TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Mental Health Through Integration With Primary Care in Rural Karnataka
Brief Summary: This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model.


Options:
A: incidence of dually diagnosed participants (1 year); anxiety or depression (1 year); blood glucose control (1 year); blood pressure (1 year); cholesterol (1 year)
B: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
C: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
D: Savings and asset-accumulation (12-month post-intervention); Educational outcomes (12-month post-intervention); Sexual risk taking (12-month post-intervention); Savings and asset-accumulation (24-month post-intervention); Educational outcomes (24-month post-intervention); Sexual risk taking (24-month post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Point-of-care Versus Standard Coagulation Tests Versus Restrictive Strategy to Guide Transfusion in Chronic Liver Failure Patients Requiring Central Venous Line: Prospective Randomized Trial
Brief Summary: The aim of this study is to compare three different blood transfusion strategies for coagulopathy correction before central venous catheterization in patients with chronic liver failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.


Options:
A: Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures (Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26)
B: Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization (Day of randomization)
C: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
D: Point Of Care (POC) Transfusion Algorithm Cardiac Study (2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
Brief Summary: In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. It is expected that 78 couples of becoming first time parents are recruited. It is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.


Options:
A: Psychopathology (3 months)
B: Change in family economic hardship (Quarterly change for up to 15 months)
C: Number of symptoms on the BSI 18 and the PFB-K (Before birth (T1), two months after birth (T2)); Severity rating (0-8) of regulatory problems in infants (six months after birth (T3))
D: Change in PTSI symptoms (Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg
Brief Summary: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.


Options:
A: Incidence Rate of the Composite Efficacy Outcome (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days)); Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days))
B: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
C: Safety of nadroparine or heparin (DAY 3,7,30,90); Efficacy of nadroparine or heparin (DAY 3,7, 30, 90)
D: New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death (every 4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg
Brief Summary: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.


Options:
A: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
B: Incidence Rate of the Composite Efficacy Outcome (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days)); Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days))
C: Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (90 days)
D: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
Brief Summary: The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.


Options:
A: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
B: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
C: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
D: overall cognition (2 Monhths)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
Brief Summary: The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.


Options:
A: overall cognition (2 Monhths)
B: Working Memory function. (Changes from baseline (3, 6 and 12 months after intervention).)
C: Aggregate Cognitive Performance (Baseline to 10 weeks)
D: sleep measures (3-6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
Brief Summary: The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.


Options:
A: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
B: overall cognition (2 Monhths)
C: Useful Field of View Test (12 months)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
Brief Summary: The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.


Options:
A: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
B: overall cognition (2 Monhths)
C: Working Memory function. (Changes from baseline (3, 6 and 12 months after intervention).)
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Brief Summary: To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude


Options:
A: Visual Analogic Scale Low Back pain (Month 6)
B: Visual Analog Scale (VAS) on Back Pain (12 weeks)
C: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline (90 days post activation)
D: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics
Brief Summary: The aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis.

The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.


Options:
A: Treatment Failure (4-6 weeks)
B: Time-to-full-recovery (6 months follow-up)
C: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
D: Readmission ratio (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Study of an Interactive, Educational Programme to Facilitate Proactive Assessment of Overweight Risk During Infancy
Brief Summary: Children who are above healthy weight are more likely to be ill and to miss time off school. Being overweight in childhood can also sow the seeds for health problems in later life such as heart disease and diabetes. Most overweight children become overweight adults. One solution is to try to prevent children becoming overweight by intervening very early in life. The risk factors for childhood overweight are known and this project aims to facilitate parents' (and other carers') understanding about this for their infant and to enable them to access intervention. UK health visitors (public health nurses) will use an interactive, multimedia programme (Proactive Assessment of Overweight Risk during infancy (ProAsk)), with parents to calculate their infant's risk and to discuss strategies for risk reduction as appropriate. Health visitors will be trained to communicate obesity risk and in Motivational Interviewing techniques to enable them to offer intervention to parents of infants identified as at risk.

A feasibility study of ProAsk will take place in two health provider organisations in the UK. The purpose of this is to a) determine the acceptability and utility of the ProAsk intervention with health visitors and parents and b) gather information to inform the trial design and data collection procedures for a future Randomised Controlled Trial (RCT).


Options:
A: Lost to Follow-up (12 months)
B: Acceptability and utility of the ProAsk intervention (12 months)
C: Blood glucose control with changes in Glycated hemoglobin (HbA1c) values (At the baseline and at the end of the intervention (3 months))
D: antiretroviral treatment (primary) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
Brief Summary: Lohja Depression Treatment Study is a randomized treatment trial which compares three approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2) Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to test and adapt known short term treatment models for Finnish patients and circumstances.


Options:
A: Change from baseline Hamilton Rating Scale for Depression at 12 months (12 months)
B: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))
C: Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) (Baseline and Week 8 (or ET))
D: Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II) (0- 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
Brief Summary: The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing lavages with normal saline (Group 1), patients undergoing lavage gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution (Group 3). Drainage volume discharge is investigated


Options:
A: Drainage volume discharge (14 days)
B: Intra-operative nausea (intra-operative)
C: Drainage volume (7 days)
D: Surgical site infection (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Vibrational Force and Orthodontic Tooth Movement: a Randomised Controlled Trial
Brief Summary: The aim of this study is to compare the clinical efficiency of conventional fixed appliance orthodontic treatment with that supplemented by the daily application of cyclic forces to the dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root length.


Options:
A: Duration of fixed appliance orthodontic treatment (Completion of orthodontic treatment, an expected average of 24 months.)
B: Orthodontic tooth movement (incisor alignment) (2-12 months from start)
C: Changes in the Expression of Salivary Biomarkers of Bone Remodeling (Up to Week 17 of alignment (From T0 to T3)); Alignment of Mandibular Anterior Teeth (Up to Week 17)
D: The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. (Time to Space Closure, an average of 22 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Vibrational Force and Orthodontic Tooth Movement: a Randomised Controlled Trial
Brief Summary: The aim of this study is to compare the clinical efficiency of conventional fixed appliance orthodontic treatment with that supplemented by the daily application of cyclic forces to the dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root length.


Options:
A: 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.)
B: Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts) (5 months)
C: Orthodontic tooth movement (incisor alignment) (2-12 months from start)
D: Primary outcome (Alignment efficiency) (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema
Brief Summary: The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to receive treatment with open-label CSL830 for up to an additional 88 weeks.


Options:
A: Part 1: The Rate of Expert-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 1: 24 weeks (Week 0 to 24 to 52), Part 2: 28 weeks (Week 24 to 52)); Part 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat Administered QD Over a 52- to up to 104-week Administration Period in Subjects With HAE. (Part 3: Week 52 to up to Week 104.)
B: Person-time Incidence Rates (Subject Based) (Up to 146 weeks.); The Person-time Incidence Rates (Event Based) (Up to 146 weeks.)
C: Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period (12 weeks)
D: Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) (From Day 1 up to final follow-up (Day 123))

Answer: B