TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia
Brief Summary: This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.


Options:
A: Angiographic Late Lumen Loss (6 months)
B: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (12 months or at Target Lesion Revascularization (TLR) time); Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients (12 months); Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) (6 months)
C: MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) (6 months)
D: angiographic binary re-restenosis (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
Brief Summary: Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.


Options:
A: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. (Baseline and 12 weeks)
B: Time to First Serious Asthma Exacerbation (Up to 21 months)
C: FEV1, (Forced expiratory volume in the 1st second).
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 Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
Brief Summary: Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.


Options:
A: Time to First Serious Asthma Exacerbation (Up to 21 months)
B: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period (Day 28 of the relevant treatment period (up to Study Day 112))
C: Change from baseline methacholine bronchoprotection at 96 hours (pre treatment versus 96 hour post treatment)
D: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
Brief Summary: Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.

This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.

This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.

Primary research hypothesis: A pragmatic structured education programme aimed at promoting walking activity initiates long-term increases in physical activity in individuals identified through a risk score as having an increased risk of developing type 2 diabetes.


Options:
A: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
B: Weight Change From Baseline to 12 Months (12 months)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: Change in ambulatory activity (walking) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
Brief Summary: Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.

This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.

This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.

Primary research hypothesis: A pragmatic structured education programme aimed at promoting walking activity initiates long-term increases in physical activity in individuals identified through a risk score as having an increased risk of developing type 2 diabetes.


Options:
A: Changes in weight (6, 12, 19 and 24 months from baseline)
B: Change in ambulatory activity (walking) (12 months)
C: 2-hour glucose (2 hours)
D: 2-hour glucose levels; insulin resistance

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Exercise Training in Combination With Dopamine Agonist to Physical Fitness Parameters and Quality of Life in Dialysis Patients With the Restless Legs Syndrome.
Brief Summary: Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with dopamine agonists. However it not known whether the exercise anabolic stimulus and the dopamine agonist treatment could act synergistically for the improvement of physical functioning and muscle performance as well as in the amelioration of augmentation symptoms in hemodialysis patients with RLS.


Options:
A: IRLS severity scale (24 and 48 wks)
B: The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score. (12-week treatment period); The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement (12-week treatment period)
C: Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) (Baseline and Week 12); Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF (Week 12)
D: Mean Css, Max and Css, Min (Weeks 4 and 12); Mean Tmax and T1/2 (Weeks 4 and 12); Mean AUCss (Weeks 4 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Exercise Training in Combination With Dopamine Agonist to Physical Fitness Parameters and Quality of Life in Dialysis Patients With the Restless Legs Syndrome.
Brief Summary: Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with dopamine agonists. However it not known whether the exercise anabolic stimulus and the dopamine agonist treatment could act synergistically for the improvement of physical functioning and muscle performance as well as in the amelioration of augmentation symptoms in hemodialysis patients with RLS.


Options:
A: Sleep onset latency < 15 minutes; sleep efficiency > 85%; Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour
B: clinical response rate (at 8 weeks from baseline)
C: IRLS severity scale (24 and 48 wks)
D: Bedtime (Mean Bedtimes over 21 days for each period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Exercise Training in Combination With Dopamine Agonist to Physical Fitness Parameters and Quality of Life in Dialysis Patients With the Restless Legs Syndrome.
Brief Summary: Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with dopamine agonists. However it not known whether the exercise anabolic stimulus and the dopamine agonist treatment could act synergistically for the improvement of physical functioning and muscle performance as well as in the amelioration of augmentation symptoms in hemodialysis patients with RLS.


Options:
A: Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT) (3 months)
B: Quantify toxin removal (6 months)
C: IRLS severity scale (24 and 48 wks)
D: Change in non-invasive measures of arterial stiffness using applanation tonometry. (4 months and 8 months after study initiation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)
Brief Summary: The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.


Options:
A: Patients With Complete Clearance of Actinic Keratosis (AKs) (57 days)
B: Complete Clearance of Actinic Keratoses (AK) Lesions (baseline and 57 days)
C: Number of Participants With Recurrence of AK Lesions (Up to one year)
D: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions (57 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Supplementing Glutamine on the Gastric Emptying Time of a Preoperative Metabolic Conditioning Drink in Healthy Volunteers: a Randomized Crossover Pilot Study
Brief Summary: Surgical patients are usually starved for 8 hours before operation in order to ensure the stomach is empty and thus reduce the chances of vomiting during the anaesthetic. Recent studies have shown that this period of starvation is harmful as it 'weakens' the body before operation. To avoid the harmful effects of starvation, patients are now given carbohydrate (sugar-containing) drinks 2 to 4 hours before surgery. These drinks have been shown to make patients feel better, reduce sickness after the anaesthetic/surgery and result in a quicker recovery from operation. The optimum time of giving these drinks to patients before operation is unknown. Previous studies have shown that the drinks empty from the stomach within 2 - 4 hours depending on their ingredients. The investigators would like to study the effects of adding protein and fat to these drinks on how quickly the drinks empty from the stomach. This study will investigate the hormone responses of the body following intake of 3 different drinks in order to determine the mechanisms that underlie the control of stomach emptying. This information will also allow us to improve the design of these drinks and this could help patients who undergo surgery who receive them.


Options:
A: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
B: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
C: protein balance (two days after surgery)
D: Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine. (4 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
Brief Summary: This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).


Options:
A: Spleen Volume (60 months)
B: Change From Baseline in Spleen Volume Measured by MRI. (Baseline and 9 months)
C: Hemoglobin (Every 3 months for 12 months)
D: Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period (Baseline up to Week 52); Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP (Week 52 up to week 208)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Brief Summary: RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.


Options:
A: Progression-free survival (up to 5 years after randomisation)
B: Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD (36 Months); 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. (at 36 months)
C: Progression-free survival
D: 3-year progression-free survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Brief Summary: RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.


Options:
A: Progression-free survival (up to 5 years after randomisation)
B: Progression-free survival
C: To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. (4 years)
D: Progression free survival (PFS) (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Brief Summary: RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.


Options:
A: Progression-free survival (up to 5 years after randomisation)
B: Event-free Survival (5 years)
C: Progression-free survival
D: Progression free survival (PFS) (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.


Options:
A: N/A
B: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))
C: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months (6 months)
D: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.


Options:
A: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))
B: Overall survival (12 months)
C: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
D: Progression Free Survival (PFS) time (5 years)

Answer: A