TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcomes Assessment in Chronic GVHD
Brief Summary: The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this complication. We will accomplish our goals by studying a large number of people with chronic GVHD over several years using information collected from health care providers, patients, laboratory studies and diagnostic tests. Several transplant centers in the United States are collaborating on this project.


Options:
A: Number of Participants With an Overall Response at Week 28 (Week 28)
B: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
C: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)
D: To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. (To end of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcomes Assessment in Chronic GVHD
Brief Summary: The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this complication. We will accomplish our goals by studying a large number of people with chronic GVHD over several years using information collected from health care providers, patients, laboratory studies and diagnostic tests. Several transplant centers in the United States are collaborating on this project.


Options:
A: N/A
B: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)
C: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
D: To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. (To end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
Brief Summary: The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.


Options:
A: Change in pain score and treatment success
B: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (within 15 days)
C: Brief Pain Inventory-Short Form (BPI-SF) will be used to evaluate pain management and interference between the groups. (Change in baseline, weeks 2, 4, 6 and 8.); MD Anderson Symptom Inventory (MDASI) will be used to evaluate symptom interference between the groups. (Change in baseline, weeks 2, 4, 6 and 8.)
D: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
Brief Summary: The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.


Options:
A: Proportion of Non-Responder (NR) Participants (28 days)
B: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (within 15 days)
C: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale (Baseline, Last 3 Days of Study Drug Administration (4 weeks))
D: Change in pain score and treatment success

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study
Brief Summary: The objective of the study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.


Options:
A: Change of the intestinal and urinary microbiome (3 months to 12 months)
B: Presence/absence of Asymptomatic bacteriuria (15 days post-op)
C: Occurrence of the first recurrence (12 months)
D: Rate of UTIs (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke
Brief Summary: The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.


Options:
A: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)
B: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)
C: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
D: Clinical: Functional handicap (90 days); Proof of concept: Early neurological improvement (22-36 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke
Brief Summary: The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.


Options:
A: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)
B: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
C: Modified Rankin Scale (mRS) 0-1 (3 months)
D: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)


Options:
A: Plasma levels of beta-carotene (12 weeks)
B: Time to First Pulmonary Exacerbation (36 weeks)
C: Change in Sputum Myeloperoxidase (MPO) Level (Baseline (Visit 2) to Week 16 (Visit 4))
D: The Safety and Tolerability of a Single-dose of KB001. (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Brief Summary: This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.


Options:
A: Percent of Participants Who Responded to Therapy (12 weeks after the start of treatment)
B: Number of Participants With Improvement of Espohageal Eosinophilia (3 Months)
C: Passing the Week 117 DBPCFC to Peanut (Week 117 - Number of participants with no clinical reactivity to peanuts)
D: Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments. (12 weeks after last dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Brief Summary: Aims:

1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier.
2. Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.

Main hypothesis:

The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.


Options:
A: caries reduction (3 years)
B: combined root and coronal D2FS (dental caries) increment (3 year)
C: new decayed surfaces (1 year)
D: MS colonization (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Brief Summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.


Options:
A: Overall Survival Time (3 years)
B: Overall Survival (From the date of randomization up to 104 weeks (study cut-off))
C: Overall survival (1:Not applicable)
D: Overall Survival (Up to 60 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
Brief Summary: The aim of this pilot study was to determine the effect of physiotherapy on impairments and health-related quality of life in people with a painful osteoporotic spinal fracture. It is hypothesised that physiotherapy will reduce impairments and improve quality of life in this patient group.


Options:
A: The primary outcome measure is actual LBP, as measured with an "11 point box scale". (10 weeks and 12 months)
B: Back pain as assessed by a numeric rating scale (Baseline and 10 weeks)
C: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
D: Back pain (Baseline and six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke
Brief Summary: The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.


Options:
A: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
B: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)
C: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)
D: Clinical: Functional handicap (90 days); Proof of concept: Early neurological improvement (22-36 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke
Brief Summary: The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.


Options:
A: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
B: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
C: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)
D: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis
Brief Summary: To assess the efficacy of Memantine in improving the cognitive impairment in patients with Multiple Sclerosis (MS)


Options:
A: N/A
B: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
C: N/A
D: to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial
Brief Summary: The present study was conducted as a prospective, randomized, controlled study to compare:

* the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock
* to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine in patients suffering from septic shock


Options:
A: mortality (day 28)
B: Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) (over a period of 6 hrs from the time of randomization); Oxygen transport variables (over a period of 6 from the time of randomization)
C: Systemic and regional hemodynamics (during the first 12 hours from the onset of septic shock)
D: 28 Day mortality (28 Day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BREAST CANCER AND EXERCISE BREX: A Multicenter Phase III Open Randomised Trial of the Efficacy of Exercise in the Prevention of Long-term Adverse Effects of Adjuvant Treatments and Breast Cancer Recurrences in Women With Primary Breast Cancer.
Brief Summary: A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant treatments and breast cancer recurrences in women with primary breast cancer. The aim of the study is to investigate whether regular exercise training could reduce the long-term side effects of adjuvant treatments of primary breast cancer and improve quality of life and well being.


Options:
A: VO2max and resting systolic blood pressure (at 6 months)
B: The aim of the study is to investigate whether regular exercise after adjuvant treatments of breast cancer could prevent osteoporosis and improve quality of life. (1-10 years)
C: HAM-D17 (Before and after 3 months intervention)
D: Endothelium-dependent flow mediated dilation (Baseline / week 32-36 of gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
Brief Summary: The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.


Options:
A: In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. (Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization)
B: response (WHO criteria) (staging every 8 weeks)
C: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))
D: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients
Brief Summary: Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)
C: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
D: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients
Brief Summary: Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.


Options:
A: Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage (1,2,3,4, and 5 days); Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36) (90 days); Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome (90 days)
B: The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (14d)
C: The improvement of the right hart function on echocardiograms (within the 1st 14 days); Perfusion defect score of lung V/Q scans (within the 1st 14 days); Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment. (within the 1st 14 days)
D: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients
Brief Summary: Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.


Options:
A: Incidence of chronic thromboembolic pulmonary hypertension (within 3 years)
B: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)
C: Resolution of hypoxia (Post-procedure and 3 months); Survival from acute PE (Post-procedure and 3 months); Stabilization of hemodynamics (Post-procedure and 3 months)
D: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)

Answer: B