TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Randomized Trial on the Effectiveness of Mindfulness Training for Smokers, a Novel Intervention Designed to Help Smokers Quit Smoking
Brief Summary: The Mindfulness Training for Smokers study follows a randomized controlled design with 240 total participants. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line and will receive four weeks of nicotine patches. The control group will receive the Quit Line intervention alone where as the study group will receive the Quit Line intervention plus the Mindfulness for Smokers Intervention. The Mindfulness for Smokers Intervention provides four weeks of instruction in mindfulness meditation followed by four weeks of participation in a weekly meditation group. The principal hypothesis for the study is that Mindfulness for Smokers plus the Quit Line will lead to significantly higher rates of smoking cessation at 6 months than the Quit Line alone.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Smoking Abstinence (24 weeks post quit day)
C: smoking cessation: 7-day point prevalence abstinence (6 months)
D: Smoking Abstinence (6 months post quit day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnerships to Overcome Obesity Disparities in Hawaii
Brief Summary: This is a 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment.


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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
B: Days of abstinence following the programmed lapse (7 days)
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
B: Treatment Satisfaction (End of treatment (seven weeks after baseline))
C: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Number of Participants With Smoking Cessation (12 WEEK)
B: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: 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.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
B: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
C: Short term continuous abstinence (weeks 9 to 12)
D: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
C: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Participants Abstinent From Cigarettes (Two years)
B: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
C: 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.
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Study of Dronabinol, a Cannabinoid Agonist, for Obsessive Compulsive Disorder and the Obsessive-Compulsive Spectrum Disorders Trichotillomania and Pathological Skin Picking
Brief Summary: The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with these disorders. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Options:
A: Clinical Global Impression (CGI)-Improvement Scale ≤ 2
B: Massachusetts General Hospital Hairpulling Scale (Baseline and final visit after 12 weeks)
C: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (First 6 weeks of treatment)
D: Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score (Subjects were followed for their duration of participation in the study (12-weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life. The most common complication is postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%) especially in developing countries .Three to five percent of deliveries are complicated by PPH and is 50 times more common in developing countries. Retained placenta is an another complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal of placenta, which needs an operating theatre, a surgeon, and an anaesthetist-facilities that are often unavailable to women in resource-poor settings. As a result, this condition has a case fatality rate of nearly 10% in rural communities.

The length of the third stage of labor, and its subsequent complications depends on a combination of the length of time it takes for placental separation and the ability of the uterine muscle to contract. Principal management of the third stage of labor is aimed at reducing the time of delivery of placenta so minimising serious adverse effects, such as blood loss and retained placenta. Active management of the third stage of labor, which includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for PPH prevention .

Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine wall, resulting in an earlier uterine contraction and placental separation. However, very limited published literature is available, which evaluated the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. The purpose of this investigation was to find out the beneficial effect of adding intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of labor, length of third stage of labor, and reduction in the incidence of manual removal of retained placenta.


Options:
A: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
B: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
C: The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value (1 year)
D: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life. The most common complication is postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%) especially in developing countries .Three to five percent of deliveries are complicated by PPH and is 50 times more common in developing countries. Retained placenta is an another complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal of placenta, which needs an operating theatre, a surgeon, and an anaesthetist-facilities that are often unavailable to women in resource-poor settings. As a result, this condition has a case fatality rate of nearly 10% in rural communities.

The length of the third stage of labor, and its subsequent complications depends on a combination of the length of time it takes for placental separation and the ability of the uterine muscle to contract. Principal management of the third stage of labor is aimed at reducing the time of delivery of placenta so minimising serious adverse effects, such as blood loss and retained placenta. Active management of the third stage of labor, which includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for PPH prevention .

Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine wall, resulting in an earlier uterine contraction and placental separation. However, very limited published literature is available, which evaluated the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. The purpose of this investigation was to find out the beneficial effect of adding intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of labor, length of third stage of labor, and reduction in the incidence of manual removal of retained placenta.


Options:
A: need for additional uterotonics (30 minutes)
B: The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. (3 minutes)
C: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
D: Incidence of PPH (24 hours after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
Brief Summary: In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.

Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.


Options:
A: Cognitive development
B: visual development
C: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)
D: Calcium absorption (18 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
Brief Summary: In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.

Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.


Options:
A: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)
B: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
C: visual development
D: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Deep Brain Stimulation of the Nucleus Basalis Meynert to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
Brief Summary: In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.


Options:
A: Change in Yale Global Tic Severity Scale (Three months after stimulation switched ON v three months after stimulation switched OFF)
B: cognitive improvement (one- year)
C: Reduction of Levomethadone (seven month)
D: Number of Participants With a 40% Reduction in Total Tics on the Yale Global Tic Severity Scale (YGTSS) With CDBS (Period 1) (Baseline to 6 months post-surgery)

Answer: B