TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.


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
* Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
* HbA1c greater than or equal to 7.0% and less than 10.0%
* BMI (Body Mass Index) 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
C: Inclusion Criteria:

* Diagnosed with type 2 diabetes,
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
* HbA1c \>6.5% and ≤10.0%

Exclusion Criteria:

* Type 1 diabetes,
* history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
D: Inclusion Criteria:

* Males and females, age 50-75 years
* Type 2 diabetes of at least 2 years duration
* BMI 20-45 Kg/m2
* Stable treatment for the last two months with metformin in monotherapy (at least 2 gr/die)
* HbA1c \>=7.0% and \<=9.0%

Exclusion Criteria:

* Type 1 diabetes
* Previous treatment with thiazolidinediones in the last six months
* Contraindication/intolerance to metformin or SUs or TZDs
* Documented coronary or cerebrovascular events in the previous 3 months
* Serum creatinine \> 1.5 mg/dl
* History of congestive heart failure, NYHA I or higher
* Chronic use of glucocorticoids
* Ischemic ulcer or gangrene
* Liver cirrhosis or severe hepatic dysfunction (ALT increase of 2.5 times the upper normal limit)
* Pregnancy or breast feeding
* Cancer, substance abuse, or any health problem that may interfere with the compliance to the study protocol or limit life expectancy

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of a 6-month Outpatient Rehabilitation Program Including Structured Exercise Training on Participation in Physical Activities in Daily Life in Lung Transplant Recipients
Brief Summary: The purpose of this study is to compare participation in physical activities in daily life and functional outcomes of lung transplant recipients attending a six-month multicomponent rehabilitation program including exercise training against others receiving only instructions on how to increase their participation in physical activities in daily life.


Options:
A: Inclusion Criteria:

* Stable medical condition in the opinion of the enrolling investigator
* Able and willing to give informed consent

Exclusion Criteria:

* Expected survival less than 12 months
* Unable to complete a maximal exercise test on a treadmill until exhaustion
* Language barrier that interferes with data collection
B: Inclusion Criteria:

* Recipients of single or double lung transplants

Exclusion Criteria:

* Recipients of multiple organ transplants
* Patients scheduled for retransplantation
* Patients not leaving hospital within 6 weeks after surgery
C: Inclusion Criteria:

* All patients who have undergone either a lung or heart-lung transplant.
* Fit for discharge from the Transplant Unit's Intensive Care Unit.
* \> 18 years of age.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients unable to understand or comprehend the study.
D: Inclusion Criteria:

* 18 years of age or older

  -\>4 weeks after the participant had lung transplant surgery
* Discharged from the hospital after your lung transplant surgery
* MD report of difficulty walking ¼ mile or climbing 10 steps without resting
* Medical monitor approves patient eligibility for participation

Exclusion Criteria:

* concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the active eligible study period with no plans to stop formal exercise
* having other chronic conditions that may severely limit participation in exercise training, i.e., cardiac, musculoskeletal or cognitive impairments
* does not have home internet or smart device with Bluetooth capabilities
* medical issue precluding participation
* declining to be asked screening questions, or declining an introduction to the research team to hear about research
* greater than 18 months post-transplant hospital discharge (time/scheduling delays, transportation issues, etc.)

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Assess the Effectiveness of Six-Monthly Deworming With Vitamin A Administration on Growth in 1-5 Year Old Children in the Urban Slums of Lucknow
Brief Summary: Background. More than a third of the world's population is infected with intestinal nematodes. A majority of these infections occur in children. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS) infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis: Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenIntervention One group will receive usual health care by the existing health care staff, which included six monthly administration of Vitamin A concentrate. The other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline \& Beecham) in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main objective: To assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2 yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.


Options:
A: Inclusion Criteria:

* Pregnant women with severe anemia (Hb\<70g/L)
* Children 6-24 months with severe anemia (Hb\<70 g/L)

Exclusion Criteria:

* Gestational age \>=36 weeks
* Edema
* Breathlessness
B: Inclusion Criteria:

* Local residents
* Aged 1-5 years
* Informed written parental consent

Exclusion Criteria:

* Refusal to give consent
* prior enrollment in the study
C: Inclusion Criteria:

* Cochrane review users
* Authors of systematic reviews
* Health professionals
* Guideline developers
* Researchers

Exclusion Criteria:

-
D: Inclusion Criteria:

* infants living in the study area

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial
Brief Summary: The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).


