linjc16/ctgov huggingface dataset:
Exisulind Versus Placebo After Surgical Removal of the Prostate

Study Overview
=================
Brief Summary
-----------------
This is a study in which patients with prostate cancer treated by surgical removal of the prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind 250 mg twice a day or placebo twice a day for two years.

Official Title
-----------------
Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Exisulind


Participation Criteria
=================
Eligibility Criteria
-----------------
Males 18 years of age or older with prostate cancer treated primarily by radical prostatectomy and randomized within 45 days after surgery may be eligible for enrollment into this protocol. Participants cannot have had hormonal therapy, cryotherapy, thermotherapy, or radiotherapy prior to entering the study.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Exisulind|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy of drug vs placebo regarding overall rate of biochemical progression |  |  | 
| Assess the efficacy of drug vs placebo regarding time to biochemical progression |  |  | 
| Assess efficacy of drug vs placebo regarding overall rate of clinical progression |  |  | 
| Assess efficacy of drug vs placebo regarding time to clinical progression |  |  | 
| Assess efficacy of drug vs placebo regarding cancer specific survival |  |  |
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Conditions
-----------------
Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Intervention / Treatment
-----------------
* Drug: OTO-201
* Drug: Placebo
* Drug: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria includes, but is not limited to: Subject is a male or female aged 6 months to 12 years, inclusive Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement Subject's caregiver is willing to comply with the protocol and attend all study visits Exclusion Criteria includes, but is not limited to: Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement Subject has a history of sensorineural hearing loss Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mg OTO-201<br> | Drug: OTO-201<br>* Single intra-operative injection<br>* Other names: ciprofloxacin;|
| Experimental: 12 mg OTO-201<br> | Drug: OTO-201<br>* Single intra-operative injection<br>* Other names: ciprofloxacin;|
| Placebo Comparator: Vehicle for OTO-201<br> | Drug: Placebo<br>* Single intratympanic injection<br>|
| Sham Comparator: Sham<br> | Drug: Sham<br>* Simulated single intratympanic injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Activity | Evaluation of physician reported and caregiver reported otorrhea | Up to 1 month | 
| Microbiological Eradication | Microbiological eradication of pretherapy bacteria | Up to 1 month |
Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to prospectively evaluate Impedance Cardiography as a tool to detect pulmonary hypertension. According to our hypothesis Impedance Cardiography is a valuable method to differentiate patients without pulmonary hypertension from patients with pulmonary hypertension. The main objective is to determine the sensitivity and specificity in comparison to the gold standard right heart catheterization.

Official Title
-----------------
Non-invasive Diagnosis of Pulmonary Hypertension by Thoracic Impedance Cardiography - a Prospective Study

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: Impedance Cardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Informed Consent Patients with clinical indication for right heart catheterization Exclusion Criteria: known Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Impedance Cardiography<br>Impedance Cardiography | Diagnostic Test: Impedance Cardiography<br>* Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension. At the same time electrocardiography and non-invasive continuous blood pressure will be measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of pulmonary hypertension | The sensitivity and specificity of Impedance Cardiography in the diagnosis of pulmonary Hypertension (as compared with the Gold Standard right heart catheterization) will be determined. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
impedance cardiography
Comparison of the Efficacy of Oral Sucrose Administration at Two Different Times of a Painful Procedure in Neonates.

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.

Official Title
-----------------
Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Sucrose 24%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates whose parents and/or guardians have signed the informed consent form. Exclusion Criteria: Neonates connected to invasive mechanical ventilation. Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture. Neonates who have received sedation. Neonates presenting withdrawal syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Sucrose will be administered 2 minutes before the puncture following the current protocol of the unit. Venous or arterial puncture will be performed only in case it is required for therapeutic or care purposes. | Other: Sucrose 24%<br>* According to the age of the newborn: 24-26 weeks : 0.1 mL, 27-31weeks : 0.25 mL, 32-36 weeks : 0.5 mL, >37 weeks : 1 mL<br>|
| Experimental: Experimental Group<br>The administration of the sucrose dose is started by means of a syringe. Once 50% of the dose has been administered, puncture will be performed. The remaining 50% will be administered during the puncture. The pacifier will be left in the mouth until the end of the procedure, facilitating the non-nutritive sucking of the neonate. | Other: Sucrose 24%<br>* According to the age of the newborn: 24-26 weeks : 0.1 mL, 27-31weeks : 0.25 mL, 32-36 weeks : 0.5 mL, >37 weeks : 1 mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during a painful procedure | The primary variable is pain, and will be measured by the Premature Infant Pain Profile-Revised (PIPP-R) scale. The score ranges from 0 (no pain or minimal pain) to 21 (maximum pain). | 15 seconds after extraction |
Audio Vestibular Functions in COVID 19 Patients in Sohag Governate

Study Overview
=================
Brief Summary
-----------------
There is evidence that up to 30% of COVID-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in COVID-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by COVID-19.This study will be conducted to evaluate the effect of the novel coronavirus on audio-vestibular functions in confirmed COVID19 patients.

