TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Metformin and Oral Contraceptives in PCOS
Brief Summary: Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women. More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function. No studies however, evaluated the long term effects of insulin sensitizing treatment.

Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS.

Design: Randomized open study in 3\*30 PCOS patients. Patients are randomised to 24 months of treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.

Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH, FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and c-peptid during OGTT.

Inclusioncriteria:

1. Irregular menses or anovulaty cycles
2. High free testosterone \> 0,035 nmol/l or hirsutism
3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.

Design:


Options:
A: 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
B: Inclusion Criteria:

* Women of fertile age presenting with PCOS
* Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)

Exclusion Criteria:

* Severe disease not related to the condition under study
* Pregnancy
* Medical or surgical treatment of PCOS during the previous 3 months
* Contraindication for the use of oral contraceptives or metformin
* Inability to understand the proposal of the study precluding effective informed consent
* Minors who are not accompanied by their legal representative
C: Inclusion Criteria:

* Irregular menses or anovulaty cycles
* High free testosterone \> 0.035 nmol/l or hirsutism
* PCO in vaginal US Criteria 1 and 2 OR 2 and 3

Exclusion Criteria:

* Age \> 18 years
* Postmenopausal
* Diagnosis diabetes mellitus
* Use of medicine known to affect hormones measured in the project
* Pregnancy or planned pregnancy during study period
* Non-Caucasian
* Previous tromboembolic disease
* Heavy smoker \> 35 years and BMI \> 35 kg/m2
D: Inclusion Criteria:

* PCOS

Exclusion Criteria:

* diabetes
* pregnancy
* contraindications to oral contraceptives

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer
Brief Summary: The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.


Options:
A: Inclusion Criteria:

1. pathologically proven gastric adenocarcinoma
2. age: 20 \~ 80 years
3. preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0
4. no history of other cancer
5. no history of chemotherapy or radiotherapy
6. written informed consent

Exclusion Criteria:

1. ASA \>3
2. combined resection
3. total gastrectomy
B: Inclusion Criteria:

* Histologically proven adenocarcinoma of the stomach
* Surgically resectable (cT1-4a, N0-3b, M0) tumor
* Age ≥ 18 years
* European Clinical Oncology Group (ECOG) performance status 0, 1 or 2.
* Written informed consent

Exclusion Criteria:

* Siewert type I esophagogastric junction tumor
* Non-elective surgery
* Previous gastric resection or recurrent gastric cancer
* Pregnancy
C: Inclusion Criteria:

* Age equal to or above 18 years
* Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
* Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
* Surgical resectable (T1-3, N0-1, M0)
* Informed consent

Exclusion Criteria:

* Previous or coexisting cancer
* Previous surgery of the stomach
* ASA classification (American Society of Anaesthesiologists) score 4 or higher
D: Inclusion Criteria:

* histologically proven primary gastric adenocarcinoma
* T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
* No evidence of other distant metastasis
* not stump carcinoma,(vi) aged 20-80 year old
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
* adequate organ functions defined as indicated below:

  * WBC 3000/mm3, WBC 12 000/mm3
  * Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
  * Plt 100 000/mm3
  * AST 100 IU/l
  * ALT 100 IU/l
  * T.Bil 2.0 mg/dl
  * written informed consent

Exclusion Criteria:

* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
* pregnant or breast-feeding women
* severe mental disorder
* systemic administration of corticosteroids
* unstable angina or myocardial infarction within 6 months of the trial
* unstable hypertension
* severe respiratory disease requiring continuous oxygen therapy
* previous upper abdominal surgery except laparoscopic cholecystectomy

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Marketing Workplace Chronic Disease Prevention
Brief Summary: The objective of the project is to understand how best to help mid-size employers adopt evidence-based chronic disease prevention practices that improve employee health behaviors.


