linjc16/ctgov huggingface dataset:
OPTIMAL STENTS DURING RENAL COLIC

Study Overview
=================
Brief Summary
-----------------
From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.

Official Title
-----------------
COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY

Conditions
-----------------
Ureteral Stent Occlusion

Intervention / Treatment
-----------------
* Device: polyurethane stent
* Device: silicone stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria included age (18 to 60 years old), confirmed ureteral stone prescribed ureteral stent placement for pain syndrome relief Exclusion Criteria: an active urinary tract infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: group A<br>patients who received polyurethane stents | Device: polyurethane stent<br>* patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group<br>|
| Experimental: group B<br>patients who received silicone stents | Device: silicone stent<br>* silicone stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body pain | At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled | 4 weeks | 
| bladder overactivity | At each follow-up appointment, patients completed a survey in which the bladder awareness tool (VASP) was filled | 4 weeks |
Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers

Study Overview
=================
Brief Summary
-----------------
With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.

Official Title
-----------------
Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers

Conditions
-----------------
Aging, Skin Abnormalities

Intervention / Treatment
-----------------
* Drug: Polypodium leucotomos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, 18 years of age or older, with Fitzpatrick skin types II and III. Exclusion Criteria: Pregnancy Personal history of skin cancer History of abnormal photosensitivity Smokers Patients with history or being exposed to other forms of radiation (other than sunlight) History or current exposure to asbestos Patients taking any drug that might alter the response of skin to UVR (including, but are not limited to, doxycycline, sulfas, psoralens, and amiodarone) Patients unable to undergo skin biopsies History of abnormal scarring History of adverse reaction to local anesthesia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polypodium leucotomos extract<br>Subject is given a 7.5 mg/kg dose of Polypodium leucotomos. | Drug: Polypodium leucotomos<br>* Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.<br>* Other names: Heliocare;|
| No Intervention: No intervention<br>Subject is not given any treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample | CD is determined by semiquantitative real-time polymerase chain reaction. | baseline, 24 hours | 
| 8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos, Skin Aging and Damage
A Dose-finding Study of Silodosin in Patients With Urinary Calculi

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi

Conditions
-----------------
Urinary Calculus

Intervention / Treatment
-----------------
* Drug: silodosin
* Drug: silodosin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0. Patients who are able to visit the site continually as out-patient during the study Exclusion Criteria: Patients who have multiple urethral stones. Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side. Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome. Patients who have a clinically significant hepatic or renal disorder. Patients with postural hypotension or with a history of postural hypotension. Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin. Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silodosin, arm 1<br> | Drug: silodosin<br> <br> |
| Experimental: silodosin, arm 2<br> | Drug: silodosin<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous stone passage rate |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to spontaneous stone passage |  | 4 weeks | 
| Analgesic use |  | 4 weeks | 
| Pain severity |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary calculus, ureteral stones, medical expulsive therapy
The Polarization and Expression of Chemokine Receptors of T Help Cell in the Pathogenesis of Acute and Chronic GVHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see the correlation of polarization and the expresison of chemokine receptors of T help cells after allogeneic hematopoietic stem cell transplantation and clinical course graft-versus-host disease.

Conditions
-----------------
Hematopoietic Stem Cell Transplantation, Graft-Versus-Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient received allogeneic stem cell transplantation at CMUH can be regularly followed at CMUH Exclusion Criteria: patient who do not want to enter in this study

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
cytokine, T-cell, chemokine, graft-versus-host disease
Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions

Study Overview
=================
Brief Summary
-----------------
Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation.

Detailed Description
-----------------
Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study such pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation. A systematic recording of airway pressures, tidal volumes and blood gases are carried out during ordinary therapeutic procedures requested by the staff physician. No additional study interventions are carried out. The aim of the project is to examine negative effects of pressure/volume changes.

