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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3509 | Saline placebo Wiki | 0.38 |
| drug210 | Activity plan to break up sitting time Wiki | 0.38 |
| drug3951 | Temsirolimus Wiki | 0.38 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D058729 | Peripheral Arterial Disease NIH | 0.76 |
| D016491 | Peripheral Vascular Diseases NIH | 0.65 |
| D007383 | Intermittent Claudication NIH | 0.38 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014652 | Vascular Diseases NIH | 0.19 |
| D008103 | Liver Cirrhosis, NIH | 0.19 |
| D009362 | Neoplasm Metastasis NIH | 0.17 |
| D051437 | Renal Insufficiency, NIH | 0.15 |
| D007676 | Kidney Failure, Chronic NIH | 0.14 |
| D007511 | Ischemia NIH | 0.13 |
| D006333 | Heart Failure NIH | 0.11 |
| D008175 | Lung Neoplasms NIH | 0.11 |
| D017563 | Lung Diseases, Interstitial NIH | 0.10 |
| D002908 | Chronic Disease NIH | 0.10 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.10 |
| D008171 | Lung Diseases, NIH | 0.08 |
| D009369 | Neoplasms, NIH | 0.06 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004417 | Intermittent claudication HPO | 0.38 |
| HP:0001395 | Hepatic fibrosis HPO | 0.19 |
| HP:0000083 | Renal insufficiency HPO | 0.15 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001635 | Congestive heart failure HPO | 0.11 |
| HP:0100526 | Neoplasm of the lung HPO | 0.11 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.10 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.10 |
| HP:0002088 | Abnormal lung morphology HPO | 0.08 |
| HP:0002664 | Neoplasm HPO | 0.06 |
Navigate: Correlations HPO
There are 7 clinical trials
Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.
Description: Participants will be walk up and down a 100-foot hallway for 6 minutes to cover the maximum distance possible. The distance, measured in feet, completed after 6 minutes will be recorded.
Measure: Change in 6-minute walk distance Time: Baseline, Month 3, Month 6, Month 9Description: Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes. The peak walking time (PWT) is the time until exercise is terminated because of severe claudication. Exercise testing will be performed twice and longest time will be used as the PWT for that study visit.
Measure: Change in Peak Walking Time (PWT) Time: Baseline, Month 3, Month 6, Month 9Description: The Walking Impairment Questionnaire (WIQ) domain of walking distance asks respondents to rate how difficult it is to walk around home, as well as distances of 50, 150, 300, 600, 900 and 1500 feet. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 28 with higher scores indicating increased ability to walk further distances.
Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Distance Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: The Walking Impairment Questionnaire (WIQ) domain of walking speed asks respondents to rate how difficult it is to walk the distance of one block slowly, at an average speed, quickly, and running/jogging. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 16 with higher scores indicating increased ability to walk fast.
Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Speed Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: The Walking Impairment Questionnaire (WIQ) domain of stair climbing asks respondents to rate how difficult it is to climb 1, 2, and 3 flights of stairs. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 12 with higher scores indicating better ability to climb stairs.
Measure: Change in Walking Impairment Questionnaire (WIQ): Stair Climbing Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: 36-item Short-Form Health Survey (SF-36) consists of eight scaled scores for the domains of: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Study participants respond to questions relating to their health and activity level by selecting from a variety of Likert scale and yes/no response options. Each scale is directly transformed into a 0-100 scale and lower scores indicate more disability (a score of 0 equates to maximum disability while a score of 100 indicates no disability).
Measure: Change in 36-item Short-Form Health Survey (SF-36) Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: Claudication onset time (COT) during the treadmill exercise will be recorded along with the peak walking time (PWT). The claudication onset time (COT) is the duration of exercise until onset of the participant's typical claudication. This is differentiated from the peak walking time (PWT) which is the time until exercise is terminated because of severe claudication. Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes.
