TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Brief Summary: This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.


Options:
A: Percentage of Participants With Clinical Response (Week 8)
B: Percentage of Participants With Remission at Week 8 (Week 8)
C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Laboratory Test Abnormalities (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Vital Sign Abnormalities (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Electrocardiogram (ECG) Abnormalities (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group))
D: Number of Participants With Remission Based on Modified Mayo Score at Month 6 (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute Respiratory Distress Syndrome (ARDS)
Brief Summary: This international multicenter, randomized, open trial will evaluate the impact of Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal ventilatory management and maximum medical treatment, on the morbidity and mortality associated with this disease.


Options:
A: Ventilator free days within 28 days after enrollment (28 days)
B: All cause mortality on day 60 following randomization (60 days)
C: All cause mortality (90 days after randomisation)
D: Development of ARDS (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
Brief Summary: This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.


Options:
A: Weight (Study Day (SD) 1, 28 and 84)
B: Level of fatty acids in whole blood of infants (4 months)
C: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)
D: Number of Participants With Weight<10th Percentile for Age (36 weeks post-conceptual age); Number of Participants With Length <10th Percentile for Age (36 weeks post-conceptual age); Number of Participants With Head Circumference <10th Percentile for Age (36 weeks post-conceptual age); Cognitive Development Score (18-22 months corrected gestational age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bispectral Index (BIS) Monitoring on Faster Recovery Time and Analgesic Consumption in Abdominal Surgery Patients
Brief Summary: Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
B: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
C: Bispectral index (BIS) monitoring in abdominal surgery patients (six months)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bispectral Index (BIS) Monitoring on Faster Recovery Time and Analgesic Consumption in Abdominal Surgery Patients
Brief Summary: Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.


Options:
A: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
B: Bispectral index (BIS) monitoring in abdominal surgery patients (six months)
C: Cognitive impairment at hospital discharge after elective outpatient colonoscopy (Before discharge from daycare facility)
D: evaluation of intra-operative awareness in all the patients investigated (within 4 days after the general anesthesia)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Practical Health Co-operation - a Randomised Controlled Intervention Study. The Impact of a Referral Template on Quality of Care and Health Care Co-operation Between Primary and Secondary Care
Brief Summary: The purpose of this study is to examine whether the implementation of a referral template will increase quality of health care delivered and the quality of health care co-operation. The investigators intent to implement a referral template, at the level of the general practitioner (GP), for the referral of patients within 4 separate diagnostic groups:

* dyspepsia/upper GI symptoms
* colonic cancer investigation/lower GI symptoms
* chronic obstructive pulmonary disease (COPD)
* chest pain

Local GP clinics will be randomised to use the referral template or to use standard referral practice. Using a predefined set of quality criteria the investigators will score the process of care in each patient, and compare intervention and control groups. In addition other criteria will be collected and compared between the two groups, e.g.

* time to diagnosis/treatment
* quality of referral
* more appropriate referrals
* patient satisfaction (as measured by a questionnaire)

The investigators hypothesize that the implementation of a referral template will lead to a measurable increase in the quality of health care delivered.


Options:
A: Collated quality indicator score (The care period for each patient (approx. 3 weeks up to 1 year))
B: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)
C: Health related quality of life (Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
D: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.


Options:
A: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment)
B: Change in physical activity (Baseline and 12 months follow-up)
C: Change From Baseline in Endurance Time (Seconds) (Week 3)
D: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
Brief Summary: The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.


Options:
A: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
B: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (Week 0 and 12 visits)
C: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (Week 0 and 12 visits); Discontinuation due to lack of efficacy. (Whole duration of study)
D: Change in evening PEF (Daily throughout the 12 week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
Brief Summary: The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.


Options:
A: Time to First Serious Asthma Exacerbation (Up to 21 months)
B: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
Brief Summary: The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.


Options:
A: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
B: 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)
C: 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)
D: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
Brief Summary: The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.


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: 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)
C: Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. (12 weeks)
D: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ZEroPLASmaTrial (ZEPLAST): a Randomized, Controlled Trial on Transfusion Avoidance in High Transfusion-risk Cardiac Surgery Patients
Brief Summary: Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed).

Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding.

Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each


Options:
A: Percentage of Participants Achieving Hemostatic Efficacy During Surgery (From the start of infusion until the end of surgery); Percentage of Participants Who Had a Rapid Decrease of the INR (30 minutes after the end of infusion)
B: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
C: Avoidance of allogeneic blood products transfusion (30 days)
D: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. (within 12 hours.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma
Brief Summary: The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.


Options:
A: Progression Free Survival (PFS) (Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months))
B: Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation (From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months))
C: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
D: progression-free rate (at 48 weeks post-treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
Brief Summary: This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


Options:
A: overall survival (9 months)
B: Overall survival comparison between treatment groups (every 4 weeks for 3 years)
C: Overall Survival (OS) (From day of randomization to the date of death, assessed up to 60 months)
D: Progression free survival (Up to 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dipeptidyl Peptidase (DPP) IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Patients With Type 2 Diabetes
Brief Summary: A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.


Options:
A: HbA1c (after 26 weeks of treatment)
B: Full Epithelialization of the Wound (3 months of treatment with vildagliptin); Capillary Density (3 months of treatment with vildagliptin)
C: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
D: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Premature Termination of Resuscitation in Survivors of Cardiac Arrest
Brief Summary: The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on using innovative knowledge translation strategies to improve appropriate neuroprognostication for survivors of cardiac arrest and prevent premature termination of life sustaining therapies. This is important because any early gains achieved during resuscitation will be nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate prognostic information. An effective translation strategy for neuroprognostication will result in improved physician adherence to evidence-based medicine and an increase in the proportion of patients surviving to achieve a good neurological outcome following cardiac arrest.


Options:
A: Survival to Hospital Discharge. (at 30 days post arrest)
B: Hospital Discharge (From time of first contact until hospital discharge, up to 90 days.)
C: 1) Return of Spontaneous Circulation for > 15 min and 2) Survival to discharge either to home or to a rehabilitation facility. (60 days (actual))
D: Effective knowledge strategy (Two years)

Answer: D