TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches
Brief Summary: * to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine
* to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and
* to evaluate the safety of the Trexima.


Options:
A: Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose (From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).)
B: To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine. (2 hours post dose)
C: Score on a 4-point migraine pain scale for a single menstrual migraine attack (2 to 48 hours)
D: Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD).
Brief Summary: This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.


Options:
A: N/A
B: Dermal Reactions (7 weeks)
C: N/A
D: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Brief Summary: The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.


Options:
A: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment)
B: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
C: Six point drop in NIH-CPSI total Score
D: NIH-CPSI total score and change from baseline (baseline, week 1-8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Brief Summary: The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: The change in the average pain intensity score. (The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).)
C: Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12 (Baseline and Week 12)
D: Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. (12 WEEKS); Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). (12 WEEKS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Brief Summary: The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.


Options:
A: Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks (Baseline and 12 weeks)
B: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
C: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
D: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Brief Summary: The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: Six point drop in NIH-CPSI total Score
C: NIH-CPSI total score and change from baseline (baseline, week 1-8)
D: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh
Brief Summary: A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution


Options:
A: neonatal mortality (3 Month intervals); omphalitis among live born infants. (3 Month intervals)
B: neonatal mortality; umbilical cord infection
C: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh
Brief Summary: A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution


Options:
A: neonatal mortality (3 Month intervals); omphalitis among live born infants. (3 Month intervals)
B: neonatal mortality; umbilical cord infection
C: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)
D: Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life; Rate of vertical transmission of colonization with group B streptococcus (GBS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Active Observational Study of the Adoption and Transfer of Clinical Practice Guidelines Through Education, for Ventilator Associated Pneumonia (ABATE VAP Study)
Brief Summary: The purpose of this prospective, multicentre, time-series study is to develop, implement, refine, and evaluate a sustainable behaviour change strategy in the intensive care unit (ICU).


Options:
A: difference in change in systolic BP between the intervention and usual care groups (6 months)
B: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
C: Number of LTC residents on vitamin D (16 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.
Brief Summary: Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.


Options:
A: Number of Subjects With Any Episodes of Herpes Zoster (HZ) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ (During the entire study period (3 to 5 year period following Day 0))
B: 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)
C: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
D: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.
Brief Summary: Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.


Options:
A: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)
B: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
C: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
D: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
Brief Summary: This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.


Options:
A: Overall Objective Response (1 year after end inclusion)
B: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))
C: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
D: 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.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
Brief Summary: This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.


Options:
A: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
B: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))
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): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
Brief Summary: This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.


Options:
A: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
B: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))
C: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))
D: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency
Brief Summary: In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.

Specifically, we have studied the effects on:

* symptoms suggestive of low testosterone levels
* blood testosterone and other hormone levels
* bone mass
* muscle mass and fat mass
* muscle strength
* prostate
* lipids, hematocrit


Options:
A: Change from baseline on the total score of the AMS rating scale (Month 6)
B: Absolute Change From Baseline in T Cholesterol (Approximately 365 days); Absolute Change From Baseline in HDL (Approximately 365 days); Absolute Change From Baseline in LDL (Approximately 365 days); Absolute Change From Baseline in Hgb (Approximately 365 days); Absolute Change From Baseline in Hct (Approximately 365 days); Absolute Change From Baseline in Prostate Volume (Approximately 365 days)
C: Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL (Following 90 days of treatment)
D: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event (Randomization to event or last known date if no event (up to approximately 52 months)); Time From Randomization to the First Component Event of MACE (Randomization to event or last known date if no event (up to approximately 52 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury
Brief Summary: Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.


Options:
A: 28 days mortality (28 days)
B: change in extravascular lung water within 7 days of treatment (change from baseline - day 7)
C: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
D: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury
Brief Summary: Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.


Options:
A: Mortality at 28 days (day 28)
B: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)
C: Oxygenation as measured by the PO2/FiO2 (P/F) ratio (72 hours from enrollment)
D: Hospital Mortality

Answer: B