TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: tDCS in Chronic Stroke Recovery-pilot
Brief Summary: The hypothesis of this study is that different subgroups of stroke will respond differently to direct current stimulation.


Options:
A: Change in Modified Rivermead Mobility Index Score (12 weeks)
B: Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
C: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)
D: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: tDCS in Chronic Stroke Recovery-pilot
Brief Summary: The hypothesis of this study is that different subgroups of stroke will respond differently to direct current stimulation.


Options:
A: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))
B: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
C: Four Square Step Test (Change from Baseline in Risk of Falls at 3 months)
D: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Pain After Pediatric Umbilical Hernia Repair: a Randomized Clinical Trial of Ultrasound-guided Bilateral Rectus Sheath Blocks Versus Local Anesthetic Infiltration
Brief Summary: The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric population of patients undergoing umbilical hernia repair.


Options:
A: Narcotic requirement (24 hours post intervention)
B: Surgical Pleth Index (SPI) at the time of start of surgery (intraoperative)
C: postoperative pain (from emergence to 24 hrs post-discharge)
D: time to first use of analgesic (24 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Troponin Elevation in Consecutive Patients With Hip Fracture
Brief Summary: The aims of this study is to study the occurrence of the troponin elevations, ECG changes, and cardiac symptoms in unselected consecutive patients with hip fracture.

Followup will be carried out up to one year period.


Options:
A: Cardiovascular Events (30 days postoperative)
B: Postoperative myocardial injury (7 days)
C: For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) (30 days post surgery.)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
Brief Summary: The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.


Options:
A: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
B: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))
C: Maximum measured plasma concentration (336 hours)
D: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
Brief Summary: The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.


Options:
A: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
B: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
C: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
D: Phase Ib: Dose Limiting Toxicities of Dose of Pazopanib and Fosbretabulin (4 weeks after starting treatment (1 cycle)); Phase II: Progressive disease (Progressive disease (average of 4 months from start of treatment) measured by RECIST)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
Brief Summary: The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.


Options:
A: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
B: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
C: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
D: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.
Brief Summary: The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.


Options:
A: 24-hourly urinary sodium excretion (up to 9 months)
B: Change in 24-hour urinary creatinine clearance from baseline to final follow-up, measured from 24-hour urinary collection and corresponding serum creatinine measurement at randomisation and final visit. (24 months)
C: feasibility of intensive sodium management (12 months)
D: Dietary sodium intake as assessed from 3-day recalls. (baseline and 4 months); Dietary sodium effluent and urine concentration. (baseline and 4 months); Morning blood pressure. (baseline and 4 months); Morning post dialysis weight. (baseline and 4 months); Feasibility and acceptability of PDA-based dietary monitoring. (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA
Brief Summary: The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II study, the study assesses, duration of erythroid response, overall survival and time to progression as well as toxicity.


Options:
A: To determine the major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria (after 6 courses of treatment in the respective treatment arm)
B: Hb response rate (up to week 15)
C: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)
D: Red blood cell (RBC) transfusion rate (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-national, Double-blind, Placebo-controlled, Randomized, Phase III Clinical Trial of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Asian Subjects With Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Demonstrated Either Stable Disease or Objective Response Following Primary Chemo-radiotherapy
Brief Summary: The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of Asian subjects with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called placebo controlled study).


Options:
A: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
B: Maximum Tolerated Dose (MTD) (28 Days)
C: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs (Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years); Number of Participants With Abnormal Serum Chemistry Laboratory Values (Day 1 up to June 2013, approximately 4 years); Number of Participants With Abnormal Hematology Laboratory Values (Day 1 up to June 2013, approximately 4 years)
D: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-national, Double-blind, Placebo-controlled, Randomized, Phase III Clinical Trial of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Asian Subjects With Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Demonstrated Either Stable Disease or Objective Response Following Primary Chemo-radiotherapy
Brief Summary: The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of Asian subjects with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called placebo controlled study).


Options:
A: The anti-MAGE-A3 seroconversion (After the fourth dose of ASCI and at the end of treatment); The anti-protein D seroconversion (After the fourth dose of ASCI and at the end of treatment); The anti-CpG seroconversion (After the fourth dose of ASCI and at the end of treatment); The MAGE-A3 cellular (T cell) response (After the fourth dose of ASCI and at the end of treatment); Occurrence of adverse events, including abnormal hematological and biochemical laboratory values (During the study); Occurrence of serious adverse events (During the study)
B: Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population (From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)); Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population (From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
C: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)
D: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Brief Summary: To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.


Options:
A: Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis (12 months)
B: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
C: Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 (Week 52)
D: Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period (Day 1 (randomization) to 12 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Anti-TNF Therapy Plus Methotrexate, Combination Therapy of DMARDs, and Methotrexate Alone in Very Early Polyarticular Juvenile Idiopathic Arthritis. A National Randomized Multicenter Clinical Trial.
Brief Summary: The objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (DMARDs), and methotrexate alone.


Options:
A: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase (Week 16 to Week 48 (32 weeks))
B: Time to Treatment Failure (From baseline until 48 weeks post-randomization)
C: ACR Pedi 75 response (54 weeks from baseline (0))
D: To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline (Final visit could occur at any point up to 78 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project
Brief Summary: This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.


Options:
A: Change in BMI z-score (Baseline (0 months) and 9 months)
B: N/A
C: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
D: Body mass index (Baseline, 3 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project
Brief Summary: This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.


Options:
A: Nighttime self-regulated sleep duration at 6, 12 and 24 months of age (Up to 24 months)
B: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
C: Weight for Length Body Mass Index (BMI will be assessed at three years of age for the study participants)
D: Preventing childhood obesity (Offspring age until six years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project
Brief Summary: This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.


Options:
A: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
B: Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA) (Measured at baseline and 10 months for each wave of data collection)
C: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
D: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Life-style Intervention to Reduce Weight and Increase Workability in Health Care Workers
Brief Summary: The purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers.


Options:
A: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
B: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)
C: weight loss (3 months); Weight loss (1 year)
D: Body weight (3 months); Blood Pressure Control (3-Months)

Answer: C