TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Palliative Care for Patients With Cancer
Brief Summary: RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.

PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.


Options:
A: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)
B: Quality of life of the patient and his family caregiver at baseline. (at baseline); Quality of life of the patient and his family caregiver at 12 weeks. (at 12 weeks); Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks. (6-weekly after 12 weeks)
C: Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90. (Baseline, Day 90.); Change from baseline in satisfaction with care on the FAMCARE-patient scale at days Days 45, 90, 120 and 180. (Baseline, Days 45, 90, 120 and 180.); Descriptive results about feasibility of the study. (Average duration in minutes of each intervention session (both regarding Palliative Care consultation and Psychological session); number of non-attendance to the interventions (absences); reasons reported by patients for missing.)
D: Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased (Baseline, one month, every three months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex™) With or Without Concomitant Anastrozole (Arimidex™) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
Brief Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.

PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.


Options:
A: 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.)
B: Progression-free survival
C: 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)
D: Time to Disease Progression (TTP)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
Brief Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer.

PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.


Options:
A: Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy (3 years)
B: Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease (4 months); Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia (4 months); No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia (4 months); Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer (4 months)
C: Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) (Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)); Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention (End of study)
D: Rate of Progression to Prostate Cancer (PCa) (12 months); Rate of Progression From HGPIN to ASAP or PCa (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
Brief Summary: The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
B: Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. (6-month follow-up); Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million. (6-month follow-up)
C: Point prevalence abstinence at 6 months (6 months after beginning treatment)
D: Prolonged Abstinence (Weeks 7-10)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
Brief Summary: The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Prolonged Abstinence (Weeks 7-10)
B: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
C: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
D: Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
Brief Summary: To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.


Options:
A: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
B: N/A
C: The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. (two 4-week feeding periods (56 days total))
D: Fasting Insulin (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
Brief Summary: To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.


Options:
A: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
B: For adults: body weight loss maintenance (6 Month)
C: plaque volume (1, 3 years)
D: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Brief Summary: This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.


Options:
A: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
B: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
C: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (Week 0, Week 26); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Week 0, Week 52); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 (Week 0, Week 78); Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 (Week 52, Week 78)
D: To assess the pharmacokinetics of exenatide (Three day-long (8 hour) assessments over a 5-week period); To assess the pharmacodynamics of exenatide (Three day-long (8 hour) assessments over a 5-week period); Number of adverse events (Visit 2 through Visit 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)
Brief Summary: The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.


Options:
A: Proportion of patients with an ACR20 response (24 weeks)
B: Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS) (Days 71 to 85); Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE) (Day 85 to 56 days post last dose); Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE) (Day 85 to Day 533); Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing) (Day 533 to 56 Days Post last dose)
C: ASAS 40 at week 12
D: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Pharmacotherapy of Late-Life Mania (GERI-BD)
Brief Summary: This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.


Options:
A: Sedation Score (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9); Young Mania Rating Scale (YMRS) Scores (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9)
B: To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate; mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).
C: The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint. (8 weeks)
D: Clinical Global Impressions-Bipolar Mania Improvement (Measured at Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
Brief Summary: In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far as the investigators know, no well designed controlled studies have been performed on the effect of one of the newer atypical antipsychotics on psychotic symptoms.

It is of interest to investigate the benefit of quetiapine treatment in these types of patients. Quetiapine possibly gives less side-effects because of the expected lack of elevated prolactin levels, which is of importance in this patient group, overrepresented by young females. In this double blind, randomized, placebo controlled, 8 week, parallel group, multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be compared with the placebo.


Options:
A: BSSI score (Day 3)
B: To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms (assessed at each visit for 8 weeks)
C: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
D: Suicide repetition (or death by suicide) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
Brief Summary: In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far as the investigators know, no well designed controlled studies have been performed on the effect of one of the newer atypical antipsychotics on psychotic symptoms.

It is of interest to investigate the benefit of quetiapine treatment in these types of patients. Quetiapine possibly gives less side-effects because of the expected lack of elevated prolactin levels, which is of importance in this patient group, overrepresented by young females. In this double blind, randomized, placebo controlled, 8 week, parallel group, multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be compared with the placebo.


Options:
A: To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms (assessed at each visit for 8 weeks)
B: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))
C: Clinical Global Improvement Scale (0, 1, 5, 10 week)
D: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
Brief Summary: The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.


Options:
A: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. (30 Days post-dose 3 vaccination); Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) (30 Days post-dose 3 vaccination); Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. (30 Days post-dose 3 vaccination.)
B: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
C: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
D: Percentage of subjects with vaccine take (At 2 months post-Dose 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
Brief Summary: The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.


Options:
A: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. (30 Days post-dose 3 vaccination); Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) (30 Days post-dose 3 vaccination); Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. (30 Days post-dose 3 vaccination.)
B: 116E rotavirus vaccine (6,10 and 14 weeks)
C: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
D: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological Treatment of Separation Anxiety Disorder
Brief Summary: The purpose of this study is to determine whether a specific family based cognitive behavioral treatment program is effective in the treatment of children with separation anxiety disorder.


Options:
A: N/A
B: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)
C: Anxiety Disorders Interview Schedule - Child/Parent Version (Post Treatment (16 weeks))
D: Score on anxiety diagnostic interview after treatment or waitlist (post-treatment); Score on anxiety rating scale after treatment or waitlist (post-treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological Treatment of Separation Anxiety Disorder
Brief Summary: The purpose of this study is to determine whether a specific family based cognitive behavioral treatment program is effective in the treatment of children with separation anxiety disorder.


Options:
A: Pediatric Anxiety Rating Scale. (Post-treatment, which is an average of 16 weeks after Baseline)
B: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)
C: Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis (Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment)
D: Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Soy Isoflavones in Prostate Cancer Prevention
Brief Summary: This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.


Options:
A: Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) (During radiation therapy and up to 6 weeks post radiation therapy)
B: Survival (3 years or death)
C: Freedom from biochemical and/or disease failure rates (weekly during treatment, at 3 months, 6 months or 2 years then yearly)
D: Effect of Soy Isoflavones on Serum Testosterone Levels. (Two weeks)

Answer: D