TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: New Hampshire Medicaid Wellness Incentive Program
Brief Summary: The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health disparity and increased costs by providing incentivized health promotion programs to overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New Hampshire's 10 regional Community Mental Health Centers (CMHCs).


Options:
A: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
B: Percent negative CO readings; Percent negative cotinine readings; Longest period of continuous abstinence
C: Smoking abstinence at 12 months post-enrollment (12 months)
D: Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score (from treatment entry until 6 weeks post-partum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Vaginal Health Trial - Effects of Vaginal Estradiol Tablet and Moisturizing Gel on Postmenopausal Vaginal Symptoms
Brief Summary: This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.


Options:
A: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole (Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months))
B: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)
C: Most Bothersome Symptom (MBS) Severity (Baseline, Week 4, Week 12)
D: Relief of vaginal symptoms (following 12 weeks of treatment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer
Brief Summary: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer


Options:
A: Objective Response Rate ( ORR ) (60 months)
B: Objective Response Rate Per BIRC Assessment (From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)); ORR Per BIRC Assessment by PD-L1 Expression Level (From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)); Time to Response (TTR) (From first dosing date to the date of the first confirmed response (up to approximately 14 months)); Duration of Response (DOR) (From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months))
C: To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set (From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).); To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set (From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).)
D: Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)); Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST (Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months))

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 VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)
Brief Summary: Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).


Options:
A: Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites (From Day 1 through Day 15); Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Day 43); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 28)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 (Baseline, Through Week 12)
C: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)

Answer: B
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 VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)
Brief Summary: Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 (Baseline, Through Week 12)
B: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)
C: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
D: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Utility of Two Patients Decision Aids About Asthma Inhaled Controller Medication Use in Adult Patients With Asthma
Brief Summary: The purpose of this study is to determine whether the use of shared decision making aids is more effective than usual care in improving asthma knowledge, lessening decisional conflict, and enhancing adherence to treatments and asthma control in adult patients with mild to severe asthma.


Options:
A: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
B: Pursuit of Living Related Transplantation (6 months)
C: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)
D: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Utility of Two Patients Decision Aids About Asthma Inhaled Controller Medication Use in Adult Patients With Asthma
Brief Summary: The purpose of this study is to determine whether the use of shared decision making aids is more effective than usual care in improving asthma knowledge, lessening decisional conflict, and enhancing adherence to treatments and asthma control in adult patients with mild to severe asthma.


Options:
A: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))
B: quality of life (9 months)
C: N/A
D: Patient Perception of Shared Decision Making (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients
Brief Summary: This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.


Options:
A: Rate of COPD Exacerbations (52 weeks)
B: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)
C: Change From Baseline in Trough Pre-dose FEV1 in Both Arms (Baseline, week 12)
D: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Pathological Phenotype to Determine Optimal Management for Moderate to Severe Preschool Wheeze
Brief Summary: This is a single-centre, randomised-controlled trial, comparing management of preschool wheeze. It specifically aims to compare management of preschool wheeze using current clinical guidelines to management determined by eosinophilic inflammation and infection. Participants will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of two treatment groups, either current clinical care or pathological phenotype based management. They will be asked to make 2 study visits to the Royal Brompton Hospital over the course of 4 months.


Options:
A: Number of Unscheduled Healthcare Visits (UHCV) (4 months)
B: Objective Adherence to ICS (Baseline); Change in objective adherence to ICS (Change from baseline in objective adherence to ICS at 1 month); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control); Feasibility, Acceptability and Usability of the Text Messaging Website (At time of text messaging intervention); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 1 month after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 2 months after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 3 months after receiving text messages)
C: Number of Emergency Room Visits Secondary to Asthma Exacerbation (6 months)
D: device monitored adherence rate (up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
Brief Summary: The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).


Options:
A: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)
B: proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (CPAP use was evaluated for 4 months)
C: Hopkins Verbal Learning Test-Revised (HVLT-R) (Change from baseline at 6 months and 1 year); Digit Symbol Subtest (DS) (Change from baseline at 6 months and 1 year); Mini Mental State Evaluation Exam (MMSE) (Change from baseline at 6 months and 1 year); Stroop Color and Word Test (SCW) (Change from baseline at 6 months and 1 year); The Psychomotor Vigilance Task (PVT) (Change from baseline at 6 months and 1 year); Epworth Sleepiness Scale [ESS] (Change from baseline at 6 months and 1 year)
D: CPAP adherence at 3 months (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Top-down Infliximab Study in Kids With Crohn's Disease
Brief Summary: The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.


Options:
A: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)
B: Clinical remission without need for additional CD related therapy or surgery (52 weeks)
C: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
D: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus Dialectical-Behavioral Therapy in Reducing Trauma Related Symptoms in Women Suffering From Borderline Personality Disorder (BPD) and Posttraumatic Stress Disorder (PTSD)
Brief Summary: Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).


Options:
A: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)
B: Rate of suicide attempts (Annual)
C: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
D: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus Dialectical-Behavioral Therapy in Reducing Trauma Related Symptoms in Women Suffering From Borderline Personality Disorder (BPD) and Posttraumatic Stress Disorder (PTSD)
Brief Summary: Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).


Options:
A: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)
B: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
C: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
D: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus Dialectical-Behavioral Therapy in Reducing Trauma Related Symptoms in Women Suffering From Borderline Personality Disorder (BPD) and Posttraumatic Stress Disorder (PTSD)
Brief Summary: Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).


Options:
A: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))
B: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
C: level of depression (Baseline to 3 months)
D: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)

Answer: A