linjc16/ctgov huggingface dataset:
A Meta-analysis of Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease

Study Overview
=================
Brief Summary
-----------------
A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease.

Detailed Description
-----------------
To compare outcomes (death, myocardial infarction, target vessel revascularization) of drug eluting stent versus bare metal stent in saphenous vein graft disease.

Official Title
-----------------
Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis

Conditions
-----------------
Saphenous Vein Graft Disease

Intervention / Treatment
-----------------
* Device: drug eluting stent
* Device: bare metal stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CABG disease randomized studies not randomized studies Exclusion Criteria: studies reporting composite and not single endpoints, duplicate reporting
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cabg disease<br>pts with saphenous vein graft disease | Device: drug eluting stent<br>* pts with cabg disease treated with drug eluting stent<br>* Other names: des;Device: bare metal stent<br>* pts with cabg disease treated with bare metal stent<br>* Other names: bms;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | years depending from studies retrieved | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial infarction |  | years depending from study retrieved | 
| target vessel revascularization |  | years depending from study retrieved | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saphenous vein graft, stent
Relation Between Complication in Repeated Cesarean Sections, Newborn Outcome and Surgical Characteristics and Maternal Information

Study Overview
=================
Brief Summary
-----------------
To examine the relation between complication in Repeated Cesarean Sections and Newborn Outcome compared to number of repeated cesarean section and reasonf or surgery and personal medical information to the mother

Official Title
-----------------
Relation Between Complication in Repeated Cesarean Sections Compared With Newborn Outcome,Surgical Characteristics and Maternal Information

Conditions
-----------------
Women Who Had at Lease One Cesarean Section in the Past

Intervention / Treatment
-----------------
* Other: compare complication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who had at least one cesarean section - Exclusion Criteria: women that this was their first cesarean section -

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| previous 1<br>women who have had in their past one cesarean section | Other: compare complication<br> <br> |
| previous 2<br>women who have had in their past 2 cesarean sections | Other: compare complication<br> <br> |
| previous 3<br>women who have had in their past 3 cesarean sections | Other: compare complication<br> <br> |
| previous 4<br>women who have had in their past 4 cesarean sections | Other: compare complication<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complication compared to number of repeated cesarean sections |  | during the surgery |
A Study on Rheumatoid Arthritis Patients Treated With Rituximab

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to obtain an overall picture of rituximab treatments and treatment responses in RA patients.

Official Title
-----------------
Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.

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

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis (RA) patients treated with rituximab in Finland Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with rheumatoid arthritis<br>Patients with rheumatoid arthritis receiving rituximab will be observed for treatment responses. | Drug: Rituximab<br>* This is an observational study. Patients with rheumatoid arthritis and having received treatment previously will be assessed for the treatment responses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information on previous RA treatments |  | 3 months | 
| Information on rituximab treatment responses |  | 3 months | 
| Information on concomitant medications |  | 3 months |
Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

Study Overview
=================
Brief Summary
-----------------
To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.

Official Title
-----------------
Long-term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Drug: Cetirizine Dry Syrup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic urticaria Eczema & dermatitis group Atopic dermatitis Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous Giving informed consent Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary. Children with a pruritus severity of 2.Mild or severer on the first day of the treatment period. Exclusion criteria: have a history of drug hypersensitivity are pregnant, lactating or possibly pregnant female children. have asthma that requires the treatment with corticosteroid. cannot avoid the use of external steroid classified into strong, strongest or very strong. have pruritus only on face and head. have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug. are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetirizine Dry Syrup|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cetirizine, various type of cutaneous disease accompanied with Pruritus, pediatrics
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare cardiac MRI with positron emission tomography (PET) with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better, than PET with FDG.

Official Title
-----------------
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PET-FDG ordered to assess myocardial viability Exclusion Criteria: Contraindicated for MRI Pregnant Age <25 yrs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI |  | time of initial scans | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare size of regions of viable and non viable myocardium as % left ventricle by MRI vs. PET |  | at time of initial scans | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD
Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.

