linjc16/ctgov huggingface dataset:
Efficacy of Lutein, Zeaxanthine and Trypan Blue to Stain the Anterior Lens Capsule

Study Overview
=================
Brief Summary
-----------------
Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.

Detailed Description
-----------------
Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract surgery will be selected to participate in this study.

Official Title
-----------------
A Descriptive Study to Evaluate the Efficacy of the Dye Compound of the Combination of Lutein, Zeaxanthin and Trypan Blue to Stain the Anterior Lens Capsule During Cataract Phacoemulsification.

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

Intervention / Treatment
-----------------
* Other: dye of lutein, zeaxanthin, trypan blue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients over 50 years Diagnosis of cataract (nuclear, entumecente, total) Absence of red reflex Indication of cataract surgery Exclusion Criteria Posterior subcapsular cataract Any history of eye disease Glaucoma Eye infection affecting any structure prior ocular Any previous ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dye of lutein, zeaxanthin, trypan blue<br>during the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule | Other: dye of lutein, zeaxanthin, trypan blue<br>* dye composed of lutein, zeaxanthin, trypan blue<br>* Other names: combination of lutein, zeaxanthin, trypan blue;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of the anterior lens capsule after the injection of dye | The visibility of the anterior lens capsule after the injection of dye, should be graduated as Bad OR Fair OR Good OR Fine | during the cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of impregnation of the dye | The degree of impregnation of the anterior lens capsule by the dye should be graduated acording to the following scale:(0)not flushed; (1)stained weakly (light green); (2)moderately stained (medium green); (3)stained intensely (dark green) | during the surgery | 
| usefulness of the dye | the physician should evaluate the usufelness of the dye, according to the following scale: Bad, Fair, Good, Fine | at the end of the cataract surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lutein, zeaxanthin, trypan blue, dye
A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD: Group 1 Patients using Azilect and no other therapy. Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.

Official Title
-----------------
Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: rasagiline mesylate
* Drug: Rasagiline mesylate plus Mirapex
* Drug: Rasagiline mesylate with Levodopa
* Drug: Rasagiline mesylate with Requip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism. Requiring therapy for PD symptom control Azilect monotherapy. Azilect as adjunct therapy.. Exclusion Criteria: Patients previously exposed to Azilect Patients with pheochromocytoma Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rasagiline mesylate<br> | Drug: rasagiline mesylate<br>* Azilect®<br>|
| Experimental: Rasagiline mesylate plus adjunct therapy<br>Rasagiline mesylate with one of three adjunct therapies | Drug: Rasagiline mesylate plus Mirapex<br>* Mirapex, Azilect®<br>Drug: Rasagiline mesylate with Levodopa<br>* Azilect®, Levodopa<br>Drug: Rasagiline mesylate with Requip<br>* Azilect®, Requip<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the earliest scheduled visit of symptomatic effect |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the effectiveness of Azilect in a usual community neurological |  | 8 months |
Intraperitoneal Versus Extraperitoneal Colostomy

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques for construction of terminal iliac fossa colostomies.

Official Title
-----------------
Prospective Randomized Trial of Intraperitoneal Versus Extraperitoneal Techniques for Construction of Terminal Iliac Fossa Colostomies

Conditions
-----------------
Colostomy

Intervention / Treatment
-----------------
* Procedure: intraperitoneal or extraperitoneal colostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: permanent colostomy Exclusion Criteria: none

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: intraperitoneal colostomy<br> | Procedure: intraperitoneal or extraperitoneal colostomy<br>* creation of colostomy<br>|
| Active Comparator: extraperitoneal colostomy<br> | Procedure: intraperitoneal or extraperitoneal colostomy<br>* creation of colostomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parastomal hernia, stoma dysfunction |  | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intra versus extraperitoneal colostomy
Coronary Screening in a High Risk Subset

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that the incidence of coronary heart disease and cardiovascular mortality could be accurately predicted by the presence of coronary calcific deposits detected by cardiac fluoroscopy.

Detailed Description
-----------------
BACKGROUND: Because of its low cost and non-invasive nature, fluoroscopy was thought to be a potentially powerful screening tool for coronary heart disease if its efficiency could be demonstrated. The utility of exercise testing for screening had been limited by its relatively low sensitivity since it could only detect atherosclerotic plaque large enough to significantly impede coronary flow. DESIGN NARRATIVE: Asymptomatic high risk subjects were screened with cardiac fluoroscopy and exercise testing at baseline and followed for six years with annual visits. The sensitivity and specificity of fluoroscopy in relation to the incidence of coronary heart disease and the incidence of cardiovascular mortality was determined and compared at 3.5 and 6 years of follow-up. The predictive utility of fluoroscopy and exercise testing, in relation to the incidence of coronary events, was assessed by logistic regression analysis. Multivariate analysis was also performed on baseline risk factors. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Comparison of Two Treatment Strategies in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.

