linjc16/ctgov huggingface dataset:
The Clinical Trial for Primary Chronic Venous Insufficiency

Study Overview
=================
Brief Summary
-----------------
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.

Official Title
-----------------
The Clinical Research of Surgery on Primary Chronic Venous Insufficiency

Conditions
-----------------
Primary Chronic Venous Insufficiency

Intervention / Treatment
-----------------
* Procedure: valve reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCVI patients with III degree back flow in deep vein that is confirmed by color doppler or phlebography Exclusion Criteria: age over 70 years old pregnancy patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reconstruction<br>patients in this group will have both valve reconstruction and superficial vein surgery | Procedure: valve reconstruction<br>* reconstruct valve at the same time of superficial vein surgery<br>|
| No Intervention: unreconstruction<br>patients in this group will only have superficial vein surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical-etiology-anatomic-pathophysiologic classification system |  | 3 month, 1 year, 3 year, 5 year, 7 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phlebography |  | 3 month, 1 year, 3 year, 5 year, 7 year | 
| color doppler |  | 3 month, 1 year, 3 year, 5 year, 7 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Chronic Venous Insufficiency, surgery, reconstruction, valve
Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues. Experimentations are performed on vocal folds biopsies obtained from patients, surgered at ENT department, university hospital of Besançon. After being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.

Official Title
-----------------
Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales

Conditions
-----------------
Laryngeal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient view in ENT department, presenting vocal fold lesion that necessitate biopsy patient informed and with non opposition Exclusion Criteria: small (<1mm) and/or brittle sample Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hyperspectral fluorescence of vocal folds |  | 30 minutes after biopsy |
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.

Detailed Description
-----------------
All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Official Title
-----------------
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital

Conditions
-----------------
Bronchiolitis, Wheezing, Cough

Intervention / Treatment
-----------------
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infant in 3-12 months of age with first episode of wheezing or bronchiolitis written informed consent by parents Exclusion Criteria: Previous wheezing episode or confirmed asthma or bronchiolitis recent bronchodilator use immune deficient immunosuppressive drug use croup or pneumonia diagnosis loss of follow up

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Months

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 |
| --- | --- |
| No Intervention: Control<br>Control group | |
| Experimental: Montelukast<br>4mg Montelukast daily for 2 months | Drug: Montelukast<br>* Montelukast 4mg daily for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Distress Severity Score (RDSS) | RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores | participants will be followed for the duration of hospital stay, an expected average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average number of cough daily= as expressed parents during visits | none= No cough, Mild=less than 10 daily, Severe=More than 10 daily | 6 months | 
| Wheezing severity in the physical examination by physician | None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postbronchiolitis wheezing, Bronchiolitis, Montelukast
Fluid Responsiveness Prediction Using Extra Systoles

Study Overview
=================
Brief Summary
-----------------
Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness The overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: The second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. As such, the post ectopic beat shows how the heart responds to increased filling. Therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness

Official Title
-----------------
Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients

Conditions
-----------------
Fluid Responsiveness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for a 500 ml volume expansion Patients without atrial fibrillation Patients equipped with ECG, arterial pressure and non-invasive cardiac output monitoring Exclusion Criteria: Changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion). Changes in positive end-expiratory pressure the study period Changes in bed positioning the study period Infusion time with crystalloids exceeding 30 minutes Infusion time with colloids exceeding 75 minutes

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Change in stroke volume (SV) following fluid administration. A positive fluid response is defined as a 15% or more increase in SV | A positive fluid response is defined as a 15% or more increase in SV. From the arterial pressure curve, post ectopic changes (comparing with 10 preceding sinus beats) in systolic blood pressure and pre-ejection period will be derived and used to predict the fluid response. Time frame used is the 30 minutes prior to the volume expansion (from t = -30 min to t = 0 min) | Change in SV from immediately before fluid infusion (t=0 min) to immediately after fluid administration (t < 30 min for crystalloid infusions; t < 75 min for colloid infusions) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid responsiveness, Volume responsiveness, Hemodynamics
Postprandial Lipid Metabolism in Patients With Hypertriglyceridemia and Normo-lipidemic Controls: Medium Chain Fatty Acids (MCT) in Comparison to Long-chain, Saturated Fatty Acids (SFA) and Mono-unsaturated Fatty Acids (MUFA)

Study Overview
=================
Brief Summary
-----------------
Postprandial lipid metabolism will be evaluated in patients with hypertriglyceridemia and normo-lipidemic controls; different fats will be used (saturated fatty acids, mon-unsaturated fatty acids and medium chain fatty acids) for the oral fat challenge.