Options:
A: Inclusion Criteria:

* Adults between 21 and 65 years
* Sedentary (engaging in moderate intensity physical activity for less than 60 minutes per week)
* Working full time (35+ hours/week) at a sedentary desk dependant occupation
* Overweight (Body Mass Index \> 25.0 kg/m2 but less than 40.0 kg/2)
* Apparently healthy as assessed by a health history screening survey
* Devoid of overt complicated or acute cardiovascular, metabolic, respiratory, or neurological diseases
* Free from exercise/physical activity limitations

Exclusion Criteria:

* Adults with significant health problems exacerbated by exercise, such as uncontrolled hypertension, diabetes, orthopedic limitations, etc. will be excluded from the study. Note, with physician approval and adequate control of these health problems, these conditions will not necessarily preclude participation.
* Being unable to exercise
B: Inclusion Criteria:

* Corporate size equal to 100 to 999 part-time and full-time employees (excluding seasonal and temporary workers)
* Headquarters located in King County, Washington, and in a zip code within a 30 mile radius of the research center
* Within an industry with an average annual salary below the median annual salary for King County, Washington (defined by 3-digit NAICS code)
* 50% or more employees are age 35 or older

Exclusion Criteria:

* Do not offer health insurance to full-time employees
* In existence for less than 3 years
* No physical address to which employees report
* Current or previous participation in other workplace health promotion study
* Recent refuser or non-responder for other current workplace health promotion study
* Current participant in other American Cancer Society employer program
* Not willing to be randomized to intervention or comparison group
C: Inclusion Criteria:

* 18-65 years old
* overweight or obese
* prediabetes with elevated glucose value

Exclusion Criteria:

* recent cardiovascular event
* use of corticosteroids
* concurrent participation in a structured weight loss program
* pregnant or lactating
D: Inclusion Criteria:

* age 18 or older
* generally in good health
* part- or full-time employee in one of the participating worksites

Exclusion Criteria:

* work on site \<50% of the time
* work second or third shift

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Family Lifestyle Overweight Prevention Program: Evaluation of a Weight Management Program for Mexican American Youth
Brief Summary: The purpose of the study was to design a weight management program for Mexican American youth and to determine the effectiveness of the program for weight management compared to a self help program.

1. At the end of 6 months, individuals randomly assigned to Intensive Intervention (II) (instructor/trainer led intervention) will lose more weight than individuals assigned to Self Help (SH) only.
2. At the end of 1 year, individuals randomly assigned to II will maintain their weight losses better than individuals assigned to SH.

Secondary hypotheses will include examination of main effects and interactions at the end of 6 months with the following secondary dependent measures: treatment adherence (e.g., attendance, food diaries, exercise diaries), blood levels, changes in percent body fat, overall psychological functioning (PEDS-QL 4.0), and eating behaviors as assessed by food frequency checklists.


Options:
A: Inclusion Criteria:

* Enrolled in the 6th or 7th grade at the target school.
* Parent consent and child assent to participate.

Exclusion Criteria:

* Taking medications for weight control.
B: 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
C: Inclusion Criteria:

* Being student in the included public high school in Region of Lorraine (East of France) whatever the age

Exclusion Criteria:

* None
D: Inclusion Criteria:

* Girls enrolled in 6th grade of selected schools
* Student assent
* Parental consent
* No fractures or medications that compromise bone health or strength
* Enrolled in 2 semesters of physical education

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Family Lifestyle Overweight Prevention Program: Evaluation of a Weight Management Program for Mexican American Youth
Brief Summary: The purpose of the study was to design a weight management program for Mexican American youth and to determine the effectiveness of the program for weight management compared to a self help program.

1. At the end of 6 months, individuals randomly assigned to Intensive Intervention (II) (instructor/trainer led intervention) will lose more weight than individuals assigned to Self Help (SH) only.
2. At the end of 1 year, individuals randomly assigned to II will maintain their weight losses better than individuals assigned to SH.

Secondary hypotheses will include examination of main effects and interactions at the end of 6 months with the following secondary dependent measures: treatment adherence (e.g., attendance, food diaries, exercise diaries), blood levels, changes in percent body fat, overall psychological functioning (PEDS-QL 4.0), and eating behaviors as assessed by food frequency checklists.


Options:
A: Inclusion Criteria:

* enrolled in 9th or 10th grade at participating schools

Exclusion Criteria:

* blood pressure in the range of stage 2 hypertension
* previously diagnosed type 1 or type 2 diabetes
* use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia
* inability to perform moderate to vigorous physical activity
* not ambulatory
* a score of 20 or more on Eating Attitudes Test (EAT)-26 screening measure
* developmental disorders that affect weight or ability to understand the study procedures or counseling
B: Inclusion Criteria:

* Ages 11-16, willing to participate in a randomized controlled trial for health promotion

Exclusion Criteria:

* Outside of age range
C: Inclusion Criteria:

* Student enrolled in Health, Biology, or Public Health course

Exclusion Criteria:

* Cognitive ability unable to read or respond to questions in program
D: Inclusion Criteria:

* Enrolled in the 6th or 7th grade at the target school.
* Parent consent and child assent to participate.

