linjc16/ctgov huggingface dataset:
Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.

Official Title
-----------------
Characterisation of Fractionated Electrograms Critical for Maintenance of AF

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with persistent AF listed for first time catheter ablation Exclusion Criteria: age < 18 years pregnancy contraindications to procedure recent myocardial infarction, coronary intervention, or cardiac surgery

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 |
| --- | --- |
| Experimental: Targeting of most fractionated electrograms first<br>During catheter ablation of AF patients will have fractionated electrograms targeted. In the experimental group the fractionated electrograms believed to be most critical will be targeted first. | Procedure: catheter ablation<br>* catheter ablation using radiofrequency energy<br>|
| Active Comparator: Targeting least fractionated electrograms first<br>During catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first. | Procedure: catheter ablation<br>* catheter ablation using radiofrequency energy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in AF cycle length when targeting fractionated electrograms of different morphology. |  | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AF, catheter ablation, fractionated electrogram, complex fractionated atrial electrogram (CFAE)
Fungal Infection After Oral Cavity Surgeries

Study Overview
=================
Brief Summary
-----------------
this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug

Official Title
-----------------
Fungal Infection After Oral Cavity Surgeries

Conditions
-----------------
Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal Drug

Intervention / Treatment
-----------------
* Diagnostic Test: Throat culture for fungal pathogens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Exclusion Criteria: Previous oral cavity surgery. Previous radiotherapy to the head and neck. Previous treatment with antifungal drugs in the 30 days preceding the surgery Immunocompomised state at the date of surgery. Pregnancy Lack of follow-up

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group with antifungal drug<br> | Diagnostic Test: Throat culture for fungal pathogens<br>* Throat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation<br>|
| A control group<br>A control group will be taken ,patients undergoing thyroidectomy or parotidectomy | Diagnostic Test: Throat culture for fungal pathogens<br>* Throat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug. | 40 patients undergoing oral cavity surgery and 40 patients (control group) undergoing thyroidectomy or parotidectomy for our research measurement :Throat culture for fungal pathogens | 2 years |
RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists

Study Overview
=================
Brief Summary
-----------------
This is an observational, ambrispective study of patients in real world clinical practice, who has pulmonary arterial hypertension in whom a prostacyclin IP receptor agonist (Selexipag) is initiated between 2017 and 2021. The aim of this study answer the following questions: Changes in the mortality risk profile of these patients after treatment administration. Baseline characteristics of patients initiating Selexipag. Parameters used for risk stratification prior to treatment escalation. Events during follow-up. No comparison group available

Official Title
-----------------
Real World Andalusian Multicenter Data on Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: No intervention - Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They agree to participate in the study by signing an informed consent form Exclusion Criteria: Decline to participate in the study Patients living 6 months or less in the reference health area Patients with active malignant tumors

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 |
| --- | --- |
| Cohort 1<br>Patients with pulmonary arterial hypertension on treatment with prostacyclin IP receptor agonists because they are at intermediate risk of mortality at one year | Drug: No intervention - Observational study<br>* Real life drug evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement (risk profile) | Percentage of patients reducing annual mortality risk profile according to ESC/ERS Clinical Practice Guidelines 2015 Risk Stratification. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk stratification variables | Percentage of clinical tests that have been used to include study treatment. | Basaline | 
| Events | Incidence of events in follow-up: admission for worsening pulmonary hypertension; need for systemic prostacyclins; unscheduled admission for any cause; death related to pulmonary hypertension; death from any cause. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real World Data, Effectiveness, Pulmonary Arterial Hypertension, Selexipag
Asthma Surveillance and Education in Preschool Settings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of a bilingual intervention in improving asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs.

Detailed Description
-----------------
BACKGROUND: Proposed is a non-randomized, controlled, prospective trial to test the efficacy of a bilingual intervention to improve asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs. Because of high rates of asthma prevalence, subsidized preschool childcare programs offer ideal settings to test innovative strategies to improve asthma care within communities at highest risk of morbidity. DESIGN NARRATIVE: The study will comprise three arms. Arm 1 is surveillance, in which children with asthma are identified. In Arm 2, children with asthma are identified and given written Asthma Action Plans (monitoring). Arm 3 consists of surveillance, monitoring, and education.

Official Title
-----------------
Asthma Surveillance and Education in Preschool Settings

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in specific subsidized preschools in New York City 2.8 to 4 years old Persistent asthma as defined by symptom reports Use of quick-relief agents or controller medications Exclusion Criteria: History of intubation

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 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 |
| --- | --- |
| South Bronx, Harlem, Lower East Side<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
End Button Tenodesis in Failed Developmental Dysplasia of the Hip Surgery

Study Overview
=================
Brief Summary
-----------------
Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia & dislocation

Official Title
-----------------
The Role of End Button Tenodesis in the Management of Failed Developmental Dysplasia of the Hip Surgery

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Procedure: Tenodesis by end button


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient with Developmental dysplasia of the hip (DDH) with : Age: up to 9 years old. Recurrent DDH . Failed open reduction through medial approach in the management of DDH. Traumatic hip dislocation . Exclusion Criteria: • Paralytic hip dislocation . Post septic hip dislocation. Refusal to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- |
| Tenodesis by end button<br>open reduction of the dislocated hip and stabilization by end button | Procedure: Tenodesis by end button<br>* open reduction of the dislocated hip and stabilization by end button<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Harris Hip Score | score for function of the hip | 6 months |
Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology

Study Overview
=================
Brief Summary
-----------------
The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.

