TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics, Emotional Reactivity and Smoking
Brief Summary: The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Long term abstinence (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics, Emotional Reactivity and Smoking
Brief Summary: The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics, Emotional Reactivity and Smoking
Brief Summary: The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
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 (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics, Emotional Reactivity and Smoking
Brief Summary: The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.


Options:
A: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics, Emotional Reactivity and Smoking
Brief Summary: The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
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 Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
Brief Summary: To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.


Options:
A: renal function as measured by serum creatinine at 6 months post-transplant
B: The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
C: Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH) (3 years)
D: A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain
Brief Summary: This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.


Options:
A: Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP (Change from baseline to final 24-hour average pain score)
B: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
C: Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period (Day 1 through 8 weeks); Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 (Baseline, 8 weeks)
D: Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form (Week 8, Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
Brief Summary: There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.


Options:
A: Biochemically-validated smoking cessation (middle and late pregnancy)
B: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
C: 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)
D: Cotinine validated quit rates.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
Brief Summary: There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.


Options:
A: Cotinine validated quit rates.
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: 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)
D: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
Brief Summary: There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.


Options:
A: 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)
B: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
C: Smoking cessation (6 month follow-up)
D: sustained smoking abstinence (during the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.


Options:
A: The number of wound infections (30 days after the operation)
B: Frequency of wound infection (Within the first 30 days after surgery); Frequency of incisional hernia (One year after surgery)
C: Incisional hernia occurrence within one year after operation clinical and/or radiographically detected (one year)
D: Clinical recurrence after ventral hernia repair (up to 4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobilizing Peer Support for Effective Heart Failure Self-Management
Brief Summary: Heart failure (HF) patients living in low-income or isolated areas may have limited access to necessary clinic services and more difficulty in self-managing their illness. This study will evaluate a program that combines group health care visits and a peer-to-peer telephone buddy system at improving health outcomes among low-income and racial minority HF patients.


Options:
A: Hospital admissions for any cause (Twelve months)
B: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up))
C: Recurrent cardiovascular events (12 months (or more for first recruited participants, but until 36 months).)
D: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobilizing Peer Support for Effective Heart Failure Self-Management
Brief Summary: Heart failure (HF) patients living in low-income or isolated areas may have limited access to necessary clinic services and more difficulty in self-managing their illness. This study will evaluate a program that combines group health care visits and a peer-to-peer telephone buddy system at improving health outcomes among low-income and racial minority HF patients.


Options:
A: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
B: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
C: Perceived control measure by Control Attitude Scale (3 months)
D: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobilizing Peer Support for Effective Heart Failure Self-Management
Brief Summary: Heart failure (HF) patients living in low-income or isolated areas may have limited access to necessary clinic services and more difficulty in self-managing their illness. This study will evaluate a program that combines group health care visits and a peer-to-peer telephone buddy system at improving health outcomes among low-income and racial minority HF patients.


Options:
A: Hemoglobin A1c (6 months)
B: HbA1c level (6 months)
C: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
D: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study examined the benefit of continued treatment with an antidepressant medication, sertraline, in adolescents with depression who improved on sertraline acutely. We hypothesize that adolescents who remained on sertraline long term were less likely to have a recurrence of depression compared to those on placebo.


Options:
A: N/A
B: recurrence of depression (52 weeks)
C: N/A
D: Relapse of depressive symptoms (Measured at Months 3 and 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study examined the benefit of continued treatment with an antidepressant medication, sertraline, in adolescents with depression who improved on sertraline acutely. We hypothesize that adolescents who remained on sertraline long term were less likely to have a recurrence of depression compared to those on placebo.


Options:
A: N/A
B: N/A
C: recurrence of depression (52 weeks)
D: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Brief Summary: Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.


Options:
A: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (6 weeks)
B: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)
C: Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
D: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Brief Summary: Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.


Options:
A: Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (single value between 7-11 am); Correlation between post meal salivary phosphorus and estimated glomerular filtration rate (single value after meal between 1-4 pm)
B: Calcium balance (48 hour)
C: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)
D: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Brief Summary: Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.


Options:
A: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)
B: The composite of cardiovascular death, myocardial infarction (MI) and stroke
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: Cumulative notified malaria incidence in the MDA and control Shehias (6 months after second round of MDA)
B: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
C: Decrease in Parasite prevalence according to RDT (6 months); Decrease in Parasite prevalence according to PCR (6 months); Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages (12 months)
D: Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) (For up to 12 months); P.falciparum infection incidence rate among individuals ≥3 months (For up to 12 months)

Answer: B