Official Title
-----------------
Postprandial Lipid Metabolism in Patients With Hypertriglyceridemia and Normo-lipidemic Controls: Medium Chain Fatty Acids (MCT) in Comparison to Long-chain, Saturated Fatty Acids (SFA) and Mono-unsaturated Fatty Acids (MUFA)

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Other: MCT
* Other: SFA
* Other: MUFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertriglyceridemia (150 mg/dl-900 mg/dl) Exclusion Criteria: Lipid lowering drugs or indication for Lipid lowering drugs LDL-cholesterol > 190 mg/dl Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCT<br>subjects start with MCT fat load | Other: MCT<br>* patients will receive fat load with MCT<br>Other: SFA<br>* patients will receive fat load with SFA<br>Other: MUFA<br>* patients will receive fat load with MUFA<br>|
| Experimental: SFA<br>subjects start with SFA fat load | Other: MCT<br>* patients will receive fat load with MCT<br>Other: SFA<br>* patients will receive fat load with SFA<br>Other: MUFA<br>* patients will receive fat load with MUFA<br>|
| Experimental: MUFA<br>subjects start with MUFA fat load | Other: MCT<br>* patients will receive fat load with MCT<br>Other: SFA<br>* patients will receive fat load with SFA<br>Other: MUFA<br>* patients will receive fat load with MUFA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial hypertriglyceridemia | area under the curve following oral fat load | 8 hours after fat meal |
Effect of Hand-off Skills Training for Students During the Medicine Clerkship

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of an educational intervention on handoffs implemented during the third year of medical school. It also assesses whether these skills are maintained over time into their fourth year of training and whether there is transfer from the simulated setting into the clinical environment.

Official Title
-----------------
Effect of Hand-off Skills Training for Students During the Medicine Clerkship: A Randomized Study

Conditions
-----------------
Patient Handoff

Intervention / Treatment
-----------------
* Other: Handoff Workshop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Third Year Medicine Clerks Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Students in the intervention group participated in a one-hour interactive, small-group handoff workshop facilitated by a study investigator. The workshop focused on the importance of specific handoff skills to patient safety. | Other: Handoff Workshop<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate workshop effectiveness of students undergoing the intervention, rated before and after the workshop utilizing standardized cases and a validated Handoff Rating Scale. |  | up to 45 minutes post-intervention |
Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL

Study Overview
=================
Brief Summary
-----------------
To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.

Detailed Description
-----------------
The objective of this post approval safety study is to evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to three years post implantation.

Official Title
-----------------
A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL)

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Trulign™ Toric IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are able and willing to comply with the follow-up schedule Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction Subjects must require a lens power from 4 to 33 D Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source Exclusion Criteria: Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery Subjects with associated ocular conditions which could affect the stability of the IOL Subjects with clinically significant irregular corneal astigmatism in the study eye
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trulign™ Toric IOL<br>Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens | Device: Trulign™ Toric IOL<br>* Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically significant IOL vaulting | IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method. | Up to 3 years |
Implantable Cardioverter-Defibrillator Use in the VA System

Study Overview
=================
Brief Summary
-----------------
Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. Based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. In this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.

Official Title
-----------------
Implantable Cardioverter-Defibrillator (ICD) Utilization in a Potentially Eligible VA Population

Conditions
-----------------
Cardiomyopathies

Intervention / Treatment
-----------------
* Behavioral: Clinical Reminder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Meeting published criteria for receipt of an implantable cardioverter defibrillator Exclusion Criteria:provider is not affiliated with the VA health care system

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: Clinical Reminder<br>Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient. | Behavioral: Clinical Reminder<br> <br> |
| No Intervention: Control<br>This group does not receive an intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral for Implantable Cardioverter Defibrillator | Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation. | 6 months |
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis

Study Overview
=================
Brief Summary
-----------------
This 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.

Official Title
-----------------
A Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)

Conditions
-----------------
Secondary Hyperparathyroidism, End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: AMG 073


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 073<br>AMG 073 | Drug: AMG 073<br>* 30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. |  | Efficacy Assessment phase - final 10 weeks of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase |  | Efficacy Assessment phase - final 10 weeks of study | 
| To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase |  | Efficacy Assessment phase - final 10 weeks of study | 
| To evaluate the safety of AMG 073 compared with placebo |  | Entire study - 26 weeks |