TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.
Brief Summary: The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.


Options:
A: Common infections
B: Efficacy (6 months of observation); Efficacy (6 months of observation); efficacy (6 months of observation); efficacy (6 months of observation)
C: Body composition (4 months)
D: Acute respiratory infections and diarrheal disease (28 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease
Brief Summary: The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).


Options:
A: Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) (Week 0, week 12 and week 16)
B: Change from baseline in urine protein creatinine ratio (9 months)
C: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)
D: Serum creatinine; 24 hour urinary protein excretion

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life
Brief Summary: The purpose of this study is to examine the effectiveness and applicability of different interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as psychological and physiological health variables are assessed. The interventions are based on the principles of cognitive behavioural therapy, and delivered either face-to-face, via mobile phone application, or Internet.


Options:
A: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)
B: Change in Weight from Baseline to 6 Months (Baseline and 6 Months); Change in Weight from Baseline to 30 Months (Baseline and 30 Months)
C: Weight (Baseline to 6-Months)
D: Psychological Flexibility (AAQ-2) (Change from Baseline in Psychological Flexibility at 8.5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life
Brief Summary: The purpose of this study is to examine the effectiveness and applicability of different interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as psychological and physiological health variables are assessed. The interventions are based on the principles of cognitive behavioural therapy, and delivered either face-to-face, via mobile phone application, or Internet.


Options:
A: change in severity of depressive symptoms (change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months)
B: Psychological Flexibility (AAQ-2) (Change from Baseline in Psychological Flexibility at 8.5 months)
C: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
D: coronary blood flow as measured by PET (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial
Brief Summary: To determine if respiratory support at birth guided by RFM decreases BPD.


Options:
A: Return of Spontaneous Circulation (up to 60 Minutes of chest compression)
B: Combined Outcome of Death or Bronchopulmonary Dysplasia (36 weeks)
C: Difference in bronchopulmonary dysplasia (36 weeks corrected gestational age)
D: Time Needed to Achieve Return of Spontaneous Circulation (within the first 10 minutes after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable
Brief Summary: This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery \[IDS\]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.


Options:
A: Percentage of Participants with Complete Resection After IDS (After IDS (approximately 4 months from randomization)); Percentage of Participants with Different CC Scores After IDS (After IDS (approximately 4 months from randomization))
B: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)
C: Progression-free Survival (3 years)
D: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable
Brief Summary: This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery \[IDS\]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.


Options:
A: Progression-free Survival (Duration of time from start of treatment to time of progression, approximately 4 years and 6 months.)
B: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))
C: Percentage of Participants with Complete Resection After IDS (After IDS (approximately 4 months from randomization)); Percentage of Participants with Different CC Scores After IDS (After IDS (approximately 4 months from randomization))
D: Progression-free Survival(PFS) (up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Brief Summary: Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.


Options:
A: Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (6 months)
B: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
C: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)
D: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology
Brief Summary: The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.


Options:
A: Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
B: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)
C: Change in left ventricular ejection fraction (6 months)
D: • Change in global left ventricular ejection fraction (3, 6, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients
Brief Summary: There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.


Options:
A: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
B: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)
C: Kidney recipients'knowledge level (7-8 weeks post kidney transplantation); Kidney recipients'knowledge level (6 months post kidney transplantation)
D: Time to First Occurrence of Acute Rejection, Failure, Death (1 year post-transplant)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients
Brief Summary: There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.


Options:
A: Patient LDKT Attitude & Decision-Making Measure: Readiness (up to 8 months post-Baseline)
B: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
C: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)
D: Change in Anxiety and Depression (HADS) scores from baseline (Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Polymedication Check - Evaluation of the Impact of Community Pharmacy Based Medication Review on Medicines Use and Humanistic Outcomes
Brief Summary: Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to patients on ≥4 prescribed drugs taken over ≥3 months.

Aims:

To evaluate first experiences shortly after implementation, missed pharmaceutical care issues and barriers to implementation on pharmacist's level as well as patient's acceptance through qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary Care and to evaluate economic, clinical and humanistic outcomes in a subsequent randomized controlled trial.


Options:
A: Qualitative description of process-related challenges and successes as assessed by observation and survey (3 months)
B: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
C: Medication possession ratio (MPR), gaps and persistence in medicines use (Seven months after recruitment)
D: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Polymedication Check - Evaluation of the Impact of Community Pharmacy Based Medication Review on Medicines Use and Humanistic Outcomes
Brief Summary: Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to patients on ≥4 prescribed drugs taken over ≥3 months.

Aims:

To evaluate first experiences shortly after implementation, missed pharmaceutical care issues and barriers to implementation on pharmacist's level as well as patient's acceptance through qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary Care and to evaluate economic, clinical and humanistic outcomes in a subsequent randomized controlled trial.


Options:
A: Medication possession ratio (MPR), gaps and persistence in medicines use (Seven months after recruitment)
B: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
C: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
D: Change in Quality of Life (one year after baseline assessment); Change in Caregiver Burden (one year after baseline assessment); Change in Behavioral and Psychological Symptoms of Dementia (one year after baseline assessment); Change in Medical Treatment With Antidementia Drugs (one year after baseline assessment); Reduction of Potential Inapropriate Medication (PIM) (one year after baseline assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study of Intraperitoneal Paclitaxel With Oxaliplatin and Capecitabine in Patients With Advanced Gastric Cancer
Brief Summary: This is a single arm phase 2 trial evaluating the efficacy and tolerability of intraperitoneal paclitaxel with oxaliplatin and capecitabine in advanced gastric cancer patients with peritoneal metastasis and/or cancer cells on peritoneal cytology. Twenty patients will be recruited into the study for an estimated period of two years. Paclitaxel will be administered intraperitoneally at 40mg/m2 on Day 1 and 8 in patients receiving standard intravenous oxaliplatin 130mg/m2 on Day 1 and capecitabine 1000mg/m2 on day 1-14. The study hypothesizes that the addition of intraperitoneal paclitaxel with chemotherapy will improve treatment efficacy.


Options:
A: Median Survival (The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).)
B: Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Percentage of Participants Who Died: Second Interim Analysis (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Overall Survival: Second Interim Analysis (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Percentage of Participants Who Died: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Overall Survival: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Percentage of Participants Who Were Alive at Year 1 (Year 1); Percentage of Participants Who Were Alive at Year 2 (Year 2)
C: Overall survival (OS) rate (1 year)
D: Failure-free survival (six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe Sepsis
Brief Summary: Ventilated ICU patients frequently have sepsis and the majority have delirium, a form of brain dysfunction that is an independent predictor of increased risk of dying, length of stay, costs, and prolonged cognitive impairment in survivors. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction. The available alternative sedation regimens, the shorter acting GABA-ergic propofol, and the alpha2 agonist, dexmedetomidine, have both been shown to be superior to benzodiazepines, and yet are different with regard to their effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The MENDS2 study will compare propofol and dexmedetomidine, and determine the best sedative medication to reduce delirium and improve survival and long-term brain function in our most vulnerable patients- the ventilated septic patient.


Options:
A: delirium (during admission at the critical care)
B: delirium (during admission at the critical care)
C: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
D: Delirium/Coma Free Days (DCFDs) (14 days)

Answer: D