TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)
B: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)
C: reducers (week-24 from baseline)
D: verified abstinence 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
C: verified abstinence 6 months (6 months)
D: Toxicant Exposure (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
B: verified abstinence 6 months (6 months)
C: Cigarette use (Weeks 1-3); Ecigarette use (Weeks 1-3)
D: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)
B: Smoking cessation (14 months post baseline)
C: End-of-intervention Varenicline Adherence (4 Weeks)
D: verified abstinence 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Virtual Reality for Rehabilitation for Individuals With Lower Limb Amputation
Brief Summary: A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation. The system is composed of a treadmill that can simulate different environmental situations such as walking up stairs and hills and going around curves. The treadmill is synchronized with an immersive display and an avatar of the user. The combination of variable terrain and visual feedback is extremely promising as a means for amputee patients to achieve improved functional mobility after gait training. The proposed work is relevant to public health because it is the first step in developing a novel rehabilitation system that will use visual feedback for gait training in amputees and others with pathological gait disorders. The research is pertinent to the mission of the Department of Veterans Affairs which is committed to improve the quality of life of Veterans with disability.


Options:
A: Change from Baseline in Knee Joint Symmetry at 6 weeks (Baseline and at 6 weeks); Change from Baseline in Gait Speed (m/s) at 6 weeks (Baseline, at 3 weeks and at 6 weeks); Change from Baseline in Gait Variability at 3 weeks and 6 weeks (Baseline, at 3 weeks and at 6 weeks); Change from Baseline in Trunk Lean on the Prosthetic versus Non-Prosthetic Side of the Body (measured in degrees) at 6 weeks. (Baseline and at 6 weeks)
B: Prosthetic Limb Users Survey of Mobility (PLUS-M) (5-10 minutes); Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (5-10 minutes)
C: Community integration (24 weeks)
D: To evaluate the relevance of the intervention of a physical therapist and a psychologist in the management of amputee patients in vascular surgery at 10 days post-operatively. (at 10 days post-operatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Skills-based RCT for Physical Activity Using Peer Mentors
Brief Summary: This approach will train peer mentors to deliver a culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active \[MBA\]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens


Options:
A: BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis) (2 years)
B: Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study (Baseline to two years); Change in Physical Activity (Baseline to two years); Change in Reported Added Sugar Intake (Baseline to two years); Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) (Baseline to two years); Change in BMI Z-score (Baseline to two years); Change in HOMA-IR (Baseline to two years)
C: Change in Body Mass Index From T1 to T3 (T1 (Baseline) to T3 (9 months-post baseline)); Change in Total Body Weight From T1 to T3 (T1 (baseline) to T3 (9-month post baseline)); Change in Pounds of Body Fat From T1 to T3 (T1 ( Baseline) to T3 (9-months post baseline))
D: Adult BMI change (Change from baseline at 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
Brief Summary: To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wider-scale deployment.


Options:
A: Decrease in Parasite prevalence according to RDT (6 months); Decrease in Parasite prevalence according to PCR (6 months); Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages (12 months)
B: Cumulative notified malaria incidence in the MDA and control Shehias (6 months after second round of MDA)
C: prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of treatment with dihydroartemisinin-piperaquine and primaquine. (1017-13 and 23-15) (12 months); prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of targeted malaria elimination (1015-13) (12 months); prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 4 months after the first administration of target malaria-elimination (23-15) (4 months)
D: Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) (For up to 12 months); P.falciparum infection incidence rate among individuals ≥3 months (For up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of the Respiratory Rehabilitation Exercise Training Package in Hospitalized Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Randomized Control Trial
Brief Summary: The purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31). The experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days. The control group participants received usual care and health education. Data were collected at baseline and at the end of the four-day intervention.


Options:
A: thoracoabdominal motion (2 years)
B: respiratory muscle strength measurements (baseline and 8 weeks)
C: Change from baseline in dyspnea at 4th day (At baseline and at the 4th day of the study)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of the Respiratory Rehabilitation Exercise Training Package in Hospitalized Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Randomized Control Trial
Brief Summary: The purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31). The experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days. The control group participants received usual care and health education. Data were collected at baseline and at the end of the four-day intervention.


Options:
A: Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death) (3-months)
B: Hospital Readmission (12 months)
C: Change from baseline in dyspnea at 4th day (At baseline and at the 4th day of the study)
D: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Anagliptin and Sitagliptin on Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes and Cardiovascular Risk Factors: Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.


Options:
A: Change of global myocardial function from baseline to 6 months of follow-up. (Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.)
B: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
C: Progression of Albuminuria (Up to 3 years)
D: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures
Brief Summary: Proposed is a randomized, controlled, modified Latin square parallel design study with two treatment arms to examine walnut consumption effects on diet quality, body composition, and markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A modified crossover design (Latin square)27-29 will allow for both paired and unpaired analyses.


Options:
A: Markers of glycemic control: Fasting serum fructosamine (From prestudy and week 0, to end of treatment weeks 8, 10, 12); Fasting serum HbA1c (From prestudy and week 0, to end of treatment weeks 8, 10, and 12); Fasting glucose (From prestudy and week 0, to end of treatment and weeks 8, 10, and 12); Fasting insulin (From prestudy and week 0, to end of treatment and weeks 8, 10, and 12)
B: Metabolic syndrome status (12 weeks)
C: Change in Weight (2, 4, 6, 8, 10, and 12 weeks); Change in Blood Lipids (4, 8, and 12 weeks); Change in Blood Pressure (2, 4, 6, 8, 10, and 12 weeks); Change in Hedonics of peanut consumption (12 weeks); Change in Body Composition (2, 4, 6, 8, 10, and 12 weeks); Change in Fasting Blood Glucose (4, 8, and 12 weeks); Change in Cortisol (4, 8, and 12 weeks); Change in Insulin (4, 8, and 12 weeks); Change in Pulse (2, 4, 6, 8, 10, and 12 weeks)
D: Diet Quality assessed using the Alternative Healthy Eating Index (AHEI) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open-label Trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) Plus Standard Care Versus Standard Care Alone to Prevent/Attenuate Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Brief Summary: Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment.

There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem.

The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.


Options:
A: Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up (Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks))
B: Fatigue (immediately before and after the intervention)
C: change in body weight (6 weeks)
D: Change from Baseline in Body Composition (At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
Brief Summary: The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.


Options:
A: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)
B: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
C: Change in frequency of MBP-reactive Th17 cells (From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)
D: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Granulocyte Colony-stimulating Factor(G-CSF) in the Treatment of Hepatic Failure: a Prospective Randomized Controlled Clinical Study
Brief Summary: This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard treatment in combination, while half participants will receive standard treatment.


Options:
A: Transplant free survival (1 year)
B: Overall Survival (One year)
C: Survival rates (12 weeks)
D: transplant free survival at 1 year (3 Months)

Answer: C