TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Parallel, Time-lagged, Ascending, Multi-centre, Multiple-dose Study to Measure the Magnitude and Time Course of the Effect of FTY720 on FEV1 and Other Pulmonary Function Tests (FVC, FEF25-75%, and FEV1/FVC) in Patients With Moderate Asthma
Brief Summary: This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma


Options:
A: Inclusion Criteria:

* Forced Expiratory Volume in 1 second of at least 60%
* History of asthma for at least 6 months
* Current use of short-acting beta agonists, inhaled long-acting beta agonists and inhaled corticosteroids (up to a specified dose)

Exclusion Criteria:

* History of lung disease other than asthma
* Smokers
* Use of inhaled corticosteroid above specified dose
* Use of oral beta agonists or corticosteroids or other asthma medications
* Hypersensitivity to the drug
* Respiratory tract infections within 1 month of the study

Other protocol-defined inclusion/exclusion criteria may apply
B: Inclusion Criteria:

* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
* Patients with a relapsing-remitting disease course
* Patients with expanded disability status scale (EDSS) score of 0-5.5

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women

For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.

Other protocol-defined inclusion/exclusion criteria may apply.
C: Inclusion Criteria:

* Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
* Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

* Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.
D: Inclusion Criteria:

* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
* Patients with a relapsing-remitting disease course
* Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
* Pregnant or nursing women
* Patients who cannot tolerate treatment with an interferon

Other protocol-defined inclusion/exclusion criteria applied to the study.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children
Brief Summary: Milk contains a vast number of bioactive components that have been suggested to have a positive impact on human health, of special interest is the effects related to metabolic syndrome and obesity but the effect of the individual milk components is not clear. This study examine whether it is beneficial for overweight and obese children to increase the intake of skim milk, or whey or casein in relation to bodyweight and markers of MS.

The participants will be randomized to receive skim milk, whey milk drink, casein milk drink or mineral water for 3 mo. They will be examined at baseline, end of intervention and followed up 3 month later.


Options:
A: Inclusion Criteria:

* American Indian women
* Aged 18-40 years
* Living in Albuquerque area
* Not having diabetes

Exclusion Criteria:

* Pregnancy
* Planning to become pregnant within 2 years
* Diagnosed with diabetes fasting blood glucose \> 126 planning to move out of town in next 2 years
B: Inclusion Criteria:

* Employee at Massachusetts General Hospital who uses a cafeteria debit card to pay for cafeteria purchases

Exclusion Criteria:

* Employees who do not have a cafeteria debit card
* Employees with cafeteria debit card but who use it fewer than 3 times a month for the 3 months prior to start of trial
C: Inclusion Criteria:

* Body Mass Index: 27 - 40 kg/m2
* Must drink no calorie, sweetened drinks

Exclusion Criteria

* Cardiovascular disease
* Uncontrolled blood pressure
* Smoker
* Medications that affecting metabolism
* Oral steroids
* History of stroke or seizures
* Thyroid disease
* Type 1 or 2 diabetes
* Cushings syndrome
* Renal disease
* Liver disease
* Cancer in the past 5 years
* HIV
* Active tuberculosis
* Major psychiatric disorders
D: Inclusion Criteria:

* 12 years to 15 years old
* iso BMI larger than 25
* habitual milk intake less than 250 ml/day
* non-smoker
* healthy at the time of inclusion

Exclusion Criteria:

* chronic illnesses
* intake of antibiotic 1 mo before start of intervention

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
Brief Summary: Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.


Options:
A: Inclusion Criteria:

* premature infants with gestational age less than 36 weeks,
* clinically stable, showing behavioral abnormalities such as intolerance to the touch, excessive crying, showing signs of pain in accordance with the scale
* difficulty of NFCS leave the stage of crying and agitation for a period of deep sleep during a period of not less than 60 minutes.

Exclusion Criteria:

* premature medically unstable because of the difficulty of monitoring in liquid medium, with a change in temperature on mechanical ventilation who had an infectious process due to the exacerbation of it in hot water, and syndromic children with congenital facial deformities that impede the use of scale NFCS for evaluation.
B: Inclusion Criteria:

* Healthy infant
* 2 - 6 months of age
* receiving primary DPT and PCV vaccinations

Exclusion Criteria:

* chronic illness
* immune deficiency
* immunosuppression
* a history of allergy to DPT or PCV or any of its components
* fever
* any acute illness that prevents the administration of the vaccine
C: Inclusion Criteria:

* Children aged 2 to 18 years undergoing an LP

Exclusion Criteria:

* Children who had already participated or used the LP pillow
* medical condition (orthopaedic anomaly) contraindicating the use of the LP pillow
* Parents refusal
D: Inclusion Criteria:

* Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery

Exclusion Criteria:

* Neurological impairment
* Eczema or other skin disorders
* Nut allergy

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
Brief Summary: Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.


