TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Change in body weight (measured at Year 2)
B: body weight (prior to and after 4, 8, and 12 months of dieting)
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Fat mass (Baseline - 12 weeks)
B: Change in body weight (measured at Year 2)
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: weight loss

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Change in body weight (measured at Year 2)
B: Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. (After 3 months of intervention)
C: Cardiovascular Disease Prevention based on dietary approach. (Two years)
D: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Change in body weight (measured at Year 2)
B: N/A
C: body weight (prior to and after 4, 8, and 12 months of dieting)
D: Hemoglobin A1c (22 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
B: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
C: Change in body weight (measured at Year 2)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
Brief Summary: This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.


Options:
A: Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population (6 Weeks)
B: The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients))
C: Treatment emergent adverse events (Throughout the study period of approximately 2 year, 4 months)
D: To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis (From day 1 of treatment until end of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
Brief Summary: The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.


Options:
A: Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC) (Up to 23 months after first subject randomized)
B: Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later); Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later)
C: Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) (Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)); Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) (2 cycles (e.g., one cycle = 28 days)); Number of Participants With a Best Observed Response (Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)); Number of Participants With a Best Response (Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days))
D: Progression-free Survival (Randomization until progression (up to 2 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
Brief Summary: The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.


Options:
A: N/A
B: Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later); Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later)
C: Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects (4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression
Brief Summary: The purposes of this study are to determine:

* The safety of duloxetine and any side effects that might be associated with it.
* How duloxetine compares to escitalopram and placebo (an inactive ingredient)


Options:
A: Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
B: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
C: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment (Baseline and Week 8)
D: To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Depression in At-Risk Adolescents
Brief Summary: This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.


Options:
A: Presence or absence of a depressive episode (child) (T4 (9 months after completion of the programme))
B: Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) (Time to a score of 4 or higher between baseline and 9 months using survival analysis)
C: N/A
D: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis fungoides.


Options:
A: Progression-free survival
B: Ratio of Response Rates Based on CAILS (Assessment made at Day 1 and every subsequent visit during treatment)
C: Overall Response Rate (ORR) (2 years)
D: Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant
Brief Summary: HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.


Options:
A: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)
B: HIV infection rate of infants (6 months of age); Safety of the regimens for HIV-infected mothers and their breast-fed infants (Through 12 months post-partum)
C: Infant HIV infection status (At Months 6 and 12)
D: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant
Brief Summary: HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.


Options:
A: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
B: HIV infection rate of infants (6 months of age); Safety of the regimens for HIV-infected mothers and their breast-fed infants (Through 12 months post-partum)
C: HIV PCR (1 month)
D: Infant HIV infection status (At Months 6 and 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
Brief Summary: The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.


Options:
A: Measure the number of infants who have HBV infection at the age of 28 weeks (From the date of birth to age of 28 weeks); Assessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events (From the date of randomization until 28 weeks of postpartum.)
B: Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm (Week 48)
C: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)
D: Percentage of Infants With Hepatitis B Infection at 6 Months of Age (6 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
Brief Summary: The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.


Options:
A: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)
B: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
C: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)
D: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women
Brief Summary: The majority of HIV infected people worldwide became infected with the virus through heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner. This study will test the safety and effectiveness of these gels.


Options:
A: Safety of BufferGel and 0.5% PRO 2000/5 Gel (P), as assessed by deep epithelial disruption, other genital symptoms, or other systemic symptoms (Throughout study); HIV infection as measured by seroconversion (Throughout study)
B: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. (24 months); All Adverse Events (24 months)
C: Effectiveness (30 months); Safety (30 months)
D: Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. (minimum of 12 months and a maximum of 14 months per participant); The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). (minimum of 12 months and a maximum of 14 months per participant)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Brief Summary: This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).


Options:
A: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
B: Percentage of patients with ACR 20 response (Week 24)
C: Percentage of patients with ACR 20 response (Week 24)
D: Proportion of patients with an ACR20 response (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Brief Summary: This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).


Options:
A: Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment (From first treatment with rituximab (Day 1) through Week 24)
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Proportion of patients with an ACR20 response (24 weeks)

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: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
B: 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.
C: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
D: N/A

Answer: D