TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria
Brief Summary: The purpose of this study is to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria.


Options:
A: Inclusion Criteria:

* Participated in ADVANCE
* Ability to provide informed consent

Exclusion Criteria:

* None
B: Inclusion Criteria:

* Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.

Exclusion Criteria:

* Angina pectoris, Canadian Class I-II,
* congestive heart failure, Class III-IV,
* stroke, incapacitating or in last 6 months,
* Myocardial infarction (MI) or invasive cardiovascular procedure within the past six months,
* ongoing diabetic gangrene,
* BMI \> 40,
* hemoglobinopathy that interferes with A1c monitoring,
* serum creatinine \> 1.6 mg/dL,
* fasting C-peptide \< 0.21 pmol/ml,
* Alanine Amino Transaminase (ALT) \> 3 times normal or serum bilirubin \> 1.9 mg/dL,
* malignancy or noncardiac life-threatening diseases making life expectancy \< 5 years,
* autonomic neuropathy,
* symptomatic pancreatic insufficiency (endocrine or exocrine),
* recurrent seizures within the past year,
* hypopituitarism,
* pregnancy, lactation, or planning a pregnancy,
* active psychosis or substance abuse,
* lack of access to a person who can assist or be called in an emergency,
* underlying conditions that in the site PI's judgment may prevent adherence to protocol,
* current participation in another clinical trial
C: Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest
* For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina)
* For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors
* HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)
D: Inclusion Criteria:

* Type 2 diabetes
* Microalbuminuria

Exclusion Criteria:

* Stimulated serum C-peptide concentration less than 600 pmol/L
* Pancreatic insufficiency or diabetes secondary to pancreatitis
* Alcohol abuse
* Non-diabetic kidney disease
* Life-threatening disease with death probable within 4 years of study start

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock
Brief Summary: This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone


Options:
A: Inclusion Criteria:

Patients admitted in intensive care units for septic shock and meeting all following criteria

* Proven infection
* Need for vasopressor to maintain systemic arterial tension above 90 mmHg
* Multiple organ dysfunction as defined by a SOFA score ³ 8.
* Need for treatment with moderate dose of corticosteroids

Exclusion Criteria:

One of the following :

* Pregnancy
* Less than 18 years old
* Moribund (i.e. expected to die on day of intensive care unit admission)
B: Inclusion Criteria:

* males and females,
* between 18 and 75 year old
* who present a burned surface more than 30% of the body surface
* who need catecholamine infusion
* between J0 and J3 after the injury.

Exclusion Criteria:

* pregnancy,
* trauma,
* sepsis,
* cardiac insufficiency,
* AIDS,
* etomidate administration
C: Inclusion Criteria:

1. Patients admitted to any of the five intensive care units
2. Older than 18 years
3. Nutritional risk screening score (NRS) higher or equal to three upon ICU admission

Exclusion Criteria:

1. Patients with a do not resuscitate (DNR) code or moribund at the time of ICU admission
2. Patients already enrolled in another trial
3. Patients transferred from another intensive care unit with an established nutritional therapy
4. Patients suffering from ketoacidotic or hyperosmolar coma on admission
5. Patients with a body mass index (BMI) below 17 kg/m\^2
6. Short bowel syndrome
7. Patients known to be pregnant or nursing
8. Patients on mechanical ventilation at home
9. NRS score lower than three
10. Patient readmitted to ICU after randomization to the EPaNIC trial.
11. Patient not critically ill on admission. (No clinical indication for central intravenous catheter or patient ready for oral nutrition on admission.)
D: Inclusion Criteria:

Clinical symptoms of community-acquired pneumonia:

* Fever, cough, sputum, pleural pain, dyspnoea
* Radiological symptoms of pneumoniä

Exclusion Criteria:

* Any conditions wich requires corticosteroid therapy.
* Pregnancy of lactation
* Malignancy
* Immune-compromised patients (eg chemotherapy or AIDS)
* Pre-treatment with macrolide for \>24 hours

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Insulin Therapy With Enhanced Care Management and Peer Support
Brief Summary: VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services; many also lack social support to help them meet the demands of their illness. Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks, such as initiating or intensifying insulin treatment regimens. Although some VAs have implemented telephone nurse care management programs supported by automated calling services, many are reluctant to adopt these models due to nursing shortages.


Options:
A: Inclusion Criteria:

* type 2 diabetes
* HbA1c \> 7%
* age \> 21

Exclusion Criteria:

* substance abuse disorder
* serious psychiatric illness
* serious hearing loss
* life expectancy \< 12 months
B: Inclusion Criteria:

Patients must obtain their primary care at the Iowa City VAMC and have been diagnosed with Diabetes Mellitus and hypertension. Must be cognitively intact and have a telephone line in the home.

Exclusion Criteria:

Patients with corrected vision worse than 20/40 or cognitive impairment (Mini-Mental Status Exam score of 17 or less) will not be eligible.
C: Inclusion Criteria:

* discharged alive from hospital after acute MI
* receive health services and prescription drug benefits through Aetna, Inc.

