linjc16/ctgov huggingface dataset:
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops

Conditions
-----------------
Contact Lens Dry Eye

Intervention / Treatment
-----------------
* Drug: azithromycin ophthalmic solution, 1%
* Drug: Visine® for Contacts®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a history of and current complaint of CLDE. Use properly fitted daily-wear soft contact lenses. Able to wear contact lenses for at least 8 hours a day. If female, are non-pregnant or non-lactating. Exclusion Criteria: Have changed brand of contact lens or care solutions within one month prior to Visit 1. Use extended (overnight) wear contact lenses. Have a clinically significant ophthalmic abnormality. Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening. Have any active ongoing ocular infection or ocular disease. Have a serious medical condition which could confound study assessments.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: azithromycin ophthalmic solution, 1%<br> | Drug: azithromycin ophthalmic solution, 1%<br>* 1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)<br>|
| Experimental: rewetting drops<br> | Drug: Visine® for Contacts®<br>* 1-2 drops QID for the treatment period (29 ± 1 day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint |  | 2 weeks | 
| Subject-reported duration of total contact lens daily wear |  | 4 weeks | 
| Subject-reported rating of overall eye dryness |  | 4 weeks | 
| Contact Lens-Related Dry Eye Questionnaire |  | 4 weeks | 
| Tear hyperosmolarity (mOsm) |  | 4 weeks | 
| Habitual low-contrast visual acuity (LCVA) |  | 4 weeks |
Cytokine Profile and Metal Ion Concentrations at Patients Undergoing a Revision THR

Study Overview
=================
Brief Summary
-----------------
To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from patients undergoing a hip revision.

Conditions
-----------------
Hip Revision

Intervention / Treatment
-----------------
* Device: Hip prosthesis revision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: THR revision

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hip prosthesis revision|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prevalence of Lymphoma in IBD

Study Overview
=================
Brief Summary
-----------------
Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The majority of lymphomas in patients with IBD occur in areas of active inflammation. The relationship between IBD and lymphoproliferative disease is however unclear, since both chronic inflammation as well as medications used to treat IBD (especially immunosuppressives - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed, community based and referral population from the IBD database at Indiana University.

Official Title
-----------------
Prevalence and Risk Factor for Lymphoproliferative Disease in Patients With Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Disease, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inflammatory Bowel disease Lymphoma

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> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Mandala Intervention on Mental Distress in Nurses Working With Terminally Ill Patients

Study Overview
=================
Brief Summary
-----------------
Mandala application intervention of mental distress in nurses working with terminally ill patients

Detailed Description
-----------------
Questionnaires were applied to the control and experimental groups. Mandala painting was done to the experimental group. Questionnaires were applied to the control and experimental groups again. Distress, anxiety, depression, death anxiety, death depression and psychological well-being of the experimental and control groups were evaluated.

Official Title
-----------------
Mandala Intervention on Mental Health Problems of Nurses Caring for Terminally Ill Patients

Conditions
-----------------
Mental Health Issue

Intervention / Treatment
-----------------
* Behavioral: mandala painting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteer active employee year of study Exclusion Criteria: paint allergy use of psychiatric drugs Loss of loved one in the last six 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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This study is an experimental study with pre-test and post-test control grups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mental health<br>The effect of mandala painting on mental health. Mental health-related anxiety, depression, well-being, distress and death anxiety and depression will be measured. | Behavioral: mandala painting<br>* nurse painted mandala for relaksing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck depresion scale | depresion is mental breakdown, depresion for beck depresion scale, 0-9 depresion emity, 10-15 light depression, 16-23 middle depresion, 24- 63 severe depression | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI-trait anxiety scale | anxiete is boredom, anxiete for trait anxiety scale, 0-15 anxiety none,n , 15-30 light anxiety, 30-60 middle anxiety, over 60 severe anxiety | 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mental health, anxiety, depression
Genetics of Progressive Multifocal Leukoencephalopathy and Acquired Immunodeficiency Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will identify genetic factors associated with the development of progressive multifocal leukoencephalopathy (PML) in patients with acquired immunodeficiency syndrome (AIDS). PML is a life-threatening infection of the brain that affects about 5 percent of untreated patients with AIDS. Its symptoms include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and coma. PML is caused by a polyomavirus called the JC virus. It is estimated that up to 80 percent of the human population has been exposed to the JC virus, but the disease is very rare. The virus only becomes active in people who have compromised immune systems, such as those undergoing immune suppressive chemotherapy for cancer and those with damaged immune systems due to HIV. Patients who have participated in the Multicenter AIDS Cohort Study may be eligible for this study, as well as healthy normal volunteers who will serve as controls. The study will review clinical information from patients and analyze genetic factors from both patients and control subjects to investigate genes associated with AIDS and JC virus infection.

Detailed Description
-----------------
The purpose of this study is to identify host genetic factors that contribute to the development of Progressive Multifocal Leukoencephalopathy (PML) associated with JC virus. JC virus is one of many opportunistic infections that arise in AIDS patients. JC virus is widely distributed in the general population, with estimates of population exposure ranging from 30-80%. JC virus remains latent in the host, and in profoundly immunosuppressed patients, JC virus can cause PML, a fatal disease associated with neurotropic JC virus that lytically infects oligodendrocytes. In untreated AIDS populations, the frequency of PML has been estimated at roughly 5%. This study will identify host genetic factors that may contribute to the development of PML in the AIDS population.

