TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Treatment for Comorbid Depression and Obesity in Adolescents
Brief Summary: Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al., 2008). Overweight children and adolescents are at increased risk for type 2 diabetes (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994). There is a substantial percentage of adolescents who are both overweight and depressed with estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and psychiatric conditions such as overweight/obesity and depression has received little to no attention in the psychosocial treatment research literature. Due to the large number of adolescents who are both depressed and overweight, developing a behavioral treatment that addresses both problems simultaneously has important public health significance. The purpose of this proposal is to combine treatments for depression and overweight to address these co-occurring conditions in one intervention. The long-term objectives of this research are to develop efficient and effective treatments for co-occurring physical and emotional disorders. The research program will be divided into 3 major phases: a development phase (Stage 1a), a pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a), a treatment for overweight teens and CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating. As part of this phase, we will adapt existing intervention manuals and therapist training materials, and gain some initial clinical experience with the intervention via an open trial with 6 teens. During the randomized pilot study phase (Stage 1b), the integrated intervention will be compared to a control group receiving CBT treatment for depression alone (N=40 in total). During the pilot phase, the feasibility and acceptability of administering the program will be assessed. In addition, we will compare change in depressed mood at end of treatment and 6 month follow-up periods across the two groups. During the revision phase, the intervention manual will be further developed and refined, based on experiences and observations made during the development and pilot study phases.


Options:
A: Change in Adolescent Body Mass Index (BMI) (12 and 24 months)
B: depressed mood (baseline, posttreatment , 6 month follow-up)
C: To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents. (baseline, 6 mo, 12 mo)
D: Change in Body mass index percentile (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
Brief Summary: The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.


Options:
A: Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold (1 week)
B: Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC). (72 hours postoperatively after CABG surgery)
C: Impact of RIPC on length of hospital stay. (Assessed through post-operative hospitalization.)
D: Decrease of tissue oxygen saturation below 95 % of baseline (4 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
Brief Summary: The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.


Options:
A: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
B: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
C: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) (16weeks)
D: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain (baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response Study of Exercise for Age-related Cognitive Changes
Brief Summary: This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.


Options:
A: Disease activity (12 weeks after baseline assessment)
B: Visuospatial Processing (26 weeks); Change in Maximal Oxygen Consumption (26 weeks); Change in Physical Performance Test (26 Week)
C: Diagnosis of Spondyloarthritis (2 years)
D: Bath Ankylosing Spondylitis Functional Index (BASFI) (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Network Support for Alcohol Treatment: Mechanisms and Effectiveness
Brief Summary: The Network Support project is part of an ongoing effort to improve treatment for alcohol dependent patients. The Network Support Project is designed to help patients change their social network from one that reinforces drinking behavior to one that reinforces sobriety.

160 patients will be assigned to one of two treatments. Each of the treatments will last 12 weeks. The first is a Network Support (NS) treatment designed to help patients develop new acquaintances and social networks. It is expected that alcohol dependent patients will benefit from increasing their contact with non-drinking people. This NS condition will be compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number of skills to help people stop drinking, but does not address social networks per se.

In order to better understand what is happening to the investigators patients, the investigators will be using daily computerized telephone calls to ask about people's experiences. This will be done both before and after treatment. Patients will also be asked to participate in follow-up interviews every 3 months for 2 years following the end of treatment.


Options:
A: Mean Number of Alcohol and Drug Use Days Out of Past 30 (30 days previous, assessed at 12-month follow-up)
B: Drug abstinence
C: Proportion Days Abstinent (PDA) (Every 3 months out to 2 years)
D: Change in number of alcohol use days from baseline to 6 months (Baseline, 1, 3, and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial
Brief Summary: A randomized controlled trial of the efficacy of classification based cognitive functional physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual therapy and exercise in patients with non specific chronic low back pain.

The investigators hypothesis was that treatment targeted at the mechanism behind the problem from a multidimensional perspective would be superior to traditional treatment.


Options:
A: Pain (12 months); Disability (12 months)
B: N/A
C: Low back pain, referred pain and disability (Baseline, 2, 6 and 12 months)
D: Change of self-reported pain on 100mm Visual Analogue Scale (VAS) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)); Change of functional status recorded with the Oswestry Disability Index (ODI) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Brief Summary: Gestational diabetes mellitus (GDM)is a major health problem

* growing prevalence of obesity
* the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

* feasibility of an early intervention
* glucose tolerance at weeks 26-28


Options:
A: Waist Circumference (Month 9); Body Weight (nine month); Body Weight (4 month); Waist Circumference (4 month)
B: Number of at risk participants developing GDM during pregnancy
C: Waist Circumference (2 Years)
D: For adults: body weight loss maintenance (6 Month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Brief Summary: Gestational diabetes mellitus (GDM)is a major health problem

* growing prevalence of obesity
* the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

* feasibility of an early intervention
* glucose tolerance at weeks 26-28


Options:
A: Excessive weight gain during pregnancy (2007-2023)
B: Gestational Weight Gain (Delivery)
C: Number of at risk participants developing GDM during pregnancy
D: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Brief Summary: Gestational diabetes mellitus (GDM)is a major health problem

* growing prevalence of obesity
* the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

* feasibility of an early intervention
* glucose tolerance at weeks 26-28


Options:
A: Birth weight as assessed by z-scores (At birth)
B: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
C: Number of at risk participants developing GDM during pregnancy
D: Maternal gestational weight gain (40-42 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Brief Summary: Gestational diabetes mellitus (GDM)is a major health problem

* growing prevalence of obesity
* the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

* feasibility of an early intervention
* glucose tolerance at weeks 26-28


Options:
A: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
B: Number of at risk participants developing GDM during pregnancy
C: Birth weight as assessed by z-scores (At birth)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
B: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: 6 Month Bleeding Rate (Up to 6 months)
B: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
C: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
D: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death (30 days)
B: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
C: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
D: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
B: Progression free survival (5 years)
C: symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death (30 days)
D: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
B: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
C: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
D: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
B: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)
D: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
B: Incidence of venous thromboembolism reduction
C: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
D: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy
Brief Summary: The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.


Options:
A: Fatigue (immediately before and after the intervention)
B: Change in inspiratory muscle strength (Before surgery, 5.postoperative day, 2 weeks after surgery)
C: Systemic inflammation measured by c-reactive protein. (12 weeks)
D: VO2peak (baseline and after 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy
Brief Summary: The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.


Options:
A: Change in inspiratory muscle strength (Before surgery, 5.postoperative day, 2 weeks after surgery)
B: Postoperative pain (12 months)
C: Change in Maximal oxygen uptake (VO2max) from baseline (An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years)
D: Systemic inflammation measured by c-reactive protein. (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Brief Summary: Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.


Options:
A: Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record
B: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
C: Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses (2 years)
D: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)

Answer: D