linjc16/ctgov huggingface dataset:
Influence of Hypoxia on Electroretingraphy (ERG) Measurements

Study Overview
=================
Brief Summary
-----------------
To investigate the influence of induced hypoxia on the ERG.

Conditions
-----------------
ERG Under Hypoxia

Intervention / Treatment
-----------------
* Device: ERG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: under 18 and over 80 years, respiratory diseases, cataracta and corneal hazes, myopia more than 6 dpt, hyperopia more than 3 dpt, allergy for any topical anesthetics in ophthalmology, photic epilepsy, asthma bronchiale.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Hypoxia<br> | Device: ERG<br>* scotopic and photopic ERG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroretingraphy Measurements |  | 01.02.2011-01.06.2011 |
Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether power Doppler sonography (PDS) can be used to diagnose synovitis in patients with inherited bleeding disorders.

Detailed Description
-----------------
Aim #1 - To determine if PDS can be used to diagnose synovial hypertrophy and inflammation in joint disease associated with inherited bleeding disorders. MRI will be used as a reference standard. Aim #2 - To determine if PDS can be used to assess therapeutic response to treatment. Aim #3 - To determine if PDS can be used as a screening tool for diagnosing early synovitis.

Official Title
-----------------
Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease

Conditions
-----------------
Inherited Bleeding Disorders

Intervention / Treatment
-----------------
* Procedure: Power Doppler Sonography
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of inherited bleeding disorder For Aim 1: Age of at least 6 years History of at least 4 bleeds in the same joint in the preceding 6 months Joint swelling, synovitis or deformity For Aim 2: Meet inclusion criteria for Aim 1 and will be having a synovectomy For Aim 3: Age of at least 1 year Have had at least 2 joint bleeds Exclusion Criteria: Not meeting inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Power Doppler Sonography|Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.|
|Procedure: MRI|Magnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint |  | Up to 1 month | 
| Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention |  | 1. day of synovectomy; 2. 6 months post synovectomy. | 
| Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia, Factor Deficiency, synovitis, sonogram
Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH. The study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.

Detailed Description
-----------------
The cardiac metabolic disturbance are assessed by a 18F-FDG PET/CT in the first week after SAH and monthly until normal result. The myocardial sympathetic innervation is assessed by a cardiac 123I-MIBG scintigraphy in the first week after SAH and six months later. Clinical outcome is assessed by Glasgow Outcome Scale, modified Rankin Scale and MOS-SF36 at 1, 3 and 6 months after SAH.

Official Title
-----------------
Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.

Conditions
-----------------
Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age SAH Hospitalization in the Military Teaching Hospital Sainte Anne Exclusion Criteria: Refusal of consent

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 |
| --- | --- |
| Subarachnoid hemorrhage<br>Patients presenting a SAH | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac 18F-FDG PET |  | first week after SAH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac 123I-MIBG scintigraphy |  | first week after SAH | 
| cardiac 18F-FDG PET |  | one month after first cardiac 18F-FDG PET | 
| cardiac 123I-MIBG scintigraphy |  | Six months after SAH | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subarachnoid hemorrhage, scintigraphy, neurocardiogenic injury
A Bioequivalence Study of Tobradex AF

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.

Official Title
-----------------
A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
* Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Other protocol-defined exclusion criteria may apply

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobradex AF<br> | Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension<br>* One drop in the study eye, single dose<br>|
| Active Comparator: TOBRADEX<br> | Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)<br>* One drop in the study eye, single dose<br>* Other names: TOBRADEX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of dexamethasone in aqueous humor following a single topical ocular administration |  |  |
Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes

Official Title
-----------------
Efficacy and Efficiency of Uterocervical Angle for Prediction of Labor Timing in Patients With Preterm Premature Rupture of the Membranes: a Prospective Cohort Study

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Diagnostic Test: uterocervical angle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no previous systemic illnesses Preterm Premature Rupture of the Membranes Exclusion Criteria: abnormal Pap smear previous cesarean section history of dilatation and curettage (D&C) history of loop electrosurgical excision procedure (LEEP) and cervical conization

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

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: uterocervical angle<br>uterocervical angle is the angle between lower segment of uterus and cervix | Diagnostic Test: uterocervical angle<br>* uterocervical angle is the angle between lower segment of uterus and cervix<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes | During the study period, women were enrolled and uterocervical angle were measured in the first evaluations of polyhydramnios patients in policlinics. Routine pregnancy follow-up was done by our team and weeks of delivery and maternal-fetal outcomes were noted. | 7 month] |
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

Detailed Description
-----------------
Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).

