linjc16/ctgov huggingface dataset:
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Study Overview
=================
Brief Summary
-----------------
To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.

Official Title
-----------------
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: NGENUITY
* Device: Conventional microscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent Either eye or both eyes may participate Exclusion Criteria: Lack of patient cooperation severely affecting ability to place stent with any visualization technique Angle abnormalities including PAS in nasal quadrant Unable to properly visualize the angle due to complicated cataract 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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGENUITY<br>Research fellow participants utilize NGENUITY during micro-stent placement | Device: NGENUITY<br>* Device for 3-D viewing during placement of micro-stent placement.<br>|
| Active Comparator: Conventional microscope<br>Research fellow participants utilize conventional microscope during micro-stent placement | Device: Conventional microscope<br>* Device for stereoscopic viewing during placement of micro-stent placement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first cannula in until satisfactory stent placement and cannula out |  | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of trabecular meshwork piercing attempts needed to place stent |  | up to 1 hour | 
| Number of anterior chamber entry and reentry attempts during stent placement |  | up to 1 hour | 
| Number of microscope focus or position readjustments needed during stent placement |  | up to 1 hour | 
| Change in attending/fellow questionnaire | Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Rating are on a scale of 1 to 5. Higher scores correspond to excellent ratings; or confidence in using the system and system performance, lower numbers correspond to a preference for NGenuity visualization. | Up to 5 minutes |
CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients. Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of patient standard of care stress echocardiogram (SE) and of diastolic function. We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications, CIMT and plaque assessment will provide useful risk stratification beyond use of traditional risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise capacity and 3) Exercise capacity will correlate with diastolic function.

Official Title
-----------------
Carotid Intima-Media Thickness and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification

Conditions
-----------------
Cardiovascular Risk Stratification, Carotid Intima-media Thickness (CIMT), Stress Echocardiography (SE)

Intervention / Treatment
-----------------
* Other: Carotid Intima-Media Thickness (CIMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic No prior cardiac history (MI, PTCA, CABG, angina) No peripheral vascular disease No history of stroke or TIA Statins, antihypertensives, ASA treatment OK Exclusion Criteria: History of CAD, CABG, PTCA, coronary or peripheral stenting History of stroke/TIA/peripheral vascular disease Inability to exercise on the treadmill Unwilling/unable to sign informed consent History of neck radiation or neck surgery or inability to obtain neck images End stage renal disease Preoperative evaluation History of chest pain

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 |
| --- | --- |
| Stress Echocardiography (SE)<br>Subjects will undergo CIMT measurements. | Other: Carotid Intima-Media Thickness (CIMT)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram | We are comparing the % of patients with abnormal IMT defined as presence of plaque (= or >1.5mm) or CIMT >75% percentile for age, race, and gender compared to % of patients with positive ischemia on stress echocardiogram as defined by a new wall motion abnormality on echocardiogram with stress. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Risk Stratification, Carotid intima-media thickness (CIMT), Stress echocardiography (SE)
A Comprehensive Study to Isolate Tumor-initiating Cells From Human Epithelial Malignancies

Study Overview
=================
Brief Summary
-----------------
We hypothesize that all human malignancies harbour a subpopulation of tumor initiating cells/cancer stem cells (CSCs) that drives tumor development and potentially recurrence or metastasis of the disease. The primary aim of this study is to develop strategies for prospective isolation/enrichment of CSCs from human tumors of different tissue origins. In addition, we will characterize the signaling pathways and/or tumor specific antigens that are specific for CSCs, in order to specifically target these CSCs as the endpoint of this study.

Official Title
-----------------
A Comprehensive Study to Isolate Tumor-initiating Cells From Human Epithelial Malignancies

Conditions
-----------------
Bladder Cancer, Skin Cancers, Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:N/A. We will recruit all non-melanoma skin and bladder cancer patients that are recommended for surgical removal of tumor tissues. This includes patients from all ages, gender and ethnicity background. Our sample collection criteria based on the tumor size of individual (e.g. tumor samples will only be collected if it will not affect the pathological diagnosis or treatment procedures of patients). Exclusion Criteria:N/A

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 |
| --- | --- | --- |
| Measurement of cancer stem cells (CSCs) |  | The current study does not include the active involvement of patients. Our study involves the collection of tumor samples from patients after surgical procedures. |
Study of Blood Samples in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying the genes expressed in samples of blood from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to chemotherapy. PURPOSE: This clinical trial is studying blood samples in patients with breast cancer.

Detailed Description
-----------------
OBJECTIVES: Identify constitutional gene variants associated with a change in response. OUTLINE: Blood samples are collected periodically for analysis of genetic factors.

