TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary: This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.


Options:
A: Rate of moderate/severe exacerbations over a 52 week treatment period
B: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
C: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
D: All cause mortality at 3 years

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Brief Summary: The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.


Options:
A: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
B: 1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (6 weeks, 9 months, 18 months)
C: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
D: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Brief Summary: The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.


Options:
A: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
B: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
C: HIV PCR (1 month)
D: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Treatment for Pregnant Smokers
Brief Summary: Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.


Options:
A: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
B: Cotinine validated quit rates.
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Treatment for Pregnant Smokers
Brief Summary: Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.


Options:
A: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
B: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)
C: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (32-34 weeks gestation (Visit 6))
D: Cotinine validated quit rates.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Treatment for Pregnant Smokers
Brief Summary: Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.


Options:
A: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
B: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Treatment for Pregnant Smokers
Brief Summary: Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.


Options:
A: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
D: Cotinine validated quit rates.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Treatment for Pregnant Smokers
Brief Summary: Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.


Options:
A: Cotinine validated quit rates.
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
D: seven-day point prevalence smoking abstinence (28 weeks gestation and 12 months post-randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial
Brief Summary: The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.


Options:
A: Changes in estrone, estradiol and adiposity levels (Up to 12 months)
B: Quality of Life
C: Change in QoL between baseline and postintervention. (12 weeks)
D: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial
Brief Summary: The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.


Options:
A: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)
B: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
C: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
D: Quality of Life

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial
Brief Summary: The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.


Options:
A: Change in weight (6 months); change in weight (12 months)
B: Quality of Life
C: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
D: Proportion of participants with completed assessments at 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Proactive Smoking Cessation for Adolescents
Brief Summary: The primary goal of the Hutchinson Study of High School Smoking, a group-randomized trial conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington State high schools, is to develop and evaluate an innovative proactive smoking cessation intervention, based upon Motivational Interviewing (MI) and Cognitive Behavioral Skills Training (CBST), for its effectiveness in reaching teen smokers and helping them succeed in quitting smoking. A positive finding would have significant implications for reducing youth smoking and, ultimately, improving the nation's health.


Options:
A: Smoking cessation (14 months post baseline)
B: 6-months prolonged smoking abstinence at age 19 and at age 25 (6 months)
C: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)
D: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Proactive Smoking Cessation for Adolescents
Brief Summary: The primary goal of the Hutchinson Study of High School Smoking, a group-randomized trial conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington State high schools, is to develop and evaluate an innovative proactive smoking cessation intervention, based upon Motivational Interviewing (MI) and Cognitive Behavioral Skills Training (CBST), for its effectiveness in reaching teen smokers and helping them succeed in quitting smoking. A positive finding would have significant implications for reducing youth smoking and, ultimately, improving the nation's health.


Options:
A: 6-months prolonged smoking abstinence at age 19 and at age 25 (6 months)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
D: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Home-Based Management of Fever in Urban Ugandan Children
Brief Summary: The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.


Options:
A: The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.
B: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
C: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
D: Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine; during 42 days follow-up.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
Brief Summary: The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.


Options:
A: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
B: Cessation of all clinical seizure activity within 10 min of drug administration (10 min)
C: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given (Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).)
D: Length of Seizure After Study Medication Administration (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise to Prevent Disability Pilot Study
Brief Summary: The purpose of this study is to gather preliminary data that will determine the feasibility of conducting a Phase III, randomized, controlled trial (RCT) that will provide definite evidence in the use of physical exercise to prevent mobility disability in older persons.


Options:
A: Combined outcome of ability to walk 400 m without the use of an assistive device or adjudicated evidence of inability to walk 400 m or death; Drop-in, drop-out, and loss to follow-up rates; Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance score; 4 m gait speed; 400 m gait speed; Self-reported disability scale
B: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
C: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
D: Blood pressure at 6 months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Brief Summary: This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.


Options:
A: Disease-free survival; Survival; Toxicity/morbidity of treatment,; Locoregional remission rate; Time to treatment failure
B: To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone. (Years)
C: Death from any cause at 8 years
D: Survival (Throughout study period); Time to clinical progression (Throughout study period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial
Brief Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.

The main hypotheses are:

1. Aripiprazole will significantly reduce maniac scores compared to placebo
2. Aripiprazole will significantly reduce ADHD scores compared to placebo


Options:
A: Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment); Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)
B: NCBRF-TIQ D-Total Score (Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9)
C: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight
D: Aggressive behavior (Measured weekly for 11 to 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial
Brief Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.

The main hypotheses are:

1. Aripiprazole will significantly reduce maniac scores compared to placebo
2. Aripiprazole will significantly reduce ADHD scores compared to placebo


Options:
A: Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 (Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]))
B: Change in a mania rating scale at endpoint
C: Change from baseline to endpoint in a mania rating scale
D: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight

Answer: D