TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.
Brief Summary: The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.


Options:
A: Percentage of Participants With Less Than 11 Tender Points at Month 6 (Month 6); Percentage of Participants With Less Than 11 Tender Points at Month 12 (Month 12)
B: reduction number of tender points (paired) (one year treatment)
C: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
D: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
Brief Summary: In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.


Options:
A: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
B: the risk of disease specific failure (within 1 month COPD)
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
Brief Summary: In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.


Options:
A: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
B: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: mortality/survival (28 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
Brief Summary: In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.


Options:
A: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
B: The absolute reduction of the duration of antibiotic therapy with unchanged outcome (1 month)
C: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma
Brief Summary: This is a multi-centre Phase III randomized controlled study of patients with multiple myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment. Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed for the:

1. Incidence and grade of any toxicity
2. Level of maximum disease response
3. Time to disease progression
4. Time to death


Options:
A: Time to tumor progression (TTP) (Up to 3 years)
B: response rate (12 months)
C: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (Up to disease progression, approximately 3 years)
D: Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) (up to 165 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
Brief Summary: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).


Options:
A: Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 (Baseline, Week 48)
B: Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose (Baseline and Week 24); Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose (Baseline and Week 24); Percentage of Participants With Treatment-emergent Adverse Events (TEAE) (Up to Week 156); Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03) (Up to Week 156); Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03 (Up to Week 156)
C: Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 (Baseline and Week 24)
D: Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
Brief Summary: The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.

Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.


Options:
A: Treatment Failure (Loss of Glycemic Control) (Study duration - 2 years to 6.5 years of follow up from randomization)
B: N/A
C: Reduction in BMI (2 years)
D: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months (Baseline and 6 months); Change From Baseline in Fibrinogen at 6 Months (Baseline and 6 months); Change From Baseline in Interleukin 6 (IL-6) at 6 Months (Baseline and 6 months); Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months (Baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
Brief Summary: The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.


Options:
A: Length of stay (hours)
B: symptom free days (2 weeks runin and 8 weeks treatment)
C: Percentage of Symptom-Free Days
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Brief Summary: Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).


Options:
A: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery. (36 hours)
B: Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome (Until hospital discharge, up to 4 months)
C: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
D: immunologic markers, health care related quality of life, PTSD (one and a half year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment (The CANTREAT Study): A Prospective, Randomized, Double Blind, Placebo Controlled Pilot Study
Brief Summary: The purpose of the study is to determine whether the effect of treating Candida spp. isolated in the respiratory tract secretions of patients with a clinical suspicion of ventilator associated pneumonia (VAP) on clinical outcomes will be feasible and supported by biomarker data obtained.


Options:
A: survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion) (28 days follow-up)
B: Overall Recruitment Rate (32 months)
C: Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients. (Participants were followed until ICU discharge, an average of 17 days); Safety and Tolerability of Preemptive Anidulafungin (weekly until ICU discharge)
D: course of the colonization index over time. (AT 15 day from ICU admission)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Irritable Bowel Syndrome in Primary Care: Feasibility Randomised Controlled Trial of Mebeverine, Methylcellulose, Placebo and a Patient Self-management Cognitive Behavioural Therapy Website. (MIBS Trial)
Brief Summary: Aims:

1. To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based self-management website.
2. To assess the level of support needed for patients using the patient CBT based self-management website for IBS (i.e., initial 30 minute telephone support session with a nurse and email support or not).


Options:
A: IBS Symptom Severity Score (Baseline, 6 and 12 weeks); IBS QOL (Baseline, 6 and 12 weeks)
B: Change in catastrophizing cognitions (T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1)
C: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Collaborative Model to Improve BP Control and Minimize Racial Disparities-CCC
Brief Summary: The purpose of the study is to determine the degree to which pharmacist-physician collaborative management (PPCM) of hypertension can be adopted and implemented in clinics with geographic and racial diversity and whether patients in clinics which implement PPCM achieve greater blood pressure control than patients in clinics which do not implement PPCM.

Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.


Options:
A: Self-reported medication adherence (6 months)
B: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
C: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)
D: Blood Pressure Control (9 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomized Controlled Trial of Fluid Resuscitation With Starch (6%Hydroxyethyl Starch 130/0.4) Compared to Saline (0.9% Sodium Chloride) in Intensive Care Patients on Mortality
Brief Summary: The aim of this study is to determine whether patients in the Intensive Care Unit who receive fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline (a salt solution), have an increased rate of survival at 90 days.


Options:
A: All cause mortality (90 days)
B: 28-day mortality (Day 28)
C: mortality rate at the 28th day after randomization, with a further control at 90th day. (mortality at 28th and 90th day after randomization)
D: Mortality; Quality of Life

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomized Controlled Trial of Fluid Resuscitation With Starch (6%Hydroxyethyl Starch 130/0.4) Compared to Saline (0.9% Sodium Chloride) in Intensive Care Patients on Mortality
Brief Summary: The aim of this study is to determine whether patients in the Intensive Care Unit who receive fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline (a salt solution), have an increased rate of survival at 90 days.


Options:
A: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
B: Mortality or dialysis-dependency (90 days)
C: Mortality; Quality of Life
D: All cause mortality (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Continuous abstinence (from week 7 until week 24)
B: Change From Baseline Smoking Abstinence Rates at 12 Weeks (12 weeks)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: N/A
C: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
D: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
D: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Smoking behavior (after 5 hrs abstinence)
B: Smoking status at 6 months after enrollment (6 months)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
C: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
D: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
B: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
Brief Summary: This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.


Options:
A: N/A
B: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Answer: C