TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Brief Summary: The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Options:
A: 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)
B: Inclusion Criteria:

* Type 2 diabetes
* Treatment with oral anti-diabetic drugs for at least 3 months
* HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy.
* Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion Criteria:

* Treatment with insulin within the last 3 months
* 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 Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
D: Inclusion criteria:

* .Diagnosis of type 2 diabetes mellitus prior to informed consent
* Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
* glycosylated haemoglobin (HbA1c) at Visit 1: \>=7.0 to =\<10.0% (national glycohemoglobin standardization program)

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L)
* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
Brief Summary: This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care


Options:
A: Inclusion Criteria:

* Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
* Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
* For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
* Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.

Exclusion Criteria:

* Patients will be excluded if they have multiple primary cancer sites.
* Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.
B: Inclusion Criteria:

* 21 to 64 years of age
* Willingness to attend a 1-hour program every week for 4 weeks
* Able to understand and speak basic English
* Able to understand and complete self-report questionnaires with minimal assistance
* Be the primary adult family member who provides care and support for the patient and lives together with the patient

Exclusion Criteria:

* Younger than 21 years of age, or 65 years of age and older
* Unable to understand and speak basic English
* Unable to understand and complete self-report questionnaires with minimal assistance
C: Inclusion Criteria:

* Relative identified by patients diagnosed with inoperable lung cancer as their principal family caregiver; having a family physician

Exclusion Criteria:

* Cognitive disorder
D: Inclusion Criteria:

* Women newly diagnosed with a primary breast cancer (in the last 4 weeks)
* Women cohabiting with a male partner in a romantic relationship
* Patient and partner speaks and reads danish

Exclusion Criteria:

* Patients having a previous cancer diagnosis
* Neoadjuvant therapy for breast cancer
* Previous hospital admission with diagnosed psychotic episodes

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effective Analgesia Using the 5 S's During Routine Immunizations at 2 and 4 Months
Brief Summary: The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits.


Options:
A: Inclusion Criteria:

* infants with a gestational age between 32-42 weeks at delivery and post-natal age of less than 20 weeks old

Exclusion Criteria:

* acetaminophen or ibuprofen administration within 4 hours prior to immunization, current neurological disorder, known genetic anomaly, moderate to severe illness with or without fever at the time of vaccination, anaphylactic reaction to previous dose of vaccine, or if infant was previously enrolled in the study at 2 months.
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:

* All medically stable twin infants admitted to the NICU who are:

  1. Free from infection; and
  2. Breathing room air or receiving oxygen via nasal prongs.
* Twins may be receiving feeds via gavage tubes, IV therapy via peripheral or central line, and may be experiencing periods of apnea.

Exclusion Criteria:

* Weigh less than 1000 grams;
* Receiving ventilator support;
* Have chest tubes or umbilical catheter in situ;
* Have major congenital anomalies or chromosomal aberrations; OR
* If only one of the twins require overhead phototherapy.
D: Inclusion Criteria:

* unilateral inguinal hernia
* age age \> 4 months, \<16 years
* fully descended testes
* study consent signed

Exclusion Criteria:

* previous abdominal or inguinal surgery
* testes not fully descended
* not healthy enough for day surgery
* age \< 4months or \>16 years
* study consent not signed

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus
Brief Summary: This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773


Options:
A: Inclusion Criteria:

* Participated in ADVANCE
* Ability to provide informed consent

Exclusion Criteria:

* None
B: Inclusion Criteria:

* \> 18 years
* stable patients on maintenance hemodialysis for \> 3 months
* well-functioning arteriovenous (AV) shunt with recirculation \< 5%
* informed consent

Exclusion Criteria:

* diabetes mellitus
* body mass index \< 18.5 kg/m2 or \> 30 kg/m2
* malnutrition (subjective global assessment (SGA) score C)
* malignancy
* use of immunosuppressive drugs including glucocorticosteroids
* severe infectious disease \< 4 weeks
* pregnancy

Exclusion Criteria during the study:

* myocardial infarction or arrythmia with hemodynamic derangements
* permanent thrombosis in the arteriovenous (AV) shunt
* severe infectious disease
* renal transplantation
C: 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.
D: Inclusion criteria:

1. Patients \>=18 years with type 2 diabetes
2. HbA1c of \>= 7.0% (53 mmol/mol) and =\< 10% (86 mmol/mol)
3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg

Exclusion criteria:

1. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast before randomization
2. Known or suspected secondary hypertension
3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Brief Summary: This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.


Options:
A: Inclusion Criteria:

* HIV-infected patients
* adults
* regular smokers (at least 10 cigarettes a day during the last year)
* motivated to stop smoking
* followed in one of the participating clinical ward,
* signed written inform consent

Exclusion Criteria:

* current co-dependency to another psychoactive substance
* ongoing depressive episode
* history of suicidal attempt
* ongoing treatment by interferon
* treatment by efavirenz for less than three months or not tolerated
* previous use of varenicline
* ongoing treatment by bupropion-SR or nicotinic substitute
* ongoing pregnancy
* ongoing breastfeeding
* hypersensitivity to varenicline or to one of its excipients
* drivers, air traffic controller
B: 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.
C: Inclusion Criteria:

* Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

* Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
D: Inclusion Criteria:

* Smokers seeking treatment
* Aged 18 and over
* Consenting to take part in the trial

Exclusion Criteria:

* Pregnant or breastfeeding
* End-stage renal disease
* Used varenicline in the past 6 months
* Unable to fill in questionnaires in English
* Current psychiatric illness
* Current serious illness including uncontrolled hypertension and recent cardiac event
* Sensitivity to varenicline currently enrolled in other research projects.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Brief Summary: This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.


