linjc16/ctgov huggingface dataset:
Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)

Study Overview
=================
Brief Summary
-----------------
This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.

Official Title
-----------------
Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: pegaptanib sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wet AMD, Visual Acuity from 20/320 to 20/40 Exclusion Criteria: Diabetic retinopathy, laser coagulation history

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: pegaptanib sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment. |  |  |
Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage

Study Overview
=================
Brief Summary
-----------------
evaluation of serum CA125 level and yolk sac morphology in women with threatened miscarriage is very important to predict pregnancy outcome

Official Title
-----------------
Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage

Conditions
-----------------
Threatened Miscarriage in First Trimester

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women between 20-40 years. Pregnancy between 6-10 weeks. single intrauterine spontaneous pregnancy. vaginal bleeding or bloody vaginal discharge with or without pelvic pain for patients with threatened miscarriage. Exclusion Criteria: medical disorders with pregnancy. History of recurrent miscarriage. Any maternal disease that would cause an increase in CA125 level. Local gynecological disorders e.g. fibroid. Presence of any uterine malformation. History of congenital abnormalities in previous pregnancy Presence of multiple pregnancy. Presence of anembryonic sac. Absent fetal heart pulsation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Evaluation of serum CA125 | Measuring serum level of CA125 by ELIZA kits. | 6 - 10 weeks | 
| Evaluation of yolk sac morphology | Evaluating yolk sac size and shape by transvaginal ultrasound | 6 - 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow up of participants | measuring fetal heart rate by transvaginal ultrasound. | up to 20 weeks | 
| follow up of participants | measuring crown rump length by transvaginal ultrasound. | up to 20 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CA125, Yolk sac morphology, Threatened miscarriage
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.

Official Title
-----------------
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

Conditions
-----------------
Pneumonia, Community-Acquired

Intervention / Treatment
-----------------
* Drug: Azithromycin SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000). Exclusion Criteria: Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. (Severe assessed by the Severity of underlying diseases and complications of Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft) by the Japan Society of Chemotherapy (1997)).

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is Data Review Committee's Clinical efficacy at Day 8. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Review Committee's clinical efficacy (at Day 15 and 29) Investigator's clinical efficacy (at Day 8, 15 and 29), and the tendency toward clinical improvement (at Day 4) Bacteriological efficacy (at Day 4, 8, 15 and 29) |  |  | 
| Adverse events and safety Laboratory data |  |  |
Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Detailed Description
-----------------
The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Official Title
-----------------
CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence

Conditions
-----------------
Heroin Dependence, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age Exclusion Criteria: Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine/naloxone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Drug use |  |  | 
| Retention |  |  | 
| Opioid withdrawal |  |  | 
| Subjective rating |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependence
Changes After Suprachoroidal Injection.

Study Overview
=================
Brief Summary
-----------------
Changes after suprachoroidal injection are analyzed for statistical analysis.

Detailed Description
-----------------
Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.

Official Title
-----------------
Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.

Conditions
-----------------
Retina; Change, Intraocular Pressure, Cataract, Macular Edema

Intervention / Treatment
-----------------
* Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study. Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies. Exclusion Criteria: Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations. Choroidal neovascularization that require anti-vascular endothelial growth factors. Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Suprachoroidal triamcinolone injection<br>Eyes treated with suprachoroidal injection of triamcinolone acetonide. | Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection<br>* Suprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide.<br>* Other names: SCTA injection;|
| No Intervention: Non-treated eyes<br>Eyes that are receiving no interventions during the study period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in visual acuity | Changes in best corrected visual acuity after injection | Monthly after injection till six months of follow up | 
| Changes in central foveal thickness | Changes in central macular thickness after injection | Monthly after injection till six months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in intraocular pressure | Changes in intraocular pressure after injection | Monthly after injection till six months of follow up | 
| Changes in lens | Cataract progression after injection | Monthly after injection till six months of follow up |
The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

Study Overview
=================
Brief Summary
-----------------
ACE inhibitors have been studied extensively in the treatment of heart failure and have been shown to be beneficial in all its stages. Studies with the use of angiotensin receptor blockers (ARBs) in chronic heart failure have not shown equivalent results. Many patients are on an ARB for a variety of reasons. Some of these may have had cough as a symptom of heart failure and not due to medication side effect. According to guidelines, angiotensin converting enzyme inhibitors (ACEi) are still first-line therapy in the treatment of heart failure. As ACEi have been extensively studied showing improvement in morbidity and mortality all patients should be on this treatment unless absolutely contraindicated.

