TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preventing Recurrent Sexually Transmitted Infections in Minority Women
Brief Summary: This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.


Options:
A: Inclusion Criteria:

* Attending a family planning clinic visit
* At risk for unintended pregnancy (using no contraceptive method, using condoms for contraception, or not using a hormonal contraceptive method continuously for the last 3 months)

Exclusion Criteria:

* Pregnant
* Using a hormonal contraceptive method continuously for the last 3 months
* Not willing to be contacted by phone for the intervention.
B: Inclusion Criteria:

* Mexican American,
* 14 - 45 years old,
* English Speaking,
* non-viral sexually transmitted infection

Exclusion Criteria:

* Non-English speaking,
* viral sexually transmitted infection
C: Inclusion criteria:

* Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.

Exclusion criteria:

* Women who are currently pregnant or breastfeeding.
* Women who wish to become pregnant within the next 12 months.
* Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
* Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
* Current and previous users of oral contraceptives.
D: Inclusion Criteria:

* Aged 14 years and over on 1st Jan 1999
* About to enter year 5, 6 or 7 of a primary school in one of the 20 trial communities

Exclusion Criteria:

\* Parent/guardian and/or young person unable or unwilling to give informed consent

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.
Brief Summary: Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.


Options:
A: Inclusion Criteria:

* Aged 18 years and over
* Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
* Willing to stop tobacco cigarettes for period of study if required
* Willing not to use electronic cigarettes if required
* Able to give informed consent

Exclusion Criteria:

* Pregnant or lactating.
* Women of childbearing potential who do not abstain from sex or use effective contraception.
* On current prescribed medication for cardiovascular disease.
* History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
* Nut allergy
* Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1.
B: Inclusion Criteria:

* Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
* Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
* Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

* PANSS score \>70 at Screen or Baseline Visit.
* Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
* Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
* Subjects taking Bupropion.
C: Inclusion Criteria:

* Subjects must have smoked on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with any history of clinically significant cardiovascular disease
* Uncontrolled hypertension
D: Inclusion Criteria:

* Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months

Exclusion Criteria:

* Insufficient level of motivation
* Another participant in the household
* Patients with current psychotic disorder or major depressive disorder

The investigator will evaluate whether there are other reasons why a patient may not participate.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
Brief Summary: This randomized pilot study will evaluate the feasibility and acceptability of a phone-based wellness program for improving mood, physical activity, and smoking abstinence rates among people with depression who also are physically inactive and smoke cigarettes.


Options:
A: Inclusion Criteria:

* Member of Group Health insurance plan
* Aged 18 to 75
* Experiencing at least moderate depressive symptoms
* Low physical activity defined as failure to meet Centers for Disease Control (CDC) guidelines for weekly activity OR low to moderate physical activity as assessed by International Physical Activity Questionnaire (IPAQ)
* Current smoker
* Has a phone
* Able to read and speak in English
* No mobility or physical impairments that would prevent engaging in moderate physical activity
* Without a hearing impairment that would prevent participation with the phone-based counseling or assessments

Exclusion Criteria:

* Self-report of bipolar disorder or schizophrenia
* Currently receiving specialty mental health care or smoking cessation treatment
* If on an antidepressant, has been taking it less than 30 days
B: Inclusion Criteria:

* Must complete the baseline survey
* Current self-reported cigarette smoker
* Has a valid home address
* An adequate proficiency in English to complete study surveys and participate in telephone counseling.

exclusion Criteria:

* adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).
C: Inclusion Criteria:

* Age 18-80
* Current and regular smoker 5 or more cigarettes per day
* Interested in making a quit attempt in the next 14 days
* Personal phone available

Exclusion Criteria:

* Pregnancy or plans to become pregnant in the next year
* Cannot speak English
* Not a union member or employee of specified worksite or immediate family member
* Member of household is currently enrolled in the study
* Not willing to comply with study protocol
D: 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.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


Options:
A: Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression
B: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
C: Inclusion Criteria:

* ACR criteria for fibromyalgia
* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications
D: Inclusion Criteria:

* Clinical diagnosis of primary osteoarthritis of the knee(s)
* Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment

Exclusion Criteria:

* Arthritis other than primary osteoarthritis
* Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics
* Subtotal or total joint replacement in the affected knee
* Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study
* Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


Options:
A: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
B: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
C: Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression
D: Inclusion Criteria:

* patient who completed the 3-month F02207 GE 302 study
* patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

Exclusion Criteria:

