TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Brief Summary: The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.


Options:
A: Inclusion Criteria: Children between 0 and 3 years old enrolled in the aforementioned DCCs, attended the DCCs for at least 15 hours per week and whose parents/guardians had signed an informed consent document were included.

Exclusion Criteria: Children whit chronic illnesses or medication that could affect their likelihood of contracting an infection. Families who used hydroalcoholic gel prior to the start of the study and/or antiseptic soaps in the control group.
B: Inclusion Criteria:

* Residence in selected University of Michigan Residence Halls

Exclusion Criteria:

* Non-residence in selected Residence Halls
* Unwillingness to utilize face mask and hand sanitizer and complete online surveys
* Already study employee
C: Inclusion Criteria:

* aged from 15 to 20 years
* obtained written informed consent from both the student and parent before participation
* possible to gargle during 90 days
* possible to fill in questionnaire

Exclusion Criteria:

* Possessing allergy to green tea
* Possessing history of influenza infection within 6 months before entering the study
* Possessing severe immune disease or whole body infection
* severe cardiac, respiratory, renal, or hepatic dysfunction
* diagnosed as inadequate to participate in the study by student doctor
D: Inclusion Criteria:

* Nurses who work in emergency departments and medical units
* Nurses expected to work full time (defined as \> 37 hours per week)

Exclusion Criteria:

* Nurses who were not fit tested
* Nurses who could not pass a fit test

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Brief Summary: The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.


Options:
A: Inclusion Criteria:

* Member of a designated elementary school classroom in the Avon school system
B: Inclusion Criteria:

* Nurses who work in emergency departments and medical units
* Nurses expected to work full time (defined as \> 37 hours per week)

Exclusion Criteria:

* Nurses who were not fit tested
* Nurses who could not pass a fit test
C: Inclusion Criteria:

* Volunteers working in defined units

Exclusion Criteria:

* Persons with open wounds or chronic eczema in hands
D: Inclusion Criteria:

* Member of family with influenza infected member

Exclusion Criteria:

* Age less than 2 yr

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feeding Young Children Study (FYCS)- a Randomized Control Trial of a Bottle Weaning Intervention Aimed at Reducing the Risk of Overweight in Low Income Multi-ethnic Toddlers.
Brief Summary: This Integrated Project (Research + Extension) aims to reduce the risk of early childhood overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months, "inappropriate bottle-feeding," has been linked to overweight. Our pilot of this intervention reduced bottle use.

COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):

1. Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income multi-ethnic toddlers, will enroll n=464 12 month olds using \>2 bottles/day from two WIC sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will be assessed at Baseline, and 4 times over a 12 month follow-up.
2. Observational Study- nested within the RCT, will describe dietary intake and nutrient density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap in knowledge about this population's dietary habits, and their relationship to bottle use.
3. Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and pediatric websites, and; a public TV segment. We will disseminate findings through a) the National WIC Association, b) nutrition \& pediatric journals, and; c) lay print, media, and websites with assistance from our Public Relations Department.


Options:
A: Inclusion Criteria:

Children participants 3rd or 4th grade student in participating school (during first school year of study)

Exclusion Criteria:

Not a 3rd or 4th grade student
B: Inclusion Criteria:

* after-school program participant in fourth grade group
* informed parental consent
* assent to participate in Body Mass Index assessment

Exclusion Criteria:

* third or fourth grade student
* participant in study in previous year
C: Inclusion Criteria:

* 12 month olds using 2 bottles a day of non-water liquids.

Exclusion Criteria:

* Health or developmental conditions that may affect the child's health or weight.
* On chronic medications that may affect the child's appetite or growth rate.
* Medical conditions that may affect the child's appetite or growth rate.
* Neurological or muscular conditions that affect the child's ability to feed themselves.
* Steroid treatments such as prednisone that may affect the growth rate of the child.
D: Inclusion Criteria:

* Children in participating kindergartens

Exclusion Criteria:

* Health conditions restricting physical activity
* Age \< 43 months or \> 67 months

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.
Brief Summary: To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the sacrospinous ligament on the ischial spine would be a source of pain and therefore be a target for therapy.

Primary outcome measure is reported pain intensity on visual analogue scale and secondary outcome measures number of pain-drawing locations, pain-provoking test results and tests of function.


Options:
A: Inclusion Criteria:

* Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks.

Exclusion Criteria:

* Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic
B: Inclusion Criteria:

* Healthy
* 20-49 years old
* Pregnant with a singleton
* Low back pain began during pregnancy and has lasted more than one week
* Low back pain is reproducible with palpation

Exclusion Criteria:

* Health conditions such as hypertension, diabetes, cancer, thyroid condition etc.
* Pain radiates below knee
* Cannot read English
* Plans to move away from Portland area during pregnancy
* Not willing to be randomized to one of the three arms of the study
C: Inclusion Criteria:

* reported ongoing pain in the sacral region with onset during pregnancy with six months to seven years duration after delivery
* reported pain intensity at present between 30 and 50 mm on a 100 mm horizontal visual analogue scale (VAS)
* at least one positive pain provocation test out of three and pain elicited on internal palpation at the ischial spine at least unilaterally.

Exclusion Criteria:

* on-going low back pain with onset before pregnancy
* previous back surgery
* positive straight leg-raising test
* loss of tendinous reflex in the legs
D: Inclusion Criteria:

1. Pregnant women aged between 16 and 40 years old
2. gestational age \>20 weeks
3. nulliparous women
4. single fetus
5. Performing pre-natal care.

