Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4441 | convalescent plasma Wiki | 0.37 |
| drug4711 | risankizumab SC Wiki | 0.35 |
| drug4710 | risankizumab IV Wiki | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4154 | Upadacitinib Wiki | 0.30 |
| drug4423 | chlorine dioxide 3000 ppm Wiki | 0.30 |
| drug1120 | Cytochrome P450 (CYP) Substrates Wiki | 0.30 |
| drug4424 | chloroquine Wiki | 0.30 |
| drug4655 | placebo for risankizumab IV Wiki | 0.30 |
| drug1261 | Double-Blind NT-I7 Wiki | 0.30 |
| drug2709 | Ontamalimab Wiki | 0.30 |
| drug2964 | Placebo for Upadacitinib Wiki | 0.30 |
| drug844 | Cannabis, Medical Wiki | 0.30 |
| drug2963 | Placebo for Risankizumab SC Wiki | 0.30 |
| drug3374 | Risankizumab IV Wiki | 0.30 |
| drug4433 | comparison of sample collection methods Wiki | 0.30 |
| drug3859 | TAK-018 Wiki | 0.30 |
| drug1157 | Darvadstrocel Wiki | 0.30 |
| drug4415 | care as usual Wiki | 0.30 |
| drug3375 | Risankizumab SC Wiki | 0.30 |
| drug2962 | Placebo for Risankizumab IV Wiki | 0.30 |
| drug3860 | TAK-018 Placebo Wiki | 0.30 |
| drug1262 | Double-Blind Placebo Wiki | 0.30 |
| drug4432 | community health worker support Wiki | 0.30 |
| drug4417 | carotid-femoral pulse-wave velocity Wiki | 0.30 |
| drug1248 | Disulfiram Wiki | 0.21 |
| drug3373 | Risankizumab Wiki | 0.21 |
| drug4654 | placebo for risankizumab Wiki | 0.17 |
| drug492 | BNT162b1 Wiki | 0.17 |
| drug4744 | standard care Wiki | 0.15 |
| drug2916 | Placebo Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000070627 | Chronic Traumatic Encephalopathy NIH | 0.30 |
| D005879 | Tourette Syndrome NIH | 0.30 |
| D005402 | Fistula NIH | 0.21 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012008 | Recurrence NIH | 0.21 |
| D001714 | Bipolar Disorder NIH | 0.21 |
| D015212 | Inflammatory Bowel Diseases NIH | 0.20 |
| D003092 | Colitis NIH | 0.18 |
| D003093 | Colitis, Ulcerative NIH | 0.18 |
| D000690 | Amyotrophic Lateral Sclerosis NIH | 0.17 |
| D012640 | Seizures NIH | 0.17 |
| D016472 | Motor Neuron Disease NIH | 0.17 |
| D000755 | Anemia, Sickle Cell NIH | 0.15 |
| D007410 | Intestinal Diseases NIH | 0.15 |
| D005356 | Fibromyalgia NIH | 0.13 |
| D001927 | Brain Diseases NIH | 0.13 |
| D000070642 | Brain Injuries, Traumatic NIH | 0.10 |
| D010300 | Parkinsonian NIH | 0.10 |
| D014456 | Ulcer NIH | 0.09 |
| D001930 | Brain Injuries, NIH | 0.08 |
| D059350 | Chronic Pain NIH | 0.08 |
| D009103 | Multiple Sclerosis NIH | 0.07 |
| D012598 | Scoliosi NIH | 0.07 |
| D040921 | Stress Disorders, Traumatic NIH | 0.05 |
| D014947 | Wounds and Injuries NIH | 0.05 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.05 |
| D004194 | Disease NIH | 0.05 |
| D013577 | Syndrome NIH | 0.03 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.01 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| D018352 | Coronavirus Infections NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100280 | Crohn's disease HPO | 1.00 |
| HP:0100754 | Mania HPO | 0.21 |
| HP:0002037 | Inflammation of the large intestine HPO | 0.20 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002583 | Colitis HPO | 0.18 |
| HP:0100279 | Ulcerative colitis HPO | 0.18 |
| HP:0006802 | Abnormal anterior horn cell morphology HPO | 0.17 |
| HP:0007354 | Amyotrophic lateral sclerosis HPO | 0.17 |
| HP:0001250 | Seizure HPO | 0.15 |
| HP:0002242 | Abnormal intestine morphology HPO | 0.15 |
| HP:0001298 | Encephalopathy HPO | 0.13 |
| HP:0012532 | Chronic pain HPO | 0.08 |
Navigate: Correlations HPO
There are 11 clinical trials
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time: Week 12Description: Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Measure: Percentage of Participants With Endoscopic Response Time: Week 12Description: Clinical remission per average daily SF and average daily AP score.
