TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Plant Stanol Ester-Containing Spread Based on Extra Virgin Olive Oil on Estimated Cardiovascular Risk, and Lipid-Inflammatory-Haemostatic Factors in Comparison to Mediterranean Diet: A Randomized, Placebo-Controlled Trial.
Brief Summary: Since it is very difficult to have the real thing (Mediterranean diet) we need to find an alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this proposed study is designed to assess if giving olive oil supplements, with or without stanol ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil combination may prove to be superior to olive oil alone.


Options:
A: Glucose metabolism (Study weeks 0); Glucose metabolism (12 weeks); Glucose metabolism (24 weeks)
B: Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. (three months)
C: Composity of Major Cardiovascular Events (up to 48 month)
D: Changes in Mediterranean diet scale (6, 12, and 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.


Options:
A: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
B: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24); Trough FEV1 Response at Week 24 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks (Baseline, Week 24); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis (Baseline, Week 24)
C: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)
D: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 1) The Effect of Xenon and Sevoflurane on Hypnosis Monitors. 2) Prevention of Postoperative Nausea and Vomiting. 3) Rescue Treatment of Established Postoperative Nausea and Vomiting. Sevoflurane.
Brief Summary: The purpose of this study is ad 1) to measure the depth of hypnosis as assessed by BIS and cAAI during an average general anesthesia with xenon or sevoflurane and to establish a reliable monitoring system for measuring and documenting the actual depth of hypnosis for the volatile anesthetics investigated. Ad 2) the question is to be answered whether 4 mg dexamethasone i.v. is an effective prophylactic treatment against postoperative nausea and vomiting in case of xenon or sevoflurane anesthesia. Ad 3) it serves to gain evidence about the (non-)effectiveness and kinetics of ondansetron as antiemetic remedy after xenon or sevoflurane anesthesia.


Options:
A: The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. (During anaesthesia); Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10. (After anesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anesthesia the maximum nausea will be rated for the 30-120 min, 2-6 h, and 6-24 h interval.); Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration. (Maximum nausea will be rated at 2, 6 and 24 hours after treatment for the 30-120 min, 2-6 h and 6-24 h interval.)
B: Pain score by numeric rating scale (At 8 hours postoperatively)
C: Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration (0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours)
D: Pain was assessed immediately on return to the recovery room and at 6, 12 and 24 h after the operation using a visual analogue scale (VAS; 0 = no pain to 10 = most severe pain). (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
Brief Summary: Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes is scant and controversial. While the efficacy of aspirin versus placebo in patients with diabetes is currently under investigation in big randomized controlled trials, the putative additive effects of aspirin and statins in this population remain to be investigated. Moreover there are no data examining the pathophysiologic means by which aspirin with or without statins affects thrombosis in diabetic patients.

The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily), statins, both or neither for the reduction of thrombin generation. These preventive strategies will be evaluated on the top of the other strategies aimed at optimizing the care of diabetic patients in terms of metabolic control and control of the other cardiovascular risk factors.


Options:
A: This clinical trial of atorvastatin 40 mg vs. placebo will determine if atorvastatin will:. Reduce progression of atherosclerosis on helical CT or carotid duplex.; Determine whether atorvastatin 40 mg is more effective than placebo in retarding coronary calcification on multislice helical CT over two years.; Determine whether atorvastatin 40 mg is more effective than placebo in preventing new or preventing progression of old atherosclerotic plaque on carotid duplex over two years.; Determine whether atorvastatin 40 mg is more effective than placebo in preventing carotid intimal medial thickness on carotid duplex over two years.
B: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) (Baseline and 16 weeks)
C: From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).
D: Thrombin generation (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
Brief Summary: Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes is scant and controversial. While the efficacy of aspirin versus placebo in patients with diabetes is currently under investigation in big randomized controlled trials, the putative additive effects of aspirin and statins in this population remain to be investigated. Moreover there are no data examining the pathophysiologic means by which aspirin with or without statins affects thrombosis in diabetic patients.

The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily), statins, both or neither for the reduction of thrombin generation. These preventive strategies will be evaluated on the top of the other strategies aimed at optimizing the care of diabetic patients in terms of metabolic control and control of the other cardiovascular risk factors.


Options:
A: Decrease in incidence of deep vein thrombosis
B: Thrombin generation (8 weeks)
C: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). (Baseline and Week 6)
D: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)
Brief Summary: This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.


Options:
A: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 (Week 72)
B: Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients) (Baseline and up to 4 weeks); Occurrence of Adverse Events (AEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time (Baseline and up to 4 weeks)
C: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)
D: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)
Brief Summary: This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.


Options:
A: Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients) (Baseline and up to 4 weeks); Occurrence of Adverse Events (AEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time (Baseline and up to 4 weeks)
B: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
D: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.


Options:
A: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. (From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8) (Baseline (BL) and Day 85)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
C: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation
Brief Summary: Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
B: Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) (Baseline and 12 months)
C: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
D: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
Brief Summary: The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.


Options:
A: To compare processes and outcomes between CHC patients receiving practice-based collaborative care to CHC patients receiving telemedicine-based collaborative care (OUTREACH intervention). (6, 12, 18 months after baseline)
B: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment (12 months); Depression Care: Treatment Response (Baseline and 12 months); Depression Care: Depression Remission (Baseline and 12 months); Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months (From Baseline to 12 months)
C: Adherence to Antidepressant Medication (At 3 and 6 months)
D: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
Brief Summary: The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.


Options:
A: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)
B: Adherence to Antidepressant Medication (At 3 and 6 months)
C: Quality of life. (12 months)
D: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
Brief Summary: The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.


Options:
A: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)
B: Metabolic Syndrome (MetS) (Baseline)
C: Adherence to Antidepressant Medication (At 3 and 6 months)
D: Quality of life. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial Investigating a Mobile Phone Self-monitoring Tool (Mobiletype) to Increase Emotional Self-awareness and Reduce Depressive Symptoms in Young People.
Brief Summary: The mobiletype program is a mental health assessment and monitoring tool that runs on mobile phones.

The program assesses the general mental health of young people in real-time and transmits this data to a website to be reviewed by their general practitioner (GP) in consultation with their patient. The website consists of individualised feedback reports for each participant, and graphical displays of the monitoring data. The primary aims of the current project are to examine: (1) whether the process of self-monitoring via the mobiletype program increases young people's awareness of their mood and reduces depressive symptoms and (2) whether emotional self-awareness mediates the relationship between self-monitoring and depressive symptoms.


Options:
A: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)
B: Symptom burden and quality of life 2-4 weeks post treatment (3 years)
C: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)
D: Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period. (Measured on all participants included one time a month for six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial Investigating a Mobile Phone Self-monitoring Tool (Mobiletype) to Increase Emotional Self-awareness and Reduce Depressive Symptoms in Young People.
Brief Summary: The mobiletype program is a mental health assessment and monitoring tool that runs on mobile phones.

The program assesses the general mental health of young people in real-time and transmits this data to a website to be reviewed by their general practitioner (GP) in consultation with their patient. The website consists of individualised feedback reports for each participant, and graphical displays of the monitoring data. The primary aims of the current project are to examine: (1) whether the process of self-monitoring via the mobiletype program increases young people's awareness of their mood and reduces depressive symptoms and (2) whether emotional self-awareness mediates the relationship between self-monitoring and depressive symptoms.


Options:
A: Weight loss (3 months, 6 months, 12 months)
B: Personal Health Partner (PHP) assessment with electronic health record (EHR) data exchange before pediatric primary care visits (2 week -1day before doctor's appointment and 1 week after appointment)
C: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
D: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)

Answer: D