TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Promotion in the Workplace Using Personally Controlled Health Records
Brief Summary: The purpose of this study is to determine whether personally controlled electronic health records can be used for health promotion in a workplace setting.


Options:
A: - Rate of influenza immunization among subjects
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Adherence; Self-efficacy; Quality of life
D: Readmission and death rate at 6 months' follow up.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Cost-effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-treated Nets.
Brief Summary: The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands.

The strategies being compared are:

* intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
* an insecticide treated net (ITN), and
* intermittent preventive treatment with SP plus an ITN

In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.


Options:
A: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)
B: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
C: mean birthweight (April 2004-Jan 2007); prevalence of low birthweight (April 2004 - Jan 2007)
D: HB at delivery (with inseven 7days of delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya
Brief Summary: This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.


Options:
A: Parasite clearance time
B: Prevalence of anaemia (Hb <112g/L) (March 2006)
C: Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period. (during malaria transmission period); Cost-effectiveness of the delivery system. (during the study period)
D: Risk of Parasitaemia (Unadjusted by Genotyping) (after 42 days of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya
Brief Summary: This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.


Options:
A: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)
B: Prevalence of anaemia (Hb <112g/L) (March 2006)
C: Clinical episodes of malaria
D: Incidence of malaria (Four months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.


Options:
A: relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
B: Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group) (3 months)
C: Improvement in neck postures/movements; Improvement in quality of life
D: The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. (at six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia That is Unresponsive to a Psychological Intervention
Brief Summary: Primary Aim

To determine whether;

* Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment

Secondary Aims

To determine whether;

* Donepezil has a significant positive or negative impact upon quality of life compared with placebo
* whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
* the cost effectiveness of the pharmacological treatment for agitation


Options:
A: Change From Baseline to Week 24 in SIB Total Score (Baseline and Week 24); Overall Change From Baseline in Modified CIBIC+ to Week 24 (Baseline and Week 24)
B: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
C: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
D: Cohen Mansfield Agitation Inventory

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
Brief Summary: To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer


Options:
A: overall survival
B: Overall Survival (3 years)
C: Failure-free survival (six months)
D: Progression-free survival rate (at 24weeks from patient enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
Brief Summary: To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer


Options:
A: Overall Survival (From randomization until death due to any cause (average of 51 weeks)); Overall Survival in All Randomized Participants (From randomization until death due to any cause (average of 51 weeks))
B: Overall Survival (OS) (approx. 12 month)
C: overall survival
D: 6 Month Progression Free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
Brief Summary: To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer


Options:
A: Objective Response Rate ( ORR ) (60 months)
B: Overall Survival (OS) (From randomization up to 627 days)
C: overall survival
D: Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in All Participants (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
Brief Summary: This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.


Options:
A: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
B: Adverse Pregnancy Outcomes (0-28 days postpartum)
C: Safety (28 days)
D: Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 30-day (Days 0-29) follow-up period after the first vaccination); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (From Day 0 up to Month 24))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
Brief Summary: This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.


Options:
A: Humoral immune responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in HIV-infected pregnant women vaccinated between 20-34 weeks of gestational age (1 month post vaccination, delivery (+7 days), 24 weeks post delivery); The proportion of newborns born to HIV-infected mothers with hemagglutination inhibition (HAI) antibody titers of ≥1:40 to TIV strain will be determined and compared to newborns born to TIV-vaccinated HIV-uninfected women (parallel trial) (Delivery (+7 days))
B: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
C: The number of laboratory-confirmed influenza cases in infants born to mothers who received TIV or placebo will be used to determine efficacy of TIV vaccination of pregnant women against laboratory-confirmed influenza illness in their infants (24 weeks of age); Humoral and cell-mediated immune (CMI) responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in pregnant women vaccinated between 20-34 weeks of gestational age (one month post vaccination, delivery (+7 days), 24 weeks post natal)
D: The proportion of influenza vaccination (2 weeks postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Examining Psychosocial Mediators of Exercise Behavior
Brief Summary: The purpose of this study is to examine psychosocial mediators of exercise behavior.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Respiratory muscle endurance (Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1))
C: Physical activity (Measured at baseline, 6, and 12 months)
D: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1
Brief Summary: Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.


Options:
A: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
B: Number of Participants With a Quit Attempt (6 months)
C: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
D: 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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1
Brief Summary: Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.


Options:
A: 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)
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
C: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
D: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1
Brief Summary: Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.


Options:
A: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
B: Tobacco use abstinence (26 week)
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1
Brief Summary: Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.


Options:
A: 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)
B: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
C: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
D: Quit Rate (Study weeks 6 through 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1
Brief Summary: Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.


Options:
A: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
D: Days of abstinence following the programmed lapse (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Clinical Efficacy, Safety, and Immunogenicity of a Human Cocaine Vaccine (TA-CD) in the Treatment of Cocaine Dependence
Brief Summary: The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).


Options:
A: Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline (14 days after each dose of vaccine or placebo)
B: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)
C: Cocaine Abstinence During Weeks 9 to 16 Inclusive (Over 8 weeks ( Study Weeks 9 to 16 inclusive))
D: culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility. (1095 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Breaking Down Barriers to Diabetes Self-Care
Brief Summary: Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.


Options:
A: Self-Care Behaviors; Glycemic control (HbA1c); fitness
B: the absolute change in HbA1c (baseline; 6 months and 18 months)
C: Hemoglobin A1c (6 and 12 months)
D: HbA1c (6 months)

Answer: A