TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?
Brief Summary: To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.


Options:
A: Hematologic status at 6 months of age; Iron status at 6 months of age
B: To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation. (2 years)
C: Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen. (inmediately after birth until 2 minutes after birth)
D: Hemoglobin (8 months plus/minus one month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Brief Summary: This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)
D: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Brief Summary: This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Options:
A: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
B: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)
C: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Brief Summary: This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Options:
A: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)
C: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Baseline to Week 12)
D: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Brief Summary: This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Options:
A: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)
C: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
D: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Parallel-group, Double-blind, Placebo-controlled Study of Methylphenidate as an Add on Therapy for Mirtazapine in the Treatment of Major Depressive Disorder in Cancer Patients Under Palliative Care
Brief Summary: Primary Objective To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the treatment of depression in cancer patients under palliative care Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in (Montgomery Asberg Depression Rating Scale) MADRS between baseline and Day 3.

Secondary Objective

1. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the treatment of anxiety in cancer patients under palliative care.

   Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in anxiety score of HADS than Mirtazepine alone treated subjects between baseline and Day 3.
2. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in reducing distress in cancer patients under palliative care.

   Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in distress score of distress thermometer than Mirtazepine alone treated subjects between baseline and Day 3.
3. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in improving function in cancer patients under palliative care.

   Hypothesis Methyphenidate add on to mirtazapine treated subjects will show increase in the (Eastern Cooperation Group performance status) ECOG score than Mirtazepine alone treated subjects between baseline and Day 3
4. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in reducing somatic complaints in cancer patients under palliative care.

Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in the score of Numeric Rating Scale (NRS) for Pain and Visual Analogue Scale (VAS) for Fatigue than Mirtazapine alone treated subjects between baseline and Day 3.


Options:
A: depressive symptoms (3 to 28 days)
B: GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. (Baseline, 5 weeks post session 1 and 2, 6-month follow-up); HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). (Baseline, 5 weeks post session 1 and 2, 6-month follow-up)
C: Hot Flash Symptom Severity Score (12 weeks)
D: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 (Up to 2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Parallel-group, Double-blind, Placebo-controlled Study of Methylphenidate as an Add on Therapy for Mirtazapine in the Treatment of Major Depressive Disorder in Cancer Patients Under Palliative Care
Brief Summary: Primary Objective To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the treatment of depression in cancer patients under palliative care Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in (Montgomery Asberg Depression Rating Scale) MADRS between baseline and Day 3.

Secondary Objective

1. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the treatment of anxiety in cancer patients under palliative care.

   Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in anxiety score of HADS than Mirtazepine alone treated subjects between baseline and Day 3.
2. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in reducing distress in cancer patients under palliative care.

   Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in distress score of distress thermometer than Mirtazepine alone treated subjects between baseline and Day 3.
3. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in improving function in cancer patients under palliative care.

   Hypothesis Methyphenidate add on to mirtazapine treated subjects will show increase in the (Eastern Cooperation Group performance status) ECOG score than Mirtazepine alone treated subjects between baseline and Day 3
4. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in reducing somatic complaints in cancer patients under palliative care.

Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early reduction in the score of Numeric Rating Scale (NRS) for Pain and Visual Analogue Scale (VAS) for Fatigue than Mirtazapine alone treated subjects between baseline and Day 3.


Options:
A: Hot Flash Symptom Severity Score (12 weeks)
B: depressive symptoms (3 to 28 days)
C: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 (Up to 2 weeks)
D: Overall Response Rate (ORR) (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine MVA85A Administered by the Aerosol Inhaled Route and the Intradermal Route in Healthy BCG-vaccinated Adult Subjects
Brief Summary: This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.


Options:
A: To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. (AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.)
B: Culture and RT-PCR quantification of BCG in challenge site biopsy (10 weeks post biopsy)
C: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each mmunisation (and after 7 days).; Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination.
D: Safety of MVA85A vaccination by the aerosol inhaled route (24 weeks following vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Effect of Novel Intervention to Improve Stroke Symptom Recognition
Brief Summary: Despite the abundance of stroke education materials available, studies continue to reveal severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention measures). Expensive mass media stroke education campaigns are not sustainable for this purpose, particularly in economically disadvantaged populations. Instead, the investigators propose to intervene in school classrooms with children aged 9 to 11 years, to teach the five cardinal stroke symptoms, the correct course of action when they occur, and to highlight the potential therapeutic benefit of early hospital arrival, with the intent that the children will then educate their parents. To help accomplish this, the investigators have developed a program called Hip Hop Stroke (HHS), which is comprised of rap songs and two animated musical cartoons that incorporate stroke knowledge.


Options:
A: Number of Participants Returning to the ED Within 30 Days of the Original ED Visit (30 days after emergency department discharge); Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care (Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits); Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge (up to 30 days)
B: Stroke Symptom and Response Knowledge Assessment (student) (Up to 3 days from baseline); Assessment of child's communication to parent regarding stroke symptoms. (Up to 7 days from baseline)
C: Surveillance methodologies will measure arrival times of acute strokes from stroke symptoms onset to ER among participants for the length of the study, as well as increase in stroke knowledge at one month and one year post stroke event. (at one month and one year post stroke event)
D: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
Brief Summary: The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.


Options:
A: Overall Survival (at 12 months)
B: Groups 1 and 2: Progression-free survival rate (6 months post-Day 1); Group 2C: Objective Response Rate (Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy)
C: Overall Survival (OS) (From randomization at PD1 until death from any cause or end of study (overall approximately 35 months))
D: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
Brief Summary: The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.


Options:
A: Adult Study: Overall Survival (OS) (From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.); Adult Study: Progression-Free Survival (PFS) (Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years); Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug (From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks); Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Half-life (t1/2) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8)
B: Groups 1 and 2: Progression-free survival rate (6 months post-Day 1); Group 2C: Objective Response Rate (Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy)
C: Progression free survival (12 months)
D: Progression Free Survival (PFS) time (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 8 Weeks of Treatment in Adult Patients With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis
Brief Summary: The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.


Options:
A: Proportion of Patients With Sterile Sputum Cultures (8 weeks)
B: The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. (8 weeks)
C: To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers. (Monitor adverse events daily; safety eval pre-dose, specified times , discharge, follow-up/as needed)
D: Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). (18 months (within one year of completion of therapy)); Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) (18 months (within one year of completion of therapy))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate (FF/VI) Inhalation Powder Delivered Once Daily Compared to Fluticasone Propionate Delivered Twice Daily in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry Currently Treated With High-strength Inhaled Corticosteroids or Mid-strength ICS/LABA Combination Therapy.
Brief Summary: A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination therapy


Options:
A: Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period (Baseline and Weeks 1-12 (up to Day 84))
B: safety: adverse events, vital sign, ECGs, and clinical laboratory test; PK： Cmax, tmax and AUC(0-t); PD: serum cortisol
C: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. (Baseline (Day 0) and Week 24)
D: Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period (Baseline; Week 1 up to Week 4)

Answer: A