TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Kidney Awareness Registry and Education Study
Brief Summary: The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.


Options:
A: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
B: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months (6 and 12 months)
C: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline (6- and12-month follow-ups)
D: Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview (change from baseline at 16 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Kidney Awareness Registry and Education Study
Brief Summary: The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.


Options:
A: Number of patients that start home-based dialysis. (1 year)
B: Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) (Baseline recruitment/screening)
C: Systolic Blood Pressure (SBP) (one year)
D: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Kidney Awareness Registry and Education Study
Brief Summary: The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.


Options:
A: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
B: medication adherence (5 months)
C: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)
D: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
Brief Summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.


Options:
A: Weight (g) (From 4 to 6 weeks after inclusion)
B: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants (up to 6 months)
C: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)
D: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
Brief Summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.


Options:
A: The primary outcome measurement was death or NEC (≧stage 2) (From April 1, 2005 to May 30, 2007)
B: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants (up to 6 months)
C: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea
Brief Summary: A randomized, double-blind, placebo-controlled clinical trial of azithromycin in Campylobacter concisus culture positive patients with diarrhea. The clinical characteristics of emerging Campylobacter concisus in adults is vomiting and persistent diarrhea. Whether patients may benefit from antibiotic treatment is unknown. The purpose of this trial is to investigate whether antibiotic treatment with azithromycin of Campylobacter concisus induced diarrhea can better the symptoms and shorten the duration of illness.


Options:
A: Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo (10 weeks)
B: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)
C: Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of isolates of pneumococcus exhibiting macrolide resistance by nasopharyngeal swabs in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months); Prevalence of macrolide resistance in the stool as determined by genetic determinants or phenotypic testing (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of conjunctival swabs yielding ocular chlamydia in children 1-60 months (24 months); Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Weight for Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months)
D: Duration of diarrhea in days (up to 10 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III Clinical Trial to Compare Standard Care (Observation) With Alternative Therapy (Hydroxyurea) for Reducing the Risk of Converting to an Abnormal TCD Velocity in Children With Sickle Cell Anemia and Conditional Pre-treatment TCD Velocities.
Brief Summary: The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.


Options:
A: N/A
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
D: Conversion to Abnormal Maximum TAMV (30 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III Clinical Trial to Compare Standard Care (Observation) With Alternative Therapy (Hydroxyurea) for Reducing the Risk of Converting to an Abnormal TCD Velocity in Children With Sickle Cell Anemia and Conditional Pre-treatment TCD Velocities.
Brief Summary: The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.


Options:
A: Conversion to Abnormal Maximum TAMV (30 months)
B: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
C: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III Clinical Trial to Compare Standard Care (Observation) With Alternative Therapy (Hydroxyurea) for Reducing the Risk of Converting to an Abnormal TCD Velocity in Children With Sickle Cell Anemia and Conditional Pre-treatment TCD Velocities.
Brief Summary: The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.


Options:
A: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
B: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
C: Conversion to Abnormal Maximum TAMV (30 months)
D: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III Clinical Trial to Compare Standard Care (Observation) With Alternative Therapy (Hydroxyurea) for Reducing the Risk of Converting to an Abnormal TCD Velocity in Children With Sickle Cell Anemia and Conditional Pre-treatment TCD Velocities.
Brief Summary: The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.


Options:
A: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
B: N/A
C: N/A
D: Conversion to Abnormal Maximum TAMV (30 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III Clinical Trial to Compare Standard Care (Observation) With Alternative Therapy (Hydroxyurea) for Reducing the Risk of Converting to an Abnormal TCD Velocity in Children With Sickle Cell Anemia and Conditional Pre-treatment TCD Velocities.
Brief Summary: The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.


Options:
A: Number of Malaria Episodes (12 months)
B: Conversion to Abnormal Maximum TAMV (30 months)
C: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
D: Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function (Baseline up to Day 29); Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease (Baseline up to 30 days post last dose on Day 29); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 to 30 days post last dose on Day 29); Number of Participants With Laboratory Test Abnormalities (Baseline up to 30 days post last dose on Day 29)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Recovery Processes in Women Diagnosed With Borderline Personality Disorder Using a Dynamic Cognitive Intervention
Brief Summary: The field of psychiatric rehabilitation focuses on creating a personal narrative and developing coping strategies and environmental supports. The concept of recovery is person-centered and emphasizes the person's ability to change and to live meaningful life. The strengths approach has a central role in the recovery concept, emphasizing the person's abilities and potential. A preserved cognitive ability can be a significant strength in the recovery process.

Research had shown growing support for the use of cognitive-behavioral approaches as the most effective therapy for people with borderline personality disorder, using structured interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive modifiability and suggests the use of mediated learning in order to enhance sense of competence and develop better psychological coping skills.

The present study will focus on women diagnosed with borderline personality disorder, with normative cognitive ability seen as a strength as opposed to their emotional ability. This study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and on symptoms severity.

The study will include 30 women aged 18-45 years. Participants will be randomly assigned to an intervention group and a control group. All participants will be assessed before and after intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.

The intervention designed for this study is based on the principles of the Dynamic Cognitive Intervention. The intervention tools that will be used include: a. Instrumental Enrichment tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The intervention encompasses 12 sessions of 1.5 hours, with a routine structure.

The results are expected to contribute to the understanding of the impact of a dynamic cognitive intervention in women diagnosed with borderline personality disorder.


Options:
A: Change in the self-rating of affective reactivity (ARI-S) (Assessed at Baseline, at week 5, week 10 and week 11.); Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). (assessed at weeks 5, 10, and 11.)
B: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
C: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)
D: Self-harm Ideation (pre-treatment (week 0) to post-treatment (end of week 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Recovery Processes in Women Diagnosed With Borderline Personality Disorder Using a Dynamic Cognitive Intervention
Brief Summary: The field of psychiatric rehabilitation focuses on creating a personal narrative and developing coping strategies and environmental supports. The concept of recovery is person-centered and emphasizes the person's ability to change and to live meaningful life. The strengths approach has a central role in the recovery concept, emphasizing the person's abilities and potential. A preserved cognitive ability can be a significant strength in the recovery process.

Research had shown growing support for the use of cognitive-behavioral approaches as the most effective therapy for people with borderline personality disorder, using structured interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive modifiability and suggests the use of mediated learning in order to enhance sense of competence and develop better psychological coping skills.

The present study will focus on women diagnosed with borderline personality disorder, with normative cognitive ability seen as a strength as opposed to their emotional ability. This study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and on symptoms severity.

The study will include 30 women aged 18-45 years. Participants will be randomly assigned to an intervention group and a control group. All participants will be assessed before and after intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.

The intervention designed for this study is based on the principles of the Dynamic Cognitive Intervention. The intervention tools that will be used include: a. Instrumental Enrichment tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The intervention encompasses 12 sessions of 1.5 hours, with a routine structure.

The results are expected to contribute to the understanding of the impact of a dynamic cognitive intervention in women diagnosed with borderline personality disorder.


Options:
A: 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)
B: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
C: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
D: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))

Answer: D