Official Title
-----------------
The ACEi SwitchBack Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart failure patients who have indications for ACEi but are currently on ARBs with no absolute contraindications to ACEi patients with an ejection fraction of < or = 35% verified in the last 12 months by echo, angio, or nuc med who are NYHA class I to IV and followed in a heart failure clinic for three months on beta-blockers, unless contra-indicated stable on current meds for 3 months (except dose of diuretics) able to give informed consent Exclusion Criteria: documented angioedema/anaphylaxis with prior ACEi use documented worsening renal failure, hyperkalemia, cough and gastrointestinal symptoms that are definitely believed to be due to ACEi potassium >5.0 mmol/L
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 |
| --- | --- | --- |
| proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi | Patients with heart failure who are on ARB who do not clear contra-indication to ACEi will be switched to an ACei. their tolrance to this will be evaluated | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACE inhibitors, ARBs
Cardiac Tumors in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors.

Detailed Description
-----------------
Primary cardiac tumors in children are extremely rare. Benign tumors are typically myxomas, lipomas, and rhabdomyomas, while malignant tumors are typically angiosarcomas and rhabdomyosarcomas. Due to the rarity of these tumors, it is difficult to gather meaningful information regarding their natural history, pathology and treatment. The primary aims are to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors. The secondary aims are to discover patterns and consistencies among primary cardiac tumors and to define the best treatment options for these patients. The study will be conducted through a retrospective chart review of about 70 patients.

Official Title
-----------------
Cardiac Tumors in Children

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the congenital surgery database Children who have been treated for a primary cardiac tumor
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric health, cardiac, cardiac tumor, children
Neurological Features During COVID19

Study Overview
=================
Brief Summary
-----------------
Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

Detailed Description
-----------------
Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.

Official Title
-----------------
Description of neurolOgical Involvement Observed During SARS COV2 Infection

Conditions
-----------------
Encephalitis

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCR SARS COV2 positive or CT Scan Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral. Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection Exclusion Criteria: Contraindication to performing an MRI scan Minor Pregnant woman No follow-up possible at 6 months

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 |
| --- |
|Other: Observation|Observation of recorded neurological signs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary | incidence of objective neurological damage | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary | incidence of clinical neurological damage incidence of radiological neurological damage incidence of neurophysiological neurological damage | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cranial nerves, brainstem, dysautonomia
System for Measuring Non-invasive Blood Flow in the Tracheobronchial Mucosa: Validation of Reproducibility

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the reproducibility of a method of measuring blood flow rates to the tracheo-bronchial mucosa using diluted dimethyl ether as a tracer.

Official Title
-----------------
System for Measuring Non-invasive Blood Flow in the Tracheobronchial Mucosa: Validation of Reproducibility

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

Intervention / Treatment
-----------------
* Biological: Blood flow to the tracheo-bronchial mucosa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan Exclusion Criteria: The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient Patient is pregnant Patient is breast feeding The patient is a smoker The patient has, or has a history of, chronic respiratory insufficiency The patient has a contra-indication for a treatment necessary in this study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>All patients included in this study according to stated inclusion and exclusion criteria. | Biological: Blood flow to the tracheo-bronchial mucosa<br>* Measurement of blood flow to the tracheo-bronchial mucosa via differential absorption of diluted dimethyl ether tracer gas.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reproducibility of two measures of Qaw at a five minute interval | Qaw is the blood flow measured in the tracheobronchial mucosa. Qaw = VDME/(FDME*alpha*10s) where VDME is the volume of dimethyl-ether exhaled (ml), FDME is the mean concentration of dimethyl-ether (%), alpha is the Bunsen coefficient for the dissolution of dimethyl ether in tissues and blood at 37°C (i.e. 9ml/ml). | Five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time necessary to complete one measure of Qaw (minutes) | Qaw = blood flow measured in the tracheobronchial mucosa | Day 1 |