TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
Brief Summary: The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.


Options:
A: Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 (0-24 Hours); Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 (24-120 Hours)
B: Patient vomiting
C: Plasma levels of study drugs will be taken on Day 1 & 8. (taken on Day 1 & 8.)
D: Number of Patients Who Reported No Vomiting (Overall phase (0-120 hours post initiation of MEC) in Cycle 1.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
Brief Summary: The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.


Options:
A: Patient Perception of Pain (At time of uterine aspiration (baseline))
B: Pain and anxiety experienced during first trimester abortion. (1 day. Outcome measured immediately after procedure without additional follow-up.)
C: Pain scale
D: Pain reported with cervical dilation (1 Year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Triple-Blind, Parallel Study to Investigate the Effect of Losartan Versus Atenolol on the Reduction of Morbidity and Mortality in Hypertensive Patients With Left Ventricular Hypertrophy
Brief Summary: The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with high blood pressure and thickening of the main pumping chamber of the heart. The results showed that after an average treatment time of 4.8 years, treatment that was based on losartan was better than treatment based on atenolol for reducing the risk of having a stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: N/A
C: Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack)
D: Blood Pressure (baseline and six month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Brief Summary: The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.


Options:
A: Progression Free Survival (From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years))
B: Incidence of adverse events (throughout study)
C: To determine the major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria (after 6 courses of treatment in the respective treatment arm)
D: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Convergence Insufficiency Treatment Trial (CITT)
Brief Summary: The purposes of the CITT are:

* To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than placebo treatment, and whether there are differences between the three treatments in improving subject symptoms and signs.
* To evaluate whether improvements in outcome measures are still present after one year of observation.


Options:
A: The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT). (After 16 weeks of treatment)
B: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey (12 weeks)
C: The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
D: Symptom score on the Convergence Insufficiency Symptom Survey

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Obesity - Programming by Infant Nutrition
Brief Summary: Primary hypothesis to be tested:

Early protein intake predicts infant growth and later risk of childhood obesity.

* Childhood obesity is a major public health problem and is an identified priority concern for the health care. Infants fed formula are more likely to become obese than breastfed infants. The higher protein content of infant formulae, compared with breast milk, could be a causal factor.
* The study will in a multicentre intervention trial on newborn infants investigate whether feeding infant formulae, which differ in their level of milk proteins, can influence the risk of later childhood obesity. The trial will take place in five countries with different habitual total protein intakes to increase the range of protein intakes
* The investigators will study body composition, hormonal status, protein metabolism and anthropometric markers of childhood obesity. The whole cohort will be followed up until age 18 years, to assess the long term impact on the prevalence of obesity.
* The investigators will explore the impact of consumer (parental) attitudes to, and perceptions of, different practices of infant feeding in relation to infant behaviour (satisfaction, crying, sleep duration). This consumer science information will help improve the understanding of consumer (infants and parents) acceptance of and preference for foods that contribute to healthy diets.
* If a relationship between early dietary protein intake and later childhood obesity risk is confirmed, it offers possibilities for the prevention of obesity, for improving advice given to parents and for developing nutritionally improved dietary products for infants.


Options:
A: Sequence Recall using 3-dimensional props (365 days of age)
B: Growth velocity of formula regimen 1 and 2 versus WHO growth curve (0-6 months); Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group (0-6 months)
C: Mean weight gain (3 years); Mean weight gain (5 years)
D: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Obesity - Programming by Infant Nutrition
Brief Summary: Primary hypothesis to be tested:

Early protein intake predicts infant growth and later risk of childhood obesity.

* Childhood obesity is a major public health problem and is an identified priority concern for the health care. Infants fed formula are more likely to become obese than breastfed infants. The higher protein content of infant formulae, compared with breast milk, could be a causal factor.
* The study will in a multicentre intervention trial on newborn infants investigate whether feeding infant formulae, which differ in their level of milk proteins, can influence the risk of later childhood obesity. The trial will take place in five countries with different habitual total protein intakes to increase the range of protein intakes
* The investigators will study body composition, hormonal status, protein metabolism and anthropometric markers of childhood obesity. The whole cohort will be followed up until age 18 years, to assess the long term impact on the prevalence of obesity.
* The investigators will explore the impact of consumer (parental) attitudes to, and perceptions of, different practices of infant feeding in relation to infant behaviour (satisfaction, crying, sleep duration). This consumer science information will help improve the understanding of consumer (infants and parents) acceptance of and preference for foods that contribute to healthy diets.
* If a relationship between early dietary protein intake and later childhood obesity risk is confirmed, it offers possibilities for the prevention of obesity, for improving advice given to parents and for developing nutritionally improved dietary products for infants.