Official Title
-----------------
Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions

Conditions
-----------------
Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age on mechanical ventilation daily endotracheal suctioning performed Exclusion Criteria: < 18 years of age non-invasive ventilation

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 |
| --- | --- |
| mechanically ventilated patients<br>ICU patients on mechanical ventilation. Daily endotracheal suctioning performed to reduce secretions. Data recorded during these therapeutic interventions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrabronchial airway pressure |  | 2013 |
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed Description
-----------------
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (CHG) application.

Official Title
-----------------
Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: Chlorhexidine gluconate
* Drug: DynaHex-2
* Other: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or Females 18 years of age or older Signed informed consent Good Health Six inches of abdomen and groin areas without tattoos, or skin disorders Exclusion Criteria: Dermatological Conditions Sensitivity to latex Sensitivity to CHG

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine Gluconate Cloth<br>2% CHG, single application | Drug: Chlorhexidine gluconate<br>* 2% CHG solution on cloth<br>* Other names: CHG;|
| Placebo Comparator: Vehicle Cloth<br>Excipients on cloth | Other: Vehicle<br>* Excipients of CHG product only<br>* Other names: Control;|
| Active Comparator: Active Chlorhexidine gluconate solution<br>Dynahex 2% CHG | Drug: DynaHex-2<br>* 2% CHG solution<br>* Other names: CHG 2%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively. | 10 minutes, 6 hours, 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoperative surgical skin preparation
Epstein-Barr Detection in Oral Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze oral squamous cell carcinoma and healthy oral mucosa for the possible presence of Epstein-Barr virus (EBV).

Detailed Description
-----------------
Epstein-Barr virus has been implicated in a range of malignant neoplasms, including in some studies, in the aetiology of oral squamous cell carcinoma but the influence of EBV in oral cancer remains unclear. This study will examine the prevalence of EBV infection in oral cancer by means of nested polymerase chain reaction.

Official Title
-----------------
Epstein-Barr Detection in Squamous Cell Carcinoma and Healthy Oral Mucosa

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of Oral Cancer Centre - UNESP/Araçatuba - SP with oral squamous cell carcinoma Exclusion Criteria: without oral squamous cell carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| oral cancer<br>patients with oral squamous cell carcinoma | |
| control group<br>healthy patients without any oral pathology | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of EBV | Epstein-Barr virus has been implicated in a range of malignant neoplasms, including in some studies, in the aetiology of oral squamous cell carcinoma but the influence of EBV in oral cancer remains unclear. This study will examine the prevalence of EBV infection in oral cancer by means of nested polymerase chain reaction. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral cancer, EBV, PCR
Adherence Risk Indicator Validation Study

Study Overview
=================
Brief Summary
-----------------
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.

Official Title
-----------------
A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Administration of the questionnaire and monitoring of CPAP adherence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18years of age Diagnosed with OSA (AHI >5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years Exclusion Criteria: Contraindicated for CPAP therapy Medically unstable condition/diagnosis that is not yet under control Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study) PLMA (Periodic Limb Movement Activity) Index greater than 15/hr Home titration of longer than 5 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPAP therapy<br> | Other: Administration of the questionnaire and monitoring of CPAP adherence<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP Therapy Adherence | Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection. | 90 days |
Effect of Vitamin D Replacement on Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.

Official Title
-----------------
Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency

Conditions
-----------------
Insulin Sensitivity

Intervention / Treatment
-----------------
* Drug: Ergocalciferols
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months Exclusion Criteria: 1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension. 2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months. 3. Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2 drinks/day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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 |
| --- | --- |
| Experimental: Vitamin D<br>ERgocalcifoerol 50,000 units q weekly for 8 weeks | Drug: Ergocalciferols<br>* ERgocaclciferol 50,000 units weekly for 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M Value (Insulin Stimulated Glucose Uptake) | Insulin stimulated glucose uptake will be measured by glucose clamp studies | Baseline and at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D deficiency, insulin sensitivity