Measure: Change in Claudication Onset Time (COT) Time: Baseline, Month 3, Month 6, Month 9Description: To obtain the ankle-brachial index (ABI), bilateral upper and lower extremity blood pressure cuffs are inflated about 30 millimeters of mercury (mmHg) above the systolic pressure. Doppler flow signals are used to detect the reappearing perfusion while reducing the cuff pressure. The results is expressed as a segmental/arm pressure ratio (ABI index). The highest pressure of the two arms will be used for calculating the ABI. The average ratio is about 1.0+/-0.10; an index of 0.90 or lower is considered abnormal. In patients with calcific, non-compressible arteries (certain diabetics) where ABI measurements are unreliable, a toe/ arm pressure index ratio will be performed, with a 2.5 cm cuff used on the great or second toes. A toe/arm index less than 0.65 is considered abnormal.
Measure: Change in Ankle-Brachial Index (ABI) Time: Baseline, Month 3, Month 6, Month 9Description: Foot transcutaneous oxygen tension (TcPO2) is a noninvasive way to measure peripheral arterial disease. TcPO2 is obtained with a monitor before exercise after the patients have been standing for three minutes and is monitored throughout exercise. Values are recorded at initial claudication distance, absolute claudication distance, and after recovery from exercise. A commonly used cut point is 60 millimeters of mercury (mmHg), with values below this indicating the presence of peripheral arterial disease.
Measure: Change in Foot Transcutaneous Oxygen Tension (TcPO2) Time: Baseline, Month 3, Month 6, Month 9Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.
Description: Participants will be walk up and down a 100-foot hallway for 6 minutes to cover the maximum distance possible. The distance, measured in feet, completed after 6 minutes will be recorded.
Measure: Change in 6-minute walk distance Time: Baseline, Month 3, Month 6, Month 9Description: Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes. The peak walking time (PWT) is the time until exercise is terminated because of severe claudication. Exercise testing will be performed twice and longest time will be used as the PWT for that study visit.
Measure: Change in Peak Walking Time (PWT) Time: Baseline, Month 3, Month 6, Month 9Description: The Walking Impairment Questionnaire (WIQ) domain of walking distance asks respondents to rate how difficult it is to walk around home, as well as distances of 50, 150, 300, 600, 900 and 1500 feet. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 28 with higher scores indicating increased ability to walk further distances.
Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Distance Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: The Walking Impairment Questionnaire (WIQ) domain of walking speed asks respondents to rate how difficult it is to walk the distance of one block slowly, at an average speed, quickly, and running/jogging. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 16 with higher scores indicating increased ability to walk fast.
Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Speed Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: The Walking Impairment Questionnaire (WIQ) domain of stair climbing asks respondents to rate how difficult it is to climb 1, 2, and 3 flights of stairs. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 12 with higher scores indicating better ability to climb stairs.
Measure: Change in Walking Impairment Questionnaire (WIQ): Stair Climbing Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: 36-item Short-Form Health Survey (SF-36) consists of eight scaled scores for the domains of: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Study participants respond to questions relating to their health and activity level by selecting from a variety of Likert scale and yes/no response options. Each scale is directly transformed into a 0-100 scale and lower scores indicate more disability (a score of 0 equates to maximum disability while a score of 100 indicates no disability).
Measure: Change in 36-item Short-Form Health Survey (SF-36) Score Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3Description: Claudication onset time (COT) during the treadmill exercise will be recorded along with the peak walking time (PWT). The claudication onset time (COT) is the duration of exercise until onset of the participant's typical claudication. This is differentiated from the peak walking time (PWT) which is the time until exercise is terminated because of severe claudication. Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes.
