TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: Inclusion Criteria:

* adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
* inadequate response to a stable dose of MTX;
* 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;
* prior treatment failure with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
B: Inclusion Criteria:

* Completed double-blind portion of the IM101064 study.
* Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
* American College of Rheumatology (ACR) functional class I, II, III
* Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria:

* Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
* History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
C: Inclusion Criteria:

Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 \[NCT00152386\], or must have completed the entire Week 52 assessment of C87027 \[NCT00152386\] trial.

Exclusion Criteria:

* A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
* A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
* Any concomitant biological therapy
* Any experimental therapy, within or outside a clinical trial
D: 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

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease
Brief Summary: To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.


Options:
A: Inclusion Criteria:

* Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study

Exclusion Criteria:

* Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
B: Inclusion Criteria:

* Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450
* If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy

Exclusion Criteria:

* Ulcerative colitis or indeterminate colitis
* History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
* Body weight is below 30 kg
* Surgical bowel resections within the past 6 months
* Females who are pregnant or breast-feeding or considering becoming pregnant during the study
C: Inclusion:

* Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of \>= 220 and \<= 450, normal laboratory parameters,
* are willing and able to give informed consent, and
* are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Exclusion:

* History of certain types of cancer, diagnosis of ulcerative colitis,
* female or breast feeding subjects,
* surgical bowel resection(s) with in the past 6 months,
* history of listeria,
* human immunodeficiency virus (HIV),
* central nervous system demyelinating disease or untreated TB,
* history of a poorly controlled medical condition,
* unsuccessful response to infliximab or any anti-TNF agent use in the past.
D: Inclusion Criteria:

* Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
* Diagnosis of Crohn's disease
* Willing and able to give informed consent

Exclusion Criteria:

* Diagnosis of ulcerative colitis
* Women cannot be pregnant or breastfeeding
* Previous history of listeria infection or untreated tuberculosis
* Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Brief Summary: The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis


Options:
A: Inclusion Criteria:

* Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
* Subject met the definition of AS based on the Modified New York Criteria.
* Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator

Exclusion Criteria:

* Subject had previously received anti-TNF therapy.
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
B: Inclusion Criteria:

Include newly referred patients if:

* Onset of symptoms (back pain/arthritis/enthesitis) \< 45 years
* Undiagnosed disease with the following symptoms:

  * chronic back pain (duration of back pain more than 3 months)
  * and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs)
  * and/or enthesitis
  * and/or dactylitis

Exclusion Criteria:

* No symptoms such as specified in inclusion criteria: back pain, arthritis, enthesitis
* Definite diagnosis
C: Inclusion criteria

* Active and severe ankylosing spondylitis
* Ankylosing spondylitis refractory to standard anti-rheumatic treatment
* Between 18 and 70 years of age

Exclusion criteria

* Prior exposure to any TNF-inhibitor, including etanercept
* DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
* Dose of NSAIDs changed within two weeks of study drug initiation
D: Inclusion Criteria:

* Subjects must be \>= 18 years of age
* meet Modified NY Criteria definition of ankylosing spondylitis (AS)
* have diagnosis of active AS based on protocol specified criteria
* inadequate response or intolerance to \>= 1 nonsteroidal antiinflammatory drug (NSAID)
* be able and willing to learn to self-administer subcutaneous (SC) injections

Exclusion Criteria:

* Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
* History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
* Previous anti-tumor necrosis factor therapy
* Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
* Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
* Biologic or investigational therapy within 6 weeks of study dosing
* Treatment with intravenous (IV) antibiotics within 30 days of study dosing
* Treatment with oral antibiotics within 14 days of study dosing

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women
Brief Summary: This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.


Options:
A: Inclusion Criteria:

* Generally healthy
* Postmenopausal
* Hysterectomized or non-hysterectomized
* Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

* Known, suspected, or past history of breast cancer
* Known, suspected, or past history of hormone-dependent tumor
* Genital bleeding of unknown etiology
* Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
* Vaginal infection
* Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
* Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
* History of treatment with diethylstilbestrol
B: Inclusion Criteria:

* postmenopausal women with age between 40-60 years
* Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5

Exclusion Criteria:

* women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months
* women with history of or present premalignancies/malignancies
* women present with liver disease or abnormal liver enzyme
* women with active cardiovascular, cerebrovascular or thromboembolic disorders
* women with Present psychiatric disease
* Partner have sexual dysfunction
C: Inclusion Criteria:

* Naturally or surgically postmenopausal
* Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

Exclusion Criteria:

* Known sensitivity or contraindication to estrogens or progestins
* History or current diagnosis of endometrial hyperplasia
* Recent history of vaginal bleeding of unknown cause
* Recent history or diagnosis of endometriosis
* Any contraindication to estrogen therapy
D: Inclusion Criteria:

* Between 49-60 years
* Body mass index (BMI) of \< 30
* Met the ACR-90 criteria for the diagnosis of fibromyalgia
* Postmenopausal state since at least six months
* Not been using any hormonal treatments for the past three months
* Had normal mammography screenings

Exclusion Criteria:

* Using psychotropic drugs or having a history of thromboembolism
* Diabetes mellitus, polyneuropathy, chronic liver disease,
* Alcohol or substance abuse, hemoglobinopathy,
* Endometrial adenomatous hyperplasia, or malignancy.
* Presence of untreated hypertension (\>160/95).
* Undiagnosed vaginal bleedings

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants
Brief Summary: Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.