Options:
A: Inclusion Criteria:

* Interested in quitting gradually
* At least 18 years old
* Daily cigarette smoker
* Smoke at least 15 cigarettes per day (CPD)
* No change greater than 20% in CPD in the last month
* Interested in quitting in next 30 days
* Must agree to not use non-cigarette tobacco during study
* No use of smoking cessation medication in last month
* Have phone with voice mail
* Willing to use nicotine lozenge
* No other person in household in study
* Fluent/literate in English

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Currently using medication for depression or asthma
* Heart disease requiring medication
* Heart attack in last month
* Irregular heartbeat
* High blood pressure not controlled by medication
* Stomach ulcers
* Diabetes
B: Inclusion Criteria:

1. Over 60 years of age,
2. Have smoked 100 cigarettes in their lifetime and currently smoke five or more cigarettes a day on average,
3. Have an address in a rural census tract defined by a RUCA code of 4-10,
4. Interested in participating in a cessation program,
5. Own a phone that has texting ability and free texting,
6. Have general knowledge of text messaging and
7. Are willing to receive and respond to text messages from the study teams, throughout the duration of the study.

Exclusion Criteria:

1. criteria include non-English speaking patients
2. already participating in a smoking cessation intervention study.
C: Inclusion Criteria:

* Clinically stable patients with schizophrenia

Exclusion Criteria:

* Refractory schizophrenia
* Mental Retardation
* Serious Medical illness
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: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder
Brief Summary: Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of the population. Recent research point at the relevance and persistence of cognitive dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment has been classically associated with schizophrenia and not bipolar disorder. Current findings suggest that some intervention is needed in order to improve not only affective symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive remediation techniques to improve cognitive impairment and the functional outcome. There is no previous research on the efficacy of cognitive remediation programs on bipolar disorder.


Options:
A: Inclusion Criteria:

* Male or Female
* Age, greater than or equal to 19 and less than 61.
* Enrollment in the TVAMC VRP
* Signed informed consent
* Chronic post-traumatic stress disorder
* Any race or ethnic origin
* Anticipation of remaining in the catchment area for the 12-month study duration

Exclusion Criteria:

* Lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment
* History of schizophrenia, schizoaffective, disorder, or bipolar I disorder
* Pending litigation
* In need of immediate detoxification.
B: Inclusion Criteria:

* Outpatients
* Diagnosis of bipolar disorder type I or II, according to DSM-IV-TR 4ª Ed criteria
* Adult patients, aged between 18 and 55 years old
* Euthymic (YMRS \< 6, HDRS \< 8) for at least three months prior to study entry.
* Signed inform consent
* Severe or moderate functional impairment (FAST \> 18)

Exclusion Criteria:

* IQ \< 85
* Neurological illness
* Present diagnosis of substance abuse or dependence according to DSM-IV criteria the last three months
* Significant medical illness considered as severe by the study that may interfere with assessments
* having been enrolled in any kind of cognitive rehabilitation intervention the last two years
C: Inclusion Criteria:

* Chronic mental disorder
* Minimum age 18
* Unemployed
* Wants employment
* Must be a recipient of services at one of two participating agencies
* Fluent in English
* Willing and legally able to provide informed consent to participate in study -Subjects with court appointed legal guardians will be included

Exclusion Criteria:

* History of neurological conditions that impair cognition
D: Inclusion Criteria:

* pscychotic illness of at least a years duration
* unemployed for at least a year

Exclusion Criteria:

-

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: Inclusion Criteria:

* Adults between 21 and 65 years
* Sedentary (engaging in moderate intensity physical activity for less than 60 minutes per week)
* Working full time (35+ hours/week) at a sedentary desk dependant occupation
* Overweight (Body Mass Index \> 25.0 kg/m2 but less than 40.0 kg/2)
* Apparently healthy as assessed by a health history screening survey
* Devoid of overt complicated or acute cardiovascular, metabolic, respiratory, or neurological diseases
* Free from exercise/physical activity limitations

Exclusion Criteria:

* Adults with significant health problems exacerbated by exercise, such as uncontrolled hypertension, diabetes, orthopedic limitations, etc. will be excluded from the study. Note, with physician approval and adequate control of these health problems, these conditions will not necessarily preclude participation.
* Being unable to exercise
B: Inclusion Criteria:

Member of staff at the Northern Ireland Civil Service

Exclusion Criteria:

Physically active (defined as compliance with current physical activity guidelines (Pate, 1995), age \> 65 years, resting BP \> 159/99 mm Hg, total cholesterol \> 6.2 mmol•L-1, fasting blood glucose \> 7.0 mmol•L-1, body mass index (BMI) \> 34.9 kg•m-2, current cigarette smokers, individuals with cardiovascular, pulmonary or metabolic disease, pain or discomfort in the chest, dizziness or heart murmur.

individuals taking medication known to interfere with lipid metabolism, females who were pregnant or planning to become pregnant in the following five months
C: Inclusion Criteria:

* 18-65 years old
* overweight or obese
* prediabetes with elevated glucose value

Exclusion Criteria:

* recent cardiovascular event
* use of corticosteroids
* concurrent participation in a structured weight loss program
* pregnant or lactating
D: Inclusion Criteria:

* African American community-dwelling adults aged 60 to 85 who were recruited from senior centers.
* had to be healthy (no restrictions and medical clearance to walk)
* had to have a mobile phone with text messaging capability

Exclusion Criteria:

* (a) any physical, psychological illness, or medical problems that restricted them from walking; (b) did not own a mobile phone with text messaging capability; or (c) were not willing or able to follow study procedures.

Answer: A