymphocytes in human tonsils

Official Title
-----------------
Single-centre Study of the Expression of Heat Shock Proteins in the Lymphocytes From the Tonsils of Patients With Various Diseases Requiring Tonsillectomy

Conditions
-----------------
Tonsillectomy

Intervention / Treatment
-----------------
* Procedure: tonsillectomy
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who have provided oral consent Tonsillectomy in children or adults Exclusion Criteria: Persons without national health insurance cover Adults under guardianship Pregnant or breast-feeding women Persons with positive HIV or HCV serology
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient<br> | Procedure: tonsillectomy<br> <br> Biological: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of heat shock proteins |  | Day one |
Paracervical Block During Office Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.

Official Title
-----------------
Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial

Conditions
-----------------
Paracervical Block

Intervention / Treatment
-----------------
* Drug: Lidocaine paracervical block
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women eligible and scheduled for office hysteroscopic placement of essure devices Exclusion Criteria: Planned secondary procedures Lidocaine allergy Repeat procedures

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine paracervical block<br>5cc 1% lidocaine injection in each paracervical region | Drug: Lidocaine paracervical block<br>* 5cc 1% lidocaine injection in each paracervical region<br>|
| Placebo Comparator: Saline placebo injection<br>5cc Normal Saline injection in each paracervical region | Drug: Normal Saline<br>* 5cc Normal Saline injection in each paracervical region<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. | This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation. | During Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysteroscopy, Pain medication, Lidocaine, Office Procedures
Heart Valve Prosthesis-Patient Mismatch

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.

Detailed Description
-----------------
Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch. The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis. Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension. Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases. However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical course of this condition.

Official Title
-----------------
Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement

Conditions
-----------------
Heart Valve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years with a clinical condition of mitral valve prosthesis Exclusion Criteria: Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve) Concomitant aortic valve prosthesis and tricuspid valve prosthesis Presence of > +2 aortic valve regurgitation and/or mild aortic stenosis Prosthetic mitral valve replacement operation < 6 months Left ventricular ejection fraction < 50% Chronic obstructive pulmonary disease Concomitant hypertrophic cardiomyopathy, atrial septal defect Patients with poor ehocardiographic window

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A1<br>Patients with prosthesis-patient mismatch after mitral valve replacement | |
| A2<br>Patients without prosthesis mismatch after mitral valve replacement | |

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
-----------------
Heart valve prosthesis