Measure: Percentage of Participants With Clinical Remission Time: Up to Week 12Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response Time: Up to Week 12Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities.
Measure: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Time: Week 12Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time: Week 4Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. Endoscopic response defined as decrease from Baseline in SES-CD.
Measure: Percentage of Participants With CDAI Clinical Response and Endoscopic Response Time: Week 12Description: SF remission is defined using the average daily SF, and not worse than baseline.
Measure: Percentage of Participants With Stool Frequency (SF) Remission Time: Week 12Description: AP remission is defined using the average daily AP score, and not worse than baseline.
Measure: Percentage of Participants With Abdominal Pain (AP) Remission Time: Week 12Description: Endoscopic remission is defined as decrease in SES-CD as compared to baseline
Measure: Percentage of Participants With Endoscopic Remission Time: Week 12Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
Measure: Percentage of Participants With Enhanced Clinical Response Time: Up to Week 12Description: Endoscopic healing was assessed using SES-CD.
Measure: Percentage of Participants With Ulcer-Free Endoscopy Time: Week 12Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Measure: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Time: Week 12Description: Participants with an event that results in admission to the hospital.
Measure: Percentage of Participants With CD-Related Hospitalization Time: Up to Week 12Description: Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Measure: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline Time: Week 12The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.
Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time: Week 52Description: Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Endoscopic Response Time: Week 52Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Measure: Sub-Study 3: Number of Participants With Adverse Events Time: Up to Week 220Description: Clinical remission per average daily stool frequency (SF) and average daily AP score.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Clinical Remission Time: Week 52Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0 Time: Week 52Description: Endoscopic healing was assessed using SES-CD.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Ulcer-Free Endoscopy Time: Week 52Description: Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Endoscopic Remission Time: Week 52Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Measure: Sub-Study 1 and Sub-Study 2: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time: Week 52Description: Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline Time: Week 52Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response Time: Week 52Description: SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Stool Frequency (SF) Remission Time: Week 52Description: AP Remission is defined by an average daily AP <= 1 and not worse than baseline.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Abdominal Pain (AP) Remission Time: Week 52Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response Time: Week 52Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Enhanced Clinical Response Time: Week 52Description: Deep remission defined as subjects with both clinical remission (per average daily SF and average daily AP score) and endoscopic healing (assessed using SES-CD).
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Deep Remission Time: Week 52Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) in Participants With Any EIMs at Baseline of Induction Time: Week 52Description: Participants with an event that results in admission to the hospital.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With CD-Related Hospitalizations Time: Up to Week 52Description: Participants without draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline of Induction Time: Week 52Description: Participants who underwent surgery related to CD.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease (CD)-Related Surgeries Time: Up to Week 52The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time: Week 12Description: Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Measure: Percentage of Participants With Endoscopic Response Time: Week 12Description: Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Measure: Percentage of Participants With Clinical Remission Time: Week 12Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response Time: Up to Week 12Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities.
Measure: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Time: Week 12Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time: Week 4Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. Endoscopic response defined as decrease from Baseline in SES-CD.
Measure: Percentage of Participants With CDAI Clinical Response and Endoscopic Response Time: Week 12Description: SF remission is defined using the average daily SF, and not worse than baseline.
Measure: Percentage of Participants With Stool Frequency (SF) Remission Time: Week 12Description: AP remission is defined using the average daily AP, and not worse than baseline.
Measure: Percentage of Participants With Abdominal Pain (AP) Remission Time: Week 12Description: Endoscopic remission is defined as decrease in SES-CD as compared to baseline
Measure: Percentage of Participants With Endoscopic Remission Time: Week 12Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
Measure: Percentage of Participants With Enhanced Clinical Response Time: Up to Week 12Description: Endoscopic healing was assessed using SES-CD.
Measure: Percentage of Participants With Ulcer-Free Endoscopy Time: Week 12Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Measure: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Time: Week 12Description: Participants with an event that results in admission to the hospital.
Measure: Percentage of Participants With CD-Related Hospitalization Time: Up to Week 12Description: Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Measure: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline Time: Week 12A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Time: Week 52Description: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Response Time: Week 52Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.
Measure: Sub-Study 2: Number of Participants with Adverse Events Time: Through Week 240Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) Time: Week 52Description: Decrease of at least 100 points in CDAI from Baseline.
Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100) Time: Week 52Description: This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Measure: Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline. Time: Week 52Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. Endoscopic remission is defined per SES-CD.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission Time: Week 52Description: CDAI remission is defined as CDAI < 150.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Time: Through Week 52Description: Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission Time: Week 52Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time: Baseline (Week 0) to Week 52Description: The FACIT-F questionnaire was developed to assess fatigue.
Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Time: Baseline (Week 0) to Week 52Description: This is assessed by reviewing participant's hospitalization data.
Measure: Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) Time: Week 52Description: EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Measure: Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline Time: Week 52Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: - Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls - Interaction between these proteins and biologics in breast milk of women with IBD - Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNFα and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.
Description: Multiplex assay will be used to measure TNFα and downstream chemokines including CCL2, CCL4, CCL7, CXCL10 in breast milk of two groups of participants (women with IBD and healthy controls). (The unit of measurement is the same for all these cytokines)
Measure: Levels of TNFα and its downstream chemokines (CCL2, CCL4, CCL7, and CXCL10) in breast milk of women with IBD and healthy controls by Multiplex assay Time: 4 yearsDescription: ELISA assay will be used to measure total and free drug levels (bound and unbound to TNFα) in breast milk of lactating women with IBD. (The unit of measurement is the same for infliximab and adalimumab).
Measure: Milk concentration of TNFα inhibitors (infliximab, adalimumab) at different time-points between two doses of medication, in lactating women with IBD by ELISA assay Time: 4 yearsDescription: The infants of women with IBD and healthy controls will be examined for cognitive development using Bayley-III
Measure: Scores on cognitive subset of Bayley Scales of Infant and Toddler development- Third Version (Bayley-III) in infants of healthy controls and women with IBD Time: 4 yearsDescription: Infants of healthy controls and women with IBD will be examined for communication and problem-solving development using the ASQ®-3. This supplementary measure is intended to provide additional data as an alternative to Bayley test under unprecedented circumstances which preclude participants to complete Bayley test at the Hospital for Sick Children
Measure: Scores on the "Problem-solving" and "Communication" subscales of The Ages and Stages Questionnaire (ASQ®-3) in infants of healthy controls and women with IBD Time: 4 yearsDescription: An estimation of the population distribution of anti-TNFα antibodies (infliximab and adalimumab) in breast milk of women with IBD will be made, using population pharmacokinetic modelling
Measure: Simulated/predicted profiles of TNFα inhibitors (infliximab, adalimumab) in breast milk in a large population of lactating women with IBD by population pharmacokinetic modelling Time: 4 yearsThe purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission at Week 16 Time: Week 16Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.
Measure: Number of Participants With Endoscopic Response at Week 16 Time: Week 16Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.
Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16 Time: Week 16Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.
Measure: Number of Participants With Enhanced Endoscopic Response at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16 Time: Week 16Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.
Measure: Number of Participants With Clinical Response at Week 16 Time: Week 16Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).
Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16 Time: Week 16Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.
Measure: Number of Participants With Complete Endoscopic Healing at Week 16 Time: Week 16Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16 Time: Week 16Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission Over Time Time: Baseline up to Week 16Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).
Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16 Time: Baseline, Week 16Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.
Measure: Number of Participants With Endoscopic Healing at Week 16 Time: Week 16Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score Time: Baseline, Week 8, Week 12, up to Week 16, or early terminationDescription: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form (SF)-36 at Week 16 Time: Baseline, Week 16Description: Incidence of all cause hospitalizations will be assessed.
Measure: Incidence of Hospitalizations Time: Baseline up to Week 32Description: Incidence of total inpatient days will be assessed.
Measure: Incidence of Total Inpatient Days Time: Baseline up to Week 32Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.
Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries Time: Baseline up to Week 32The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission at Week 16 Time: Week 16Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.
Measure: Number of Participants With Endoscopic Response at Week 16 Time: Week 16Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.
Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16 Time: Week 16Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.
Measure: Number of Participants With Enhanced Endoscopic Response at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16 Time: Week 16Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.
Measure: Number of Participants With Clinical Response at Week 16 Time: Week 16Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).
Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16 Time: Week 16Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.
Measure: Number of Participants With Complete Endoscopic Healing at Week 16 Time: Week 16Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16 Time: Week 16Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission Over Time Time: Baseline up to Week 16Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).
Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16 Time: Baseline, Week 16Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.
Measure: Number of Participants With Endoscopic Healing at Week 16 Time: Week 16Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score Time: Baseline, Week 8, Week 12, up to Week 16, or early terminationDescription: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form (SF)-36 at Week 16 Time: Baseline, Week 16Description: Incidence of all cause hospitalizations will be assessed.
Measure: Incidence of Hospitalizations Time: Baseline up to Week 32Description: Incidence of total inpatient days will be assessed.
Measure: Incidence of Total Inpatient Days Time: Baseline up to Week 32Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.
Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries Time: Baseline up to Week 32The purpose of this study is to evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.
Description: Endoscopic recurrence is defined as a Rutgeerts' score greater than or equal to (>=) i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The scale ranges from i0 to i4; where i0 equal to (=) no lesions, i1= less than or equal to (<=) 5 aphthous ulcers, i2= greater than (>) 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing.
Measure: Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26 Time: Week 26Description: Stool samples will be collected for analysis of fecal calprotectin, a biomarker of intestinal inflammatory activity.
Measure: Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30 Time: Weeks 3, 6, 12, 18, 26 and 30This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).
Measure: Prevention of COVID-19 Time: Five yearsDescription: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).
Measure: Treatment of COVID-19 Time: Five yearsDescription: 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: 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 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 yearsThe purpose of this study is to evaluate the long-term safety and efficacy of repeat administration of darvadstrocel in participants with Crohn's Disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and special situation reports (SSRs).
Description: An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Measure: Percentage of Participants with at Least 1 Treatment-Emergent Adverse Event (TEAE) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measure: Percentage of Participants with at Least 1 Treatment Emergent Serious Adverse Event (TESAE) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: An SSR includes pregnancy, any case in which a pregnant participant is exposed to a study product or in which a female participant or female partner of a male participant becomes pregnant following treatment with a study product. Exposure is considered either through maternal exposure or via semen following paternal exposure or infant exposure from breast milk.
Measure: Percentage of Participants with Special Situation Reports (SSRs) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: AESI includes immunogenicity/alloimmune reactions, hypersensitivity, transmission of infectious agents, tumorgenicity, ectopic tissue formation, medication errors.
Measure: Percentage of Participants with Adverse Event of Special Interest (AESI) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: Combined remission is defined as the closure of all treated external openings that were draining at baseline (i.e., baseline visit), despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.
Measure: Percentage of Participants who Achieve Combined Remission of Perianal Fistula(s) Time: At Week 24 and at Week 156 post-repeat administrationDescription: Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Measure: Percentage of Participants who Achieve Clinical Remission Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administrationDescription: Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Measure: Percentage of Participants who Achieve Clinical Response Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administrationDescription: Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed that were in the combined remission at Week 24 or the development of a collection >2 cm (in at least 2 dimensions) confirmed by centrally read MRI assessment.
Measure: Percentage of Participants with Relapse From Week 24 Combined Remission Time: From Week 24 to Week 156 post-repeat administrationDescription: Time to Relapse is defined as the time in days to reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed, relative to Week 24.
Measure: Time to Relapse Time: From Week 24 to the Day of relapse post-repeat administrationDescription: The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) discharge; (b) pain; (c) restriction of sexual activity; (d) type of perianal disease; and (e) degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease.
Measure: Change From Baseline in Score of Discharge and Pain Items of Perianal Disease Activity Index (PDAI) Score Time: Baseline to Weeks 6, 24, 52, 104, and 156 post-repeat administrationUlcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD. Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide. In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Description: Maximum observed plasma concentration (Cmax) of Midazolam
Measure: Maximum Observed Plasma Concentration (Cmax) of Midazolam Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Midazolam
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Midazolam Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Midazolam
Measure: Terminal Phase Elimination Rate Constant (β) of Midazolam Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Midazolam
Measure: Terminal Phase Elimination Half-Life (t1/2) of Midazolam Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Caffeine
Measure: Maximum Observed Plasma Concentration (Cmax) of Caffeine Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Caffeine
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Caffeine Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Caffeine
Measure: Terminal Phase Elimination Rate Constant (β) of Caffeine Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Caffeine
Measure: Terminal Phase Elimination Half-Life (t1/2) of Caffeine Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Warfarin
Measure: Maximum Observed Plasma Concentration (Cmax) of Warfarin Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Warfarin
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Warfarin Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Warfarin
Measure: Terminal Phase Elimination Rate Constant (β) of Warfarin Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Warfarin
Measure: Terminal Phase Elimination Half-Life (t1/2) of Warfarin Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Omeprazole
Measure: Maximum Observed Plasma Concentration (Cmax) of Omeprazole Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Omeprazole
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Omeprazole Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Omeprazole
Measure: Terminal Phase Elimination Rate Constant (β) of Omeprazole Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Omeprazole
Measure: Terminal Phase Elimination Half-Life (t1/2) of Omeprazole Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Metoprolol
Measure: Maximum Observed Plasma Concentration (Cmax) of Metoprolol Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Metoprolol
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Metoprolol Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Metoprolol
Measure: Terminal Phase Elimination Rate Constant (β) of Metoprolol Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Metoprolol
Measure: Terminal Phase Elimination Half-Life (t1/2) of Metoprolol Time: Up to 71 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