TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Brief Summary: Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.

The investigators wish to explore various hypotheses:

1. Is exercise intervention feasible and tolerable in this cohort of patients?
2. Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
3. Can SRETP improve quality of life?
4. Can SRETP improve physical activity?
5. Can SRETP improve surgical outcome?
6. Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.

The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.


Options:
A: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)
B: The incidence of postoperative complications, classified by Clavien Scale (Time Frame: 30days or the postoperative hospital stay if longer than 30 days)
C: Oxygen consumption (VO2) (4 weeks (before surgery))
D: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Brief Summary: Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.

The investigators wish to explore various hypotheses:

1. Is exercise intervention feasible and tolerable in this cohort of patients?
2. Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
3. Can SRETP improve quality of life?
4. Can SRETP improve physical activity?
5. Can SRETP improve surgical outcome?
6. Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.

The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.


Options:
A: Change in physical fitness measured by CPET (ml/kg/min) (Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP)
B: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))
C: The change of 6MWD observed between pre-and post radical treatment (12 weeks); between post radical treatment and after a 12 week resistance training (12 weeks)
D: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
Brief Summary: The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.


Options:
A: At-risk drinking at 6 month followup (6 months); At-risk drinking at 12 month followup (12 months)
B: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
C: Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (6 and 12 months)
D: Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization (Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Brief Summary: Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. Recent studies demonstrate that the presence of PVT is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis.

However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was clearly recommended due to the absence of randomized controlled trials.


Options:
A: recurrence rate of variceal hemorrhage (Participants will be followed for up to 6 months starting from the date of randomization.)
B: Recurrence of variceal bleeding and patient survival (12 months)
C: Number of participants with variceal rebleeding (4 years)
D: Survival (10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Brief Summary: Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. Recent studies demonstrate that the presence of PVT is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis.

However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was clearly recommended due to the absence of randomized controlled trials.


Options:
A: Survival (10 years)
B: Number of survival without liver transplantation (2 years)
C: Survival (10 years)
D: Number of participants with variceal rebleeding (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Brief Summary: This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.


Options:
A: Absence of local recurrence at 3 years after start of treatment
B: Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS) (6 months); Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS) (6 months)
C: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
D: defect size after surgery (immediately after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration
Brief Summary: The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.


Options:
A: change in best-corrected visual acuity (6 months)
B: N/A
C: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
D: EDTRS visual acuity score (0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Selenium Supplementation on CD4 + Cell Recovery, Viral Suppression, Morbidity and Quality of Life of HIV Infected Patients in Rwanda: a Prospective, Double-Blinded, Placebo-Controlled Trial
Brief Summary: Study Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4 counts, decrease opportunistic infections, decrease viral loads and delay the need for initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.


Options:
A: Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART (Quarterly)
B: CD4 count (Baseline, 6, 12, 18, and 24 months)
C: Mortality
D: Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12 (Two time points (baseline and study week 12)); Flow Mediated Vasodilation (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-myocardial Infarction Patients With Elevated hsCRP
Brief Summary: Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events.

The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase.

Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS).

Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
C: Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components (From randomization, to end of treatment plus 30 days, up to approximately 6 years); Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery (24 months); Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits (From randomization up to approximately 6 years)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
Brief Summary: This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.


Options:
A: Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS (Every 3 months up to two years)
B: Overall Survival (OS) (From date of treatment start until date of death from any cause, up to 5 years 5 months)
C: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)
D: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: STAR: Solitaire FR Thrombectomy for Acute Revascularisation
Brief Summary: The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.


Options:
A: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
B: Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. (Immediately post procedure); Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). (90 Days)
C: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
D: Reperfusion at 24 hours (CT or MR perfusion imaging) (24 hours post stroke onset); Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) (3 days post stroke onset)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.


Options:
A: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
B: Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo. (Change from Visit 7 (Week 8) to Visit 10 (Week 16))
C: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)
D: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
Brief Summary: Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.


Options:
A: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
B: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
C: The differences of platelet aggregation according to the anti-platelet therapy. (14 days)
D: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke (From randomization to PACD, an average of 2.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
Brief Summary: This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately 116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma subjects in Arm B will be enrolled in an expanded safety portion of the study at the recommended phase 2 dose (RPTD) and schedule.


Options:
A: 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)
B: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study (Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)); Percentage of Participants With Best Overall Response in Phase II of the Study (by Cutoff Date: 31 March 2012 (within 3 years, 4 months))
C: Overall Survival (OS) (Up to approximately 11 years)
D: Time to Progression (At least 24 months following completion of therapy, an average of 5 years)

Answer: A