TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Brief Summary: This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\] also known as CARE-MS I, or CAMMS324 \[NCT00548405\] also known as CARE-MS II). The purposes of this study were:

1. To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies.
2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)
B: Annualized Relapse Rate (ARR) (Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)); Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab (Baseline (Year 0 of initial studies) up to Year 4); Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment (Year 1 prior to retreatment, Year 1, 2, 3 after retreatment); Number of Participants With Sustained Accumulation of Disability (SAD) (Baseline (Year 0) up to Year 6); Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison (Baseline (Year 0 of initial studies) up to Year 4)
C: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
D: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy
Brief Summary: The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure

Clinical significance Correlation with biomarkers and genetic markers


Options:
A: A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure (by the end of the study)
B: 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)
C: All cause mortality (3 years); Ventricular arrhythmias (3 years); Unplanned heart failure admissions (3 years)
D: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.
Brief Summary: The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.


Options:
A: Angiographic Late Lumen Loss (6 months)
B: Primary Patency (12 month); Primary Safety Composite (12 month)
C: Event-free Survival (6 months)
D: Late lumen loss of vessel segment following dilatation after 6 months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
Brief Summary: It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.

We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.


Options:
A: Mortality within 28 days after birth (within 28 days after birth)
B: Death to discharge or at six months corrected gestational age (discharge or six months corrected gestational age)
C: Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
D: Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. (Admission to the NICU)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis
Brief Summary: The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.


Options:
A: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)
B: Reduction in bacterial load (1 year)
C: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
D: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis
Brief Summary: The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.


Options:
A: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
B: Reduction in bacterial load (1 year)
C: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
D: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis
Brief Summary: The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.


Options:
A: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
D: Reduction in bacterial load (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
Brief Summary: Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2


Options:
A: relapse-free survival (two years)
B: Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.; Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.
C: To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
D: Overall Survival (Induction Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.); Disease-free Survival (Consolidation Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
Brief Summary: Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD \< 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.


Options:
A: 60-day ≥ Grade II Complication Rate (60 days)
B: Surgical Site Infection at D30 (30 days after surgical intervention)
C: Abdominal Complications (1 month)
D: Rate of clinically relevant postoperative pancreatic fistula (POPF) (Up to 60 days after Surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
Brief Summary: Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD \< 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.


Options:
A: To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo. (60 days)
B: Postoperative pancreatic fistula (30 days postoperatively)
C: 60-day ≥ Grade II Complication Rate (60 days)
D: Abdominal Complications (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder
Brief Summary: The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.


Options:
A: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
B: Scores on Hamilton Depression Rating Scale (8 time points through 6 weeks)
C: length of non-essential Internet use in hours/week as well as CGI-Improvement (baseline and biweekly for 10 weeks)
D: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
Brief Summary: People who have had a stroke or transient ischemic attack (TIA or "mini-stroke") are at high risk of having another stroke or a heart attack. Conditions like high blood pressure and high cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the risk of stroke and heart disease. Aggressive treatment of these risk factors however, can significantly reduce the chance of another stroke, heart attack or death.

This study will look at different ways to optimize blood pressure and cholesterol levels and educate people about positive lifestyle changes.


Options:
A: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
B: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)
C: Anticoagulation-related quality of life (Four months)
D: BP at 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
Brief Summary: People who have had a stroke or transient ischemic attack (TIA or "mini-stroke") are at high risk of having another stroke or a heart attack. Conditions like high blood pressure and high cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the risk of stroke and heart disease. Aggressive treatment of these risk factors however, can significantly reduce the chance of another stroke, heart attack or death.

This study will look at different ways to optimize blood pressure and cholesterol levels and educate people about positive lifestyle changes.


Options:
A: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)
B: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
C: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
D: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
Brief Summary: People who have had a stroke or transient ischemic attack (TIA or "mini-stroke") are at high risk of having another stroke or a heart attack. Conditions like high blood pressure and high cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the risk of stroke and heart disease. Aggressive treatment of these risk factors however, can significantly reduce the chance of another stroke, heart attack or death.

This study will look at different ways to optimize blood pressure and cholesterol levels and educate people about positive lifestyle changes.


Options:
A: The change in HbA1c from baseline to week 26 (6 months)
B: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)
C: BP at 6 months (6 months)
D: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.
Brief Summary: Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.


Options:
A: Mood symptom improvement. (Baseline to exit); Cocaine or methamphetamine cravings and use. (Baseline to exit)
B: Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) (6 months)
C: Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.
D: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.
Brief Summary: Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.


Options:
A: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-I at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF])); Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-S at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF]))
B: The effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy in a 8 week period from the baseline visit to the end of week 8 visit.
C: The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
D: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Brief Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Options:
A: Progression free survival (12 months)
B: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
C: Overall Survival (OS) (Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).)
D: Progression-Free Survival (PFS) (Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks))

Answer: D