TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.
Brief Summary: RATIONALE:

* Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
* In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
* The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

* To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
* To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.


Options:
A: Occurrence of myocardial infarction,stroke or cardiovascular death.
B: Any stroke at 90 days; Stroke severity
C: The composite of cardiac death or MI in the intent-to-treat population (1 year after randomization)
D: Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose (At 2 hours after first dose of study drug); Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug (4 to 72 Hours after last dose of study drug)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.
Brief Summary: RATIONALE:

* Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
* In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
* The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

* To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
* To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.


Options:
A: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
B: The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
C: acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (30 months intake; 12-42 months follow-up)
D: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
Brief Summary: This study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.


Options:
A: Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C
B: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
C: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (8 weeks); Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. (8 weeks); Change From Baseline in PANSS Negative Symptom Subscale at Week 8 (8 weeks)
D: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase II/III, Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Brief Summary: The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer.

TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to tumor cells.

TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).


Options:
A: Progression-free survival rate at 6 months
B: Progression-Free Survival (PFS) (Within the 3 months of study treatment)
C: N/A
D: TTF2 (approximate 6 months after first line treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Brief Summary: This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.


Options:
A: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
B: N/A
C: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
D: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)

Answer: B
Please select the outcome measures 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: N/A
B: Anxiety Disorders Interview Schedule - Child/Parent Version (Post Treatment (16 weeks))
C: Brief Problem Checklist (BPC, parent and child forms) (Change over time from Day 1 to Day 267)
D: Clinical Global Impression - Improvement Scale (Measured at Week 12)

Answer: D
Please select the outcome measures 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: Pediatric Anxiety Rating Scale (After an average of 16 weeks (Post-treatment))
B: Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. (16 weeks)
C: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)
D: Clinical Global Impression - Improvement Scale (Measured at Week 12)

Answer: D
Please select the outcome measures 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: Change from baseline Hamilton Rating Scale for Depression at 12 months (12 months)
B: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)
C: Hamilton Rating Scale for Depression (Measured at screening, weeks 1 through 12, and week 36)
D: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 (At Baseline and Week 12.)

Answer: C
Please select the outcome measures 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: Hamilton Rating Scale for Depression (Measured at screening, weeks 1 through 12, and week 36)
B: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
C: quality of life: RAND, GDS (pre and post treatment); caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) (pre- and post intervention)
D: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Brief Summary: The purpose of this clinical trial is to study the effects of GL701 on bone mineral density in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with glucocorticoids (e.g., prednisone).


Options:
A: blood and urine tests (beginning of treatment, and after six weeks of treatment.)
B: N/A
C: Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. (12 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents
Brief Summary: This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.


Options:
A: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (8 weeks); Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. (8 weeks); Change From Baseline in PANSS Negative Symptom Subscale at Week 8 (8 weeks)
B: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
C: Psychotic Symptoms (two years)
D: Change in Weight (Baseline, 3-, 6-, 9-, 12-, and 18-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents
Brief Summary: This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.


Options:
A: Change from baseline in weight at week eight (Baseline and week eight)
B: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (8 weeks); Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. (8 weeks); Change From Baseline in PANSS Negative Symptom Subscale at Week 8 (8 weeks)
C: Changes in body weight (baseline; week-4; week-8; week-12)
D: Change From Baseline to Endpoint in Weight (Baseline to endpoint (22 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents
Brief Summary: This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.


Options:
A: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (8 weeks); Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. (8 weeks); Change From Baseline in PANSS Negative Symptom Subscale at Week 8 (8 weeks)
B: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)
C: Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
D: Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Options:
A: Survival
B: Overall survival (1-year)
C: Overall survival (From ICF signature date until e until death date for any cause)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
Brief Summary: The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).


Options:
A: Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy (2 years)
B: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
C: N/A
D: To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. (To end of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
Brief Summary: The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).


Options:
A: N/A
B: Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy (2 years)
C: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
D: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Insulin
Brief Summary: This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have not achieved their blood glucose goal using insulin alone. This study requires a total of seven visits during 28 weeks.


Options:
A: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
B: HbA1c at each visit (28 Weeks)
C: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: B
Please select the outcome measures 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: Percent Change From Baseline Weight (Baseline, 2 years)
B: Bodyweight (Six Months)
C: Change in Weight (Baseline to 30 months)
D: Body Weight (1 year)

Answer: C
Please select the outcome measures 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: Re-hospitalizations (During the 30days after discharge)
B: Change in Weight (Baseline to 30 months)
C: Personal Health Partner (PHP) assessment with electronic health record (EHR) data exchange before pediatric primary care visits (2 week -1day before doctor's appointment and 1 week after appointment)
D: Brief Pain Inventory (Pain) (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy
Brief Summary: The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.


Options:
A: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)
B: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
C: Mortality (26 weeks from study entry)
D: Mortality (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy
Brief Summary: The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.


Options:
A: Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. (1 month and 12 months after testing)
B: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)
C: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
D: Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) (30 months); prevalence of HIV resistance (ANRS12253 associated study) (30 month after ARV initiation)

Answer: C