TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Inclusion Criteria:

* Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care
* Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day)
* Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months
* Fluent in English or Spanish

Exclusion Criteria:

* History of mouth or throat cancer
B: Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
* Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
* Smokes at least 10 cigarettes per day
* Wishes to stop smoking
* Attended last three scheduled clinic visits, prior to study entry

Exclusion Criteria:

* Significant medical or neurologic illness
* History of severe head injury with loss of consciousness
* Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
* Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
* Currently undergoing an acute exacerbation of psychotic symptoms
* Current or history of bulimia or anorexia
* Current excessive water intake
* Recent history of mania
* Known allergy or hypersensitivity to bupropion
* Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco
* Currently receiving treatment with bupropion
* Pregnant or breastfeeding
C: Inclusion Criteria:

* Healthy male and female adolescents (12 - 16 years inclusive) with a total body weight greater than 30 kg who currently smoke an average of at least 3 cigarettes per day.

Exclusion Criteria:

* Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.
D: Patients were eligible to participate if they were cigarette smokers, older than the age of 18 years, and presenting to the dentist for routine dental prophylaxis.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Brief Summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


Options:
A: Inclusion Criteria:

* Males and females, above the legal age of consent
* Hospitalized in intensive care unit
* Need fluid resuscitation (according to the physician in charge of the patient)

Exclusion Criteria:

Patients who have one or more of the following items:

* Known allergy to gelatins, albumin or starch
* Coagulation disorders (haemophilia, Willebrand disease, etc.)
* Chronic renal failure on permanent dialysis
* Severe hepatic failure
* Burns \> 20 % of body surface
* Pregnancy
* Volume replacement: As a part of anaesthesia, for anaphylactic shock, or for dehydration
* Brain death
* Advance directive of withholding or withdrawal of life-sustaining treatments
* Any other investigational drugs
B: Inclusion Criteria:

* Severe sepsis
* Requirement for fluid resuscitation

Exclusion Criteria:

* serum creatinine \> 300µmol/L
* Chronic renal failure
* Anuria lasting more than 4 hours
* Requirement for renal support
C: Inclusion Criteria:

* Blunt trauma
* Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)\*
* Age 15 years or older or 50 kg or more

  * Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP\>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.

Exclusion Criteria:

* Known or suspected pregnancy
* Age younger than 15 years or less than 50 kg if age unknown
* Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
* Administration of more than 2L crystalloid or any colloid or blood products
* Severe hypothermia (T less than 28C)
* Drowning or asphyxia due to hanging
* Burns TBSA more than 20%
* Isolated penetrating injury to the head
* Inability to obtain pre-hospital intravenous access
* Time of call received at dispatch to study intervention more than four hours
* Known prisoners
D: Inclusion Criteria:

* Witnessed cardiac arrest,
* ALS started within 15 min.
* ROSC within 60 min.
* Still unconscious,
* Age 18-80

Exclusion Criteria:

* Other malignancies,
* Persons who wake up,
* Pregnancy

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Brief Summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


Options:
A: Inclusion Criteria:

* Severe sepsis
* Requirement for fluid resuscitation

Exclusion Criteria:

* serum creatinine \> 300µmol/L
* Chronic renal failure
* Anuria lasting more than 4 hours
* Requirement for renal support
B: Inclusion Criteria:

* Witnessed cardiac arrest,
* ALS started within 15 min.
* ROSC within 60 min.
* Still unconscious,
* Age 18-80

Exclusion Criteria:

* Other malignancies,
* Persons who wake up,
* Pregnancy
C: Inclusion Criteria:

* Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Known allergy against hydroxyethyl starch
* Pre-treatment with \> 1000ml hydroxyethyl starch within 24 hours before inclusion
* Pre-existing kidney failure requiring dialysis or serum creatinine value \> 320 mmol/l (3,6 mg/dl)
* Intracerebral hemorrhage
* Severe head trauma with edema
* FiO2 at time of study inclusion \> 0,7
* Heart failure (New York Heart Association \[NYHA\] IV)
* Enrolment in another interventional study
* Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
* Do not resuscitate (DNR) order
D: Inclusion Criteria:

* Severe sepsis

Exclusion Criteria:

* Age of less than 18 years
* Pregnancy, or the presence of an acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics
* Cardiac dysrhythmias (as a primary diagnosis), contraindication to central venous catheterization, active gastrointestinal hemorrhage, seizure
* Drug overdose, burn injury, trauma, a requirement for immediate surgery, uncured cancer (during chemotherapy
* Immunosuppression (because of organ transplantation or systemic disease), do-not-resuscitate status, advanced directives restricting implementation of the protocol
* Delayed admission to ICU from emergency department (more than 4 hours), or fluid resuscitation previous to ICU with more than 1,500 cc

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Brief Summary: This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.


Options:
A: Inclusion Criteria:

* Subject is postmenopausal.
* Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion Criteria:

* Subject has clinically significant abnormal findings in the physical examination.
* Subject has a body mass index (BMI) equal to or greater than 38 kg/m\^2
* Subject has uncontrolled hypertension.
* Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
* Subject has uterine/vaginal bleeding of unknown origin.
* Subject has a vaginal infection requiring medication (may be treated and be eligible for study).
B: Inclusion Criteria:

* Postmenopausal women whose last menstruation was at least two years previously
C: 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
D: Inclusion Criteria:

* Generally healthy
* Postmenopausal
* Hysterectomized or non-hysterectomized
* Moderate or severe vaginal dryness and soreness
* Successful completion of the study VAG/PD/009/USA

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
* Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
* Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Brief Summary: This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.


