TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.


Options:
A: Chronic Respiratory Disease Questionnaire (CRQ) (12 weeks)
B: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
C: Re-hospitalizations (During the 30days after discharge)
D: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.


Options:
A: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
B: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)
C: Combined number of hospitalizations and emergency department presentations (Two years)
D: Number of hospitalizations due to exacerbation of COPD avoided (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.


Options:
A: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
B: Combined number of hospitalizations and emergency department presentations (Two years)
C: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
D: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.


Options:
A: Hospital readmission rate (all cause) (90 days)
B: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)
C: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
D: Measure of physical activity (Change from Baseline to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga as a Complex Intervention for Vets With Stroke
Brief Summary: Approximately 780,000 people suffer a stroke annually in the United States; 200,000 are recurrent strokes. The 17,000 veterans who suffer a stroke yearly are at great risk for a second stroke and therefore should be targeted for stroke risk factor management and prevention interventions.

Balance and fear of falling negatively impact activity and function. Decreased activity and blood pressure (BP) are important modifiable stroke risk factors. These can be addressed through a yoga exercise intervention. Yoga, like tai-chi, is old world alternative medicine that has the potential to greatly impact the lives of older adults.


Options:
A: Balance - Measured With the Berg Balance Scale (2 months)
B: Change from baseline in mobility at 2 and 4 months (before the intervention, month 2 and month 4); Change from baseline in Balance at 2 and 4 months (before the intervention, month 2 and month 4)
C: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
D: Difference in physical activity scale for the elderly (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategic Use of New Generation Antidepressants for Depression
Brief Summary: The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.


Options:
A: Montgomery-Asberg Depression Rating Scale (MADRS) (Baseline (Week 8) to Week 16)
B: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period (Baseline (Week 8)); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period (Baseline (Week 8) to Week 16)
C: Observer-rated depression severity (PHQ-9) (9 weeks)
D: To assess the efficacy of up to 8 weeks of treatment with OFC versus olanzapine and fluoxetine monotherapies, in patients with recurrent MDD without psychotic features; who meet study criteria for TRD, as measured by last observation carried forward (LOCF) mean change from baseline to endpoint in the MADRS total score; Treatment-resistant depression will be defined as:historic failure to achieve satisfactory response to an antidepressant (other than fluoxetine) during the current MDD episode; when treated with an acceptable antidepressant drug and dose for at least 6 weeks; prospective failure to achieve a satisfactory response to fluoxetine monotherapy during the 8 week study lead-in phase

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Paediatric Electronic Quality of Life Instrument for Childhood Asthma in the Netherlands (Pelican) in Medical Care.
Brief Summary: The objective of this project is to establish the effectiveness of implementation of a self-administered electronic asthma-specific quality of life instrument for childhood asthma in primary care and specialist care.


Options:
A: Patient Perception of Shared Decision Making (18 months)
B: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))
C: quality of life (9 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Brief Summary: Aim of this randomized controlled study is to test if intensive polyintervention therapy including life style modifications targeting at reduction of modifiable risk factors of stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients receiving standard care.


Options:
A: Canadian Occupational Performance Measure (COPM) (Change from baseline to post-intervention (12 weeks)); Performance Quality Rating Scale (PQRS) (Change from baseline to post-intervention (12 weeks))
B: Number of persons having cognitively declined at 24 months (24 months after randomization); Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months (24 months after randomization)
C: Change From Baseline in Performance Quality Rating Scale (PQRS) (A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline))
D: Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function (Baseline (pre-randomization) and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Brief Summary: Aim of this randomized controlled study is to test if intensive polyintervention therapy including life style modifications targeting at reduction of modifiable risk factors of stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients receiving standard care.


Options:
A: Motor impairment of the upper limb (Change from Baseline in motor impairment of the upper limb at 4 weeks)
B: Social Functioning: Total Social Behavior (6 weeks)
C: Number of persons having cognitively declined at 24 months (24 months after randomization); Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months (24 months after randomization)
D: Number of participants with treatment emergent serious adverse events (At 12 weeks visit (post-intervention)); Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group (At 12 weeks visit (post-intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)
Brief Summary: The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.


Options:
A: Fecal microbiota measured at each visit (8 weeks)
B: To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF. (2 years)
C: Practical handling,ease of use and safety information (number of participants with adverse events) (measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product)
D: Weight Gain (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age
Brief Summary: research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.


Options:
A: Proportion of Patients With a ≥13 Point Improvement in FIQR Score (Day 42)
B: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
C: To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age. (Day 56)
D: Red blood cell (RBC) units transfused (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prophylaxis of Hepatic Encephalopathy: A Double Blind, Randomized, Placebo Controlled Study With Supplementation With a Probiotic Preparation
Brief Summary: The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®) for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the recovery of an episode of overt HE (secondary prophylaxis)


Options:
A: episodes of cholangitis (6 months after intervention)
B: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)
C: High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) (2 months)
D: The primary end point will be development of overt HE or completion of a follow-up of 6 months after enrollment (6 months after enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lanthanum Carbonate 750 to 2250 mg in Patients With Chronic Kidney Disease Not on Dialysis Who Develop Hyperphosphatemia
Brief Summary: The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.


Options:
A: The change from baseline in serum phosphate concentrations (Week 8)
B: Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
C: electron-beam CT coronary artery calcification AGATSTON score (change at 12 mo from baseline)
D: Change From Baseline and Levels at Each Time Point for Serum Phosphorus (Every 4 weeks from baseline to Week 28); Change From Baseline and Levels at Each Time Point for Serum Calcium (Every 4 weeks from baseline to Week 28); Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH) (Every 4 weeks from baseline to Week 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline and Smoking Cessation in Schizophrenia
Brief Summary: There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.


Options:
A: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
B: urine carcinogen biomarker of exposure, NNAL (week 24)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline and Smoking Cessation in Schizophrenia
Brief Summary: There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.


Options:
A: Quit Rate (Study weeks 6 through 9)
B: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline and Smoking Cessation in Schizophrenia
Brief Summary: There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.


Options:
A: Percent Compliance With Chantix (Months 1, 2, 3)
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
C: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
D: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)

Answer: C