TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy.

Patient safety and quality of life will also be monitored throughout the study.


Options:
A: N/A
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
D: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy.

Patient safety and quality of life will also be monitored throughout the study.


Options:
A: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: N/A
D: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy.

Patient safety and quality of life will also be monitored throughout the study.


Options:
A: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
B: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
C: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy.

Patient safety and quality of life will also be monitored throughout the study.


Options:
A: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
B: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
C: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Brief Summary: This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.


Options:
A: Presence of gonococcal infection (3 months); Presence of gonococcal infection (6 months); Presence of gonococcal infection (9 months)
B: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
C: HIV-1 seroincidence; HSV2 seroprevalence
D: Cohort I: 12 month experience of intimate partner violence; Cohort II: Condom use with last non-spousal partner; Cohort III: Condom use with last non-spousal partner; Cohort III: HIV incidence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Brief Summary: This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.


Options:
A: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (96 weeks)
B: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
C: Lost to Follow-up (12 months)
D: Virologic suppression at 6 months (6 months); Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007) (Typically every 24 weeks); Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007) (Typically weekly to monthly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Brief Summary: This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.


Options:
A: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years); HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years)
B: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
C: HIV Infection (Cumulative HIV infection between enrollment and 52 weeks); Confirmed Grade 2 or Higher Serum Creatinine Toxicity (cumulative toxicity through 52 weeks of product use and 4 weeks post product); Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration (10-26 months per site); Confirmed Grade 3 or Higher Reduction in Phosphorus (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher ALT Elevation (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher AST Elevation (Through 52 weeks on product and 4 weeks post-product)
D: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants (Up to 36 months); Number of Participants With Serious Adverse Events (SAEs) (Up to 36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Brief Summary: This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.


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: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
C: Mortality (2 years)
D: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Phase 2, Open-Label Study of Fabrazyme (Recombinant Human a-Galactosidase A) Replacement Therapy in Pediatric Patients With Fabry Disease
Brief Summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In people with Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid levels (also referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood with pain in the hands and feet. This study explored the safety, efficacy and pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.


Options:
A: Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium (Baseline, Week 52, Week 156 and Week 260)
B: Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients (up to 35 months)
C: Patients Who Experienced At Least One Adverse Event (AE) (362 weeks)
D: Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin (Baseline, Week 24 and Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Fabrazyme on Progression of Renal Disease and Significant Clinical Events in Patients With Fabry Disease
Brief Summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid ("globotriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.


Options:
A: Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients (up to 35 months)
B: Patients Who Experienced At Least One Adverse Event (AE) (362 weeks)
C: Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin (Baseline, Week 24 and Week 48)
D: Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium (Baseline, Week 52, Week 156 and Week 260)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self -Care to Prevent Urinary Incontinence
Brief Summary: The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.


Options:
A: Change in Incontinent Episodes Immediately Post-treatment (Baseline and immediately post-treatment - week 8)
B: Mean number of incontinence episodes (Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline)
C: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))
D: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (From Baseline to 6 Weeks); Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) (Change from 6 weeks to 12 weeks); Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) (Baseline to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self -Care to Prevent Urinary Incontinence
Brief Summary: The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.


Options:
A: Mean number of incontinence episodes (Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline)
B: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. (Baseline and 3 months)
C: Change in life impact of pelvic floor dysfunction (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.); Change in symptoms and quality of life (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle strength (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle characteristics (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle strength (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.)
D: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas.


Options:
A: Progression-free Survival (PFS) (Time from randomization to disease progression or death from any cause (Range: 0 -10 months))
B: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
C: disease control rate (eight weeks)
D: Overall survival comparison between treatment groups (every 4 weeks for 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.


Options:
A: 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)
B: 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.)
C: Progression-free survival
D: Progression-free survival (every 3 months during treatment and, at time of discontinuation from treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
Brief Summary: RATIONALE: The hormone testosterone may improve the libido (sex drive) in women. It is not yet known whether testosterone is effective in improving libido in female cancer survivors.

PURPOSE: This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors.


Options:
A: Prevention of Entry Dyspareunia With Non-hormonal Therapy (During Phase II (0-4 weeks) and during Phase III (5-12 weeks)); Location of Pain in Postmenopausal Dyspareunia (Enrollment visit)
B: Overall mood (Up to 6 months)
C: Sexuality problems (Baseline); Intimacy problems. (Baseline); Sexuality problems (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Sexuality problems (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Sexuality problems (T3: 3 months after T2 (intervention group)); Intimacy problems. (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Intimacy problems. (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Intimacy problems. (T3: 3 months after T2 (intervention group)); Sexuality problems (T4: 6 months after T3 (intervention group)); Intimacy problems (T4: 6 months after T3 (intervention group))
D: Physical Function (14 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bone Sparing Effects of Soy Phytoestrogens in Menopause
Brief Summary: The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause.

Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.


Options:
A: Change From Baseline in Bone Mineral Density (baseline and 2 years)
B: Bone mineral density (One year and two years)
C: Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.; Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
Brief Summary: The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)
B: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
C: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.
D: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Answer: B