TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Brief Summary: Background: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. The ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. Methods: Researchers will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. Reserchers will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.


Options:
A: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
B: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
C: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)
D: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assisting in Informing Decisions in Emergency Departments: (ED-AID) Study
Brief Summary: This study will test a patient decision aid about safe firearm storage during suicidal crisis. The investigators hypothesize that participants with higher quality decisions after the decision aid will be more likely to change their firearm storage to reduce access during the time of crisis.


Options:
A: Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm. (2 years); Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure (2 years); Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm (2 years)
B: The number of contacts with mental health services appropriate to the patient's needs. (3 months)
C: Acceptability of Lethal Means Decision Aid (Baseline); Decision Making Quality in Emergency Department (ED) (Baseline); Home Firearm Storage (Baseline and 1 week follow up); Decision Making Quality - Follow up (1 week follow up); Suicidal Ideation and Behavior at One Month (1 month post baseline); Suicidal Ideation and Behavior at Three Months (3 months post baseline); Vital Statistics (Suicide death) (3 months post baseline)
D: Counting of suicidal events (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
Brief Summary: This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.


Options:
A: Incidence of dental caries (Baseline and 3 years)
B: Decayed,missing, and filled tooth surfaces (dmfs) (Over 3 years)
C: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
D: Serum 25OH-vitamin D levels (90 days after start of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Brief Summary: Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.


Options:
A: Visual analogue score (24 hours); Total morphine consumption (24 hours); First time to receive morphine (24 hours)
B: QoR 15 score (24 hours post operatively)
C: Morphine consumption (24 hour postoperatively)
D: Pain scores (1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Brief Summary: Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.


Options:
A: Morphine consumption (24 hours postoperatively.)
B: Numeric Rating Scale Pain Scores (1 day (PACU pain scores)); OR and PACU Opioid Consumption (up to 1 day, in the OR and PACU)
C: Morphine consumption (24 hour postoperatively)
D: the patient centred QoR-15 score among ESB and SAP block patients; (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Brief Summary: Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.


Options:
A: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)
B: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (Week 40 - Week 66)
C: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
D: Number of days of use of cannabis (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Brief Summary: Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.


Options:
A: SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo (2 weeks)
B: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
C: Number of days of use of cannabis (12 weeks)
D: SKAMP deportment rating scale (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Brief Summary: Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.


Options:
A: Number of days of use of cannabis (12 weeks)
B: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
C: N/A
D: Change from baseline in the ADHD rating scale total score (Through Day 42)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Crowdsourced Intervention to Promote Hepatitis B and C Testing Among Men Who Have Sex With Men in China: a Nationwide Online Randomized Controlled Trial
Brief Summary: This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.


Options:
A: Adherence to cervical cancer screening (step1) (Up to 20 months)
B: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
C: Change from Baseline HIV-1 Viral Load at 48 weeks (48 weeks)
D: Clinic attendance for pills pick up (six months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Crowdsourced Intervention to Promote Hepatitis B and C Testing Among Men Who Have Sex With Men in China: a Nationwide Online Randomized Controlled Trial
Brief Summary: This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.


Options:
A: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
B: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
C: Exclusive breastfeeding duration (Six months)
D: Smoking Abstinence (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Crowdsourced Intervention to Promote Hepatitis B and C Testing Among Men Who Have Sex With Men in China: a Nationwide Online Randomized Controlled Trial
Brief Summary: This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.


Options:
A: HIV propensity score (0, 6 and 12 months)
B: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
C: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
D: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Crowdsourced Intervention to Promote Hepatitis B and C Testing Among Men Who Have Sex With Men in China: a Nationwide Online Randomized Controlled Trial
Brief Summary: This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.


Options:
A: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
B: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
C: The Proportion who tested for HIV over 2 months follow-up (2 months following the first text message)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
Brief Summary: This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.


Options:
A: Number of Participants That Experienced Drug Related Grade 3-4 AEs (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants That Experienced Drug Related Grade 3-4 SAEs (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid (approximately up to 4 years)
B: To assess the safety of allogeneic anti-CD19 CAR (4-5 weeks after first dose)
C: Overall Response Rate (ORR) (From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months))
D: Number of patients with treatment related adverse events as assessed by CTCAE v4. (2 years); Overall Response Rate (28 days); Feasibility of CD19 CAR T cell production as defined by number of products successfully meeting release criteria (12 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)


Options:
A: Objective response rate (3 months)
B: To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose (Day 0 to 28 for DLT)
C: Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 4 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 5 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Number of Participants With Adverse Events in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion); Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion)
D: Objective Reaction Rates (0 to 180 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema
Brief Summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.


Options:
A: Part 1: The Rate of Expert-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 1: 24 weeks (Week 0 to 24 to 52), Part 2: 28 weeks (Week 24 to 52)); Part 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat Administered QD Over a 52- to up to 104-week Administration Period in Subjects With HAE. (Part 3: Week 52 to up to Week 104.)
B: Frequency of All HAE Attacks (Duration of the study)
C: Person-time Incidence Rates (Subject Based) (Up to 146 weeks.); The Person-time Incidence Rates (Event Based) (Up to 146 weeks.)
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: D