TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial
Brief Summary: There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.


Options:
A: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Glucose area-under-the-curve (During 3 days of each diet treatment)
D: Need of insulin treatment for GDM (Day of delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Brief Summary: The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.


Options:
A: Freedom from AF (18 months)
B: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. (From date of enrollment until time-to-first event over a median follow-up of 48.5 months.)
C: Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI (Continuous monitoring (24 hours loop recording)); Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure (Continuous monitoring (24 hours loop recording))
D: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Brief Summary: The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.


Options:
A: Recurrence of Atrial Fibrillation (One year)
B: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. (From date of enrollment until time-to-first event over a median follow-up of 48.5 months.)
C: Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation (3, 6, 12 weeks and 6 months post-procedure)
D: Atrial Fibrillation Burden (AFB) at Baseline (Baseline); Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12 (Baseline; Week 12); Absolute Change From Baseline in AFB by Week 12 (Baseline; Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Brief Summary: It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: \< 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.


Options:
A: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks (baseline, 24 weeks)
B: Change From Baseline in Hemoglobin A1 (A1C) at Week 24 (Baseline, Week 24)
C: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) (Baseline , Week 12 (LOCF))
D: Average Blood Glucose Over 6 Days (6 Days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Brief Summary: To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care


Options:
A: All-cause mortality and diarrheal morbidity (age 6 weeks to age 24 months)
B: incidence of pneumonia (18 months)
C: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)
D: EASI score (1 month); Investigator Global Assessment (IGA) (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Brief Summary: To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care


Options:
A: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. (Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.)
B: Vitamin D Supplementation Safety (12 months)
C: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)
D: Total Body Bone Mineral Content (Entry, 12 and 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Brief Summary: To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care


Options:
A: Change in vitamin D status (Baseline and 20 weeks)
B: Weight gain in children (2 Months)
C: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)
D: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease (change from baseline to up to three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Evaluate the Efficacy of Video-laryngoscopy vs. Direct Laryngoscopy for Endotracheal Intubation in the Critically Ill Patients: A Pilot Study
Brief Summary: Endotracheal Intubation (ETI) is done to place a plastic tube in a patient's trachea (windpipe) to assist with breathing. Patients admitted to the intensive care unit (ICU) are the sickest of patients and the majority of them require this life saving procedure. A critical illness can be sudden and ETI required urgently. The doctors performing ETI in these situations may not be experts at ETI. Studies have shown that if it takes more than one attempt to get the tube in the right position patients can have severe complications such as: decrease level of oxygen in the body, decrease blood pressure, and cardiac arrest. These complications can be life threatening and increase the length of time spent in an ICU.

To perform ETI the doctor uses a metal tool called a laryngoscope that is placed through the patient's mouth to open the throat and then pass the tube into the trachea. The type of procedure that has been used for many years is called Direct Laryngoscopy (DL) which means that the doctor looks through the mouth directly into the throat. Newer technology is available and can be used at VGH called Video Laryngoscopy (VL). With VL there is a camera on the end of the laryngoscope and a video image is displayed on a monitor making it easier to see the entrance to the trachea. VL is not available for all cases at VGH and is unavailable in many other hospitals.

In this study we will compare DL to VL. Patients will be randomly placed in one of two groups: first attempt at ETI done with DL or first attempt of ETI done with DL. Patients will only be considered eligible for this study if the doctor feels that either DL or VL would be appropriate for the patient. In this pilot study we hope show that conducting a larger study would be feasible. If a larger study were to show that VL decreases complications and shortens length of ICU stay we would be able to recommend this procedure for all ETI at VGH as well as other hospitals where it currently may not be available.


Options:
A: Classification of Glottis Visualization (At intubation)
B: risk of failure on the first attempt of endotracheal intubation
C: Proportion of successful orotracheal intubation at first laryngoscopy (intubation procedure, an expected average of 15 minutes)
D: Peak forces during intubation (Intraoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Evaluate the Efficacy of Video-laryngoscopy vs. Direct Laryngoscopy for Endotracheal Intubation in the Critically Ill Patients: A Pilot Study
Brief Summary: Endotracheal Intubation (ETI) is done to place a plastic tube in a patient's trachea (windpipe) to assist with breathing. Patients admitted to the intensive care unit (ICU) are the sickest of patients and the majority of them require this life saving procedure. A critical illness can be sudden and ETI required urgently. The doctors performing ETI in these situations may not be experts at ETI. Studies have shown that if it takes more than one attempt to get the tube in the right position patients can have severe complications such as: decrease level of oxygen in the body, decrease blood pressure, and cardiac arrest. These complications can be life threatening and increase the length of time spent in an ICU.