Exclusion Criteria:

* Taking medications for weight control.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania
Brief Summary: The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.


Options:
A: Inclusion Criteria:

1. Age between 3 months and 59 months at enrolment.
2. Informed consent obtained from parents or legal guardians.
3. No current participation in another malaria intervention trial
4. Permanent residence in the study area with no intention of leaving during the surveillance period.

Exclusion Criteria:

1. Previous adverse reaction to treatment with SP, amodiaquine or Coartem. If this is unknown, then a history of allergic reaction to any drug.
2. Temporary residence in the study area
3. Lack of informed consent
4. Presence of a severe, chronic illness such as severe malnutrition or AIDS, likely to interfere with evaluation of the trial results.
B: Inclusion Criteria:

* Age between 6 months and 5 years
* Present with history of fever or reported fever
* Present with cough or difficult breathing

Exclusion Criteria:

* Age below 6 months and above 5 years
* Presence of signs and symptoms of severe illness
C: Inclusion Criteria:

1. Aged \<5 years
2. Weight \>5 kg
3. Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
4. Having a history of fever in the preceding 24 h
5. Able to ingest tablets orally
6. Willing and able to attend stipulated follow-up visits
7. With written informed consent from parent/guardian for children to participate in the trial.

Exclusion Criteria:

Presenting with any of the following "danger signs of severe malaria":

1. Convulsions (\>1 episode within previous 24 hours)
2. Lethargic/unconscious
D: Inclusion Criteria:

* Age 1 - 5 years
* Agreement of parents or guardians to provide informed consent
* Live in Mulago III Parish

Exclusion Criteria:

* History of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy)
* Intention to move from Kampala during the 13 month follow-up period
* History of serious side effects to study medications
* Weight \< 10 kg
* Severe malnutrition defined as a weight-for-height or height-for-age Z-score \< - 3

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Weight Loss and Cardiovascular Disease (CVD) Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome
Brief Summary: The purpose of this study is to determine if intake of whole grain foods as part of a hypocaloric diet enhances weight loss and improves cardiovascular disease risk factors in men and women with metabolic syndrome.


Options:
A: Inclusion Criteria:

* body mass index (BMI) ≥ 30
* at least three out of five ATP III criteria for metabolic syndrome. These criteria are defined as: \[1\] Triacylglycerol ≥150 mg/dL, \[2\] HDL \<40 mg/dL in men or \<50 mg/dL in women, \[3\] Fasting glucose ≥100 mg/dL, \[4\] Systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥85 mg/dL, and \[5\] waist circumference ≥102 cm in men or ≥88 cm in women.

Exclusion Criteria:

* diagnosis of type I or II diabetes
* diagnosis of CVD
* diagnosis of cancer
* diagnosis of any other serious medical condition
* use of any medications that affect glucose, insulin, cholesterol, or reproductive hormones
* smoker
* drink more than 2 alcoholic beverages/d
* consume a diet high in whole grains (\>3 servings/d)
* pregnant or lactating
B: Inclusion Criteria:

* Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study
* HbA1c between 6.5 and 8.0% at recruitment
* living within a 40 km radius of St. Michael's Hospital
* Diabetes diagnosed \> 6 months prior to randomization

Exclusion Criteria:

* diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)
* taking insulin or acarbose
* smoking or significant alcohol intake (\> 1 drink/day)
* serum triglycerides \> 4.0 mmol/L
C: Inclusion Criteria:

* 12-15 years
* IsoBMI\>30

Exclusion Criteria:

* Chronical diseases
* Chronical medication
D: Inclusion Criteria:

* BMI \> 25 to \< 42
* Waist circumference of \> 40 inches for males and \> 35 inches for females and having one other of the criteria for metabolic syndrome will be recruited
* In this population, we will also accept the following:

  * LDL-C \< 175 mg/dL
  * HDL-C \> 25 mg/dL
  * Triglycerides \< 400 mg/dL
* All subjects will be required to meet one specific criteria for metabolic syndrome beyond increased waist circumference

Exclusion Criteria:

* Smokers
* Have insulin-dependent diabetes
* Are pregnant or expecting to be pregnant, lactating in the last 6 months
* Are taking NSAIDS or other medications known to affect inflammatory markers or drugs affecting glucose metabolism

Blood pressure lowering medications are acceptable if the person has controlled BP at screening, \<140/90 mmHg.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase Four Study of Intravenous Parecoxib on Post-craniotomy Pain
Brief Summary: Aim of this trial:

To investigate whether post-craniotomy analgesia with (i) intravenous (IV) parecoxib plus intravenous paracetamol is superior to (ii) intravenous paracetamol alone.

