TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections
Brief Summary: The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).


Options:
A: Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population (7 to 14 days after the last dose of study drug); Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population (7 to 14 days after the last dose of study drug)
B: Recurrence Rates of Abscesses (30 days after incision and drainage)
C: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit (up to 6 weeks)
D: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (8-15 days after last dose of study drug administration); The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. (8-15 days after last dose of study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sertraline Pharmacotherapy for Alcoholism Subtypes
Brief Summary: The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.


Options:
A: Number of Days on Which Subjects Drank (12-week treatment period)
B: Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17) (From baseline visit to Week 12 (or early discontinuation visit)); Total Drinking Days on the Alcohol Timeline Followback (TLFB) (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Week on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Drinking Day on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit))
C: The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS) (2 to 6 weeks)
D: To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD (Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Randomised, Double Blind Study Evaluating the Effects of Low Dose (10mg) and High Dose (80mg) Atorvastatin on Macrophage Activity and Carotid Plaque Inflammation as Determined by Ultra Small Super-Paramagnetic Iron Oxide (USPIO) Enhanced Carotid Magnetic Resonance Imaging (MRI)
Brief Summary: A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits known as plaques has been developed. Heart attacks and strokes occur when plaques become inflamed, depending on the artery affected. Currently used clinical tests can only tell us how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is. This new method of scanning using magnetic resonance imaging (MRI) and a special agent called Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in their arteries in their neck at risk of strokes to see whether treatment with a cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within the artery wall within the first three months of treatment. If this effect can be measured using MRI scanning with the use of Sinerim then the results of this study will provide additional clinical validation of the use of MRI scanning combined with agents such as Sinerem®.


Options:
A: Morphological carotid plaque stabilization (Six months); Carotid plaque regression (12 months)
B: Change in intima media thickness as measures by carotid ultrasound
C: Stroke and death (4 years)
D: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Randomised, Double Blind Study Evaluating the Effects of Low Dose (10mg) and High Dose (80mg) Atorvastatin on Macrophage Activity and Carotid Plaque Inflammation as Determined by Ultra Small Super-Paramagnetic Iron Oxide (USPIO) Enhanced Carotid Magnetic Resonance Imaging (MRI)
Brief Summary: A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits known as plaques has been developed. Heart attacks and strokes occur when plaques become inflamed, depending on the artery affected. Currently used clinical tests can only tell us how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is. This new method of scanning using magnetic resonance imaging (MRI) and a special agent called Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in their arteries in their neck at risk of strokes to see whether treatment with a cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within the artery wall within the first three months of treatment. If this effect can be measured using MRI scanning with the use of Sinerim then the results of this study will provide additional clinical validation of the use of MRI scanning combined with agents such as Sinerem®.


Options:
A: Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA
B: Change of intima media thickness of the common carotid artery on the leading side of the neck.
C: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
D: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Randomised, Double Blind Study Evaluating the Effects of Low Dose (10mg) and High Dose (80mg) Atorvastatin on Macrophage Activity and Carotid Plaque Inflammation as Determined by Ultra Small Super-Paramagnetic Iron Oxide (USPIO) Enhanced Carotid Magnetic Resonance Imaging (MRI)
Brief Summary: A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits known as plaques has been developed. Heart attacks and strokes occur when plaques become inflamed, depending on the artery affected. Currently used clinical tests can only tell us how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is. This new method of scanning using magnetic resonance imaging (MRI) and a special agent called Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in their arteries in their neck at risk of strokes to see whether treatment with a cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within the artery wall within the first three months of treatment. If this effect can be measured using MRI scanning with the use of Sinerim then the results of this study will provide additional clinical validation of the use of MRI scanning combined with agents such as Sinerem®.


Options:
A: Venous thrombosis and/or pulmonary embolism (PE) (Postoperative 4 weeks)
B: N/A
C: P/F ratio (At baseline and 24, 48 and 168 hours after treatment initiation); PaO2 difference (At baseline and 24, 48 and 168 hours after treatment initiation); A-a O2 difference (At baseline and 24, 48 and 168 hours after treatment initiation)
D: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Positive Airway Pressure for the Treatment of Acute Ischemic Stroke: A Feasibility Pilot Study
Brief Summary: New stroke therapies are needed. This study seeks to provide the preliminary data needed to plan a future study that will evaluate the efficacy of using continuous positive airway pressure (CPAP) to treat stroke patients who have sleep apnea. Our goal is to use this therapy to reduce stroke symptom severity.


Options:
A: proportion using CPAP within 48-hours of stroke onset (72 hours)
B: CPAP adherence in minutes used per night (after 3 months)
C: Functional Outcomes of Sleep Questionnaire (FOSQ) (Three months)
D: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
Brief Summary: The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.


Options:
A: Need for MV (Within the first 5 days of life)
B: Need for mechanical ventilation
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
Brief Summary: The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.