Options:
A: Inclusion Criteria:

* diagnosed for PCOS (Rotterdam criteria)
* aged 30-50 years
* safe non-hormonal contraception

Exclusion Criteria:

* use of cholesterol lowering agents
* use of antidepressants
* use of cortisone medication (p.o.)
* use of hormonal contraception
* nursing
* pregnancy
* DM-T2
* liver disease
* menopause
* kidney or liver failure
B: Inclusion Criteria: Women with PCOS

* 8 or fewer menstrual periods per year
* elevated serum total testosterone
* elevated LDL cholesterol

Exclusion Criteria:

* current pregnancy or breastfeeding
* current use of oral contraceptives, progestins
* insulin sensitizing medications
* thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
C: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria:oligomenorrhea (\<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone \> 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
D: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40
* Reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
* Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
* Use of oral contraceptives and other steroid hormones 3 months prior to the study
* Contraindications to oral contraceptives

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial
Brief Summary: The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).


Options:
A: Inclusion Criteria:

* Overweight/obese patients with PCOS

Exclusion Criteria:

* Other causes of hyperandrogenism and
* Use of drugs including:

  * oral contraceptive
  * anti-hypertensive agents
  * anti-diabetic drugs
  * agents for weight loss
B: Inclusion Criteria:

* Women in reproductive age
* With polycystic ovary syndrome defined by hyperandrogenism (elevated serum testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or amenorrhea (no menses in the last 6 months) after negative screening pregnancy test

Exclusion Criteria:

* Pregnancy
* Cushing' s syndrome
* Late onset congenital adrenal hyperplasia
* Androgen-secreting tumors
* Uncontrolled thyroid disease
* Hyperprolactinemia
* Diabetes any
* Cardiovascular diseases (Ischaemic heart disease, uncontrolled hypertension, heart failure)
* Acute or chronic infections at baseline
* Renal disease
* Liver disease
* Had taken any medications for at least 3 months before enrolment in the study.
C: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria:oligomenorrhea (\<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone \> 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
D: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40
* Reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
* Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
* Use of oral contraceptives and other steroid hormones 3 months prior to the study
* Contraindications to oral contraceptives

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization
Brief Summary: The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.


Options:
A: 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
B: 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
C: 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
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: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Brief Summary: Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Options:
A: Inclusion Criteria:

* premature infants with gestational age less than 36 weeks,
* clinically stable, showing behavioral abnormalities such as intolerance to the touch, excessive crying, showing signs of pain in accordance with the scale
* difficulty of NFCS leave the stage of crying and agitation for a period of deep sleep during a period of not less than 60 minutes.

Exclusion Criteria:

* premature medically unstable because of the difficulty of monitoring in liquid medium, with a change in temperature on mechanical ventilation who had an infectious process due to the exacerbation of it in hot water, and syndromic children with congenital facial deformities that impede the use of scale NFCS for evaluation.
B: Inclusion Criteria:

* Healthy infant
* 2 - 6 months of age
* receiving primary DPT and PCV vaccinations

Exclusion Criteria:

* chronic illness
* immune deficiency
* immunosuppression
* a history of allergy to DPT or PCV or any of its components
* fever
* any acute illness that prevents the administration of the vaccine
C: Inclusion Criteria:

* Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis

Exclusion Criteria:

* Clinical diagnosis of birth asphyxia or seizures
* Neurological conditions
* Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
* Abdominal distension or abdominal infection/cellulitis
* Colostomy
* Inguinal hernia
* Organomegaly
* Bleeding diatheses (thrombocytopenia or coagulopathy)
* Receiving analgesics or sedatives
D: Inclusion Criteria:

* normal full-term newborns (\>38 weeks)
* Apgar score \>=8 at five minutes after delivery.

Exclusion Criteria:

* congenital anomalies
* medical complications
* need for oxygen administration

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Brief Summary: Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Options:
A: Inclusion Criteria:

* Full term healthy infants, needing a heel-prick for metabolic screening;
* Informed consent obtained from parents.

Exclusion Criteria:

- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
B: Inclusion Criteria:

* normal full-term newborns (\>38 weeks)
* Apgar score \>=8 at five minutes after delivery.

Exclusion Criteria:

* congenital anomalies
* medical complications
* need for oxygen administration
C: Inclusion Criteria:

* born at a gestational age between 32+0 and 36+6 weeks,
* being nourished with breast milk
* the necessity for a clinical blood sample.

Exclusion Criteria:

* perinatal asphyxia,
* birth trauma,
* condition of cardio-respiratory instability,
* condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
* drug abuse of the mother
* and application of sedative medication to mother or child.
D: Inclusion Criteria:

* Term neonates, gestational age 37-42 weeks
* Apgar \>= 7
* Not fed in the last 30 minutes
* Informant consent

Exclusion Criteria:

* Congenital malformation
* Born in Caesarian Section in General Anaesthesia
* Maternal use of opioids
* Administration of Naloxone, Phenobarbital in the previous 48 hours
* Impossibility of breastfeeding

Answer: B