TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Brief Summary: Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.


Options:
A: Number of cigarettes smoked per day (End of 6 week intervention)
B: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
C: Continuous abstinence (Russell Standard) (Six months post quit date)
D: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Brief Summary: Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
C: Number of cigarettes smoked per day (End of 6 week intervention)
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: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Brief Summary: Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.


Options:
A: Maximum Nicotine Concentration in Blood (180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)); Concentration of Carboxyhemoglobin in Blood (Baseline and 8 days); Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours (Baseline and 8 days); Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours (Baseline and 8 days); Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours (Baseline and 8 days)
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
D: Continuous abstinence (Russell Standard) (Six months post quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Brief Summary: Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.


Options:
A: Number of cigarettes smoked per day (End of 6 week intervention)
B: Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (up to 1 year); Changes in withdrawal symptoms (up to 1 year); Subjective nicotine effect will be analyzed (up to 1 year); Changes in feelings and emotions (up to 1 year)
C: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
D: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Brief Summary: Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.


Options:
A: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: urine carcinogen biomarker of exposure, NNAL (week 24)
D: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection
Brief Summary: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk \[Stage IIIa (lymph node metastasis \>1 mm), IIIb or IIIc\] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or two placebos for 12 months.


Options:
A: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))
B: Relapse-free Survival (RFS) (Approximately 3.5 years)
C: Assess the pathologic complete response rate (absence of viable tumor on histologic assessment) (5 years)
D: Ganglioside Expressed by Tumor Cells (GD2) (up to 1 week); Recurrence Free Survival (RFS) (up to 24 months); Overall Survival (OS) (up to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection
Brief Summary: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk \[Stage IIIa (lymph node metastasis \>1 mm), IIIb or IIIc\] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or two placebos for 12 months.


Options:
A: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))
B: Relapse-free Survival (RFS) (Approximately 3.5 years)
C: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)
D: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial
Brief Summary: The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.


Options:
A: N/A
B: Feasibility of protocol adherence (14 days)
C: Progression free survival (90 days)
D: overall mortality (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial
Brief Summary: The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.


Options:
A: Progression free survival (90 days)
B: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
C: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
D: Overall survival (60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.
Brief Summary: This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.


Options:
A: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
C: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)
D: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.
Brief Summary: This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.


Options:
A: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)
D: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Brief Summary: This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.


Options:
A: 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)
B: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy (Baseline, Week 24); Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy (Baseline, Week 24)
C: Time from randomization to the primary action point (monotherapy failure).
D: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Brief Summary: The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.


Options:
A: For adults: body weight loss maintenance (6 Month)
B: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)
C: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
D: Body Weight (4 months); Body Weight (7 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Brief Summary: The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.


Options:
A: Body Weight (4 months); Body Weight (7 Months)
B: Change in Body Mass Index (BMI) (Baseline to 24 months)
C: Change after 3 and 6 months from Baseline in weekly steps number mean measured by a pedometer (Change after 3 and 6 months of the baseline evaluation)
D: body weight (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Brief Summary: The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.


Options:
A: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)
B: Body Weight (4 months); Body Weight (7 Months)
C: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
D: Aerobic fitness (before and after the 10 week intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
Brief Summary: Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.


Options:
A: Incidence of cholestasis (From recruitment to full enteral feeding per mouth (up to 90 postnatal days))
B: Incidence of parenteral nutrition associated cholestasis (PNAC) (Participants will be followed for the duration of hospital stay (expected average 14 weeks))
C: lipometabolism (Change from Baseline in fatty acid at 7 days and 14 days)
D: Mean serum conjugated bilirubin (umol/L) (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Screening and Brief Intervention for Latino and Non-Latino White Drug Users
Brief Summary: Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers. Although the SBIRT approach has shown promise for alcohol, relatively little is known about its effectiveness for adult illicit drug use specifically.

This will be among the first studies to rigorously test the SBIRT approach for drug use. It will evaluate the effectiveness of SBIRT for drug use and related factors for 700 multi-ethnic ED patients using a two-group randomized repeated-measures design in which biologically-validated drug use abstinence and related outcomes of an intervention group are compared to those of an attention-placebo control group. Over a 14-month period, bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and trauma units. Following consent procedures and standardized baseline assessments, Health Educators randomly assigned participants to one of the two conditions. The intervention group received "Life Shift," an SBIRT drug use intervention matched to the participant's drug use risk level. The control group received the same type and quantity of intervention in an unrelated area-Driving and Traffic Safety ("Shift Gears" program), also matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement technicians blind to the participant's assigned condition collected standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported abstinence. Additional outcome variables are changes in the frequency of drug use, functional status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health care utilization.


Options:
A: Change in alcohol consumption Score as assessed by the AUDIT-C tool . (6 months)
B: past 30 day drug use abstinence (6 months post intervention)
C: Treatment Utilization; Substance Abuse
D: Number of Times Used Alcohol (Past 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
Brief Summary: The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.

Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.

The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.


Options:
A: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 (Baseline, Month 12)
B: ocular discomfort (3 months)
C: Change of Dry Eye Symptoms (after 3 month compared to baseline value)
D: NIBUT (Non-Invasive Break-Up Time) (The difference between the change in NIBUT of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery))

Answer: B