TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Brief Summary: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.


Options:
A: Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number (Measured up to Day 730)
B: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))
C: Number of Subjects With a Vaccine Response for Anti-gE Antibodies (At Month 3); Anti-glicoprotein E (gE) Antibody Concentrations (At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)); Anti-pneumococcal Antibody Titers (At one month post-dose (Month 1)); Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups (At 1 month after vaccination); Adjusted GMCs Between Groups (At 1 month after last vaccine dose)
D: Number of Subjects With Any Episodes of Herpes Zoster (HZ) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ (During the entire study period (3 to 5 year period following Day 0))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.


Options:
A: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale (Baseline, Last 3 Days of Study Drug Administration (4 weeks))
B: percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment (Up to 3 years)
C: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
D: Quality of end-of-life care provided to dying cancer patients and their families. (six months after the implementation of the LCP Program)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.


Options:
A: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (within 15 days)
B: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale (Baseline, Last 3 Days of Study Drug Administration (4 weeks))
C: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. (5 days)
D: Proportion of Non-Responder (NR) Participants (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.


Options:
A: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale (Baseline, Last 3 Days of Study Drug Administration (4 weeks))
B: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (within 15 days)
C: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
D: Change in pain score and treatment success

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
Brief Summary: This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.


Options:
A: Useful Field of View Test (12 months)
B: overall cognition (2 Monhths)
C: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
D: Global cognitive functioning (26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
Brief Summary: This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.


Options:
A: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
B: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
C: Useful Field of View Test (12 months)
D: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
Brief Summary: This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.


Options:
A: Aggregate Cognitive Performance (Baseline to 10 weeks)
B: sleep measures (3-6 months)
C: Useful Field of View Test (12 months)
D: Neuropsychological testing (Baseline, 12 weeks, and 24 weeks); Oddball task (Baseline, 12 weeks, and 24 weeks); Wisconsin task (Baseline, 12 weeks, and 24 weeks); Speed of processing task (Baseline, 12 weeks, and 24 weeks); Spatial working memory (WM) (Baseline, 12 weeks, and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
Brief Summary: This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.


Options:
A: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.
B: overall cognition (2 Monhths)
C: Useful Field of View Test (12 months)
D: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
Brief Summary: Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.

The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.

All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures \< 30 cms H2o and PH \> 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.


Options:
A: Total ventilation time during intensive care unit stay.
B: " not acceptable " zone of ventilation (During the four hours of the study protocol); " not acceptable " zone of ventilation (During the 4 hours of the protocol)
C: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. (first extubation or 28 days)
D: Duration of mechanical ventilation (up to 4 weeks); duration of ICU stay (up to 4 weeks); duration of hospital stay (up to 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy
Brief Summary: Background:

Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clear defined and debatable. Therefore additional prophylactic pretreatments are needed.

Methods/Design:

Present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.

Discussion:

As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.


Options:
A: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
B: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization (Randomization up to 47 months); Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients (First dosing up to 48 months)
C: incidence of contrast-induced nephropathy (within 48 hours after using a contrast agent)
D: Glomerular Filtration Rate; Adverse Events

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
Brief Summary: High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.


Options:
A: Number of Participants Who Develop Hypercalcemia (6 months)
B: 24-hour systolic blood pressure (20 weeks)
C: Breast Cancer Recurrence (Lifetime)
D: fractures (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Brief Summary: The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.


Options:
A: Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes (within 3 minutes)
B: Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization (Intraoperative, 4 minutes following randomization)
C: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)
D: Receipt of blood transfusion(s) (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Brief Summary: The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.


Options:
A: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)
B: Intraoperative blood loss (End of operation)
C: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
D: To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management (All patients will have their blood checked every 30 minutes during surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial
Brief Summary: Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy, or radiation therapy. In most cases, a full course of radiotherapy has been applied after primary diagnosis, therefore application of re-irradiation has to be applied cautiously. With modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and 8 months for recurrent WHO grade II, III and IV tumors.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons.

First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of primary high-grade gliomas showed promising results in a small and heterogeneous patient collective.

In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the subsequent randomized Phase II part, the RD will be evaluated in the experimental arm, compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.

Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II is survival after re-irradiation at 12 months, secondary endpoint is progression-free survival.


Options:
A: Overall Survival (at 12 months)
B: Overall Survival (Time to event)
C: Progression Free Survival (PFS) time (5 years)
D: Survival 6 mo (Proportion of alive participants at 6 months)

Answer: A