TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
Brief Summary: The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy?

Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions.

The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.


Options:
A: Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up (Baseline to 2 months post second experimental session)
B: outcome (within study timeframe)
C: PTSD symptom score (baseline, after MBSR and 4 months later)
D: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting
Brief Summary: The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.


Options:
A: Occurrence of Post-operative Nausea and Vomiting (PONV) (First 24 hours post-extubation)
B: Prevention of PONV in the 24 hours following end of surgery; Tolerability
C: the incidence of postoperative nausea and vomiting(PONV) (After spinal surgery)
D: Incidence of Postoperative Nausea and Vomiting (postoperative 24 hours)

Answer: B
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 Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1
Brief Summary: A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.


Options:
A: Percentage of Patients With Adverse Events (Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks)
B: Number of participants who achieved complete response (Up to 120 hours of cycle 1 of HEC)
C: Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 (0 to 120 hours)
D: Patient vomiting

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants
Brief Summary: This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Options:
A: Occurrence of RV GE
B: 116E rotavirus vaccine (6,10 and 14 weeks)
C: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
D: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo (Within 42 days following any dose of RotaTeq™/placebo); Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination (At least 14 days following the 3rd vaccination through the first full rotavirus season)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants
Brief Summary: This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Options:
A: Percentage of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to (≥) the Cut-off Value (One month post third dose of DTP-IPV vaccine (At Month 5)); Percentage of Subjects With Anti-pertussis Toxoid (Anti-PT) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibody Concentrations ≥ the Cut-off Value (One month post third dose of DTP-IPV vaccine (At Month 5)); Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value (One month post third dose of DTP-IPV vaccine (At Month 5))
B: Seroprotection for each polio serotype 1 month after the 3rd dose.
C: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo (Within 42 days following any dose of RotaTeq™/placebo); Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination (At least 14 days following the 3rd vaccination through the first full rotavirus season)
D: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants
Brief Summary: This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Options:
A: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
B: Percentage of subjects with vaccine take (At 2 months post-Dose 2)
C: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
D: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo (Within 42 days following any dose of RotaTeq™/placebo); Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination (At least 14 days following the 3rd vaccination through the first full rotavirus season)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting
Brief Summary: The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.


Options:
A: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
B: Nausea (0-72 hours postoperative)
C: Incidence of postoperative nausea and vomiting (48 hours postoperative)
D: Prevention of PONV in the 24 hours following end of surgery; Tolerability (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
Brief Summary: The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.


Options:
A: Surgical site infection (30 days)
B: Incidence of incisional surgical site infection (SSI)
C: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 (assessed at Postop Day 1, 2, 3, 7, 30 & 60)
D: Surgical site infection following elective colorectal surgery based on surgical site assessment.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia
Brief Summary: A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.


Options:
A: The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy
B: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))
C: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) (8 weeks)
D: LDL-C lowering efficacy after 6 weeks.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: UW STAART Center of Excellence
Brief Summary: This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.


Options:
A: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
B: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
C: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
D: Social network involvement of autistic children (Measured before and after treatment and at 3-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: UW STAART Center of Excellence
Brief Summary: This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.


Options:
A: Child measures of autism symptoms, social communication, developmental level, and adaptive behavior (Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month)
B: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
C: Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks (Baseline, 12 weeks)
D: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: UW STAART Center of Excellence
Brief Summary: This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.


Options:
A: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
B: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
C: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavior Enhances Drug Reduction of Incontinence
Brief Summary: The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.


Options:
A: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (15 weeks)
B: 24-hour Voiding Frequency (post-treatment (week 8))
C: Proportion of Women Who Meet Definition of Success (8 months)
D: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavior Enhances Drug Reduction of Incontinence
Brief Summary: The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.


Options:
A: Change from baseline in mean number of micturitions per 24 hours after 8 weeks (8 weeks)
B: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)
C: Proportion of Women Who Meet Definition of Success (8 months)
D: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With or Without Classic CNV Secondary to Age Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Options:
A: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: N/A
C: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With or Without Classic CNV Secondary to Age Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Options:
A: N/A
B: N/A
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With or Without Classic CNV Secondary to Age Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Options:
A: change in best-corrected visual acuity (6 months)
B: N/A
C: N/A
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer
Brief Summary: RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients.

PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II, or stage IIIA primary breast cancer.


Options:
A: Score on the Cognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months.
B: Cognition and activities of daily living (18 mos)
C: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary: RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.


Options:
A: Response Rate (average 6 months)
B: Progression Free Survival (PFS) by Investigator Assessment (RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).)
C: Overall survival
D: Progression-Free Survival (Site Read, Investigator Assessment) (Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks); Median Progression-Free Survival (Site Read, Investigator Assessment) (Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Ranolazine SR at a Dose of 1000 mg Twice a Day in Patients With Chronic Angina Who Remain Symptomatic Despite Treatment With Amlodipine 10 mg Once a Day
Brief Summary: The study will be a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine. Participation in the study will last approximately 3 months.


Options:
A: Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS. (First occurrence)
B: Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization (Baseline through end of study (average 90 weeks))
C: Seattle Angina Questionnaire (SAQ) (2 weeks (first intervention) and 6 weeks (second intervention))
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
Brief Summary: The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.


Options:
A: Change in 6-minute walk distance (Baseline to End-of-Period 1)
B: 6 minute walk distance change from baseline to Week 16 (16 weeks)
C: Change from baseline at Week 12 of six minute walk distance
D: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
Brief Summary: The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.


Options:
A: Change from baseline at Week 12 of six minute walk distance
B: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough (Baseline (Day 1) and end of double-blind treatment (Day 56))
C: Change from baseline to End-of-Study in 6-minute walk distance.
D: Frequently Reported (15% or More Overall) Adverse Events by Severity (Baseline to Week 295); Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) (Baseline to Week 295)

Answer: A