TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 50 mg t.i.d. in Patients With Osteoarthritis
Brief Summary: The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.


Options:
A: Inclusion Criteria:

* Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years

Exclusion Criteria:

* Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation.
* Concomitant therapy of warfarin, heparin, high-dose aspirin (\>100 mg/day).
* Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontrolled high blood pressure, active hepatitis/hepatic disease
B: Inclusion Criteria:

* Males and females 50 years or older with rheumatoid arthritis.

Exclusion Criteria:

* History of gastrointestinal malabsorption or inflammatory bowel disease
* History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.
C: Inclusion Criteria:

* Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief

Exclusion Criteria:

* Known allergies to the study drugs
D: Inclusion Criteria:

* Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
* Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

* Active GD ulceration or GD ulceration within 90 days of the screening visit.
* Concomitant use of low dose aspirin
* Previous MI, stroke or significant vascular disease.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.


Options:
A: Inclusion Criteria:

* Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief

Exclusion Criteria:

* Known allergies to the study drugs
B: Inclusion Criteria:

* Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years

Exclusion Criteria:

* Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation.
* Concomitant therapy of warfarin, heparin, high-dose aspirin (\>100 mg/day).
* Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontrolled high blood pressure, active hepatitis/hepatic disease
C: Inclusion Criteria:

* Males and females 50 years or older with rheumatoid arthritis.

Exclusion Criteria:

* History of gastrointestinal malabsorption or inflammatory bowel disease
* History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.
D: Inclusion Criteria:

* Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
* Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

* Active GD ulceration or GD ulceration within 90 days of the screening visit.
* Concomitant use of low dose aspirin
* Previous MI, stroke or significant vascular disease.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma
Brief Summary: The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.


Options:
A: Inclusion Criteria:

* Children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute moderate to severe asthma is defined as modified pulmonary index score of more than 9.

Exclusion Criteria:

* Children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium).
* Children who had received montelukast within one week of arrival.
* Children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma.
* Children with altered sensorium/unable to take oral medication.
B: Inclusion Criteria:

* Children aged 2-16 years (inclusive) arriving at the Emergency Department with acute wheeze/asthma

Exclusion Criteria:

* Children requiring high dependency care
* Children with significant neurological or cardiac disease
C: Inclusion Criteria:

acute asthma FEV1\<60% post-standard care age 18-55 years -

Exclusion Criteria:

other chronic lung illness pregnancy -
D: Inclusion Criteria:

* Individuals with acute asthma

Exclusion Criteria:

* Women of child bearing age
* History of Chronic Obstructive Pulmonary Disease (COPD)

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trial to Reduce Cardiovascular Events With Aranesp® Therapy
Brief Summary: The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD


Options:
A: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
* active malignancy;
B: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period.

Exclusion Criteria:

* previous therapy with epoetin within 8 weeks prior to screening;
* overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
* RBC transfusions within 8 weeks before screening or during screening period;
* active malignant disease except non-melanoma skin cancer.
C: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving IV epoetin for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
D: Inclusion Criteria:

* Hemoglobin less than or equal to 11 g/dL
* History of Chronic Kidney Disease
* eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
* Tsat (transferrin saturation) greater than 15%

Exclusion Criteria:

* Uncontrolled hypertension
* Erythropoietic protein use within 12 weeks of randomization

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trial to Reduce Cardiovascular Events With Aranesp® Therapy
Brief Summary: The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD


Options:
A: Inclusion Criteria:

* adult patients, \>18 years of age;
* patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.
B: Inclusion Criteria:

* Hemoglobin less than or equal to 11 g/dL
* History of Chronic Kidney Disease
* eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
* Tsat (transferrin saturation) greater than 15%

Exclusion Criteria:

* Uncontrolled hypertension
* Erythropoietic protein use within 12 weeks of randomization
C: Inclusion Criteria:

1. Chronic renal failure with an estimated glomerular filtration rate \< 60 milliliter per minute per 1.73m\^2 and not expected to begin dialysis for at least 12 weeks.
2. Two consecutive hemoglobin values ≥ 8.0 g/dL and \< 11.0 g/dL within 4 weeks prior to randomization.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding.
2. Treatment with an ESA in the 12 weeks prior to randomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
5. Known bleeding or coagulation disorder.
6. Known hematologic disease or cause of anemia other than renal disease
7. Poorly controlled hypertension
8. Evidence of active malignancy within one year prior to randomization.
9. A scheduled kidney transplant
D: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant or lactating;
* previous treatment with erythropoietin or other erythropoietic substance;
* blood transfusion within the last 3 months;
* need for dialysis expected in the next 6 months;
* administration of another investigational drug within 30 days preceding study start, or during the study.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cranberry for Prevention of Bacteriuria in Pregnancy
Brief Summary: The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).


Options:
A: Inclusion Criteria:

* Intrauterine pregnancy
* Mother and fetus in good health
* Mother pregnant for 16 weeks or less

Exclusion Criteria:

* Suspected nonviable or ectopic pregnancy
* Mother plans to terminate pregnancy
* Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start
* Significant underlying medical complications that may interfere with the study
B: Inclusion Criteria:

* At least two UTIs in the year prior to study entry
* Willing to use acceptable methods of contraception
* Willing to refrain from consuming other forms of cranberry supplementation

Exclusion Criteria:

* Current UTI
* Allergy to cranberry-containing products
* Active urinary stone disease
* Insulin-dependent diabetes
* Immunosuppressive disease
* Current corticosteroid use
* Intermittent or indwelling catheterization
* Pregnancy
C: Inclusion Criteria:

1. Previously essentially healthy
2. Newly acquired spinal cord injury, T12 level or higher
3. Receiving in-patient care on the rehabilitation ward.
4. Expected admission duration \>= 4 weeks
5. 16 years old or older

Exclusion Criteria:

1. Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction
2. Severe head injury with impairment of cognitive function
3. Allergy to cranberry
4. Renal failure
5. Warfarin (Coumarin) treatment with unstable INR
6. Current symptomatic urinary tract infection
D: Inclusion Criteria:

1. female residents;
2. long term residents
3. English speaking; and
4. age ≥ 65 years.