Official Title
-----------------
Sedation and Analgesia in Intensive Care: Comparison of Morphine and Fentanyl/Midazolam

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Drug: Morphine infusion
* Drug: Fentanyl and Midazolam infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults admitted to ICU requiring mechanical ventilation Informed consent Exclusion Criteria: Less than 18 years old Consent denial

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br> | Drug: Morphine infusion<br>* Conventional dose<br>|
| Active Comparator: Fentanyl and Midazolam<br>Control | Drug: Fentanyl and Midazolam infusion<br>* Conventional dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from sedation discontinuation to first T-Tube time from sedation |  | 12-120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from sedation discontinuation to extubation time from sedation |  | 12-180 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, critical care, morphine, fentanyl, analgesic based sedation
Intratympanic Steroids for Sudden Hearing Loss

Study Overview
=================
Brief Summary
-----------------
For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.

Official Title
-----------------
Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study

Conditions
-----------------
Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid

Intervention / Treatment
-----------------
* Drug: Dexamethasone or Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sudden hearing loss and initial treatment is not effective Exclusion Criteria: the patients refused intratympanic steroids 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br> | Drug: Dexamethasone or Methylprednisolone<br>* steroids<br>|
| Active Comparator: Methylprednisolone<br> | Drug: Dexamethasone or Methylprednisolone<br>* steroids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hearing | the hearing level after treatment | six month |
Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

Official Title
-----------------
Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: mitoxantrone - immunomodulator
* Other: natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with remitting multiple sclerosis according to mac Donald criteria aggressive remitting multiple sclerosis according to following criteria: 2 or less disabling relapse during the 12 months before inclusion 1 or more EDSS between 2 and 5 aged less or equal to 40 years old for the women effective contraception Exclusion Criteria: patients less than 18 years old

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mitoxantrone followed by immunomodulator<br> | Other: mitoxantrone - immunomodulator<br>* mitoxantrone during 6 months and followed by immunomodulator during 2 years and half<br>|
| Active Comparator: natalizumab<br> | Other: natalizumab<br>* monthly natalizumab during 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost effectiveness |  | 30 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progressive neurological disability |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reemitting aggressive multiple sclerosis
Anterior Gen Plus Study

Study Overview
=================
Brief Summary
-----------------
A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion.

Detailed Description
-----------------
A prospective, single-center, clinical study evaluating patients undergoing primary, contiguous 2-level ALIF without supplemental fixation treated with Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM).

Official Title
-----------------
The Anterior Gen Plus Study

Conditions
-----------------
Spine Fusion

Intervention / Treatment
-----------------
* Procedure: Anterior Lumbar Interbody Fusion (ALIF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Requires anterior lumbar interbody (ALIF) fusion Are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions Willing and able to sign study specific Informed Consent Form Exclusion Criteria: Signs of acute infection Active malignancy and/or current chemotherapy Prior fusion at operative or adjacent level Institutionalized or a prisoner Documented history of alcohol or drug abuse Undergoing a worker's compensation case Pregnancy Participation in another research study involving another implant or drug that may affect the outcomes of this clinical study Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Demineralized Bone Matrix (DBM)<br>All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Study Implant (one-level) implanted with Demineralized Bone Matrix (DBM). | Procedure: Anterior Lumbar Interbody Fusion (ALIF)<br>* Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)<br>|
| Active Comparator: Cellular Bone Matrix (CBM)<br>All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM). | Procedure: Anterior Lumbar Interbody Fusion (ALIF)<br>* Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fusion for the DBM versus CBM cohorts | Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events (SAEs) | SAEs at 24 months | 24 Months |
Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.

Detailed Description
-----------------
Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.

Official Title
-----------------
Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Procedure: euglycemic and hypoglycemic clamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non obese (BMI <30), ages 18-50 Exclusion Criteria: renal or hepatic failure cancer or lymphoma malabsorption or malnourishment hypercortisolism alcoholism or drug abuse anemia eating disorder or depression coronary artery disease Arrhythmias hypertension on medications known to affect the blood glucose to be measured such as glucocorticoids on blood thinning agents Pregnant women, breastfeeding women and women who want to become pregnant in the next 6 months will be excluded from the study. Subjects who have donated blood two weeks prior to the study. Allergies to pig derived products (Heparin will be used)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Euglycemic and hypoglycemic clamp<br>Subjects will complete clamp study visit. | Procedure: euglycemic and hypoglycemic clamp<br>* Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.<br>* Other names: clamp;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function correlation to blood or interstitial glucose | This investigator initiated study will evaluate cognitive function at the onset, during and following recovery from hypoglycemia and will determine if cognitive function correlates better with blood or interstitial glucose concentrations. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoglycemia, cognitive function