TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
Brief Summary: Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.


Options:
A: Inclusion Criteria:

* Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus (HPV) vaccination
* Prior abnormal paps
* History of genital warts
B: Inclusion Criteria for the Base Study:

* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:
* Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:
* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

* Prior Human Papilloma Virus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

  --For Extension Phase:
* Prior complete HPV vaccination series
* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

  --For LTFU Study:
* There were no exclusion criteria that did not overlap the inclusion criteria for this study.
C: Inclusion Criteria:

* Healthy females 16 to 23 years of age
* Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
* Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)

Exclusion Criteria:

* No prior receipt of an Human Papillomavirus (HPV) vaccine
* No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
* No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
* No prior history of genital warts or treatment for genital warts
D: Inclusion Criteria:

* Healthy, unmarried females age 16 to 23 years with intact uteri
* Not pregnant at enrollment
* Agreed to use effective contraception through Month 7 of the study
* A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion Criteria:

* No prior history of Human Papillomavirus (HPV) vaccination
* No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
* No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Brief Summary: The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.


Options:
A: Inclusion Criteria:

* Aged 70 years or more
* Ambulant
* Likely to survive for more than 12 months, as assessed by the Implicit Review Tool employed in the FREE study
* Not taking vitamin D or calcium supplements
* No history of skin cancer in last three years

Exclusion Criteria:

* History of skin cancer in last three years
* Taking vitamin D or calcium supplements
* Not ambulant
B: On cluster level

Inclusion Criteria:

* nursing homes with at least 50 residents

Exclusion Criteria:

* other ongoing trial in the institution

On individual level

Inclusion Criteria:

* all residents within a cluster are eligible to participate in the study

Exclusion Criteria:

* diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
* respite care
C: Inclusion Criteria:

* Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
* Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department

Exclusion Criteria:

* Patients not admitted to the hospital from home or a nursing home
* Patients unable to communicate in Dutch
* Patients admitted for palliative care
* Patients who do not take any drugs at admission
D: Inclusion Criteria:

* patients on participating wards admitted for more than three days
* all nurses on participating wards

Exclusion Criteria:

* students on participating wards

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Brief Summary: The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.


Options:
A: Inclusion Criteria:

* General practitioner
* Specialist in general practice
B: Inclusion Criteria for Hospitals

Hospitals were invited to participate in the study if they fulfill the following criteria:

* have an Institutional Review Board (IRB), or existing committee which could serve as such, or have an agreement with an IRB which reviews the research protocols implemented in the hospital;
* have at least 500 vaginal deliveries per year;
* do not have an explicit policy for selective episiotomy and for active management of third stage of labor;
* are located within the study area in Argentina and Uruguay; and
* agree to participate in the study.

Exclusion Criteria for Hospitals

Preselected hospitals are performing baseline data collection. According to the results of the analysis of the baseline data collection, hospitals will be excluded if the episiotomy rate is low or the rate of active management of the third stage of labor is high, according to the following cut-off points:

* Episiotomy rate in spontaneous vaginal deliveries below 20%
* Rate of active management of third stage of labor over 25%

The sample size of the study was increased to allow for exclusions.

Expectant management is defined as "a hands-free policy" during third stage of labor until the placenta is expelled: no use of uterotonics or special maneuvers.

Sampling, Recruitment, and Screening Procedures

Latin American Center for Perinatology (CLAP) coordination team will be responsible for the hospital selection. The hospitals' fulfillment of selection criteria will be obtained through a survey of the Heads of the Obstetrical Departments.

Besides the selection criteria, the coordination unit will invite the hospitals to participate according to:

* their participation in previous trials coordinated by CLAP,
* their participation in other trials or research activities, and
* their location.

Of particular interest are the characteristics of each preselected hospital regarding the structure of the professional staff, number of deliveries, and clinical guidelines policy.
C: Inclusion Criteria:

* Residents entering their first year of training
* Scheduled for the two pediatric inpatient rotations where parent and nurse evaluations would be collected

Exclusion Criteria:

* Residents from combined Internal Medicine/Pediatric training programs
D: Inclusion Criteria:

* patients on participating wards admitted for more than three days
* all nurses on participating wards

Exclusion Criteria:

* students on participating wards

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Brief Summary: The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.


Options:
A: Inclusion Criteria:

Home-dwelling patients aged 65 or higher, who have a diagnosis of depression, according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision

Exclusion Criteria:

Patients will be excluded if they have a diagnosis of dementia, bipolar disorder or reside in nursing homes or is assessed by their practitioner to have low life expectancy.
B: Inclusion Criteria:

* General practitioner
* Specialist in general practice
C: Inclusion Criteria:

* patients on participating wards admitted for more than three days
* all nurses on participating wards

Exclusion Criteria:

* students on participating wards
D: Inclusion Criteria:

* Residents entering their first year of training
* Scheduled for the two pediatric inpatient rotations where parent and nurse evaluations would be collected

Exclusion Criteria:

* Residents from combined Internal Medicine/Pediatric training programs

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen
Brief Summary: To compare the effectiveness (efficacy, safety \& tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) \<200 copies/mL at Week 48.


Options:
A: Inclusion Criteria:

1. Patients must be self-identified as African-Americans.
2. All patients must be aged 18 years and older.
3. All patients must be diagnosed as having hypertension: For this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee (JNC VI) Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, which is a systolic blood pressure \> 140 mm hg or a diastolic blood pressure \> 90 mm hg or if participants are taking any prescribed antihypertensive medication.
4. Patients must be able to provide informed consent in English.

