linjc16/ctgov huggingface dataset:
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1. Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries. Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).

Official Title
-----------------
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: Fluoride Varnish
* Drug: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent from parents. Child assent High risk of dental caries At least one sound first permanent molar (ICDAS=0) Exclusion Criteria: Bad behaviour Any systemic condition, disability

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 7 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride Varnish each 6 months<br>Fluoride Varnish application every 6 months. | Drug: Fluoride Varnish<br>* Application of fluoride varnish every 3 and 6 months.<br>* Other names: Duraphat (Colgate);|
| Experimental: Fluoride Varnish each 3 months<br>Fluoride Varnish application every 3 months. | Drug: Fluoride Varnish<br>* Application of fluoride varnish every 3 and 6 months.<br>* Other names: Duraphat (Colgate);|
| Active Comparator: Fluoride tooth paste<br>Control group. Twice a day brush with fluoride toothpaste. | Drug: Control Group<br>* Twice a day brush with fluoride toothpaste.<br>* Other names: Colgate Total Toothpaste;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of first permanent molars with caries Lesion (taking into account ICDAS criteria) | We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Caries, Fluoride Varnish, Preschool child, Prevention
Change in MAPSE During Treatment of Sepsis

Study Overview
=================
Brief Summary
-----------------
Patients with bloodstream infections (sepsis) have been found in prior studies to have infection-related heart dysfunction, even if they did not have preexisting heart problems. Factors related to the infection may cause the heart to not pump as well as it should, causing critical illness in the form of low blood pressure (shock) and heart failure. Ultrasound is frequently used in the emergency department to evaluate why a patient might have low blood pressure. Part of that evaluation may include obtaining ultrasound images and making measurements about how well or poorly the heart is pumping. The investigators will evaluate a certain measurement that relates to cardiac function, determine how it changes in patients before and after they are treated for septic shock. This will involve placing an ultrasound probe on the patient's chest, measuring the upward and downward movement of the mitral valve, the mitral annulus systolic plane excursion (MAPSE), and comparing the measurements before and after treatment is started. The investigators are attempting to determine if this measurement improves before and after treatment.

Official Title
-----------------
Evaluation of Mitral Annulus Systolic Plane Excursion (MAPSE) in Emergency Department Patients With Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Treatment of Sepsis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Sepsis or Septic Shock Exclusion Criteria: Age equal to or less than 17 patient in the emergency department Unable to perform POCUS exam due to medical necessity Patients without sepsis unable to obtain consent or have a legal representative consent

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 |
| --- | --- |
| Patients with Sepsis<br>These are patients who present to the emergency department with sepsis. They will have a MAPSE at the time of enrollment and then after initial treatment. | Other: Treatment of Sepsis<br>* Patients will have standard care of sepsis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MAPSE measurement | Does the MAPSE change after treatment of MAPSE | 1 hour after treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POCUS, Emergency Department, echocardiography
Open and Endovascular Surgical Treatment for Artery Injuries

Study Overview
=================
Brief Summary
-----------------
Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.

Official Title
-----------------
Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries

Conditions
-----------------
Artery Injury

Intervention / Treatment
-----------------
* Procedure: Endovascular treatment
* Procedure: Open surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Injuries in the peripheral arteries; Loss of blood supply to the remote area; High-risk emergency artery reconstruction; Participate in the study voluntarily, accept follow up study. - Exclusion Criteria: Bleeding can be easily control; There is contraindications for surgical operation. -
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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovascular treatment<br> | Procedure: Endovascular treatment<br>* The arteries injuries are repaired by endovascular treatment.<br>|
| Active Comparator: Open surgery<br> | Procedure: Open surgery<br>* The arteries injuries are repaired by open surgical operation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year treatment success rate | Treatment success is defined as restored blood flow without clinical complications. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technically success rate of surgery |  | immediately after surgery | 
| Surgery-related complications or death |  | 60 months | 
| Currence of stenosis of target lesion |  | 60 months | 
| Device-related serious adverse events |  | 60 months | 
| Target lesion was treated by interventional or surgical therapy once again |  | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artery Injury, Surgery, Endovascular Repair, Peripheral Arteries
Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion. Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients. the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Interferon-alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high risk t (8; 21) AML molecular relapse after allo-SCT Exclusion Criteria: active graft-versus-host disease uncontrolled severe infection organ function failure

Ages Eligible for Study
-----------------
Maximum Age: 65 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: interferon<br> | Drug: Interferon-alpha<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate | number of participants with morphologic relapse at one year | participants will be followed for an expected average of 365 days |
A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.

Official Title
-----------------
A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: GW810781


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No prior HIV medications. HIV infection with viral load >400-50,000 copies/mL. CD4 cell count >50 cells/mm. Exclusion Criteria: Patients requiring medications that cannot be interrupted for the duration of the study. Abnormal ECG or other chronic health conditions as noted on screening physical exam. Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW810781|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HIV-1 RNA change from baseline by Day 11. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Integrase inhibitors, Monotherapy, HIV-1 infection
Margetuximab Expanded Access Program

Study Overview
=================
Brief Summary
-----------------
The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

Detailed Description
-----------------
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to margetuximab and for MacroGenics to supply margetuximab for single patient use.

Official Title
-----------------
An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients

Conditions
-----------------
HER2-positive Breast Cancer, HER2-positive Carcinoma

Intervention / Treatment
-----------------
* Biological: Margetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MacroGenics may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies. Treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent. Exclusion Criteria:

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Margetuximab|anti-HER2 monoclonal antibody|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.

Official Title
-----------------
The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery

Conditions
-----------------
Apoptosis, Liver Surgery

Intervention / Treatment
-----------------
* Procedure: Liver surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing liver surgery Exclusion Criteria: ASA IV, Cardiovascular diseases

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>1MAC intraoperatively | Procedure: Liver surgery<br>* hepatectomy<br>|
| Active Comparator: desflurane<br>1 MAC intraoperatively | Procedure: Liver surgery<br>* hepatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidotic stress after hepatectomy. | Perioperative liver and renal biopsies and follow up with liver renal function tests plus intraoperative and postoperative cardiovascular monitoring | 5 d postop. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver and renal dysfunction | liver and renal impairment due to ischemic injury | 5 d | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxidotic stress
Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

Study Overview
=================
Brief Summary
-----------------
As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).

Official Title
-----------------
Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

Conditions
-----------------
Myocardial Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine Exclusion Criteria: No consent Mitral valve surgery severe MI / severe mitral narrowing. Absence of POG catheter Urgent surgery Heart transplant / mechanical assistance Classics: minors, pregnant women, guardianship / curatorship / safeguarding,

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 |
| --- | --- | --- |
| Compare the mean values of LAP between the group high filling pressures and the group non-high filling pressures |  | 6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung edema, Myocardial Dysfunction, left ventricular, mitral valve doppler, mitral ring doppler, ultrasound signs
The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.

Detailed Description
-----------------
Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis

Conditions
-----------------
Depression, Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: escitalopram oxalate antidepressant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of multiple sclerosis Having mild to moderate depressive symptoms, with or without emotional lability Experiencing psychological distress Exclusion Criteria: Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis Cognitive impairment The presence of an unstable medical illness that might preclude completion of the 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: escitalopram oxalate antidepressant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo |  |  | 
| Adverse events for both groups will be similar |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression (mild to moderate), Affective symptoms, Emotional lability, Multiple Sclerosis