TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial
Brief Summary: The purpose of this study, and its original contribution to research, is to determine the impact of a physical activity skill development and parent centered family weight management program on the weight, cardiovascular health, physical activity, dietary intake and sedentary behaviors of overweight and obese children.


Options:
A: Inclusion Criteria:

* Overweight and obese children with the Wollongong and Newcastle regions, aged between 5.5 and 9
* BMI within specified range
* Otherwise healthy children
* Not on any medications that may influence obesity
* One parent able to attend all required sessions
* Pre-pubertal
* No sibling enrolled

Exclusion Criteria:

* Children with BMI outside the specified range
* Children on medication that may influence obesity
* Children that have conditions that may influence obesity
B: Inclusion Criteria:

* Healthy kindergarten children

Exclusion Criteria:

* Children with severe chronic disease (restricting physical activity)
C: Inclusion Criteria:

* Community criteria

Four (4) to six (6) communities in each of five (5) jurisdictions (Alaska, American Samoa, Commonwealth of Northern Mariana Islands, Guam \& Hawai'i) chosen for community randomized program based on:

* 2000 U.S. Census criteria

  * \>1000 people
  * \>25% Native population,
  * \>10% under 5y
* CHL Staff Community Evaluation

  * Sufficient Head Start/preschool, kindergarten
  * Children live \& go to school in area
  * Separation between communities to allow testing
  * Access for CHL
  * Sufficient community cohesiveness
  * Sufficient settings for program (community centers, parks, stores...)
* Child criteria • 2-10 years of age

Exclusion Criteria:

* Child criteria

  * Known orthopedic, psychological or neurologic impairments that prevent physical activity
  * Presence or history of any metabolic or chronic health problems known to affect intermediary metabolism (e.g. untreated thyroid disease, cancer, hepatic disease, renal disease, diabetes, cardiovascular disease, hypertension)
  * Irregular use of prescription or over-the-counter medications known to affect appetite, food intake or intermediary metabolism (e.g. appetite suppressants, lithium, antidepressants, etc.)
D: Inclusion Criteria:

* Children enrolled in participating schools; entering kindergarten the year after recruitment

Exclusion Criteria:

* Children not entering kindergarten within one year of recruitment.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk
Brief Summary: This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV


Options:
A: Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery).
* Patient is scheduled to receive general anesthesia.
* Patient is scheduled to receive postoperative opioids.
B: Inclusion criteria:

* Females age 18-55
* Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

* Pregnant or breastfeeding
* Post-menopausal
* Not undergoing general anesthesia
C: Inclusion Criteria:

* Patient undergoing laparoscopic gynecologic surgery.
* Patient who takes fentanyl based IV PCA
* ASA class I-II

Exclusion Criteria:

* allergy to aprepitant
* take another antiemetics before surgery
* decreased liver function
* psychological disease
* who cannot speak Korean
* take medicines that interacts with emend who do not agree to the study
D: Inclusion Criteria:

* female gender, non-smoking and use of postoperative opioids undergoing laparocopic abdominal surgery

Exclusion criteria included laparoscopic abdominal surgey, allergy to one of the study drugs, opioid dependence, history of gastro-intestinal disease or Parkinson's disease, history of previous PONV and motion sickness, contra-indication for epidural block (previous back surgery, bleeding diathesis or neurological dysfunction), anti-emetic medication within 24 h before surgery, inability to use the PCEA device or comprehend the visual analogue scales (VAS) for pain and nausea assessment, or unwillingness to be enrolled in the study.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain
Brief Summary: This clinical trial compares two psychological treatments for back pain.


Options:
A: Inclusion Criteria:

* Chronic back pain for at least 6 months
* Treatment by medication or physical therapy

Exclusion Criteria:

* Acute or life threatening physical illness
* Current alcohol or substance abuse or dependence
* Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery
B: Inclusion Criteria:

* clinical Diagnosis of Low Back Pain lasting at least 3 months
* pain of at least 4 on a 0-10 bothersomeness scale

Exclusion Criteria:

* do not currently have back pain
* current back pain episode less then 3 months in duration
* current back pain is only reported as mild in dysfunction and symptoms (i.e., less than a score of 7 on the 0-23 modified Roland Scale or a bothersomeness score lower than 4 on a 0-10 scale);
* sciatica
* underlying systemic or visceral disease
* pregnancy
* abdominal aneurisms
* spondylolisthesis
* discitis
* spinal stenosis
* spinal infections
* cancer or unexplained weight loss
* recent vertebral fracture
* current or past participation in classes or therapies closely resembling our MBSR or CBT interventions for chronic pain
* have physical problems that won't allow them to do yoga (i.e., gross obesity, severe pain when bending or twisting, unable to get up and down from the floor)
* involved with litigation or compensation claim for back pain
* evidence of severe or progressive neurologic deficits
* radiculopathy
* fibromyalgia diagnosis
* rheumatoid arthritis
* back surgery within the last 2 years
* unstable medical or severe psychiatric conditions
* unable to speak or read English
* unable to hear
* plan to move out of town
C: Inclusion Criteria:

* Magnetic Resonance Imaging (MRI) verified cervical disc disease showing cervical nerve root compression
* Positive Spurling sign and/or cervical extension test
* Clinical examination signs matching the MRI

Exclusion Criteria:

* earlier fracture or luxation of the cervical column,
* malignity,
* spinal tumour,
* spinal infection,
* previous surgery in the cervical column,
* co-morbidity such as disease or symptoms contraindicated to perform the treatment program or the measurements,
* known drug abuse,
* lack of familiarity with the Swedish language,
* diagnosed psychiatric disorder
D: Inclusion Criteria:

* Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
* age 18-70 years.