Official Title
-----------------
Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology

Conditions
-----------------
Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination. Exclusion Criteria: Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour. Patients who are participating in drug research or other clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Score of glasgow outcome scale in 6 months after shunt operation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure |  | 6 months | 
| Revised coma recovery scale (CRS-R) in 1 week after shunting |  | 1 week | 
| Modified Ashworth Scale (MAS) in 1 week after shunting |  | 1 week | 
| Revised coma recovery scale (CRS-R) in 1 month after shunting |  | 1 month | 
| Modified Ashworth Scale (MAS) in 1 month after shunting |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroelectrophysiology, hydrocephalus, disorder of consciousness
Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life

Study Overview
=================
Brief Summary
-----------------
The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.

Official Title
-----------------
Study to Characterize Patients Treated With Visanne for Their Endometriosis Under Real-life Practice Conditions and Evaluate Their Quality of Life at Baseline and After 6 Months of Treatment With Visanne.

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Visanne (Dienogest, BAY86-5258)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients older than 18 years of age Clinical or laparoscopic diagnosis of endometriosis Having endometriosis related pain as leading symptom Decision taken by physician to prescribe Visanne Signed Informed Consent Form Exclusion Criteria: Contraindications listed in the local summary of product characteristics (SPC) have to be considered.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Visanne (Dienogest, BAY86-5258)<br>* Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients, who show an improvement of the EHP-5 items |  | after 6 months of treatment | 
| Mean changes of EHP-5 items by using scores for pre-defined categories |  | after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne |  | Baseline | 
| Patient reported severity of endometriosis related pain |  | Baseline and after 6 months of treatment | 
| Reasons for treatment discontinuation |  | after 6 months of treatment | 
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | after 6 months of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-interventional study, Endometriosis,, Quality of life
Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care

Study Overview
=================
Brief Summary
-----------------
Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival. The Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.

Official Title
-----------------
Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana

Conditions
-----------------
Neoplasms, HIV, Healthcare Disparity

Intervention / Treatment
-----------------
* Other: Potlako intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Citizen of Botswana Suspected or diagnosed cancer Exclusion Criteria: Involuntary incarceration

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kweneng East District<br>Patient presenting with possible cancer symptoms/sign to a clinic or hospital in Kweneng East District during study period. | Other: Potlako intervention<br>* Multicomponent intervention including: provider training on early detection and diagnostic approaches to cancer patient education on importance of obtaining timely cancer diagnosis provision of a patient navigator to facilitate diagnosis and entry into care provision of transportation support to vulnerable patients<br>|
| No Intervention: All other districts<br>Patient presenting with possible cancer symptoms/sign to a clinic or hospital in all other districts of Botswana (or Kweneng East prior to implementation of intervention). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer stage |  | 1 day visit | 
| Time from initial clinic visit with cancer symptom/sign to entry into oncology care |  | 1 day visit |
Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms

Study Overview
=================
Brief Summary
-----------------
Dry eye syndrome is a benign situation however its impact on patient's quality of live and on health system is not trivial. One problem is the lack of correlation between patient's symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of increased interest in this pathology particularly its frequency. To date no treatment of dry eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals between 2 blinks is not gaussian but exponential. In this study, it is proposed to use modern eye-movement recorder to measure the blink frequency on longer duration (12 minutes) while reading on a screen computer and during a face-to-face interview before and after treatment of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.

Official Title
-----------------
Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms (BOSO)

Conditions
-----------------
Dry Eye Syndromes, Blinking

Intervention / Treatment
-----------------
* Device: Infrared oculography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe dry eye syndrome (Ocular Surface Disease Index> 30) following a meibomian gland dysfunction Not yet properly treated for a meibomian gland dysfunction Exclusion Criteria: History of other ophthalmological or neurological disease Pregnant or breastfeeding women Patient under 18 years old Patient under legal protection

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 |
| --- | --- |
| Dry eye syndrome<br>Meibomian gland dysfunction responsible of moderate to severe dry eye syndrome | Device: Infrared oculography<br>* The infrared oculography provides binocular recordings and allows simultaneous measurement of horizontal and vertical eye movements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration between 2 blinks | Assessment by infrared oculography while the patient is reading on a computer screen and during a face-to-face interview | 2 months after treatment |