Covid 19 Research using Clinical Trials (Home Page)
Report for D015212: Inflammatory Bowel Diseases NIH
(Synonyms: Inflammatory Bowe, Inflammatory Bowel, Inflammatory Bowel Di, Inflammatory Bowel Disease, Inflammatory Bowel Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug380 | Baricitinib or Anakinra Wiki | 0.38 |
| drug611 | Cannabis, Medical Wiki | 0.38 |
| drug2649 | Snorkel-based improvised personal protective equipment Wiki | 0.38 |
| drug1006 | Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki | 0.27 |
| drug1461 | Interview Wiki | 0.22 |
| drug1004 | Enoxaparin Wiki | 0.11 |
Correlated MeSH Terms (26)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007410 | Intestinal Diseases NIH | 0.53 |
| D000070627 | Chronic Traumatic Encephalopathy NIH | 0.38 |
| D000690 | Amyotrophic Lateral Sclerosis NIH | 0.38 |
| D016472 | Motor Neuron Disease NIH | 0.38 |
| D005879 | Tourette Syndrome NIH | 0.38 |
| D012640 | Seizures NIH | 0.27 |
| D000755 | Anemia, Sickle Cell NIH | 0.27 |
| D001714 | Bipolar Disorder NIH | 0.27 |
| D005356 | Fibromyalgia NIH | 0.22 |
| D001927 | Brain Diseases NIH | 0.19 |
| D010300 | Parkinsonian NIH | 0.19 |
| D003424 | Crohn Disease NIH | 0.17 |
| D003092 | Colitis NIH | 0.15 |
| D003093 | Colitis, Ulcerative NIH | 0.15 |
| D000070642 | Brain Injuries, Traumatic NIH | 0.14 |
| D059350 | Chronic Pain NIH | 0.13 |
| D001930 | Brain Injuries, NIH | 0.13 |
| D012598 | Scoliosi NIH | 0.11 |
| D009103 | Multiple Sclerosis NIH | 0.11 |
| D040921 | Stress Disorders, Traumatic NIH | 0.07 |
| D014947 | Wounds and Injuries NIH | 0.07 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.07 |
| D004194 | Disease NIH | 0.06 |
| D013577 | Syndrome NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.03 |
Correlated HPO Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002037 | Inflammation of the large intestine HPO | 1.00 |
| HP:0002242 | Abnormal intestine morphology HPO | 0.53 |
| HP:0006802 | Abnormal anterior horn cell morphology HPO | 0.38 |
| HP:0007354 | Amyotrophic lateral sclerosis HPO | 0.38 |
| HP:0100754 | Mania HPO | 0.27 |
| HP:0001250 | Seizure HPO | 0.22 |
| HP:0001298 | Encephalopathy HPO | 0.19 |
| HP:0100280 | Crohn's disease HPO | 0.17 |
| HP:0002583 | Colitis HPO | 0.15 |
| HP:0100279 | Ulcerative colitis HPO | 0.15 |
| HP:0012532 | Chronic pain HPO | 0.13 |
There are 7 clinical trials
Clinical Trials
1 Outcomes Mandate National Integration With Cannabis as Medicine
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
NCT03944447 Chronic Pain Chronic Pain Syndrome Chronic Pain Due to Injury Chronic Pain Due to Trauma Fibromyalgia Seizures Hepatitis C Cancer Crohn Disease HIV/AIDS Multiple Sclerosis Traumatic Brain Injury Sickle Cell Disease Post Traumatic Stress Disorder Tourette Syndrome Ulcerative Colitis Glaucoma Epilepsy Inflammatory Bowel Diseases Parkinson Disease Amyotrophic Lateral Sclerosis Chronic Traumatic Encephalopathy Anxiety Depression Insomnia Autism Opioid-use Disorder Bipolar Disorder Covid19 SARS-CoV Infection Drug: Cannabis, Medical MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic Wounds and Injuries
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure
Primary Outcomes
Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.
Measure: Treatment of Symptoms Time: Five years
Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.
Measure: Monitoring Adverse Events Time: Five years
Secondary Outcomes
Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.
Measure: Cannabis Impact on Quality of Life Time: Five years
Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.
Measure: Cannabis Route and Dosing Time: Five years
2 Prospective Multicenter Cohort of Patients With Inflammatory Bowel Disease Treated by Infliximab or Vedolizumab During COVID-19 Pandemic
Primary Outcomes
Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.