Options:
A: Need for mechanical ventilation (Death or discharge from the NICU)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Need for mechanical ventilation
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
Brief Summary: The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.


Options:
A: Need for mechanical ventilation
B: Need for mechanical ventilation (Death or discharge from the NICU)
C: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
D: Need for MV (Within the first 5 days of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
Brief Summary: The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: Need for mechanical ventilation (Death or discharge from the NICU)
C: Need for mechanical ventilation
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Brief Summary: This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was assessed by the complete healing of at least one ulcer in the treated limb, 25 week post-baseline and secondary by the rate of amputation and death.


Options:
A: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
B: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)
C: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
D: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Brief Summary: This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was assessed by the complete healing of at least one ulcer in the treated limb, 25 week post-baseline and secondary by the rate of amputation and death.


Options:
A: Tissue perfusion as measured by TcPO2 (6 months)
B: Change in the measurement of pain-free walking distance (PWD) on treadmill (3 months and 6 months after the first injection of Neovasculgen®.)
C: Peak Walking Time (at 6 months)
D: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase Four Double-Blind Randomized Comparative Study on Thestudy on the Efficacy of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism
Brief Summary: The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks and the third goal is to follow up alcohol-use with these two medicines.


Options:
A: N/A
B: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
C: Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). (14 weeks)
D: Number of Days on Which Subjects Drank (12-week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase Four Double-Blind Randomized Comparative Study on Thestudy on the Efficacy of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism
Brief Summary: The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks and the third goal is to follow up alcohol-use with these two medicines.


Options:
A: Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] (12 weeks)
B: N/A
C: recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks (40 weeks)
D: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Treatment for Depressed, Cognitively Impaired Elders
Brief Summary: This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability in treating depressed, cognitively impaired older adults.


Options:
A: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
B: Canadian Occupational Performance Measure (COPM) (30 mins)
C: Improvement in patient quality of life (baseline to 18 months)
D: Montgomery Asberg Depression Scale (MADRS) (12 week outcome); WHO Disability Assessment Schedule (WHODAS)-II (12-week outcome)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers
Brief Summary: The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction.


Options:
A: Evaluate NicVAX as an aid to smoking cessation for long term abstinence. (one year)
B: Anti-nicotine antibody concentration (12 time points between screening and week 20)
C: Continuous smoking abstinence (8 week interval (Weeks 19 to 26, inclusive, following the first vaccination))
D: Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm (Monthly up to month 6, and during follow-up at months 9 and 12); Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA (Baseline, monthly up to month 6, and months 9 and 12); Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology) (Baseline, and at various times up to month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
Brief Summary: The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.


Options:
A: Change in 10 meter walk test (Pre Test, 4 weeks, 8 weeks, 3 month follow up)
B: Box and Block Test; Data Collected = Number of Blocks Moved (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fugl-Meyer Upper Extremity Motor Test (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fractionated Reaction Time (Baseline/pretest; posttest given between days 17-22 (posttest days 3-8))
C: Change response time during a novel motor task. (Baseline, After Intervention (2 weeks), 30-day follow-up); Wolf Motor Function Task Rate (Baseline, After Intervention (2 weeks), 30-day follow-up)
D: Wolf Motor Function Test (WMFT) Log-transformed Time (Baseline to 1 year post-randomization); Wolf Motor Function Test Time (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS) Hand Function Subscale Score. (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) (Baseline to 1 year post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
Brief Summary: The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.


Options:
A: Subjective Index of Physical and Social Outcome (SIPSO) (baseline and 1 year); Subjective Index of Social Integration (Subscale of SIPSO) (baseline and one year); Subjective Index of Physical Integration (Subscale of SIPSO) (baseline and one year)
B: Change response time during a novel motor task. (Baseline, After Intervention (2 weeks), 30-day follow-up); Wolf Motor Function Task Rate (Baseline, After Intervention (2 weeks), 30-day follow-up)
C: JTT (crossover design, four different sessions with four different interventions)
D: Box and Block Test; Data Collected = Number of Blocks Moved (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fugl-Meyer Upper Extremity Motor Test (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fractionated Reaction Time (Baseline/pretest; posttest given between days 17-22 (posttest days 3-8))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
Brief Summary: The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.


Options:
A: Survival (5 years)
B: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
C: Clinical improvement assesment of 6 MWT distance (6 months)
D: distance walked in 6 minutes (baseline - 15 weeks afterwards); change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire (baseline - 15 weeks afterwards)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
Brief Summary: The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.


Options:
A: Pre and post exercise training CPET (10 wks); Accelerometry-based activity (10 wks); 6 minute walk distance (10 wks); Quality of life and functional measures (10 wks)
B: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
C: Survival (5 years)
D: distance walked in 6 minutes (baseline - 15 weeks afterwards); change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire (baseline - 15 weeks afterwards)

Answer: C