TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
Brief Summary: Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.


Options:
A: Post-operative mortality (30 days after surgery)
B: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)
C: a composite of acute VTE, arterial thrombosis, treatment with ECMO, or all-cause mortality (30 days from enrollment)
D: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
Brief Summary: Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.


Options:
A: Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU (Discharge from ICU or 30 days)
B: recurrence of VTE and/or VTE related death (at least 24 months per patient)
C: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)
D: incidence of VTE (up to 30 days after operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
Brief Summary: Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.


Options:
A: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)
B: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
C: Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks (6 weeks); Rate of post-thrombotic syndrome (PTS) (1 year)
D: Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site (after approximately 2 years or 30 days after stop of therapy); Number of patients with symptomatic recurrent venous thromboembolic events (after approximately 2 years or 30 days after stop of therapy); All cause mortality (after approximately 2 years or 30 days after stop of therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
Brief Summary: Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.


Options:
A: P/F ratio (three days of intervention)
B: Clinical (Day 1 to 10); Virological (Day 1 to 10)
C: Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality (30 days)
D: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mild Cognitive Impairment and Obstructive Sleep Apnea
Brief Summary: Obstructive sleep apnea (OSA) has been linked to increased risk for Alzheimer's disease (AD), but little prospective evidence exists on the effects of OSA treatment in preclinical AD. The objective was to determine if CPAP treatment adherence, controlling for baseline differences, predicts cognitive and everyday function after 1 year in older adults with MCI and to determine effect sizes for a larger trial. The aim of the Mild Cognitive Impairment and Obstructive Sleep Apnea (Memories 1) trial was to determine whether CPAP treatment adherence, controlling for any baseline differences in OSA severity, ApoE4, and other previously identified demographic and patient factors, might predict cognitive and everyday function after 1 year in older adults with amnestic MCI.


Options:
A: Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 1); Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 16)
B: proportion using CPAP within 48-hours of stroke onset (72 hours)
C: Residual Apnea Hypopnea Index (up to 12 weeks)
D: Hopkins Verbal Learning Test-Revised (HVLT-R) (Change from baseline at 6 months and 1 year); Digit Symbol Subtest (DS) (Change from baseline at 6 months and 1 year); Mini Mental State Evaluation Exam (MMSE) (Change from baseline at 6 months and 1 year); Stroop Color and Word Test (SCW) (Change from baseline at 6 months and 1 year); The Psychomotor Vigilance Task (PVT) (Change from baseline at 6 months and 1 year); Epworth Sleepiness Scale [ESS] (Change from baseline at 6 months and 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Open-labeled Trial Comparing RADIOEMBOLIZATION With Yttrium 90 Microspheres and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Brief Summary: The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC) with or without portal venous obstruction and no extrahepatic extension than sorafenib which is now the standard treatment of advanced HCC.


Options:
A: Median overall survival time (36 months)
B: Time to progression (TTP) (At 1, 3, 6, 12 months and every 6 months thereafter)
C: Overall Survival (2 years)
D: Time to Progression (TTP) in Patients Treated With TACE and Y90 (Up to 6 yrs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor
Brief Summary: Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors.

Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic).

Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).


Options:
A: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)
B: UKCTOCS (2001-2014): Death due to ovarian cancer (WHO 2003) determined by independent outcomes committee review of patient notes for all women identified to have a 'possible ovarian cancer' (pre-specified ICD-10 codes) till 31st December 2014.; Long term impact of screening on ovarian cancer mortality in the UKCTOCS (LTFU UKCTOCS) (2015-2021): Death due to ovarian cancer (WHO 2014) determined by independent outcomes committee review till 30 June 2020.
C: Overall Response Rate Per RECIST Version 1.1 (Part 2) (Time from first dose to date of progression, up to approximately 8 months); Number of Participants With a Dose Limiting Toxicity (DLT) (Cycle 1 Day 1 to Cycle 1 Day 21); PK Profile of Rucaparib - Cmax (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days); PK Profile of Rucaparib - Tmax (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days); PK Profile of Rucaparib - AUC Last (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days)
D: objective response rate by RECIST 1.1 (6 months after treatment initiation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.
Brief Summary: The objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties.

The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.


Options:
A: Back specific functional status(Roland) (12 mo); Pain (12 mo)
B: Impact into quality of life with the Qualeffo-41 test (Baseline, 2 weeks, 2 months, 6 months and 1 year)
C: Patient rated pain intensity (two weeks)
D: pain relief (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.
Brief Summary: The objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties.

The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.


Options:
A: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month (1 month after procedure); Patient's Rating of Average Pain at 1 Month (1 month)
B: pain relief (12 months)
C: Patient rated pain intensity (two weeks)
D: Impact into quality of life with the Qualeffo-41 test (Baseline, 2 weeks, 2 months, 6 months and 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Online Treatments for Mood and Anxiety Disorders in Primary Care
Brief Summary: Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated access to a proven-effective computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of these treatments to PCPs' "usual care" for these conditions, and evaluate the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a greater understanding of how to best scale the delivery of these interventions into a variety of primary care settings.


Options:
A: Quality of primary medical care (Measured over 2 years)
B: SF-12 MCS (6-Month Follow-up)
C: Systolic and Diastolic Blood Pressure (SBP, DBP) (24 months); Total Cholesterol (24 months); Physical Health-related Quality of Life Score (24 months)
D: The Work Behavior Inventory (Ten months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis
Brief Summary: The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: Clinical Response at Week 8 Based on Mayo Score (Eight week treatment period)
C: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)
D: Number of Participants With Clinical Response (Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
Brief Summary: To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Options:
A: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
B: Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I) (Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups)
C: depression (pre, post and 6 months post treatment)
D: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
Brief Summary: To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Options:
A: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
B: Severity of mental health symptoms (previous 4 weeks)
C: Clinician-Administered PTSD Scale (CAPS) (After 14 weeks of treatment)
D: depression (pre, post and 6 months post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
Brief Summary: To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Options:
A: CAPS-CA (10 days, 2 months, 6 months after intervention); CBCL (10 days, 2 months, 6 months after intervention); DIKJ (10 days, 2 months, 6 months after intervention)
B: depression (pre, post and 6 months post treatment)
C: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)
D: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
Brief Summary: To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Options:
A: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
B: Remission (i.e. recovery from depression) and depressive symptoms, assessed by the PHQ-9 (6 months post-child birth)
C: Severity of mental health symptoms (previous 4 weeks)
D: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)

Answer: D