TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder
Brief Summary: This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.


Options:
A: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
B: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
C: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
D: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale (Baseline and 6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin
Brief Summary: The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.


Options:
A: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
B: Clinical pregnancy (within 6 calendar months of randomisation)
C: Rate of cancellation due to low ovarian response (one month)
D: The main outcome was change in body weight. (Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin
Brief Summary: The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.


Options:
A: Clinical pregnancy (within 6 calendar months of randomisation)
B: The main outcome was change in body weight. (Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.)
C: Live birth rate
D: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial
Brief Summary: This project is being undertaken to test the hypothesis that implementing a community based package of care for women with hypertensive disorders of pregnancy will result in overall improvement in maternal and neonatal outcomes. This is based on the premise that there are three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy complications: 1) delays by the woman herself in recognizing the seriousness of her condition; 2) delays in her being assessed and then transported to a center capable of providing effective and life-saving interventions; and 3) delays in the health facility in providing those interventions. The treatments for pre-eclampsia that are poorly accessed in LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of stroke.

The CLIP pilot and definitive cRCT will investigate whether the community level intervention including implementation of the CLIP package (oral antihypertensive therapy when indicated, intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility when indicated) of care will reduce the incidence of all-cause maternal morbidity and mortality.


Options:
A: quantification of blood loss (15 minutes after treatment administration)
B: Maternal or Perinatal death or morbidity (within 42 days of pregnancy)
C: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)
D: Need for other uterotonics (2 minutes after giving the drug.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)
Brief Summary: To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).


Options:
A: Collection of Post-treatment Catheterization for Safety (Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days); Comparison of IPSS for Efficacy (3 month); Mean UroLift Improvement in IPSS at 12 Months (12 months)
B: Changes in the International Prostate Symptom Score (Baseline and 12 weeks after intervention)
C: Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met (Month 12)
D: Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up (3 Month Follow-up Visit); Safety: Device Related Serious Complications (3 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
Brief Summary: Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.


Options:
A: Scale for Suicide Ideation Index (SSI) (Over 8 weeks of treatment); Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale (8 weeks of treatment)
B: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (Weeks 1-12)
C: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
D: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
Brief Summary: Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.


Options:
A: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (Weeks 1-12)
B: Zanarini Scale for Borderline personality disorder (ZAN-BPD) (8 weeks)
C: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)
D: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety 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 efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.


Options:
A: The Time-normalized Number of Hereditary Angioedema Attacks (During the treatment phase, up to 28 weeks.)
B: Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf (Duration of the study (2.5 years)); Percent of HAE Attacks With Substantial Relief of the Defining Symptom (Within 4 hours after initial treatment)
C: 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.)
D: Part 1: The Rate of Investigator-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2 & 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 2: 24 weeks (Days 169 to 337). Part 3: 48 weeks (Days 338 to 674).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interactive Advance Care Planning Intervention to Facilitate a Good Death for Cancer Patients
Brief Summary: The purpose of this 5-year interventional study is to design, implement, and evaluate the effectiveness of an intervention aimed at facilitating prognosis communication and end-of-life care decision-making to increase the extent of congruence between the patient's preferred and actual EOL care received and patients' and family caregivers' QOL and psychological well-being, reduce futile aggressive healthcare resources utilization at end-of-life, and facilitate bereavement adjustment.


Options:
A: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study. (1 year)
B: Congruence between preferred and actual EOL care received (An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.); Quality of life for terminally ill cancer patients (An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.); Psychological well-beings for terminally ill cancer patients (An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.); Family depressive symptoms (An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.); Family quality of life (An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.); Bereavement adjustment-Family depressive symptoms (Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.); Bereavement adjustment-complicated grief (Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.)
C: Functional Assessment of Cancer Therapy (Quality of Life Measure) (12 weeks)
D: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PICO Versus Standard Dressing on Groin Incisions After Vascular Surgery - a Prospective Randomized Trial (INVIPS Trial)
Brief Summary: The wound infection rate in the groin after vascular surgery has been denoted to be high since the wound surveillance register started in 2005. The current wound infection rate based on a validation study was 22.9% (24/105 patients with groin incision(s) between 1 March to 30 June in 2012). This randomized controlled trial aims to evaluate if negative pressure wound therapy on closed inguinal incisions (INPWT) after vascular surgical procedures can reduce the risk for surgical site infections and other wound complications.


Options:
A: Wound infection rate (Wounds will be checked at 3 month follow-up)
B: Early Complications of Vascular Zone (2 weeks)
C: Time to Complete Wound Closure (42 days)
D: Post-operative wound infection (6 weeks post-operative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Brief Summary: Background The prevalence of depression is high and the elderly have an increased risk of developing a chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. Investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. Investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care.

Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. Investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. Investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. The primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations.

Discussion This trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.


Options:
A: Shortened Fresno Test of Competence in Evidence-based Practice (SAFT) (12 weeks)
B: Physician ADHD Practice Behavior (Baseline and 6 months)
C: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
D: Episiotomies; Oxytocin use in third stage of labor

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Brief Summary: Background The prevalence of depression is high and the elderly have an increased risk of developing a chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. Investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. Investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care.

Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. Investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. Investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. The primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations.

Discussion This trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.


Options:
A: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
B: Flare Occurrence (Anticipated length of study is two years.); Flare-to-visit Time (Anticipated length of study is two years.)
C: Risky drinking (6, 12, 18, 24 months)
D: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Comprehensive School Health Intervention in Improving Healthy Eating and Physical Activity and Preventing Childhood Obesity
Brief Summary: The objectives were to 1) make students eat healthier and be more active; and 2) prevent overweight and obesity. Children will therefore be less likely overweight or obese. Beginning in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta. Full-time School Health Facilitators were placed in each of the schools to implement what is know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more commonly referred to as "Coordinated School Health", while the synonymous term "Health Promoting Schools" is often used in Australia and Europe. The project was evaluated annually in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped pedometers. The comparison group included approximately 150 schools that were randomly selected to reflect the population of Alberta, Canada. Twenty of these randomly selected schools also participated in data collection which involved the use of time-stamped pedometers.


Options:
A: Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (6 months post baseline); Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (18 months post baseline)
B: Overweight and obesity (24 months)
C: Moderate-to-vigorous physical activity (MVPA) time during activity breaks (Year 3)
D: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)

Answer: B