TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating PTSD in Patients With Borderline Personality Disorder
Brief Summary: Individuals with borderline personality disorder (BPD) are the quintessential multi-problem patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral treatment for BPD that has been shown effective in reducing the primary problems it is designed to treat; namely, the frequency and severity of self-injurious and suicidal behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment manual does not currently include a protocol specifying when or how to treat posttraumatic stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed patients, thereby making it difficult to determine the generalizability of these approaches to individuals with BPD. The research proposed here is focused on the development of a protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be integrated into standard DBT, as well as the initial evaluation of this protocol's feasibility, acceptability, and efficacy. The treatment development and pilot testing process will occur in two phases, including measure development and standardization of the treatment protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to inform the design and conduct of a subsequent full-scale RCT. This research has the potential to significantly expand and improve upon the most empirically supported treatment currently available for BPD, while also demonstrating that exposure treatments for PTSD can be implemented safely and effectively in a BPD population.


Options:
A: Parasuicidal behaviour (intermittent)
B: PTSD Symptom Scale - Interview (Pre-treatment, 4-, 8-, 12-, and 15-months); Suicide Attempt Self-Injury Interview (Pre-treatment, 4-, 8-, 12-, and 15-months)
C: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)
D: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating PTSD in Patients With Borderline Personality Disorder
Brief Summary: Individuals with borderline personality disorder (BPD) are the quintessential multi-problem patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral treatment for BPD that has been shown effective in reducing the primary problems it is designed to treat; namely, the frequency and severity of self-injurious and suicidal behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment manual does not currently include a protocol specifying when or how to treat posttraumatic stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed patients, thereby making it difficult to determine the generalizability of these approaches to individuals with BPD. The research proposed here is focused on the development of a protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be integrated into standard DBT, as well as the initial evaluation of this protocol's feasibility, acceptability, and efficacy. The treatment development and pilot testing process will occur in two phases, including measure development and standardization of the treatment protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to inform the design and conduct of a subsequent full-scale RCT. This research has the potential to significantly expand and improve upon the most empirically supported treatment currently available for BPD, while also demonstrating that exposure treatments for PTSD can be implemented safely and effectively in a BPD population.


Options:
A: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
B: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
C: PTSD Symptom Scale - Interview (Pre-treatment, 4-, 8-, 12-, and 15-months); Suicide Attempt Self-Injury Interview (Pre-treatment, 4-, 8-, 12-, and 15-months)
D: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assertive Community Treatment (ACT) as Part of Integrated Care Versus Standard Care: a 12-month Trial in Patients With First- and Negatively Selected Multiple-episode Schizophrenia-spectrum Disorders Treated With Quetiapine IR
Brief Summary: The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.


Options:
A: Number of self-reported falls: Falls surveillance report (10 minutes)
B: Time to Service Disengagement (12 months)
C: Physical activity measured by pedometer. (2 years); Healthy eating index quantified by the Food Frequency Questionnaire. (2 years)
D: HIV-1 seroincidence; HSV2 seroprevalence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.


Options:
A: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
B: Change in HbA1c From Baseline to Week 26 (Main Study) (Day 1 (Baseline) and Week 26); Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy) (Day 1 (Baseline) and Week 26)
C: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (after 24 weeks of treatment)
D: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of the Liverpool Care Pathway in Improving End of Life Care for Dying Cancer Patients in Hospital. A Cluster Randomised Trial.
Brief Summary: The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices.


Options:
A: Quality of end-of-life care provided to dying cancer patients and their families. (six months after the implementation of the LCP Program)
B: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale (Baseline, Last 3 Days of Study Drug Administration (4 weeks))
C: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
D: percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment (Up to 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Brief Summary: To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Options:
A: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
B: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
C: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
D: 6 Month Progression-free Survival (PFS) (6 months); Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Up to 5 years); Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) (Up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Brief Summary: To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Options:
A: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)
B: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Brief Summary: To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Options:
A: ORR (Up to 2 years); PFS (Up to 2 years)
B: Investigator-assessed Progression-free Survival (PFS) (From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo))
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Brief Summary: To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Options:
A: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
B: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
C: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
D: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Brief Summary: To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Options:
A: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
B: Progression-Free Survival (The timeframe is from enrollment onto the study up to 3 years following enrollment.)
C: progression free survival (12 months)
D: Progression-free Survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Brief Summary: To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Options:
A: objective response rate by RECIST 1.1 (6 months after treatment initiation)
B: Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines (Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.)
C: MDS/AML reports related to PARPi (from WHO database). (From inception to May 3, 2020); MDS/AML reports related to PARPi (from French database). (From inception to May 1, 2021)
D: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercising With Computers in Later Life (EXCELL) - Pilot and Feasibility Study of the Nintendo® WiiFit in Community-dwelling Fallers
Brief Summary: This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable to a physiotherapist-led falls group in terms of improvement in balance. The acceptability of the Nintendo® Wii will also be assessed.


Options:
A: Improvement in formal balance score (4 weeks and 12 weeks following the exercise intervention)
B: Cognitive Performance of Executive Function (12 months)
C: Standing Balance (5 weeks)
D: Number of falls and injurious falls in 12 months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Solar Disinfection of Drinking Water for Use in Developing Countries or in Emergency Situations
Brief Summary: SODISWATER is a European Union funded health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was done by observing whether children younger than 5 years old who drink solar disinfected water were healthier than those who did not. Health was measured by how often the children had diarrhoea.

Participants were given plastic bottles to place in the sun, water samples were then collected from these plastic bottles to be analyzed. They were also requested to fill in diarrhea diaries.

TESTABLE RESEARCH HYPOTHESES:

Health Impact Assessment: Children who use solar disinfected water will have:

(a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden (g) increased school attendance


Options:
A: To assess the prevalence of diarrhea among under five children (four months)
B: Thermotolerant coliforms in household drinking water (5 months)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
D: Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old (Duration of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
Brief Summary: This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.


Options:
A: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
B: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle (Day 29)
C: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
D: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
Brief Summary: This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.


Options:
A: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle (Day 29)
B: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
C: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event
Brief Summary: Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization (Randomization up to 47 months); Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients (First dosing up to 48 months)
C: Glomerular Filtration Rate; Adverse Events
D: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)

Answer: D