TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)
Brief Summary: The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb \< 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb \< 7 gm/dl).


Options:
A: Methodology of the pilot study (up to 30 days)
B: Timed Up and Go-test (TUG)in seconds. (30 days)
C: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
D: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome.
Brief Summary: This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS). The purpose of this study is to find out whether BI 409306 helps reduce the symptoms of APS.

Participants are in the study for 1 year and 2 months. During this time, they visit the study site about 15 times and get about 10 phone calls. Participants are put into 2 groups by chance. They get either BI 409306 or placebo. Placebo tablets look like BI 409306 tablets but do not contain any medicine. Participants take a BI 409306 or placebo tablet two times a day.

During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether the APS symptoms change. The doctors also check the general health of the participants.


Options:
A: Brief Assessment of Cognition in Schizophrenia (BACS) (6 and 12 months)
B: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
C: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
D: Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe (Up to 52 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)
Brief Summary: Study purpose This study will explore whether an additional rehabilitation program that focus on either upper or lower extremity training facilitate the recovery in upper or lower extremity.

The recovery in both neurological status and motor functions will be explored.


Options:
A: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
B: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
C: Fugl-Meyer Assessment (upper extremity subscale) (0-, 4- week)
D: Fatigue relief (assessed by the Fatigue Severity Scale) (4 months after the stroke)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)
Brief Summary: Study purpose This study will explore whether an additional rehabilitation program that focus on either upper or lower extremity training facilitate the recovery in upper or lower extremity.

The recovery in both neurological status and motor functions will be explored.


Options:
A: Change in Behavioural Inattention Test (BIT) (6 months post intervention)
B: Changes in cortical excitability measures (Measured for approximately 6 weeks)
C: Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
D: Fugl-Meyer Assessment (upper extremity subscale) (0-, 4- week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Brief Summary: Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth. This study uses rigorous scientific methods to measure the effects and determine the mechanisms of action of a parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable to a wide variety of neonatal environments, even when parents cannot be at their child's bedside. The intervention aims to improve brain multisensory processing, reactions to sensory stimulation in the home and long term language and motor development.


Options:
A: Bonding between primary caregiver and infant (6 months)
B: Index of Multisensory Processing (IMP) (At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation)
C: Brain volume (40 gestational weeks)
D: Heart rate (Change from Baseline Heart rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Respiratory rate (Change from Baseline Respiratory rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Oxygen Saturation (Change from Baseline Oxygen Saturation at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Respond of Pain (Change from Baseline Pain at 3 minutes before, during, and at the first and 10th minute after heel lance procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Brief Summary: Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth. This study uses rigorous scientific methods to measure the effects and determine the mechanisms of action of a parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable to a wide variety of neonatal environments, even when parents cannot be at their child's bedside. The intervention aims to improve brain multisensory processing, reactions to sensory stimulation in the home and long term language and motor development.


Options:
A: Cognitive and behavioral outcome; Parenting Stress
B: Index of Multisensory Processing (IMP) (At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation)
C: Birth admission length of stay (Hospital length of stay in days, expected to range between 14 and 24 days; some infants may require a longer admission)
D: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies
Brief Summary: This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy and NKTR-255, and to see how well they work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. Giving CD19/CD22-CAR T cells and chemotherapy in combination with NKTR-255 may work better in treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia.


Options:
A: Response rate and toxicity (6 months)
B: Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/CD22 chimeric antigen receptor (CAR) T cells (Up to 28 days); Maximum tolerated dose of CD19/CD22 chimeric antigen receptor (CAR) T cells defined as the dose level immediately below the level at which the enrollment is stopped due to a dose limiting toxicity (Up to 28 days); Rate of successful manufacture and expansion of the CD19/CD22 chimeric antigen receptor (CAR) T cells to satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (Up to 15 years)
C: Incidence of adverse events defined as graft failure, grade 3, 4 graft versus host disease, grade 3,4 cytokine release syndrome, grade 3, 4, neuro-toxicity, or death from any cause (Up to 30 days within natural killer (NK) cell infusion); Complete response (CR) or partial response (PR) (At day 30 post NK cell infusion)
D: Phase I: Determination of the maximum tolerated dose (MTD); Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CareToy: a Smart System for Early Home-based Intervention in Infants at High Risk for Cerebral Palsy
Brief Summary: Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood disabilities with high cost for individuals and society. Early Intervention (EI), if intensive enough but affordable by patients, family and health services can improve its outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in gross and fine motor skills, visual development and parent infants interaction in preterm infants. Recently, a new technological tool, called CareToy has been developed as a tele-rehabilitation tool for delivering at home EI. The effects of CT training on neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants with very promising results. The aim of the project is to provide evidence, by a RCT, of the efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12 months (or with motor competencies from initial head control to unstable sitting position) at high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group will perform a training with CT while the others will perform infant massage. Both trainings will be carried out at home by parents with the monitoring of the therapists. Both interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9 wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant Motor Profile will be the primary outcome measure.


Options:
A: neurodevelopmental outcome (one year corrected age)
B: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)
C: Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores (6 months)
D: Changes in Infant Motor Profile (IMP) (Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!
Brief Summary: Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.


