TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors
Brief Summary: This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).


Options:
A: Progression-free survival during maintenance therapy (Tumor evaluation every 2 months)
B: Progression-free Survival (PFS) (From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.); Overall Survival (From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months)
C: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation
D: Progression-free Survival (PFS) (From randomization up to 65 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors
Brief Summary: This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).


Options:
A: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))
B: Progression-free Survival (PFS) (From randomization up to 65 months.)
C: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)
D: Overall Survival (From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Brief Summary: The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.


Options:
A: Time to sputum culture conversion
B: Proportion of pulmonary TB patients who are culture negative in sputum in week 4 (week 4); Difference in improvement in clinical endpoints consisting of cough clearance, percentage chest x-ray clearance, fever remission and weight increase upto 8 weeks. (8 weeks)
C: Proportion of pulmonary TB patients who are culture negative at 1 month (1 month); Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. (2 months)
D: weight gain in childhood tuberculosis (2 months after start of anti-tuberculosis therapy.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Brief Summary: The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.


Options:
A: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)
B: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
C: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
D: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Brief Summary: The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.


Options:
A: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
B: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
C: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
D: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Brief Summary: The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.


Options:
A: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
B: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
C: Percentage of Subjects With a Treatment Failure (Week 0 (First Dose) to Week 50)
D: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immune Responses Following One Versus Two Doses of Killed Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
Brief Summary: The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.


Options:
A: culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility. (1095 days)
B: Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline (14 days after each dose of vaccine or placebo)
C: Cocaine Abstinence During Weeks 9 to 16 Inclusive (Over 8 weeks ( Study Weeks 9 to 16 inclusive))
D: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Medium-Dose UVA1 Versus Narrow-Band UVB Phototherapy: A Randomized Double-Blind Controlled Cross-Over-Study
Brief Summary: Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in atopic dermatitis (AD). The past ten years have seen the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1 seems to be more effective than the above mentioned broadband spectra, in particular in acute severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and SMAD-proteins will be evaluated during the course of treatment.


Options:
A: Hierarchical criterion based on repeated measures of PO-SCORAD severity score (2 years); Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter (2 years)
B: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
C: Clinical improvement during UVA1/NB-UVB phototherapy using a validated; SCORAD index
D: The incidence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis (Prevelence reported annually by year from 2008-2018); Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis (Measures will be reported annually by year from 2008-2018); Annual prescription rates for atopic dermatitis related treatments (Measures will be reported annually by year from 2008-2018)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Respiratory Muscle Training in Ventilator Dependent Patients
Brief Summary: The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.


Options:
A: Diaphragm mobility (Diaphragm mobility at first session and after two weeks of treatment.)
B: Measurement of the MIP
C: ventilator dependent status
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Respiratory Muscle Training in Ventilator Dependent Patients
Brief Summary: The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.


Options:
A: Length of stay in ICU and length of stay in the hospital. (2 years)
B: Effect of early IVIG versus placebo on CIPNM on day 14 (day 14)
C: ventilator dependent status
D: Reduction of the mortality rate of ARDS patients at d90 (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial
Brief Summary: This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of depressive patients with acute coronary artery syndrome (CAS).


Options:
A: Score on the Hamilton Depression Rating Scale-17 item (24 weeks)
B: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (5 years)
C: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
D: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Brief Summary: It shall be investigated whether ventilated neonates and infants with a remifentanyl based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyl based analgesia and sedation.


Options:
A: Duration of the artificial ventilation after discontinuation of the opioid infusion (at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion))
B: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
C: closure of PDA (6 days)
D: The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day. (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
Brief Summary: The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.


Options:
A: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
B: Biochemically-verified point-prevalence abstinence (7, 11, 16, and 30 weeks post-quit); Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study. (At any point following the quit date.); Treatment completion. (Weeks 7 and 30.); Daily cigarette smoking rate. (Weekly); Frequency and severity of bupropion and naltrexone side effects. (Weekly during treatment)
C: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
D: Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. (Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit); Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence (Changes in log withdrawal symptoms from baseline through 66 days of abstinence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
Brief Summary: The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.


Options:
A: Biochemically-verified point-prevalence abstinence (7, 11, 16, and 30 weeks post-quit); Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study. (At any point following the quit date.); Treatment completion. (Weeks 7 and 30.); Daily cigarette smoking rate. (Weekly); Frequency and severity of bupropion and naltrexone side effects. (Weekly during treatment)
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Brief Summary: The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.


Options:
A: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (12 months); Rate of Exacerbations Per Subject-year (12 months)
B: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)
C: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12)
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Brief Summary: The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.


Options:
A: All cause mortality at 3 years
B: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (12 months); Rate of Exacerbations Per Subject-year (12 months)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks (12 weeks)
D: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Brief Summary: The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.


Options:
A: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
B: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
C: the frequency of exacerbations compared to a control group
D: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (12 months); Rate of Exacerbations Per Subject-year (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma
Brief Summary: The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.


Options:
A: Comparison of FEV1 (Forced expiratory volume in the first second) values. (8 weeks)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF (Baseline to Endpoint (12 weeks)); Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F (26-week Treatment Period)
C: Morning Peak Expiratory Flow (AM PEF) (Baseline (run-in) and throughout 12 weeks)
D: Change from start of treatment in evening pre-dose FEV1 (2, 6 and 12 weeks after starting treatment)

Answer: C