linjc16/ctgov huggingface dataset:
Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.

Conditions
-----------------
Urinary Catheter, Cesarean Section, Urinary Infection

Intervention / Treatment
-----------------
* Other: Foley urethral catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women admitted to the prenatal wards for primary or repeat elective cesarean section Exclusion Criteria: urinary infection (assessed clinically and by midstream urinalysis), significant vaginal bleeding, severe pre-eclampsia or eclampsia and/or any other conditions requiring postoperative monitoring of urinary output, and contraindications for general anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Immediate catheter removal<br>The catheter was removed immediately after the CS | Other: Foley urethral catheter<br> <br> |
| Delayed catheter removal<br>The catheter was removed 12 hours postoperatively | Other: Foley urethral catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases with significant bacteriuria and urinary symptoms |  | 1 year |
A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.

Official Title
-----------------
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Raloxifene on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: MK0217, /Duration of Treatment : 12 Months
* Drug: Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is postmenopausal (or surgically menopausal) for at least 6 months Patient must be diagnosed with osteoporosis Patient has spinal anatomy suitable for DEXA of the lumbar spine Exclusion Criteria: Patient is receiving or has received treatment prior to randomization which might influence bone turnover Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss) Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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: MK0217, /Duration of Treatment : 12 Months|nan|
|Drug: Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) in PA lumbar spine at 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months |  |  |
The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity

Study Overview
=================
Brief Summary
-----------------
The study was carried out to determine the long-term effectiveness of a school-based intervention programme when implemented over 2 years and its sustained effect one year later.

Official Title
-----------------
2-year Intervention and 1-year Follow-up of a School-based Programme to Promote Healthy Behaviours and Prevent Childhood Obesity in Lebanese Children: the Healthier Kids - Ajyal Salima Study

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Other: Ajyal Salima


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schoolchildren Aged 8-12 years Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Implementation of Ajyal Salima intervention to promote healthy eating and encourage physical activity in Lebanese school-children. | Other: Ajyal Salima<br>* It comprises in class-activities, meetings with parents and improvement of school foodservice<br>|
| No Intervention: Control group<br>Group of students not receiving any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge score | Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases | 3 school years | 
| Change in dietary habits | Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and all post- assessment phases) | 3 school years | 
| Change in self-efficacy score | Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases | 3 school years | 
| Change in Body Mass Index | Change in mean BMIz scores (based on anthropometric measurements during pre- and post- assessment phases | 3 school years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMI, Health policies, School health promotion, Intervention
Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.

Detailed Description
-----------------
The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.

Official Title
-----------------
Effects of Hookah Smoking on Vascular Regulation: Novel Insight Into Endothelial Function

Conditions
-----------------
Hookah Smoking

Intervention / Treatment
-----------------
* Other: Hookah smoking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 29 years of age Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months Have not smoked cigarettes within the past 12 months Exclusion Criteria: History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease Exhaled carbon monoxide level >10 ppm BP < 140/90 mmHg BMI <18.5 or > 30 kg•m2 Resting heart rate > 100 beats/min Taking prescription medication History of illicit drug use Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hookah smoking<br>Healthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking. | Other: Hookah smoking<br>* ad lib hookah smoking for 30 minutes in a controlled laboratory environment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation |  | change from baseline to immediately after smoking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemia peripheral arterial tonometry |  | change from baseline to immediately after smoking |
Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

Study Overview
=================
Brief Summary
-----------------
Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging

Detailed Description
-----------------
Prospective study with Grave's patients in active and fibrotic disease, myogenic and lipogenic forms, with muscle restriction and without muscle restriction and with or without optic compressive neuropathy. Blood flow was studied with Color Doppler Imaging (CDI) in the following orbital vessels: Superior Ophthalmic Vein (main target of the study protocol) Retinal Central Vein Retinal Central Artery Ophthalmic Artery

Official Title
-----------------
Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

Conditions
-----------------
Graves' Disease, Graves' Ophthalmopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Grave's Orbitopathy with well defined disease. Exclusion Criteria: Uncertain cases, with an undefined status of Grave's Ophthalmopathy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group control with healthy subjects<br>Healthy subjects without thyroid disease, ocular disease and previous surgery in the orbit or eye used in the study. | |
| Graves' Ophthalmopathy - fibrotic phase<br>Patients that are clinically inactive (CAS equal or lower than 2). This group will be subdivided in the miogenic and lipogenic groups. | |
| Graves' Ophthalmopathy - active phase<br>Patients that are clinically active, presenting a CAS of 4 or more points, with or without disthyroid optic neuropathy. | |

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
-----------------
Graves, Color Doppler Imaging, Graves' Ophthalmopathy, Orbital Venous Flow
Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to evaluate the improvement in social function following therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine. An additional purpose of this pilot study is to obtain the tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine.