Two different compositions are tested, main difference is in electrolyte composiiton.


Options:
A: Inclusion Criteria:

growing premature infants with a birth weight \< 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
B: Inclusion Criteria:

* mechanically ventilated neonates of all gestational ages and birth weights
* less than 1 month of postnatal age admitted to the NICU
* SNAP (Score of Neonatal Acute Physiology) \> 10
* projected requirement for continued parenteral nutrition of at least 1 week duration

Exclusion Criteria:

* renal or hepatic failure
* requiring insulin administration
* requiring extracorporeal life support
* known inherited metabolic disorders
* known uniformly fatal congenital anomalies
C: Inclusion

* Healthy infants
* Born vaginally (no caecerian section)
* 37+0 until 42+0
* Birth weight ± 2 SD of internationally approved growth charts
* No severe neonatal problems
* No feeding problems
* No evidence of systemic disease

Exclusion Criteria:

* Partial breast feeding at 8 weeks
* Breast feeding in the formula Group
* Formula feeding in the breast fed Group
* Caecerian section
* Treatment with antibiotics during the first 8 weeks
D: Inclusion Criteria:

* Healthy newborn infant
* Full-term (\>= 37 weeks gestation)
* Birth weight between \>= 2500 and \< =4500 g
* 0-17 days of age on enrolment (day 0 is day of birth)
* Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
* Study explained and written information provided with Caregiver demonstrating understanding of the given information
* Informed consent signed (parent/legal representative)

Exclusion Criteria:

* Congenital illness or malformation that may affect infant feeding and/or normal growth
* Suspected or known allergy to cow's milk protein
* Significant pre-natal and/or post-natal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
* Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Infant currently participating in another conflicting clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prostate Cancer Screening: Fostering Informed Decisions
Brief Summary: The primary goal of this study is to develop and evaluate a print-based method of patient education with a decision tool that is designed to provide detailed information about prostate cancer and to clarify patient preferences and values, ultimately assisting men in making an informed screening decision.


Options:
A: Inclusion Criteria:

* Female age \< 39 years
* In first cycle minimum of two embryos available for transfer

Exclusion Criteria:

* Medical necessity for single embryo transfer
B: Inclusion Criteria:

* between ages of 18 and 70 (patients above age 65 will be administered the Mini-Cog, a cognitive impairment screener)
* speak English and/or Spanish
* currently receiving outpatient mental health care

Exclusion Criteria:

* suicidal ideation or attempt within the past four weeks
* lacks capacity to consent (adapted from Zayas, Cabassa, \& Perez, 2005)
* only receiving services that are strictly case-management
C: Inclusion Criteria:

* No more than 20 weeks pregnant.

Exclusion Criteria:

* Inability to speak English or Spanish.
* Those carrying triplets or higher order gestation
D: Inclusion Criteria:

* Inclusion criteria are: 1) 40-70 years old, 2) English-speaking, and 3) ability to provide meaningful consent.

Exclusion Criteria:

* The exclusion criteria are: 1) a history of cancer (with the exception of basal cell carcinoma), and 2) a history of prostate disease that has required treatment (e.g., benign prostatic hypertrophy).

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Options:
A: Inclusion Criteria:

* Pregnant women at or before 14 weeks gestational age.

Exclusion Criteria:

* Women who anticipate moving outside of the study area before study completion
* Those with twin or multiple pregnancies
* Those who test positive for hepatitis B (HepBSAg), HIV or Syphilis (VDRL)
* Those taking vitamin supplements in addition to folate and iron
* Those with a serious pre-existing medical condition, defined as conditions that require chronic or daily medical therapy such as connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin dependent diabetes.
B: Inclusion Criteria:

* healthy women from 8th week of pregnancy

Exclusion Criteria:

* existence of hypertension
* existence of diabetes
* existence of genetic abnormalities
* smoking
* previous miscarriage
C: Inclusion Criteria:

* HIV negative
* 12-26 weeks gestational age at screening visit
D: Inclusion Criteria:

* Singleton, live born infants born to HIV- negative women
* Mothers will need to have registered for pre-natal care before 34 weeks gestation
* intend to stay in Dar es Salaam for until delivery and 18 months thereafter.