Measure: Change in Claudication Onset Time (COT) Time: Baseline, Month 3, Month 6, Month 9Description: To obtain the ankle-brachial index (ABI), bilateral upper and lower extremity blood pressure cuffs are inflated about 30 millimeters of mercury (mmHg) above the systolic pressure. Doppler flow signals are used to detect the reappearing perfusion while reducing the cuff pressure. The results is expressed as a segmental/arm pressure ratio (ABI index). The highest pressure of the two arms will be used for calculating the ABI. The average ratio is about 1.0+/-0.10; an index of 0.90 or lower is considered abnormal. In patients with calcific, non-compressible arteries (certain diabetics) where ABI measurements are unreliable, a toe/ arm pressure index ratio will be performed, with a 2.5 cm cuff used on the great or second toes. A toe/arm index less than 0.65 is considered abnormal.
Measure: Change in Ankle-Brachial Index (ABI) Time: Baseline, Month 3, Month 6, Month 9Description: Foot transcutaneous oxygen tension (TcPO2) is a noninvasive way to measure peripheral arterial disease. TcPO2 is obtained with a monitor before exercise after the patients have been standing for three minutes and is monitored throughout exercise. Values are recorded at initial claudication distance, absolute claudication distance, and after recovery from exercise. A commonly used cut point is 60 millimeters of mercury (mmHg), with values below this indicating the presence of peripheral arterial disease.
Measure: Change in Foot Transcutaneous Oxygen Tension (TcPO2) Time: Baseline, Month 3, Month 6, Month 9The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationDescription: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomizationThe objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationDescription: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomizationA multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.
Description: Superiority of treatment vs. control group in the composite freedom from the following: Clinically Relevant Target Lesion Occlusion Clinically Driven Target Lesion Revascularization Ischemia-Driven Major Amputation of the Target Limb
Measure: Freedom from Cinical Relevant Target Lesion Failure Time: 6 MonthsDescription: Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)
Measure: MALE + POD Time: 30 DaysDescription: Superiority of treatment vs. control group in the composite freedom from the following: Target Lesion Occlusion Clinically Driven Target Lesion Revascularization Ischemia-Driven Major Amputation of the target limb
Measure: Freedom from Target Lesion Failure Time: 6 MonthsDescription: Death at the following time points
Measure: To determine non-inferiority in long-term mortality rate Time: 12, 24, 36, 48, 60 monthsDescription: Composite of all-cause death or MALE of the target limb
Measure: To determine non-inferiority in freedom from all-cause death or major adverse limb event. Time: 30 days, 6, 12 monthsDescription: Freedom from death and ischemia-driven major amputation of the target limb
Measure: To determine non-inferiority in amputation-free survival. Time: 30 days, 6, 12, 24 monthsDescription: AEs/ARs will be categorized into one of the following: MALE of the target limb Non-MALE target limb SAE/SAR Other SAE/SAR Non-serious AE/AR AEs/ARs will further be classified as: Expected UADE SUSAR AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following: Revascularization procedure Use of the Bullfrog device The study drug
Measure: Safety and tolerability will be assessed from overall rate of adverse events (subclassified as major, serious, non-serious, unanticipated, revascularization procedure-related, device-related and drug-related). Time: 30 days, 6, 12, 24 monthsDescription: Taken individually: Ischemia-driven major amputation of the target limb CD-TLR Clinically relevant target lesion occlusion Any target lesion occlusion
Measure: Change of the individual components of the primary and secondary endpoints (ischemia-driven major amputation, clinically driven target lesion revascularization, clinically relevant target lesion occlusion or all target lesion occlusion) Time: 6, 12, 24 monthsDescription: MALE of the target limb
Measure: Freedom from major adverse limb events Time: 30 days, 6, 12, 24 monthsDescription: Total size of foot wounds on the target limb, percent and absolute change from baseline Status of foot wounds on the target limb Unassisted wound healing
Measure: Composite of the following wound healing measures Time: 30 days, 6, 12 monthsDescription: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)
Measure: Reduction in unplanned minor amputations Time: 30 days, 6, 12 monthsDescription: Rutherford category and change from baseline
Measure: Rutherford score improvement Time: 30 days, 6, 12, 24 monthsDescription: WIfI category and change from baseline
