TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa
Brief Summary: The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


Options:
A: Inclusion Criteria

1. Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
2. On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period

Exclusion Criteria

1. Females who are pregnant or breast-feeding.
2. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant
9. A scheduled surgery that may be expected to lead to significant blood loss.
B: Inclusion Criteria:

* adult patients, \>18 years of age;
* patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.
C: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant or lactating;
* previous treatment with erythropoietin or other erythropoietic substance;
* blood transfusion within the last 3 months;
* need for dialysis expected in the next 6 months;
* administration of another investigational drug within 30 days preceding study start, or during the study.
D: Inclusion Criteria:

* Hemoglobin less than or equal to 11 g/dL
* History of Chronic Kidney Disease
* eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
* Tsat (transferrin saturation) greater than 15%

Exclusion Criteria:

* Uncontrolled hypertension
* Erythropoietic protein use within 12 weeks of randomization

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: AFX01-11: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.


Options:
A: Inclusion Criteria

1. Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
2. On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the Screening Period.

Exclusion Criteria

1. Females who are pregnant or breast-feeding.
2. Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension.
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant.
9. A scheduled surgery that may be expected to lead to significant blood loss.
B: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving darbepoetin alfa iv for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
C: Inclusion Criteria:

1. Chronic renal failure with an estimated glomerular filtration rate \< 60 milliliter per minute per 1.73m\^2 and not expected to begin dialysis for at least 12 weeks.
2. Two consecutive hemoglobin values ≥ 8.0 g/dL and \< 11.0 g/dL within 4 weeks prior to randomization.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding.
2. Treatment with an ESA in the 12 weeks prior to randomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
5. Known bleeding or coagulation disorder.
6. Known hematologic disease or cause of anemia other than renal disease
7. Poorly controlled hypertension
8. Evidence of active malignancy within one year prior to randomization.
9. A scheduled kidney transplant
D: Inclusion Criteria:

* adult patients, \>18 years of age;
* patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.


Options:
A: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving IV epoetin for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
B: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
* receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
C: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
* active malignancy;
D: Inclusion Criteria:

1. Chronic renal failure with an estimated glomerular filtration rate \< 60 milliliters per minute per 1.73 m\^2 and not expected to begin dialysis for at least 12 weeks.
2. Two consecutive hemoglobin values ≥ 8.0 g/dL and \< 11.0 g/dL within 4 weeks prior to randomization.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding.
2. Treatment with an ESA in the 12 weeks prior to randomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
5. Known bleeding or coagulation disorder.
6. Known hematologic disease or cause of anemia other than renal disease.
7. Poorly controlled hypertension.
8. Evidence of active malignancy within one year prior to randomization
9. A scheduled kidney transplant.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
Brief Summary: Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.


Options:
A: Inclusion Criteria:

* Age\>18 years old, ASA 1 and 2
* Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery.

Exclusion Criteria:

* Age\<18 years old
* Pregnancy
* Previous major surgery of the supramesocholic compartment
* Acute cholecystitis
* Choledocolitiasis
* Acute pancreatitis at the moment of surgery
* Laparotomic conversion during surgery
B: Inclusion Criteria:

* Elective laparoscopic cholecystectomy
* 18 years old or over

Exclusion Criteria:

* Emergency surgery
* Under 18 year olds
C: Inclusion Criteria:

* Laparoscopic cholecystectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics
D: Inclusion Criteria:

* patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria:

* patients undergoing planned elective cholecystectomy

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy
Brief Summary: Epidural local anesthetics are the gold standard for shortening duration of bowel dysfunction after bowel surgery. Previous studies suggest that their effect may be in part a result of actions of the local anesthetic outside the epidural space. If local anesthetics could be administered intravenously instead, this might be a safer, easier and less expensive approach. Therefore, this trial will compare the effect on bowel function recovery of intravenous local anesthetics with those administered epidurally.


Options:
A: Inclusion Criteria:

* Informed consent
* Scheduled for colon tumor resection.
* American Society of Anesthesiologists (ASA) physical classification classes I, II, and III.

Exclusion Criteria:

* Age \<18 or \>75 years
* Allergy to local anesthetics
* Severe cardiovascular disease (myocardial infarction within 6 months, profoundly decreased left ventricular function (ejection fraction \<40%), or high-grade arrhythmias) or liver disease (known AST or ALT or bilirubin \>2.5 times the upper limit of normal)
* Systemic corticosteroid use
* Chronic use of opiates
* Unwillingness or contraindication to epidural analgesia.
B: Inclusion Criteria:

* Female patients undergoing outpatient laparoscopic gynecologic surgery
* American society of anesthesiologists class (ASA) Physical status (PS) I and II
* Age between 18 and 64 years
* Fluent in English
* Body mass index (BMI) less than 35

Exclusion Criteria:

* History of allergy to local anesthetics
* History of chronic opioid use
* Pregnant patients
* Body Mass Index (BMI) greater than 35
* History of electrocardiogram (EKG) abnormalities
* Hepatic Impairment
* History of congestive heart failure
* Electrocardiogram (EKG) abnormalities
* History of heart block (subject with history of heart block)
* Current use of anti-arrhythmic medications

Drop -Outs:

* Patient or surgeon request
* Conversion of the surgery from laparoscopic to open
C: Inclusion Criteria:

1. informed consent
2. age older than 18 to 80 years (inclusive)
3. scheduled for mastectomy because of breast cancer
4. American Society of Anesthesiologists (ASA) physical classification classes I - III

Exclusion Criteria:

1. Allergy to local anesthetics, fentanyl or morphine
2. severe cardiovascular disease (myocardial infarction within 6 months), profoundly decreased left ventricular function (ejection fraction \<40%) or high-grade arrhythmias
3. severe liver disease (known AST or ALT or billirubin \>2.5 times the upper limit of normal)
4. renal impairment (creatinine clearance less than 60)
5. pregnant or breast feeding
6. patient is enrolled in another study or have been in one in the last 30 days
D: Inclusion Criteria:

* Total thyroidectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
Brief Summary: The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.


