TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega 3 for Comorbid Depression and Heart Failure Treatment
Brief Summary: Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in heart failure patients with moderate to severe major depressive disorder.


Options:
A: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))
B: ACC Glx/Water (baseline and 10-weeks); ACC GABA/Water (baseline and 10-weeks)
C: Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. (Week 12); Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values. (Week 12)
D: Hamilton Rating Scale of Depression (HAM-D) (Baseline, Week 4, Week 8, Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Brief Summary: To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.


Options:
A: Intraocular Pressure (IOP) (Study treatment was administered for 28 days, and outcome measures collected on Day 29)
B: Intraocular Pressure (IOP) (Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90))
C: Change in Intraocular Pressure (IOP) Over Nocturnal Time Period (Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9)
D: Intraocular Pressure (IOP) (29 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Systematic Empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating Antiretroviral Therapy With CD4 Cell Counts <100/mm3: the STATIS Randomized Controlled Trial
Brief Summary: In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections are leading causes of early death in patients who initiate antiretroviral therapy (ART) with advanced immunodeficiency.

We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the introduction of ART in HIV-infected adults with severe immunosuppression (CD4\<100/mm3) and no overt evidence of TB will reduce the risk of death and invasive bacterial infections. This strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients with at least one positive test suggestive of TB.


Options:
A: All-cause mortality 12 weeks after inclusion (12 weeks)
B: All-cause mortality (8 weeks)
C: All-cause mortality and incidence of invasive bacterial infections (24 weeks)
D: Rates of TB treatment initiation (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic dermatitis patients (AD) resulted from the reduction of cathelicidin production in these patients plays the important role in pathogenesis of this disease. Recently in vivo study has showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D might be beneficial in atopic dermatitis.

Objective: To determine the effect of oral vitamin D supplement on clinical impact including skin colonization of S. aureus in atopic dermatitis patients.


Options:
A: SCORAD score (May - August 2012 (3 months))
B: Blood 25 Hydroxyvitamin D (25OHD) Concentrations (1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery))
C: Gene Expression (Baseline and Final Visits)
D: serum Vitamin D (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Brief Summary: In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or systemic OT administration decreases activation of the amygdala in response to visual fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little attention has been focused on whether OT decreases SUD vulnerability after exposure to traumatic stress in preclinical or clinical studies. This clinical project will determine whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.


Options:
A: Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6 (Baseline (Week 0) and at Week 2, Week 4 and Week 6)
B: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (2 weeks after the first infusion)
C: Clinician-Administered PTSD Scale (CAPS) for DSM-IV (Session of Week 0); Clinician-Administered PTSD Scale (CAPS) for DSM-IV (Session of Week 7); Clinician-Administered PTSD Scale (CAPS) for DSM-IV (Session of Week 26)
D: Alcohol Craving (2 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Information Systems-enabled Outreach Program for Adverse Drug Events
Brief Summary: One of the most common health care interventions in any healthcare setting is a medication prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with adverse drug events (ADEs). ADEs decrease patient health directly and can lead to non-adherence, which in turn has negative consequences.

The investigators recently conducted a pilot project in which the feasibility and potential utility of an information technology enabled outreach program for monitoring patients receiving an outpatient prescription was tested. This intervention involved the use of an interactive voice response system programmed to automatically call ambulatory care patients following a prescription. If the system identified a potential medication problem, a pharmacist was notified who contacted the patient, modified the therapy accordingly, and informed a physician when necessary.

The pilot project included 568 patients with diverse illnesses in two Canadian cities. High levels of patient and provider acceptability of the system were determined from 21 day interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary non-compliance events. Very few episodes of ameliorable ADEs were observed.

The investigators feel these results justify a randomized control trial to assess the effectiveness of the intervention for improving patient centered outcomes. Ambulatory care patients receiving incident prescriptions for one of four conditions (hypertension, diabetes mellitus, depression, and anxiety) will be randomized to the intervention or routine care. The investigators expect that the system will reduce the severity and duration of outpatient ADEs and improve adherence to medication care.


Options:
A: Quality of life. (12 months)
B: Failure to persist with medication regimen (6 months)
C: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)
D: Self-reported medication adherence (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Information Systems-enabled Outreach Program for Adverse Drug Events
Brief Summary: One of the most common health care interventions in any healthcare setting is a medication prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with adverse drug events (ADEs). ADEs decrease patient health directly and can lead to non-adherence, which in turn has negative consequences.

The investigators recently conducted a pilot project in which the feasibility and potential utility of an information technology enabled outreach program for monitoring patients receiving an outpatient prescription was tested. This intervention involved the use of an interactive voice response system programmed to automatically call ambulatory care patients following a prescription. If the system identified a potential medication problem, a pharmacist was notified who contacted the patient, modified the therapy accordingly, and informed a physician when necessary.

