TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
Brief Summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.


Options:
A: 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)
B: Inclusion criteria:

* Newly diagnosed patients (\< 3years) with type 2 diabetes.
* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
* No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

* History of lactic acidosis.
* Anemia (\<11g for males, \<10 g for females).
* Unstable or severe NY Heart Association-class 3 or 4.
* Any NY Heart Association congestive heart failure.
* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
C: Inclusion Criteria:

type 2 diabetes mellitus -age between 40 and 75 years -well controlled HbA1c (\< 7.5%) -chronic renal failure (creatinin clearance between 70 and 30 mL/(min x 1.73 m²) according to the Cockroft equation) -proteinuria \> 300 mg / 24 hours

Exclusion Criteria:

type 1 diabetes -poorly controlled type 2 diabetes (HbA1c \> 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring) -elevation of ALT, AST or GGT more than 2.5 fold the upper normal value -CHF (more than grade 1 of NYHA) -uncontrolled hypertension -malignant tumorous disorder -hyper- or hypothyroidism -pregnant women -nursing women
D: Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Treatment with metformin at a stable dose \>1500 mg/day
* HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

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

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.
Brief Summary: This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
* Hemodialysis therapy for ≥3 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
* Acute or chronic bleeding
B: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
* continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B12 deficiency.
C: Inclusion Criteria:

* adult patients, \>= 18 years of age;
* chronic renal anemia;
* continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
* regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
* significant acute or chronic bleeding.
D: Inclusion Criteria:

* regular long term hemodialysis with same schedule for greater than or equal to (\>=) 12 weeks
* continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months
* significant acute or chronic bleeding
* poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
* weekly dose of epoetin beta greater than (\>) 16000 international units (IU), or weekly dose of darbepoetin alfa \>80 micrograms during previous month

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
Brief Summary: The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Options:
A: Inclusion Criteria:

* Patients who underwent elective liver resection for the treatment of hepatocellular carcinoma or adenocarcinoma with chronic liver diseases.

Exclusion Criteria:

* Body weight loss greater than 10 per cent during the 6 months prior to surgery,
* The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
B: Inclusion Criteria:

* elective laparoscopic cholecystectomy

Exclusion Criteria:

* bile duct stones
* ileus
* conditions affecting gastric emptying
* severe, organ-specific disorders
* HIV
* inherited metabolic disorders
* known intolerance against or allergy to any component of the investigational feeds
C: Inclusion Criteria:

* Patients undergoing hepatic resection for benign or malignant conditions
* Able to understand the nature of the study and what will be required of them.
* Men and non-pregnant, non-lactating women
* BMI 18 - 30

Exclusion Criteria:

* Inability to give written, informed consent
* Patients with dementia or neurological impairment
* Patients with pre-existing condition limiting mobility
* Planned bile duct excision
* Repeat or staged procedures
* Central extended resections
* Underlying cirrhotic liver disease
* Jaundice (Bilirubin \> 50 μmol/L)
D: Inclusion Criteria:

* infrarenal aortic aneurysm
* given written informed consent

Exclusion Criteria:

* contraindication for epidural anesthesia
* suprarenal clamping

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
Brief Summary: The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Options:
A: Inclusion Criteria:

* elective laparoscopic cholecystectomy

Exclusion Criteria:

* bile duct stones
* ileus
* conditions affecting gastric emptying
* severe, organ-specific disorders
* HIV
* inherited metabolic disorders
* known intolerance against or allergy to any component of the investigational feeds
B: Inclusion Criteria:

* Patients who underwent elective liver resection for the treatment of hepatocellular carcinoma or adenocarcinoma with chronic liver diseases.

