TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.
Brief Summary: The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.


Options:
A: Inclusion Criteria:

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
B: Inclusion Criteria:

* Clinical diagnosis of Rheumatoid Arthritis
* Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
* On background methotrexate at least 3 months (≥10mg weekly)
* Must be able to self injection or allow a care giver to do it for them
* Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate

Exclusion Criteria:

* Participants who had prior exposure to abatacept or CTLA-4 Ig
* Received treatment with rituximab.
* Participants who have received treatment with leflunomide within 1 year of screening
* Participants who have received treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.
C: Inclusion Criteria:

* Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

* All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
D: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA)
* Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
* Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
* Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
* Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Controlled Clinical Trial of the Effect of Increases Time Outdoors in the Prevention of Juvenile-onset Myopia in Chinese Children
Brief Summary: The purpose of this study is to assess whether outdoor activities are effective in preventing the development and progression of juvenile-onset myopia in Chinese children.


Options:
A: Children between the ages of 6 and 12 years with myopia in both eyes (defined as spherical equivalent between -1.25 D and -4.50 D in each eye as measured by cycloplegic autorefraction), astigmatism less than or equal to 1.50 D, and no anisometropia (defined as a difference in spherical equivalent between the two eyes greater than 1.0 D) are eligible for inclusion. Exclusion criteria include visual acuity greater than 20/25, strabismus, use of contact lenses, birth weight less than 1,250 grams, use of bifocal or progressive addition lenses, or any conditions precluding adherence to the protocol.
B: Inclusion Criteria:

* All the students in Grade 1

Exclusion Criteria:

* No
C: Inclusion Criteria:

* all included patients, age from 6 to 15 years, had myopia (spherical equivalent \> -0.5 D) after cycloplegic refraction,
* The astigmatism and anisometropia were less than 2.0 D,
* IOP was less than 21 mmHg.

Exclusion Criteria:

* the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
* individuals with amblyopia or strabismus,
* individuals received any other therapies in the period of study,
* individuals suffering some sort of haemostasis disorder,
* individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days
D: Inclusion Criteria:

* 6 to 10 years old
* Myopia: between 0.50 D and 4.00 D in both eyes
* Astigmatism: \<1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
* Anisometropia: ≤ 1.50 D
* Symmetrical corneal topography with corneal toricity \<2.00 D in both eyes
* Agree for randomization

Exclusion Criteria:

* Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
* Any type of strabismus or amblyopia
* Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
* Rigid contact lenses (including orthokeratology lenses) experience
* Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
* Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
* Poor compliance for lens wear or follow-up

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Health Enhancing Strength Training in Nonagenarians
Brief Summary: The Health Enhancing Strength Training in Nonagenarians (STRONG) is a randomised control trial to assess the effectiveness of an aerobic and strength training program for improving functional capacity and quality of life in nonagenarians. Sixty (51 women) nonagenarians (age range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either a usual care (control) group (n=30) or an intervention (training) group (n=30). Participants allocated in the usual care group will receive general physical activity guidelines and participants allocated in the intervention group will also enroll in three weekly non-consecutive individualized training sessions (\~45-50 min each) during 8 weeks. The exercise program will consist of muscular strength \[with a special focus on leg press at 30% (start of the program) to 70% 1 repetition maximum (end)\] and aerobic exercises (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion scale). Results from STRONG will help to better understand the potential of regular physical activity for improving the well-being of the oldest population groups.


Options:
A: Inclusion Criteria:

* Patient admitted to one of 16 study units at Methodist University Hospital
B: Inclusion Criteria:

* Age: 90 years or over.
* Planning to stay in the same nursing home during the study.
* Able to ambulate, with or without assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Acute or terminal illness.
* Myocardial infarction in the past 3 months.
* Not capable to ambulate.
* Unstable cardiovascular disease or other medical condition.
* Upper or lower extremity fracture in the past 3 months.
* Severe dementia.
* Unwillingness to either complete the study requirements or to be randomised into control or training group.
* Presence of neuromuscular disease or drugs affecting neuromuscular function.
C: On cluster level

Inclusion Criteria:

* nursing homes with at least 50 residents

Exclusion Criteria:

* other ongoing trial in the institution

On individual level

Inclusion Criteria:

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

Exclusion Criteria:

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

* Eligible residents will be long-term care residents at least 65 years of age who have resided in the NH at least 6 months and are likely to survive at least 6 months. Residents must be potentially at risk for falls, which we define as ambulatory or transfer-independent as recorded on the Minimum Data Set.