Official Title
-----------------
A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: ZSTK474


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese males or females >= 20 years old Advanced (metastatic or unresectable) solid tumor ECOG performance status score of 0 or 1 and expected survival >12 weeks Recovered from hematological toxicities of prior cancer therapies Exclusion Criteria: Previous treatment with PI3K inhibitor Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease. Other investigational agent within previous 4 weeks Participating in another clinical study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: 5/2 Dosing<br>Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug. | Drug: ZSTK474<br>* Two arms, each with serial cohorts receiving escalating doses.<br>|
| Experimental: Arm 2: 21/7 Dosing<br>Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug. | Drug: ZSTK474<br>* Two arms, each with serial cohorts receiving escalating doses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dose-limiting toxicities |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax, tmax, t½, AUC) |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PI3K inhibitor, clinical trial
Tailored Interventions to Improve Hypertension Management After Stroke or Transient Ischemic Attack (TIA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of interventions to improve adherence to medication and healthier lifestyle choices on blood pressure over a 6 month period in a group of people at high risk for recurrent stroke events. The participants have already had a stroke or TIA, and have uncontrolled blood pressure, as well as problems with memory and problem-solving, or miss taking medications, or who do not believe in the effectiveness of their medications. Interventions focus on motivational interviewing, adherence counseling with memory cuing, and self-monitoring of blood pressure.

Detailed Description
-----------------
randomized, controlled trial at 4 sites measurement of blood pressure, missed pills, self-efficacy rating at baseline and 6 months contacting family pharmacists to evaluate prescription renewal patterns at baseline and 6 months

Official Title
-----------------
Tailored Interventions to Improve Hypertension Management After Stroke or TIA

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: lifestyle counseling, home blood pressure monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of stroke or TIA hypertension Montreal Cognitive Assessment score less than 26 self report of missed pills self-efficacy rating less than 100% Exclusion Criteria: inability to give informed consent 18 years of age or younger

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Adherence counseling<br> | Behavioral: lifestyle counseling, home blood pressure monitoring<br>* monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group<br>* Other names: motivational interviewing;|
| Usual care<br> | Behavioral: lifestyle counseling, home blood pressure monitoring<br>* monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group<br>* Other names: motivational interviewing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 6 months from baseline testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-efficacy rating |  | 6 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, stroke, adherence
The Effects of Chronic Otitis Surgery on SVV

Study Overview
=================
Brief Summary
-----------------
Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma.

Detailed Description
-----------------
All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.

Official Title
-----------------
The Effects of Chronic Otitis Surgery on Virtual Subjective Vertical

Conditions
-----------------
Chronic Otitis Media

Intervention / Treatment
-----------------
* Diagnostic Test: Subjective Visual Vertical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Otitis Media Who had surgical treatment Exclusion Criteria: A patient who had the vestibular disease before Neurologic disease Patients who had ear, brain and musculoskeletal surgery before

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery group<br>Subjects who will have chronic otitis media surgery will be included in the study. | Diagnostic Test: Subjective Visual Vertical<br>* All subjects will have Virtual SVV before and after the operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVV angle | Right and Left deviation angle when head tilted 15, 30, and 45 degree | 1 week |
Vascular Response to Isoproterenol and β2 Adrenergic Receptor Polymorphisms

Study Overview
=================
Brief Summary
-----------------
Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic receptor (ß2AR) modify its pharmacological properties and may alter the response to ß2AR agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries segments ex-vivo. Internal mammary leftover segments were collected from 96 patients undergoing coronary artery bypass graft operation. Four rings that were prepared from each specimen were allowed to reach equilibrium with physiological Krebs solution prior to precontraction with U46619. Using the organ bath technique, cumulative dose response curve of isoproterenol was constructed and mean EC50 calculated for each patient.

Official Title
-----------------
ß2 Adrenergic Receptor Polymorphisms and Vasodilation of Internal Mammary Artery Induced by Isoproterenol

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Drug: Isoproterenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled to undergo coronary artery bypass graft operation Exclusion Criteria: Chronic treatment with corticosteroids

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

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ec50% in response to rising concentration of isoproterenol |  |  |
Cesarean Postoperative Pain Satisfaction

Study Overview
=================
Brief Summary
-----------------
Hypothesis: There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.

Detailed Description
-----------------
There is a significant difference between Cesarean patients' perceptions of advantages and disadvantages of three postoperative pain management methods identified by obstetrical patients. Participants will be introduced to study by anesthesia personnel in labor and delivery. The subject will be informed of the desire for their input on their perceived satisfaction with their chosen method for post-operative pain management and will be asked to participate in an anonymous survey by their second day after surgery. They will be informed that this is voluntary. Method of post-operative medication administration will be determined by attending physician to be either: epidural, IVPCA, or oral medication. Methods will be initiated in recovery room or the operative suite. Subjects will be identified on a postpartum admission log and a screening log will be created for study purposes. Informed Consents will be obtained. The screening log entries will be numbered corresponding to a numbered survey. The screening log will contain demographic and other patient identifiers including age, ethnicity, parity, presence of labor prior to cesarean, admission status of baby, cost associated with method and presence of rescue drugs and costs of rescue drugs and method services. Refusal information, exclusion criteria, and time/date of survey completion will also be recorded. This log will be maintained under lock and key.

Official Title
-----------------
Cesarean Postoperative Pain Satisfaction With Intravenous Patient-Controlled Analgesia Intravenous, Oral, or Epidural Method

Conditions
-----------------
Cesarean

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking post-operative cesarean patients Exclusion Criteria: Cesarean patients with know fetal demise General/Local Anesthetic Method for Cesarean

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |