TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients Attending A&E Following a Suicide Attempt. A Pilot Study.
Brief Summary: Scotland has higher rates of suicide than other parts of the UK, an average rate of 15.1 per 100,000 in Scotland compared to 11.4 for England and Wales. The Scottish Government is committed to reducing suicide by 2013. Choose Life has led to staff in services such as Accident and Emergency (A\&E) receiving recent training in suicide prevention through ASIST and STORM.

Evidence for interventions specific to A\&E setting is limited despite the fact that this is the most likely point of first contact with health services for people at risk of this behaviour. Brief interventions that reduce repetition of self harm have not been particularly effective partly because of poor attendance and lack of focus on comorbidity. We propose to pilot an evaluation of a brief focused intervention, ENGAGE (based on MAnualised Cognitive Therapy,MACT, developed by the investigator (Kate Davidson) and Prof Ulrike Schmidt of the Institute of Psychiatry, London) for those who present at A\&E with a suicide attempt and who have a complex presentation - a combination of substance abuse and or personality disorder, all of which are recognized as high risk factors for suicide. ENGAGE will specifically encourage patients to seek appropriate services to meet their mental health needs. This pilot will allow us to assess the feasibility of a full scale study.


Options:
A: Suicide ideation (12 month)
B: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
C: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
D: The number of contacts with mental health services appropriate to the patient's needs. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
Brief Summary: Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. The investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two cohorts. The intervention lasted five months and consisted of eleven group sessions and weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (March and September 2005) and after five (July 2005 and January 2006) and eleven months (January and July 2006).


Options:
A: BMI (11 months)
B: Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 (10 weeks)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Change in Weight (Baseline, 3-, 6-, 9-, 12-, and 18-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal
Brief Summary: The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:

* screening on admission followed by isolation of MRSA+ patients
* screening on admission followed by isolation and decolonization of MRSA+ patients
* universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures.

The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.


Options:
A: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
B: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures (The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.)
C: To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring (until weaning of mechanical ventilation (average : 14 days))
D: ICU-Ecology (27 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal
Brief Summary: The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:

* screening on admission followed by isolation of MRSA+ patients
* screening on admission followed by isolation and decolonization of MRSA+ patients
* universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures.

The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.


Options:
A: Colonization with MRSA, VRE and ESBL (On admission); Colonization with MRSA, VRE and ESBL (During ICU stay)
B: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures (The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.)
C: Clinical: Primary blood stream infections and culture negative sepsis (Six Months); Microbiologic: Skin colonization from environment and endotracheal secretions (Six Months)
D: The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing (7 days after recieved 2% chlorhexidine wipes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
Brief Summary: The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.


Options:
A: amount of fluids collected in the operative bed by ultrasonography (participants will be followed for the duration of hospital stay, an expected average of 4 days)
B: The rate of patients with a Surgical site infection (30 days after surgery)
C: Device remains localized over corneal incision (24 hours post operative)
D: Incisional Surgical site infection (30 postoperative days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
Brief Summary: This is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy.

The hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.


Options:
A: Surgical site infection (30 days)
B: N/A
C: Post-operative infection (6 weeks)
D: changes in acute pain intensity from the baseline (at 2,4,6,12,24,36 and 48 hour postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Standard Cardiac Rehabilitation With Stress Management Training in Patients With Heart Disease
Brief Summary: The purpose of this study is to assess the extent to which combining exercise and stress management training (SMT) is more effective at improving biomarkers in vulnerable cardiac patients compared to exercise-based cardiac rehabilitation alone.


Options:
A: Clinician-rated posttraumatic stress level (3 months)
B: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
C: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
D: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Standard Cardiac Rehabilitation With Stress Management Training in Patients With Heart Disease
Brief Summary: The purpose of this study is to assess the extent to which combining exercise and stress management training (SMT) is more effective at improving biomarkers in vulnerable cardiac patients compared to exercise-based cardiac rehabilitation alone.


Options:
A: Reduction of the SCORE Risk Score (6 months after the intervention)
B: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
C: Change in total volume of weekly active energy expenditure (3 and 6 months)
D: VO2peak (baseline, after 12 weeks and after 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Standard Cardiac Rehabilitation With Stress Management Training in Patients With Heart Disease
Brief Summary: The purpose of this study is to assess the extent to which combining exercise and stress management training (SMT) is more effective at improving biomarkers in vulnerable cardiac patients compared to exercise-based cardiac rehabilitation alone.


