TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)
Brief Summary: An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart failure or other diseases. As patients near the end of life, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider deactivating the shocking function of ICDs as patients' clinical status worsens and death is near. This will be a randomized controlled trial of a physician centered counseling and education intervention to improve clinician-patient communication about the management of ICDs.


Options:
A: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)
B: Hospital Anxiety and Depression Scale (Day 90)
C: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
D: Prevalence of Conversations about ICD Deactivation (after 1st clinical encounter after enrollment for intervention group); Prevalence of Conversations about ICD Deactivation (3rd clinical encounter after enrollment for intervention group); Prevalence of Conversations about ICD Deactivation (3 months after enrollment for control group); Prevalence of Conversations about ICD Deactivation (9 months after enrollment for control group)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
Brief Summary: Transitional care strategies focused on enhancing the accuracy and comprehensiveness of medication information transfer will lead to improved health outcomes among hospitalized patients with chronic kidney disease.


Options:
A: acute care utilization (90 days)
B: medication errors in the patients (Baseline, 1, 3 and 6 months)
C: Composite measure of proportion of patients at risk of an adverse event from specified prescribing. (Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention)
D: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
Brief Summary: Transitional care strategies focused on enhancing the accuracy and comprehensiveness of medication information transfer will lead to improved health outcomes among hospitalized patients with chronic kidney disease.


Options:
A: All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations (2 year)
B: acute care utilization (90 days)
C: Number of actually stopped or adjusted drugs (Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
D: Number of patients with probable and definite adverse drug events in hospital (Up to Day 14 of hospital admission)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
Brief Summary: The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.


Options:
A: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)
B: office BP (baseline, 6 months); 24-ABPM (baseline, 6 months); Magnetic resonance imaging (MRI) (baseline, 3 and 6 months); Albuminuria (baseline, 6 months); Systemic RAS activity (baseline, 6 months); Vascular structure and function of large and small arteries (baseline, 6 months); Local RAS activity (baseline, 6 months)
C: daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement (3 months follow up)
D: Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure); Trio Cohort - Median Change in Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
Brief Summary: This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.


Options:
A: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)
B: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores (through 72 hours)
C: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefits (Wound closure to Day 30)
D: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefit (Wound closure to time hospital discharge order written or Day 30, whichever is sooner.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
Brief Summary: This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.


Options:
A: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefits (Wound closure to Day 30)
B: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores (through 72 hours post surgery)
C: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)
D: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (through 96 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
Brief Summary: This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (through 96 hours)
B: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)
C: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
D: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Brief Summary: Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)


Options:
A: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)
B: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
C: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
D: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Brief Summary: Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)


Options:
A: proportion of clinical complete remission
B: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
C: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)
D: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
C: Annualized Relapse Rate (2 years)
D: Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay (Up to 44 weeks); Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay (Up to 44 weeks); TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug (Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration); TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio (Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
Brief Summary: The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.


Options:
A: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 6 months); Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period (From Day 1 up to 6 months)
B: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
C: Morning pre-dose PEF measured daily by patients (mean of the last 2 weeks of treatment period). (mean of the last 2 weeks of treatment period)
D: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
Brief Summary: The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.


Options:
A: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
B: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808) (24 weeks)
D: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 6 months); Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period (From Day 1 up to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
Brief Summary: The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.


Options:
A: 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)
B: Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC) (At Month 7 (i.e. one month after the last dose of study vaccine))
C: To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047 (208 weeks (4 Years))
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
Brief Summary: The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.


Options:
A: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 (Up to Month 18); Number of Participants Reporting SAEs From Month 18 Through Month 37 (Month 18 to Month 37); Number of Participants Reporting Other (Non-serious) AEs Through Month 18 (Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination); Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 (Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)); Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 (Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)); Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 (Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)); Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 (Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)); Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 (Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)); Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 (Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)); Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up (Month 37 to Month 126)
B: Cervical infection with HPV-16 and/or HPV-18 (Throughout the study)
C: Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens (One month after the third dose (at Month 7))
D: Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC) (At Month 7 (i.e. one month after the last dose of study vaccine))

Answer: D