TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Brief Summary: The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Options:
A: time to clinical relapse (52 weeks)
B: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
C: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Brief Summary: The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Options:
A: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) (one year)
B: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
C: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
D: time to clinical relapse (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Brief Summary: The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Options:
A: time to clinical relapse (52 weeks)
B: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
C: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Brief Summary: The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Options:
A: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
B: time to clinical relapse (52 weeks)
C: Change in body weight (measured at Year 2)
D: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Brief Summary: The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Options:
A: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
B: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
C: time to clinical relapse (52 weeks)
D: Survival free of atrial fibrillation (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion
Brief Summary: The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.


Options:
A: The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). (Time of IUD insertion)
B: IUD expulsion (1, 3 and 6 months after insertion)
C: Primary efficacy variable will be bleeding profile (Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5)
D: Mean Maximum Procedural Pain Scores (2 minutes after the procedure.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AIEOP LLA 2000 Multicenter Study for the Diagnosis and Treatment of Childhood Acute Lymphoblastic Leukemia
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.


Options:
A: Event Free Survival (6 years)
B: Two Year Event-free Survival (EFS) (Up to Two Year After Enrollment)
C: Efficacy of dexamethasone vs prednisone during the induction phase (5 years); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (5 years); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (5 years); EFS after second delayed reintensification in intermediate-risk patients (5 years); Outcome after extended reintensification therapy in high-risk patients (5 years)
D: Number of Participants With Asparaginase-Related Toxicity (30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.); Induction and Post-Induction Nadir Serum Asparaginase Activity Level (Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Plus Activity Strategy Training for Older Adults With Osteoarthritis
Brief Summary: Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee.

Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up.

Hypothesis 2: Participants who receive Activity Strategy Training will have a greater increase in physical activity as measured by a wrist-worn accelerometer.

Hypothesis 3: Participants who receive Activity Stratgey Training will report greater improvements in health-related quality of life.


Options:
A: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)
B: Pain (Baseline and 12-month follow-up)
C: Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) from Baseline to 12-months. (Baseline and 12-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 18-months post Baseline. (post Baseline,18-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 24-months post Baseline. (post Baseline, 24-months)
D: Self-reported pain (Baseline, Post-intervention (8-wks), and 6-mos follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels
Brief Summary: In men with type 2 diabetes, low testosterone levels have been associated with insulin resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low testosterone may impair cardiac function and increase cardiovascular risk and cause osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2 diabetes mellitus and low testosterone levels, testosterone replacement improves insulin resistance, body composition, bone density, cardiac function symptoms associated with low testosterone level.

The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level (\<10 nmol/L) from Austin Health Endocrine clinics, General Practise surgeries, and from the general public by direct consumer advertising via newspaper and other local media. Men will be randomised to either intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study. All men will receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of four injections).

All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and at study end (40 weeks). The study protocol is outlined in more detail below:

Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical history and physical examination will be performed. Symptoms will be assessed by the following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2) Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4) International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached to Module 1).

Laboratory studies will consist of blood tests to measure total testosterone, fasting glucose, C-peptide, HBA1c and other routine parameters.

Imaging studies (Baseline and repeated at 40 weeks)

1. Body composition and bone mineral density by DEXA
2. Body composition by magnetic resonance imaging
3. Bony micro-architecture by high resolution quantitative computed tomography \[HR-pQCT\]),
4. Cardiac dimensions and function by transthoracic doppler echocardiography


Options:
A: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) (Week 0, week 8, week 11, week 14)
B: Insulin Resistance (40 weeks)
C: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 (Week 12)
D: Body Composition at the End of Each Study Phase (end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia: A Prospective, Randomized, Placebo-controlled, Double-blind Study
Brief Summary: This study utilizes lactobacillus, or probiotics, delivered twice daily to the mouth and stomach, via feeding tube, in effort to determine whether the oral administration of a naturally occurring Lactobacillus species reduces the incidence of ventilator associated pneumonia therefore reducing intensive care unit(ICU)complications.


Options:
A: Number of Participants Experiencing Diarrhea (14 days); Adverse Events (Days 0-180)
B: To determine whether patients given oral Lactobacillus GG will have a smaller increase in the density of pathogenic bacterial in cultures from oral swabs, nasogastric aspirates, and minimally invasive bronchoalveolar lavage samples. (daily while intubated)
C: Reduction of the incidence of loose/watery stools following antibiotic treatment in children. (19-24 days)
D: Incidence of Participants With Diarrhea by Parental Report (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette
Brief Summary: The purpose of this study is to determine the level of pain women experience during an endometrial biopsy and the effect that the biopsy tool might have on that pain. The investigators will also evaluate the adequacy of the sample each endometrial biopsy tool collects.


Options:
A: Live Birth (1 year)
B: Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). (2 minutes after biopsy procedure)
C: Clinical pregnancy rate (6 months)
D: Clinical pregnancy rate (10 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette
Brief Summary: The purpose of this study is to determine the level of pain women experience during an endometrial biopsy and the effect that the biopsy tool might have on that pain. The investigators will also evaluate the adequacy of the sample each endometrial biopsy tool collects.


Options:
A: Clinical pregnancy rate. (one year); Miscarriage rate. (one year); Multiple pregnancy rates (one year)
B: Clinical pregnancy rate (6 months)
C: Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). (2 minutes after biopsy procedure)
D: Clinical pregnancy rate (10 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Training Intervention on the Quality of Case Coordinators and Nurses' Decision Support for Patients Deciding About the Place of Care at the End Of-Life: A Randomized Control Trial
Brief Summary: Most dying cancer patients would prefer a home death yet die in an institution. Patients can experience uncertainty when weighing practical considerations, concern for others, and their personal ratings about the desirability and undesirability of various outcomes related to different locations of care. Health professionals, trained in decision support, can help patients to make decisions that are informed by both relevant information and what outcomes are most valued by patients. Therefore, I will study if an educational intervention can help nurses and case managers to strengthen their skills and confidence in providing patient decision support around place of end of life care.

Project Description:

Using a two step approach I will study if the quality of providers decision support can be improved with an education. In step one nurses and care coordinators will be interviewed to identify factors that make it easier or more difficult to provide patient decision support. This information will be used to develop an education program. In step two, nurses and care coordinator volunteers will be assigned by a flip of a coin to either receive the decision support education or not. Before and after the education program the quality of the decision support participants provide will be measured and compared. As well, participants receiving the education program will be asked about their satisfaction with the education program.


Options:
A: Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (6 month)
B: symptoms related to posttraumatic stress disorder
C: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)
D: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes


Options:
A: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
B: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)
C: Change in Glycosylated Haemoglobin A1c (HbA1c) (week 0, week 16)
D: Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years))

Answer: C