TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Single-blind, Randomised Placebo Controlled Trial of Long Term Therapy in Patients With Stable COPD Using Moxifloxacin, Azithromycin and Doxycycline: a Bayesian Decision Analysis, Including Other Criteria, Will be Used to Distinguish the Optimal Antibiotic Treatment
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD, however, there is little information available about the use of long term antibiotics in the treatment of this disease. Therefore the purpose of this study is to identify the best antibiotic regime for treating patients with COPD who have persistent bacterial infection in their lung. We will test a variety of approaches including both older and newer regimes prescribed either on a daily basis at a lower dose or in "pulsed" courses (for example, every other day or five days every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is expected that approximately 200 patients will be selected for this study. The information we get from this study may help us to treat future patients with COPD better.


Options:
A: The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach. (For upto 45 minutes from start to end of endoscopy)
B: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)
C: Reduction in number of exacerbations (1 year)
D: Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of isolates of pneumococcus exhibiting macrolide resistance by nasopharyngeal swabs in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months); Prevalence of macrolide resistance in the stool as determined by genetic determinants or phenotypic testing (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of conjunctival swabs yielding ocular chlamydia in children 1-60 months (24 months); Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Weight for Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension
Brief Summary: Background

-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.

Methods

-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.

Prospects

-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.


Options:
A: Pulmonary artery systolic pressure (PASP) (change from baseline at 12 weeks); Subjective self-report questionnaire that assesses sleep quality (change from baseline at 12 weeks); Determining sleep patterns (change from baseline at 12 weeks); Measuring aerobic fitness (change from baseline at 12 weeks)
B: Functional exercise capacity (Oxygen consumption measurement during test) (6 weeks)
C: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
D: distance walked in 6 minutes (baseline - 15 weeks afterwards); change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire (baseline - 15 weeks afterwards)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension
Brief Summary: Background

-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.

Methods

-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.

Prospects

-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.


Options:
A: Pre and post exercise training CPET (10 wks); Accelerometry-based activity (10 wks); 6 minute walk distance (10 wks); Quality of life and functional measures (10 wks)
B: distance walked in 6 minutes (baseline - 15 weeks afterwards); change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire (baseline - 15 weeks afterwards)
C: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
D: Survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Brief Summary: The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.


Options:
A: Change in intake of the target vegetable (Change in intake of the target vegetable from Baseline to day 14)
B: BMI and aerobic fitness (1 schoolyear)
C: Change in Body Mass Index Z-score (9 months)
D: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Brief Summary: The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.


Options:
A: Change in Body Mass Index Z-score (9 months)
B: Blood pressure (6 months)
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: Overweight and obesity according to IOTF references (0-1-2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
Brief Summary: Experimental intervention:

Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.

Control intervention:

Conventional Patient education by health care professionals. A paper-based patient questionnaire will be provided.


Options:
A: The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. (12 months)
B: Occurrence of adverse events (composite endpoint) (at month 60)
C: Calcineurin trough levels (6 month)
D: Comparison of Variability in Tacrolimus Levels by Group Assignment (3 months ( to 12 Months Post-Transplantation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Brief Summary: The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.


Options:
A: Functional capacity and quality of life (August 2009)
B: Number of LTC residents on vitamin D (16 months)
C: Falls (Eight months)
D: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Brief Summary: The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.


Options:
A: Number of LTC residents on vitamin D (16 months)
B: Reduction of antidepressant (Intervention period of three months for each patient.)
C: NPI-NH agitation/aggression (8 weeks and 12 weeks)
D: Participation in social, leisure and communicative activities. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Brief Summary: The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.


Options:
A: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
B: Number of LTC residents on vitamin D (16 months)
C: Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care (up to 18 months); Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates. (May 2012- September 2014)
D: functional gain as measured by motor FIM score (One year post team training intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Brief Summary: The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.


Options:
A: N/A
B: Episiotomies; Oxytocin use in third stage of labor
C: difference in change in systolic BP between the intervention and usual care groups (6 months)
D: Number of LTC residents on vitamin D (16 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Brief Summary: The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.


Options:
A: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
B: Number of LTC residents on vitamin D (16 months)
C: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
D: influenza vaccination (September through March 2011-2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
Brief Summary: The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.


Options:
A: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) (8 weeks after last assigned study treatment)
B: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
C: Change in subjective symptom score (at 0 and 3 months)
D: Cure of C. difficile infection (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
Brief Summary: The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.


Options:
A: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
B: diversity and steady state of the stool (6 months)
C: The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.)
D: co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (at 12 weeks after treatment.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
Brief Summary: The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.


Options:
A: Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment (Baseline (Day 0) through Study Day 19); Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment (Baseline (Day 0) through Study Day 19)
B: Resolution of diarrhea
C: Clinical response (resolution of all symptoms of CDAD) (End of treatment (day 12-14 after beginning treatment))
D: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
Brief Summary: The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.


Options:
A: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
B: durability of clinical remission (One year)
C: Recurrence of CDI up to 8 Weeks (Up to Week 8)
D: Safety (up to 6 mo post FMT)

Answer: A