TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients
Brief Summary: To determine whether the use of educational sessions and computerized clinical reminders can improve primary care doctors' delivery of care to CKD patients compared to educational sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD patients


Options:
A: referral to a nephrologist (12 months)
B: Physical activity CHAMPS (Baseline, 3 and 6 months); Glycemic control - HbA1c (Baseline, 3 and 6 months); Dietary adherence (Baseline, 3 and 6 months)
C: enhancing rates of family communication, donor evaluations, and transplantation (6 months)
D: Systolic Blood Pressure (SBP) (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
Brief Summary: Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.

We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.


Options:
A: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
B: NIH-CPSI total score and change from baseline (baseline, week 1-8)
C: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment)
D: Six point drop in NIH-CPSI total Score

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
Brief Summary: Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.

We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.


Options:
A: Six point drop in NIH-CPSI total Score
B: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
C: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment)
D: NIH-CPSI total score and change from baseline (baseline, week 1-8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267, Versus Vehicle in Subjects With Plaque-type Psoriasis
Brief Summary: The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.


Options:
A: Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8; Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
B: Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms (12 weeks of treatment)
C: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) (8 weeks)
D: Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001. (84 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter
Brief Summary: Antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter.

The purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.


Options:
A: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
B: the antibiotic prescribing rate (within the first 2 weeks after first consultation)
C: Antibiotic use; Length of stay in hospital
D: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter
Brief Summary: Antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter.

The purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.


Options:
A: the risk of disease specific failure (within 1 month COPD)
B: Antibiotic use; Length of stay in hospital
C: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter
Brief Summary: Antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter.

The purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.


Options:
A: Antibiotic prescribing rate (12 months); Prolonged duration prescribing rate (12 months)
B: Serious infection (1 year); Immediate antibiotic prescribing rates (1 year)
C: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
D: Proportion of patients prescribed an antibiotic in each arm (Assessed at day 28 after baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter
Brief Summary: Antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter.

The purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.


Options:
A: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
B: Antibiotic use; Length of stay in hospital
C: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
D: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Brief Summary: A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo


Options:
A: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
B: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)
C: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)
D: Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) (Week 22, 24, 26 and 28); Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2) (Week 22)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Brief Summary: A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo


Options:
A: Number of Subjects Without Mucosal Ulceration at Week 12 (Week 12)
B: Percentage of Participants With Mucosal Healing and No Deep Ulcerations (48 weeks after Randomization)
C: Endoscopic remission (Week 102)
D: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Brief Summary: A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo


Options:
A: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)
B: The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. (12 months)
C: Endoscopic remission (Week 102)
D: Number of endoscopic recurrences (52 weeks after the begin of the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Brief Summary: A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo


Options:
A: Endoscopic remission (Week 102)
B: Number of endoscopic recurrences (52 weeks after the begin of the study)
C: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)
D: The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.
Brief Summary: The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.


Options:
A: Relapse Free Survival (RFS) 4 vs. 6 Cycles (from baseline up to 4 years); Duration of Disease Free Survival (RFS) (from baseline up to 6.4 years)
B: Disease-free Survival (up to 5.25 years (63 months))
C: Number of Participants With Disease-Free Survival Events (up to 10 year follow-up)
D: disease free survival (at 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population
Brief Summary: Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.


Options:
A: Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery (Four days)
B: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method (Postoperative days up to hospital discharge)
C: Duration of delirium (3 months)
D: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population
Brief Summary: Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
B: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: Time to extubation since the interruption in the administration of anaesthetics. (30 minutes-3 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population
Brief Summary: Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.


Options:
A: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
C: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
D: electroencephalographic (BIS) and functional cognitive recovery (24h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population
Brief Summary: Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.


Options:
A: Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. (during anesthesia)
B: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
C: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder
Brief Summary: The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.


Options:
A: Change in Urge Urinary Incontinence (UUI) Episodes (Baseline through 6 months)
B: Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours (Baseline and Week 12 (final visit)); Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours (Baseline and Week 12)
C: Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours (Baseline); Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 (Baseline and Week 12)
D: Hopkins Verbal Learning Test - Revised (Week 4); Hopkins Verbal Learning Test - Revised (Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cilengitide for Subjects With Newly Diagnosed Glioblastoma and Methylated MGMT Gene Promoter - A Multicenter, Open-label, Controlled Phase III Study, Testing Cilengitide in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy) Versus Standard Treatment Alone (CENTRIC)
Brief Summary: CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.

The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.


Options:
A: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
B: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
C: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))
D: Overall Survival (Time to event)

Answer: C