Official Title
-----------------
Audiovestibular Functions in Covid 19 Patients in Sohag Governate

Conditions
-----------------
COVID19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Well educated patients Age: range between 20 to 50 years No previous history of hearing loss or otoneurologic disease Well confirmed COVID 19 patients: patients who were diagnosed with coronavirus from symptoms: fever, cough, generalized malaise, dyspnea. Laboratory finding: abnormalities have been observed in Complete blood count (CBC), high C-reactive protein and ferritin, elevated D-dimer. Imaging: Chest CT scan: bilateral ground glass opacities, crazy paving, and consolidation. nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction testing (RT-PCR). Exclusion Criteria: previous history of hearing loss or otoneurological disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic audiological evaluation: | Pure-tone audiometry. | 3 months after infection | 
| Basic audiological evaluation: | Acoustic immittance testing | 3 months after infection | 
| Basic audiological evaluation: | Speech audiometry | 3 months after infection | 
| Auditory evoked potentials: | Auditory brainstem response. | 3 months after infection | 
| Auditory evoked potentials | P300 | 3 months after infection | 
| Effect on vestibular functions | Videonystagmography | 3 months after infection | 
| Effect on vestibular functions | Video Head Implus test VHIT. | 3 months after infection | 
| Effect on vestibular functions | Vestibular evoked myogenic potential. | 3 months after infection | 
| Effect on vestibular functions | Computerized Dynamic Posturography (CDP) | 3 months after infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on cognitive functions | Cognitive function assessment: By Montreal test | 3 months after infection | 
| Vestibular questionnaire | Dizziness Handicap Inventory (DHI). | 3 months after infection |
Clinical-immunological Features of DNER Ataxia

Study Overview
=================
Brief Summary
-----------------
Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes.

Official Title
-----------------
Clinical-immunological Features of DNER Ataxia

Conditions
-----------------
DNER Ataxia

Intervention / Treatment
-----------------
* Genetic: Description of clinical characteristic and genetic tumors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 18 years old Patient with neurological disorder Patient with DNER antibodies in sera or CSF Exclusion Criteria: - No available clinical data Patient without DNER antibodies or neurological disorder

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 |
| --- | --- |
| DNER ataxia<br>Patients with well-characterized DNER antibodies. | Genetic: Description of clinical characteristic and genetic tumors<br>* This is a non-interventional study involving clinical data and biological samples (DNA). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of good clinical practice in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the Centre de Ressources Biologiques des Hospices Civils de Lyon (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale (mRS) | Residual neurological disability as assessed by the modified Rankin scale (mRS) score at last visit) | 6 month after the beginning of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNER antibodies, autoimmune cerebellar ataxia, Hodgkin lymphoma
Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.

Official Title
-----------------
Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy

Conditions
-----------------
Thyroidectomy, Fluid Responsiveness

Intervention / Treatment
-----------------
* Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 elective robot assisted thyroidectomy Exclusion Criteria: arrhythmia BMI>30 valvular heart disease pul hypertension peripheral artery occlusive disease lung disease right heart failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stroke volume variation, pleth variability index<br>stroke volume variation: recorded using the FloTrac/Vigileo system (Edwards Lifesciences) pleth variability index: recorded using the Masimo Radical-7 monitor (Masimo Corporation, Irvine, CA, USA) | Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)<br>* HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke volume variation |  | 5 minutes after volume replacement | 
| pleth variability index |  | 5 minutes after volume replacement |
A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: KUC-7483
* Drug: Placebo
* Drug: Tolterodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a symptom of overactive bladder for more than 6 months. Patients who meet the following condition during the 3-day bladder diary period. the mean number of micturitions per 24 hours is ≥8 times the mean number of urgency episodes per 24 hours is ≥1 time Exclusion Criteria: Patients who are diagnosed as stress urinary incontinence are predominant. Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

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: KUC-7483<br> | Drug: KUC-7483<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Tolterodine<br> | Drug: Tolterodine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the mean number of micturitions per 24 hours |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the mean number of urgency episodes per 24 hours |  | 12 weeks | 
| Change from baseline in the mean number of incontinence episodes per 24 hours |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB