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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2856 | Penn Microbiome Therapy - 001 Wiki | 0.71 |
| drug1180 | Degarelix Wiki | 0.71 |
| drug2858 | Penn Microbiome Therapy - 003 Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D004761 | Enterocolitis, Pseudomembranous NIH | 0.71 |
| D003141 | Communicable Diseases NIH | 0.05 |
| D007239 | Infection NIH | 0.03 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 2 clinical trials
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
Description: The primary outcome is recurrent CDI (definite or probable) or death within 56 days of randomization. Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS Laboratory confirmation of C. difficile from a stool specimen. Probable recurrence is defined as the same clinical manifestations as above, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).
Measure: Recurrent CDI (definite or probable) or death Time: Within 56 days of randomizationDescription: The incidence of recurrent CDI (definite or possible) or death within 6 months of randomization.
Measure: Recurrent CDI (definite or possible), or death Time: Within 6 months of randomizationDescription: The investigators will use a brief assessment of both overall and gastrointestinal health status, using a previously validated instrument.
Measure: Quality of Life Time: 56 days from randomizationDescription: The number of CDI recurrences within 6 months for a patient is the count of separate CDI recurrences from randomization to 6 months after randomization.
Measure: Number of CDI recurrences Time: Within 6 months of randomizationDescription: This is similar to probable recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test and PCR, not episodes that are not tested or are uninterpretable.
Measure: Diarrhea that is negative for C. difficile by EIA toxin test and PCR Time: Within 56 days of randomizationDescription: An assessment for non-diarrheal manifestations of CDI such as abdominal pain, urgency, and fecal incontinence will be performed.
Measure: Multiple related symptoms Time: Within 6 months of randomizationDescription: The incidence of definite recurrent CDI within 56 days of randomization. Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS Laboratory confirmation of C. difficile from a stool specimen.
Measure: Definite recurrent CDI Time: Within 56 days of randomizationDescription: The incidence of probable recurrent CDI within 56 days of randomization. Possible recurrence is defined as the same clinical manifestations as definite recurrent CDI, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).
Measure: Possible recurrent CDI Time: Within 56 days of randomizationDescription: The incidence of death within 56 days of randomization.
Measure: Death Time: Within 56 days of randomizationDescription: This is similar to possible recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test, not episodes that are not tested or are uninterpretable.
Measure: Diarrhea that is negative for C. difficile by EIA toxin testing but positive by PCR Time: Within 56 days of randomizationDescription: Safety outcomes to be collected include: Serious adverse events, with a focus on SAEs involving hospitalization (new or prolonged), and all-cause mortality Adverse events which may be related to FMT treatment. This includes adverse events which Site Investigators consider related/possibly related to the study treatment and all adverse events which occur within 14 days of study treatment (since an aggregate analysis of events temporally linked to treatment could show a causal relationship when compared to placebo) Infectious transmissions which are plausibly linked to FMT treatment. Development of new conditions theoretically linked to alterations in gut microbiota.
Measure: Adverse and Serious Adverse Events Time: Within 6 months of randomizationThis is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
Description: The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 24 hours: If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved Ileus/megacolon either noted as resolved by any provider documentation or not noted WBC<15,000 cells/uL Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 24 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD)) Lactate ≤2.2 mmol/L (if measured by clinical care team) No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin) Temperature <38.5 °C and ≥35.6°C < 8 bowel movements per day and < 600 mL unformed stool (if volume recorded) Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria
Measure: Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products. Time: 7 DaysDescription: All-cause mortality at 30- and 60-days following last FMT Colectomy or diverting ileostomy within 30 days after last FMT Cumulative days of hospitalization from enrollment until 30 days after FMT Cumulative days in intensive care unit from enrollment until 30 days after last FMT Bacteremia from enrollment until 30 days after last FMT Repeat hospital admission within 60 days of discharge from index hospitalization
Measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0 Time: 180 DaysAlphabetical 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