Exclusion Criteria:

1. residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal \[life expectancy \< 1 month\]);
2. residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
3. residents with end stage renal disease on dialysis (they do not regularly produce urine);
4. residents unable to produce a baseline clean catch urine specimen for collection;
5. residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
6. residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
7. have an indwelling bladder catheter in place;
8. have an allergy to cranberry products;
9. are being treated with cranberry products;
10. residence \<4 weeks.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Brief Summary: The goals of this study are:

* To determine the response rate of treatment of amblyopia in 7 to \<18 year olds.
* To determine the frequency of recurrence of amblyopia in 7 to \<18 year olds after discontinuation of amblyopia treatment.


Options:
A: Inclusion Criteria:

* Age 7 to 12 years old (inclusive)
* Amblyopia associated with strabismus, anisometropia, or both
* Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
* Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
* Interocular difference \>=15 letters (3 lines)
* Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

* Enrolled into the main study
* Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
* Birth weight \>1500 grams
* No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria:

* Amblyopia treatment (other than spectacles) in the last 6 months
* Myopia (more than -0.25D spherical equivalent) in either eye
B: Inclusion Criteria:

* Age 3 to \<7 years
* Able to perform visual acuity using the ATS single-surround HOTV protocol
* Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
* Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
* Visual acuity in the sound eye \>20/40
* Inter-eye acuity difference \>3 logMAR lines
* Cycloplegic refraction and ocular examination within 2 months prior to enrollment

Exclusion Criteria:

* No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
* No current vision therapy or orthoptics
* No ocular cause for reduced visual acuity
* No myopia more than a spherical equivalent of -6.00 D
* No prior intraocular or refractive surgery
* No known skin reactions to patch or bandage adhesives
C: Inclusion Criteria:

* Patients must be aged 7 to \<18 years and have amblyopia associated with strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be 20/40 to 20/400 inclusive and visual acuity in the sound eye must be 20/25 or better.

Exclusion Criteria:

* Patients must not have received amblyopia treatment (other than spectacles) in the past month or more than one month of amblyopia treatment in the last 6 months.
D: Inclusion Criteria:

* 3 to 8 years of age;
* Presence of anisometropia and/or strabismus;
* inter-ocular acuity difference of at least 0.1 logMAR
* parental consent

Exclusion Criteria:

* history of previous occlusion therapy
* ocular pathology
* learning difficulties

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate
Brief Summary: The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.


Options:
A: Inclusion Criteria:

* patients at least 18 years of age with moderate to severe active RA for at least 6 months;
* inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
* stable DMARD therapy for at least 8 weeks before entering study;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
* patients who have previously failed treatment with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
B: Inclusion Criteria:

* Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

* All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
C: Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to stably dosed methotrexate

Exclusion Criteria:

* Current therapy with any DMARD or biologic other than methotrexate
D: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis
* At least 3 months prior treatment with Methotrexate (MTX)
* At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
* Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

* participants who have failed more than 3 DMARDs
* participants previously treated with an approved biologic drug
* History of cancer in the last 5 years
* Severe or recurrent bacterial infection
* Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
* Women of Child Bearing Potential

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate
Brief Summary: The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.


Options:
A: Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to stably dosed methotrexate

Exclusion Criteria:

* Current therapy with any DMARD or biologic other than methotrexate
B: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis
* At least 3 months prior treatment with Methotrexate (MTX)
* At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
* Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

* participants who have failed more than 3 DMARDs
* participants previously treated with an approved biologic drug
* History of cancer in the last 5 years
* Severe or recurrent bacterial infection
* Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
* Women of Child Bearing Potential
C: Inclusion Criteria:

* Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
* Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria:

* Received any previous treatment with MTX
* Received any previous treatment with ETN or other tumour necrosis factor antagonist
D: Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Peer Related School Interventions in Autism
Brief Summary: This study will determine whether peer interaction training interventions are effective in enhancing the social relationships of children with autism.


Options:
A: Inclusion Criteria for Autistic and Nonautistic Participants:

* Autistic OR nonautistic peer of autistic child
* Full inclusion in a classroom with nonautistic children
* Currently in kindergarten or grades 1 through 5
* Intelligence quotient higher than 70
* Expectation to stay in the same school and classroom for the duration of the study
* Able to provide parent consent and child assent

Exclusion Criteria:

* Mental age-equivalent less than 4 years
* Conditions other than autism, or sensory or motor impairments
B: Inclusion Criteria

* Diagnosis of autism based on Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) criteria

Exclusion Criteria

* Seizures
* Medical or psychiatric diagnoses other than autism that potentially contribute to developmental delay (e.g., genetic syndromes)
C: Inclusion Criteria:

* Diagnosis of autism spectrum disorder
* Parent or guardian willing to give informed consent for child's participation
* Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
* English is primary language for child and family

Exclusion Criteria:

* Evidence of vision or hearing impairment
* Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
* History of severe birth trauma or traumatic brain injury
* Siblings with autism spectrum disorder
D: Inclusion Criteria:

* diagnosis of autism
* age 2-4 year old

Exclusion Criteria:

* severe mental retardation
* severe clinical CNS disorders

Answer: A