TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Brief Summary: In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.


Options:
A: N/A
B: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
C: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
D: Serum estrone concentrations as measured by radioimmunoassay (At baseline and 12 months timepoint)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: Number of Participants With a Quit Attempt (6 months)
B: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
C: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
D: Quit Rate (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: Prevention in relapse (Up to 6 months)
B: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
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 (End of trial (week 10))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
D: Smoking Abstinence (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
B: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: Number of Participants With a Quit Attempt (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
B: N/A
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: 7-Day Point-Prevalence Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: Biomarkers (Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS (Immediately Post-Consultation up to 1 week); Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal (1-Month Follow-Up); Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey (1-Month Follow-Up)
D: 7 day point prevalence of cigarette abstinence (End of trial (week 10))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Treatment Satisfaction (End of treatment (seven weeks after baseline))
C: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
D: 7 day point prevalence of cigarette abstinence (End of trial (week 10))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Treatment for Schizophrenic Smokers
Brief Summary: Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.


Options:
A: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
B: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
Brief Summary: This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.


Options:
A: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline and Week 4)
B: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID (Baseline and Week 4)
C: Pharmacokinetic parameter Cmax will be calculated (Until Day 13); Pharmacokinetic parameter tmax will be calculated (Until Day 13); Pharmacokinetic parameter AUC(0-t) will be calculated (Until Day 13); Pharmacokinetic parameter t1/2 will be calculated (Until Day 13)
D: Atopic Dermatitis (AD) Disease Control Over 36 Months (36 months); Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age (6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial of Surgery Plus Whole Brain Radiotherapy (WBRT) Versus Radiosurgery Plus WBRT for Solitary Brain Metastases
Brief Summary: This study examines surgery versus radiosurgery (highly focussed radiation) for the treatment of cancer which has spread to one spot in the brain (solitary brain "metastasis"). For these two treatment options, it will compare patients' survival times, quality of life, control rate of the brain metastases and side effects. It uses the most rigorous scientific method available called "randomisation" which minimises biases that exist with other types of studies. It will involve 30 - 40 patients.


Options:
A: Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT (from baseline up to 5 years post radiation); Overall Survival (from baseline up to 5 years post radiation)
B: Overall survival and Quality of life (Until death or study completion)
C: Time to local recurrence (6 months)
D: Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder
Brief Summary: The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.


Options:
A: Existence of a suicide (6 months); Existence of a suicide (13 months)
B: Number of suicide re-attempters (six months)
C: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)
D: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder
Brief Summary: The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.


Options:
A: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
B: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
C: Borderline Symptoms (6 weeks)
D: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial
Brief Summary: The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.


Options:
A: Depression rating scale score on HAM-D 17, SCID Mood Module (Both measured at Week 8)
B: Cognitive function; Depression
C: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))
D: ACC Glx/Water (baseline and 10-weeks); ACC GABA/Water (baseline and 10-weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Male Circumcision: HIV, STD and Behavioral Effects in Men, Women and the Community
Brief Summary: This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men.

Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (\~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ intervention arm men and for control arm men who had completed their 2 year follow should continue, contingent on a) revision of the study protocol to add additional post-surgical visits to assess wound healing, b) protocol revision to further strengthen education for both male and female partners on the need to postpone sex until certified wound healing, and c) approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional follow up visit for women be instituted at 18 months after enrollment. Protocol revision and IRB approvals have been finalized in June, 2007.

The study has also enrolled and is following 3,700 women sexual partners of men enrolled in this study and in a complementary National Institutes of Health (NIH) funded study (U1 AI51171 which is separately registered). The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).


Options:
A: Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation (4 weeks)
B: Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners; Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners
C: Sequence-verified HIV-transmission from index to partner participant (March 2009)
D: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India
Brief Summary: This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.


Options:
A: Total protection against S. typhi (2 years from zero time)
B: Clinically or microbiologically proven typhoid infection (Up to 14 days after typhoid challenge dose administration)
C: Number of Subjects Reporting Any Post Immunization Reactions (During the 7-day period after vaccination); Number of Subjects Reporting Adverse Events (During the 28-day period after vaccination); Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) (At 28 days after vaccination); Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer (At 28 days after vaccination)
D: Number of Subjects Reporting Any Post Immunization Reactions (During the 7-day period after vaccination); Number of Subjects Reporting Adverse Events (During the 28-day period after vaccination); Number of Subjects Reporting Serious Adverse Events (SAEs) (During the 6-month period after vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Weight Control for Bingeing Adolescents
Brief Summary: The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.


Options:
A: Frequency of binge eating; weight
B: depressed mood (baseline, posttreatment , 6 month follow-up)
C: Forced Expiratory Volume in the first second (FEV1 %) predicted value (2 years)
D: BMI z-score (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake
Brief Summary: The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.


Options:
A: Change from baseline in low density lipoprotein cholesterol after 12 weeks
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
C: Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion (before randomization & 9-12 months after randomization)
D: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) (Baseline, 3 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake
Brief Summary: The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.


Options:
A: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
B: Reduction in Low density lipoprotein cholesterol (LDL-C) (week 6 and 12)
C: Change from baseline in low density lipoprotein cholesterol after 12 weeks
D: compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin (4 weeks); Area Under Curve (AUC) of rosuvastatin in renal transplant recipients treated with everolimus. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose. (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
Brief Summary: The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.


Options:
A: Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate (obtention)
B: Reduction of Kristjansson Respiratory Score (Baseline; after two weeks of treatment)
C: Occurrence of chest retractions as a measure of respiratory distress (30 minutes); Occurrence of wheezing as a measure of respiratory distress (30 minutes); Number of nasal bleeding events as a measure of adverse effects (1 day); Number of vomit episodes as a measure of adverse effects (1 day)
D: Respiratory distress (on first evaluation by physiotherapyst ( until 2 hours after hospital admission))

Answer: A