TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized Trial to Assess the Safety and Immunogenicity of Inactivated Poliovirus Vaccine When Given Concomitantly With Measles and Rubella Combined Vaccine and Yellow Fever Vaccine at Nine Months and When Administered Via Different Vaccination Routes
Brief Summary: The overall goal of this study is to identify interference between intramuscular Inactivated Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at nine months of age and to confirm the safety of co-administration. In addition, the study will compare the immunogenicity and safety of IPV when administered via different routes.

A total of 1504 healthy infants between the ages of nine to ten months, who have completed their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine (tOPV) will be recruited for this study.


Options:
A: interference and immunugenicity (4 - 6 weeks after vaccination); Safety (up to 10 weeks after first vaccination)
B: Number of Subjects With Booster Responses to Diphteria and Tetanus (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
C: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
D: The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination (1 Month Post-vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Tai Chi Based Exercise Program Provided Via Telerehabilitation Compared to During Home Visits in Persons Post-Stroke Who Have Returned Home Without Intensive Rehabilitation: A Randomized, Non-inferiority Clinical Trial
Brief Summary: Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.


Options:
A: Motor Activity Log - 14, Amount of Use sub scale (Post-intervention (6 weeks))
B: Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy (from the Baseline Visit to the 30 Day Follow Up Visit)
C: The distance on the 6 minute walking test (6MWT) (6 minutes)
D: Change from baseline in mobility at 2 and 4 months (before the intervention, month 2 and month 4); Change from baseline in Balance at 2 and 4 months (before the intervention, month 2 and month 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Tai Chi Based Exercise Program Provided Via Telerehabilitation Compared to During Home Visits in Persons Post-Stroke Who Have Returned Home Without Intensive Rehabilitation: A Randomized, Non-inferiority Clinical Trial
Brief Summary: Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.


Options:
A: Balance - Measured With the Berg Balance Scale (2 months)
B: Gait speed and Barthel Index (BI) (co-primary endpoint) (3 months post stroke vs baseline)
C: Change from baseline in mobility at 2 and 4 months (before the intervention, month 2 and month 4); Change from baseline in Balance at 2 and 4 months (before the intervention, month 2 and month 4)
D: walking speed (meters/second); walking distance (distance walked in 6-minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Feasibility & Effectiveness of Acupuncture as an Adjunct to Pharmacologic Treatment for Sedation and Analgesia in Mechanically Ventilated PICU Patients - A Pilot Study
Brief Summary: The purpose of this study is to determine whether acupuncture is effective at improving comfort in children on a ventilator in the intensive care unit. Our hypothesis is that the patients receiving acupuncture will require less medications to keep them comfortable than those who receive sham or fake acupuncture.


Options:
A: Richmond Agitation-Sedation Scale (RASS) (3 days)
B: Acceptability and feasibility of the comfort intervention (Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge)
C: delirium outcome (duration of ICU stay(average duration 5 days))
D: Average Daily Dexmedetomidine mcg/kg/Day (from time of first acupuncture/sham treatment till time of extubation); Average Daily Morphine Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Midazolam Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Sedation Score (from time of first acupuncture/sham treatment till time of extubation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b
Brief Summary: This study is designed to etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The primary endpoint will be the time to onset of the first incident.


Options:
A: Left Ventricular Mass Index (9 months)
B: Reduction of Left Ventricular Hypertrophy (12 months)
C: CV Death or Hospitalization for Heart Failure (up to 5 years)
D: The time to onset of the first incident :non-fatal MI or acute coronary syndrome or hospitalization for heart failure or nonfatal stroke or cardiovascular (CV) death (25 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors
Brief Summary: This study is being done to investigate the safety, tolerability and anti-tumor activity of pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC) (Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer (Cohort C), or advanced gastric cancer (Cohort D). Additionally, for Cohort D, data is presented for Asian Pacific (AP) participants. Only participants with programmed cell death-ligand 1 (PD-L1) expressing tumors were enrolled in Cohorts A, B, C and D. Participants in Cohort B2 were enrolled irrespective of PD-L1 status.