The pilot project included 568 patients with diverse illnesses in two Canadian cities. High levels of patient and provider acceptability of the system were determined from 21 day interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary non-compliance events. Very few episodes of ameliorable ADEs were observed.

The investigators feel these results justify a randomized control trial to assess the effectiveness of the intervention for improving patient centered outcomes. Ambulatory care patients receiving incident prescriptions for one of four conditions (hypertension, diabetes mellitus, depression, and anxiety) will be randomized to the intervention or routine care. The investigators expect that the system will reduce the severity and duration of outpatient ADEs and improve adherence to medication care.


Options:
A: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
B: Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. (6, 12 and 18 months post baseline)
C: Re-hospitalizations (During the 30days after discharge)
D: Failure to persist with medication regimen (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Information Systems-enabled Outreach Program for Adverse Drug Events
Brief Summary: One of the most common health care interventions in any healthcare setting is a medication prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with adverse drug events (ADEs). ADEs decrease patient health directly and can lead to non-adherence, which in turn has negative consequences.

The investigators recently conducted a pilot project in which the feasibility and potential utility of an information technology enabled outreach program for monitoring patients receiving an outpatient prescription was tested. This intervention involved the use of an interactive voice response system programmed to automatically call ambulatory care patients following a prescription. If the system identified a potential medication problem, a pharmacist was notified who contacted the patient, modified the therapy accordingly, and informed a physician when necessary.

The pilot project included 568 patients with diverse illnesses in two Canadian cities. High levels of patient and provider acceptability of the system were determined from 21 day interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary non-compliance events. Very few episodes of ameliorable ADEs were observed.

The investigators feel these results justify a randomized control trial to assess the effectiveness of the intervention for improving patient centered outcomes. Ambulatory care patients receiving incident prescriptions for one of four conditions (hypertension, diabetes mellitus, depression, and anxiety) will be randomized to the intervention or routine care. The investigators expect that the system will reduce the severity and duration of outpatient ADEs and improve adherence to medication care.


Options:
A: Antipsychotic dispensing (6 months post-intervention)
B: Medication adherence (One month after patients receive intervention materials)
C: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
D: Failure to persist with medication regimen (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Mindfulness Based Compassionate Living in Recurrent Depression
Brief Summary: Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for patients suffering from recurrent depression. Though a number of studies show that MBCT is effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new depression developing after end of treatment is still considerable. Ergo, there is room for improvement.

Especially the development of a non-judging or compassionate attitude towards all experience seems to mediate the treatment effect. It is therefore our expectation that a follow-up intervention that focuses specifically on self-compassion could prove very useful in elaborating on the effects of MBCT.

The research question of this research is therefore: what is the effect of compassion training in people suffering from recurrent depression who have already received MBCT training?


Options:
A: Remission (Measured at Week 6 or 22)
B: Beck Depression Inventory-II (1 year)
C: N/A
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs
Brief Summary: This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.


Options:
A: Number of patients with less than a mean of one FMF attack per month (4 months)
B: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends)
C: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))
D: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs
Brief Summary: This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.


Options:
A: Number of patients with less than a mean of one FMF attack per month (4 months)
B: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)
C: Mor severity scoring system (At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.); Adverse events (up to 24 weeks)
D: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
Brief Summary: The purpose of this study is to evaluate the effect of a qigong intervention program on telomerase activity in Chinese women with a history of intimate partner violence.


Options:
A: Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. (Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment)
B: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)
C: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
D: The proportion of condom protected acts of vaginal and anal intercourse (Up to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
Brief Summary: The purpose of this study is to evaluate the effect of a qigong intervention program on telomerase activity in Chinese women with a history of intimate partner violence.


Options:
A: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
B: Change in Percent Drinking Days on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.); Change in number of standard drinks per drinking day on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) (Baseline and after completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (Baseline and after completion of study visits, approximately six weeks.)
C: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
D: Self-efficacy (Change from Baseline in Self efficacy at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
Brief Summary: The overall aim of this study is to begin establishing an effective treatment for individuals who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based treatments that directly target this problematic behavior. Existing treatments that have demonstrated initial promise in reducing NSSI consist of many skills embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI are not clear. Procedures that focus on one's emotions, particularly that aim to increase emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens emotions), may be critical in effective NSSI treatment. The specific goals of this study are to investigate the effects of two specific emotion-focused treatment elements on NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants' non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute individual weekly sessions of emotion awareness training or cognitive reappraisal. The study will use a single-case experimental design, and phase change will be determined based on each participant's changes in non-suicidal self-injurious thoughts and behaviors.


Options:
A: Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among adults. (6 months)
B: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
C: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))
D: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)

Answer: C