Options:
A: Inclusion Criteria:

* Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis

Exclusion Criteria:

* Clinical diagnosis of birth asphyxia or seizures
* Neurological conditions
* Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
* Abdominal distension or abdominal infection/cellulitis
* Colostomy
* Inguinal hernia
* Organomegaly
* Bleeding diatheses (thrombocytopenia or coagulopathy)
* Receiving analgesics or sedatives
B: Inclusion Criteria:

* premature infants with gestational age less than 36 weeks,
* clinically stable, showing behavioral abnormalities such as intolerance to the touch, excessive crying, showing signs of pain in accordance with the scale
* difficulty of NFCS leave the stage of crying and agitation for a period of deep sleep during a period of not less than 60 minutes.

Exclusion Criteria:

* premature medically unstable because of the difficulty of monitoring in liquid medium, with a change in temperature on mechanical ventilation who had an infectious process due to the exacerbation of it in hot water, and syndromic children with congenital facial deformities that impede the use of scale NFCS for evaluation.
C: Inclusion Criteria:

* unilateral inguinal hernia
* age age \> 4 months, \<16 years
* fully descended testes
* study consent signed

Exclusion Criteria:

* previous abdominal or inguinal surgery
* testes not fully descended
* not healthy enough for day surgery
* age \< 4months or \>16 years
* study consent not signed
D: Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

1. preterm birth (\<37 weeks gestation)
2. prior hospitalization/surgery (other than postnatal care),
3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.
Brief Summary: Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.


Options:
A: Inclusion Criteria:

* Patients with prior abdominal or pelvic surgery,

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable
B: Inclusion Criteria

* adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent
C: Inclusion Criteria:

* healthy individual 50 years or older
* eligible for colorectal cancer screening or surveillance

Exclusion Criteria:

* patients who do not understand or failed to sign informed consent
D: Inclusion Criteria:

* adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers
Brief Summary: the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.


Options:
A: smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE
B: Inclusion Criteria:

* Smoked at least 100 cigarettes in lifetime
* English or Spanish speaking
* Currently smoking at least 5 cigarettes a day, on average
* Willing to set a quit smoking date within a week of the enrollment

Exclusion Criteria:

* Positive history of a medical condition that precludes use of the nicotine patch
* Current use of nicotine replacement therapy (NRT)
* Current use of other smoking cessation medications (e.g., Chantix or Zyban)
* Pregnant or nursing
* Enrolled in another smoking cessation study
C: Inclusion Criteria:

* currently homeless
* smoke 5 or more cigarettes per day
* smoked 100 cigarettes in lifetime
* aged 18 years or older

Exclusion Criteria:

* unstable mental illness
* pregnancy
* current history of psychoactive or alcohol dependence or psychotic disorder
* cognitive impairment
D: Inclusion Criteria:

* Age 18 years or older
* Have a home address and telephone number
* Willing to participate in all study components
* Willing to be followed for 6 months
* Smoked at least 100 cigarettes in their lifetime
* Current smoker
* American Indian or Alaska Native

Exclusion Criteria:

* Planning to leave the state within next 24 months
* Pregnant or breast feeding or planning to become pregnant in next 4 months.
* Medically ineligible after screening

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers
Brief Summary: the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.


Options:
A: Inclusion Criteria:

* Smokers who are referred from Mental Health Clinics in VA VISNs 1 and 3.
* Patients must have access to a telephone and a regular mailing address.

Exclusion Criteria:

* No access to a telephone
* no mailing address
* not receiving care from a VISN 1 or VISN 3 Mental Health provider
B: Inclusion Criteria:

* Must be 18 years of age or older.
* Must be a current smoker.
* Must receive primary care at one of the participating clinics.
* Must have had a PCP visit within the last month at a participating clinic.
* Must have a working phone number listed in Partner's database.
* Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of \< $65,000).
* Must speak English or Spanish.

Exclusion Criteria:

* Hearing impaired patients who cannot use the telephone.
C: Inclusion Criteria:

* currently homeless
* smoke 5 or more cigarettes per day
* smoked 100 cigarettes in lifetime
* aged 18 years or older

Exclusion Criteria:

* unstable mental illness
* pregnancy
* current history of psychoactive or alcohol dependence or psychotic disorder
* cognitive impairment
D: Inclusion Criteria:

* Child enrolled in Baltimore City Head Start
* Smoker living in the home with child

Exclusion Criteria:

* No smoker in home with child
* Does not speak English
* Is enrolled in other respiratory research study

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
Brief Summary: To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.


