TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of History-indicated Early Treatment With Cervical Pessary Versus Expectant Management Treatment With Rescue Cerclage in Cases With Cervical Shortening in Singleton Pregnancies at High-risk for sPTB on Children's Long-term Outcome
Brief Summary: Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well.

The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity \< 34 week of gestation (WoG).

The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.


Options:
A: Children's survival without neurodevelopmental disability at the age of 3 years (assessment of the newborn at age of 3 years (corrected age for prematurity))
B: Pre-term Birth (at the time of delivery)
C: Spontaneous delivery before 34 completed weeks (Each 6 months)
D: Proportion of spontaneous preterm birth before 34 weeks of gestation (up to 11 weeks (from date of randomization until delivery))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Evaluating the EffectiVeness of Adding an Internet-Based Self-Management Intervention to Usual Care in the Treatment of Borderline Personality Disorder - REVISIT BPD
Brief Summary: The trial aims to evaluate the effectiveness of a novel internet intervention (Priovi), which was designed to introduce relevant schema therapy techniques to Persons with Borderline Personality Disorder (BPD). Therefore, 200 people with BPD will be recruited and randomized to two groups: (1) a control group, in which they may engage with any BPD treatment (Care-as-Usual, CAU) and receive access to Priovi after a delay of 12 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Priovi and may also use CAU. The primary outcome measure is the score of the Borderline Personality Disorder Severity Index (BPDSI), collected at three, six and 12 month post-baseline.


Options:
A: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
B: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)
C: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
D: Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Evaluating the EffectiVeness of Adding an Internet-Based Self-Management Intervention to Usual Care in the Treatment of Borderline Personality Disorder - REVISIT BPD
Brief Summary: The trial aims to evaluate the effectiveness of a novel internet intervention (Priovi), which was designed to introduce relevant schema therapy techniques to Persons with Borderline Personality Disorder (BPD). Therefore, 200 people with BPD will be recruited and randomized to two groups: (1) a control group, in which they may engage with any BPD treatment (Care-as-Usual, CAU) and receive access to Priovi after a delay of 12 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Priovi and may also use CAU. The primary outcome measure is the score of the Borderline Personality Disorder Severity Index (BPDSI), collected at three, six and 12 month post-baseline.


Options:
A: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
B: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)
C: Borderline Symptoms (6 weeks)
D: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Evaluating the EffectiVeness of Adding an Internet-Based Self-Management Intervention to Usual Care in the Treatment of Borderline Personality Disorder - REVISIT BPD
Brief Summary: The trial aims to evaluate the effectiveness of a novel internet intervention (Priovi), which was designed to introduce relevant schema therapy techniques to Persons with Borderline Personality Disorder (BPD). Therefore, 200 people with BPD will be recruited and randomized to two groups: (1) a control group, in which they may engage with any BPD treatment (Care-as-Usual, CAU) and receive access to Priovi after a delay of 12 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Priovi and may also use CAU. The primary outcome measure is the score of the Borderline Personality Disorder Severity Index (BPDSI), collected at three, six and 12 month post-baseline.


Options:
A: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)
B: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
C: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Evaluating the EffectiVeness of Adding an Internet-Based Self-Management Intervention to Usual Care in the Treatment of Borderline Personality Disorder - REVISIT BPD
Brief Summary: The trial aims to evaluate the effectiveness of a novel internet intervention (Priovi), which was designed to introduce relevant schema therapy techniques to Persons with Borderline Personality Disorder (BPD). Therefore, 200 people with BPD will be recruited and randomized to two groups: (1) a control group, in which they may engage with any BPD treatment (Care-as-Usual, CAU) and receive access to Priovi after a delay of 12 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Priovi and may also use CAU. The primary outcome measure is the score of the Borderline Personality Disorder Severity Index (BPDSI), collected at three, six and 12 month post-baseline.


Options:
A: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score (Baseline (Day 0) to Week 10)
B: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)
C: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
D: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia


