TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Brief Summary: Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.


Options:
A: Inclusion Criteria:

* adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
* inadequate response to a stable dose of MTX;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
* prior treatment failure with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
B: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis.
* Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
* Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
* Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
* Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
C: Inclusion Criteria:

* RA, symptom duration \< 12 months

Exclusion Criteria:

* Contraindication to any of the trial medications
D: * Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.
* Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Brief Summary: Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.


Options:
A: Inclusion Criteria:

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
B: * Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.
* Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.
C: Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF
D: Inclusion Criteria:

* Adult patients, ≥18 years of age
* Active rheumatoid arthritis of \>6 months duration
* Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline

Exclusion Criteria:

* Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
* Unsuccessful treatment with a biologic agent, including an anti-TNF agent
* Previous treatment with tocilizumab

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: HORIZON-PFT: Pivotal Fracture Trial
Brief Summary: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Options:
A: Inclusion Criteria:

* Postmenopausal
* Greater than or equal to 45 years of age
* Osteopenia (lumbar spine bone mineral density \[BMD\] T-score between -1.0 and -2.5, and BMD T-score \> -2.5 at the femoral neck)

Exclusion Criteria:

* Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
* Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
* Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply.
B: Inclusion Criteria:

* Female, 65-89 years old
* No history of severe liver, kidney or eye disease

Exclusion Criteria:

* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
* Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.
C: Inclusion Criteria:

* Women who are 60 to 90 years of age may be eligible to participate
* Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

Exclusion Criteria:

* BMD T-Score at the hip or the spine of less than -4.0
* Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
D: Inclusion Criteria:

* Long duration treatment with corticosteroids (started or ongoing)

Exclusion Criteria:

* History of osteogenesis imperfecta, multiple myeloma or Paget's disease
* History of Hyperparathyroidism, hyperthyroidism
* History of Osteomalacia

Other protocol-defined inclusion/exclusion criteria may apply.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: HORIZON-PFT: Pivotal Fracture Trial
Brief Summary: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Options:
A: Inclusion Criteria:

* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
* Glycated haemoglobin (HbA1c) \>7.0 % to = 9.0 % at visit 1.
* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
* Body mass index \>25.0 kg/m2.

Exclusion Criteria:

* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
* Patients with systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg.
* Patients who have required the use of insulin for glycaemic control at any time in the past.
* Hospitalisation for any major cardiovascular event in the last 3 months.
B: Inclusion Criteria:

* 60-85 years of age
* Female
* At least two years since last menstrual cycle

Exclusion Criteria:

* Abnormal or unexplained vaginal bleeding.
* Bone disorders, other than osteoporosis or low bone mass
* History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
* History of cerebral vascular accidents or venous thromboembolic events
* Medications outlined
C: Postmenopausal women ages 50 to 79.
D: Inclusion Criteria:

* Female, 65-89 years old
* No history of severe liver, kidney or eye disease

Exclusion Criteria:

* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
* Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: HORIZON-PFT: Pivotal Fracture Trial
Brief Summary: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Options:
A: Inclusion Criteria:

* Postmenopausal
* Greater than or equal to 45 years of age
* Osteopenia (lumbar spine bone mineral density \[BMD\] T-score between -1.0 and -2.5, and BMD T-score \> -2.5 at the femoral neck)

Exclusion Criteria:

* Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
* Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
* Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply.
B: Inclusion Criteria:

* Male or female ages 50 years or older
* Must have a recent hip fracture repair in the past 90 days
* Must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture

Exclusion Criteria:

* Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate)

Other protocol-defined inclusion/exclusion criteria may apply.
C: Inclusion Criteria:

* Female, 65-89 years old
* No history of severe liver, kidney or eye disease

Exclusion Criteria:

* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
* Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.
D: Inclusion Criteria:

* Male, 25-85 years old

Exclusion Criteria:

* Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
* History of severe liver, kidney or eye disease

Other protocol-defined inclusion/exclusion criteria may apply.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Family Psychoeducation: Efficacy in Child Mood Disorders
Brief Summary: The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.


