linjc16/ctgov huggingface dataset:
An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

Study Overview
=================
Brief Summary
-----------------
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.

Detailed Description
-----------------
This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.

Official Title
-----------------
An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

Conditions
-----------------
Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, age ≧ 50 years Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) IPSS score ≧ 8 points and prostate volume ≧ 30 mL Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months. Dutasteride combination therapy will be allowed by investigator's prescription Ability to understand and willingly provide written informed consent Exclusion Criteria: History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN) With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study Use of finasteride within 6 months of screening visit Use of dutasteride within 12 months of screening visit

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostatic Hyperplasia
Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (Nd: YAG) laser capsulotomy procedures.

Detailed Description
-----------------
Participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. Participants will undergo the Nd: YAG laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. Follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. The complication rate following the laser capsulotomy procedure is typically minimal.

Official Title
-----------------
Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy: Efficacy and Outcomes Performed by Optometrists

Conditions
-----------------
Posterior Capsule Opacification Obscuring Vision

Intervention / Treatment
-----------------
* Procedure: Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent; At least 18 years of age, male or female; Prior cataract surgery; Diagnosed with posterior capsule opacification obstructing vision; Best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an ETDRS visual acuity chart or significant effect on activities of daily living Exclusion Criteria: History of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings) Previous myopic refractive error greater than 6.00 diopters Complications following previous ocular procedures (i.e. intraocular lens decentration) Ocular surgery other than uncomplicated cataract or uncomplicated refractive 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy|A Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Visual Acuity | Pre and Post Procedure Visual Acuity | 3 months |
Clinical Study of Lyophilized Plasma in Patients With Liver Disease

Study Overview
=================
Brief Summary
-----------------
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.

Official Title
-----------------
A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Biological: Lyophilized Plasma
* Biological: Licensed Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 18 years of age. Patients with liver disease. Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding. Patients with an elevated international normalized ratio due to liver disease. Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf. Patients able and willing to comply with the procedures laid out in the study protocol. Exclusion Criteria: Patients who are clinically unstable. Patients who have received mediations that could interfere with results of laboratory testing. Patients who have congenital or acquired coagulopathies of non-hepatic origin. Pregnant or nursing women. Active illicit drug use. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion. Patients previously enrolled in 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Licensed Plasma<br> | Biological: Licensed Plasma<br>* Plasma that has been authorized for transfusion.<br>|
| Experimental: Lyophilized Plasma<br> | Biological: Lyophilized Plasma<br>* Licensed plasma that has been lyophilized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess and compare adverse events | The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control. | Duration of Study (Less than or equal to 7 days) |
Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

Study Overview
=================
Brief Summary
-----------------
Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown that glucose present in the fluid in the front of the eye, called the aqueous humor, correlates well with blood glucose. As blood glucose changes, the optical properties of the aqueous humor change, causing a change in the appearance of the iris of the eye.. The data collected in this study will be shared with IRISense to assist in validating the algorithm being used to develop the database needed. The data collected so far is in a narrow band of the normal glycemic range (healthy volunteers). We will collect standard digital photographic images of the eyes of subjects with diabetes along with corresponding blood glucose concentrations using the finger stick glucose monitoring method. In order to do this we will use standard digital photography techniques that is embedded in our benchtop prototype device

Official Title
-----------------
Blood Glucose Monitoring Based on Imaging of the Eye

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Contour, Bayer Healthcare, LLC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Diabetes Type 1 and 2 and can be verified by the principal investigator Exclusion Criteria: Patients with any disease or abnormality of the eye Patients who are mentally incapacitated, cognitively impaired or with severe psychological disorders and cannot sign consent on their own

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New device for OPTICAL determination of blood glucose level<br> | Device: Contour, Bayer Healthcare, LLC<br>* Blood glucose measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Images of the eye | The subject will be scheduled for 3 visits. Scheduling for testing will be performed by the principal investigator. Each subject will be required to take part in three individual or group testing sessions of 45-90 minutes over a 60 day period. Eight digital photographic image of the subject's iris will be obtained at various times during each visit under standard illumination using the developed instrumentation. A point-of-care fingerstick blood glucose reading will be taken with an FDA approved blood glucose measurement device (i.e., Contour, Bayer Healthcare, LLC) as close to simultaneously as possible with the photograph. | 60 day period |
Satisfaction With Phosphodiesterase 5 Inhibitors Treatment In Patients With Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
Evaluate satisfaction in people treated with IPDE5 inhibitors over time

Detailed Description
-----------------
12 first patients that are eligible

Official Title
-----------------
Satisfaction With Treatment In Patients With Erectile Dysfunction And Cardiovascular Risk And/Or Previous Cardiovascular Event.

Conditions
-----------------
Erectile Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CV risk factors Male above 18 Exclusion Criteria: Non-informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Questionnaire<br>filling in questionnaires | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDITS |  | 6 months | 
| SEAR |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication prescribed |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
satisfaction
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

Study Overview
=================
Brief Summary
-----------------
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.