Exclusion Criteria:

* enrollment in a Health Savings Account (HSA) plan
* age ≥ 65 years of age at the time of hospital discharge
* plan sponsor has opted out of participating in the study
* receive only medical services or pharmacy coverage but not both through Aetna
D: Inclusion Criteria:

* 65 years or older taking 4 or more chronic medications independently living

Exclusion Criteria:

* assisted living or nursing home residents presence of any serious medical condition for which 1-year survival was expected to be unlikely

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Correction of Myopia Evaluation Trial 2 (COMET2): A Randomized Trial of the Effect of Progressive Addition Lenses Versus Single Vision Lenses on Low Myopia Associated With Large Accommodative Lags and Near Esophoria in Children
Brief Summary: The purpose of the study is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e., large accommodative lags) and near esophoria.


Options:
A: Inclusion Criteria:

* Refractive error determined by cycloplegic autorefraction which meets all of the following:

  1. Spherical equivalent: -0.50 to -3.00 D in both eyes
  2. Astigmatism \<= 1.5 D in both eyes
  3. Anisometropia \<= 1.00 D difference between eyes in spherical equivalent
* Visual acuity is at least 20/20 with best subjective refraction in both eyes
* Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction
* Near esophoria (\>= 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction

Exclusion Criteria:

* Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over best subjective refraction
* Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)
B: Inclusion Criteria:

* All the students in Grade 1

Exclusion Criteria:

* No
C: Inclusion Criteria:

* Children aged from 6 to 12 years with myopia, defined as spherical equivalent (SE) of -0.5 diopter (D) or less, were recruited from the outpatient clinics from January 2011 to June 2012.

Exclusion Criteria:

* (1) abnormal IOP (\>21 mmHg) at presentation, (2) astigmatism or anisometropia of more than 1.5 D, (3) amblyopia or strabismus, (4) the presence of any related eyelid diseases, ocular diseases, or auricular diseases, (5) the presence of hemostatic disorders or other related major systemic diseases, (6) history of allergy to atropine, (7) previous or current use of contact lenses, bifocals, progressive lenses, or other forms of treatment for myopia.
D: Inclusion Criteria:

* Age: 8 to 13 years
* Myopia: -1.00 to -5.00 D
* Myopia progression: at least 0.50 D/yr
* Astigmatism and anisometropia: not more than 1.50 D
* Distance monocular visual acuity: 6/6 or better
* Near monocular visual acuity: 0.4 M or better
* Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

* Strabismus
* Ocular diseases

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Correction of Myopia Evaluation Trial 2 (COMET2): A Randomized Trial of the Effect of Progressive Addition Lenses Versus Single Vision Lenses on Low Myopia Associated With Large Accommodative Lags and Near Esophoria in Children
Brief Summary: The purpose of the study is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e., large accommodative lags) and near esophoria.


Options:
A: Inclusion Criteria:

* Age: 8 to 13 years
* Myopia: -1.00 to -5.00 D
* Myopia progression: at least 0.50 D/yr
* Astigmatism and anisometropia: not more than 1.50 D
* Distance monocular visual acuity: 6/6 or better
* Near monocular visual acuity: 0.4 M or better
* Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

* Strabismus
* Ocular diseases
B: 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
C: Inclusion Criteria:

* 1.00 to 6.00 D spherical component myopia, based on cycloplegic autorefraction
* 1.00 DC or less astigmatism, based on cycloplegic autorefraction
* 20/20 or better best-corrected visual acuity in each eye
* Global stereoacuity of 250 seconds of arc or better based on Randot stereoacuity

Exclusion Criteria:

* Contact lens wear within the past month
* Ocular health problems that could affect vision, eye development, or contact lens wear
* Systemic health problems that could affect understanding of surveys or contact lens wear
* Participation in other eye or vision studies that prescribed a treatment
D: Inclusion Criteria:

* Refractive error determined by cycloplegic autorefraction which meets all of the following:

  1. Spherical equivalent: -0.50 to -3.00 D in both eyes
  2. Astigmatism \<= 1.5 D in both eyes
  3. Anisometropia \<= 1.00 D difference between eyes in spherical equivalent
* Visual acuity is at least 20/20 with best subjective refraction in both eyes
* Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction
* Near esophoria (\>= 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction

Exclusion Criteria:

* Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over best subjective refraction
* Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Aminocaproic Acid and Bleeding in Spinal Surgery
Brief Summary: Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.


Options:
A: Inclusion Criteria:

* Undergoing thoracic and/or lumbar surgery for correction of adolescent idiopathic scoliosis, neuromuscular scoliosis, or adult deformity for correction of condition via posterior spinal fusion of 6 levels or greater.

