TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab
Brief Summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).


Options:
A: Overall Response Rate (ORR) (From 3 cycles (90 days) up to 6 cycles (approximately 180 days))
B: Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death (Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)); Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines (Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months))
C: Overall response rate (ORR) (84 days after first dose of last induction cycle)
D: Determination of dose limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase two dose (RPTD), and lead-in period regimen (Lead-in period (2-5 weeks) plus 3 weeks of study drug administration at the designated cohort dose (continuous dosing)); Number of subjects with adverse events (First 16 weeks of study drug administration and every 4 weeks thereafter (continuous dosing for an anticipated maximum duration of 9 months)); Determination of plasma peak concentration (Cmax) of ABT-199 (Up to Week 24 for ABT-199); Determination of trough concentration (Ctrough) of ABT-199 (Up to Week 24 for ABT-199); Determination of area under the concentration versus time curve (AUC) of ABT-199 (Up to Week 24 for ABT-199)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection: Double Blind Randomised Clinical Trial (RCT) to Study the Efficacy of Different Co-administration and Sequential Administration
Brief Summary: Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as standard treatment for the clearance of W. bancrofti infection. It takes about one year for the individuals to completely clear the microfilaria from the blood. It takes another two to four years to clear the antigen. The aim of the present study is to shorten the time taken for clearing the Mf and antigen from the blood either by co-administration or sequential administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a randomized, double blind, controlled clinical trial to study the efficacy of these drug combinations in complete clearance the Mf and antigen from the blood in shorter span of 180 days and 365 days respectively.


Options:
A: Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) (at 36 months)
B: adverse reactions (6 weeks)
C: complete clearance of mf in 80% of the infected (At 13th week (91 days) post therapy)
D: Number of Participants Achieving Microfilarial Clearance (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study on Bicycle Trains to Improve Children's Physical Activity
Brief Summary: US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Programs to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and related chronic disease risk are necessary. The Bicycle Train is an innovative program in which children cycle to and from school led by adults. Bicycle Trains provide another option for ACS, especially for children who live too far to walk to school. No randomized controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.

The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent accelerometer and GPS data and validate algorithms to identify and measure physical activity intensity and duration for children's cycling compared to heart rate monitors.

Our Specific Aims will be to:

SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned full-scale cluster RCT (b) promoting their participation, and (c) identifying barriers/facilitators to their participation; and SA2) validate algorithms examining concurrent accelerometry and global positioning system (GPS) data to identify and measure children's physical activity intensity and duration while cycling compared to the criterion standards of heart rate monitoring and direct observation

Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be determined to be feasible if:

FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data have high agreement, i.e. \>90% agreement, with heart rate data/direct observation in distinguishing children's cycling-related physical activity duration and intensity from other physical activities and riding in a motor vehicle


Options:
A: Post-Intervention Bicycling to School (During weeks 3-5 of the intervention)
B: Overweight and obesity according to IOTF references (0-1-2 years)
C: Decrease in children's sedentary time during school hours (One schoolyear)
D: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Phase II, Single-centre Study to Assess the Safety and Efficacy of Silymarin 700 mg Capsules TID for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Brief Summary: This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo (12 months)
C: Liver enzyme (1year)
D: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients
Brief Summary: The investigators hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.


Options:
A: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)
B: Change in Sunnybrook Neglect Assessment Procedure (SNAP) (Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start))
C: Change of Repeatable Battery for the Assessment of Neuropsychological Status (Up to 12 weeks)
D: Action Research Arm Test (within 4 months post stroke)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Options:
A: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)
B: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study (12 weeks treatment); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 (12 weeks treatment)
C: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)
D: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Options:
A: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)
B: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
C: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study (12 weeks treatment); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 (12 weeks treatment)
D: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Drug Reconciliation at Discharge and Pharmaceutical Communication Between Hospital and Community Pharmacists on Drug Related Problems: Study Protocol for a Cluster Randomized Cross-over Trial
Brief Summary: This study will evaluate the impact of a communication between hospital pharmacist and community pharmacists in addition to drugs reconciliation procedure at discharge. It will be conducted in 21 french public hospitals.


Options:
A: Any Hospital Readmission (180-day from indexed hospital discharge)
B: Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. (30 days after discharge)
C: drug related problems (DRP) (7 days after patient discharge)
D: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Brief Summary: The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.


Options:
A: Number of Participants With Wound Complications (Four weeks after cesarean section)
B: Postoperative Surgical Site Infection (SSI) (30 days following operation)
C: Surgical site infection rate (30 days)
D: Groin Wound Complication (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Brief Summary: The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.


Options:
A: Surgical site infection rate (30 days)
B: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
C: Postoperative Surgical Site Infection (SSI) (30 days following operation)
D: Early Complications of Vascular Zone (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Brief Summary: The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.


Options:
A: Wound infection rate (Wounds will be checked at 3 month follow-up)
B: Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) (30 days postoperatively)
C: Postoperative Surgical Site Infection (SSI) (30 days following operation)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Using Social Networking Service to Prevent Smoking Relapse Among Self-reported Quitters: A Pilot Randomized Control Trial
Brief Summary: According to the Census \& Statistics Department, there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they could not maintain abstinence. Relapse prevention is aimed at providing interventions to prevent relapse after starting the abstinence status. This pilot single-blind randomized controlled trial (proof of concept study) will test the effectiveness of social networking services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for a qualitative interview for the design of intervention. Then, the pilot-RCT trial will recruit 120 participants who have recently quitted smoking, and they will be randomly allocated to 2 intervention groups and one control group. The 2 intervention groups will be arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group moderators and sharing quitting experience with other participants. All participants will receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3 months and 6 months. The primary outcome is the self-report relapse rate (Relapse is tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among the 3 study arms.


Options:
A: evaluate the abstinence of tobacco consumption (12 months)
B: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Using Social Networking Service to Prevent Smoking Relapse Among Self-reported Quitters: A Pilot Randomized Control Trial
Brief Summary: According to the Census \& Statistics Department, there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they could not maintain abstinence. Relapse prevention is aimed at providing interventions to prevent relapse after starting the abstinence status. This pilot single-blind randomized controlled trial (proof of concept study) will test the effectiveness of social networking services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for a qualitative interview for the design of intervention. Then, the pilot-RCT trial will recruit 120 participants who have recently quitted smoking, and they will be randomly allocated to 2 intervention groups and one control group. The 2 intervention groups will be arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group moderators and sharing quitting experience with other participants. All participants will receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3 months and 6 months. The primary outcome is the self-report relapse rate (Relapse is tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among the 3 study arms.


Options:
A: Participant smoking status. (6 and 12 month follow-up)
B: evaluate the abstinence of tobacco consumption (12 months)
C: Quitting success rates at the end of the 1st, 3rd and 6th month (6 months)
D: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.

Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).


Options:
A: Pain Scores on the Visual Analog Scale (Three months)
B: Patient Perception of Pain (At time of uterine aspiration (baseline))
C: Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale (At time of cervical dilation, 30 minutes after lidocaine administration)
D: Subject Perception of Pain and Anxiety During Uterine Aspiration (at time of uterine aspiration (30-60 minutes after premedication))

Answer: A