linjc16/ctgov huggingface dataset:
Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting

Detailed Description
-----------------
To assess physical and emotional symptoms of depressed patients

Official Title
-----------------
Lilly's Emotional and Physical Symptoms of Depression Study

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: duloxetine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria Outpatients at least 18 years of age Sign the informed consent All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study Exclusion Criteria: Are investigator site personnel directly affiliated with the study or immediate family Are employed by Eli Lilly and Company Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry Current substance dependence, excluding nicotine and caffeine Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug Acute liver injury or severe (Child-Pugh Class C) cirrhosis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Severity |  |  | 
| Somatic Symptom Inventory |  |  | 
| Depressive Symptomatology-Self Report |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Improvement |  |  | 
| Mood and Physical Symptoms in Depression |  |  | 
| Quality of Life Enjoyment Satisfaction Questionnaire-Short form |  |  |
BSSPlus Versus Lactated Ringer's for Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery.

Official Title
-----------------
Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution

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

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification
* Drug: BSSPlus solution
* Drug: Lactated Ringer's solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with senile cataract Visual acuity between 20/400 and 20/40 Exclusion Criteria: Presence of corneal opacity Presence of corneal disease Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis) Anterior chamber cells or flare detected before surgery Previous ocular surgery Any condition which may affect documentation or follow-up

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Active Comparator: BSSplus<br> | Procedure: Phacoemulsification<br> <br> Drug: BSSPlus solution<br> <br> |
| Experimental: Ringer<br> | Procedure: Phacoemulsification<br> <br> Drug: Lactated Ringer's solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial cell density |  | baseline and at 1, 8, 15, 30 and 60 days postoperatively | 
| central corneal thickness |  | baseline and at 1, 8, 15, 30 and 60 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of anterior chamber cells and flare grade |  | baseline and at 1, 8, 15, 30 and 60 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, phacoemulsification, irrigation solution, endothelial cell density, corneal thickness
Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics

Study Overview
=================
Brief Summary
-----------------
The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.

Official Title
-----------------
Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study

Conditions
-----------------
Alcohol Related Disorders

Intervention / Treatment
-----------------
* Drug: acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Any patient, regardless of gender or ethnicity, who was: 18 years or older admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance signed a written informed consent form. Patients were excluded from the study at baseline if any of the following were present: serum acetaminophen level greater than 20 mcg/ml serum AST or ALT levels greater than 200 IU/L INR greater than 1.5 if female, positive for beta-subunit of chorionic gonadotropin clinically intoxicated, psychiatrically impaired or unable to give informed consent known hypersensitivity to acetaminophen history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment currently enrolled in another trial or had been enrolled in another trial in the preceding three months.

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change in serum aminotransferase levels between study groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects tht developed an abnormal aminotransferase level |  |  | 
| proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L) |  |  | 
| proportion of subjects that developed drug induced liver injury |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acetaminophen, alcohol, liver injury
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.

Official Title
-----------------
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: vorinostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug Patient did not withdraw from the base protocol Patient agrees to practice effective birth control during the study Exclusion Criteria: Patient is receiving other standard and/or investigational anticancer therapy Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vorinostat<br> | Drug: vorinostat<br>* All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.<br>* Other names: MK-0683;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With a Serious Drug-related Adverse Event (AE) | A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug. | From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months) |
Lees Screen in Concomitant Strabismus

Study Overview
=================
Brief Summary
-----------------
Preoperative and postoperative Lees screen was done after concomitant horizontal strabismus surgery to detect any limitation in the field of operated muscle

Detailed Description
-----------------
Preoperative and postoperative Lees screen was done for concomitant esotropia and exotropia patients to record any change in ocular motility as regards underaction or overaction in the operated extra ocular muscles

Official Title
-----------------
Changes in Range of Ocular Motility Following Horizontal Rectus Muscle Surgery in Concomitant Strabismus; a Quantitate Measurements Using Lees Screen

Conditions
-----------------
Strabismus

Intervention / Treatment
-----------------
* Procedure: strabismus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Concomitant esotropia Concomitant exotropia Above 10 years old patients Exclusion Criteria: Restrictive and paralytic strabismus Previous strabismus surgery Mental disability

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 40 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
Interventional Model Description: detect if there are any change in motility after concomitant horizontal muscle surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Concomitant strabismus patients<br>Horizontal strabismus surgery | Procedure: strabismus surgery<br>* Lees screen before and after concomitant strabismus surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative Lees screen | detect any restriction in muscle field | 3 months |
Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Study Overview
=================
Brief Summary
-----------------
To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.