Exclusion Criteria:

1. Pathological heart condition
2. diabetes
3. hypertension
4. asthma bronchial
5. HIV+
6. gestational hypertension
7. gestational diabetes
8. pre-eclampsia
9. persistent bleeding
10. premature labor
11. cervical incompetence
12. acute infection with fever
13. restriction in fetal growth
14. indication of elective caesarian-section
15. in psychotherapy
16. performing other physical activity more than once a week.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Brief Summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Options:
A: 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
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:

* 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:

* 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: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Brief Summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


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
* Sleep apnea
* Inflammatory bowel disease
B: 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
C: Inclusion Criteria:

* patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* psychiatric illness
* depression of generalised anxiety disorder
* suicidal risk
* substance abuse
* active cardiac disease
* pulmonary dysfunction
* liver disease
* renal impairment
* autoimmune disease
* chronic inflammatory rheumatoid disease
* current systemic infection
* epileptic
* active cancer
* sleep apnea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* for men : prostatic enlargement of genito-urinary disorders
* for women : pregnancy or breast feeding
D: 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

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pain Reactivity to Non-pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit
Brief Summary: Switzerland is having one of the highest premature rates in Europa and most of the preterm neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive care units are either "off label used" or "non-licensed" used. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population.

This multicenter pilot study will use a randomized three group,repeated measures design.

The primary aims of this study of premature neonates are to:

1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking alone, sucrose alone and sucrose in combination with tucking)on pain reactivity.

2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact of the numbers of painful procedures the infant experiences and the concurrent use of analgesic medications on the estimates of efficacy


Options:
A: Inclusion Criteria:

* must be born between 24 0/7 and 32 0/7 weeks of gestation
* must be hospitalized in the NICU
* it must be anticipated that they will need at least 5 routine heel sticks
* their parents give informed consent

Exclusion Criteria:

had a high-grade intraventricular hemorrhaging (grade III and IV);

* have a severe, life-threatening malformations;
* are suffering from any condition involving partial or total loss of sensitivity
* had a pHa \< 7.00;
* had surgery for any reason; or
* have a congenital malformation affecting brain circulation or the cardiovascular system.
B: Inclusion Criteria:

-VLBW infants \<32 weeks of gestational age

Exclusion Criteria:

* infants \>32 weeks of gestational age
* neuromuscular abnormality
* major abnormality
C: Inclusion Criteria:

* born at a gestational age between 32+0 and 36+6 weeks,
* being nourished with breast milk
* the necessity for a clinical blood sample.

Exclusion Criteria:

* perinatal asphyxia,
* birth trauma,
* condition of cardio-respiratory instability,
* condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
* drug abuse of the mother
* and application of sedative medication to mother or child.
D: Inclusion Criteria:

* Requiring retinal exam for ROP screening
* Clinically stable
* At least 30 0/7 weeks of corrected gestational age at the time of study
* Not on mechanical ventilation or CPAP at the time of study
* Requiring an inspired concentration of oxygen less than 50%

Exclusion Criteria:

* - Craniofacial malformations
* Cyanotic cardiac disease
* Hemodynamically significant cardiac lesions
* Known pneumothorax or pneumomediastinum
* Congenital pulmonary malformations
* Neuromuscular disease
* Receiving opiates, benzodiazepines or barbiturates at the time of study

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot and Feasibility Evaluation of a Walking School Bus Program Intervention for Elementary School Students
Brief Summary: Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. However, increasing child pedestrian activity could increase the risk of child pedestrian injuries. Walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. Walking with an adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. Children may join the WSB at various points along the set route. Despite the growing popularity of WSB programs in the United States, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. We seek to help fill this gap in the literature by piloting a WSB program in elementary schools in the Houston Independent School District to test feasibility. We hypothesize that a WSB program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.


Options:
A: Inclusion Criteria:

* Attends first grade in one of the ASPs included

Exclusion Criteria:

* Does not attend first grade in one of the ASPs included
B: Inclusion Criteria:

* students in 4th grade in a participating elementary school and their 4th grade teachers

Exclusion Criteria:

* none
C: Inclusion Criteria:

* • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Exclusion Criteria:

* No exclusion criteria.
D: Inclusion Criteria:

* 4th grade student at a study school in the Houston Independent School District
* Must be physically able to walk to and from school

Exclusion Criteria:

* Any condition that would prevent the student from walking to or from school

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years
Brief Summary: The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population.

This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired population, but should these levels decline overtime, to use this as a predictor of cardiovascular and cerebrovascular events, taking into account established cardiovascular risk factors.


Options:
A: Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects who have used bupropion (Zyban, or Wellbutrin) previously.
B: Inclusion Criteria:

* 65 years old
* informed consent signed

Exclusion Criteria:

* prior myocardiac infarction
* prior stroke
* hearth failure
* atrial fibrillation
* insulin-treated diabetes mellitus
* cardiac pacemaker
* disease limiting life expectancy to \< 5 years
* contraindication to brain MRI
* living in an institution
C: Inclusion Criteria:

* informed consent signed
* to participate in the PROOF study

Exclusion Criteria:

* prior myocardiac infarction
* prior stroke
* hearth failure
* atrial fibrillation
* insulin-treated diabetes mellitus
* cardiac pacemaker
* disease limiting life expectancy to \< 5 years
* contraindication to brain MRI
* living in an institution
* respiratory failure with oxygenotherapy
* sleep-related breathing disorders known and treated
D: Inclusion Criteria:

* Be at least 18 years of age
* Be between 13 and 25 weeks of pregnancy
* Be receiving prenatal care at one of the participating clinics
* Have smoked at least 100 cigarettes in their lifetime
* Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
* Speak and write English

Exclusion Criteria:

* Evidence of cognitive or mental health problems
* Evidence of possible drug or alcohol addiction
* Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
* Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy

Answer: B