The primary study hypothesis is that pembrolizumab is safe and well-tolerated.


Options:
A: Objective response rate; Safety
B: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
C: Overall Survival (OS) (2.5 years)
D: overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial: Comparison Between Quadrantectomy Followed by External Fractionated Radiotherapy and Quadrantectomy Associated With Intraoperative Radiotherapy in Women >= 48 Years of Age Affected by Early-stage Breast Carcinoma.
Brief Summary: The purpose of this study is to investigate the efficacy of exclusive intraoperative radiation therapy after conserving surgery in early-stage breast cancer compared with whole breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence occurring in quadrants other than the previous one) and the recurrence free survival.


Options:
A: Number of local relapses (5 YEARS)
B: rate of local recurrence (5 years)
C: ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. (ongoing throughout study)
D: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial: Comparison Between Quadrantectomy Followed by External Fractionated Radiotherapy and Quadrantectomy Associated With Intraoperative Radiotherapy in Women >= 48 Years of Age Affected by Early-stage Breast Carcinoma.
Brief Summary: The purpose of this study is to investigate the efficacy of exclusive intraoperative radiation therapy after conserving surgery in early-stage breast cancer compared with whole breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence occurring in quadrants other than the previous one) and the recurrence free survival.


Options:
A: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)
B: Number of local relapses (5 YEARS)
C: rate of local recurrence (5 years)
D: Local control (5-years, 10 ten-years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.


Options:
A: Perioperative Blood Loss (5 days after surgery); Total Hemoglobin Loss (5 days after surgery)
B: Blood loss in postoperative drainage. (Blood loss in 24 hours postoperative drainage)
C: Blood transfusion rate (participants will be followed for the duration of hospital stay, an expected average of 5 days)
D: Number of Patients Managed With Blood Transfusion (daily during hospital stay (an expected average of 4 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.

The investigators assume equal improvement of physical function in both groups and reduced costs with conservative treatment.


Options:
A: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)
B: International Knee Documentation Committee 'Subjective Knee Form' (3, 6, 12, 24 and 60 months)
C: KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale (12 month)
D: KOOS4 - Change From Baseline (24 months); Peak Torque Knee Extension - Change From Baseline (at 3 months); Peak Torque Knee Flexion - Change From Baseline (3 months); Knee Osteoarthritis Incidence (5 years); Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years] (10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.

The investigators assume equal improvement of physical function in both groups and reduced costs with conservative treatment.


Options:
A: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)
B: Knee injury and Osteoarthritis Outcome Score - KOOS (2 year follow-up)
C: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)
D: International Knee Documentation Committee 'Subjective Knee Form' (3, 6, 12, 24 and 60 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial
Brief Summary: The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives

Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR\>60 mL/min per 1.73m2) and according to baseline office BP.

Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.


Options:
A: Change in BP (measured by ABPM) (6 months)
B: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)
C: Freedom of AF or other atrial arrhythmias (1 year)
D: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial
Brief Summary: The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives

Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR\>60 mL/min per 1.73m2) and according to baseline office BP.

Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.


Options:
A: To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. (3 years)
B: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
C: Change in BP (measured by ABPM) (6 months)
D: To investigate the combined effect of aliskiren and valsartan on vascular structure, assessed by wall to lumen ratio of retinal arterioles, in hypertensive patients. (After 8 weeks of treatment with aliskiren versus placebo)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
Brief Summary: Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed.

Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%.

The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study.

Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time.

Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.


Options:
A: Incidence of AKI within the 7 days after the surgery (Within 7 days after the surgery)
B: Peak post-operative troponin (ng/L) (At 6-12, 24, 48, 72h)
C: Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. (Within six months after carotid artery stenting); Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. (Within 48 hours after carotid artery stenting.)
D: Troponin I Elevation Above the Upper Reference Limit (URL) (Within 3 days of the vascular operation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)
C: Sustained Virological Response (SVR12) (60 weeks)
D: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive (At 12 weeks post-treatment)

Answer: B