Name (Synonyms) | Correlation | |
---|---|---|
drug433 | CFTR Modulators Wiki | 0.58 |
drug862 | Environmental Decontamination Wiki | 0.58 |
drug2563 | Trimethoprim Sulfamethoxazole (TMP/SMX) Wiki | 0.58 |
drug559 | Chlorhexidine Gluconate Wiki | 0.58 |
drug1531 | Mupirocin Wiki | 0.58 |
drug2601 | Unsupervised exercise Wiki | 0.58 |
drug1506 | Minocycline Wiki | 0.58 |
drug880 | Exercise Wiki | 0.41 |
drug1243 | Interview Wiki | 0.33 |
drug1978 | Questionnaire Wiki | 0.12 |
Name (Synonyms) | Correlation |
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There are 3 clinical trials
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
Description: Descriptive summary with corresponding 95% confidence interval.
Measure: Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial Time: Day 28Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA Time: Period ranging from start of Baseline and continuing through Day 28Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with any oral, inhaled, or IV antibiotics regardless of potential activity against MRSA Time: Period ranging from start of Baseline and continuing through Day 28Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Time to protocol-defined pulmonary exacerbation over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Number of protocol-defined pulmonary exacerbations over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6Description: Proportion of subjects with a negative culture for MRSA at Day 56
Measure: MRSA Culture Status Time: Day 56Description: Compliance refers to the amount of prescribed medication consumed.
Measure: Proportion of subjects with >80% compliance for study drug during the first 28 days Time: Day 28This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
Description: Changes in strength will be measured using a five repetition maximum test (5RM)
Measure: Change in Strength Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Measure: Change in Cardiorespiratory Fitness Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory volume in 1 second (FEV1) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced vital capacity (FVC) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in FEV1/FVC ratio (FEV1%) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory flow (FEF) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S
Measure: Sweat chloride level Time: Four assessment points throughout the study: baseline and after each 8-week interventionImpacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),
Measure: Cancellation or postponement of consultations by the health professional or patient, Time: Up to 6 monthsDescription: Number of consultations cancelled by the teleconsultation/replacement patient,
Measure: Patient cancellation of teleconsultations/telecare replacement, Time: Up to 6 monthsDescription: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)
Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled), Time: Up to 6 monthsDescription: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).
Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration). Time: Up to 6 monthsDescription: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)
Measure: The reduction of each of the elements of care provision and health care utilization: Time: Up to 6 monthsDescription: Intravenous instead of intravenous administration
Measure: The change of modality of administration of antibiotic cures Time: Up to 6 monthsDescription: Questionnaire about taking or not taking treatment during confinement
Measure: Compliance Time: Up to 6 monthsDescription: Scale 0-21
Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well) Time: Up to 6 monthsDescription: A questionnaire on the presence or absence of toxic consumption
Measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown Time: Up to 6 monthsDescription: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)
Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19 Time: Up to 6 monthsDescription: Role of social inequalities in the consequences of containment assessed by qualitative methods
Measure: Assessing the role of social inequalities in the consequences of lockdown Time: Up to 6 monthsDescription: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis
Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis. Time: Up to 6 months