Options:
A: Inclusion Criteria:

* Age 60+
* Continuously enrolled in Group Health one year prior to sample pull
* Primary care clinic at selected clinics
* Not in "No Contact File"
* Diagnosis 715xx (Osteoarthritis) in prior three years

Exclusion Criteria:

* Not continuously enrolled in Group Health for at least one year
* Medical record information indicates a diagnosis of:

  1. rheumatoid arthritis
  2. obstructive sleep apnea
  3. periodic leg movement disorder
  4. restless leg syndrome
  5. sleep-wake cycle disturbance
  6. rapid eye movement (REM) behavior disorder
  7. dementia or receiving cholinesterase inhibitors
  8. Parkinson's disease or other neurodegenerative disease known to directly impact sleep
  9. cancer in the past year and receiving chemotherapy or radiation therapy in the past year
  10. inpatient treatment for congestive heart failure within the previous 6 months
B: 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
C: Inclusion Criteria:

* chronic pain in the neck and/or back with or without pain in one or more quadrants of the body

Exclusion Criteria:

* Inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs
D: Inclusion Criteria:

* Diagnosis of fibromyalgia
* Diagnosis of insomnia
* No sleep medications for at least 1 month, or stable on medications for at least 6 months
* Willing to be randomly assigned to a treatment
* Able to read and understand English

Exclusion Criteria:

* Sleep disorder other than insomnia
* Bipolar disorder
* Seizure disorder
* Severe untreated psychopathology
* Cognitive impairment

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
Brief Summary: The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. The secondary goal of the study is to determine if MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.


Options:
A: Inclusion Criteria:

* Currently living with HIV or AIDS
* Score of 75 or higher on the Mini-Mental Status Examination

Exclusion Criteria:

* Active use of drugs and/or alcohol
* Poor cognitive functioning
B: Inclusion Criteria:

* HIV seropositive
* Currently enrolled in methadone maintenance treatment for at least one month
* Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))
* Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.
* Between the ages of 18 and 65.

Exclusion Criteria:

* Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S \>6)
* Unable or unwilling to provide informed consent.
* Currently in cognitive behavioral therapy for depression.
C: Inclusion Criteria:

* Diagnosed HIV for \> 6 months
* English speaking
* 18 years old or older
* Indicate some distress (\>4 on the Patient Health Questionnaire-9)
* Willing to be randomized

Exclusion Criteria:

* Any substance abuse or treatment for a psychiatric disorder in the past 30 days
* Currently diagnosed with AIDS or had CD4+ T lymphocytes \<200 cells
* Hepatitis (A, B, or C)
* Indicate a regular mind-body practice (e.g., yoga, meditation) in the past six months
D: Inclusion Criteria:

1. Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish-speaking country of the Americas
2. First-time offenders or Hispanic adolescents, identified by Miami Dade County Public Schools as exhibiting Level III behaviors which include: assault/threat against a non-staff member, breaking and entering/burglary, fighting (serious), hazing, possession or use of alcohol and/or controlled substances, possession of simulated weapons, trespassing, and vandalism.
3. Adolescents between 12 and 17 years of age
4. Adolescents living with an adult primary caregiver who is willing to participate

Exclusion Criteria:

(a) Family reports to have (tentative or firm) plans to move out of the South Florida area during the year of the study

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Phase IV Trial to Assess the Efficacy of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Reduce or Replace Cigarette Smoking Among Adult Smokers in Serbia
Brief Summary: The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.


Options:
A: Inclusion Criteria:

* Male and female smokers in good general health aged 20-65 years regularly smoking \>10 cigarettes per day for more than 1 year who are motivated to reduce or quit smoking

Exclusion Criteria:

* Subjects with uncontrolled hypertension, history of coronary heart disease or other significant heart condition
* History of other significant medical condition that might interfere with study procedures
* Pregnant or nursing mother
* Current drug abuse.
B: Inclusion Criteria:

1. Patients ≥ 18 yrs. scheduled for elective non-cardiac surgery at Mayo Clinic Rochester;
2. Current smoking, defined as \> 100 cigarettes lifetime consumption and self-report of smoking every day.

Exclusion Criteria:

1. An inability to understand consent procedures;
2. Inability to complete a written questionnaire.
C: Inclusion Criteria:

* Schizophrenic subjects (according to DSM-IV-TR criteria) from throughout Sicily, (Italy), who smoke tobacco cigarettes, in stable phase of illness.
* smoke ≥10 factory made cig/day, for at least the past five years
* age 18-65 years
* in good general health
* not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months
* committed to follow the trial procedures.

Exclusion Criteria:

* use of smokeless tobacco or nicotine replacement therapy
* pregnancy or breastfeeding.
* current or recent (less than 1 yr) past history of alcohol and/or drug abuse
* other significant co-morbidities according to the Investigator's clinical assessment
D: Inclusion Criteria:

* Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) \>10 ppm at screening.
* Subjects with mild to moderate depression or anxiety may be included if their condition is stable.

Exclusion Criteria:

* Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
* Subjects with severe depression or anxiety.
* Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
* Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.

Answer: A