TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Methylation Status of BDNF Gene After Receiving Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Brief Summary: Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neuro-development of BPD.

Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function.

In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. In addition, the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level.

Hypothesis:

Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.


Options:
A: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
B: episodes of parasuicide, alcohol intoxication, institutional care (12 months)
C: Parasuicidal behaviour (intermittent)
D: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Methylation Status of BDNF Gene After Receiving Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Brief Summary: Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neuro-development of BPD.

Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function.

In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. In addition, the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level.

Hypothesis:

Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.


Options:
A: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
B: Parasuicidal behaviour (intermittent)
C: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
D: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: Feasibility of study recruitment into the three interventions (Baseline); Feasibility of retention of participants at 3-month follow-up (3-month follow-up); Feasibility of retention of participants at 6-month follow-up (6-month follow-up); Acceptability of the three interventions (3-month follow-up)
B: Smoking Abstinence Rate (Baseline up to 6 weeks)
C: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
C: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
C: The Number of Participants Reporting 7 Day Point Prevalence Abstinence (12-months); Change in Perceived Stress Scores (Baseline, 4 weeks); Change in Depressive Symptoms Scores (Baseline, 4 weeks)
D: Self-reported 7-day Point Prevalence Abstinence (3 months); Self-reported 30 Day Smoking Abstinence (3 months); Self-reported Continuous Abstinence at 3 Months (3 months); Self-reported 7-day Point Prevalence Abstinence (6 months); Self-reported 30-day Point Prevalence Abstinence (6 months); Self-reported Continuous Abstinence (6 months); Self-reported 7-day Point Prevalence Abstinence (12 months); Self-reported 30-day Point Prevalence Abstinence (12 months); Self-reported Continuous Abstinence (12 months); Objective Smoking Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: Number of Participants With Abstinence (6-month follow-up)
B: Point prevalence abstinence at 6 months (6 months after beginning treatment)
C: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)
D: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
B: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)
C: The primary outcome will be self-reported and biologically verified continuous smoking abstinence. (Six month)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: The Dutch Eating Behavior Questionnaire (Baseline in experimental and control groups.); The Dutch Eating Behavior Questionnaire (Post-treatment 8 weeks from baseline in experimental and control groups); The Dutch Eating Behavior Questionnaire (twelve-months follow-up in experimental and control groups)
B: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
C: change in severity of depressive symptoms (change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smartphone Application for Smoking Cessation
Brief Summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: Smoking Abstinence (2 weeks post quit day)
C: 30-day point prevalence abstinence (12 month post randomization)
D: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
Brief Summary: In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:

1. To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)
2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)
3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses\] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)


Options:
A: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)
B: Sleep apnoea severity, daytime symptoms of sleep apnoea (2 weeks)
C: 30-day mortality (12 months)
D: resident-related preventable adverse events and near misses. (Each resident (subject) will be observed for 1 month.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Brief Summary: Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.

The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).

The investigators hypothesize:

1. Bed rest reduces the incretin effect
2. Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet


Options:
A: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (Every 6 months- baseline, 6 month and 12 month)
B: Insulin Sensitivity (HOMA-IR) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (QUICKI) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (ISI-Index) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (Matsuda-Index) (4 weeks (from Baseline to 4 weeks))
C: Incretin effect (24 weeks); Cognitive function (18 months); Insulin resistance (12 weeks)
D: Revised QUICKI (RQUICKI) (Baseline); RQUICKI (day 29); RQUICKI (day 31)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sucrose Practices for Pain in Neonates: A Program of Research: Part A (Trial 1 and 2): Determining the Minimally Effective Dose of Sucrose for Procedural Pain in Infants
Brief Summary: Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.


Options:
A: Pain reaction (first 14 days of life)
B: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)
C: The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). (Change from baseline 30 seconds post painful procedure)
D: Pain-specific event related potential (Isolated within the one-minute window post-procedure.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sucrose Practices for Pain in Neonates: A Program of Research: Part A (Trial 1 and 2): Determining the Minimally Effective Dose of Sucrose for Procedural Pain in Infants
Brief Summary: Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.


Options:
A: N/A
B: Hypersensitivity to pain (At 15 month vaccination (Visit 5))
C: The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). (Change from baseline 30 seconds post painful procedure)
D: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins
Brief Summary: This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.


Options:
A: Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis (From Baseline to Week 24); Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis) (From Baseline to Week 24)
B: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins
Brief Summary: This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.


Options:
A: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
B: Number of Participants With Adverse Events (52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis (From Baseline to Week 52)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL)
Brief Summary: This research study is evaluating a combination of drugs called Ofatumumab and Idelalisib as a possible treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL).

The main purpose of this study is to examine the combination of the two drugs, Ofatumumab and Idelalisib, in participants who have been diagnosed with CLL/SLL and have not previously received treatment but do require treatment. The investigators hope to observe how participants' disease will be impacted by this treatment and whether they will benefit more from combining these drugs together rather than taking them separately. Both of these drugs have been used in treatment for CLL / SLL and information from those research studies suggests that these drugs may help patients with CLL/SLL.

Ofatumumab is an antibody engineered in the lab against CD20, a protein on the surface of CLL cells, which is expressed in CLL. An antibody is a molecule your body creates to identify foreign substances so that it can destroy them. Ofatumumab has been FDA approved for treatment of CLL/SLL that has relapsed or progressed on other therapies. Idelalisib is a drug that blocks one of the signals inside the cells that cause this type of cancer to grow and survive. The investigators hope that combining Ofatumumab with Idelalisib will stop the growth of disease.

In this research study, the investigators are evaluating the side effects of combining these two drugs, gathering information on the CLL/SLL disease process and how the study affects the patient's cells, as well as assessing the outcome of the disease. This combination of drugs has been previously tested, and appeared to be well tolerated.


Options:
A: Overall Response Rate (ORR) (Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.)
B: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)
C: Overall response rate (ORR) (84 days after start of the last cycle of induction therapy)
D: Progression-free survival (PFS) based on independent review committee (up to 6 years)

Answer: A