Exclusion Criteria:

* Osteoporosis
* Newly operation on the back up to 2 years before the beginning of the study
* Fresh vertebral fracture
* Malignancy
* Infection in the back
* spondylolisthesis
* Problem in understanding Farsi Language

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT
Brief Summary: This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.


Options:
A: Inclusion Criteria:

* Body mass index 30 or greater
* Stable health
* Desire to lose weight
* Agrees to attend regular visits
* Access to telephone and reliable transportation
* Has a Veterans Affairs Medical Center (VAMC) provider

Exclusion Criteria:

* Certain chronic or unstable disease (kidney or liver disease, type 1 diabetes, hemoglobin A1c 12% or more, insulin use, unstable heart disease, transplant recipient, blood pressure 160/100 or greater, fasting blood triglycerides 600 or greater, LDL cholesterol 190 or greater)
* Pregnancy, breastfeeding, lack of birth control
* Active dementia, psychiatric illness, or substance abuse (past year)
* Weight loss therapy in previous month
* Pacemaker or defibrillator
* Enrolled in another study that might affect measurements
* Previously in study of low-carbohydrate or low-fat diet for weight loss
* Unable to complete all study measures
B: Inclusion Criteria:

* BMI\>27
* age\>40
* History of CHD or diabetes in any age or BMI level

Exclusion Criteria:

* Pregnant or lactating women.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serum creatinine \> 3 mg/dl.
* Liver dysfunction ( ³ 2 fold level of ALT and AST enzymes).
* Participation in another trial in which active intervention is being received.
* Any intestinal problem that would prevent the patient from eating one of the test diets (for example, gastric stapling that might prevent consumption of vegetables).
C: Inclusion Criteria.

* Healthy men.
* BMI 30-40.
* Fasting blood glucose \< 7 mM.
* Stable body weight last 2 months.

Exclusion Criteria.

* High intake of alcohol.
* Medication affecting glucose or lipid metabolism.
* Allergy towards important food items in the diet.
* Inflammatory bowel disease.
* Surgery or use of antibiotics last 2 months.
D: Inclusion Criteria:

* Male or female subjects \> 18 years of age
* Clinical diagnosis of type 2 diabetes mellitus or on insulin or oral hypoglycemic agents
* Body mass index of \> 30 kg/m2
* The subject must we willing and able to monitor their blood glucose with a glucometer at least 2 times per week.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise Dose and Insulin Sensitivity in Obese Children
Brief Summary: The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren.

The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases.

An ancillary study examined effects on cognition and achievement.


Options:
A: Inclusion Criteria:

* BMI \> 27 kg/m2 (adults)

Exclusion Criteria:

* weight loss of more than 5kg in the last 2 months
* pregnancy, breastfeeding
* patients with:

  * severe heart failure
  * impaired hepatic or renal function
  * anaemia
  * disturbed coagulation (biopsies will not be taken in those subjects)
  * infection, malabsorption
  * severe hypertension
  * cancer within the last 5 years
  * eating disorders or any other psychiatric condition that would interact with the trial intervention
  * any other endocrine disorder
* changes of smoking habits or diets within the last 3 months prior to study inclusion
B: Inclusion Criteria:

* Schools with at least one full course of 3rd of early childhood education and one of 1st primary school.
* The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course.
* Children 4 to 7 years old.
* Children's parents/caregivers will give their written consent to the children's participation.
* Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project.

Exclusion Criteria:

* Have a malformation that prevents learning of the Spanish language (or Spanish sign language).
* Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity.
* Have a chronic illness such as heart disease, diabetes or asthma, as determined by their pediatrician/family doctor -after analysis of the activities program- prevents participation in them.
C: Inclusion Criteria:

* All children in 3-5 grades who provide parental consent and child assent will be eligible to participate in the project.

Exclusion Criteria:

* Participants who meet the following exclusion criteria will not be considered for participation.
* Do not provide consent
* unable or unwilling to adhere to project procedures
D: Inclusion Criteria:

* Overweight, sedentary children
* Black or white race
* Attending specific schools in Augusta, GA area from which this study is recruiting

Exclusion Criteria:

* Unable to participate in testing or vigorous exercise program
* Diabetes
* Taking medication that would affect study results
* Sibling enrolled in project

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Diabetes Through Primary Care Translation (IMPACT)
Brief Summary: The goal of our research program is to successfully translate empirical knowledge regarding diabetes treatment and management into sustainable clinical practice. The study hypothesis is that implementation of a multicomponent intervention will result in meaningful improvement in clinical performance measures at the clinic that include average A1c (Hemoglobin A1c), average systolic blood pressure, and national clinical performance measures at a reasonable cost to the health system.