Options:
A: Inclusion Criteria:

* Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
* Clinical Global Impression severity score of 4 or greater
* Children's Depression Rating Scale score of 40 or greater
* Currently attending school
* Willing and able to use acceptable methods of contraception, if applicable
* In good general health
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* History of psychotic disorders
* Alcohol or substance abuse or dependence within 6 months prior to study entry
* History of anorexia nervosa or bulimia
* Chronic medical illness requiring regular medication
* Current use of medication with psychotropic effects
* First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder
* At risk for suicide
* Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
* IQ less than 80
* Pregnancy or breastfeeding
B: Inclusion criteria:

* Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)
* IQ greater than 70
* At least one parent/caregiver willing to participate in the study
* Able to attend six or more of the eight treatment sessions with at least 1 parent
C: Inclusion Criteria:

* Meets criteria for alcohol use disorder and major depressive disorder.

Exclusion Criteria:

* Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.
* Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and those with significant liver disease.
* Receiving antipsychotic or antidepressant medication in the month prior to entering the study.
* Use of any illicit substance abuse or dependence other than cannabis abuse (and alcohol abuse).
* History of intravenous drug use.
* Pregnancy, inability or unwillingness to use contraceptive methods.
* Inability to read or understand study forms
* Less than 15 years of age or over 18 years of age will be excluded.
D: Inclusion Criteria:

* Age 13-19
* Diagnosis of Major Depression

Exclusion Criteria:

* History of mania/hypomania
* Current psychotic symptoms
* Substance dependence
* Medical conditions (contraindication for sertraline)
* Pregnancy
* Past treatment with sertraline

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Child/Adolescent Anxiety Multimodal Treatment Study
Brief Summary: This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.


Options:
A: Inclusion Criteria:

* Diagnosis of social phobia

Exclusion Criteria:

* Pervasive developmental disorders (PDD)
* Schizophrenia
* Major Depression
* IQ of less than 80
* Medical conditions contraindicating use of fluoxetine
B: Inclusion Criteria:

* 7 - 14 years
* Diagnosis of an autism spectrum disorder (meets DSM-IV criteria for autism, Asperger syndrome, or Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS))
* Clinically significant anxiety (meets DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder)
* IQ \> 70
* Primary spoken language: English

Exclusion Criteria:

* IQ \< 70
* Comorbid psychotic disorder
C: Inclusion Criteria:

* 7 - 13 year olds and their parents
* seeking services at community mental health clinics
* primary problem or disorder related to anxiety, depression, or conduct problems

Exclusion Criteria:

* Child is younger than 7 years, 9 months or older than 13 on the day of the phone screen.
* Child has attempted suicide within the past year.
* Schizophrenic spectrum diagnosis (including MDD w/ psychotic features)
* Autism or another Pervasive Developmental Disorder (e.g., PDD NOS, Asperger's Disorder, Child Disintegrative Disorder, Rett's Disorder).
* Anorexia Nervosa
* Bulimia Nervosa
* Mental Retardation
* No relevant T-scores validate target disorders.
* ADHD identified as primary reason for seeking treatment at phone screen
* Child's sibling already included
* Child's medication has not been regulated for one month or longer
D: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria:

* Major neurological disorder or medical illness that would interfere with participation in the study

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: PST in Geriatric Depression With Executive Dysfunction
Brief Summary: This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems.


