linjc16/ctgov huggingface dataset:
Magnetic Resonance Imaging in Subjects With Gouty Tophi

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.

Detailed Description
-----------------
This is a multi-center, validation study of MRI in the quantitative assessment of gouty tophi. Subjects with palpable gouty tophi (confirmed by aspiration of the tophus) in select anatomical sites (foot, hand or elbow) will undergo pre- and post contrast MRI on two occasions separated by 5 to 10 days. This study will consist of up to 4 study visits.

Official Title
-----------------
A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.

Conditions
-----------------
Hyperuricemia, Gout

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with gout and at least one tophi. Exclusion Criteria: Unable to undergo MRI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| 1<br>Volumes/measurements of tophi determined by serial MRIs | Procedure: MRI<br>* Subjects underwent MRI to evaluate tophi.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Tophi by MRI - Difference in Volument Between Visits | Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers. | Visit 1 (Day 1) and Visit 2 (Days 6-11) | 
| Measurement of Tophi by MRI - Difference in Volume Between Readers | Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits. | Visit 1 (Day 1) and Visit 2 (Days 6-11) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gout, Tophus, MRI
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.

Study Overview
=================
Brief Summary
-----------------
To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.

Official Title
-----------------
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.

Conditions
-----------------
LSIL, Low-Grade Squamous Intraepithelial Lesions

Intervention / Treatment
-----------------
* Procedure: Ablative treatment
* Procedure: Expectant management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Low-Grade Squamous Intraepithelial Lesion by cervical cytology. Positive Biopsy for Low-Grade Squamous Intraepithelial Lesion after colposcopy. Exclusion Criteria: Serological detection of human immunodeficiency virus (HIV).
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: Expectant treatment<br>Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis. | Procedure: Expectant management<br>* Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.<br>|
| Experimental: Ablative treatment<br>Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis. | Procedure: Ablative treatment<br>* Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that progressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that regressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low-Grade Squamous Intraepithelial Lesions
Spectroscopic Evaluation of Middle Ear Infection

Study Overview
=================
Brief Summary
-----------------
Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.

Detailed Description
-----------------
The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Official Title
-----------------
Spectroscopic Evaluation of Middle Ear Infection

Conditions
-----------------
Middle Ear Infection

Intervention / Treatment
-----------------
* Device: Spectroscopic otoscope measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/ female at all age- newborn to adult. Non- pregnant woman. Diagnose of middle ear infection and plan for surgery procedure. Exclusion Criteria: Pregnant woman Incompetent adults (i.e. individuals with cognitive impairment) No diagnose of middle ear infection and no plan for surgery procedure. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical Tool<br>Spectroscopic otoscope | Device: Spectroscopic otoscope measurements<br>* Spectroscopic otoscope measurements are taken with the investigational device. Each measurement consists of placing the device in the ear canal and illuminating the ear with multiple light sources in a short period of time. If wax is present in the ear canal, it is removed by the study physician and another measurement is taken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle Ear Exam | The level of light scattering and absorption as measured will be the predictor and presence of fluid behind the ear drum as determined by the surgeon during ear tube placement procedure will be our outcome variable. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Middle Ear Infection
Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm the safety and performance/efficacy of the FIM when exposed to a larger and more varied population of users.

Detailed Description
-----------------
70 Eligible subjects will be enrolled to the study and examined with the FIM to determine the degree of pupil dilation/Contraction resistance. The study will be conducted in two main stages: 1) pupil dilation measuring and 2) functional examination. The tests' sequence will be randomized, at least 30 minutes between each test.

Official Title
-----------------
Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)

Conditions
-----------------
Pupil Dilation

Intervention / Treatment
-----------------
* Device: FIM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and not diagnosed with any chronic disease that might influence the eye and pupilary muscle. Age 18-45 years old. Willing and able to sign the informed consent, after reading the study information form Exclusion Criteria: Any known or diagnosed neurological disorders. A known medical history of ophthalmic surgery or any other disease that might influence the iris control muscle. Volunteers with a narrow or closed angle of the anterior chamber Presence of a corneal pathology which precludes measurement of the pupil dilatation Using of psychiatric medications Pregnancy Recent use (last 48hr) of pupil dilator eye drops. The volunteer is participating in other trials using drugs or devices Drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIM<br>safety and efficacy of the FIM when exposed to a large and varied population of patients and users and operated according to its instructions for use | Device: FIM<br>* Field Induced Mydriasis device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | number, severity and causality of unexpected, device related adverse events | 4 months | 
| Functionality | Functionality - ability to perform standard ophthalmologic examination | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Device usability and user satisfaction | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Field Induced Mydriasis, FIM, ATI
Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

