TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.


Options:
A: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
B: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))
C: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)
D: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.


Options:
A: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
B: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)
C: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
D: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.


Options:
A: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
B: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
C: Treatment Failure (16 weeks)
D: Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (Baseline to Endpoint (weeks 3-4)); Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population (Baseline to Endpoint (weeks 3-4))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Dopamine and Norepinephrine as the First Vasopressor Agent in the Management of Shock
Brief Summary: The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two commonly used vasopressor agents, in the treatment of shock.


Options:
A: The primary outcome measure for the study is death from all causes (90 days)
B: Gastric mucosal blood flow assessed using a laser-Doppler flowmeter
C: mortality (day 28)
D: 28 day survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea
Brief Summary: This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).


Options:
A: Cure Rate at End of Therapy (Study day 10 (+/- 2 days))
B: Clinical cure rate at test-of-cure (Day 13 or 24-72 hours after end of treatment)
C: Resolution of diarrhea
D: Duration of diarrhea (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy.

Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy.

Study design: A randomised controlled trial

Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.

Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles.

Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy.

Secondary study parameters/outcome of the study:

* patient knowledge
* patient decisional conflict
* patient satisfaction
* IVF/ICSI treatment outcome.


Options:
A: Feasibility of Data Collection at Month 12 (Data collection occurred at month 12)
B: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
C: Incidence choice for eSET (after embryo transfer)
D: Multiple CVD risk factor control targets (42 months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy.

Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy.

Study design: A randomised controlled trial

Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.

Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles.

Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy.

Secondary study parameters/outcome of the study:

* patient knowledge
* patient decisional conflict
* patient satisfaction
* IVF/ICSI treatment outcome.


Options:
A: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
B: Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching (30 months)
C: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
D: Incidence choice for eSET (after embryo transfer)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy.

Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy.

Study design: A randomised controlled trial

Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.

Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles.

Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy.

Secondary study parameters/outcome of the study:

* patient knowledge
* patient decisional conflict
* patient satisfaction
* IVF/ICSI treatment outcome.


Options:
A: Incidence choice for eSET (after embryo transfer)
B: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
C: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
D: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Brief Summary: Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.


Options:
A: Visual acuity (8 weeks)
B: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)
C: Visual acuity improvement
D: Visual acuity in the amblyopic eye (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Brief Summary: Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.


Options:
A: maximal improvement in visual acuity
B: Visual acuity
C: Visual acuity (8 weeks)
D: The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old
Brief Summary: The purpose of the study is:

* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.


Options:
A: maximal improvement in visual acuity
B: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)
C: Visual acuity
D: Visual Acuity Mean Score in the Amblyopic Eye (18 weeks); Visual Acuity Distribution in the Amblyopic Eye (18 weeks); Mean Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old
Brief Summary: The purpose of the study is:

* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.


Options:
A: Change from baseline in visual acuity (6 weeks)
B: Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y (2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia))
C: Visual acuity improvement
D: Visual Acuity Mean Score in the Amblyopic Eye (18 weeks); Visual Acuity Distribution in the Amblyopic Eye (18 weeks); Mean Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
Brief Summary: The purpose of this study is:

* To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds.
* To determine the maximum improvement in vision of the amblyopic eye with each treatment.
* To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.


Options:
A: Visual acuity
B: The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains
C: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)
D: Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks (24 weeks); Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks (24 weeks); Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks (Baseline to 24 weeks); Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks (Baseline to 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
Brief Summary: The purpose of this study is:

* To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds.
* To determine the maximum improvement in vision of the amblyopic eye with each treatment.
* To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.


Options:
A: Distribution of Amblyopic Eye Visual Acuity at 10 Weeks (10 Weeks); Mean (SD) Distribution of Visual Acuity at 10 Weeks (10 Weeks); Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks (baseline to 10 Weeks); Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam (baseline to 10 Weeks)
B: Visual acuity in the amblyopic eye (6 months)
C: Visual acuity improvement
D: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)

Answer: D