To perform ETI the doctor uses a metal tool called a laryngoscope that is placed through the patient's mouth to open the throat and then pass the tube into the trachea. The type of procedure that has been used for many years is called Direct Laryngoscopy (DL) which means that the doctor looks through the mouth directly into the throat. Newer technology is available and can be used at VGH called Video Laryngoscopy (VL). With VL there is a camera on the end of the laryngoscope and a video image is displayed on a monitor making it easier to see the entrance to the trachea. VL is not available for all cases at VGH and is unavailable in many other hospitals.

In this study we will compare DL to VL. Patients will be randomly placed in one of two groups: first attempt at ETI done with DL or first attempt of ETI done with DL. Patients will only be considered eligible for this study if the doctor feels that either DL or VL would be appropriate for the patient. In this pilot study we hope show that conducting a larger study would be feasible. If a larger study were to show that VL decreases complications and shortens length of ICU stay we would be able to recommend this procedure for all ETI at VGH as well as other hospitals where it currently may not be available.


Options:
A: CERVICAL MOTIONS (January 2011 and December 2012)
B: Time to intubation (seconds) (Immediate)
C: Intubation Time (At intubation)
D: risk of failure on the first attempt of endotracheal intubation

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Clinical Trial to Compare the Safety and Efficacy of Cerebrolysin and Aricept (Donepezil) and a Combination Therapy in Patients With Probable Alzheimer's Disease (AD)
Brief Summary: The study was performed to compare the safety and efficacy of Cerebrolysin (10 mililiters \[ml\]), Aricept (10 miligrams \[mg\]), and a combination of both treatments on cognitive performance and global function in patients with probable Alzheimer's Disease (AD). It should also be assessed if the treatments have a positive effect on activities of daily living and neuropsychiatric symptoms.

Oral treatment with Aricept or Placebo was given once daily throughout the study. Intravenous treatment with Cerebrolysin or Placebo was given once daily for 5 days per week during week 1 to 4 and during week 13 to 16 of the study. During the study patients had six visits at the hospital for evaluation.


Options:
A: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
B: Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 (baseline and week 28); Clinical Interview-based Impression of Change (CIBIC+) Score (week 28)
C: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
D: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma
Brief Summary: The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).


Options:
A: Overall survival
B: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (Up to disease progression, approximately 3 years)
C: Progression-Free Survival (PFS) (Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.)
D: Progression-Free Survival (From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome
Brief Summary: Identifying a simple dietary recommendation for weight loss and metabolic health may demonstrate potential for a simple public health message to impact coronary heart disease (CHD) prevention and metabolic syndrome. In a randomized clinical trial, the investigators propose to compare the efficacy of two intervention approaches to dietary change for CHD prevention among persons with metabolic syndrome. The two approaches are 1) the AHA Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. The investigators hypothesize that a message promoting high fiber intake may be the simple message that has potential to produce broad impact.


Options:
A: Weight loss (12 months)
B: Number of at risk participants developing GDM during pregnancy
C: Postpartum weight retention (no more than 1.5 years)
D: 1: Differences in Change in Weight between Groups - Body Weight (kg) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Weight between Groups - waist circumference (cm) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
Brief Summary: This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.


Options:
A: Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 (Study Baseline, Week 12); Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 (Study Baseline, Week 12)
B: Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours (Baseline); Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 (Baseline and Week 12)
C: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 (Baseline and Week 12)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure
Brief Summary: This trial aims to study the effect of combining continuous and a new polyamide membrane with larger pores in the treatment of critically ill patients with acute renal failure and low blood pressure (shock) requiring noradrenaline. The investigators wish to compare the clinical effect of this new therapy to that of haemofiltration with a standard membrane.


Options:
A: the time of 1st membrane exchange (the time of 'filter is clotted')
B: The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process (6 months); The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter (6 months); The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading (6 months)
C: endotoxin level in blood (change from baseline to 48 hours)
D: The primary outcome measure for this study is noradrenaline free time in the first week after randomization (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
Brief Summary: The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep apnea patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.


Options:
A: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
B: Polysomnography parameters: respiratory parameters, sleep structure (baseline, 28 days, 15 days, 28 days)
C: Incidence of hypertension; Incidence of cardiovascular events
D: Obstructive Apneas (at one month of treatment); Desaturations (at one month of treatment); Sleep Time With Oxygen Saturation Below 90% (at one month of treatment); Apneas (at one month of treatment); Hypopneas (at one month of treatment); Index Apnea/Hypopnea (at one month of treatment); Mixed Apneas (at one month of treatment); Central Apneas (at one month of treatment); Index of Apneas (at one month of treatment); Index of Hypopneas (at one month of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis
Brief Summary: This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.


Options:
A: time of complete healing (days) (180 days)
B: Time to Re-epithelialization (Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete)
C: Healing (Three months)
D: Time From Surgery to Device Loss or Replacement (2 years)

Answer: B