linjc16/ctgov huggingface dataset:
Multifocal Electroretinogram in Normal Egyptian Population

Study Overview
=================
Brief Summary
-----------------
Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.

Detailed Description
-----------------
Normal parameters for electroretinogram (ERG) is important in studying specific population, studying normal subjects is important to create specific normal database for each population. This will help in accurate differentiation for various ocular diseases and in research trials.

Official Title
-----------------
Normal Multifocal Electroretinogram in Egyptian Population.

Conditions
-----------------
Retinal Disease, Healthy Population

Intervention / Treatment
-----------------
* Device: Multifocal electroretinogram (mf-ERG) by electroretinogram device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects seeking regular ophthalmic check-up at banha university hospital. Exclusion Criteria: Any retinal diseases that may affects mf-ERG waves. Subjects with best corrected visual acuity less than 0.7 in decimal form at time of examination. Refractive errors more than 0.5 diopter as measured by autorefractometer.

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Multifocal electroretinogram in normal population
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal subjects<br>Normal subjects at banha university that are seeking regular ophthalmic check-up. | Device: Multifocal electroretinogram (mf-ERG) by electroretinogram device<br>* Measurement of mf-ERG parameters with 61 stimulus elements to asses amplitude of waves in nano volt/degree square (nv/deg2) and latency in millisecond (msec) as measured by electroretinogram device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of waves in nv/deg2 | Measurement of the amplitude of N1 and P1 waves. | immediately after mf-ERG diagnostic test for each eye. | 
| Latency of waves in msec. | Measurement of the latency of N1 and P1 waves. | immediately after mf-ERG diagnostic test for each eye. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between different age groups in mf-ERG readings. | Statistical analysis for mf-ERG amplitude and latency in different age groups. | immediately after mf-ERG diagnostic test for each eye. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
normal, electroretinogram, delta population
Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function

Study Overview
=================
Brief Summary
-----------------
Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.

Conditions
-----------------
Executive Function

Intervention / Treatment
-----------------
* Other: Cognitive function after exercise test
* Genetic: Blood sample analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical Education Students Able to sign consent form Exclusion Criteria: Competitive athletes Smokers Neurologic or psychologic orders Chronic diseases Head Injuries Hospitalization in the previous 3 months Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>Each individual subject will give a blood sample for genetic analysis and undertake an exercise session and a rest session as a control. Cognitive function will be tested before and after each session. | Other: Cognitive function after exercise test<br>* The individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests.<br>Genetic: Blood sample analysis<br>* In the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Functioning After Exercise | Computerized battery of tests evaluating cognitive functioning | Five minutes |
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health

Study Overview
=================
Brief Summary
-----------------
During the current COVID-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. Patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks. Scientific studies regarding the effects of face masks have so far focused exclusively on medical staff. Studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion). Therefore, the present study aims at performing a questionnaire survey regarding self-perceived dry mouth and halitosis and the use of face masks (type, wearing time).

Official Title
-----------------
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health

Conditions
-----------------
Dry Mouth, Halitosis

Intervention / Treatment
-----------------
* Other: Invitation to participate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, visitors, and staff members of the University Medical Center Goettingen Exclusion Criteria: N/A

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
Intervention Model: Single Group Assignment
Interventional Model Description: Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within the survey study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Questionnaire survey<br>Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment. | Other: Invitation to participate<br>* Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-perceived dry mouth | Questionnaire items based on the shortened Xerostomia Inventory | During the 1 day of questionnaire survey | 
| Self-perceived halitosis | Questionnaire items | During the 1 day of questionnaire survey |
Vienna Versus SARS-CoV-2 Virus Study

Study Overview
=================
Brief Summary
-----------------
This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.

Detailed Description
-----------------
This study consists of 2 parts: a longitudinal study enrolling 3,000 health care professionals at the Vienna General Hospital testing their antibody status 6 times over a period of 12 months (Cohort A), and a serial cross-sectional study of 3,000 patients (i.e., a total of 9,000 patients) admitted to the Vienna General Hospital for non-COVID-19-related symptoms at 3 different time points during this pandemic (Cohort B).

Official Title
-----------------
Vienna Versus SARS-CoV-2 Virus: A Prospective Large-scale Antibody Study of SARS-CoV-2 in Patients and Health Care Workers

Conditions
-----------------
SARS-CoV-2, COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: Laboratory Analyses


Participation Criteria
=================
Eligibility Criteria
-----------------
Cohort A: Inclusion criteria: Physicians Nursing staff Midwives Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants) Administrative personnel with patient contact Exclusion Criteria: Not employed at the Medical University of Vienna or the Vienna General Hospital No signed informed consent Cohort B: Inclusion Criteria: ● Patients with available residual serum samples Exclusion Criteria: ● Serum samples from COVID-19 triage units at the Vienna General Hospital
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health care workers<br>Physicians, Nursing staff, Midwives, Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants), administrative personnel with patient contact | Diagnostic Test: Laboratory Analyses<br>* Storage of serum for SARS-CoV-2-antibodies and biomarkers<br>|
| Patients<br>Patients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples. | Diagnostic Test: Laboratory Analyses<br>* Storage of serum for SARS-CoV-2-antibodies and biomarkers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of sero-conversion |  | 1 year | 
| Identification of risk markers/factors for SARS-CoV-2 infection |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunity, COVID-19, SARS-CoV-2, Antibodies, Virus, Respiratory Virus, Immunoglobulins
Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote

Study Overview
=================
Brief Summary
-----------------
This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote

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

Intervention / Treatment
-----------------
* Biological: PRT064445
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men or women between the ages of 18 and 50 years old, inclusive BMI 19-32 and weighs at least 60kgs Exclusion Criteria: History or symptoms of bleeding problems or thrombotic conditions Clinically significant medical history Major surgery, severe trauma, or bone fracture within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRT0064445 Dose 1<br>Dose 1 versus Placebo | Biological: PRT064445<br>* Intravenous<br>Drug: Placebo<br>* Intravenous to mimic PRT064445<br>* Other names: Placebo (for PRT064445);|
| Experimental: PRT064445 Dose 2<br>Dose 2 versus Placebo | Biological: PRT064445<br>* Intravenous<br>Drug: Placebo<br>* Intravenous to mimic PRT064445<br>* Other names: Placebo (for PRT064445);|
| Experimental: PRT064445 Dose 3<br>Dose 3 versus Placebo | Biological: PRT064445<br>* Intravenous<br>Drug: Placebo<br>* Intravenous to mimic PRT064445<br>* Other names: Placebo (for PRT064445);|
| Experimental: PRT064445 Dose 4<br>Dose 4 versus Placebo | Biological: PRT064445<br>* Intravenous<br>Drug: Placebo<br>* Intravenous to mimic PRT064445<br>* Other names: Placebo (for PRT064445);|
| Experimental: PRT064445 Dose 5<br>Dose 5 versus Placebo | Biological: PRT064445<br>* Intravenous<br>Drug: Placebo<br>* Intravenous to mimic PRT064445<br>* Other names: Placebo (for PRT064445);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics assessments |  | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Plasma levels of PRT064445 |  | Up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.

Official Title
-----------------
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: denosumab
* Drug: teriparatide
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 45+ postmenopausal osteoporotic with high risk of fracture Exclusion Criteria: no significant previous use of bone health modifying treatments

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose teriparatide<br>teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 | Drug: denosumab<br>* denosumab subcutaneous injection<br>* Other names: Prolia;Drug: teriparatide<br>* teriparatide daily subcutaneous injection<br>* Other names: Forteo;Drug: Zoledronic acid<br>* zoledronic acid infusion<br>* Other names: Reclast;|
| Active Comparator: High dose teriparatide<br>teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 | Drug: denosumab<br>* denosumab subcutaneous injection<br>* Other names: Prolia;Drug: teriparatide<br>* teriparatide daily subcutaneous injection<br>* Other names: Forteo;Drug: Zoledronic acid<br>* zoledronic acid infusion<br>* Other names: Reclast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) |  | Baseline and 42 months |
Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: KLS-0611


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal and conjunctival damage Insufficiency of lacrimal secretion Ocular symptom Exclusion Criteria: Severe ophthalmic disorder Punctual plugs or surgery for occlusion of the lacrimal puncta

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: KLS-0611<br> | Drug: KLS-0611<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal-conjunctival staining |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndromes, Corneal diseases, Conjunctival Diseases
Coherence Imaging of the Cervical Epithelium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.

Official Title
-----------------
Coherence Imaging of the Cervical Epithelium

Conditions
-----------------
Cervical Epithelia

Intervention / Treatment
-----------------
* Device: mLCI Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to provide informed consent willing to abstain from sexual intercourse for at least 24 hours before study visit Exclusion Criteria: pregnant using an intrauterine device (IUD) have a current gynecological infection or discharge have had any cervical surgery had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months currently enrolled in any research studies involving the application of vaginal formulations employed or supervised by the study investigators have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

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

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: mLCI imaging<br>mLCI device images cervical epithelium | Device: mLCI Device<br>* imaging of cervical epithelium using mLCI device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Interferometric Data Acquired From Cervical Epithelium | measured by: ability to receive interferometric data from at least one portion of the cervical epithelium | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Automated Classification of Cervical Epithelium | The number of patients for which an interferometric tissue classification was made using optical mLCI data | day 1 | 
| Number and Frequency of Adverse Events | Number of adverse events experienced by patients during the mLCI study. | day 1 |
Treatment of Vesico-vaginal Fistula by a Robot Assisted Laparoscopy : Results of a Multicentric Series (FFVLARO)

Study Overview
=================
Brief Summary
-----------------
Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.

Official Title
-----------------
Multicentric Retrospective Evaluation of the Vesico-vaginal Fistula Repair by Robot Assisted Laparoscopy

Conditions
-----------------
Vesico-vaginal Fistula

Intervention / Treatment
-----------------
* Procedure: vesico-vaginal fistula robot assisted laparoscopic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of a vesico-vaginal fistula Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: vesico-vaginal fistula robot assisted laparoscopic repair|realization of O'conor technique or extra-vesical technique for vaginal vesico fistula repair in robot assisted coelioscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube |  | 1 years |