TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-related Cognitive Decline: Effects of Video Game Training on Behavioral and Neuroimaging Measures of Attention and Memory
Brief Summary: Neuroplasticity-based approaches seem very promising to maintain cognitive health in older adults and postpone the onset of cognitive-decline and dementia symptoms. The aims of this project are threefold:

1. the evaluation of the effects of a neuroplasticity-based-cognitive randomized computer-based intervention consisting in training with non-action video games on brain and cognitive functions that decline with ageing, including attention and spatial working memory (WM), in older adults using behavioral measures and electrophysiological recordings (event-related potentials -ERPs- and event-related spectral perturbations -ERSPs);
2. the study of the effects of age and 3 months maintenance on the cognitive and neural signatures of transfer effects to attentional and spatial WM tasks; and
3. to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in saliva from participants underlying cognitive training-induced effects.

A better understanding of these mechanisms elucidates pathways that may be targeted in the future, either by behavioral or neuropsychological interventions. To achieve these aims, the investigators will recruit between 60-80 older adults volunteers to participate in the randomized, controlled, single-blind study. After screening, participants will be randomly distributed in one of these two groups: experimental and active control. Participants in the experimental group will receive 16 1 hour computerized training with non-action video games. The active control group will receive 16 1 hour training sessions with a social video game. The design is a mixed factorial design with type of intervention (experimental, active control) and assessment session (pre, post, maintenance). The results from the proposed research project will clarify the existence of transfer-of-benefit and neural mechanisms underlying cognitive improvement. The hypothesis is that mental stimulation through non-action video games will improve attention and memory, promoting brain and mental health, and extending independence among elderly people by avoiding the negative personal and economic consequences of long-term care.


Options:
A: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)
B: Change in cognitive function summary score (12 weeks)
C: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
D: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk
Brief Summary: TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (\>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.


Options:
A: Blood Volume Loss (24 hours postpartum.)
B: Incidence of PPH (24 hours after birth)
C: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
D: Bleeding (between inclusion (T0) and 6 hours after inclusion (T360).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.
Brief Summary: Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin in Chinese pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical characteristics aiming to reduce the incidence of preeclampsia.


Options:
A: Number of Participants With Preeclampsia (within 3 months prior to delivery)
B: Pregnancy rate (Five weeks after embryo transfer)
C: Prevention of preeclampsia (6 months)
D: Delivery with preterm-preeclampsia (Before 37 weeks of gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
Brief Summary: Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.


Options:
A: Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks (0, 4, 8, 12, 16 weeks)
B: Objective 1: clinical manifestations (lifetime of protocol); Objective 2: behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates (lifetime of protocol); Objective 3: genetic and familial correlates (lifetime of protocol)
C: Child Behaviour Check List (CBCL) (12 months)
D: Aberrant Behavior Checklist scale (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Aerobic Training on Physical Activity Levels and Sedentary Behavior in Subjects Post-stroke: a Randomized Controlled Trial
Brief Summary: Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Therefore, the primary objective will be to investigate the effects of aerobic treadmill training on physical activity levels and sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation.

A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve), or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4 participants, by a trained physiotherapist. Primary outcomes: physical activity levels and sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the trainings will be analyzed from the collected data and intention-to-treat analysis. Between-groups differences will be measured by two-way ANOVA with repeated measures considering the baseline, post-training, and a 4-week follow-up.

The results of this trial will likely provide valuable new information about the effects of aerobic treadmill training in improving physical activity levels and sedentary behavior, through changes in cardiorespiratory fitness, for individuals following stroke.


Options:
A: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)
B: Ambulatory Activity Profile (6 months)
C: Change from baseline in Physical activity levels - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in Physical activity levels - Human Activity Profile (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in sedentary behavior - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up)
D: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Aerobic Training on Physical Activity Levels and Sedentary Behavior in Subjects Post-stroke: a Randomized Controlled Trial
Brief Summary: Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Therefore, the primary objective will be to investigate the effects of aerobic treadmill training on physical activity levels and sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation.

A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve), or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4 participants, by a trained physiotherapist. Primary outcomes: physical activity levels and sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the trainings will be analyzed from the collected data and intention-to-treat analysis. Between-groups differences will be measured by two-way ANOVA with repeated measures considering the baseline, post-training, and a 4-week follow-up.

The results of this trial will likely provide valuable new information about the effects of aerobic treadmill training in improving physical activity levels and sedentary behavior, through changes in cardiorespiratory fitness, for individuals following stroke.


Options:
A: Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE) (before and after 4 weeks intervention)
B: Motor Assessment Scale (18 months after inclusion)
C: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)
D: Change from baseline in Physical activity levels - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in Physical activity levels - Human Activity Profile (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in sedentary behavior - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The present study is designed to determine whether adjuvant concurrent chemoradiotherapy improves overall survivals.