Exclusion Criteria:

* None.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.


Options:
A: Inclusion Criteria:

* Type 2 diabetes
* Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks
* HbA1c greater than or equal to 7.0% and less than 10.0%
* BMI less than 35 kg/m2

Exclusion Criteria:

* Treatment with insulin within the last 12 weeks
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have intention of becoming pregnant or are breastfeeding
B: Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating, or \<6 weeks post-partum
* CHF NYHA class III-IV
C: Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating or \<6 weeks post-partum
* current symptomatic heart failure (NYHA Class III or IV)
D: Inclusion criteria:

* Male or female patients with type 2 diabetes and insufficient glycaemic control.
* Age 18 or over and not older than 80 years

Exclusion criteria:

* Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
* Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.


Options:
A: Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2

Exclusion Criteria:

* NYHA Class II to IV heart failure
* females who are pregnant, lactating, or less than 6 weeks post-partum
B: Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating or within \<6 weeks post-partum
* current symptomatic heart failure (NYHA Class III-IV)
C: Inclusion Criteria:

* Confirmed Type 2 Diabetes diagnosis
* Plan to fast during Ramadan
* Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1
* Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
* Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
* Inability to comply with the study procedures or medications.

"Other protocol-defined inclusion/exclusion criteria may apply"
D: Inclusion Criteria:

* 18 years or older
* Diagnosed with type 2 diabetes
* On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

* History of type 1 diabetes
* Pregnant
* HIV positive
* On a weight loss program or medication
* Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Alberta Population-based, Prospective Evaluation of the Quality of Life Outcomes and Economic Impacts of Bariatric Surgery
Brief Summary: The purpose is to determine the economic, clinical and quality of life outcomes of bariatric surgery and describe the consequences of protracted wait-times (\~ 2 years) for this procedure.


Options:
A: Inclusion Criteria:

* All adult patients seen in the study practices within the previous year

Exclusion Criteria:

* Age \<18 years
* Age \>75 years
B: Inclusion Criteria:

* Adult, cognitively intact, consenting people with diabetes within enrolled practices

Exclusion Criteria:

* Non-english speaking
* Cognitively impaired
C: Inclusion Criteria:

1. 18-60 years old
2. Male and Female
3. BMI Levels greater than or equal to 35 kg/m2 and a major medical comorbidity OR BMI levels greater than or equal to 40 kg/m2
4. Able to provide written informed consent

Exclusion Criteria:

1. Pregnant or nursing
2. Previously enrolled in this study (e.g Community Control Arm)
3. Currently participating in a clinical trial
4. Individual expected to have difficulty with follow-up visits, completion of questionnaires, etc.
5. Any contraindications to bariatric surgery and/or anti-obesity medical treatment
6. Ability and willingness to complete questionnaires.
7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
8. Patients in whom protein sparing very low calorie diet therapy is planned.
D: Inclusion Criteria:

* adults predominantly African American and Hispanic/Latino with uncontrolled asthma recruited from low income urban neighborhoods

Exclusion Criteria:

* severe psychiatric or cognitive problems that would make it impossible to understand and complete the protocol.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hormonal Regulation of Body Weight Maintenance
Brief Summary: The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.


Options:
A: Inclusion Criteria:

* Live in close proximity of the community centers

Exclusion Criteria:

* Medical or physical conditions that prevent the child from participating in the physical activities
B: African-American girls, age 8-10 years.
C: Inclusion Criteria:

* all children attending 5th grade at the invited schools in Sogn og Fjordane county (Norway) during the school-year 2014/2015

Exclusion Criteria:

* those children whom for language barriers are unable to perform national tests in Numeracy, Norwegian and English
D: 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

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hormonal Regulation of Body Weight Maintenance
Brief Summary: The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.