Options:
A: Death or late-onset sepsis (At hospital discharge)
B: Weight (Study Day (SD) 1, 28 and 84)
C: The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
D: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Obesity - Programming by Infant Nutrition
Brief Summary: Primary hypothesis to be tested:

Early protein intake predicts infant growth and later risk of childhood obesity.

* Childhood obesity is a major public health problem and is an identified priority concern for the health care. Infants fed formula are more likely to become obese than breastfed infants. The higher protein content of infant formulae, compared with breast milk, could be a causal factor.
* The study will in a multicentre intervention trial on newborn infants investigate whether feeding infant formulae, which differ in their level of milk proteins, can influence the risk of later childhood obesity. The trial will take place in five countries with different habitual total protein intakes to increase the range of protein intakes
* The investigators will study body composition, hormonal status, protein metabolism and anthropometric markers of childhood obesity. The whole cohort will be followed up until age 18 years, to assess the long term impact on the prevalence of obesity.
* The investigators will explore the impact of consumer (parental) attitudes to, and perceptions of, different practices of infant feeding in relation to infant behaviour (satisfaction, crying, sleep duration). This consumer science information will help improve the understanding of consumer (infants and parents) acceptance of and preference for foods that contribute to healthy diets.
* If a relationship between early dietary protein intake and later childhood obesity risk is confirmed, it offers possibilities for the prevention of obesity, for improving advice given to parents and for developing nutritionally improved dietary products for infants.


Options:
A: increased physical activity (4 months)
B: BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis) (2 years)
C: Body mass index (BMI) at 1 year.
D: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
Brief Summary: A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.


Options:
A: Overall progression-free survival
B: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
C: Number of Subjects With Overall Confirmed Objective Response (OR) (From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter)
D: Progression Free Survival (PFS) (Up to 5 years); Overall Survival (OS) (Up to 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone & SSRI in Alcoholics With Depression/PTSD
Brief Summary: The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.

We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.


Options:
A: 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)
B: Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). (14 weeks)
C: Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17) (From baseline visit to Week 12 (or early discontinuation visit)); Total Drinking Days on the Alcohol Timeline Followback (TLFB) (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Week on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Drinking Day on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit))
D: Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS) (beginning of treatment (week 1), and end of treatment (13 weeks)); Clinician-Administered PTSD Scale (CAPS) (beginning of treatment (week 1), and end of treatment (13 weeks)); Hamilton Depression Rating Scale (HAM-D) (beginning of treatment (week 1), and end of treatment (13 weeks)); Mean Number of Side Effects (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Skills Training for Schizophrenia
Brief Summary: This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus goal-focused supportive contact in improving social functioning in people with schizophrenia.


Options:
A: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
B: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))
C: Social Functioning (Measured at baseline and Months 9 and 21)
D: sucessful employment for one day in the open labour market

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in HIV Infected Children 7 to 12 Years of Age
Brief Summary: The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.


Options:
A: Time to the First New Persistent Infection of HPV 6, 11, 16, or 18 (From baseline to participant's last study visit, for up to 4 years)
B: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 (At Month 7); Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) (At Month 7)
C: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 48)
D: Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) (Within 14 days of first three doses of vaccination); Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment (Within 14 days of first three doses of vaccination); Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion (At week 28 after beginning the vaccination series); Serum Anti-HPV Antibody Titers (cLIA) (Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Training and Enhanced Supported Employment
Brief Summary: This study will evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals.


Options:
A: Psychotic Symptoms (two years)
B: Independent Living Skills Survey (ILSS) (Baseline, 18 mos.)
C: Social Functioning (Measured at baseline and Months 9 and 21)
D: Schizophrenia symptoms (Measured at Year 1); Vocational functioning (Measured at Year 2); Schizophrenia symptoms (Measured at Year 2); Quality of life (Measured at Year 2); Quality of life (Measured at Year 1); Vocational functioning (Measured at Year 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
Brief Summary: The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.


Options:
A: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation
B: To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab. (3 years)
C: Progression-free Survival (PFS) (From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.); Overall Survival (From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months)
D: Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006); Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006); Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: NCI-AARP Diet and Health Study
Brief Summary: This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.

In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.


Options:
A: Incident Cancer (12/31/2030); All cause and disease specific mortality (12/31/2030); Chronic diseases (12/31/2030)
B: Systolic Blood Pressure (12 months)
C: Ambulatory Activity Profile (6 months)
D: Motor Assessment Scale (18 months after inclusion)

Answer: A