TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: Rating of urges to smoke 1-week after the target quit (1 week)
C: 6 Month Self-reported Abstinence From Smoking (6 months)
D: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
Brief Summary: This study will develop:

1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.


Options:
A: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)
B: Smoking Status at 6 Months (6 months after enrollment)
C: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
D: Efficacy of extended versus standard quit and win contests (6 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
Brief Summary: This study will develop:

1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.


Options:
A: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)
B: Abstinence From Smoking (Measured 6 months after enrollment at follow-up assessment)
C: Smoking abstinence at 12 months post-enrollment (12 months)
D: Cigarette smoking abstinence. (Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
Brief Summary: This study will develop:

1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.


Options:
A: Cotinine validated quit rates.
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
D: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
Brief Summary: This study will develop:

1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.


Options:
A: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
B: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
C: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
Brief Summary: Introduction:

Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and substantially affects both their own well-being and their offspring's mental and emotional development. Whereas PPD is a form of major depression, its etiology is probably related to a combination of biological (hereditary, hormonal etc.), and psychological factors. In practice, most women suffering from PPD do not seek treatment, or are treated with psychotherapy alone due to concerns regarding pharmacotherapy. This is despite the obvious importance of reaching a rapid remission in these women. In fact, data regarding the treatment of PPD with antidepressants is surprisingly sparse and is limited to only one blinded and placebo-controlled study (with fluoxetine) and a number of studies without a placebo arm . The reason for the paucity of double-blinded placebo-controlled studies is probably due to 3 main limiting factors: Firstly, the reluctance of women to "admit" to and seek professional help due to depression, Secondly, the difficulty to administer antidepressant medication to lactating women, and, Thirdly, the ethical difficulties in designing a study with a real placebo group.

In contrast to the very limited number of drug studies in this population, there are a number of studies that have shown the efficacy of psychotherapy in the treatment of PPD. Positive studies have been published using different types of psychotherapy, including cognitive, dynamic and interpersonal psychotherapy.

The investigators propose to study the efficacy of psychotherapeutic treatment in women suffering from PPD with add-on sertraline in a randomized double-blind, placebo-controlled design. To overcome the difficulties described above in studying antidepressants in the postpartum period, the investigators propose to include active brief dynamic psychotherapy for all women. Furthermore, the investigators will selectively allow inclusion of women who only suffer from either mild or moderate major PPD (not severe / suicidal) .

Hypothesis:

The investigators hypothesize that women with PPD randomized to the arm receiving psychotherapy + active sertraline will show a greater response rate than the psychotherapy + placebo group. Furthermore, the investigators hypothesize that the difference in response between the 2 groups will demonstrate a significant early response in the active sertraline group.


Options:
A: Hamilton Depression Rating Scale (HAM-D) (Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
B: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)
C: EPDS (3 and 6 months)
D: depression (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Reduced Carbohydrate Diet Intervention for PCOS
Brief Summary: Polycystic ovary syndrome (PCOS) affects 5-10% of women of reproductive age, and is associated with infertility, risk for obesity and type 2 diabetes, and impaired quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. Manipulation of dietary carbohydrate quantity and quality (glycemic load; GL) may lower insulin and improve both reproductive and metabolic outcomes. The purpose of this study is to determine if a lower GL diet intervention is more effective than a standard (STD) diet in improving reproductive and metabolic outcomes of women with PCOS in the absence of weight loss.


Options:
A: Pregnancy rate (six months)
B: To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS. (One year)
C: Improving reproductive and metabolic outcomes of women with PCOS (8 weeks)
D: Weight loss (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Brief Summary: The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.


Options:
A: Glucose Monitoring Adherence at Acute Outcome (Measured at Month 4); Percent Medication Adherence Via MEMS (month 4); Clinician Rated Depression (MADRS) at the Acute Timepoint (month 4); Depression on the CGI at Acute Outcome (Month 4)
B: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)
C: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
D: Overall Decisional Comfort (0-100, 100=no Conflict) (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Brief Summary: The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.


Options:
A: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
B: Participant-reported most important attribute from survey (1 day)
C: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
D: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Brief Summary: The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.


Options:
A: Greater reduction in CHD risk in case group vs. control (6 months)
B: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
C: Physical activity (4 years); Modelled cardiovascular risk (4 years); Health related quality of life (4 years); Functional capacity (4 years)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Brief Summary: The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.


Options:
A: The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions. (1 Day)
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
D: Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings (Baseline to Three Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy
Brief Summary: The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)


Options:
A: Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months (Day 183 to Day 364 (6 months))
B: AUC from time 0 to the last data point (Pre-Dose and up to 120 hours post dose)
C: Incidence Rate of FVIII Inhibitor Development (up to 52 weeks ± 2 weeks); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline (up to 52 weeks ± 2 weeks); Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs (up to 52 weeks ± 2 weeks); Annualized Bleeding Rate (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3 (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay) (See Measure Description for complete time frame.); Elimination Half Life (t1/2; One-stage Clotting Assay) (See Measure Description for complete time frame.); Clearance (CL; One-stage Clotting Assay) (See Measure Description for complete time frame.); Mean Residence Time (MRT; One-stage Clotting Assay) (See Measure Description for complete time frame.); Incremental Recovery (One-stage Clotting Assay) (See Measure Description for complete time frame.)
D: Part A - Area Under the Drug Concentration-time Curve (AUC) (Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.); Part A - Half-life (t 1/2) (Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.); Part B - Annualized Number of Total Bleeds (12 months after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Overweight Youth: A Family Based Approach in Primary Care
Brief Summary: The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI \>27 kg/m2.


Options:
A: Percent BMI overweight for child and parent (baseline-6,12,18, 24 months)
B: Feasibility (1 year); Efficacy (1 year)
C: Child BMI Percentile (2 years after recruitment)
D: Body mass index (BMI) at 1 year.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life
Brief Summary: The purpose of this study is to test the effectiveness of a DVD-delivered, home-based, six-month physical activity intervention for older adults.

A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in 2014.


Options:
A: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)
B: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life
Brief Summary: The purpose of this study is to test the effectiveness of a DVD-delivered, home-based, six-month physical activity intervention for older adults.

A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in 2014.


Options:
A: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
B: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)
C: Acceptability and feasibility (3 weeks)
D: Change in Physical Activity From Baseline to 12 Weeks (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life
Brief Summary: The purpose of this study is to test the effectiveness of a DVD-delivered, home-based, six-month physical activity intervention for older adults.

A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in 2014.


Options:
A: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
B: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
C: Physical activity level
D: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)

Answer: D