TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder
Brief Summary: The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.


Options:
A: Inclusion Criteria:

* Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

* Patients known to be allergic to aripiprazole
* Hospitalized patients
* Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
B: Inclusion Criteria:

* Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
C: Inclusion Criteria:

* You must be 18 to 60 years old
* You must have been diagnosed with schizophrenia or schizoaffective disorder
* You must be able to visit the doctor's office 8 times over a 9 week period
* You must agree to participate with all tests and examinations that are required for this study

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding
* You presently have an acute or unstable medical illness
* You have a history of an allergic reaction to olanzapine
* You are taking medications that are not permitted in this study. Your physician will discuss these with you
* You have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.
D: Inclusion Criteria:

* Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder
* Taking a stable dose of olanzapine for at least 30 days
* Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months
* Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism

Exclusion Criteria:

* Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone
* A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization
* Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances
* Diagnosis of substance dependence
* Pregnant or nursing female, or those lacking adequate contraception

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Brief Summary: This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.


Options:
A: Inclusion Criteria:

* Recently diagnosed type 2 diabetes
* No previous anti-diabetic medications

Exclusion Criteria:

* Heart failure
* Renal disease
* Liver disease
* Life-threatening diseases
B: Adults 20-75 with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, and have an HbA1c greater than 6.7%
C: Inclusion Criteria:

* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
D: Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of insulin as defined by the protocol
* Body mass inde (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol defined exclusion criteria may apply
B: Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
C: Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
D: Inclusion Criteria:

* Not previously treated with oral antidiabetic agents as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Aripiprazole in Adolescents With Schizophrenia
Brief Summary: The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.


Options:
A: Inclusion Criteria:

* Primary diagnosis of Schizophrenia 1

Exclusion Criteria:

* Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
B: Inclusion Criteria:

* Patients experiencing their first psychotic episode
* Male or Female
* Aged 15-25

Exclusion Criteria:

* Previous treatment with antipsychotic medication (longer than 1 week)
* History of a clinically significant physical illness
* Organic disorder presenting with psychotic symptoms
C: Inclusion Criteria:

* Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years
* have a confirmed diagnosis of schizophrenia and are suffering from an acute episode
* provide their assent and parental informed consent to participate
* are otherwise relatively healthy on the basis of a medical and physical examination
* and are able to be in-patients for approximately 2 weeks.

Exclusion Criteria:

* Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia
* have moderate or severe mental retardation
* fail to respond to treatment with at least two typical or atypical antipsychotics
* have a history of substance dependence within the 3 months before screening
* are considered at risk for suicidal or violent behavior
* have a seizure disorder
* have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome, or tardive dyskinesia
* or receive prohibited medication within a specified period before screening.
D: Inclusion Criteria:

* Are male or female patients, 13 to 17 years of age
* Patients must have a diagnosis of schizophrenia per DSM-IV-TR.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment.
* Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
* Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)

Exclusion Criteria:

* Female patients who are either pregnant or nursing.
* Patients with acute or unstable medical conditions.
* Patients who have been judged clinically to be at serious suicidal risks.
* Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
* Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparing the Effects of an Internet-Based to an Established Dyspnea Self-Management Program on Dyspnea, Exercise Behavior, and Pulmonary Exacerbations in Patients With COPD
Brief Summary: The overall goal of this study is to compare the impact of a new Internet Dyspnea Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management Program (DSMP) in patients with COPD. The primary aim of the study is to test the following two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.


Options:
A: Inclusion Criteria:

* Diagnosis of COPD, clinically stable for 1 month;
* Spirometry results showing at least mild disease (FEV1/FVC \< 70% and FEV1 \< 80% predicted after bronchodilator);
* ADL limited by dyspnea;
* Ability to speak English and sign consent form;
* Actively use computer and the Internet;
* Maintain O2 saturation \> 85% on \< 6 L/min of nasal oxygen during the six minute walk;
* Understands and is able to rate shortness of breath during exercise

Exclusion Criteria:

* Active symptomatic illness other than COPD;
* Formal pulmonary rehabilitation training in the past 6 months
B: Inclusion Criteria:

One or more of the following:

* Hospital admission for COPD within the prior year
* Unscheduled visit for COPD within the prior year
* Home oxygen use for COPD
* Systemic steroid use for COPD within the prior year
* Post bronchodilator FEV1 \< 70% predicted
* Post bronchodilator FEV1/FVC \< 70% predicted

Exclusion Criteria:

* Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to \< 1 year
* Inability to contact patient by telephone
C: Inclusion Criteria:

* Patients with
* Advanced cancer
* Congestive heart failure
* COPD
* End stage renal disease

Exclusion Criteria:

* Cognitive impairment
* inability to speak
* non-English speaking
D: Inclusion Criteria:

* COPD
* FEV1 \< 60% predicted value and FEV1/ FVC \< 70%
* 6-minute walking distance \< 400 m

Exclusion Criteria:

* Patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test
* Patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed)
* Patients with room air PaO2 \< 60 mm Hg will be excluded.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
Brief Summary: The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Options:
A: Inclusion Criteria:

* Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Patients must be agitated
* Patients must display psychotic symptoms
* Patients must be inpatients who are expected to stay in the hospital for at least 5 days
* Patients must be 18 to 55 years of age

Exclusion Criteria:

* Patients may not be hospitalized for greater than 72 hours prior to study start
* Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
* Patients may not be actively suicidal
* Patients may not be diagnosed with substance-induced psychosis or substance dependence
* Patients may not have acute, serious, or unstable medical conditions
B: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR criteria
* Has been able to achieve outpatient status for more than 3 months in the past year
* Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
* Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Receipt of any antipsychotic medication by IM injection within 60 days before Screening
* Current involuntary hospitalization or incarceration
* Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.
C: Inclusion Criteria:

* Agitated schizophrenic patients
D: Inclusion Criteria:

* Person with a major mental disorder needs acute intramuscular sedation because of disturbed and dangerous behavior as decided by the attending physician.

