TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Brief Summary: Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse survivors and is associated with substantial psychosocial and medical problems, but evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered therapy.


Options:
A: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
B: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
C: depression (pre, post and 6 months post treatment)
D: Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I) (Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).


Options:
A: 30-day survival rate with favorable neurological status (30 days)
B: Cardiac index (within 1 hour after device implantation)
C: To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. (3-5 days)
D: Survival at 60 days (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).


Options:
A: Major Adverse Cardiac and Cerebrovascular Events (Hospital discharge or 28 days following PCI, whichever occurs sooner)
B: Cardiac index (within 1 hour after device implantation)
C: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
D: Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. (30 days +/- 10 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Development and Evaluation of an "E-Visit" Program for the Management of Acne
Brief Summary: The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an online "E-Visit" application that uses store-and-forward technology for acne patients requiring dermatologic care for their condition. Hypotheses:

1. That an "E-Visit" is an effective alternative to in-person clinic care for patients with mild to severe facial acne.
2. That providers and patients will be satisfied with this model.
3. That mean wait times for new and return visits will be reduced through the "E-Visit" model.
4. That this prototype for care will improve clinic workflow, offer additional patient access, and allow urgent cases to be seen earlier.


Options:
A: All-cause mortality (Until December 2015)
B: Absence of local recurrence at 3 years after start of treatment
C: Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment (6 months)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipsychotic Discontinuation in Alzheimer's Disease
Brief Summary: In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation.


Options:
A: Apathy (at baseline); Apathy (after 8 weeks of treatment)
B: N/A
C: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))
D: Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipsychotic Discontinuation in Alzheimer's Disease
Brief Summary: In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation.


Options:
A: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))
B: Quality of Communication and Decision-making (3 months)
C: Change From Baseline in the Mini-Mental State Examination (MMSE) Score (Baseline, Month 24); The Number of Deaths Reported in Participants (Up to 2 years)
D: Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) (From time of hospital discharge up to 60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipsychotic Discontinuation in Alzheimer's Disease
Brief Summary: In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation.


Options:
A: Change From Baseline in the Mini-Mental State Examination (MMSE) Score (Baseline, Month 24); The Number of Deaths Reported in Participants (Up to 2 years)
B: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
C: Decisional Conflict Scale (3 months)
D: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight in USAF Personnel: Minimal Contact Program
Brief Summary: The prevalence of overweight in the United States Air Force (USAF) is about 22%. The objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW) and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as compared to UC.


Options:
A: Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure); Energy intake (Food Frequency Questionnaire); Physical activity level (Physical Activity Scale for the Elderly)
B: Bodyweight (Six Months)
C: Body Weight (1 year)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)
Brief Summary: Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in younger patients. However, the disease will eventually relapse and new treatment is demanded. Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a different biological effect and response even in patients refractory to conventional chemotherapy. The purpose of the study is in a randomized design to investigate if addition of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can prolong the time to progression compared to patients receiving no consolidation or maintenance therapy.


Options:
A: Rate of CR+nCR to induction treatment (63 days after the start day of either TD or VTD as induction therapy)
B: N/A
C: Number of Patients With Combined Complete Response and Very Good Partial Response (Up to 48 weeks or until disease progression)
D: Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation (1 year after randomization of the last patient)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The STAR 3 Study - A Prospective, Randomized, Two-Arm Study to Compare the Efficacy of the MiniMed Paradigm REAL-Time System Versus Multiple Daily Injections (MDI) in Subjects Naïve to Insulin Pump Therapy
Brief Summary: Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".

Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)


Options:
A: Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms (during the 48 hours of using blind vs. unblind continuous glucose monitoring)
B: Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) (Baseline and 26 weeks); Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) (Baseline and 26 weeks)
C: Change in A1c From Baseline to 52 Weeks (Baseline and 52 weeks)
D: Difference in HbA1C From Baseline and 6 Months (Baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine
Brief Summary: The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.


Options:
A: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-I at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF])); Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-S at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF]))
B: The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
C: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Brief Summary: The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD. Both the behavior and the academic achievements aspects will be evaluated. In addition, we intend to measure side-effects and adverse events and to examine the possible correlation between biochemical and behavioral alterations.


Options:
A: Conners Rating Scale - School Version (change from baseline in conners raiting scale at 15 weeks)
B: Cognitive control task - functional MRI (change over 16 week intervention period (pre/post))
C: Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA); Blood lipids profile
D: Change in ADHD RS-IV total score (Baseline, month 4, and month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: Respiratory distress syndrome; Intraventricular hemorrhage; Neonatal mortality
C: severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life (48 hours of life)
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined CABG and Stem-Cell Transplantation for Heart Failure
Brief Summary: This is a prospective double blind trial of intraoperative transmyocardial bone marrow-derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction scheduled to coronary bypass operation.


Options:
A: Does a bone marrow transplantation therapy increase the ejection fraction of the heart measured with MRI, when compared with placebo treatment? (1 year after the transplantation)
B: Left ventricular ejection fraction at rest, measured by MRI (6 months)
C: Change in global left ventricular function (measured by quantitative left ventricular angiography)
D: Number of Angina Episodes Per Week at 6 and 12 Months (6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Control Trial of a Group Therapy Intervention Addressing Body Image and Psychosocial Functioning for Women With Breast Cancer
Brief Summary: The purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, quality of life, psychosocial/sexuality/relational functioning.


Options:
A: Self image and communication(using standardized instruments)
B: Oral morbidity (Up to two years)
C: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
D: Changes in depressive symptoms (Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy
Brief Summary: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.


Options:
A: N/A
B: To determine the safety profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests. (On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period)
C: Occurrence of adverse events (side effects) (12 weeks (1 cycle of study treatment))
D: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) (Every 12 weeks up to recurrence or up to 3 months after last administered dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.
Brief Summary: This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
B: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
C: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
D: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.
Brief Summary: This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
B: The Portion of Drug Responders as Defined by Hematologic Improvements (12-16 weeks)
C: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
D: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.
Brief Summary: This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
B: Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence (Up to 2 years)
C: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
D: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)

Answer: C