Options:
A: Inclusion Criteria:

* Major Depressive Disorder - diagnosed
* Comorbid anxiety disorders

Exclusion Criteria:

* Psychosis
* Suicidal patients
* Serious acute somatic illness
* Inability to read and write
* alcohol dependence or use of illicit drugs
B: Inclusion Criteria:

* Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
C: Inclusion Criteria:

* Nonpsychotic, unipolar major depression
* Cognitive impairment
* English speaking

Exclusion Criteria:

* High suicide risk
* Dementia
* Acute or severe medical illness
* Current psychotherapy
D: Inclusion Criteria:

* Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
* Employed for 20 hours or more for a minimum of 1 month prior to baseline.
* Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria:

* Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
* Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
* Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: PST in Geriatric Depression With Executive Dysfunction
Brief Summary: This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems.


Options:
A: Inclusion Criteria:

* Nonpsychotic, unipolar major depression
* Cognitive impairment
* English speaking

Exclusion Criteria:

* High suicide risk
* Dementia
* Acute or severe medical illness
* Current psychotherapy
B: Inclusion Criteria:

* English speaking; diagnosis of dementia; a willing informant who knows the subject well and who can provide past personality and other data; a stable dose of any psychoactive drug from pre-baseline through final observation; and presence of agitation or passivity.

Exclusion Criteria:

* delirium or an unstable medical condition; history of Parkinson's disease, Huntington's disease, seizure disorder, stroke, alcoholism, drug abuse, head trauma with loss of consciousness, or psychiatric illness preceding the onset of memory loss; severe vision or hearing impairment; and receiving a new psychoactive medication within the past 30 days.
C: Inclusion Criteria:

* Patients with MCI (MCI criteria, Petersen, 2001 and Grundman, 2004) and their primary caregivers.

Exclusion Criteria:

* Mini-Mental State Examination (MMSE) \< 23
* Severe mood disorder.
* No motivation.
* Severe language problems.
* Premorbid relationship problems
D: Inclusion Criteria:

* Age 65 years and older
* Having a friend/relative willing to serve as a Knowledgeable Informant (KI)
* Diagnosis of aMCI-MD
* Self-identified as African American

Exclusion Criteria:

* Psychiatric diagnosis, including dementia and major depression
* Sensory deficits that preclude neuropsychological testing
* Institutional residence
* Reduced life expectancy due to known terminal illness

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Weight Loss Maintenance (WLM)
Brief Summary: To determine the effectiveness of continuous patient contact on weight loss maintenance.


Options:
A: Inclusion Criteria:

* CHF/COPD patients
* English-speaking
* Medicare beneficiaries

Amendment to Inclusion Criteria:

* Recruited non-Medicare eligible beneficiaries

Exclusion Criteria:

* Prognosis of 6 months or less
* Cognitive impairment with no available proxy/caregiver
* No possession of a phone

Amendments to exclusion criteria:

* heart or lung transplant recipients
* dialysis patients
* individuals already in the Cystic Fibrosis program or receiving intensive monitored care
* individuals with a ventricular assist device (LVAD; RVAD; BiVAD)
* individuals utilizing a pre-paid phone service
B: Overweight men and women who took medication for hypertension, type 2 diabetes and/or hyperlipidemia in the six month weight loss phase. and who were able to lose approximately 9 pounds. There will be approximately 60% women and 40% African Americans.
C: Inclusion Criteria:

* Parents of children will be enrolled in the study if they meet a set of eligibility criteria which includes:

  1. Age 0 - 11 years old
  2. A primary care patient at Boston Medical Center
  3. An English speaking child and parent.

Exclusion Criteria:

* Children will be considered ineligible for the study if they plan to move away from the Boston area in less than 3 months, or are participating in another primary care research project with content that overlaps the content within this study. Currently, there are no studies being conducted that would lead to exclusion.
D: Inclusion Criteria:

SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomize them to either the stepped care intervention or usual care control group.

Exclusion Criteria:

Individuals who:

* have filed a pain-related disability claim in the last 6 months;
* do not speak English;
* have moderately severe cognitive impairment;
* have schizophrenia, bipolar disorder, or other psychosis;
* are actively suicidal;
* have current illicit drug use; or
* have an anticipated life expectancy of less than 12 months.

Answer: B