Exclusion Criteria:

* The clinician believes that one of the two treatments represents an additional risk for the patient and/or
* Patients who lack capacity to give informed consent and who do not have a relative to obtain consent.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Framing Messages for Smoking Cessation With Buproprion
Brief Summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Options:
A: Inclusion Criteria:

* Long-term, daily NRT users (except nicotine patch) (\>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
* More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
* more than 10 puffs of nasal spray per day.

Exclusion Criteria:

* Age \< 18 years,
* CO Smokers,
* Pregnant and lactating women,
* Used varenicline before,
* Not able to cooperate,
* Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air \> 7 ppm.
B: Inclusion Criteria:

* 12-21 years of age
* arriving for routine care to dental office

Exclusion Criteria:

* dentally, medically, or psychologically unstable at the time of the visit
* cannot read or understand English at a 6th grade level
* unavailable for 1-month post-visit assessment
C: Inclusion Criteria:

* Students in 7th grade
* Gave verbal assent

Exclusion Criteria:

* no assent
D: Exclusion Criteria:

* Pregnant or nursing women, or women of child-bearing potential who are not using an adequate method of contraception
* Psychiatric illnesses requiring psychotropic medications (i.e., psychosis, major depression, mania), or the presence of suicidality or homocidality
* Current use of nicotine replacement therapies (i.e., nicotine patch, gum, or lozenges, nasal spray, or inhaler), bupropion (Zyban, Wellbutrin), or marijuana or current participation in another smoking cessation treatment
* Presence of unstable medical conditions (i.e., cardiac, hepatic, renal disease, diabetes mellitus) that would make a trial of bupropion SR hazardous
* Have taken monoamine oxidase inhibitors or metoprolol succinate within the past six weeks
* History of anorexia nervosa or bulimia
* Previous hypersensitivity to bupropion
* History of alcohol or other drug dependence in the past one year
* History of seizure disorder of any etiology (i.e., brain tumor, traumatic brain injury, substance-induced seizures, etc.)
* Any finding that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol visit schedule and visit requirements or put the subject at risk
* Sharing home or work environment with current or past participant
* No couples or participants who see each other every day

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Telemedicine Intervention to Improve Depression Care in Rural CBOCs
Brief Summary: We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.


Options:
A: Inclusion Criteria:

1. Clinical Diagnosis of Type 2 diabetes mellitus
2. Glycosylated Hemoglobin (HbA1c) \> 7.0 = Uncontrolled
3. Positive score on diabetes related distress 2 question screener and/or
4. Positive score on Patient Health Questionnaire (PHQ-2) 2 question screener

Exclusion Criteria: a diagnosis \[from billing records using International Classification of Disease, 9th Edition (ICD-9) codes\] of:

1. advanced disease (e.g., end stage renal disease, advanced heart failure, blindness, metastatic cancer and including those who are in active treatment for cancer), or
2. alcoholism or
3. cognitive impairment, or
4. major psychiatric disease or
5. any type of physical or mental impairment that would preclude active participation
B: Inclusion Criteria:

* Age 60 and older
* Medicare Primary Payer
* Impaired Medication Management ability as indicated by a score of 1 or higher on OASIS discharge assessment item M0780
* Impaired Cognitive Functioning but able to follow directions with prompting as indicated by a score of 1 or 2 on OASIS discharge assessment item M0560
* working telephone line
* Discharge from home health care

Exclusion Criteria:

* Not English speaking
* Terminal diagnosis or hospice care
* Use of other device for medications
* Medicare via managed care
* Use of private home care agency for medication management
C: Inclusion Criteria:

* Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months).
* Informed consent.

Exclusion Criteria:

* Institutionalized patient at nursing homes or similar
* Life expectancy \< 12 months
D: Inclusion Criteria:

PHQ9 Score \> or = to 12

Exclusion Criteria:

A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Telemedicine Intervention to Improve Depression Care in Rural CBOCs
Brief Summary: We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.


Options:
A: Inclusion Criteria:

1. current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and
2. current treatment in the HIV clinic.

Exclusion Criteria:

1. patients who do not have access to a telephone,
2. patients with current suicidal ideation,
3. patients with significant cognitive impairment as indicated by a score \< 10 on the HIV Dementia Scale, and
4. patients with a chart diagnosis of schizophrenia.
B: Inclusion Criteria:

* Clinical diagnosis for depression from a general practitioner
* Beginning a pharmacological antidepressant treatment
* Going to one of the participant community pharmacies

Exclusion Criteria:

* Used antidepressant medication in the past 2 months
* Had an appointment with an specialist in mental disorders in the past 2 months
* History of psychotic or bipolar episodes
* History of drug abuse or dependency
* Cognitive impairment that not allows assessment
C: Inclusion Criteria:

* confirmed untreated infection (positive HCV RNA test)
* current PHQ-9 score of 10 or more
* current treatment in the CHC clinic

Exclusion Criteria:

* non-Veterans
* patients who do not have access to a telephone
* patients with current suicidal ideation
* patients with significant cognitive impairment as indicated by a score \> 10 on the Blessed Orientation Memory and Concentration Test
* patients with a chart diagnosis of schizophrenia
* patients with a chart diagnosis of bipolar disorder who have been hospitalized for a mental health condition within the last 12 months
D: Inclusion Criteria:

PHQ9 Score \> or = to 12

Exclusion Criteria:

A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment

Answer: D