TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma
Brief Summary: This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.


Options:
A: Overall Survival (OS) (24 months)
B: Overall Survival (OS) (From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.); Overall Survival (OS) Rate (From randomization to 6 months and or to 12 months)
C: Pathological response rate (From baseline to 6 weeks)
D: Best Response Rate (Partial Response [PR] + Complete Response [CR]) (Up to 12 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Study of High-Dose Ketoconazole With or Without Alendronate Sodium in Patients With Androgen-Independent Metastastic Adenocarinoma of the Prostate
Brief Summary: RATIONALE: Ketoconazole may suppress the production of hormones and may interfere in the growth of prostate cancer cells. Alendronate sodium may be effective in preventing bone metastases and bone pain associated with prostate cancer. It is not known if ketoconazole is more effective with or without alendronate sodium.

PURPOSE: Randomized phase II trial to study the effectiveness of ketoconazole with or without alendronate sodium in treating patients who have metastatic prostate cancer.


Options:
A: N/A
B: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
C: Time to First Skeletal Related Event (Up to 10 years)
D: Time to treatment failure (TTF) (6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.


Options:
A: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)
B: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) (Week 12)
C: Event-free survival; Overall survival
D: To determine the objective response (Weeks 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II/III Trial of Paclitaxel Plus Carboplatin With or Without Bevacizumab (NSC #704865) in Patients With Advanced Nonsquamous NSCLC
Brief Summary: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance


Options:
A: Progression-free survival (Event driven)
B: Survival (Up to 5 years); Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Up to 5 years)
C: Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) (Randomization to Month 6)
D: Progression Free Survival (PFS) Rate at Month 6 (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II/III Trial of Paclitaxel Plus Carboplatin With or Without Bevacizumab (NSC #704865) in Patients With Advanced Nonsquamous NSCLC
Brief Summary: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance


Options:
A: Survival (Up to 5 years); Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Up to 5 years)
B: Progression-Free Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Chronic Whiplash Pain: Biobehavioral Approach
Brief Summary: This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents.


Options:
A: Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months (6 months)
B: N/A
C: Pain (Measured 3 months after the accident); Functional activity (Measured 3 months after the accident); Mood (Measured 3 months after the accident)
D: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Treatment Alternatives to Relieve Depression
Brief Summary: STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated


Options:
A: To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD (Week 8)
B: N/A
C: The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS) (2 to 6 weeks)
D: Number of Days on Which Subjects Drank (12-week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Treatment Alternatives to Relieve Depression
Brief Summary: STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated


Options:
A: Change in depression (From baseline and 10 months later (after intervention)); Change in anxiety (From baseline and 10 months later (after intervention))
B: depression (pre, post and 6 months post treatment)
C: School presence (one year); Severity of fatigue (one year); Physical functioning as measured by the subscale physical functioning (one year)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Treatment Alternatives to Relieve Depression
Brief Summary: STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: N/A
C: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
D: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Treatment Alternatives to Relieve Depression
Brief Summary: STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated


Options:
A: N/A
B: Montgomery-Åsberg Depression Rating Scale (MADRS) (Baseline and final MADRS scores during the double-blind phase.)
C: Change in Total MADRS Scores From Baseline to Week 8 (Baseline, Week 8); Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) (Baseline, week 9); Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) (Baseline, Weeks 8)
D: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (Baseline (Week 8) and Week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Treatment Alternatives to Relieve Depression
Brief Summary: STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated


Options:
A: N/A
B: Change from Baseline in CDI at 14 weeks (Week 0, Week 14)
C: Change from baseline in CDRS at 3 months (Month 0, Month 3)
D: HbA1c (Change from Baseline to 3 months and from 3 months to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Treatment Alternatives to Relieve Depression
Brief Summary: STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated


Options:
A: recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks (40 weeks)
B: Scores on Hamilton Depression Rating Scale (8 time points through 6 weeks)
C: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Project Sugar 2: Health Events Costs in Diabetic Blacks
Brief Summary: Diabetes mellitus imposes a major burden on the public health of the United States, leading annually to over 300,000 deaths and over $130 billion in costs. This burden falls disproportionately upon ethnic minority groups, particularly African Americans, who are at excess risk for the development of type 2 diabetes and for a variety of its most serious complications. Suboptimal health care - in terms of access, quality, and adherence -appears to be an important contributing factor. Prior work suggests two possible approaches aimed at prevention to enhance risk factor control in outpatients with type 2 diabetes. One approach uses Nurse Case Managers (NCMs) to coordinate care plans with the provider team following protocols/clinical guidelines and algorithms designed to guide treatment including initiating and adjusting drug therapy, enhancing continuity of care, promoting interventions and self-management which include educational and behavioral strategies incorporating feedback and self-regulation. Another approach uses Community Health Workers (CHWs) to enhance culturally sensitive outreach, linkage, and monitoring service; to provide important patient and family education; and to improve access to and continuity of care. Results indicate that this intensive team approach, compared to usual care alone, produces substantial improvements in metabolic control. However, the cost-effectiveness of such interventions is unknown in the ''real-world''.

This has led to our current study, a randomized controlled trial within a managed care organization to determine the effects of a NCM/CHW team on metabolic control, on the occurrence of diabetes-related health events, health care utilization, and on direct health care costs. The participants will be African American adults with type 2 diabetes who receive primary care within a managed care organization in inner-city Baltimore.


Options:
A: N/A
B: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
C: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)
D: Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both (Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Treatment for Spinal Stenosis
Brief Summary: Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. This condition can lead to significant pain and limit a person's ability to function. Moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis.

In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.


Options:
A: SF-36 (physical component summary score) (2 year)
B: Medical Outcomes Study 36-item Short Form Health Survey (Measured at Month 24)
C: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
D: Oswestry Disability Index (ODI) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Treatment for Spinal Stenosis
Brief Summary: Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. This condition can lead to significant pain and limit a person's ability to function. Moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis.

In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.


Options:
A: Mean Change in VAS (Baseline and 6 weeks prior to cross-over); Mean Change in ODI (Baseline and 6 weeks prior to cross-over); Mean Change in VAS (Baseline and 26 weeks After ESI to mild cross-over); Mean Change in ODI (Baseline and 26 weeks After ESI to mild cross-over)
B: Medical Outcomes Study 36-item Short Form Health Survey (Measured at Month 24)
C: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
D: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
Brief Summary: The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)


Options:
A: Opioid Use (24 weeks)
B: Self-reported frequency of illicit opioid use (6 months); Percentage of opioid-negative urine specimens (6 months); Maximum number of weeks abstinent from illicit opioids (6 months)
C: Illicit Opioid Use (18 weeks)
D: Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 (Weekly from Weeks 5-24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TBTC Study 26: Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment of Latent Tuberculosis Infection
Brief Summary: Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).


Options:
A: Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment (Baseline up to Month 33)
B: TB incidence (Jan 2003 to July 2011); Mortality (Jan 2003 to July 2011)
C: Adverse events of all grades (Treatment duration)
D: Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) (6/2008)

Answer: A