TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)
Brief Summary: The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. (6 months)
B: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
C: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
D: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)
Brief Summary: The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.


Options:
A: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
B: Disease specific Quality of Life (12 months); Maximum Walking Distance (12 months)
C: Health Related Quality of Life (HRQOL) (24 months with intermistic analysis at 12 months)
D: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)
Brief Summary: The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.


Options:
A: Quality of Life (1 year)
B: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
C: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
D: Maximal treadmill walking distance (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)
Brief Summary: The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.


Options:
A: Primary (and -assisted) patency (5 years); Quality of life (5 years)
B: Clinical improvement (12 Month Post Operatively); Patency rate (12 Month Post Operatively); Cost effectiveness (12 Month Post Operatively)
C: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)
D: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia
Brief Summary: Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.


Options:
A: Number of Participants With Adverse Events (AEs) (84 months); Number of Participants With Laboratory Toxicities of Grade ≥ 3 (84 months); Number of Participants With Antibodies to Denosumab (Every 12 months through Month 84)
B: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
C: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia
Brief Summary: Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.


Options:
A: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
B: Incidence of hip fxs; Incidence of new vertebral fxs
C: Number of Participants With New Vertebral Fractures (36 months)
D: To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)
Brief Summary: The primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD) in patients with symptoms that are persistent enough to require corticosteroid therapy.


Options:
A: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)
B: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
C: Treatment success as defined by the proportion of subjects in clinical remission (i.e. complete discontinuation of prednisone therapy and a CDAI score of <150) at week 14, and maintenance of clinical remission between study weeks 14 and 50 (one year)
D: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
Brief Summary: The purposes of this study are:

* to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
* to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
* to document the adverse effects of surgery in patients with cervical dystonia.


Options:
A: The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. (at six months)
B: Improvement in neck postures/movements; Improvement in quality of life
C: relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
D: Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group) (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine whether the addition of omalizumab in patients with poorly controlled asthma (because of poor adherence) will decrease allergic airway inflammation and improve asthma control.


Options:
A: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)
B: Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) (Baseline (Week 0) to Week 240)
C: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
D: adenosine, PC20, forced expiratory volume in one second (FEV1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine whether the addition of omalizumab in patients with poorly controlled asthma (because of poor adherence) will decrease allergic airway inflammation and improve asthma control.


Options:
A: Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results (Throughout study or until early discontinuation); Incidence, nature, and severity of adverse events (Throughout study or until early discontinuation)
B: The prednisone-sparing effect of SB-240563 versus placebo as; indicated by the absolute and percentage dose reduction possible without a clinical exacerbation (as measured by the Juniper ACQ in patients with asthma or by Likert symptom scores +/- FEV1 in patients with eosinophilic bronchitis without asthma).
C: Percentage of Participants With Asthma Exacerbation (Baseline up to Week 12)
D: adenosine, PC20, forced expiratory volume in one second (FEV1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: A Randomized Prospective Multicentre Study (MANTRA-PAF)
Brief Summary: Atrial fibrillation is the most common heart arrhythmia afflicting approximately 1% of the Danish population. Medical antiarrhythmic treatment is only moderately effective and has the risk of severe side effects. The present study is a prospective, randomized, multicentre study comparing medical antiarrhythmic drug strategy with catheter based radiofrequency strategy in patients with paroxysmal atrial fibrillation. The primary end point is atrial fibrillation burden (symptomatic and asymptomatic) judged by multiple 7-day Holter monitorings during 2 years follow-up. Three hundred patients considered candidates for antiarrhythmic drug treatment will be randomized. The study will be performed as a Scandinavian/German multicentre study.


Options:
A: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)
B: Recurrence of Atrial Fibrillation (One year)
C: Atrial fibrillation burden (Two years)
D: Peak oxygen consumption at cardiopulmonary exercise test (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
Brief Summary: The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: stroke; new or recurrent transient ischemic attack; new or recurrent acute myocardial infarction; new occurrence or exacerbation of heart failure; new occurrence or exacerbation angina pectoris; dissecting aneurysm of the aorta; lower limb arterial obstruction; transition to dialysis; doubling of plasma creatinine (Cr) levels
C: Change from baseline in diastolic blood pressure after 26 weeks
D: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
Brief Summary: The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.


Options:
A: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)
B: stroke; new or recurrent transient ischemic attack; new or recurrent acute myocardial infarction; new occurrence or exacerbation of heart failure; new occurrence or exacerbation angina pectoris; dissecting aneurysm of the aorta; lower limb arterial obstruction; transition to dialysis; doubling of plasma creatinine (Cr) levels
C: Change from baseline in diastolic blood pressure after 52 weeks
D: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PPAR Alpha (LY518674): A Phase 2 Study of the Combinatorial Effect of LY518674 and Atorvastatin in Subjects With Hypercholesterolemia
Brief Summary: The purposes of this study are to determine:

* The safety of the study medication and any side effects that might be associated with it
* Whether the study medication can help patients with high levels of "bad" cholesterol (low-density lipoprotein-cholesterol \[LDL-C\]), alone or in combination with additional study medication


Options:
A: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
B: Effects on "bad" cholesterol, LDL-C, after 12 weeks
C: Thrombin generation (8 weeks)
D: LVEF (Left Ventricular Ejection Fraction) (baseline and three months); Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography) (Baseline and three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Impact and Intervention for Diarrhea in Brazil
Brief Summary: The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.


Options:
A: Pregnancy-related mortality and all cause mortality (Continuous)
B: Mortality; Morbidity; All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
C: L:M ratio at 1.5 months (1.5 months)
D: intestinal parasitic infections (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Impact and Intervention for Diarrhea in Brazil
Brief Summary: The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.


Options:
A: Change in Length for Age (Once per month for 6 months, then once after 12 months.)
B: L:M ratio at 1.5 months (1.5 months)
C: The mean number of episodes and duration of acute diarrheal disease (24 weeks)
D: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Impact and Intervention for Diarrhea in Brazil
Brief Summary: The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.


Options:
A: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
B: Febrile malaria episodes (60 weeks)
C: cognitive development(visual attention, executive processing, vigilance) (6, 9, 12, and 18 months)
D: L:M ratio at 1.5 months (1.5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Impact and Intervention for Diarrhea in Brazil
Brief Summary: The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.


Options:
A: 24-week infant mortality rate
B: intestinal parasitic infections (6 months)
C: L:M ratio at 1.5 months (1.5 months)
D: Thymus size measured by ultrasound (through 15 wk of age); peripheral blood naive T-helper lymphocyte concentration (through 15 wk of age); T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) (through 15 wk of age); T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization (through 15 wk of age); Antibody response to oral polio virus (OPV) immunization (through 15 wk of age); T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age (through 15 wk of age); bacterial translocation to blood (through 15 wk of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of Influenza Vaccines in Adults - FLU-VACS
Brief Summary: The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.


Options:
A: Safety (local and systemic reactogenicity, laboratory tests and AEs. (6 months)
B: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)
C: The appearance among patients of symptomatic laboratory-confirmed influenza. (Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI).)
D: Adverse Pregnancy Outcomes (0-28 days postpartum)

Answer: C