Official Title
-----------------
Influence of Host Genetic Factors in Development of PML in an AIDS Cohort

Conditions
-----------------
PML, AIDS

Participation Criteria
=================
Eligibility Criteria
-----------------
No available subjects will be excluded.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JC Virus, Opportunistic Infection, Single Nucleotide Polymorphism, Genotype, Sequencing
Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss

Study Overview
=================
Brief Summary
-----------------
This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to apply feature extraction and machine learning techniques to non-invasive hemodynamic data to identify early signs of acute blood loss. The availability of this information may help to establish required interventions for treating trauma patients and battlefield casualties. Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation process can be modeled to provide early estimations of blood loss.

Official Title
-----------------
Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss.

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Other: No treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved by Children's Hospital Colorado Blood Donation Center for blood donation Age 18 -89 years Previously donated blood (lower likelihood of vasovagal response) Exclusion Criteria: Pregnant Incarcerated Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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 |
| --- | --- |
| Blood donors<br>Healthy volunteers who are donating a pint of whole blood | Other: No treatment<br>* No treatment, only collecting observational data.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algorithm | Mathematical model of early blood loss | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemorrhage
Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. The investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (LV and RV function) and valvular (Aortic / Mitral / Tricuspid) function and expanded major adverse cardiac events (X-MACE).

Official Title
-----------------
Vascular Surgery Outcomes: Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients

Conditions
-----------------
Left-Sided Heart Failure, Right-Sided Heart Failure, Heart Valve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major vascular surgery operation (e.g. CEA, open aortic repair, suprainguinal and infrainguinal bypasses, EVAR, TEVAR) captured in the UVA Vascular Quality Initiative database Echocardiography within two years of index operation Exclusion Criteria: If patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left ventricular function<br>Depressed LV function LV ejection fraction < 50% LV systolic function; defined as mild / mod / sev decreased LV diastolic function; defined as mild (g1 ) / mod (g2) / sev ( g3) decreased Normal LV function | |
| Right ventricular function<br>Depressed RV function a. RV systolic function defined as mild / mod / sev decreased Normal RV function | |
| Valvular lesions<br>Moderate or severe valvular lesions Aortic stenosis Aortic regurgitation Mitral stenosis Mitral regurgitation Tricuspid regurgitation Clinically normal valvular lesions No valvular lesion Mild stenosis / regurgitation of above mentioned lesions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Major Adverse Cardiac Events | Composite outcome defined as any cardiovascular death, non-fatal MI, non-fatal stroke, post-operative CHF, or new dysrhythmias, all within the index hospital admission. | In-hospital admission (within 120 days of index surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major vascular surgery, major adverse cardiac events
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.

Detailed Description
-----------------
The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate

Official Title
-----------------
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Diagnostic Test: Pharyngeal width measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets the indications for the Inspire Upper Airway Stimulation Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery. Exclusion Criteria: Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement Any other reason the investigator deems that the patient is unfit for participation in the study.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Pharyngeal width measurement|A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy | Pharyngeal width will be measured in millimeters using a caliper | Baseline, prior to routine diagnostic drug induced sleep endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA
The Correlation Between the Thickness of Lipid Layer and the Meibomian Gland Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the correlation between the thickness of lipid layer and the meibomian gland dysfunction.

Official Title
-----------------
The Correlation Between the Thickness of Lipid Layer and the Meibomian Gland

Conditions
-----------------
Meibomian Gland Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent the Meibomian Gland Dysfunction through the signs. Exclusion Criteria: Eye surgery history

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 |
| --- | --- |
| Low-MGD<br> | |
| High-MGD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Layer Thickness |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrophy of Meibomian Gland |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meibomian Gland Dysfunction, Lipid Layer Thickness
Abdominal Versus Vaginal Morcellation in Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

Detailed Description
-----------------
Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.

Official Title
-----------------
Abdominal Manual Morcellation Versus Spiral Morcellation for Retrieval of Large Uteri During Laparoscopic Hysterectomy

Conditions
-----------------
Hysterectomy, Laparoscopy, Uterine Bisection, Large Uteri

Intervention / Treatment
-----------------
* Procedure: Vaginal bisection
* Procedure: Abdominal bisection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: large uterus ≥ 12weeks, benign pathology, mobile uterus Exclusion Criteria: unfit for laparoscopy, pelvic adhesions, endometriosis malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups parallel allocation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Vaginal bisection of uterus | Procedure: Vaginal bisection<br>* Uterine bisection vaginally by scalpel 24<br>|
| Experimental: Control group<br>Abdominal bisection | Procedure: Abdominal bisection<br>* Uterine bisection by endokinfe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrieval time of uterus | Time from end of colpotomy to extraction of uterus | 6 months | 
| Blood loss | Amount of blood in suction | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury of other organs | Number of cases with intraoperative injuries | 6 months |