Options:
A: 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
B: Inclusion Criteria:

* Postmenopausal women
* serum estradiol level less than or equal to 20 pg per mL
* serum FSH greater than 40 mIU per mL

Exclusion Criteria:

* Pathological cancer findings on screening
* abnormal endometrium
* serious hepatic, renal or cardiac disease
C: 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
D: 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

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Brief Summary: Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the elderly, and are an increasingly important public health concern. A comprehensive multidisciplinary and integrated community-based approach is needed to identify and manage the population at highest risk of these complications. Unfortunately, current gaps in continuity of care and health intervention result in a sub-optimal state of health service for these individuals. The Falls, Fracture and Osteoporosis Risk Control and Evaluation (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of coordinated community-based, multidisciplinary approach for fall and fracture prevention in Sault Ste. Marie.


Options:
A: Inclusion Criteria:

* Definite multiple sclerosis diagnosis
* ambulatory
* aged 50-75 years of age
* fallen within 12 months

Exclusion Criteria:

* non-ambulatory
* outside age range
* no fall history
B: Inclusion Criteria:

* 55 years of age or older
* independent living within the city of Sault Ste. Marie, Ontario, Canada
* capable of providing informed consent

Exclusion Criteria:

* not at risk for falls
* unable to give informed consent
C: Inclusion Criteria:

* Patients residing in the community

Exclusion Criteria:

* to be institutionalized
* Immobilized or bedridden
* Present a terminal disease or severe psychiatric illness
* Have contraindications to physical exercise
D: Inclusion Criteria:

* Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months

Exclusion Criteria:

* A previous diagnosis of dementia or a cognitive decline;
* A previous stroke with a severe neurological impairment;
* A progressive neurological disease;
* A severe visual deficiency;
* Any acute illness that the physician considers as an exercise contra-indication;
* An acute vertigo or dizziness less than 3 months duration;
* Inability to keep on standing, even with the use of a walking aid or other device;
* Unable to communicate;
* Those who are engaged in a regular exercise program, including physical therapy, with a frequency of equal to or more than twice a week such as: muscle strengthening, balance or gait exercise, Tai Chi and Yoga

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Inclusion Criteria:

* survivor of sexual violence
* mental health symptom severity cut-off
* functional impairment cut-off

Exclusion Criteria:

* active suicidality
* not living in the study site
B: Inclusion Criteria:

* Pregnant women 31 weeks or less gestation, over age 18, with a history of intimate partner violence within the past 2 years, and who are willing to participate in the home visit program

Exclusion Criteria:

Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English
C: Inclusion Criteria:

* Female
* English or Spanish speaking
* 18-64 years of age
* Report current physical, or sexual intimate partner violence or emotional abuse within the context of threats of physical or sexual intimate partner violence
* Live in one of the target states (Oregon, Arizona, Missouri, or Maryland)
* Express comfort with and access to a safe computer with internet

Exclusion Criteria:

* Male
* Younger than 18 years of age
* Older than 64 years of age
* Cannot read/speak English/Spanish
* Live outside targeted 4 states
* No access to safe computer with internet
* Uncomfortable with computers
* Does not report past year violence from an intimate partner
D: 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

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Inclusion Criteria:

* Child 0 - 5 years
* Family English speaking
* Parent agrees to participate

Exclusion Criteria:

* Child in foster care
* Another child in the family already enrolled
B: Inclusion Criteria:

* Pregnant women 31 weeks or less gestation, over age 18, with a history of intimate partner violence within the past 2 years, and who are willing to participate in the home visit program

Exclusion Criteria:

Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English
C: Inclusion criteria:

1. Between the ages of 15-49 years;
2. Consent to participation;
3. Resident of at least 6 months in study community;
4. Enrollment into RCCS at baseline (2005-06);
5. Report of sexual activity or being in a partnership in the year prior to the baseline interview;
6. Provision of follow-up information on variables of interest.
7. For HIV incidence, only participants with initial HIV-negative serostatus at their baseline visit were included in the analyses.

Exclusion criteria:

1. Younger than 15 years and older than 49 years;
2. Did not consent to participation;
3. Non-resident in study community;
4. Not enrolled in RCCS between 2005-06;
5. Not yet sexually active or not sexually active during year prior to baseline;
6. Incomplete follow up information on variables of interest;
7. HIV positive at baseline
D: Inclusion Criteria:

* African American or Latina (by self report)
* At least 18 years of age
* English speaking
* Pregnant less than or equal to 28 weeks gestation
* Receiving prenatal care in the District of Columbia
* Had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence

Exclusion Criteria:

* Non-minority race (by self report)
* Younger than 18 years of age
* Non-English speaking
* Not pregnant or pregnant greater than 28 weeks gestation
* Receiving prenatal care outside the District of Columbia
* Responded negatively to questions about risk factors
* Suicidal ideation

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Inclusion Criteria:

* Pregnant women 31 weeks or less gestation, over age 18, with a history of intimate partner violence within the past 2 years, and who are willing to participate in the home visit program

Exclusion Criteria:

Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English
B: Inclusion Criteria:

* Ages 18-44
* Currently in heterosexual relationship with a male partner
* Responds in affirmative to past year sexual or physical violence

Exclusion Criteria:

* Cognitive impairment (slurred speech, inability to follow directions)
* Seeking treatment for life threatening emergency care
* Intends to relocate within 2 years.
C: Inclusion Criteria:

* Age 16 years and older
* NFP program participants (woman with first live birth and living in poverty)
* English speaker

Exclusion Criteria:

- Woman who cannot communicate in English
D: Inclusion:

* female clients
* ages 16-29
* English or Spanish speaking
* able to provide their own consent
* plan to be in area for the next 12 months
* willing to be contacted for follow up survey and able to provide additional contact information

Exclusion Criteria:

* female clients not of the specified age range
* neither English nor Spanish speaking
* clients who are intoxicated or otherwise not able to provide their own consent

Answer: A