TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: N/A
C: The primary efficacy outcome measure is the mean change from baseline in BCVA score (6 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye (Baseline, Month 1 through Month 3)
B: N/A
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: The difference from baseline in mean Best Corrected Visual Acuity (BCVA) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses (Up to 4 months)
B: N/A
C: N/A
D: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: EDTRS visual acuity score (0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)
B: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
C: N/A
D: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: N/A
B: Mean Visual Acuity; Total number of treatments
C: Preservation of 5Ve isopter Goldmann visual field versus baseline at 1 year (12 and 24 months); Estimate the % of subjects progressing to neovascular glaucoma requiring pan-retinal photocoagulation or glaucoma surgery after treatment with ranibizumab (comparing 0.3mg to 0.5mg doses) (12 and 24 mponths)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel TB Prevention Regimens for HIV-Infected Adults
Brief Summary: This study compares three different tuberculosis (TB) prevention regimens against the standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa. People who are HIV positive and have a positive tuberculin skin test without signs of active tuberculosis may join.


Options:
A: Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children (Through to week 96); Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children (Through to week 96)
B: Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) (6/2008)
C: Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.; Safety : occurrence of serious adverse events at any time during chemotherapy
D: TB incidence (Jan 2003 to July 2011); Mortality (Jan 2003 to July 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Antipsychotic Adherence Among Patients With Schizophrenia
Brief Summary: This is a randomized controlled trial examining the effectiveness of a pharmacy-based intervention designed to improve adherence with antipsychotic medications among patients with serious mental illness.


Options:
A: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (6 months)
B: Medication Possession Ratio at baseline, 1-6 months, 6-12 months, and 12-18 months. Aggregate adherence categories based on MPR, anti-psychotic blood levels (present/not present) and patient self-report at baseline, 6 months, and 12 months.
C: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
D: Percentage of Visits With Appropriate Hypertension Management (1 month clinic visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Antipsychotic Adherence Among Patients With Schizophrenia
Brief Summary: This is a randomized controlled trial examining the effectiveness of a pharmacy-based intervention designed to improve adherence with antipsychotic medications among patients with serious mental illness.


Options:
A: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
B: Medication Possession Ratio at baseline, 1-6 months, 6-12 months, and 12-18 months. Aggregate adherence categories based on MPR, anti-psychotic blood levels (present/not present) and patient self-report at baseline, 6 months, and 12 months.
C: - unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months; - lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months; -health care visits for HIV primary care in the past 6 months; -90% or more adherence to HIV medication yesterday and in the past week
D: Pill count (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Study of Olanzapine in Children With Autism
Brief Summary: This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.


Options:
A: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
B: Children's Psychiatric Rating Scale (Weekly)
C: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
D: The primary measure will be a global composite derived by calculating the z scores on each measure other than CGI from published norms (or from the baseline descriptives, then averaging the z scores of the various outcome measures for each individual. (Baseline, weeks 2, 4, 6, 8, 10,12, and 14.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Study of Olanzapine in Children With Autism
Brief Summary: This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.


Options:
A: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
B: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
C: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
D: Children's Psychiatric Rating Scale (Weekly)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Study of Olanzapine in Children With Autism
Brief Summary: This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.


Options:
A: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
B: Mean Conners' Teacher ADHD Index T Score by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high)); Mean Continuous Performance Test (CPT)-Commission Errors by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high))
C: Children's Psychiatric Rating Scale (Weekly)
D: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS
Brief Summary: The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.


Options:
A: Mortality
B: Vitamin D Supplementation Safety (12 months)
C: To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover. (Baseline, Week 4, Week 12); To measure the safety of 50,000 IU dose of vitamin D3 (Baseline, Week 4, and Week 8)
D: Comparison of the change in CD8CD38 percentage (24 weeks); Comparison of the change in CD8CD38 percentage during the ER niacin + ART period (48 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS
Brief Summary: The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.


Options:
A: Mortality
B: Change in Z score for weight and improvement in X ray film (6 months)
C: Final outcome according to WHO (8 months)
D: Proportion of pulmonary TB patients who are culture negative at 1 month (1 month); Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CBASP Augmentation for Treatment of Chronic Depression
Brief Summary: This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.


Options:
A: N/A
B: Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors) (18 months)
C: Remission (12 weeks)
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma
Brief Summary: To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma


Options:
A: Progression-Free Survival (PFS) (Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.)
B: Time to tumor progression (TTP) (Up to 3 years)
C: Progression Free Survival (PFS) (From randomization until disease progression. Median follow-up time was 43 months.)
D: Number of Patients With Combined Complete Response and Very Good Partial Response (Up to 48 weeks or until disease progression)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Recurrence in Depression With Drugs and CT
Brief Summary: This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.


Options:
A: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
B: Hamilton Depression Scale (HAM-D) - continuous (End point week 19 and Week 24)
C: Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors) (18 months)
D: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Recurrence in Depression With Drugs and CT
Brief Summary: This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.


Options:
A: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)
B: N/A
C: Hamilton Anxiety Rating Scale (56 weeks); Penn State Worry Questionnaire (56 weeks)
D: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Outreach and Treatment for Depression in the Labor Force
Brief Summary: This study will assess the effects of depression treatment on employee productivity. This study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.


Options:
A: HAMD-17
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: N/A
D: Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Outreach and Treatment for Depression in the Labor Force
Brief Summary: This study will assess the effects of depression treatment on employee productivity. This study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.


Options:
A: Hamilton Rating Scale for Depression (Screen, Week 9, 17, 24)
B: N/A
C: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Outreach and Treatment for Depression in the Labor Force
Brief Summary: This study will assess the effects of depression treatment on employee productivity. This study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.


Options:
A: Self-reported number of sick-days (3 months)
B: time until full sustainable return-to-work (RTW) (1 year); Total number of sickness absence days (1 year)
C: N/A
D: Return to work from sick leave (Up to 1,5 years post intervention completion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Early Age Mania (TEAM) Study
Brief Summary: This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.


Options:
A: The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint. (8 weeks)
B: The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study. (August 2012)
C: Sedation Score (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9); Young Mania Rating Scale (YMRS) Scores (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9)
D: Clinical Global Impressions-Bipolar Mania Improvement (Measured at Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial of Combination Anastrozole (NSC #719344) Plus ZD1839 (Iressa, NSC #715055, IND #61187) and of Combination Fulvestrant (NSC #719276) Plus ZD1839 in the Treatment of Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer
Brief Summary: This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer.


Options:
A: Progression-free survival (every 3 months during treatment and, at time of discontinuation from treatment)
B: Clinical Benefit Rate (assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years)
C: Time to Tumor Progression (Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.)
D: Time to Disease Progression (TTP)

Answer: B