Options:
A: African-American girls, age 8-10 years.
B: Inclusion Criteria:

* all children attending 5th grade at the invited schools in Sogn og Fjordane county (Norway) during the school-year 2014/2015

Exclusion Criteria:

* those children whom for language barriers are unable to perform national tests in Numeracy, Norwegian and English
C: 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
D: Inclusion Criteria:

* Healthy kindergarten children

Exclusion Criteria:

* Children with severe chronic disease (restricting physical activity)

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
Brief Summary: This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.


Options:
A: Inclusion Criteria:

* Age 6 months to 10 years
* Agree to seek initial medical care for all medical illness in the study clinic during the study period
* Written informed consent by a parent or legal garden,
* No plan to travel for a long time during the study period.

Exclusion Criteria:

* History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
* Chronic illness or symptomatic malaria at the time of enrollment
B: Inclusion Criteria:

1. Age between 3 months and 5 years at enrolment.
2. Informed consent obtained from parents or legal guardians.
3. No current participation in another malaria intervention trial.

Exclusion Criteria:

1. Previous adverse reaction to treatment with SP or amodiaquine. If this is unknown, then a history of allergic reaction to any drug.
C: Inclusion Criteria:

* Age ≥ 8 to \< 14 years (boys), ≥ 8 to \< 12 years (girls)
* Student enrolled at participating school in classes 3-7
* Provision of informed consent from parent or guardian
* Provision of assent by student

Exclusion Criteria:

* Known allergy or history of adverse reaction to study medications
* Onset of menstruation (girls)
* Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
* Evidence of severe malaria or danger signs
* Haemoglobin \< 7.0 gm/dL
* Parasite density \> 10,000/ul
D: Inclusion Criteria:

* Ages 1 - 5 years
* Residence in the study area
* Informed consent

Exclusion Criteria:

* Known allergy to study drugs
* Chronic, underlying illness

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Restrictive Versus Liberal Intraoperative Goal-directed Fluid Management During Major Abdominal Surgery:a Prospective Randomized Study
Brief Summary: Postoperative organ dysfunction severely affects the prognosis of surgical patients. Despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains controversial. Owing to the risk of altered tissue perfusion, a key trigger of organ dysfunction, the purpose of this study was to compare the influence of restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and postoperative organ dysfunction.


Options:
A: Inclusion Criteria:

* all patients admitted for open colonic surgery

Exclusion Criteria:

* no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients
B: Inclusion Criteria:

* Adults (18 years old or greater) who are able to provide informed consent.
* Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Exclusion Criteria:

* Active coronary disease.
* Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.
* Active symptomatic cerebrovascular disease.
* Active congestive heart failure and ejection fraction \<35%.
* Active severe restrictive or obstructive pulmonary disease and resting SpO2 \<90%.
* Active renal dysfunction (Cr \>1.8)
* Abnormal coagulation parameters (INR \> 1.8 not on Coumadin, or platelet count \< 100,000 per mcL)
* Presence of active infection including HIV
* Patients with active atrial fibrillation or flutter.
* Preoperative hypoalbuminemia (Albumin \< 2g/dl).
* Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery).
* Presence of ascites.
* BMI \> 45 or \<17
C: Inclusion Criteria:

* age greater than 18 years
* signed informed consent
* listed for deceased donor transplantation.

Exclusion Criteria:

* esophageal surgery or cancer
* esophageal stricture, varices or diverticulum
* upper airway surgery
* coarctation of the aorta
* significant valvular heart disease
* clinically significant cardiac arrhythmias
* patient randomized to other trials with an outcome variable of delayed graft function or early graft function will also be excluded
D: Inclusion Criteria:

* Major intraabdominal surgery

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Body mass index \> 35 kg/m2
* Emergency surgery
* Coagulopathy
* Sepsis or Systemic inflammatory response syndrome (SIRS)
* Hepatic failure (prothrombin ratio \< 50%, factor V \< 50%)
* Contraindication for epidural analgesia

Answer: D