TrialPanorama/Dataset huggingface dataset:
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: Rate of suicide attempts (Annual)
B: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
C: To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or; equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation; carried forward (LOCF) change in the ZAN-BPD; total score in up to 12 weeks of double-blind treatment.
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: Neoadjuvant and Adjuvant Checkpoint Blockade in Patients With Clinical Stage III or Oligometastatic Stage IV Melanoma
Brief Summary: This randomized phase II trial studies how well nivolumab with or without ipilimumab or relatlimab before surgery works in treating patients with stage IIIB-IV melanoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, and relatlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab alone or in combination with ipilimumab or relatlimab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


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: Arm C: Number of Participants With the Pathologic Response Rate (up to 2 years)
C: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
D: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant and Adjuvant Checkpoint Blockade in Patients With Clinical Stage III or Oligometastatic Stage IV Melanoma
Brief Summary: This randomized phase II trial studies how well nivolumab with or without ipilimumab or relatlimab before surgery works in treating patients with stage IIIB-IV melanoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, and relatlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab alone or in combination with ipilimumab or relatlimab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Options:
A: Objective Response Rate (ORR) (From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)); Overall Survival (OS) (Up to 96 months)
B: Arm C: Number of Participants With the Pathologic Response Rate (up to 2 years)
C: Major Pathologic Response (MPR) (54 weeks)
D: Progression-Free Survival (PFS) as Assessed by the Investigator (From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Super-Mini Percutaneous Nephrolithotomy (SMP) Versus Retrograde Intrarenal Surgery (RIRS) for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlled Trial (IAU-01)
Brief Summary: Shock wave lithotripsy (SWL) is recommended for kidney stones \< 20 mm. However, the stone clearance of lower pole calculi after SWL is limited, thus leading to an extended indication for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments. However, this issue remains controversial.

On the other hand, improvements in endoscopy technology have made retrograde stone removal more attractive. This has led to an increasing use of RIRS as a primary treatment although it is recommended only as 2nd-line option by current guidelines. However, the treatment of symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates.

The purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.


Options:
A: The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size. (Within 3 months of enrollment)
B: Proportion of Patients Passing Their Stone Within 28 Days by Self Report (28 days)
C: Stone free rate (SFR) (The primary endpoint was the SFR at 3-months after surgery.)
D: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)
Brief Summary: The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.


Options:
A: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
B: Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value (At Month 3)
C: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
D: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Titers of H1N1-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of H3N2-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ph 3 Multicenter DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD
Brief Summary: This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.


Options:
A: Change from Baseline in Clinician-administered ADHD-5-Rating Scale (Baseline week 2, weeks 3-6)
B: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)
C: Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score. (Last week of 3-week treatment period assessed at Visit 5.)
D: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 (Baseline, 8 weeks); Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group (Baseline, 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
Brief Summary: The emergency department (ED) is a common source of acute illness care for older adults. Many older adults who are discharged home from the ED return within 30 days due to numerous challenges faced during the ED-to-home transition. Unless programs to improve the ED-to-home transition are identified, the health and financial costs will only increase as the older adult population doubles by 2040. This study will apply Coleman's Care Transitions Intervention to the ED-to-home transition by adapting the program to account for the unique aspects of the ED setting. The research will evaluate the process, ED use, and cost outcomes of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion, this study will provide empiric evidence regarding this innovative approach to help the rapidly growing older adult population remain healthy and independent after an ED visit.


Options:
A: time from ACS symptom onset to admission to emergency department (two years)
B: Surveillance methodologies will measure arrival times of acute strokes from stroke symptoms onset to ER among participants for the length of the study, as well as increase in stroke knowledge at one month and one year post stroke event. (at one month and one year post stroke event)
C: Rates of stillbirth (36 months)
D: Number of Participants Returning to the ED Within 30 Days of the Original ED Visit (30 days after emergency department discharge); Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care (Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits); Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge (up to 30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: Continuous abstinence (Russell Standard) (Six months post quit date)
B: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
C: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
D: Treatment Satisfaction (End of treatment (seven weeks after baseline))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: Continuous abstinence (Russell Standard) (Six months post quit date)
C: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
D: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: Continuous abstinence (Russell Standard) (Six months post quit date)
B: Days of abstinence following the programmed lapse (7 days)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD) (12 weeks); Average change in score on the mMRC Dyspnea Scale (Baseline, 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: Continuous abstinence (Russell Standard) (Six months post quit date)
B: Maximum Nicotine Concentration in Blood (180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)); Concentration of Carboxyhemoglobin in Blood (Baseline and 8 days); Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours (Baseline and 8 days); Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours (Baseline and 8 days); Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours (Baseline and 8 days)
C: smoking cessation (52 weeks)
D: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: 30 day abstinence (6 months)
B: Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date (26 Weeks Following Smoking Quit Date (Study week 29)); 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date (52 Weeks Following Smoking Quit Date (Study week 55))
C: Continuous abstinence (Russell Standard) (Six months post quit date)
D: Smoking Behaviour (56 weeks post participant start date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
B: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
C: 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)
D: Continuous abstinence (Russell Standard) (Six months post quit date)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: reducers (week-24 from baseline)
B: Continuous smoking abstinence rate (Weeks 9 to 12)
C: Continuous abstinence (Russell Standard) (Six months post quit date)
D: Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (up to 1 year); Changes in withdrawal symptoms (up to 1 year); Subjective nicotine effect will be analyzed (up to 1 year); Changes in feelings and emotions (up to 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: College Students Who Self-Harm: An Intervention Study
Brief Summary: Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.


Options:
A: Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 (The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.)
B: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
C: episodes of parasuicide, alcohol intoxication, institutional care (12 months)
D: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)

Answer: D