TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Milnacipran
Brief Summary: Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).


Options:
A: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
B: Self-reported axial pain (0 - 10 numeric rating scale) (through 6 weeks after enrollment visit)
C: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
D: Global Clinical Improvement Scale (After 13 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Milnacipran
Brief Summary: Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).


Options:
A: Adverse Events (Baseline (Visit 1) to Week 53 (Visit 9))
B: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
C: Composite responder analysis based on pain and patient global status, with or without physical function.
D: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Milnacipran
Brief Summary: Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).


Options:
A: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: Composite responder analysis based on pain and patient global status, with or without physical function.
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Milnacipran
Brief Summary: Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).


Options:
A: Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity. (Baseline, Week 9, and Week 12)
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
D: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin in Reducing Events in the Elderly
Brief Summary: ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants \[ASPREE Investigator Group, 2013; www.aspree.org; McNeil et al 2017\]. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality. In addition to monitoring the incidence of malignancy within the ASPREE cohort, the opportunity will be taken to observe any other residual effects of aspirin on the endpoints being monitored in the cohort. Continuity of contact with study participants is the key to retention of the cohort for any ongoing or future studies.


Options:
A: Volume of white matter changes (WMCs) (baseline, week 104)
B: The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (every 6 months)
C: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
D: changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of A3309, an Ileal Bile Acid Transport Inhibitor, on Gastrointestinal and Colonic Motor Functions in Female Patients With Functional Constipation
Brief Summary: This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation.


Options:
A: Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only). (4 weeks)
B: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)
C: Colonic Transit at 24 Hours (24 hours post-radiolabeled meal)
D: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency (Change from Baseline to Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health
Brief Summary: Previous studies have shown "Doing the month", a traditional practice for postpartum women in China and other Asian countries, may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women.


Options:
A: BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI
B: Body weight (12 weeks)
C: Postpartum weight retention (no more than 1.5 years)
D: Changes in the knowledge and belief about postpartum practice among the women (December 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
Brief Summary: The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.


Options:
A: BMI percentile at 3 years (3 years)
B: Vegetable Intake in Preschool Children (1 year 11 months)
C: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
D: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
Brief Summary: The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.


Options:
A: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
D: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
Brief Summary: The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
C: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
D: Vitamin D plasma concentrations (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
Brief Summary: The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
C: Infant weight for height (One year after study entry)
D: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
Brief Summary: The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.


Options:
A: BMI variation from baseline (12 months)
B: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduction of Person-job Mismatch to Increase Work Capacity, by Education of, and Dialogue Between Involved Parties - Evaluation of an Intervention Program
Brief Summary: The study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. The intervention intends to reduce job-person mismatch through patient-supervisor communication.The hypothesis is that the intervention group will show a more favourable outcome than a control group with respect to return to work.


Options:
A: Self-reported number of sick-days (3 months)
B: Efficiency of the 3 programs (One year)
C: Return to work from sick leave (Up to 1,5 years post intervention completion)
D: length of sickness absence (6 months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Conservative Treatment for Hip Osteoarthritis: Effect of Manual Treatment and Hip School on Pain, Disability and Quality of Life - a Single-blinded Randomized Controlled Trial
Brief Summary: The purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery.


Options:
A: Numerical rating scale of pain (NRS) : (collected at baseline up to 3 months after therapy)
B: WOMAC pain subscale (End of treatment (at 24 weeks))
C: Changes in the intensity of hip pain before and after the treatment (participants will be assessed before and after intervention (interval: 15-20 minutes))
D: Pain: Numerical pain scale (Baseline, 6 weeks, 3 months, 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.


Options:
A: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline (baseline and end of the chewing treatment during three week treatment period)
B: 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)
C: FGF23 serum level (Change over 2 weeks of treatment)
D: electron-beam CT coronary artery calcification AGATSTON score (change at 12 mo from baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.


Options:
A: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline (baseline and end of the chewing treatment during three week treatment period)
B: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)
C: Calcium balance (48 hour)
D: To determine if the dietary protein source affects fasting serum and urinary phosphorus excretion in patients with CKD stages 3 and 4. (6 months after baseline)

Answer: A