linjc16/ctgov huggingface dataset:
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.

Official Title
-----------------
Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis

Conditions
-----------------
Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis

Intervention / Treatment
-----------------
* Drug: tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patient Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: Dermatomyositis group<br>patients with interstitial pneumonia associated with dermatomyositis | Drug: tacrolimus<br>* oral<br>* Other names: Prograf;|
| 2: Polymyositis group<br>patients with interstitial pneumonia associated with polymyositis | Drug: tacrolimus<br>* oral<br>* Other names: Prograf;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory function test value (%FVC, %DLco) | Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO). | Up to three years | 
| Arterial blood gas analysis value (PaO2, AaDO2) | Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference) | Up to three years | 
| Chest CT findings | CT: computed tomography | Up to three years | 
| Serum KL-6 value (serum SP-D value) | KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia | Up to three years | 
| Patient disposition | patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy | Up to three years | 
| Safety assessed by the incidence of adverse events | Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests | Up to three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tacrolimus, interstitial pneumonia, prograf
Levetiracetam for Benign Rolandic Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.

Detailed Description
-----------------
This is a 6 month study in which children on another anticonvulsant would have EEG, language testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would be done after 6 months to evaluate for improvement.

Official Title
-----------------
Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 6-12 Benign rolandic epilepsy Language difficulties as reported by parents or teachers On another anticonvulsant other than levetiracetam Exclusion Criteria: Prior use of levetiracetam On 2 or more anticonvulsants Language problems prior to epilepsy Another seizure disorder Status epilepticus within the past 6 months Significant psychiatric disease Progressive neurologic disease

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language improvement |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure control |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Benign rolandic, Levetiracetam
3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.

Official Title
-----------------
An Analysis of the Clinical Applicability of a Three-Dimensional Imaging Platform Used to Register the Influence of Orthognathic Surgery on Facial Hard and Soft Tissue in Patients With Congenital Maxillofacial Deformities.

Conditions
-----------------
Craniofacial Abnormalities, Maxillofacial Abnormalities, Cleft Lip, Cleft Palate

Intervention / Treatment
-----------------
* Procedure: 3D stereophotogrammetric imaging
* Procedure: 3D CT-imaging with cone-beam CT
* Procedure: Case report form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dysgnathic deformity Caucasian > 15 years No history of orthognathic surgery Informed Consent Exclusion Criteria: < 15 years History of Orthognathic surgery Not Caucasian

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 3D stereophotogrammetric imaging|nan|
|Procedure: 3D CT-imaging with cone-beam CT|nan|
|Procedure: Case report form|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All postoperative changes in functionality at 1 year |  |  | 
| patients' satisfaction of facial proportions at 1 year |  |  | 
| surgeons' satisfaction of the 3D planning platform at 1 month |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D computer assisted imaging, maxillofacial surgery, cephalometry, normative value
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.

Detailed Description
-----------------
The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.

Official Title
-----------------
The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients

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

Intervention / Treatment
-----------------
* Drug: certolizumab pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe RA (DAS > 4.4) at least two swollen and tender joints in one of the hand/ wrist patients must have failed at least one non-biologic or biologic DMARDs currently receiving MTX therapy Exclusion Criteria: concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certolizumab pegol<br> | Drug: certolizumab pegol<br>* 400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks<br>* Other names: Cimzia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline in synovitis and bone edema RAMRIS score. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline in RAMRIS erosion score |  | 16 and 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Certolizumab pegol, Magnetic Resonance Imaging, Rheumatoid Arthritis, RAPID 3
The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
It has been proven in in-vitro studies that dates decrease the oxidative stress in serum. There have been no in-vivo studies to this date. The current study aims to test whether dates consumption by healthy adults decreases serum oxidative stress and improves serum PON1 activity and serum lipid profile.

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: dates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria:

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: dates|5 maedjool dates or 7 emery dates per day for 2 weeks each with a washout period of 2 weeks between|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum oxidative stress |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum lipid profile |  | 30 days |
COVID-19 With Convalescent Plasma

Study Overview
=================
Brief Summary
-----------------
To clarify the effects of convalescent plasma therapy on SARS-CoV-2 negative conversion rate during hospital stay and 28-day mortality of severe and life-threatening COVID-19 patients.

Official Title
-----------------
Efficiency of Convalescent Plasma Therapy in Management of Critically Ill Patients With COVID-19: a Matched Case-control Study

Conditions
-----------------
COVID-19 Convalescent Plasma Treatment

Intervention / Treatment
-----------------
* Biological: convalescent plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age; laboratory-confirmed diagnosis of COVID-19; respiratory failure requiring advanced respiratory support (i.e. high flow nasal cannula[HFNC], noninvasive mechanical ventilation [NIV], and invasive mechanical ventilation [IMV]). Exclusion Criteria: no

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 |
| --- | --- |
| convalescent plasma therapy group<br>the patients received convalescent plasma therapy | Biological: convalescent plasma<br>* convalescent plasma was get from the patients who recovery from COVID-19<br>|
| Control group<br>the patients with similar situation without convalescent plasma therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | the mortality from ICU admission to 28 days after admission | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 negative conversion rate | SARS-CoV-2 viral shedding | up to 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
convalescent plasma therapy, COVID-19, mortality
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

Study Overview
=================
Brief Summary
-----------------
To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Official Title
-----------------
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Xalacom
* Drug: Xalatan
* Drug: Timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xalacom|nan|
|Drug: Xalatan|nan|
|Drug: Timolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean IOP measurements obtained in the study eye at each time point |  |  |
North American Study for the Treatment of Refractory Ascites (NASTRA)

Study Overview
=================
Brief Summary
-----------------
The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.

Official Title
-----------------
The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial

Conditions
-----------------
Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Procedure: Transjugular intrahepatic portasystemic shunts (TIPS)
* Procedure: Total paracentecis (TP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy) Exclusion Criteria: Causes of ascites other than cirrhosis and portal hypertension Terminal liver failure Portal vein thrombosis Congestive heart failure Acute renal failure Active encephalopathy Alcoholic hepatitis Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transjugular intrahepatic portasystemic shunts (TIPS)|nan|
|Procedure: Total paracentecis (TP)|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
-----------------
paracenteses, refractory ascites
Prognosis of Failure Treatment of Amebic Liver Abscess

Study Overview
=================
Brief Summary
-----------------
Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.

Official Title
-----------------
Prognosis Factors of the Response After Medical Treatment of Amebic Liver Abscess

Conditions
-----------------
Amebic Liver Abscess

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess. Both genders Older 15 years Exclusion Criteria: Clinically suspected piogenous liver abscess Positive hemoculture Negative ELISA for amoebic antigens Immunosupresion (HIV) Abdominal or biliary surgery antecedents Abdominal neoplasia antecedents

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Response to medical treatment | |
| 2<br>Failure to medical treatment (surgery or percutaneous resolution) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of medical treatment |  | Day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amebic liver abscess, failure, prognosis
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients

Official Title
-----------------
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging

Conditions
-----------------
Retinoblastoma, Pineoblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of retinoblastoma brain MRI available Exclusion Criteria: insufficient quality of brain MRI

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 50 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 |
| --- | --- |
| Retinoblastoma patients<br>patients with diagnosed retinoblastoma | |
| non-retinoblastoma patients<br>aged matched control cohort without the diagnosis of ocular or brain tumor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignancy criteria of pineal gland | size of pineal gland solid or cystic component (all at baseline) | clinical follow-up 1-year after baseline imaging | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinoblastoma, pineoblastoma