Options:
A: Inclusion Criteria:

* Alive on 1 July 2009 with prevalent diabetes

Exclusion Criteria:

* Age \<= 39
* Residing in long-term care

Secondary Analysis:

* Analysis will be repeated using all people alive on 1 July 2009 without prevalent diabetes using the same exclusion criteria, to determine the spill-over effect of the Intervention on physicians' other patients.
B: Inclusion Criteria:

(The unit of randomization is the medical clinic)

* Clinics were excluded if they participated in an effective quality improvement program within the last two years.
* Clinics must have 3-22 full time equivalent providers
* Clinics must be located in Minnesota or Western Wisconsin
* Clinics must be willing to implement a diabetes registry
* Must be a single specialty, general internal medicine or family practice clinic
C: Inclusion Criteria:

* has type 2 diabetes
* treated with oral agents in monotherapy or combined therapy ± basal insulin
* previously educated to self-monitoring blood glucose (SMBG) use

Exclusion Criteria:

* has type 2 diabetes non-pharmacologically treated
* has type 2 diabetes treated with multiple daily injections of insulin
* is unable to use the telemedicine system
* pregnancy
* has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6 months
* has any disease or condition, including alcohol or drugs abuse, that may interfere with study completion
D: Inclusion Criteria:

* Initiating long-acting insulin treatment or initiating the titration of long-acting insulin treatment
* Speaks English or Spanish
* Hemoglobin A1c \> or = 8%
* Able and willing to inject insulin
* Able and willing to provide informed consent

Exclusion Criteria:

* Short-acting insulin treatment
* Systemic glucocorticoids
* Sustained elevated serum creatinine \> or = 1.5 mg/dL for men and \> or = 1.4 mg/dL for women
* Hypoglycemia unawareness
* Type 1 diabetes

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Diabetes Through Primary Care Translation (IMPACT)
Brief Summary: The goal of our research program is to successfully translate empirical knowledge regarding diabetes treatment and management into sustainable clinical practice. The study hypothesis is that implementation of a multicomponent intervention will result in meaningful improvement in clinical performance measures at the clinic that include average A1c (Hemoglobin A1c), average systolic blood pressure, and national clinical performance measures at a reasonable cost to the health system.


Options:
A: Inclusion Criteria:

* African-American
* 65 years of age or older
* no dilated fundus exam in past 2 years

Exclusion Criteria:

* appointment for dilated fundus exam scheduled
* no access to phone
B: Inclusion Criteria:

(The unit of randomization is the medical clinic)

* Clinics were excluded if they participated in an effective quality improvement program within the last two years.
* Clinics must have 3-22 full time equivalent providers
* Clinics must be located in Minnesota or Western Wisconsin
* Clinics must be willing to implement a diabetes registry
* Must be a single specialty, general internal medicine or family practice clinic
C: Inclusion Criteria:

* people with no health insurance

Exclusion Criteria:

* people with any type of health insurance coverage
D: Inclusion Criteria:

* Alive on 1 July 2009 with prevalent diabetes

Exclusion Criteria:

* Age \<= 39
* Residing in long-term care

Secondary Analysis:

* Analysis will be repeated using all people alive on 1 July 2009 without prevalent diabetes using the same exclusion criteria, to determine the spill-over effect of the Intervention on physicians' other patients.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Options:
A: Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF
B: Inclusion Criteria:

* adult patients \>=18 years of age;
* RA for \>=6 months;
* receiving outpatient treatment;
* inadequate response to methotrexate, having received and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks.

Exclusion Criteria:

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
* inflammatory joint disease other than RA, or other systemic autoimmune disorder;
* diagnosis of juvenile arthritis, or RA before the age of 16;
* previous treatment with \>1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
C: Inclusion Criteria:

* adult patients at least 18 years of age with active RA for at least 3 months;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
* treatment with methotrexate (MTX) within 6 months of entering study;
* patients who have stopped previous MTX treatment due to toxicity or lack of response;
* women who are pregnant or breast-feeding.
D: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis
* At least 3 months prior treatment with Methotrexate (MTX)
* At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
* Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

* participants who have failed more than 3 DMARDs
* participants previously treated with an approved biologic drug
* History of cancer in the last 5 years
* Severe or recurrent bacterial infection
* Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
* Women of Child Bearing Potential

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: Inclusion Criteria:

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

Exclusion Criteria:

* infants born with multiple congenital abnormalities
B: Inclusion Criteria:

* Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (\<10th percentile of the National Center for Health Statistics \[NCHS\] median birth weight)
* Either sex
* Resides within 7 km of the hospital

Exclusion Criteria:

* Likely to leave the area of residence within 6 months of enrollment
* Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
* Non consent for participation
* Illness requiring hospitalization
* Twins
* Preterm
C: Inclusion Criteria:

* All available children who received iron and zinc study during infancy

Exclusion Criteria:

* Neurological disorder
D: Inclusion Criteria:

* All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

Exclusion Criteria:

* Parent refusal

Answer: D