TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Perinatal Nurse Home Visiting Enhanced With mHealth Technology
Brief Summary: This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their child.


Options:
A: Intimate partner violence (One year)
B: Change in IPV assessments (Screening and at 2 months post-birth.)
C: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
D: depression (On completion of intervention and six months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Perinatal Nurse Home Visiting Enhanced With mHealth Technology
Brief Summary: This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their child.


Options:
A: Lost to Follow-up (12 months)
B: Satisfaction with the health coach intervention as assessed by surveys (From enrollment until the end of the intervention at 36 weeks of gestation.); Satisfaction with the health coach intervention as assessed by phone interviews (From enrollment until the end of the intervention at 36 weeks of gestation.)
C: Proportion of mothers and infants non-retained in care at 6 months (6 months)
D: Change in IPV assessments (Screening and at 2 months post-birth.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Perinatal Nurse Home Visiting Enhanced With mHealth Technology
Brief Summary: This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their child.


Options:
A: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
B: Change in IPV assessments (Screening and at 2 months post-birth.)
C: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
D: Initiation of Long acting reversible contraception method (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduction of Inequalities in Overweight and Obesity Management Care Access Among High School Adolescents
Brief Summary: Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management (CM) for socially less advantaged adolescents in school in the short and long term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.

Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as advantaged are allocated to the standard-CM and those less advantaged are randomized to standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The strengthened-CM consists of 5 collective sessions with the same standard operating procedure as the standard-CM with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after the intervention=T2). Process evaluation data are also collected during the trial.

Expected results: To confirm the effectiveness of overweight CM for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight care.


Options:
A: Change in the prevalence of overweight and obesity (Baseline, Month 9)
B: Change in Body Mass Index from to baseline to 1 and 2 years (0-1-2 years); Change in overweight and obesity status according to IOTF norms (up to 2 years); Change in BMI Z score from baseline to one and two years (up to 2 years)
C: Overweight and obesity according to IOTF references (0-1-2 years)
D: BMI (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes
Brief Summary: The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: The primary endpoint is the A1c level or the change in A1c level. (6 months)
C: Glycated hemoglobin (A1C) (1 year); Blood pressure (systolic and diastolic blood pressure (1 year); Lipids (LDLc, HDLc, cholesterol, and triglyceride) (1 year)
D: Changes in HbA1c (Baseline, 16 weeks, 32 weeks, 6 months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients
Brief Summary: Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.


Options:
A: Change in length of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in frequency of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in minutes spent standing (baseline, 2, 4, and 6 weeks); Change in minutes spent in light intensity physical activity (baseline, 2, 4, and 6 weeks); Change in minutes spent in moderate intensity physical activity (baseline, 2, 4, and 6 weeks)
B: Average daily sedentary minutes (4 weeks)
C: Physical Activity Behavior (3 years)
D: Body Fat (36 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.
Brief Summary: The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.


Options:
A: CPC (6 month)
B: all cause mortality at 6 months (6 months)
C: Number Alive at Hospital Discharge (at hospital discharge)
D: Mortality (180 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Brief Summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


Options:
A: The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm. (10 weeks)
B: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
C: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
D: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Brief Summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


Options:
A: Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants (6 months); Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression (6 months)
B: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
C: Recurrence-free Survival (RFS) (up to 36 months)
D: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Brief Summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


Options:
A: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
B: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
C: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
D: The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen (Through study completion, an average of 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Brief Summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


Options:
A: Recurrence-Free Survival (1 year)
B: 2-month Progression-free Survival Rate (Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.)
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Disease-free survival

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Suicidal Ideation Through Insomnia Treatment
Brief Summary: Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.


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: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
C: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)
D: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Suicidal Ideation Through Insomnia Treatment
Brief Summary: Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.


Options:
A: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation (Baseline, 4 months post baseline, 12 months post baseline)
B: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)
C: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Suicidal Ideation Through Insomnia Treatment
Brief Summary: Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.


Options:
A: Suicide Attempts (Assessed bimonthly)
B: Suicide Attempt Self Injury Interview SASII (Change in scores from baseline to 12th months)
C: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
Brief Summary: This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
B: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (Week 16)
C: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)
D: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
Brief Summary: This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.


Options:
A: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
B: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)
C: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)
D: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)

Answer: C