TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Telehealth Care Management and Tobacco Cessation for Veterans With PTSD
Brief Summary: The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.


Options:
A: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)
B: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)
C: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
D: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telehealth Care Management and Tobacco Cessation for Veterans With PTSD
Brief Summary: The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.


Options:
A: Quit Attempt(s) (Any time within 26 weeks)
B: Tobacco Abstinence (3 months)
C: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)
D: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Brief Summary: Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.


Options:
A: Number of Participants With Venous Thromboembolic Events (VTE) (16 weeks of treatment)
B: 2-Month Cumulative Incidence of VTE (Assessment with lower extremity ultrasound occured at day 60/ month 2)
C: Progression Free Survival (during chemotherapy and follow-up)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Brief Summary: Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.


Options:
A: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
B: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
C: 2-Month Cumulative Incidence of VTE (Assessment with lower extremity ultrasound occured at day 60/ month 2)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-aided Diagnosis of Endoscopic Ultrasound Elastography Used in the Differentiation of Focal Pancreatic Masses
Brief Summary: The aim of the study is to assess elastography during EUS examinations of focal pancreatic masses, and to consequently differentiate benign versus malignant pancreatic masses in a prospective multi-center design.


Options:
A: accessing the rate for procurement of the histologic core (up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy)
B: number of passes (up to 12 months)
C: Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses. (18 months)
D: Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts (Within 6 months after the end of Follow-up period); Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes (Within one year after the end of the follow-up period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Of Eltrombopag On Thrombocytopenia, Platelet Function and Bleeding In Patients With Wiskott-Aldrich Syndrome/X-Linked Thrombocytopenia.
Brief Summary: The purpose of this project is to describe the pathophysiology of thrombocytopenia and bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to thrombopoietic agents in vitro and in vivo.


Options:
A: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
B: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)
C: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
D: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Of Eltrombopag On Thrombocytopenia, Platelet Function and Bleeding In Patients With Wiskott-Aldrich Syndrome/X-Linked Thrombocytopenia.
Brief Summary: The purpose of this project is to describe the pathophysiology of thrombocytopenia and bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to thrombopoietic agents in vitro and in vivo.


Options:
A: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)
B: Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days) (throughout entire study)
C: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
D: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
D: Glycemic control (serum hemoglobin A1c) (3 month after start of trial)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
B: Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞ (up to 5 days)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for ELX/TEZ/IVA Group (From Baseline Through Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
D: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
B: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
C: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
D: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm (Day 1 up to Week 108 (Study 112))
B: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
C: Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16 (Part A baseline through Week 16)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroregeneration Enhanced by TDCS in Stroke
Brief Summary: Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.


Options:
A: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
B: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
C: Upper Extremity Fugl-Meyer-Assessment (UEFMA) (1-7 days after the end of the intervention)
D: Motor Skill Retention (Day 9)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroregeneration Enhanced by TDCS in Stroke
Brief Summary: Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.


Options:
A: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
B: Median Change in Upper Extremity Fugl Meyer Assessment Score (baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention))
C: Upper Extremity Fugl-Meyer-Assessment (UEFMA) (1-7 days after the end of the intervention)
D: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.


Options:
A: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) (Study 105: Day 1 up to Week 168)
B: Part A: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Day 43 (Part A: Baseline (pre-dose Day 15), Day 43); Part B: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Week 48 (Part B: Baseline (Day -1), Week 48)
C: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea
Brief Summary: To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.


Options:
A: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
B: Doppler indices of uterine artery blood flows. (up to 10 minutes)
C: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) (16weeks)
D: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain (baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))

Answer: D