Options:
A: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
B: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
C: Psychological distress (Within one year after the treatment)
D: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CAROTID: CAD Randomized Omega-3 Trial In Depression
Brief Summary: Depressive disorders are common in patients with Coronary Artery Disease (CAD), occurring in up to 47% of patients. Left untreated, these symptoms not only have a strong negative impact on quality-of-life, but also increase risk of future cardiac events and death. Unfortunately, about 64% of CAD patients do not respond to current antidepressant treatments. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are two omega-3 (ω-3) fatty acids found in fatty fish that are important for brain function. Recent evidence showed that depressed CAD patients have lower levels of EPA and DHA than non-depressed CAD patients. This information, taken together with the known roles of ω-3 fatty acids in brain function, suggests that deficiencies may contribute to depression. However, it is unknown if increasing consumption of ω-3 fatty acids would alleviate depression and improve quality of life. While intake of adequate levels of ω-3 fatty acids is difficult to obtain through diet, concentrated supplements containing EPA and DHA that are safe, readily available, and inexpensive are now obtainable in Canada. CAROTID (CAD Randomized Omega-3 Trial In Depression) will randomize patients with CAD, with and without depressive symptoms, after 6 months of cardiac rehabilitation and usual care to receive either ω-3 fatty acid supplements or placebo daily during their final 6 months of cardiac rehabilitation. The investigators hypothesize that CAD patients randomized to receive ω-3 fatty acid supplements will show greater improvement in depressive symptoms and quality-of-life over time. The investigators will also evaluate possible improvements in other important determinants of quality of life: memory and other cognitive abilities.


Options:
A: Cognitive function; Depression
B: Hamilton Rating Scale for Depression (HAMD) Changes (From Week 0 to Week 12)
C: Hamilton Rating Scale of Depression (HAM-D) (Baseline, Week 4, Week 8, Week 12)
D: Serum Fasting Blood Sugar(FBS) (Change from baseline at 10 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CAROTID: CAD Randomized Omega-3 Trial In Depression
Brief Summary: Depressive disorders are common in patients with Coronary Artery Disease (CAD), occurring in up to 47% of patients. Left untreated, these symptoms not only have a strong negative impact on quality-of-life, but also increase risk of future cardiac events and death. Unfortunately, about 64% of CAD patients do not respond to current antidepressant treatments. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are two omega-3 (ω-3) fatty acids found in fatty fish that are important for brain function. Recent evidence showed that depressed CAD patients have lower levels of EPA and DHA than non-depressed CAD patients. This information, taken together with the known roles of ω-3 fatty acids in brain function, suggests that deficiencies may contribute to depression. However, it is unknown if increasing consumption of ω-3 fatty acids would alleviate depression and improve quality of life. While intake of adequate levels of ω-3 fatty acids is difficult to obtain through diet, concentrated supplements containing EPA and DHA that are safe, readily available, and inexpensive are now obtainable in Canada. CAROTID (CAD Randomized Omega-3 Trial In Depression) will randomize patients with CAD, with and without depressive symptoms, after 6 months of cardiac rehabilitation and usual care to receive either ω-3 fatty acid supplements or placebo daily during their final 6 months of cardiac rehabilitation. The investigators hypothesize that CAD patients randomized to receive ω-3 fatty acid supplements will show greater improvement in depressive symptoms and quality-of-life over time. The investigators will also evaluate possible improvements in other important determinants of quality of life: memory and other cognitive abilities.


Options:
A: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
B: Hamilton Depression Rating Scale (Measured at 16 weeks)
C: Hamilton Rating Scale of Depression (HAM-D) (Baseline, Week 4, Week 8, Week 12)
D: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)
Brief Summary: The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.


Options:
A: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
C: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
D: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)
Brief Summary: The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.


Options:
A: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
C: The primary aim of the study is to compare the major hemorrhage risk between the use of LMWH plus thrombolytic treatment and UFH plus thrombolytic in the treatment of acute massive PE. (7 day)
D: Number of Patients With Clinically Relevant Bleeding Events (prior to day 90 +/- 5)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Cerebral Autoregulation Monitoring to Reduce Brain Injury From Cardiac Surgery
Brief Summary: Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life. New strategies of care are needed to avoid rising complications for the growing number of aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing brain injury during surgery from inadequate brain blood flow using techniques that could be widely employed.


Options:
A: composite of post-operative all-cause mortality and major complications (participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks)
B: Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. (Up to 6 weeks post-operative)
C: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (up to 10 days post procedure)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Incision Versus Laparoscopic Cholecystectomy
Brief Summary: Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.


Options:
A: Post-operative pain scores (visual analogue pain scale from 0-10) (Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery)
B: Postoperative Quality of Life (QoL) (one month)
C: Postoperative pain (24h)
D: Operative Time (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Brief Summary: The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Options:
A: Development of moderate to severe disease in the 2 weeks after the index visit (Measured daily for 14 days)
B: Number of Participants With Modified Vesikari Scale Score >=9 (14 days)
C: Clinical symptom 2 days after medication; Microbiology study 3 days and one week after medication
D: Duration of diarrhea (within the first 72 hours during hospitalization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Brief Summary: The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Options:
A: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
B: Duration of diarrhea (within the first 72 hours during hospitalization)
C: secondary influenza infection (7 days)
D: Secondary infection with influenza of the household members who are healthy at the start of the study

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Brief Summary: The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Options:
A: Change in target behaviour: zinc use (six weeks post-intervention); Change in target behaviour: correct ORS preparation (six weeks post-intervention); Change in target behaviour: Exclusive breastfeeding (six weeks post-intervention); Change in target behaviour: Handwashing with soap (six weeks post-intervention)
B: Direct observation of hand washing prior to eating a snack (8 weeks)
C: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
D: Duration of diarrhea (within the first 72 hours during hospitalization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Brief Summary: The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Options:
A: Diarrhoea (<5s) (21 months)
B: Duration of diarrhea (within the first 72 hours during hospitalization)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)

Answer: B