* known hypersensitivity to milnacipran
* major depressive episode
* significant risk of suicide
* generalised anxiety disorder
* substance abuse
* clinically significant cardiac disease
* pulmonary dysfunction
* active liver disease
* renal impairment
* autoimmune disease
* current systemic infection
* epileptic
* active cancer
* severe sleep apnoea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* (for men) prostatic enlargement or other genito-urinary disorders
* (for women) pregnancy or breastfeeding

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


Options:
A: Inclusion Criteria:

* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* psychiatric illness,
* depression,
* suicidal risk,
* substance abuse,
* pulmonary dysfunction,
* renal impairment,
* active cardiac disease,
* liver disease,
* autoimmune disease,
* cancer,
* inflammatory bowel disease
B: Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression
C: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
D: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Prenatal DHA Supplements on Infant Development
Brief Summary: This research study research is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, the study team will assess the effect of docosahexanoic acid (DHA) supplementation during pregnancy on infant growth and development through a randomized controlled intervention trial in Cuernavaca, Mexico. This is a collaborative effort between the Rollins School of Public Health, Emory University, the Instituto Nacional de Salud Publica (INSP) and the Instituto Mexicano del Seguro Social (IMSS), Cuernavaca, Mexico. Pregnant women attending the IMSS General Hospital I are recruited between 18-22 weeks gestation and assigned randomly to receive either DHA (400 mg) or a placebo daily until delivery. The main study outcomes include a) birth outcomes: birth size, gestational age, cord blood levels of DHA and neurodevelopment b) maternal blood and breast milk DHA levels at 1 and 3 months post-partum, c) postnatal growth and development during the first 5 years of age and d) infant DHA status at 3, 12 and 18 months.


Options:
A: Inclusion Criteria:

* Gestational age \<= 15th week of gestation
* Age: 18-43 years
* Written informed consent
* Body mass index (BMI) before pregnancy between 18 and 30 km/m2

Exclusion Criteria:

* High risk pregnancy
* Hypertonus
* Chronic diseases (i.e. diabetes mellitus)
* Psychiatric diseases
* Former supplementation with LC-PUFA
B: Inclusion Criteria:

* singleton pregnancy
* gestation \<20 week at enrollment
* intention to deliver in one of the study centers
* body weight at time of enrollment from 50 kg to 92 kg

Exclusion Criteria:

* serious chronic illness (eg, diabetes, hepatitis)
* use fish oil supplements since the beginning of pregnancy
* use of folate or vitamin B-12 supplements after gestation week 16
C: Inclusion Criteria:

* 18-22 weeks pregnant (based on last menstrual period)
* 18 - 35 years old
* Resident of Cuernavaca who intends to deliver at the IMSS General Hospital I and remain in the area for the 2 years following recruitment
* Intends to predominantly breastfeed infant until 3 months of age
* Agrees to participate with informed consent

Exclusion criteria

* High risk pregnancy: If documented in the clinical record at recruitment and will include history and prevalence of abruptio placentae, any serious bleeding episode in the current pregnancy, gestational diabetes, pregnancy induced hypertension, maternal toxoplasmosis infection during pregnancy, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use.
* Lipid metabolism (hyperlipidemia) and/or absorption disorders
* Regular intake of fish oil or DHA supplements during pregnancy
* Chronic use of medication for illnesses like epilepsy
D: Inclusion Criteria:

* Pregnant 8-20 wks at enrollment
* single fetus
* BMI \<40

Exclusion Criteria:

* diabetes (Type I, ii, GDM)
* hypertension (primary, PIH, preeclampsia/eclampsia)

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
Brief Summary: Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.


Options:
A: Inclusion Criteria:

* Age between 16-40 years
* axial topography consistent with keratoconus
* minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months

Exclusion Criteria:

* history of ocular herpes or non-healing corneal ulcers
* subjects with current ocular infection
* severe preoperative corneal haze or scar
* severe ocular surface disease
* autoimmune diseases
* pregnant women
B: Inclusion Criteria:

* Diagnosis of keratoconus with documented progression over the previous 12 months.
* Diagnosis of corneal ectasia
* Must be able to complete all study visits

Exclusion Criteria:

* Prior corneal surgery in the keratoconus group
* Corneal scarring
C: Inclusion Criteria:

* Diagnosis of keratoconus
* Documented progression over previous 24 months
* Decreased BSCVA
* Must complete all study visits

Exclusion Criteria:

* Prior corneal surgery or Intacs
* History of delayed wound healing
D: Inclusion Criteria:

* Diagnosis of ectasia after refractive surgery
* Documented ectasia on Pentacam or topography map
* BSCVA worse than 20/20
* Must complete all study visits

Exclusion Criteria:

* History of delayed wound healing
* History of corneal melt or corneal dystrophy

Answer: C