Official Title
-----------------
Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.

Conditions
-----------------
Panic Disorders

Intervention / Treatment
-----------------
* Drug: VENLAFAXINE
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM IV criteria for Panic Disorder (with or without agoraphobia) for at least 3 months before study day 1. Have a minimum of 8 full-symptom panic attacks during the 4 weeks before the screening visit. Provide a written informed consent Exclusion Criteria: Treatment with Venlafaxine within 6 months of study day 1, as well Paroxetine Known hypersensitivity to Venlafaxine or related compounds as well to Paroxetine. Psychopharmacologic drugs within 14 days of study day 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VENLAFAXINE|nan|
|Drug: Paroxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the improvement of social function following therapy with Venlafaxine extended release (XR)in the Treatment of Panic Disorder in comparison to Paroxetine. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparison to Paroxetine. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Panic Disorders
A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda

Detailed Description
-----------------
Studies have shown that a favorable microbiome can be the difference between response and non-response of certain cancer treatments such as PD-1 blockade inhibitors. As such the investigators propose to ensure a favorable microbiome in this patient by fecal microbiota transplant to enhance the efficacy of such a drug, Keytruda.

Official Title
-----------------
A Single Dose FMT Infusion From a Healthy Family Donor Via Colonoscopy as an Adjunct to Keytruda for the Benefit of Improving Efficacy of Immunotherapy for Metastatic Mesothelioma

Conditions
-----------------
Mesothelioma

Intervention / Treatment
-----------------
* Biological: Fecal Microbiota Transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with metastatic mesothelioma deemed a candidate for PD-1 blockade inhibitor therapy Exclusion Criteria: Patient unable/unwilling to comply with protocol Patient deemed not a candidate for PD-1 Blockade inhibitor therapy
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: Fecal Microbiota Transplant<br>The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy. | Biological: Fecal Microbiota Transplant<br>* Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy<br>* Other names: FMT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | The time from transplant that the patient's tumors remain stable or shrink. | Five years |
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma

Study Overview
=================
Brief Summary
-----------------
Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.

Detailed Description
-----------------
Episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. However, local failure has been reported in a substantial proportion of patients. Since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. Poor plaque localization is an important contributing factor to local failure. With the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. However, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. To address this question, we perform intraoperative B-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.

Official Title
-----------------
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma

Conditions
-----------------
Uveal Melanoma

Intervention / Treatment
-----------------
* Procedure: Intraoperative ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with uveal melanoma treated with brachytherapy Exclusion Criteria: Ciliary melanoma

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intraoperative ultrasonography|Intraoperative ultrasonography will be used to determine plaque placement.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque tilt using intraoperative ultrasonography |  | End of study | 
| Local melanoma failure |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Brachytherapy, Ultrasonography
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)

Official Title
-----------------
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

Conditions
-----------------
Mesenchymal Stromal Cells

Intervention / Treatment
-----------------
* Drug: pneumostem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 23-34w IVH grade 3-4, confirmed with brain ultrasonogram within 7 days after IVH diagnosis Exclusion Criteria: severe congenital anomaly intrauterine intracranial bleeding intracranial infection severe congenital infection active and uncontrolled infection, CRP>10mg/dl Platelet count <50,000/ml severe metabolic acidosis (PH<7.1, BE<-20)

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 34 Weeks

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 |
| --- | --- |
| Other: pneumostem group<br>single arm, pneumostem treated infants | Drug: pneumostem<br>* human umbilical cord blood derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unsuspected death or anaphylactic shock |  | within 6 h after pneumostem transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or hydrocephalus required shunt operation | outcome measurement time frame would not exceed 1 year after birth | First discharge home, maximum time frame : 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraventricular hemorrhage