Exclusion Criteria:

1. Patients who refuse to participate
2. Patients who are unable to provide informed consent.
B: Inclusion Criteria:

* type 2 diabetes
* HbA1c \> 7%
* age \> 21

Exclusion Criteria:

* substance abuse disorder
* serious psychiatric illness
* serious hearing loss
* life expectancy \< 12 months
C: Inclusion Criteria:

* HIV-1 positive patients who have maintained an HIV-1 viral load \<200 copies/mL, for at least 3 months.
* Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
* HAART must consist of either:

  1. A PI (with or without ritonavir) + at least 2 NRTIs or
  2. An NNRTI + at least 2 NRTIs.
* Negative serum pregnancy test.

Exclusion Criteria:

* Patients who have taken any NNRTI prior to their current therapy.
* Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
* Patients who are currently taking EFV+FTC+TDF.
* Patients who have a creatinine clearance of \<60 mL/min by Cockcroft-Gault estimation.
* Patients who have experienced virologic failure with any previous ARV therapy.
* Patients who have documented resistance to any of the study agents at any time in the past.
D: 1. Age 2-12 years.
2. A current diagnosis of asthma or reactive airway disease
3. Resident of Baltimore City.
4. Two or more ED visits at the JHPED for asthma in the past 12 months, or hospitalization for asthma at the JHPED in the past 12 months by parent report.
5. Not currently participating in other research studies (participation in previous studies will be noted).

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Brief Summary: The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Options:
A: Participation as a volunteer in the Diabetes Prevention Program (DPP).
B: Inclusion Criteria:

* diagnosed for PCOS (Rotterdam criteria)
* aged 30-50 years
* safe non-hormonal contraception

Exclusion Criteria:

* use of cholesterol lowering agents
* use of antidepressants
* use of cortisone medication (p.o.)
* use of hormonal contraception
* nursing
* pregnancy
* DM-T2
* liver disease
* menopause
* kidney or liver failure
C: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria:oligomenorrhea (\<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone \> 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
D: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40
* Reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
* Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
* Use of oral contraceptives and other steroid hormones 3 months prior to the study
* Contraindications to oral contraceptives

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Brief Summary: The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Options:
A: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40
* Reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
* Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
* Use of oral contraceptives and other steroid hormones 3 months prior to the study
* Contraindications to oral contraceptives
B: Inclusion Criteria:

* Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
* Elevated testosterone levels
* General good health
* Off of current medications which may confound response to study medications

Exclusion Criteria:

* Pregnancy
* Lactose Intolerance
* Medical Contraindications
* Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
* Diabetes, liver, heart, kidney or uncorrected thyroid disease
C: Inclusion Criteria:

* Overweight/obese patients with PCOS

Exclusion Criteria:

* Other causes of hyperandrogenism and
* Use of drugs including:

  * oral contraceptive
  * anti-hypertensive agents
  * anti-diabetic drugs
  * agents for weight loss
D: Inclusion Criteria:

* normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.

Exclusion Criteria:

* pregnancy
* past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
* neoplasms
* unstable mental illness

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults
Brief Summary: This study will evaluate the effectiveness of a telephone-delivered coping improvement group intervention in improving quality of life in older adults with HIV.


Options:
A: Inclusion Criteria:

* 18 years or older, pregnant, and HIV+
* Enrolled in the PMTCT program at the study site clinic
* Receiving medical care from study site clinic
* Residing in study area for duration of study
* No psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
* Ability to give informed consent as judged by an interviewer

Exclusion Criteria:

* Less than 18 years, or not pregnant, or not HIV+
* Not enrolled in the PMTCT program at the study site clinic
* Not receiving medical care from study site clinic
* Not residing in study area for duration of study
* Psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
* Clinical provider (nurse or physician) believes it is not in the best interest of the MLH
* Unable to give informed consent
B: Inclusion Criteria:

* Currently living with HIV or AIDS
* Score of 75 or higher on the Mini-Mental Status Examination

Exclusion Criteria:

* Active use of drugs and/or alcohol
* Poor cognitive functioning
C: Inclusion Criteria:

1. Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish-speaking country of the Americas
2. First-time offenders or Hispanic adolescents, identified by Miami Dade County Public Schools as exhibiting Level III behaviors which include: assault/threat against a non-staff member, breaking and entering/burglary, fighting (serious), hazing, possession or use of alcohol and/or controlled substances, possession of simulated weapons, trespassing, and vandalism.
3. Adolescents between 12 and 17 years of age
4. Adolescents living with an adult primary caregiver who is willing to participate

Exclusion Criteria:

(a) Family reports to have (tentative or firm) plans to move out of the South Florida area during the year of the study
D: Inclusion Criteria:

* HIV seropositive
* Currently enrolled in methadone maintenance treatment for at least one month
* Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))
* Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.
* Between the ages of 18 and 65.

Exclusion Criteria:

* Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S \>6)
* Unable or unwilling to provide informed consent.
* Currently in cognitive behavioral therapy for depression.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
Brief Summary: This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.


Options:
A: Inclusion Criteria for the Base Study:

* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:
* Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:
* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

* Prior Human Papilloma Virus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

  --For Extension Phase:
* Prior complete HPV vaccination series
* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

  --For LTFU Study:
* There were no exclusion criteria that did not overlap the inclusion criteria for this study.
B: Inclusion Criteria:

* Healthy females 16 to 23 years of age
* Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
* Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)

Exclusion Criteria:

* No prior receipt of an Human Papillomavirus (HPV) vaccine
* No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
* No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
* No prior history of genital warts or treatment for genital warts
C: Inclusion Criteria:

* Healthy, unmarried females age 16 to 23 years with intact uteri
* Not pregnant at enrollment
* Agreed to use effective contraception through Month 7 of the study
* A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion Criteria:

* No prior history of Human Papillomavirus (HPV) vaccination
* No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
* No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)
D: Inclusion Criteria:

* Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus (HPV) vaccination
* Prior abnormal paps
* History of genital warts

Answer: B