Detailed Description
-----------------
The purpose of the study is to conduct surveillance for Hib disease. Prospective active population-based surveillance for invasive Hib disease, conducted by the Center for Disease Control and Prevention (CDC) Active Bacterial Core (ABCs) program within geographic regions currently representing 12% of the US population, will provide Hib case-occurrence (numerator) data. The ABCs program and the National Center for Health Statistics will provide annual estimates of the number of persons under surveillance, by age group, within the ABCs catchment area. Ongoing telephone sample surveys, conducted by M/A/R/C, a national sampling organization, will provide brand-specific vaccine exposure data by age group within the ABCs program catchment area at appropriate pre-specified intervals (denominator data).

Official Title
-----------------
Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

Conditions
-----------------
Haemophilus Infections, Diphtheria, Tetanus, Polio, Pertussis

Intervention / Treatment
-----------------
* Biological: DTaP-IPV/Hib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residence within the geographic scope of Active Bacterial Core surveillance (ABCs) during the period of surveillance Aged 0 through 59 months (prior to 5th birthday) on the day of inclusion for Hib disease surveillance and 2 through 23 months (prior to 2nd birthday) for Hib vaccine brand usage survey. 2009-2014 calendar years inclusive. For the Hib vaccine usage survey, agreement to complete the required survey. Exclusion Criteria: Not applicable.

Ages Eligible for Study
-----------------
Maximum Age: 59 Months

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 |
| --- | --- |
| Hib vaccine<br>Participants has received at least one dose of an Hib vaccine | Biological: DTaP-IPV/Hib<br>* 0.5 mL, Intramuscular<br>* Other names: PedvaxHIB™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. |  | Up to 6 years post vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diphtheria, Tetanus, Pertussis, Poliovirus types 1-3, Haemophilus influenzae type b, Pentacel®
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.

Official Title
-----------------
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Sugammadex
* Drug: Neostigmine
* Drug: Glycopyrrolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing burn surgery under general anesthesia Exclusion Criteria: Patients without a non-burned upper extremity Renal insufficiency or failure Sensitivity or hypersensitivity reaction to sugammadex Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Sugammadex<br>Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV. | Drug: Sugammadex<br>* Sugammadex is indicated for the reversal of neuromuscular blockade.<br>|
| Active Comparator: Neostigmine<br>Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV. | Drug: Neostigmine<br>* Neostigmine is indicated for the reversal of neuromuscular blockade.<br>Drug: Glycopyrrolate<br>* Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to a 90% Train of Four (TOF) neuromuscular twitch |  | Within 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to endotracheal extubation |  | Within 24 hours after surgery | 
| Time to discharge from the operating room |  | Within 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle function
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. This study is based on the hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women receiving surgical abortions up to 12 weeks gestation.

Detailed Description
-----------------
We intend to conduct a prospective cohort study at Oregon Health and Science University and the University of Hawaii. This study will not be blinded and subjects will not be randomized. Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. For patients who are receiving anticoagulant medications, the decision to continue anticoagulant therapy or interrupt it will be made by the patient's physician, independently of this study. We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment. This is a matched study and our control group will be matched for gestational age, parity, and cesarean section history.

Official Title
-----------------
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women

Conditions
-----------------
Blood Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female seeking abortion services Less than or equal to 12 weeks gestation Age 18-50 Willing and able to sign informed consent Use of Coumadin or LMW heparin (treatment group only) Exclusion Criteria: Unwilling or unable to sign informed consent Women taking daily aspirin or herbal therapies containing gingko biloba Women with a known history of a bleeding disorder such as von willebrand's disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women who are anticoagulated. | |
| 2<br>Matched case controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Intraoperative Blood Loss | Quantitative blood loss using volume measurement and weight | Post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulation, surgical abortion