TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: SystemCHANGE: An Intervention for Medication Adherence in Transplant Recipients
Brief Summary: With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence (MA) in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This intervention shows great promise for increasing MA with a large effect size of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. The Medication Event Monitoring System cap, which contains microelectronics that record the date and time of the cap removal, will be used to measure MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.


Options:
A: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
B: Progression of albuminuria (1,2,3,4 and 5 year)
C: Taking Adherence (12 months); Timing Adherence (12 months)
D: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Brief Summary: Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.


Options:
A: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)
B: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
C: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
D: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Brief Summary: Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.


Options:
A: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
B: Changes in cortical excitability measures (Measured for approximately 6 weeks)
C: Reaction time (millisecond) (24 hours post intervention)
D: JTT (crossover design, four different sessions with four different interventions)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial
Brief Summary: Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. The patients who meet the inclusion criteria and accept to participate in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet) and follow the study protocol for 12 week. Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment.


Options:
A: Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation (12 months)
B: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
C: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)
D: Clinical Pregnancy Rate (up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial
Brief Summary: Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. The patients who meet the inclusion criteria and accept to participate in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet) and follow the study protocol for 12 week. Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment.


Options:
A: Improvement in ovulatory cycling (24 months)
B: The main outcome was change in body weight. (Patient's body weight was measured at the base point and after 12 weeks of clinical trial.)
C: Clinical Pregnancy Rate (up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle)
D: Glucose infusion rate (M value) below euglycaemic hyperinsulinaemic clamp (comparing baseline with 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Do You Really Expect Me to Get MST Care in a VA Where Everyone is Male? Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma (MST)
Brief Summary: The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.


Options:
A: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)
B: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
C: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
D: Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery (36 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
Brief Summary: The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.


Options:
A: Job satisfaction (baseline to 3 month)
B: Perceived Stress (3 months post-intervention)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Significant score reduction at the Perceived Stress Scale (T0 inclusion); Significant score reduction at the Perceived Stress Scale (T1 (3-month follow-up)); Significant score reduction at the Perceived Stress Scale (T1 (up to 8 weeks treatment)); Significant score reduction at the Perceived Stress Scale (T2 (6-month follow-up))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
Brief Summary: The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
C: Job satisfaction (baseline to 3 month)
D: Perceived Stress (3 months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
Brief Summary: The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.


Options:
A: 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)
B: N/A
C: Perceived Stress (3 months post-intervention)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
Brief Summary: The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.


Options:
A: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
B: Perceived Stress (3 months post-intervention)
C: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)
D: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
Brief Summary: The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.


Options:
A: Memory tests (Before ECT, after 6 ECT treatments, at the end of the ECT course)
B: 17-item Hamilton Depression Rating Scale (week 0, 2, 4, 6); Remission rate (week 0, 2,4, 6); GAF(Global Assessment of Function) (Week 0, 2, 4, 6)
C: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (Baseline up to Double-blind Endpoint (Day 28))
D: Montgomery-Asberg Depression Rating Scale (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
Brief Summary: The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.


Options:
A: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (Baseline up to Double-blind Endpoint (Day 28))
B: Change in depression score (14 days)
C: Panel A and B: Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Day 8- Analysis of Covariance (ANCOVA) Analysis (Baseline (Day 1) and Endpoint (Day 8) of Period 1); Panel A and B: Change From Baseline (Day 8) in Montgomery Asberg Depression Rating Scale Total Score at Day 15- ANCOVA Analysis (Baseline (Day 8) and Endpoint (Day 15) of Period 2)
D: The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score. (Change from Baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Engagement to HIV Prevention and Care in North West, South Africa
Brief Summary: This study will evaluate the efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in South Africa: short message service (SMS) text messaging and peer navigation services.


Options:
A: Change from Baseline HIV-1 Viral Load at 48 weeks (48 weeks)
B: Use of effective contraception (4 months); Acceptability of at least one method of effective contraception (4 months)
C: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
D: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)

Answer: C