Exclusion Criteria:

* No renal dysfunction identified by elevated blood urea nitrogen (BUN) and creatinine (CR) or BUN to CR ratio greater than 20:1
* Hold religious and/or other beliefs limiting blood transfusion
* Currently use anti-coagulant medication or have past medical history leading to abnormal coagulation profile pre-operatively
* Significant past medical history preventing the use of TXA or EACA described in the protocol
B: Inclusion Criteria:

* Diagnosis of spondylosis, pseudoarthrosis, kyphoscoliosis, or acquired or congenital spine deformity
* Willing to undergo elective spinal surgery by a participating surgeon; eligible procedures include the following: spine osteotomy, arthrodesis, instrumentation and/or corpectomy, surgery for lumbar spinal stenosis, or surgery for degenerative disc disease

Exclusion Criteria:

* Requires urgent or emergent surgery
* Has kidney failure that requires dialysis
* Has a known bleeding diathesis, defined as a documented history of an inherited bleeding disorder (e.g., hemophilia or von Willebrand's disease) OR prothrombin time ratio greater than 1.5 seconds OR a documented previous arterial or venous thrombosis within 1 year of study entry
* Pregnant
C: Inclusion Criteria:

* Patient requiring surgery for an isolated hip fracture of less than 48 hours

Exclusion Criteria:

* Contraindication to tranexamic acid
* Contraindication to fondaparinux
* Contraindication to general anesthesia associated with a femoral nerve block
* pregnancy
D: Inclusion Criteria:

* informed consent
* Patients undergoing primary CABG or Aortic valve replacement surgery

Exclusion Criteria:

* Previous sternotomy
* OPCAB surgery
* urgent/emergency operation
* Coumadin treatment
* previous aprotinin exposure
* preoperative renal impairment (Creatinine \> 2 mg/dL)
* patients refusing blood transfusions
* no informed consent

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Brief Summary: The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer


Options:
A: Inclusion Criteria:

* Men \>/= 18 years of age with histologically confirmed prostate cancer
* Radiographic evidence of at least one bone metastasis
* Failure of at least one hormonal therapy as evidenced by a rising PSA
* Serum testosterone level of \<50 ng/dL
* ECOG PS 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Current or prior IV bisphosphonate administration
* Current or prior oral bisphosphonates for bone mets
* Life expectancy of less than 6 months
B: Inclusion Criteria:

* Patients must have a diagnosis of Smoldering or Indolent myeloma
* All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines.

Exclusion Criteria:

* Prior bisphosphonate therapy within 30 days prior to study entry.
* Serum creatinine \> 5 mg/dl, ascites, or serum direct bilirubin \> 2.5 mg/dl.
* Prior plicamycin or calcitonin within 2 weeks of study entry.
* Severe cardiac disease, unstable thyroid disease, or epilepsy.
* Prior radiation therapy to \> 20% of the skeleton.
C: Inclusion Criteria:

* New diagnosed multiple myeloma with treatment demanding disease

Exclusion Criteria:

* Life-expectancy less than 3 months, another active malignant disease, treatment with bisphosphonates for more than 3 months within the last 6 months, patients with creatinine above 400 µmol/l 4 weeks after starting chemotherapy, patients who cannot cooperate for monthly infusions, patients who do not give their informed consent
D: Inclusion Criteria:

* Adults with histologically or cytologically confirmed breast adenocarcinoma
* radiographic evidence of at least one bone mets
* Easter Cooperative Oncology Group status of 0, 1 or 2;
* adequate organ function

Exclusion Criteria:

* Current or prior IV bisphosphonate administration
* current or prior oral bisphosphonates for bone mets
* life expectancy of less than 6 months

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Brief Summary: The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

* cardiovascular and flexibility exercise
* strength training, cardiovascular and flexibility exercise
* Arthritis Foundation's Fibromyalgia Self-Help course
* a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions


Options:
A: Inclusion Criteria:

* Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

* Other severe diseases
B: Inclusion Criteria:

* Women aged 25 to 75 years of age
* A confirmed diagnosis of FMS by a primary care physician (and rheumatologist if present) using the American College of Rheumatology criteria
* Currently under care for their FMS by a primary care physician or rheumatologist
* Determined to be medically stable by their primary care physician and capable of participation in a supervised program of low to moderate intensity exercise
* Willingness to commit to time and travel requirements of project

Exclusion Criteria:

* Do not fulfill ACR definition of FMS
* Presence of a concurrent condition that limits a person's ability to perform the exercise program (i.e., advanced RA or OA, recent MI)
* History of a positive exercise/stress test, or current cardiovascular, pulmonary, neurological, or renal disease where an exercise program is contraindicated
* Uncontrolled hypertension, diabetes, asthma, or heart failure
* Physician does not want his/her patient to participate for any reason
C: Inclusion Criteria:

* classification of fibromyalgia based on the criteria of the American College of Rheumatology
* female gender
* aged between 18 and 65 years

Exclusion Criteria:

* not having altered treatment in previous three years
* having signed a term of informed consent
* patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded
D: Inclusion Criteria:

* fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

* physical or psychological comorbidity that interferes with cognitive-behavioral treatment
* participation in other clinical trials
* other psychological treatments
* pregnancy
* illiteracy
* difficulties with understanding Dutch language

Answer: B