Options:
A: overall survival (24 months)
B: Disease free survival (DFS) (Disease free survival rate at 24 months (DFSR@24))
C: Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 (One year)
D: Progression-free survival (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dental Arches Response to Haas-type RME Anchored to Deciduous vs Permanent Molars in Children With Unilateral Posterior Crossbite
Brief Summary: Posterior crossbite is a common clinical condition often associated with transverse maxillary deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting and can lead to the development of craniofacial asymmetries and mandibular dysfunction.

The aim of the current study was to evaluate maxillary and mandibular arch widths' response to RME when it is anchored to the upper second deciduous molars or to the upper first permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition patients.


Options:
A: Primary outcome (Alignment efficiency) (2 months)
B: Orthodontic tooth movement (incisor alignment) (2-12 months from start)
C: Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts) (5 months)
D: Duration of tooth alignment (This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation); Change in Tooth Alignment at one month (Little Index of Irregularity will be measured at 30 days after the onset of treatment.); Change in Tooth Alignment at two months (Little Index of Irregularity will be measured at 60 days after the onset of treatment.); Change in Tooth Alignment at last assessment time (Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial
Brief Summary: This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.


Options:
A: N/A
B: Incidence of postoperative nausea and vomiting (48 hours postoperative)
C: Cumulative 24 Hour Oral Morphine Equivalent Consumption (24 hours (Day 1))
D: Post-operative Nausea or Vomiting (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating a Technology-augmented Self-monitoring Model for Glycemic and Blood Pressure Control and Medication Adherence in Type 2 Diabetes and Hypertension Patients: a Randomized Controlled Trial
Brief Summary: Objective: To develop and evaluate a technology-augmented self-monitoring model using a randomized controlled trial to demonstrate whether patients with co-morbid type 2 diabetes mellitus and hypertension can improve their glycemic and blood pressure control, adherence to medication regimens, and other relevant outcomes by using a tablet-based consumer health information technology (CHIT) to support the self-monitoring and self-management of their chronic conditions.

Design: A two-group, randomized controlled trial with follow-up assessments 8, 12, 16, and 24 weeks after the baseline evaluation.

Setting: Patients' homes.

Participants: Two hundred and ninety-six adult patients with type 2 diabetes mellitus and hypertension who receive their health care from a local community health service network or a major hospital will be recruited.

Interventions: Participants in the technology-augmented self-monitoring model (intervention group) will use a tablet-based, interactive touch screen self-monitoring system to monitor and manage their chronic conditions. The system is designed to augment patients' abilities to assess, record, and review their health signs while providing text-, audio-, and video-based resources supporting disease self-care. The participants in the usual-care group will perform conventional self-monitoring.

Outcome measures: The primary outcomes will be glycemic control measured by changes in HbA1c,blood pressure control assessed by changes in systolic and diastolic blood pressure, and medication compliance. The secondary outcomes will be adherence to diabetes and hypertension self-care activities and knowledge of diabetes and hypertension.

Implication: This study will improve our understanding of the clinical value of CHITs in chronic disease self-monitoring and self-management.


Options:
A: glycosolated hemoglobin (HbA1c) levels (one year)
B: Hemoglobin A1c (6 and 12 months)
C: Changes in HbA1c (Baseline, 16 weeks, 32 weeks, 6 months after intervention)
D: changes in HbA1c (from baseline to 12 and 24 weeks); changes in systolic and diastolic blood pressure (from baseline to 8, 16, and 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial
Brief Summary: For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent studies from Europe have challenged the notion that surgery is the best option, showing that antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out of 4 patients and without safety issues for up to one year of follow up. Despite these results, it remains to be determined if the antibiotic strategy is as good as an appendectomy for the outcomes that most patients care about. The Patient-Centered Outcomes Research Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will be the first American, and largest-ever randomized trial of the issue and its results should help surgeons and patients make more informed healthcare decisions.


Options:
A: rate of intra abdominal infections in both therapeutic strategies (30 days)
B: Patient-reported Quality of Life as Measured by EuroQol (EQ-5D) (Four-weeks after randomization)
C: Negative Appendectomy (1 week after surgery)
D: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids in utero.


Options:
A: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)
B: Length of Hospitalization (Up to 4 months)
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Number of Participants Administered Morphine Treatment (Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days); Cumulative Pharmacological Treatment- Morphine Dose (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Hospitalization Length of Stay (Day of life infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Untreated Infants (Day of life untreated infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Treated Infants (Day of life treated infants discharged home, which is an expected mean of 21 days.); Length of Pharmacological Treatment-Duration (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Trajectory of Symptom Severity Among Treated Infants (Day of life infant started morphine treatment); Velocity of Weight Gain (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Neurobehavioral Outcomes Assessment (6 month and 12 months of life)

Answer: D