Exclusion Criteria:

* Body weight loss greater than 10 per cent during the 6 months prior to surgery,
* The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
C: Inclusion Criteria:

* Men and women between 18 and 68 years of age
* Scheduled for first liver transplantation
* Written informed consent
* Protein-calorie malnutrition: Mid-arm muscle area (MAMA) \<85% standard

Exclusion Criteria:

* Patients \< 18 and \> 68 years
* Pregnant or nursing women
* History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
* Inability to take oral nutrition
* Patients with fulminant or subacute hepatic failure requiring urgent transplantation
* Mental condition rendering the subject incapable to understand the nature, scope, and consequences of the trial
* Simultaneous participation in another clinical trial
D: Inclusion Criteria:

* Patients undergoing hepatic resection for benign or malignant conditions
* Able to understand the nature of the study and what will be required of them.
* Men and non-pregnant, non-lactating women
* BMI 18 - 30

Exclusion Criteria:

* Inability to give written, informed consent
* Patients with dementia or neurological impairment
* Patients with pre-existing condition limiting mobility
* Planned bile duct excision
* Repeat or staged procedures
* Central extended resections
* Underlying cirrhotic liver disease
* Jaundice (Bilirubin \> 50 μmol/L)

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Brief Summary: The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment


Options:
A: Inclusion Criteria:

* Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements \>=130 mg/dL and \<=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea \[SU\] or a meglitinide or a dipeptidyl peptidase-4 \[DPP-4\] inhibitor) are eligible for enrollment in the study.

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* history of a severe hypoglycemic episode within 6 months before screening
* Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements \>=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
* History of or current illness considered to be clinically significant by the investigator
B: Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Treatment with metformin at a stable dose \>1500 mg/day
* HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

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

Born 1930 or later, Type 1 diabetes appearing at age 30 or earlier and with insulin dependency within 1 year from diagnosis, no known abuse of alcohol or drugs, non-prolipherative retinopathy of any degree present, no previous photocoagulation, normal serum creatinine, unsatsifactory blood glucose control according to the physician in charge of the patients.

Exclusion Criteria:

Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.
D: Inclusion Criteria:

* Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
* Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

* AST and /or ALT \> 3.0 times the upper limit of normal
* Serum total bilirubin \> 1.5 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Proactive Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.


Options:
A: Inclusion Criteria:

Participants recruit adults who:

1. Discharge from an emergency department of a teaching hospital after attempt suicide
2. Aged above 18 years old
3. Agree to provide written inform consent.

Exclusion Criteria:

1. Patients were too ill to be interviewed
2. Patients have immediate and severe suicide risk.
B: Inclusion Criteria:

We propose to include all patients at the participating sites who:

* Complete PHQ questionnaire and respond to item 9 (regarding thoughts of death or self-harm) "more than half the days" or "nearly every day"
* Are currently enrolled in one of the four participating health systems
* Are age 18 or older
* Recent use of Epic Secure Messaging

Exclusion Criteria:

* Recorded diagnosis of dementia or developmental delay
* Previously invited to participate in the UH2 pilot trial
* Non-English speaker
C: Inclusion Criteria:

* \>2 self-harm episodes.
* With high levels of unipolar depressive symptoms (BDI-2 score of 17 or more).
* Sufficient understanding of English (spoken and written).
* Ability to give informed consent

Exclusion Criteria:

* Clinical judgement of high level of suicide risk, other risk to self or others requiring other urgent approaches e.g. admission to mental health unit.
* Other severe mental illness e.g. psychosis, bipolar disorder, substance use disorder or organic mental disorder e.g. secondary to head injury as the primary mental health problem as determined by a structured psychiatric interview (SCID).
* Currently receiving structured psychological therapy
D: Inclusion Criteria:

1. Current suicide ideation;
2. More than one intentional self-injury or suicide attempt;
3. Has difficulties with emotion and impulsive behavior or has characteristics similar to borderline personality disorder;
4. 13-17 years of age;
5. At least one family member or responsible adult available to participate in assessments and treatment.

Exclusion Criteria:

* Has significant developmental delays
* Has significant current mania, psychosis or life threatening anorexia
* Has a court order for treatment

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Brief Summary: To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.