Official Title
-----------------
Search for Genetic Factors Predictive of Response to Chemotherapy in Patients With or Who Has a Mammary Adenocarcinoma in Neo-adjuvant or Metastatic Setting

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed breast carcinoma Received first-line chemotherapy (in neoadjuvant or metastatic setting) comprising anthracyclines and/or taxanes, including for a second primary cancer Patient agrees to conservative surgery Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified No contraindication for chemotherapy comprising anthracyclines and/or taxanes PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior adjuvant therapy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

Study Overview
=================
Brief Summary
-----------------
Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.

Official Title
-----------------
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

Conditions
-----------------
Hepatitis, Tuberculosis

Intervention / Treatment
-----------------
* Drug: N Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Two sputum specimens positives for tubercle bacilli on direct smear microscopy No previous anti-TB chemotherapy higher than two weeks Aged 60 years and over Agreement to participate in the study Exclusion Criteria: Alcohol consumption Viral disease (Hepatitis,...) Abnormal pretreatment LFT level Chronic disease (liver and kidney disease, asthma,...) Additional hepatotoxic drug use HIV positive Liver TB Patient in a moribund state Hemoptysis

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N Acetylcysteine|1200 mg, BD, 2weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatotoxicity |  | Two weeks |
Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.

Detailed Description
-----------------
The data will be retrieved from the archival files and analyzed

Official Title
-----------------
Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM) at AIN Shams Maternity Hospital: A Retrospective Analysis of Last Five Years Admissions

Conditions
-----------------
Premature Rupture of Membrane

Intervention / Treatment
-----------------
* Biological: rupture of membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rupture of membrane Exclusion Criteria: medical disorder

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ROM before 34 weeks (A)<br>premature rupture of membrane before 34 weeks | Biological: rupture of membrane<br> <br> |
| ROM after 34 weeks (B)<br>premature rupture of membrane after 34 weeks | Biological: rupture of membrane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal mortality | maternal mortality | up to 48 hours after delivery |
Tear Dynamics After Restasis Treatment in Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.

Detailed Description
-----------------
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.

Official Title
-----------------
Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant will be eligible for entry in the study if s/he: Is at least 18 years old and has full legal capacity to volunteer; Has read and signed the IRB Informed Consent Document; Is willing and able to follow participant instructions; Has clear corneas; Has 20/100 uncorrected visual acuity or better; Has dry eye according to the study definition of DES (study subjects); Has not use Restasis within 3 months. Exclusion Criteria: The subjects will ineligible for entry into the study if s/he: Has any systemic disease affecting ocular health except for Sjögren's syndrome; Is using any systemic or topical medications that will affect ocular health except for artificial tears; Has an active ocular disease other than DES, or Sjögren's syndrome Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities; Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES; Has worn rigid gas permeable lenses within 1 year and during the study; Has had surgery or an eye injury within 6 months; Was a soft contact lens wearer within 2 weeks and during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment. |  | 3 months for treatment and follow-up of 6 months after discontinuation of study treatment. | 
| Tear meniscus volume after treatment | Significant increase in tear meniscus volume was found in patients after 3 months of treatment. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, Optical coherence tomography
Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?

Study Overview
=================
Brief Summary
-----------------
The present study will seek to quantify the muscle protein synthetic response to mycoprotein feeding, comparing it to milk protein as a gold standard and heavily researched positive control

Official Title
-----------------
Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?

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

Intervention / Treatment
-----------------
* Other: Mycoprotein beverage
* Other: Milk protein beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • BMI between 18 and 30 - Exclusion Criteria: Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) Any diagnosed cardiovascular disease or hypertension. Elevated blood pressure at the time of screening (e.g. blood pressure of ≥140/90mmHg). Chronic use of any prescribed or over the counter pharmaceuticals. A personal or family history of epilepsy, seizures or schizophrenia. Anyone with previous motor disorders. An allergy to mycoprotein / Quorn, penicillin, or milk.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mycoprotein beverage<br> | Other: Mycoprotein beverage<br>* Mycoprotein protein beverage<br>|
| Placebo Comparator: Milk protein beverage<br> | Other: Milk protein beverage<br>* Milk protein beverage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle fractional synthetic rate (muscle protein synthesis) |  | 7.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma amino acid concentration |  | 7.5 hours | 
| Serum insulin concentration |  | 7.5 hours | 
| Molecular markers of muscle anabolism |  | 7.5 hours |
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).

Official Title
-----------------
Post-Approved Phase III Study of 1-LV/5FU Therapy

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Isovorin
* Drug: TS-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastric cancer diagnosed histologically or cytologically Normal organ function of bone marrow, heart, liver and kidney Age of 20-77 Other inclusion applies Exclusion Criteria: Serious infection, heart disease, complication or organ disorder Ongoing administration of flucytosine Pregnant or breastfeeding women Other exclusion applies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 77 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Isovorin|nan|
|Drug: TS-1|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, duration of response, time to progression, safety, quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Advanced/Recurrent Gastric Cancer