TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))
B: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
C: Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding (From first dose to 2 days following last dose of study drug)
D: incidence of VTE (up to 30 days after operation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: incidence of VTE (up to 30 days after operation)
B: Progression free survival (5 years)
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)
B: incidence of VTE (up to 30 days after operation)
C: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
D: Progression free survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: incidence of VTE (up to 30 days after operation)
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
D: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
B: Incidence of venous thromboembolism reduction
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
D: incidence of VTE (up to 30 days after operation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength and Mobilization in Healthy Volunteers: a Randomized Study
Brief Summary: The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.


Options:
A: Pain (Average): Numeric Rating Scale for Pain (Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal))
B: Pain during 45 degrees active flexion of the knee (1 hour postoperative)
C: Timed Up and Go test (2-3 days post srugery)
D: the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo (0-6 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.


Options:
A: Forced Expiratory Volume in 1 second (FEV1) (12 Months)
B: Pulmonary function testing at various time points through one year; Exercise tolerance at various time points through one year; Major complications at various time points through one year
C: St. George's Respiratory Questionnaire (SGRQ) (three month Follow-Up Visit)
D: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.


Options:
A: Forced Expiratory Volume in 1 second (FEV1) (12 Months)
B: The difference between the response rates of the treatment and control groups. (3-months post randomization)
C: St. George's Respiratory Questionnaire (SGRQ) (three month Follow-Up Visit)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
Brief Summary: Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.

Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.

Our study hypothesis is that different types of anesthetics reduce PONV further.

Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).

The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.


Options:
A: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
B: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)
C: PONV During the First 24 Hours After Bariatric Surgery (24 hours)
D: The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion (At baseline and 15 minutes after starting study drug (prior to topicalization), and every 3 minutes thereafter throughout study drug infusion, at the end of topicalization, and prior to administration of any rescue medication.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants
Brief Summary: Adolescents with solid organ transplants have poorer outcomes than adults, and do not respond as well to post-rejection treatment. In addition to well-recognized declines in individual health-related quality of life, premature graft loss creates considerable health and economic burdens. High nonadherence rates among adolescents are believed to contribute majorly to rejection, premature allograft dysfunction and failure. Studies suggest that a telephone-based peer mentoring approach, with texting and e-communication, is a promising, practical means to promote medication adherence in adolescent solid organ transplant recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring to improve medication adherence and health-related quality of life vs. usual care in adolescents and young adults with solid organ transplants, and 2) to determine the mechanisms through which peer mentoring impacts medication adherence and health-related quality of life.


Options:
A: Medication adherence (1 year)
B: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
C: Compliance (1 year)
D: Kidney recipients'knowledge level (7-8 weeks post kidney transplantation); Kidney recipients'knowledge level (6 months post kidney transplantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a New Molecular Tuberculosis (TB) Test on TB/HIV Outcomes Among HIV-
Brief Summary: The specific aims of this project are: (1) to compare the impact of using the routine screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a "disruptive technology"10 that could allow TB/HIV programs in resource-limited settings to leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key barrier to scale up of ICF and IPT.


Options:
A: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
B: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
C: increase TB case detection (6 months)
D: Retention in care with viral suppression (48 weeks after HIV testing)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a New Molecular Tuberculosis (TB) Test on TB/HIV Outcomes Among HIV-
Brief Summary: The specific aims of this project are: (1) to compare the impact of using the routine screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a "disruptive technology"10 that could allow TB/HIV programs in resource-limited settings to leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key barrier to scale up of ICF and IPT.


Options:
A: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
B: Sensitivity and specificity (10 months)
C: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
D: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a New Molecular Tuberculosis (TB) Test on TB/HIV Outcomes Among HIV-
Brief Summary: The specific aims of this project are: (1) to compare the impact of using the routine screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a "disruptive technology"10 that could allow TB/HIV programs in resource-limited settings to leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key barrier to scale up of ICF and IPT.


Options:
A: All-cause mortality and incidence of invasive bacterial infections (24 weeks)
B: All-cause mortality (8 weeks)
C: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
D: Rates of TB treatment initiation (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
Brief Summary: The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.


Options:
A: Child PTSD Symptom Scale (CPSS) (After 12 therapy sessions, up to 28 weeks.)
B: Snake Questionnaire (SNAQ) (2 weeks)
C: Liebowitz Social Anxiety Scale (LSAS) (Week 13); CGI - Clinical Global Impression of Improvement (Week 13)
D: Child PTSD Symptom Scale (CPSS) (After 12 therapy sessions, up to 28 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Antimicrobial Use and Time of Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction (PCR) in Real Time Multiplex to the Conventional Blood Culture for Etiologic Agents Identification. Randomized Clinical Trial.
Brief Summary: The objective of this study is to evaluate the consumption of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.


Options:
A: Number of bacteraemia and of fungemia - overall - each condition (max Day 30)
B: Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. (After fourteen days of antimicrobial treatment)
C: Hours to First Antibiotic Modification (72 hours after randomization)
D: mortality at D90 and infection recurrence during the ICU stay (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Short Course (One-week) Radiation Therapy Versus Standard Course (Three-week) Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme
Brief Summary: This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection.

This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥\>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).


Options:
A: Overall Survival (2.5 years)
B: Overall Survival (7 years)
C: Overall survival (12 months)
D: 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))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Short Course (One-week) Radiation Therapy Versus Standard Course (Three-week) Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme
Brief Summary: This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection.

This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥\>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).


Options:
A: Overall Survival (2.5 years)
B: Overall survival (12 months)
C: N/A
D: Overall Survival (From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Dialysis Patients, in Conjunction With Standardized Care of Treatment
Brief Summary: A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.


Options:
A: the Occurrence of Cardiovascular Event and Peritonitis Events (6 month follow-up)
B: PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid (six months); Changes in BUN, Creatinine and uric acid levels (six months)
C: All-cause postoperative mortality (90 days after the date of liver transplantation); Postoperative infection (30 days from the date of liver transplantation)
D: 15-20% Changes in BUN. (6 months); 15-20% Changes in Creatinine (6 months); 15-20% Changes in CRP (6 months); 15-20% Changes in Uric Acid Levels (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
Brief Summary: This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.


Options:
A: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (up to 20-24 hours after surgery)
B: Urinary Tract Infections (three weeks post-operative)
C: To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures. (Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.)
D: Pelvic floor muscle changes (3 months after the begining of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
Brief Summary: This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.


Options:
A: To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. (6 weeks)
B: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
C: Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence (6 weeks); Incidence of Post-operative UTI in Placebo Group (6 weeks); Incidence of Post-operative UTI in Treatment Group (6 weeks)
D: Urinary Tract Infections (three weeks post-operative)

Answer: D