Official Title
-----------------
A 8-week Comparison, in a General Practice Setting, Between Two Treatment Strategies With Valsartan and Valsartan/HCTZ Aiming at Normalizing de Novo Hypertensive Patients Who Are Not Adequately Controlled With Their Monotherapy or Biotherapy Treatment or Experiencing Unacceptable Side-effects, According to Their Baseline Blood Pressure

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Medical education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Male or female patients >18 years of age Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects, Exclusion Criteria: • Severe hypertension, secondary hypertension, type 1 diabetes mellitus History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc. Other protocol-defined exclusion criteria may apply.

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Medical education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure after 8 weeks |  |  | 
| Change from baseline diastolic blood pressure after 8 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg |  |  | 
| Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
valsartan+hydrochlorothiazide, hypertension,
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
We hypothesize that early and continuous administration of oxygen via high flow nasal cannula in patients with lung contusion and non-severe acute lung injury might reduce the incidence of intubation and hold the deterioration of pulmonary functions.

Official Title
-----------------
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial

Conditions
-----------------
Traumatic Lung Injury

Intervention / Treatment
-----------------
* Device: high flow nasal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written informed consent prior to performing study procedures, currently hospitalized and requiring medical care for blunt chest trauma, within 24h of trauma Exclusion Criteria: face trauma or surgery, airway obstruction, known to have chronic chest condition

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high flow nasal cannula<br>will receive oxygen through high flow nasal cannula | Device: high flow nasal cannula<br>* Patients in the intervention group receive oxygen through HFNC with a flow rate of set initially at 40 L / min, FiO2 adjusted to maintain SpO2 ≥ 92%, and will be humidified, heated to 34-37 °C, disconnection will be allowed only when ambulation is required, patients will be instructed to practice mouth closing throughout the HFNC therapy as much as possible<br>|
| No Intervention: oxygen mask<br>will receive oxygen through oxygen mask | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for intubation and mechanical ventilation within 28 days of randomization. | the incidence of intubation in patients with lung contusion who receive oxygen through high flow nasal cannula | 3 months |
Structured Treatment of Gastroesophageal Reflux in a Company Health Care Setting, -Effect on Quality of Life, Symptoms and Productivity

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients.

Official Title
-----------------
A Prospective, Non Interventional Study to Evaluate the Effects on Quality of Life, Symptoms and Productivity in Patients With Gastroesophageal Reflux Disease (GERD) After 6 Weeks Structured Treatment in a Company Health Care Setting

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and/or male aged > 18 years Diagnosis of GERD confirmed Prescription of GERD treatment or already receiving GERD treatment Exclusion Criteria: Any symptom suggesting a need for further investigation Previous participation in the present study Current participation in a clinical study or participation in a clinical study during the last 30 days

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Quality of life, Structured treatment
Problems With Immune Recovery in the Gut Tissue

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out if the process of HIV replication in the lymph tissue and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut to protect you from other infections and health problems.

Official Title
-----------------
A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C)

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Procedure: Genital and rectal swabbing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+ individuals Seropositive for HIV On ART for at least 12 months Seropositive for Herpes Simplex Type 2 and Cytomegalovirus Age ≥ 18 years Negative pregnancy test for eligible women of childbearing potential HIV- individuals Seronegative for HIV Seropositive for Herpes Simplex Type 2 and Cytomegalovirus Age ≥ 18 years Negative pregnancy test for eligible women of childbearing potential Exclusion Criteria: Taking daily suppressive therapy for Herpes Simplex Type 2 Contraindication to surgical & endoscopic procedures (as judged by PI) Psychiatric or psychological illness that would make adherence to protocol procedures unlikely Pregnancy

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Genital and rectal swabbing|Subjects swabs their genitals and rectum daily. The amount of HSV shed over the previous 24 hours is measured and the daily HSV shed rate is calculated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Herpes Simplex Virus - Type 2 shed rate |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of HIV replication in blood and lymphoid tissue |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV 1, Herpes Simplex Type 2, Treatment experienced
Biofilm Formation and Antibiotic Sensitivity Patterns

Study Overview
=================
Brief Summary
-----------------
Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.

Detailed Description
-----------------
The available number of patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…) will be subjected to full history and examined by physician. Swabs from site of infection will be taken and subjected to the following steps to identify the causative bacteria: Culturing on blood agar, chocolate agar, MacConkey agar and Mannitol salt agar , gram staining and biochemical tests. Enzyme-linked immunosorbent assay (ELISA) to detect biofilm formation. Antimicrobial Susceptibility Testing using the Kirby-Bauer disk diffusion method.

Official Title
-----------------
In Vitro Biofilm Formation and Antibiotic Susceptibility Patterns of Bacteria From Surgical Site Infection After Orthopedic Surgery

Conditions
-----------------
Orthopedic Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…) Exclusion Criteria: if patient has no orthopedic surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: swab|Swabs from site of infection will be taken|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect biofilm formation | The available number of patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…) will be subjected to full history and examined by physician. Swabs from site of infection will be taken and subjected to Enzyme-linked immunosorbent assay (ELISA) to detect biofilm formation. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biofilm antibiotics