Exclusion Criteria:

* infants born with multiple congenital abnormalities

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Options:
A: Inclusion Criteria:

* Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria:

* Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant \<9 months of age
B: Inclusion Criteria:

* HIV negative
* 12-26 weeks gestational age at screening visit
C: Inclusion Criteria:

* pregnant women with 8-12 weeks of gestation

Exclusion Criteria:

* known multiple pregnancy
* known fetal anomaly
* known thrombophilia
* known infections and mola hydatidosa
* chronic renal failure
* uncontrolled hypertension
* known placental abnormalities
* documented uterine bleeding within a week of screening
* uterine malformation
* history of medical and metabolic complication such as heart disease or diabetes
D: Inclusion Criteria:

* Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.
* Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.

Exclusion Criteria:

* Consanguineous couples (up to third degree, i.e. first cousins or closer).
* Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.
* Couples either one of which have been sterilized.
* Taking any form of seizure medication.
* Planning to move outside of the study catchment area within the next year.
* B12 deficiency (\<174 pg/mL or 129.15 pmol/L).
* Being allergic to folic acid.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Options:
A: Inclusion Criteria:

* HIV negative
* 12-26 weeks gestational age at screening visit
B: Inclusion Criteria:

* Children 6-24 months of age with acute childhood diarrheal illness.

Exclusion Criteria:

* Severe dehydration, suspected cholera or pneumonia, chronic illness, bipedal edema (seriously ill children will be referred to ICDDR,B/Shishu Hospital).
* The child is currently receiving zinc (as a treatment or supplement)
* Wt/length, z-score below -3 (these children will be referred to ICDDR,B/ Shishu Hospital)
* Already participating in another study involving nutritional or therapeutic interventions
C: Inclusion Criteria:

* Children in the age group 6-30 months
* Either sex

Exclusion Criteria:

* Refused consent
* Likely to move out of study area within the next four months
* Urgent admission to hospital on the enrollment day
* Had received massive dose of vitamin A within the two months before enrollment
D: Inclusion Criteria:

* 6-27 months of age
* Plan to remain in study area for 1 year

Exclusion Criteria:

* Evidence of congenital abnormalities and chronic infection
* Severe anemia and severe acute malnutrition
* Consumption of micronutrient supplementation including zinc

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Brief Summary: The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.


Options:
A: Inclusion Criteria:

* Mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to HIV-1 testing and participation; HIV-1 infected by ELISA confirmed by Western blot; etc.
B: Inclusion Criteria:

* HIV-1 infected
* Antiretroviral naive, defined as never receiving anti-HIV medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (MTCT)
* CD4% between 15 and 24 within 30 days prior to study entry
* CDC pediatric clinical classification A or B
* Parent or guardian willing to provide informed consent and willing to follow all study procedures and requirements

Exclusion Criteria:

* Use of systemic chemotherapy, immunomodulators, HIV vaccines, immune globulin, interleukins, or interferons within 30 days prior to study entry
* Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry
* Certain abnormal laboratory values
* Known kidney disease
* Known allergy or sensitivity to study drugs
* Require certain medications
* Pregnancy
C: Inclusion Criteria:

* NVP-exposure as part of pMTCT-prophylaxis around delivery
* HIV-positive
* Eligible for treatment
* Plans to stay in the area for the next 6 months

Exclusion Criteria:

* Already on anti-retroviral treatment
* History of toxicity to perinatal NVP
* Grade 3 or greater elevation of liver function tests
* Being treated for a severe acute opportunistic infection or tumor
D: Inclusion Criteria for Infants:

NOTE: Per Letter of Amendment dated 04/04/07, Part B of this study is no longer recruiting participants. Per Letter of Amendment dated 09/16/08 Arm 1 of this study is longer recruiting.

* HIV infected
* Antiretroviral naive. Infants who have previously received antiretroviral drugs used to prevent mother-to-child transmission are eligible for the study.
* Parent or legal guardian willing to provide informed consent and comply with study requirements

Exclusion Criteria for Infants:

* Any major life-threatening congenital abnormalities
* Severe CDC Stage B or C disease
* Liver enzyme, absolute neutrophil count, hemoglobin, electrolyte, creatinine, or clinical toxicity of Grade 3 or higher at screening
* Any acute or clinically significant medical event that would preclude participation in the study. Randomization can take place as soon as the incurrent illness has resolved if the child is still less than or equal to 12 weeks of age.
* Use of investigational drugs
* Require certain medications. More information on this criterion can be found in the protocol.
* Inability to tolerate oral medication
* Birth weight less than 2 kg (4.4 lbs)

Answer: A