Measure: Treatment of Symptoms Time: Five yearsDescription: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.
Measure: Monitoring Adverse Events Time: Five yearsSecondary Outcomes
Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.
Measure: Cannabis Impact on Quality of Life Time: Five yearsDescription: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.
Measure: Cannabis Route and Dosing Time: Five yearsMulticenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells
NCT04344249 IBD COVID MeSH:Inflammatory Bowel Diseases
HPO:Inflammation of the large intestine
Primary Outcomes
Description: Impact of antibodies du to immunosuppressive protocol on the risk of viral infection
Measure: IgG and IgM anti SARS-CoV-2 Time: through study completion, an average of 2 year
Secondary Outcomes
Description: Describe clinical factors of the population of IBD patients treated with vedolizumab or infliximab who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management.
weight (Kg)
height (m)
ABO Group ....
Measure: Clinical factors and severity of COVID-19 infection Time: through study completion, an average of 2 year
Description: Describe demographic factors of the population of IBD patients treated with vedolizumab or infliximab who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management.
ACCOMMODATION
HOUSING AREA
number of people at home ....
Measure: demographic factors and severity of COVID-19 infection Time: through study completion, an average of 2 year
Description: Describe residual rates of treatments (edolizumab or infliximab) of the population of IBD patients who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management.
Measure: pharmacologic factors and severity of COVID-19 infection Time: through study completion, an average of 2 year
3 The Effect of Patient's Perceptions for COVID-19 on the Inflammatory Bowel Disease-related Healthcare Utilization in the Hyperepidemic Area
Primary Outcomes
Description: Impact of antibodies du to immunosuppressive protocol on the risk of viral infection
Measure: IgG and IgM anti SARS-CoV-2 Time: through study completion, an average of 2 yearSecondary Outcomes
Description: Describe clinical factors of the population of IBD patients treated with vedolizumab or infliximab who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management. weight (Kg) height (m) ABO Group ....
Measure: Clinical factors and severity of COVID-19 infection Time: through study completion, an average of 2 yearDescription: Describe demographic factors of the population of IBD patients treated with vedolizumab or infliximab who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management. ACCOMMODATION HOUSING AREA number of people at home ....
Measure: demographic factors and severity of COVID-19 infection Time: through study completion, an average of 2 yearDescription: Describe residual rates of treatments (edolizumab or infliximab) of the population of IBD patients who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management.
Measure: pharmacologic factors and severity of COVID-19 infection Time: through study completion, an average of 2 yearThe rapid spread of COVID-19 is expected to have a significant impact on medicine as well as all sectors worldwide. In particular, inflammatory bowel disease (IBD) is a chronic immune disease in which remission and activation are repeated and must be treated consistently throughout life. In addition, patients with IBD may be vulnerable to various infectious diseases due to the immuno-compromised state due to the use of immuno-suppressants or biological agents. During a pandemic, patients with IBD may postpone hospital visits due to concerns about infection with COVID-19, and if they cannot continue drug treatment, there is a concern about the flare up IBD disease activity. Therefore, in this study, we would like to investigate the current status of hospital utilization of IBD patients in Daegu, the epidemic area of COVID-19, and to investigate the effect of patient perception of COVID-19 on hospital ultilization.
