TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Brief Summary: This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households


Options:
A: secondary influenza infection (7 days)
B: To characterize the pharmacokinetics of amantadine following twice daily administration alone or in combination with twice daily oseltamivir in healthy volunteers.; To characterize the pharmacokinetics of oseltamivir following twice daily administration alone or in combination with twice daily amantadine in healthy volunteers.
C: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (24 weeks)
D: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Brief Summary: This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households


Options:
A: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
B: Laboratory-confirmed Influenza Infection (one year)
C: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: secondary influenza infection (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Brief Summary: This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households


Options:
A: Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert (7 days after the concert (-1/+8 days))
B: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
C: the incidence rates of influenza infection (Until 3 months gargling)
D: secondary influenza infection (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Effects of Pine Bark Extract
Brief Summary: The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile.


Options:
A: Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. (three months)
B: Changes in visual function (At baseline and again at six months)
C: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)
D: The primary objective of this study is to evaluate the effects of treatment with Pycnogenol® on endothelial function in subjects with stable coronary artery disease. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Brief Summary: Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV, reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to prevent HIV infection.


Options:
A: Sequence-verified HIV-transmission from index to partner participant (March 2009)
B: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. (15 weeks)
C: HIV acquisition; safety of circumcision
D: Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners; Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Brief Summary: Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV, reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to prevent HIV infection.


Options:
A: HIV incidence (2 years); surgical complications (2 years)
B: Measure the protective effect of medicalized male circumcision on HIV infection (M3, M12 and M21)
C: HIV sero-incidence (24 months post-baseline)
D: HIV acquisition; safety of circumcision

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Brief Summary: Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV, reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to prevent HIV infection.


Options:
A: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing (Up to 30 minutes)
B: Procedure time (9 weeks)
C: HIV acquisition; safety of circumcision
D: HIV incidence (2 years); surgical complications (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.


Options:
A: The occurrence of PTS at 24 months after the event of acute DVT (At 24 months after the event of the acute DVT)
B: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)
C: N/A
D: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
Brief Summary: This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.


Options:
A: Duration of recurrence free survival.
B: Progression Free Suvaival (During the protocol treatment then 18 months from the last day of the protocol treatment)
C: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
Brief Summary: The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).


Options:
A: To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients (8 weeks)
B: Percentage of Participants Who Attained Remission. (3 months)
C: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups (16 weeks)
D: Proportion of Participants Who Had Relapse During the Entire Week 36 Period (Week 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
Brief Summary: a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy have been proved,and the efficacy of probucol in combination with valsartan is to be proved in patients with IgA nephropathy.

This is a prospective randomized controlled, double blinded pilot study to identify the efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The renal function deterioration will be the primary outcome studied. The expected study duration will be 36 months.


Options:
A: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
B: Proteinuria （g/d） (every two months(total six months))
C: Serum creatinine; 24 hour urinary protein excretion
D: urinary protein loss whithin 24 hours (2-3years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: pain subscale of the WOMAC (week 12)
B: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
C: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
D: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).
B: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
C: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
D: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Resistance Training on Cognitive Performance, Cortical Plasticity, and Fall Risk in Women Aged 65-75 Years Old: A 12-Month RCT
Brief Summary: Primary Objectives:

1. To ascertain whether a 12-month, twice-weekly or once-weekly resistance training (RT) program will significantly improve executive function in community-dwelling women aged 65 to 75 years old compared with a 12-month, twice-weekly stretch and relax (S \& R) program (shame exercise). We will assess executive function by standard neuropsychological tests.

Secondary Objectives:

1. To describe the neural mechanisms that underpin the observed changes in executive function associated with a 12-month, twice-weekly or once-weekly RT training (by using functional magnetic resonance imaging (fMRI)).
2. To investigate whether RT-induced changes in executive function are independently associated with changes in physiological fall risk profile.
3. To investigate the dose response of RT (resistance training) on bone health as measured by dual energy x-ray and peripheral quantitative computed tomography.
4. To conduct a one-year follow-up after the formal cessation of the resistance training programs to determine the persisting effect of resistance training on cognitive performance, cortical plasticity, physiological falls risk, and bone health.


Options:
A: Cognitive Performance of Executive Function (12 months)
B: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)
C: Number of Subjects Reporting Any Fall (3 months); Number of Subjects Reporting a Fall-related Injury (3 months)
D: Falls rate (6 months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Resistance Training on Cognitive Performance, Cortical Plasticity, and Fall Risk in Women Aged 65-75 Years Old: A 12-Month RCT
Brief Summary: Primary Objectives:

1. To ascertain whether a 12-month, twice-weekly or once-weekly resistance training (RT) program will significantly improve executive function in community-dwelling women aged 65 to 75 years old compared with a 12-month, twice-weekly stretch and relax (S \& R) program (shame exercise). We will assess executive function by standard neuropsychological tests.

Secondary Objectives:

1. To describe the neural mechanisms that underpin the observed changes in executive function associated with a 12-month, twice-weekly or once-weekly RT training (by using functional magnetic resonance imaging (fMRI)).
2. To investigate whether RT-induced changes in executive function are independently associated with changes in physiological fall risk profile.
3. To investigate the dose response of RT (resistance training) on bone health as measured by dual energy x-ray and peripheral quantitative computed tomography.
4. To conduct a one-year follow-up after the formal cessation of the resistance training programs to determine the persisting effect of resistance training on cognitive performance, cortical plasticity, physiological falls risk, and bone health.


Options:
A: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)
B: Falls incidence rate (6 months)
C: Cognitive Performance of Executive Function (12 months)
D: Number of falls and injurious falls in 12 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Brief Summary: Patients with T2T3 low rectal cancer (size =\< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =\< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.


Options:
A: N/A
B: Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after (24 months)
C: locoregional recurrence rate (3 years post operatively)
D: Recurrence free at 3 year follow-up (3 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
Brief Summary: SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?


Options:
A: Reduction of systemic inflammatory response (Through study completion, an average of 1 year)
B: SOFA Score (24 hours before until day 9 post-surgery)
C: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
D: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection (4 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
Brief Summary: SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?


Options:
A: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
B: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (7 days postoperatively)
C: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)
D: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method (Postoperative days up to hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
Brief Summary: SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?


Options:
A: Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome (Until hospital discharge, up to 4 months)
B: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery. (36 hours)
C: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
D: Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests (9 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Received BCG Immunisation 1 Month Previously
Brief Summary: This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis). This vaccine is delivered intradermally by a needle injection in healthy volunteers previously vaccinated with BCG.


Options:
A: Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.
B: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each mmunisation (and after 7 days).; Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination.
C: Safety evaluation through actively and passively collected data on adverse events (Up to 24 weeks)
D: To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. (AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.)

Answer: B