Measure: WIfI score improvement Time: 30 days, 6, 12, 24 monthsDescription: Ankle-brachial index and change from baseline Toe-brachial index and change from baseline Toe pressure and change from baseline
Measure: Composite of hemodynamic improvement measures (ABI, TBI and toe pressure) Time: 30 days, 6, 12, 24 monthsDescription: VascuQoL results and change from baseline
Measure: Patient reported quality of life benefits (VascuQoL) Time: 30 days, 6, 12, 24 monthsDescription: WIQ results and change from baseline
Measure: Patient reported outcomes (walking impairment questionnaire) benefits Time: 30 days, 6, 12, 24 monthsDescription: Primary patency rate Primary assisted patency rate
Measure: Primary and primary assisted patency rates Time: 30 days, 6, 12, 24 monthsDescription: Primary sustained clinical improvement rate Secondary sustained clinical improvement rate
Measure: Primary and secondary sustained clinical improvement rates Time: 30 days, 6, 12, 24 monthsIntermittent claudication is the most common manifestation of peripheral arterial disease, a common cardiovascular disease that causes blocked blood vessels (arteries) in the leg. Symptoms consist of persistent pain in one or both legs during exercise that is relieved with rest. Evidence suggests that high levels of uninterrupted sitting and sedentary behaviour are associated with cardiovascular disease risk, mortality and all-cause mortality. One of the main goals for treating people with intermittent claudication, is increased participation in physical activity. Supervised Exercise Programmes are recommended however these are not well tolerated and compliance is low. Alternative exercise, including short bouts of physical activity to break up sedentary time, has been suggested to help improve physical function. This study will investigate whether alternative exercise, in the form of breaking up prolonged sitting time, will improve physical function in patients with intermittent claudication. A suite of multi-modal activities will be developed offering a variety of exercise activities which will inform a personalised activity plan for each participant. Patients will be screened during their routine clinic appointment at Glenfield Hospital. All other study activity will take place in a laboratory within the Leicester Diabetes Centre at the Leicester General Hospital (LGH). Patients will be expected to attend LGH for up to a maximum of 4 visits where study data will be collected from performing physical measurements and assessments, and the completion of various questionnaires. Additional data will be collected from activity monitors which will be worn for up to 8 days at baseline and follow-up, measuring step count and time, inactivity, activity time and intensity, and sleep duration. Participants will also be expected to wear activity monitors for the duration of the 8-week intervention to measure steps. Participants will be in the study for approximately 18 weeks in total.
Description: Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
Measure: To investigate overall changes in sitting time Time: 8 weeksDescription: Total score for 16 questions measuring walking distance, speed and stair climbing from 0 (worst/inability) to 4 (best/without limitations)
Measure: The walking impairment questionnaire Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent performing physical activity at baseline vs. follow up assessed via mean acceleration mg/day )
Measure: To investigate overall changes in time spent performing physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent in light physical activity at baseline vs. follow up assessed via acceleration mins/day)
Measure: To investigate overall changes in time spent in light physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent in moderate physical activity at baseline vs. follow up assessed via acceleration mins/day)
Measure: To investigate overall changes in time spent in moderate physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent in vigorous physical activity at baseline vs. follow up assessed via acceleration mins/day)
Measure: To investigate overall changes in time spent in vigorous physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
Measure: To investigate overall changes in time spent in prolonged sitting Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent sleeping at baseline vs. follow-up assessed via acceleration)
Measure: To investigate overall changes in time spent in sleep Time: 8 weeksDescription: Measured using the Vascular Quality of Life (VascuQoL) questionnaire
Measure: To investigate whether personalised activity breaks in sitting time improve quality of life Time: 8 weeksDescription: Measured using the Euro Quality of Life (EQ-5D-5L) questionnaire
Measure: To investigate whether personalised activity breaks in sitting time improve quality of life Time: 8 weeksDescription: Measured using the modified medical research council (mMRC) dyspnoea scale
