TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
Brief Summary: A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.


Options:
A: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.)
B: Overall Survival (OS) (From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).); Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: objective response rate by RECIST 1.1 (6 months after treatment initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
Brief Summary: The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.


Options:
A: rate of hospital acquired pneumonia (day-28)
B: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
C: 28-day Mortality (28 days)
D: All cause mortality at 90 days after randomisation (90 days after randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.


Options:
A: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)
B: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (One month after dose 2, at Month 3); Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) (During the 30-day (Days 0-29) period after each dose.); Number of Subjects With Any and Related Serious Adverse Events (SAEs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)); Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3))
C: GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) (6 weeks after IP(Investigational Product) vaccination); GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA (6 weeks after IP(Investigational Product) vaccination)
D: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
Brief Summary: The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.


Options:
A: Groin Wound Complication (30 days)
B: Early Complications of Vascular Zone (2 weeks)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
Brief Summary: The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.


Options:
A: Groin Wound Complication (30 days)
B: Early Complications of Vascular Zone (2 weeks)
C: Post-operative wound infection (6 weeks post-operative)
D: Number of Participants With Wound Complications (Four weeks after cesarean section)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
Brief Summary: The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.


Options:
A: Groin Wound Complication (30 days)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
Brief Summary: The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.


Options:
A: questionnaire (1 YEAR)
B: Post-operative Seroma Formation (Two weeks following drain removal)
C: Groin Wound Complication (30 days)
D: Time to Complete Wound Closure (42 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy
Brief Summary: This pilot randomized clinical trial studies how well bupropion hydrochloride works compared with patient's choice for quitting smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may help patients quit smoking by enhancing central nervous system neurotransmitters noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride is more effective than patient's choice in helping quit smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy.


Options:
A: Treatment Satisfaction (End of treatment (seven weeks after baseline))
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: Proportion of patients who are not smoking (At 12 months post RT or CRT)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect and Meaning of a Designed Guided Imagery and Music Intervention on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Teenagers With Cancer: a Randomized Controlled Multisite Study
Brief Summary: The purpose of this study is to determine whether a modified and resource-oriented form of Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in teenagers with cancer.


Options:
A: Resiliency Scale (At 6 months)
B: Duration (minutes) of Acute Nausea (Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study)
C: Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G) (Baseline, week 4, week 8); Change in symptoms (Patient Health Questionnaire - PHQ-9 Item) (Baseline, week 4, week 8); Change in symptoms (Generalized Anxiety Disorder - GAD7 Item) (Baseline, week 4, week 8); Change in symptoms (Quality of Life and Satisfaction Questionnaire - Q-LES-Q) (Baseline, week 4, week 8)
D: Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale (1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect and Meaning of a Designed Guided Imagery and Music Intervention on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Teenagers With Cancer: a Randomized Controlled Multisite Study
Brief Summary: The purpose of this study is to determine whether a modified and resource-oriented form of Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in teenagers with cancer.


Options:
A: Sleep quality (Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum); Sleep quality - insomnia symptoms (Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum)
B: Resiliency Scale (At 6 months)
C: Duration (minutes) of Acute Nausea (Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study)
D: Sleep Quality - subjective (Change of sleep quality from baseline at 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
Brief Summary: One of the important complications of pregnancy is preterm labor (PTL) and delivery. There are different tocolytic agents to enhance the time of delivery. The aim of this study was to compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as gestation age at the time of delivery have been monitored and evaluated in both groups of patient. Our main goal has been delay of delivery to have the most beneficial effect of primary corticosteroid administration for fetus.


Options:
A: The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor. (3-5 days after delivery)
B: the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
C: The time of delivery (6 months)
D: Time of Delivery (Delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco-Related Disease Prevention Among Korean Americans
Brief Summary: The study evaluates the effectiveness of an internet-based smoking cessation program for Korean Americans.


Options:
A: Smoking cessation (14 months post baseline)
B: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)
C: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
D: smoking status (six month followup)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco-Related Disease Prevention Among Korean Americans
Brief Summary: The study evaluates the effectiveness of an internet-based smoking cessation program for Korean Americans.


Options:
A: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
B: Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months (6 months)
C: percent of patients eligible for quality measures (ABCS) (1 year)
D: smoking status (six month followup)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco-Related Disease Prevention Among Korean Americans
Brief Summary: The study evaluates the effectiveness of an internet-based smoking cessation program for Korean Americans.


Options:
A: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
B: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
C: smoking status (six month followup)
D: Primary outcome measure was step count (6-weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma
Brief Summary: This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to standard platinum-based chemotherapy concurrently in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.


Options:
A: Progression-free Survival(PFS) (up to 2 years)
B: Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (Cycle 1 (21-days)); Objective Response Rates (ORR) - Part 2 (Phase 2a) (12 months); Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) (12 Months)
C: Progression free survival (PFS) (4 months)
D: Progression-Free-Survival (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma
Brief Summary: This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to standard platinum-based chemotherapy concurrently in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.


Options:
A: Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (Cycle 1 (21-days)); Objective Response Rates (ORR) - Part 2 (Phase 2a) (12 months); Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) (12 Months)
B: Progression-Free-Survival (2 years)
C: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
D: Progression-Free Survival (PFS) (Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
Brief Summary: The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.


Options:
A: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))
B: Success rate of arterial or femoral catheter placement (1 day)
C: Success rate of the radial artery cannulation at first attempt (intraoperative)
D: Success rate (at first attempt, as average 5 min)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
Brief Summary: The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.


Options:
A: First pass success rate (1 year); Final/ultimate success rate of an intervention (1 year)
B: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))
C: First Pass Success When Attempting Arterial Catheterization. (Immediate, upon study entry)
D: Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography (Immediately, during procedure.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
Brief Summary: The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.


Options:
A: The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis (up to 1 hour after arterial puncture)
B: Success rate of arterial or femoral catheter placement (1 day)
C: Time to Successful Radial Arterial Catheterization (up to 5 minutes)
D: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.
Brief Summary: This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).


Options:
A: Rotavirus vaccine lots Immunogenicity (Four weeks after the third dose of vaccination); Immunogenicity of UIP vaccines (Four weeks after the third dose of vaccination)
B: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
C: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
D: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))

Answer: A