Official Title
-----------------
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

Conditions
-----------------
Baska Mask Efficacy and Safety in Children

Intervention / Treatment
-----------------
* Device: Placement and use of Baska mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consent BMI 15-35 weight over 30kg or age 8-16 yrs non-urgent surgery of planned duration up to 2 hrs Exclusion Criteria: neck pathology previous or anticipated problems with the upper GI or upper airway increased risk of gastric aspiration expected difficult airway

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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: Baska mask<br> | Device: Placement and use of Baska mask<br>* Use of Baska mask as a supraglottic airway during general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device insertion success rate |  | within 30 minutes of induction of general anesthesia | 
| device airway leak pressure | the airway l;eak pressure is defined as the plateau airway pressure measured while the patient is apnoeic with the APL valve of the anaesthetic machine set to 35 cm H2O and the fresh gas flow set to 6 L/min | within 10 minutes of successful device placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway stability | the tidal volumes will be measured in different head positions and the leak fractions calculated. | within 30 minutes of device placement | 
| ease of device placement | the ease of device placement will be evaluated by Visual Analogue Scale | within 30 minutes of induction of general anesthesia | 
| complications during the anesthetic | complications that may be related to the device use will be monitored including but not limited to desaturation episodes, laryngospasm, loss of airway, need to switch ot alternative device, blood staining on mask removal sore throat, dysphonia, dysphagia | from the start of device insertion untill discharge from recovery, an expected average of 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Baska Mask, Supraglottic airway device, Children, Pediatric
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.

Detailed Description
-----------------
The study objectives are to: 1. assess the changes from pre- to post- oral supplementation on retinal and choroidal thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal function

Official Title
-----------------
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Gingko Biloba


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 20 - 55 years, inclusive Good general and ocular health Corrected visual acuity of 20/40 or better No gingko biloba supplementation within the last 3 months Exclusion Criteria: All significant ocular and any systemic disorders considered likely to affect the systemic or ocular vasculature History of ocular surgery, including refractive surgery Use of ocular medications Conditions where ginkgo supplementation is contraindicated Any eye or systemic disease that affect vision or refractive error Current smokers Subjects who are pregnant, breastfeeding, or planning conception

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gingko Biloba<br>oral intake of gingko biloba for 4 weeks | Dietary Supplement: Gingko Biloba<br>* oral intake of Gingko Biloba, 240mg/day for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular blood flow | ocular blood flow measured with doppler ultrasound | 4 weeks |
Surgeon Compared to Nuclear Radiology Readers for Tc-99m Sestamibi Scans for Parathyroid Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear radiologists of 61 individual thyroid scans. The goal is to determine if surgeons are more prone to making a definitive diagnosis based on a given scan than a nuclear radiologist. Accuracy of localization of the two groups will be analyzed. A secure website has been designed to which the physician will be able to login and view and rate the quality of each image and make a localizing diagnosis. Once they are finished, they will not be able to make any more changes, and their responses will be compared to the responses of their colleagues. The results will be analyzed to find if there is a significant variation in the ratings between the surgeons and the nuclear radiologists as to the quality, location, and number of parathyroid glands, if any, on the scans.

Official Title
-----------------
Surgeon Compared to Nuclear Radiology Readers for Tc-99m Sestamibi Scans for Parathyroid Disease

Conditions
-----------------
Parathyroid Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a surgeon or nuclear radiologist to be eligible read scans for this study. 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the findings of individual thyroid scans | The results will be analyzed to find if there is a significant variation in the ratings between the surgeons and the nuclear radiologists as to the quality, location, and number of parathyroid glands, if any, on the scans. | 1 day |
Predictive Models for Betalactam Allergy

Study Overview
=================
Brief Summary
-----------------
Background: ß-lactam (BL) antibiotics represent the main cause of allergic reactions to drugs, inducing both immediate and non-immediate reactions. The diagnosis is well established, usually based upon skin tests and drug provocation tests, but cumbersome. Objectives: To design predictive models for the diagnosis of BL allergy, based on the clinical history of patients with suspicions of allergic reactions to BL. Methods: The study included a retrospective phase in which records of patients consulting and explored for a suspicion of BL allergy (in the Allergy Unit of the University Hospital of Montpellier between September 1996 and September 2012) where used to construct predictive models; a prospective phase, in which we performed an external validation of the chosen models, in patients with suspicion of BL allergy recruited from 3 allergy centres (Montpellier, Nîmes, Narbonne), between March and November 2013. Data related to clinical history and allergy work-up results were retrieved and analysed. Logistic regression and decision tree method were used to design two models to predict the diagnosis of allergy to BL.

Official Title
-----------------
Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Other: Creating models for the diagnosis of BL allergy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines Exclusion Criteria: patient refusal to take part in the study pregnancy breast feeding women contraindication to provocation test
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Creating models for the diagnosis of BL allergy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provocation test | Results of provocation test for allergy diagnosis | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire SF36 | Questionnaire SF36 will be compared to provocation test results | 18 months | 
| Questionnaire ENDA | Questionnaire ENDA will be compared to provocation test results | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betalactam, Decision tree, Drug hypersensitivity, Logistic regression, Predictive modelling