Study Overview
=================
Brief Summary
-----------------
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Drug: BT-11 low
* Drug: BT-11 high
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
No patients enrolled

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT-11 low<br>Oral | Drug: BT-11 low<br>* Oral<br>|
| Experimental: BT-11 high<br>Oral | Drug: BT-11 high<br>* Oral<br>|
| Placebo Comparator: Placebo<br>Oral | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs |  | 12 Weeks |
The Effect of the Mode of Delivery to the Pelvic Floor Function

Study Overview
=================
Brief Summary
-----------------
The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. The investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. In order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.

Official Title
-----------------
The Effect of the Mode of Delivery to the Pelvic Floor Function

Conditions
-----------------
Incontinence, Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous women 5-10 years after birth Exclusion Criteria: Multiparous women Women with connective tissue disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group 1<br>Primiparous women who gave birth with ceserean section | |
| Study group 2<br>Primiparous women who gave birth with vaginal route delivery without episiotomy | |
| Study group 3<br>Primiparous women who gave birth with vaginal route delivery with episiotomy | |
| Control group<br>Nulliparous women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle tonus | Pelvic floor muscle tonus is going to measure by vaginal perineometry. | 25.05.2020- 25.08.2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female sexual function | Female sexual function is going to evaluate by validated FSFI questionnaire | 25.05.2020- 25.08.2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse
EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study

Study Overview
=================
Brief Summary
-----------------
The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant. Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.

Official Title
-----------------
EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be undergoing a new St. Jude Medical CRT-D or CRT-P device implantation Have the ability to provide informed consent for study participation and be willing to comply with the prescribed perioperative evaluations Exclusion Criteria: Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures Be less than 18 years of age Be pregnant women Be currently participating in a clinical study that includes an active treatment arm

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Quantification of Autonomic Nervous Activity During Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.

Detailed Description
-----------------
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during HD session. The subjects will be divided into 3 groups, those with UFR < 10 ml/hr/kg; ≥10 ml/hr/kg but ≤ 15 ml/hr/kg; and >15 ml/hr/kg, and Holter ECG are recorded continuously during HD session using frequency analysis of RR intervals.

Official Title
-----------------
Quantification of Autonomic Nervous Activity by Heart Rate Variability and Approximate Entropy in High Ultrafiltration Rate During Hemodialysis

Conditions
-----------------
Chronic Kidney Disease on Hemodialysis

Intervention / Treatment
-----------------
* Other: Analysis of the holter electrocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis. Exclusion Criteria: Patients with chronic atrial fibrillation Patients with frequent ventricular premature beats Patients with a permanent pacemaker Patients with taking antihypertensive drugs Patients with medical treatment due to changes in blood pressure

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: measuring Holter electrocardiogram<br>Hotter ECG will be recorded continuously during hemodialysis | Other: Analysis of the holter electrocardiogram<br> <br> * Other names: Analysis of heart rate variability with using holter electrocardiogram;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome measures was low frequency power (LF, ms2) to high frequency power (HF, ms2) ratio (LF/HF ratio) of heart rate variability. The three subject groups with difference ultrafiltration were compared by LF/HF ratio during hemodialysis session. | Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability. | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart rate variability
Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to prospectively examine the relationship of the uterine junctional zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment outcome. The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy

Detailed Description
-----------------
Ultrasounds of women who achieve pregnancy after IVF treatment will be compared to ultrasounds of women who do not achieve pregnancy. Their uterine junctional zone thickness will be compared. The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy.

Official Title
-----------------
Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Other: Ultrasonographic imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing IVF treatment due to male factor, polycystic ovary syndrome and unexplained infertility Exclusion Criteria: Low ovarian reserve Having undergone more than one D&C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ultrasonographic imaging|Ultrasound pelvic scan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickened uterine junctional zone | Observed and measured by ultrasound | 2 months |