TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Multidisciplinary Self-care Management Program on Quality of Life, Self-care Behavior, Adherence to the Anti-hypertensive Treatment, Glycemic Control, and Renal Function in Adults Living With Diabetic Kidney Disease
Brief Summary: Diabetic Kidney Disease (DKD) is becoming a global health concern that affects largely the elderly population. Despite advances in pharmacological and management strategies, DKD remain associated with high morbidity and mortality. Patients living with such chronic disease, are expected, on daily basis to manage their self-care activities. Patients' non-adherence to the treatment is thought to be the major cause for the poor control and the occurrence of complications. Previous researchers have shown that multidisciplinary management of chronic disease can improve patients' self-care and outcomes. However, none of these programs was centered on self-care and targeted patients with DKD. A multidisciplinary self-care management program could improve the outcomes of patients with DKD, and delay the progression of the disease.

The aim of the study is to investigate the effect of a multidisciplinary self-care management program on self-care behavior, quality of life, medication adherence, glycemic control and renal function, in adults with DKD.

The study will use a cross-over design. 32 adult with DKD, will be randomly recruited from the Vaud University Medical Center, nephrology department and will be enrolled in the program for 12 month. All variables will be measured at baseline, three, six, nine and 12 month. We will measure the patients' self-care behavior, quality of life, adherence to the anti-hypertensive medication taking using, the Revised Summary of Diabetes Self-Care Activities questionnaire, the Audit of Diabetes-Dependent Quality of life questionnaire and the Medication Events Monitoring System. We will assess the patients' glycemic control by measuring the glycated hemoglobin and the renal function by measuring the serum creatinine and the microalbumin creatinine ratio.

The study will clearly show if a multidisciplinary self-care management program will improve the health outcomes of patients with DKD and will allow us to recommend the establishment of such a program.


Options:
A: Quality of life (12 months)
B: feasibility of intensive sodium management (12 months)
C: Reduction in blood pressure (Six months)
D: Change in 24-hour urinary creatinine clearance from baseline to final follow-up, measured from 24-hour urinary collection and corresponding serum creatinine measurement at randomisation and final visit. (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Examining the Effects of Diet on Health With an Online Program
Brief Summary: The study is a pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.


Options:
A: Change in body weight (measured at Year 2)
B: N/A
C: Hemoglobin A1c (baseline to 16 weeks)
D: Laboratory findings and body composition (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age
Brief Summary: Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.


Options:
A: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study (Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through follow-up period, up to 1 year after study entry)
B: Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Grade 2 and Grade 3 Fever (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Related Serious Adverse Events (SAEs) (During the 7-day (Days 0-6) post-vaccination period); Neutralizing Antibody Titers Against RSV-A Subtype (At Day 0); Neutralizing Antibody Titers Against RSV-A Subtype (At Day 30); Palivizumab Competing Antibody (PCA) Concentrations (At Day 0); Pavilizumab Competing Antibody (PCA) Concentrations (At Day 30)
C: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
D: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28) (Measured through Day 28); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through study follow-up period, up to 1 year after study entry)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China-a Prospective Multicenter Registry Study
Brief Summary: The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rate in patients in stenting group. However the intravascular therapy is going on because of low complication rate in considerable Chinese studies coming from several high volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the SAMMPRIS study, it is imperative to performing an multiple prospective registry study of stenting for patients with ICAS in China.


Options:
A: Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. (Mean length of follow-up was 2.4 years)
B: stroke or death within 30 days after enrollment, any stroke in the territory of the symptomatic intracranial artery beyond 30 days through 12 months (12 months)
C: the target vessel stroke event (within 30 days after stenting)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China-a Prospective Multicenter Registry Study
Brief Summary: The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rate in patients in stenting group. However the intravascular therapy is going on because of low complication rate in considerable Chinese studies coming from several high volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the SAMMPRIS study, it is imperative to performing an multiple prospective registry study of stenting for patients with ICAS in China.


Options:
A: Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. (Mean length of follow-up was 2.4 years)
B: Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. (30 days and 4 years)
C: Rate of Stroke or Death Among Participants (within 72 hours of the procedure)
D: the target vessel stroke event (within 30 days after stenting)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )
Brief Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.


Options:
A: 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.)
B: 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))
C: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)
D: Overall survival (Approximately 36 months after last patient randomized and observation of 244 events)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )
Brief Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.


Options:
A: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
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: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)
D: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications (Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )
Brief Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.


Options:
A: 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.)
B: Number of Participants With Progression-free Survival Incidence at Week 24 (Week 24)
C: Progression free survival (3 years)
D: 6-month Progression-Free Rate (6 months after initiation of study treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )
Brief Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.


Options:
A: objective response rate (24month)
B: Progression-Free Survival (8 Months on average)
C: 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.)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )
Brief Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.


Options:
A: 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.)
B: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.)
C: Objective Response Rate (ORR) (RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months))
D: 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.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: To Investigate the PRevention of OM-85 on Bronchiectasis Exacerbation (iPROBE): a Multicenter, Randomised, Double-dummy, Placebo-controlled Clinical Trial in Chinese Patients
Brief Summary: Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation and infection. Bronchiectasis airways are often colonized with bacterial species. Infections of the airways are thought to play an important role in bronchiectasis exacerbation. The non-specific prevention of recurrent airway infections by immunostimulating agents has gained growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria important in respiratory infections, has shown the benefit for significantly reducing the incidence of exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of this study is to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese patients (iPROBE).

This study is designed as a prospective randomised double-blind placebo-controlled multi-centred trial.


Options:
A: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
B: Reduction in bacterial load (1 year)
C: Bronchiectasis Exacerbation (1 year)
D: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: To Investigate the PRevention of OM-85 on Bronchiectasis Exacerbation (iPROBE): a Multicenter, Randomised, Double-dummy, Placebo-controlled Clinical Trial in Chinese Patients
Brief Summary: Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation and infection. Bronchiectasis airways are often colonized with bacterial species. Infections of the airways are thought to play an important role in bronchiectasis exacerbation. The non-specific prevention of recurrent airway infections by immunostimulating agents has gained growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria important in respiratory infections, has shown the benefit for significantly reducing the incidence of exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of this study is to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese patients (iPROBE).

This study is designed as a prospective randomised double-blind placebo-controlled multi-centred trial.


Options:
A: all-cause mortality (one year)
B: Morbidity (Up to end of follow-up (data presented up to 15 years)); Lung Function (Up to end of follow-up (data presented up to 15 years)); Mortality (Up to end of follow-up (data presented up to 15 years))
C: Bronchiectasis Exacerbation (1 year)
D: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms Ordered by Attending Physicians
Brief Summary: The utilization of transthoracic echocardiography in the United States has been increasing. This has resulted in increased costs to the healthcare system. In an effort to curb excessive utilization of this technology, the American College of Cardiology created Appropriate Use Criteria to help guide clinicians to use this diagnostic imaging modality more appropriately. The investigators previously showed that an educational intervention can reduce the rate of inappropriate echocardiograms ordered by physicians-in-training. It is unknown if such an intervention would be successful in attending, staff level of physicians. The investigators hypothesize that an educational and feedback intervention will reduce the rate of inappropriate outpatient transthoracic echocardiograms ordered by staff cardiologists and internal medicine physicians.


Options:
A: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
B: Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria (As patients exit the health facility)
C: Rate of Inappropriate transthoracic echocardiograms (12 months)
D: Shortened Fresno Test of Competence in Evidence-based Practice (SAFT) (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Brief Summary: This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.


Options:
A: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
C: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
D: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: C