Options:
A: change from baseline in meeting physical activity recommendation at 1 month (baseline and 1 month); change from baseline in physical activity recommendation at 7 months (baseline and 7 months); change from baseline in meeting screen time recommendation at 1 month (baseline and 1 month); change from baseline in meeting screen time recommendation at 7 month (baseline and 7 month)
B: Body fat percentage (One year (interim analysis))
C: Executive function accuracy (Up to 8 months)
D: Executive function (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial
Brief Summary: Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor impairments are present in 67% of the stroke patients, resulting in problems with independency and performance of activities of daily life. In addition, the pattern of recovery in the brain is still a matter of ongoing debate. Although the importance of somatosensory function on motor performance is well described, evidence for somatosensory or sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the effect of a sensorimotor therapy compared to pure motor therapy on motor function of the upper limb. A second objective is to investigate therapy-induced brain-behavior associations using resting state functional Magnetic Resonance Imaging of the brain.


Options:
A: Action Research Arm Test (within 4 months post stroke)
B: Change score in Behaviorial Inattention Test (BIT) - Chinese version (Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)
C: Change in the Posner reaction times (The primary outcome variable is measured at 8 timepoints: First timepoint = Baseline (pre-intervention), Timepoints 2 until 6 = during intervention, Timepoint 7 = immediately after intervention, Timepoint 8 = 1 week after intervention.)
D: Change in excitability of fronto-parietal connectivity (Participants will be assessed at baseline and 30 minutes later)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
Brief Summary: The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.


Options:
A: Number of Health risk behaviors (3 months); Number of risk behaviors counseled on during primary care appointment (1 day)
B: Decision quality (40 to 52 weeks after baseline)
C: Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI) (Baseline and Month 12)
D: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: GP Practice Based Pharmacist Input to Medicines Optimisation
Brief Summary: The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of a medication optimisation intervention (delivered in GP practices by pharmacists to patients at risk of medication related problems), on healthcare resource utilisation and patient outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will engage with patients, thought to be at a higher risk of medication related problems, within their GP practice in order to help identify areas for improvement


Options:
A: Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI) (12 months); Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #2: change in the Assessment of Underutilization (AOU) (12 months)
B: Number of unplanned hospital admissions (Recruitment - 6 months post intervention); Number of A&E attendances (Recruitment - 6 months post intervention); Number of GP consultations (Recruitment - 6 months post intervention)
C: Successful medication discontinuation (4 months)
D: Medication Appropriateness Index (MAI)-Score (6 months from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Teledermatology Mobile Apps: Implementation and Impact on Veterans' Access to Dermatology
Brief Summary: This study was designed to measure the impact of two teledermatology apps to provide direct to patient teledermatology follow up care, Patient Viewer and My VA Images, with a trial on access to dermatology care. The overall hypothesis was that sites implementing Department of Veterans Affairs' (VA) teledermatology mobile apps would significantly augment the use of teledermatology and improve Veterans' access to skin care relative to control sites. Specifically, the investigators hypothesized that these apps would improve established patients' ability to follow-up with dermatology care remotely, reducing patient travel to dermatology clinics while opening up dermatology clinic space for other patients. Due to a lack of participation by sites during the study which was conducted during the novel coronavirus (COVID-19) pandemic, the groups examined are Veterans who live in rural areas compared to those in urban areas.

Previously the study included a parallel trial to evaluate another teledermatology mobile app, VA Telederm. This trial was no longer feasible within this study's funding timeline due to limitations imposed on the mobile app by Office of Information \& Technology that were not under the control of the PI or the operational partner, Office of Connected Care (OCC).


Options:
A: Intervention-related adverse events (1 day)
B: Total Number of Participants That Successfully Completed Remote Follow up (1 year 4 months); Total Number of Participants Who Ever Completed Remote Follow-up Requests (1 year 4 months)
C: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))
D: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Megestrol Acetate Plus LNG-IUS to Megestrol Acetate or LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
Brief Summary: To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate or LNG-IUS alone in patients with endometrial atypical hyperplasia.


Options:
A: Regression of hyperplasia related to treatment arm after 6 months of therapy (Six months)
B: Regression and remission rate of endometrial hyperplasia (3 month)
C: Pathologic Response (6-12 months); Pregnancy Rate (7-144 months); Live Birth Rate (16-144 months)
D: Pathological response rate (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months); Pathological response time (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Avoiding Anticoagulation After IntraCerebral Haemorrhage
Brief Summary: Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH). Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an intracerebral haemorrhage.

Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid anticoagulation and LAAC.


Options:
A: Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events (within 24 months after randomization.)
B: Number of patients who experience the combination of vascular death or non-fatal stroke (cerebral infarction, intracerebral haemorrhage, or subarachnoid haemorrhage) (Throughout the study. Patients will be followed up between 12 (minimum) and 72 (maximum) months.)
C: Stroke or Systemic Embolism (From randomization until the common study end date (average of 3 years)); Major hemorrhage (From randomization until the common study end date (median 2 years))
D: Combined endpoint: stroke OR systemic cardioembolic event OR clinically significant bleeding OR cardiovascular death OR procedure or device-related complications (From the date of randomization until the date of 6 month follow-up visit of the last enrolled patient)

Answer: A