TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double-blind Cross-over Patient Preference Study of Pazopanib Versus Sunitinib in Treatment naïve Locally Advanced or Metastatic Renal Cell Carcinoma.
Brief Summary: This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. \>=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety.


Options:
A: progression-free rate (at 48 weeks post-treatment)
B: To evaluate if progression-free survival from randomization to progression or death during second-line therapy (Total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib. (4 years)
C: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
D: Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ) (End of treatment of both study drugs (maximum of 22 weeks)); Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire (End of treatment of both study drugs (maximum of 22 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
B: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
C: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
D: Annualized Relapse Rate (ARR) at 1 Year (1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.


Options:
A: Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke (Up to approximately 8 years)
B: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
C: Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A) (Baseline and Week 24); Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B) (Up to 107 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B) (Up to 104 weeks); Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B) (Up to 104 weeks)
D: Change From Baseline in Hemoglobin A1C at Week 54 (Baseline and Week 54); Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue (Up to Week 57); Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue (Up to Week 54)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Brief Summary: The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.


Options:
A: Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer. (Time to first event during study period (for each patient 24-48 months, mean 36 months ))
B: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
C: Time from randomization to the primary action point (monotherapy failure).
D: New onset of hypertension (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Dietary Glycemic Index on Brain Function
Brief Summary: The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.


Options:
A: Weight; measured at each study visit; Percent body fat; measured at each study visit
B: Blood Flow in Brain Areas of Intake Control. (4 hours postprandial)
C: For adults: body weight loss maintenance (6 Month)
D: Change from baseline in weight at 12 months (Baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Therapeutic Education Improve Heart Failure Patient Quality of Life?
Brief Summary: Use lay language. Background: Heart failure is an increasingly frequent current pathology due to the population aging and the improvement of acute and chronic heart failure management. Heart failure patients have a poor quality of life because of their symptoms (asthenia, dyspnea...) and frequent hospitalizations. Heart failure is an expensive disease: 1.5 % of the health expenses, 85 % in hospital cost with 200 000 hospitalizations in France per year. Previous studies were multidisciplinary interventions and not realistic in a daily practice for a general practitioner. The aim of this project is to integrate therapeutic education for heart failure patients in a current practice. The patient becomes competent to manage his disease and to identify acute heart failure signs.

Main objective: Improve therapeutic education efficiency on life quality of heart failure patients in general practice.

Second objectives: Describe heart failure patient's hospitalizations.

Methods: Cluster randomized controlled clinical trial comparing intervention and control groups with a follow through for 19 months for each patient. A therapeutic education program will be proposed to the heart failure patients in primary care. The intervention group GP will follow a workshop concerning the therapeutic education concepts and the intervention.

Endpoints: Life quality evaluation (SF-36 and Minnesota scales) and number of hospitalizations of patients in each group.

Population: Heart failure patients in stages I, II, and III of NYHA in primary care. Cluster randomized surgeries in Auvergne (France).

Expected results: The therapeutic education allows the patients to improve their quality of life, to be able to detect their illness signs worsening in a early manner, and to contact their doctor if needed. This would limit the acute heart failure due to treatment adaptation or life habits.


Options:
A: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
B: Life quality evaluation of both groups (control and intervention) at 0, 7, 13, and 19 months from the beginning of the inclusion filled in by the patient or his/her main caregiver (husband or wife, a friend...) thanks to a closed envelope given by the GP (at 0, 7, 13 and 19 months from the beginning of the incusion)
C: Care Transition Measure-3 score (CTM-3) (30-days post discharge)
D: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Control Study of Concerta and Strattera on the Improvement of Executive Function in Attention Deficit Hyperactivity Disorder Children
Brief Summary: The objective of this study is to compare the effect of Concerta (Osmotic Release Oral System Extended Release Methylphenidate HCL, OROS MPH) and Strattera (Atomoxetine) on the laboratory and ecological executive function in children with attention deficit hyperactivity disorder.


Options:
A: N/A
B: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
C: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
D: Executive function test (seven to ten weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-based Cognitive Therapy for Chronic Depression
Brief Summary: The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive Therapy (MBCT, Segal, Williams, \& Teasdale, 2002) for patients suffering from Chronic Major Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).


Options:
A: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
B: Depressive Relapse or MDD (Measured at month 8); Depressive Relapse/Recurrence or MDD (Measured at month 20); Depressive Relapse/Recurrence or MDD (Measured at month 32)
C: Depressive Relapse or MDD (Measured at month 8); Depressive Relapse/Recurrence or MDD (Measured at month 20); Depressive Relapse/Recurrence or MDD (Measured at month 32)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-based Cognitive Therapy for Chronic Depression
Brief Summary: The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive Therapy (MBCT, Segal, Williams, \& Teasdale, 2002) for patients suffering from Chronic Major Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).


Options:
A: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
B: Hamilton Depression Rating Scale - Grid version (6 months)
C: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
D: Hamilton Depression Scale (HAM-D) - continuous (End point week 19 and Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs
Brief Summary: Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.


Options:
A: Peak Walking Time (at 6 months)
B: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
C: evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
D: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs
Brief Summary: Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.


Options:
A: Major amputation
B: N/A
C: Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale. (Primary follow up in a 6 month period)
D: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs
Brief Summary: Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.


Options:
A: Limb salvage/wound healing at t=6 months; Pain free walking distance (6 months)
B: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
C: major-amputation-free survival rate (at 6 months)
D: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs
Brief Summary: Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.


Options:
A: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
B: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
C: Ankle brachial index (6 months); Healing (1 year); Amputation rate (1 year)
D: Survival without major amputation (6 months after implantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Brief Summary: The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years); Number of Participants With Death (From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit))
B: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)
C: Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12) (Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12))
D: Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16 (Baseline and visit 6 (16 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Termination Enhancement Project (STEP)
Brief Summary: The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.


Options:
A: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
B: TC/HDL ratio (one year)
C: smoking cessation (12 months)
D: Smoking cessation: quit and reduction rates (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Termination Enhancement Project (STEP)
Brief Summary: The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.


Options:
A: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
B: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
C: Self-reported 7-day Point Prevalence Abstinence (3 months); Self-reported 30 Day Smoking Abstinence (3 months); Self-reported Continuous Abstinence at 3 Months (3 months); Self-reported 7-day Point Prevalence Abstinence (6 months); Self-reported 30-day Point Prevalence Abstinence (6 months); Self-reported Continuous Abstinence (6 months); Self-reported 7-day Point Prevalence Abstinence (12 months); Self-reported 30-day Point Prevalence Abstinence (12 months); Self-reported Continuous Abstinence (12 months); Objective Smoking Abstinence (12 months)
D: Prolonged Abstinence (Weeks 7-10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Brief Summary: The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.


Options:
A: The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery); change of potential of hydrogen ( pH) in remnant stomach (1-6 days after surgery); the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery)
B: the incidence of Roux stasis syndrome (3 month after surgery)
C: the postoperative quality of life (QOL) (3 years after operation)
D: Quality of life (one year)

Answer: C