NCT04387279 COVID-19 Perception, Self Facilities and Services Utilization Other: Interview MeSH:Inflammatory Bowel Diseases
HPO:Inflammation of the large intestine
Primary Outcomes
Description: Correlation between patient's perception of COVID-19 and medical use patterns during the pandemic period
Measure: Patient's perception of COVID-19 and medical use patterns Time: 1day
Secondary Outcomes
Description: Exacerbation of symptoms in patients with IBD during the pandemic period
Measure: Exacerbation of symptoms Time: 1day
4 PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic
Primary Outcomes
Description: Correlation between patient's perception of COVID-19 and medical use patterns during the pandemic period
Measure: Patient's perception of COVID-19 and medical use patterns Time: 1daySecondary Outcomes
Description: Exacerbation of symptoms in patients with IBD during the pandemic period
Measure: Exacerbation of symptoms Time: 1dayTo find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease
NCT04410484 Inflammatory Bowel Diseases Coronavirus Infection MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Intestinal Diseases Inflammatory Bowel Diseases
HPO:Abnormal intestine morphology Inflammation of the large intestine
Primary Outcomes
Measure: Flare of IBD needing change in therapy or surgery Time: 3 months
5 PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study
Primary Outcomes
Measure: Flare of IBD needing change in therapy or surgery Time: 3 monthsWhether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes
NCT04411784 Inflammatory Bowel Diseases COVID MeSH:Colitis Colitis, Ulcerative Inflammatory Bowel Diseases
HPO:Colitis Inflammation of the large intestine Ulcerative colitis
Primary Outcomes
Description: The need for in-hospital colectomy or rescue therapy
Measure: Primary outcome measure: The need for in-hospital colectomy or rescue therapy Time: 3 months
Secondary Outcomes
Description: Duration and type/route of steroid use
Measure: 2.1: Duration and type/route of steroid use Time: 3 months
Description: 30 day colectomy free survival rates
Measure: 2.2: 30 day colectomy free survival rates Time: 3 months
Description: Covid-19 infection rates
Measure: 2.3: Covid-19 infection rates Time: 3 months
Description: Rate of Rescue therapy use
Measure: 2.4: Rate of Rescue therapy use Time: 3 months
Description: Duration of hospital stay
Measure: 2.5: Duration of hospital stay Time: 3 months
Description: Admission severity scoring
Measure: 2.6: Admission severity scoring Time: 3 months
Description: Readmission rates
Measure: 2.7: Readmission rates Time: 3 months
6 Impact of Isolation in Patients With IBD During the 2020 COVID-19 Crisis: a Mixed Methods Study
Primary Outcomes
Description: The need for in-hospital colectomy or rescue therapy
Measure: Primary outcome measure: The need for in-hospital colectomy or rescue therapy Time: 3 monthsSecondary Outcomes
Description: Duration and type/route of steroid use
Measure: 2.1: Duration and type/route of steroid use Time: 3 monthsDescription: 30 day colectomy free survival rates
Measure: 2.2: 30 day colectomy free survival rates Time: 3 monthsDescription: Covid-19 infection rates
Measure: 2.3: Covid-19 infection rates Time: 3 monthsDescription: Rate of Rescue therapy use
Measure: 2.4: Rate of Rescue therapy use Time: 3 monthsDescription: Duration of hospital stay
Measure: 2.5: Duration of hospital stay Time: 3 monthsDescription: Admission severity scoring
Measure: 2.6: Admission severity scoring Time: 3 monthsDescription: Readmission rates
Measure: 2.7: Readmission rates Time: 3 monthsThe coronavirus pandemic has changed healthcare dramatically in a short time. Individuals with chronic illnesses and services for them have had to adapt and change to deal with requirements for shielding and social isolation to reduce infection risk and management of medication investigation and ongoing review. It is increasingly recognised that the pandemic and the changes to daily life will have had a series of impacts on patients and health care services, including impacts on patients psychological well-being and the opportunity to seek medical care for non-CoViD illness. Psychological symptoms such as depression, anxiety and hopelessness is well described in adults and young people with inflammatory bowel disease. Quarantine has also been associated with these psychological symptoms and also post-traumatic stress. It is important to identify the extent of and factors that influence negative psychological consequences of isolation in patients with inflammatory bowel disease. This study will aim to assess what impact the isolation of patients during social isolation had in terms of psychological well-being - and what are the factors affecting this impact, particularly in younger and old age groups.
NCT04488471 Inflammatory Bowel Diseases MeSH:Inflammatory Bowel Diseases
HPO:Inflammation of the large intestine
Primary Outcomes
Description: Psychological morbidity will be assessed through the 4 questionnaires
Measure: What impact has the isolation of patients during social isolation had in terms of psychological morbidity? Time: Changes in psychological morbidity at 12 months
Secondary Outcomes
Description: psychological morbidity will be assessed via comparison of questionnaires from affiliated study against the time points of this study
Measure: Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic? Time: Changes in psychological morbidity at 12 months
7 SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management
Primary Outcomes
Description: Psychological morbidity will be assessed through the 4 questionnaires
Measure: What impact has the isolation of patients during social isolation had in terms of psychological morbidity? Time: Changes in psychological morbidity at 12 monthsSecondary Outcomes
Description: psychological morbidity will be assessed via comparison of questionnaires from affiliated study against the time points of this study
Measure: Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic? Time: Changes in psychological morbidity at 12 monthsMost of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.