TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time
Brief Summary: The purpose of the study is to test an intervention aiming to reduce sitting time during work hours among office workers.

Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day (primary). Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks increased by 3 pr. day (primary). 20 % of participants report a reduction of musculoskeletal pain (secondary). A reduction in waist circumference of 1 cm (secondary). A reduction of 0.5 % in bodyfat (secondary).


Options:
A: Pain intensity (change from baseline to week 10)
B: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
C: Reduced total time spend sitting at work (1 month); Reduced number of prolonged siting periods (>30 min) (1 month); Increased number of breaks from sitting time (1 month)
D: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Intervention Supporting Adolescent Girls From Marginalized Communities to Complete Secondary Schooling
Brief Summary: This cluster Randomised Control Trial is evaluating an intervention to support adolescent girls from marginalised communities in northern Karnataka State, South India to complete secondary school, thereby reducing their vulnerability to HIV infection from early marriage and entry into sex work at young ages. The intervention will test innovations to address both supply and demand side barriers to girls' completion of secondary school, and will have long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.

School-based constraints will be addressed by improving academic outcomes through teacher training and academic support to students; addressing gender-related and skill-based gaps among teachers; training of local female teachers; and increasing the content knowledge of secondary school teachers. Demand side barriers will be addressed by reducing economic pressures that households face to withdraw girls' from school; building appreciation and value of girls' education; building family and community accountability for school attendance; creating safe spaces for girls and strengthening their agency; and engaging boys in promoting and supporting girls' education.

Primary stakeholders will include teachers and students, especially adolescent girls in the school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will include school development and management committees (SDMCs), families, boys and the communities that are served by the schools. 80 village clusters (40 intervention; 40 control) were randomly selected from 125 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented with village communities and high schools in 40 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented in collaboration with the Department of State Educational Research and Training (DSERT), Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE), Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.


Options:
A: Self-report of Ever Having Sexual Intercourse (24 months post-intervention)
B: Number of Participants Completing Secondary School [Sit 10th Standard Exam] (May-August 2016 (cohort one) and May-August 2017 (cohort two)); Number of Participants Married [by Trial End Line] (May-August 2016 (cohort one) and May-August 2017 (cohort two))
C: Understanding of key findings (30 minutes)
D: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Phase III Study of XELIRI With/Without Bevacizumab Versus FOLFIRI With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
Brief Summary: The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.


Options:
A: Overall survival (Assessed until 1.5 years after the last patient enrolment)
B: N/A
C: Loco-regional disease control as assessed by evidence of tumor at 3 years (Time from randomization to first local recurrence up to 3 years)
D: To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma. (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Phase III Study of XELIRI With/Without Bevacizumab Versus FOLFIRI With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
Brief Summary: The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.


Options:
A: Overall Survival (Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death))
B: Overall Survival (From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).)
C: To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. (The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).)
D: Overall survival (Assessed until 1.5 years after the last patient enrolment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MOVE - A Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (baseline); Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (3 years)
B: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
C: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment)
D: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MOVE - A Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)
B: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Week 12)
D: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MOVE - A Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Trough FEV1 Response (Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
D: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Brief Summary: This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.


Options:
A: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
B: Global disability on modified Rankin scale at 90 days.
C: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
D: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Brief Summary: This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.


Options:
A: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
B: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
C: Global disability on modified Rankin scale at 90 days.
D: Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 (baseline and week 28); Clinical Interview-based Impression of Change (CIBIC+) Score (week 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Brief Summary: This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.


Options:
A: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
B: Global disability on modified Rankin scale at 90 days.
C: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
D: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Brief Summary: This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.


Options:
A: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
B: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
C: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
D: Global disability on modified Rankin scale at 90 days.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
Brief Summary: In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions.

Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment.

Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers.

Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser procedure will be performed as a sham procedure by a second podiatrist.

Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.


Options:
A: Change from baseline in area of infected nail (9 months)
B: Percentage of patients who achieve clinical cure (52 weeks)
C: complete cure of the target nail (outcome measured after 1 year)
D: Percentage of patients who achieve clinical cure (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
Brief Summary: This program of research tested the effectiveness of an iPad delivered multiple behavior intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It was hypothesized that the intervention would reduce the number of health behavior risks reported by pregnant women in the treatment group. The target behaviors of the intervention are smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption.


Options:
A: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
B: Full on time early vaccination coverage (OPV0 and BCG) (First month of life)
C: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
D: Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
Brief Summary: This program of research tested the effectiveness of an iPad delivered multiple behavior intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It was hypothesized that the intervention would reduce the number of health behavior risks reported by pregnant women in the treatment group. The target behaviors of the intervention are smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption.


Options:
A: Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery)
B: MV Coverage at 12 months of age (12 months of age)
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Initiation of Long acting reversible contraception method (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
Brief Summary: OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in this respect.

DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical records and other primary care databases.

SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan Health Institute (ICS)

SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been started on lipid-lowering therapy during 2 consecutive years of study.

INTERVENTION: Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information).

VARIABLES:

1. Primary Outcomes are:

   * Variable RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.
   * Variable EVITA: New lipid-lowering treatments started during the intervention period and considered as inadequate.
2. Secondary Outcomes are:

   * Variable COST: total cost of the inadequate new lipid-lowering treatments.
   * Variable RECORD: recording of the cardiovascular risk.

2.Other variables:

* Principal: intervention/control group assignment of health professional.
* Patient variables: demographic and clinical.
* Professional variables: quality of care indicators.

STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be performed and subsequently multilevel analysis techniques will be used to estimate the effect of intervention according to hierarchic data structure and, in particular, patient variables effect.


Options:
A: percentage of participants with increase of the adequacy of lipid-lowering prescription (up to 24 months)
B: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)
C: Greater reduction in CHD risk in case group vs. control (6 months)
D: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
Brief Summary: In this prospective double-blinded study, The investigators compared acute postoperative pain and rescue analgesic demand during postoperative period after robot thyroidectomy between ketamine and placebo groups.


Options:
A: Morphine consumption (12 hours)
B: pain score (4 hours)
C: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)
D: Pain at 24 hour postoperatively (at 24 hour postoperatively)

Answer: D