Options:
A: Inclusion Criteria:

* Singleton birth
* Term infant at birth
* Birth weight of 2500 g (5 lbs 8 oz) or more
* 4 - 18 days of age at Study Visit 1

Exclusion Criteria:

* History of underlying metabolic or chronic disease or congenital malformation
* Infant switched formulas more than one time between birth and Study Visit 1
* Known feeding problems at Study Visit 1
B: Inclusion Criteria:

* the participant must have a mother, biological father or sibling with type 1 diabetes
* the participant must carry a susceptible HLA genotype(HLA-DQB1\*02 and/or DQB1\*0302 without protective alleles (DQB1\*0301, \*0602 and \*0603)

Exclusion Criteria:

* no telephone
* no accessibility to any of the research centers
* inability of parents to understand the study and instructions
* unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
* gestational age less than 36 weeks
* Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
* the newborn infant has received any cow's milk-based product prior to randomization
C: Inclusion Criteria:

* Healthy, term infants of any racial background
* Infants may be of either sex
* Infants must be 2 weeks of age
* Infants must be exclusively feeding a cow's milk-based formula
* Mothers must be over 18 years of age

Exclusion Criteria:

* Infants who were preterm
* Infants who have medical conditions that interfere with feeding or eating
* No major complications during pregnancy or at birth
D: Inclusion Criteria:

* Term infant
* Solely formula fed
* 14 days of age

Exclusion Criteria:

* History of underlying disease
* Evidence of formula intolerance
* Current illness

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: High Dosis of Vitamin D as Treatment for COPD.
Brief Summary: This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, study was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are randomized during the course of the study


Options:
A: Inclusion Criteria:

* Age 65 years or older
* Acute hip fracture admitted to one hospital center

Exclusion Criteria:

* A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
* Primary hyperparathyroidism
* Current cancer with wasting or bone metastases
* Hyperparathyroidism
* Sarcoidosis
* A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)
* Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
* non-surgical treatment
* no German language skills
* severe hearing or visual impairment
B: Inclusion Criteria:

* Primary diagnosis of COPD exacerbation
* Smoking history of at least ten pack years
* GOLD stage II, III and IV as assessed by a post-bronchodilator spirometry
* Informed consent

Exclusion Criteria:

* Tiffeneau index \>70% or FEV1 \>80%
* Hypercalcemia
* Sarcoidosis
* Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
* Active cancer
C: Inclusion Criteria:

1. diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
2. age at presentation between 11 and 35 years;
3. duration of clinical disease (since the beginning of insulin therapy) \<12 weeks;
4. baseline C-peptide \>0.25 nmol/l;
5. no medical contra-indications or any other major chronic disease;
6. willingness and capability to participate in a regular follow-up.

Exclusion Criteria:

1. cardiovascular disease;
2. renal disease;
3. liver disease;
4. neurological disorders;
5. allergic diathesis;
6. hyperparathyroidism;
7. neoplasia.
D: Inclusion Criteria:

* Body mass index \> 27 kg/m2

Exclusion Criteria:

* pregnant and lactating women
* vegetarians
* patients with renal insufficiency (creatinine \> 1.5 mg/dl)
* History of renal stones and gallstones
* patients with insulin dependent diabetes mellitus
* parallel participation in another clinical study
* missing informed consent
* subjects with pacemaker implantation

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode
Brief Summary: The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.


Options:
A: Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* HAM-D score of 8 or above
* Antipsychotic medication treatment
B: Inclusion criteria:

* At least 18 years of age
* Have major depression and are currently in a severe depressive episode
* Have a degree of understanding such that patient can communicate with the investigator and study staff
* All females must test negative for pregnancy
* Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

Exclusion criteria:

* Have not responded to duloxetine for depression in the past
* Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
* Are at significant risk for suicide
* Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
* Have a serious, unstable medical condition
* Have a current or recent history of substance abuse or dependence
* Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
* Have started psychotherapy within 6 weeks prior to study entry
* Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
C: Inclusion Criteria:

* Subject has diagnosis of Major Depressive Disorder

Exclusion Criteria:

* Subject is suffering from cognitive, bipolar, or psychotic disorder
* Subject has had a course of ECT within the past six months
* Subject has any known contraindication for use of any of the study drugs
* Subject has a known drug dependency or substance abuse within the past six mon ths
* Subject is currently pregnant or not using a medically acceptable means of birth control
D: Inclusion Criteria:

* Stroke within the last 120 days

Exclusion Criteria:

* DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
* Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
* Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
* Pre-existing dementia or aphasia with severe language comprehension deficits
* Alcohol or substance abuse or dependence within the last 12 months
* Recurrent unipolar or bipolar disorder prior to the stroke

Answer: B