TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.

Patients will be randomised in a 1:1:1 ratio to three treatment arms:

* Arm A: Paclitaxel 80 mg/mq every week
* Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
* Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks


Options:
A: UKCTOCS (2001-2014): Death due to ovarian cancer (WHO 2003) determined by independent outcomes committee review of patient notes for all women identified to have a 'possible ovarian cancer' (pre-specified ICD-10 codes) till 31st December 2014.; Long term impact of screening on ovarian cancer mortality in the UKCTOCS (LTFU UKCTOCS) (2015-2021): Death due to ovarian cancer (WHO 2014) determined by independent outcomes committee review till 30 June 2020.
B: objective response rate by RECIST 1.1 (6 months after treatment initiation)
C: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
D: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Altering The Transition From Acute to Chronic Pain (ATTAC-Pain): A Randomized Clinical Trial of Duloxetine for the Treatment and Prevention of Musculoskeletal Pain
Brief Summary: The current way that pain is treated after trauma and injury is problematic. Most often pain after trauma is treated with opioids (ex. Percocet® or Vicodin®) or anti-inflammatories (ex. ibuprofen). Both of these medications can cause side effects and opioids have been related to the development of addiction. In addition, there are not any treatments that prevent pain from going on to become persistent (last beyond it is supposed to) or chronic (lasting 3 months or longer).

Chronic pain is an enormous problem and there an urgent need to find both alternatives to opioid pain medications and medications that prevent pain from becoming chronic. The ATTAC-Pain (Altering The Transition from Acute to Chronic Pain) study proposes to examine whether duloxetine (a medication that is marketed for depression, anxiety, and specific types of pain conditions), can reduce acute and chronic pain among adults who come to the emergency department (ED)with muscular pain (such as neck pain after a car accident or low back pain). Investigators will enroll 60 patients who come to the ED. Patients will be eligible if they report moderate to severe muscular pain (such as pain in the back, neck, or shoulders). Consenting patients will be randomized to receive duloxetine 30mg, duloxetine 60mg, or placebo (2/3rd chance of being in one of the duloxetine groups). The study team will follow patients for six weeks and collect information on pain outcomes and use of pain medications. Investigators aim to determine if duloxetine can (1) reduce acute pain symptoms following the ED visit, (2) prevent the transition to persistent pain (having pain 6 weeks after the initial ED visit), and (3) decrease opioid use following a motor vehicle collision (MVC). The results of this study will ultimately help determine if duloxetine can be used as a non-opioid pain treatment option that reduces acute pain and prevents the transition to chronic pain. This in turn can improve recovery, reduce opioid use and its consequences, and decrease health care costs.


Options:
A: Composite responder analysis based on pain and patient global status, with or without physical function.
B: Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score (Baseline, 12 weeks)
C: Self-reported axial pain (0 - 10 numeric rating scale) (through 6 weeks after enrollment visit)
D: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center, Parallel Control Phase 3 Study to Compare the Efficacy and Safety of Full Human Anti-TNF Alpha Antibody (HLX03) Versus Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis
Brief Summary: This is a multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and adalimumab (Humira) in subjects with moderate to severe plaque psoriasis. This study will recruit 216 subjects (18-75 years old, male and female) with moderate to severe plaque psoriasis. The 216 subjects will be randomly assigned per 1:1 ratio into the following two treatment groups (HLX03 OR Adalimumab). The study will be conducted in three periods, including the screening period, treatment period and follow-up period. For each participating subjects, the maximal length of the study will be 56 weeks (including up to four weeks of screening time).


Options:
A: Percentage improvement of PASI from baseline to Week 16 (Week 16)
B: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
D: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
Brief Summary: The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients


Options:
A: Reduction of ICU delirium duration assessed by ICDSC checklist (during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided)
B: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
C: Delirium/Coma-free Days (DCFDs) (14 days)
D: duration of agitation (in hours), defined by a RASS ≥ +1 (at day 1); duration of delirium (in days), defined by a positive CAM-ICU (at day 1); delay (in hours) between inclusion and intubation requirement to control delirium with deep sedation and mechanical ventilation (at day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation: a Randomized Controlled Exploratory Study (CANVAS-Ⅱ)
Brief Summary: There is few randomized controlled clinical to investigated the impact of anesthetic type on outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is unknown whether the choice of anesthesia is impacted on the outcomes for these patients or not. The investigators will perform a randomized controlled pilot clinical trial of general anesthesia versus local anesthesia/conscious sedation to explore and find out a potential fact whether anesthetic type alters perioperative neurological function in patients with acute ischemic stroke in posterior cerebral circulation.


Options:
A: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
B: modified rankin score（mRS） (post-procedural 90 days)
C: Score on the modified Rankin scale (3 months)
D: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
Brief Summary: A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with \<20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).


Options:
A: Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function (Baseline (pre-randomization) and 12 months)
B: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Six minute walk test (walking ability) (1-3 months); Functional Independence Measure (1-3 months); Functional Ambulation Category (1-3 months)
D: Difference in the percentage of patients who Door-to-Needle Time≤60min (Up to 24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
Brief Summary: A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with \<20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).


Options:
A: Six minute walk test (walking ability) (1-3 months); Functional Independence Measure (1-3 months); Functional Ambulation Category (1-3 months)
B: Difference in the percentage of patients who Door-to-Needle Time≤60min (Up to 24 hours)
C: Mortality (30 days after hospital admission)
D: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Measurement and Treatment of Post-stroke Neglect
Brief Summary: This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.


Options:
A: Neglect symptom severity (neuropsychological test performance) (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)); Neglect-related functional disability (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22))
B: Change in excitability of fronto-parietal connectivity (Participants will be assessed at baseline and 30 minutes later)
C: Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Corsi block tapping test from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Star Cancellation test from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up))
D: Change of Repeatable Battery for the Assessment of Neuropsychological Status (Up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
Brief Summary: Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices).

The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.


Options:
A: Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups (At 6 months)
B: Framingham Risk Score (15 months)
C: Composite endpoint death and cardiovascular events (1-year after randomization); Hospitalization (1-year after randomization); Composite endpoint death and broader cardiovascular events (1-year after randomization)
D: Change in proportion of patients taking oral anticoagulants (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
Brief Summary: Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices).

The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.


Options:
A: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) (At 1 year from the time of initiation of the intervention); Mean HbA1c (At 1 year from the time of initiation of the intervention)
B: Changes in mean SBP (From baseline (T1) to 12 months (T3))
C: Blood Pressure (one year)
D: Composite endpoint death and cardiovascular events (1-year after randomization); Hospitalization (1-year after randomization); Composite endpoint death and broader cardiovascular events (1-year after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
Brief Summary: The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type stimulant (ATS) addiction.


Options:
A: Reduction in Condomless Anal Sex Acts (CAS) over study follow-up (Baseline, 4 month, 8 month, 12 month)
B: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months (Baseline, 1 month, 3 month and 6 months)
C: Longest Duaration of Achieved Abstinance (12 weeks of treatment); Percentage Samples Submitted Negative for Crack Cocaine Use (12 weeks); Number of Participants Completing 4, 8 and 12 Weeks of Treatment (Number of participant retained in treatment at weeks 4, 8 and 12.); Treatment Attendance (12 weeks)
D: HIV Viral Load (15 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Severity of Co-morbidity on Outcomes of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients
Brief Summary: Our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes.


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: Exercise Capacity (6 minute)
C: Maximum Plasma Concentration at Steady-state (Cmax,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.); Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.)
D: Quality of Life as Measured by SF-36 (Baseline, 6 months)

Answer: B