Options:
A: Inclusion Criteria:

* Age ≥ 20 years outpatient (regardless of sex)
* Patients diagnosed as non-valvular atrial fibrillation (NVAF)
* One or more following risks of stroke.

Exclusion Criteria:

* Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
* Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
* Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
B: Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Non- valvular atrial fibrillation documented by ECG
* Patients with a risk of stroke and non-CNS systemic embolism

Exclusion Criteria:

* Significant mitral stenosis
* Patients in whom anticoagulants are contraindicated
C: Inclusion criteria:

* Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
* Male or female, being 18 years of age or older
* Written informed consent for study participation

Exclusion criteria:

* Persistent symptoms of VTE
* PE requiring urgent intervention
* Use of vena cava filter
* Contraindications to anticoagulant therapy
* Allergy to study medications
* Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
* Severe renal impairment
* Patients considered unsuitable for inclusion
D: Inclusion criteria:

Inclusion_Criteria

* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN
* Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Brief Summary: 1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.


Options:
A: Inclusion Criteria:

* 6 to 11 years of age
* Best corrected vision of at least 20/30 in each eye
* Birth weight \> 1250g

(The criteria below will be evaluated at a screening visit to find out if the child can participate)

* Accommodative lag \>= 1.30 D (for a 4D stimulus)
* At least -0.75 D myopia in each meridian measured with cycloplegic autorefraction but not more than -4.50 D in each meridian in each eye
* Esophoria at near if more than -2.25 D spherical equivalent (high myopia)
* Astigmatism \< 2.00 DC in each eye
* Anisometropia \< 2.00 D

Exclusion Criteria:

* Strabismus (eye turn)
* History of contact lens wear
* History of previous bifocal wear
* Diabetes mellitus
B: Inclusion Criteria:

* Age: 8 to 13 years
* Myopia: -1.00 to -5.00 D
* Myopia progression: at least 0.50 D/yr
* Astigmatism and anisometropia: not more than 1.50 D
* Distance monocular visual acuity: 6/6 or better
* Near monocular visual acuity: 0.4 M or better
* Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

* Strabismus
* Ocular diseases
C: Inclusion Criteria:

Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.

-

Exclusion Criteria:

Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)

-
D: Inclusion Criteria:

* Age 8-13 years
* Myopia (SE) between -1D to -5D
* Astigmatism less than or equal to -1D
* Anisometropia: less than or equal to 1.25D
* aided VA (monocular): 0.00 log MAR or better
* willingness to wear contact lens constantly
* availability for follow-up for at least 2.5 years
* parents' understanding and acceptance
* willing to provide refractive status of grandparents

Exclusion Criteria:

* Severe ocular or systemic allergies
* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
* Ocular or systemic condition that might affect refractive development
* Strabismus at distance or near
* Prior use of bifocal or progressive lenses
* Prior use of rigid gas permeable lenses and Ortho-K lenses

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Translational Research: Applying Drug Prevention to Obesity Prevention
Brief Summary: The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. The aim of this project is to adapt and revise parts of two nationally recognized programs for drug prevention for use with children in grades 4-6 with the express purpose of obesity prevention. The current study will attempt to promote emotion regulation, neuro-cognitive function, and social competence in order to prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange County will be randomly assigned to either the obesity prevention program or control group (N=1587) 4th grade students and their parents). A cohort of students will be followed from the 4th through 6th grades. Intervention students will be administered the Pathways obesity prevention program by trained teachers. The population is ethnically diverse (36% white, 57% Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th , and 6th grade. Teacher, administrative, and parent surveys will be administered on the same schedule to measure school environment. Program implementation will be measured by teacher self-report and research staff observations. Data will be analyzed with statistical approaches that capture effects of school and classroom, test the theoretical model of change, and evaluate developmental trends in mediators and outcomes across the three grades. Findings should be generalizable to most elementary schools, and will be used to develop evidence-based program standards for childhood obesity prevention.


Options:
A: Inclusion Criteria:

* 7 grade youth
* attending participating middle schools

Exclusion Criteria:

* In grades other than 7th grade
B: Inclusion Criteria:

* Resident at baseline in one of the 24 participating communities
* Student in the Class of 2011 panel sample or in grades 6, 8, 10, or 12 during a survey year
* Community leader or prevention service provider in one of the participating communities

Exclusion Criteria:

* Unable to read and comprehend consent materials and/or survey questions in either english or spanish
C: Inclusion Criteria:

* 4th grade students at participating schools

Exclusion Criteria:

* None
D: Inclusion Criteria:

* Pregnant women prior to the 25th week of gestation
* no previous live births
* one of the following sociodemographic risk characteristics:

  * young age (\< 19 years at registration);
  * unmarried
  * low socioeconomic status (Medicaid status or no private insurance)

Answer: C