Study Hypothesis:

Post-operative analgesia with intravenous parecoxib in combination with intravenous paracetamol will be superior to intravenous paracetamol alone.


Options:
A: Inclusion Criteria:

1. ASA Ι and II.
2. Both males and females, age (18-60) years.
3. Supine position.
4. Glasco coma scale more than 12.
5. Elective craniotomy operations.

Exclusion Criteria:

1. ASA ΙII or IV
2. History of allergy to the study drugs.
3. Surgery to remove pituitary tumours or affecting pituitary hormones.
4. Glasco coma scale less than 12.
5. The need for postoperative ventilation.
B: Inclusion Criteria:

* Adult patient undergoing ENTS surgery for resection of pituitary tumor.
* Adults \>18 years and \<80 years of age.
* English speaking and literate or able to understand the use of a pain scale.
* Body Mass Index \>19 and \<40 kg/m2

Exclusion Criteria:

* Renal failure (acute or chronic) or creatinine \>2.0
* Allergy or intolerance to acetaminophen, ibuprofen, or opioids
* Pre-operative opioid tolerance, dependence, or abuse
* Anaphylaxis to opioids
* History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery
* Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range, defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin\> 3x upper limit of normal range
* Subject unwilling or unable to sign informed consent for the study
* Pregnancy
* Incarcerated patients
C: Inclusion Criteria:

* Supratentorial craniotomy, glasgow coma scale 15

Exclusion Criteria:

* Chronic pain,
* Chronic opioid use.
* History of significant alcohol or benzodiazepine (BZD) use,
* Inability to speak English,
* Pre-operative aphasia or dysphasia,
* Renal impairment (Creatinine level \> 0.1),
* Asthma (or evidence of reversible airway obstruction,
* Known ischaemic heart disease or cerebrovascular disease,
* American Society of Anaesthesiologists (ASA) grade IV or V,
* Allergy to any study drug (paracetamol, parecoxib, sulphas, morphine, bupivacaine, propofol, remifentanil;
* Administration of oral paracetamol within previous 8 hours.
* Pregnancy or breastfeeding
D: Inclusion Criteria:

* Diagnosis of supratentorial neoplasms

Exclusion Criteria:

* Neurological disorders hindering the communication, aphasia, Glasgow Coma Score (GCS) less than 15, drug or alcohol addiction, chronic pain, raised intracranial pressure, allergies to any of the drugs used in this study, hepatic or renal dysfunction, peptic ulcer disease, dementia.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Brief Summary: We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.


Options:
A: Inclusion Criteria:

* children at the age of 7 months and their families, recruited from the general population

Exclusion Criteria:

* severe sickness
B: Inclusion Criteria:

* Middle school student body is at least 50% minority (defined as African American, Hispanic/Latino, and/or Native American) and/or greater than 50% eligible for free or reduced lunch.
* Middle school annual school-wide attrition from all causes is \<= 25% (estimate determined from data provided by the school).
* Middle school expected cohort size at end of study is at least 50 per school determined by applying 50% anticipated enrollment rate and annual school-wide attrition rate over 3 years.
* Student able to participate in the school's standard PE program.
* Student's parent/guardian has provided informed consent for the child to participate in data collection and evaluation procedures.
* Student has provided informed assent to participate in data collection and evaluation procedures.

Exclusion Criteria: (none specified)
C: Inclusion Criteria:

* second- or third-grade pupils
* affiliation with the French Health Care System
* written informed consent

Exclusion Criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators
D: Inclusion Criteria:

* African American, European American, or Hispanic American, aged 7-12, healthy, weight is equal to or greater than 25 Kg

Exclusion Criteria:

* Type 1 or 2 diabetes, polycystic ovary disease, disturbances in glucose or lipid metabolism disturbances
* Use of medication known to affect body composition or physical activity, diagnosis of genetic disorders known to affect body composition or fat distribution
* Use of tobacco, alcohol consumption in excess of 400 g per week
* Menstruated for more than a year prior to the recruitment; OR
* A medical history that counter-indicates inclusion of the study

Answer: C