Options:
A: Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) (Day 1 to Day 42)
B: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and week 12 to 16)
C: Rate of rise in hemoglobin (g/dL/week) (Baseline and at Week-6)
D: Responder rate: proportion of responders among the subjects (Week 30 to 36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Knowledge and Awareness Regarding Association of Arecanut/Betel Quid and With Oral Cancer and Other Serious Illnesses Among Children 11-16 Years; A Cluster Randomized Intervention Study
Brief Summary: Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the eighth most common cancer worldwide.The annual estimated incidence is around 275,000 for oral and 130,300 for pharyngeal cancers excluding nasopharynx, two-thirds of these cases occurring in developing countries. In Pakistan, it is the second most common cancer in women and third most common cancer in men. The Age Standardized Rates (ASR) for oral cancers are 13.8 and 14.1 in males and females respectively.To the best of investigators knowledge, no intervention study has been done to improve knowledge and awareness of adults regarding association of areca nut/betel quid with oral cancer. Therefore, the study aims to implement a cluster randomized intervention trial in secondary schools to improve the knowledge and awareness regarding this association among children 11-16 years. For resource poor countries such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its important risk factor such as betel quid, areca nut and chew tobacco. A school-based intervention study will be carried out in secondary schools in Karachi. The target population will be male and female school students in school grades 6 to 10 with intervention group and control group at each site. School-based educational intervention will be given to the intervention group while no specific education will be given to the control group. Differences in attitudes, knowledge and behaviors between the intervention and control groups will be compared each site separately before and after the intervention. The minimum sample size required was 22 schools (clusters). The number of subjects in each arm will be 529 with average cluster size of 50. The selected schools will be randomly assigned to a control group or Interventions group. Randomization will be done at the school level to avoid contamination between groups.The health education programme will be conducted for 3 consecutive weeks in one academic year for all the selected schools.


Options:
A: Student: SSB Change From Baseline to 7-months (All Participants) (Baseline and 7-months)
B: Knowledge about hazards of smokeless tobacco (6 months)
C: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)
D: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Knowledge and Awareness Regarding Association of Arecanut/Betel Quid and With Oral Cancer and Other Serious Illnesses Among Children 11-16 Years; A Cluster Randomized Intervention Study
Brief Summary: Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the eighth most common cancer worldwide.The annual estimated incidence is around 275,000 for oral and 130,300 for pharyngeal cancers excluding nasopharynx, two-thirds of these cases occurring in developing countries. In Pakistan, it is the second most common cancer in women and third most common cancer in men. The Age Standardized Rates (ASR) for oral cancers are 13.8 and 14.1 in males and females respectively.To the best of investigators knowledge, no intervention study has been done to improve knowledge and awareness of adults regarding association of areca nut/betel quid with oral cancer. Therefore, the study aims to implement a cluster randomized intervention trial in secondary schools to improve the knowledge and awareness regarding this association among children 11-16 years. For resource poor countries such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its important risk factor such as betel quid, areca nut and chew tobacco. A school-based intervention study will be carried out in secondary schools in Karachi. The target population will be male and female school students in school grades 6 to 10 with intervention group and control group at each site. School-based educational intervention will be given to the intervention group while no specific education will be given to the control group. Differences in attitudes, knowledge and behaviors between the intervention and control groups will be compared each site separately before and after the intervention. The minimum sample size required was 22 schools (clusters). The number of subjects in each arm will be 529 with average cluster size of 50. The selected schools will be randomly assigned to a control group or Interventions group. Randomization will be done at the school level to avoid contamination between groups.The health education programme will be conducted for 3 consecutive weeks in one academic year for all the selected schools.


Options:
A: Knowledge about hazards of smokeless tobacco (6 months)
B: Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (Baseline, 8-months post-intervention, and 24-months post-intervention)
C: Number of smokers referred to tobacco cessation website (12 months)
D: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Study of Brexpiprazole in the Treatment of Borderline Personality Disorder.
Brief Summary: The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.


Options:
A: Functioning Assessment Scale Test (FAST) (up to three years)
B: Zanarini Rating Scale for Borderline Personality Disorder (Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8))
C: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
D: BSSI score (Day 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Study of Brexpiprazole in the Treatment of Borderline Personality Disorder.
Brief Summary: The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.


Options:
A: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
B: Zanarini Rating Scale for Borderline Personality Disorder (Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8))
C: Self-harm Ideation (pre-treatment (week 0) to post-treatment (end of week 8))
D: Functioning Assessment Scale Test (FAST) (up to three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE)
Brief Summary: The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. Based on optimal supportive care, the trial is aiming to assess superiority with regard to renal protection and reduction of severe treatment-related adverse events of Yi-Qi-Qing-Jie formula (YQF) combined therapy compared with immunosuppression monotherapy in high-risk IgAN.


Options:
A: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)
B: change in the degree of proteinuria (16 weeks)
C: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
D: First occurrence of 40% decrease in eGFR from baseline (Baseline, until the first occurrence or 3 years); First occurrence of progression to continuous renal replacement (Until occurrence or 3 years); Death due to renal disease (Until occurrence or 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial
Brief Summary: The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).


Options:
A: Difference between treatment groups in responder rates. (3 Months)
B: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
C: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
D: The Difference in Responders Between Both Groups (6 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial
Brief Summary: The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).


Options:
A: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
B: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
C: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
D: Composite of Safety and Effectiveness (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial
Brief Summary: The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).


Options:
A: Difference between treatment groups in responder rates. (3 Months)
B: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)
C: The Difference in Responders Between Both Groups (6 Months)
D: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
Brief Summary: There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.


Options:
A: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
B: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
C: Gentamicin serum concentration (Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.)
D: Mortality (90 day)

Answer: A