Measure: To investigate whether personalised activity breaks in sitting time improve breathlessness Time: 8 weeksDescription: Measured using Chalder's Fatigue Scale
Measure: To investigate whether personalised activity breaks in sitting time improve fatigue Time: 8 weeksDescription: Measured using the hospital anxiety and depression scale
Measure: To investigate whether personalised activity breaks in sitting time improve anxiety and depression Time: 8 weeksIntermittent claudication is the most common manifestation of peripheral arterial disease, a common cardiovascular disease that causes blocked blood vessels (arteries) in the leg. Symptoms consist of persistent pain in one or both legs during exercise that is relieved with rest. Evidence suggests that high levels of uninterrupted sitting and sedentary behaviour are associated with cardiovascular disease risk, mortality and all-cause mortality. One of the main goals for treating people with intermittent claudication, is increased participation in physical activity. Supervised Exercise Programmes are recommended however these are not well tolerated and compliance is low. Alternative exercise, including short bouts of physical activity to break up sedentary time, has been suggested to help improve physical function. This study will investigate whether alternative exercise, in the form of breaking up prolonged sitting time, will improve physical function in patients with intermittent claudication. A suite of multi-modal activities will be developed offering a variety of exercise activities which will inform a personalised activity plan for each participant. Patients will be screened during their routine clinic appointment at Glenfield Hospital. All other study activity will take place in a laboratory within the Leicester Diabetes Centre at the Leicester General Hospital (LGH). Patients will be expected to attend LGH for up to a maximum of 4 visits where study data will be collected from performing physical measurements and assessments, and the completion of various questionnaires. Additional data will be collected from activity monitors which will be worn for up to 8 days at baseline and follow-up, measuring step count and time, inactivity, activity time and intensity, and sleep duration. Participants will also be expected to wear activity monitors for the duration of the 8-week intervention to measure steps. Participants will be in the study for approximately 18 weeks in total.
Description: Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
Measure: To investigate overall changes in sitting time Time: 8 weeksDescription: Total score for 16 questions measuring walking distance, speed and stair climbing from 0 (worst/inability) to 4 (best/without limitations)
Measure: The walking impairment questionnaire Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent performing physical activity at baseline vs. follow up assessed via mean acceleration mg/day )
Measure: To investigate overall changes in time spent performing physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent in light physical activity at baseline vs. follow up assessed via acceleration mins/day)
Measure: To investigate overall changes in time spent in light physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent in moderate physical activity at baseline vs. follow up assessed via acceleration mins/day)
Measure: To investigate overall changes in time spent in moderate physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent in vigorous physical activity at baseline vs. follow up assessed via acceleration mins/day)
Measure: To investigate overall changes in time spent in vigorous physical activity Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
Measure: To investigate overall changes in time spent in prolonged sitting Time: 8 weeksDescription: Measured using accelerometers (comparison of time spent sleeping at baseline vs. follow-up assessed via acceleration)
Measure: To investigate overall changes in time spent in sleep Time: 8 weeksDescription: Measured using the Vascular Quality of Life (VascuQoL) questionnaire
Measure: To investigate whether personalised activity breaks in sitting time improve quality of life Time: 8 weeksDescription: Measured using the Euro Quality of Life (EQ-5D-5L) questionnaire
Measure: To investigate whether personalised activity breaks in sitting time improve quality of life Time: 8 weeksDescription: Measured using the modified medical research council (mMRC) dyspnoea scale
Measure: To investigate whether personalised activity breaks in sitting time improve breathlessness Time: 8 weeksDescription: Measured using Chalder's Fatigue Scale
Measure: To investigate whether personalised activity breaks in sitting time improve fatigue Time: 8 weeksDescription: Measured using the hospital anxiety and depression scale
Measure: To investigate whether personalised activity breaks in sitting time improve anxiety and depression Time: 8 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports