anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy for 10 weeks

Raltegravir: Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy
Eligibility criteria:
Inclusion Criteria:

Male or female
Documented HIV-infection
Age ≥ 18 years
Willing to comply with the protocol requirements
On stable antiretroviral therapy (ART) for ≥ 6 months at screening
Undetectable plasma HIV viral load (<50 copies/mL) for at least 6 months
CD4 cell count > 300 cells/mm3 at last measurement
Current ART regimen at screening consisting of a backbone of two NRTI's (either TDF/FTC or ABC/3TC) with either a NNRTI (EFV or RPV) or a boosted PI (DRV/r, ATZ/r or LPV/r) and on this regimen for > 3 months
If female and of childbearing potential using effective birth control methods

Exclusion Criteria:

Use of platelet function inhibitors, such as aspirin and adenosine diphosphate (ADP) receptor antagonists
Known hypersensitivity to raltegravir or any other component of the formulation
Using any concomitant therapy disallowed as per summary of product characteristics (SPC) for the study drug
Signs of symptoms of an active (opportunistic) infection other than HIV
Active hepatitis B or C
Estimated glomerular filtration rate (by MDRD) <50 ml/min
Clinical or laboratory evidence of significantly decreased hepatic function, defined as alanine aminotransferase (ALAT) level > 2 upper limit of normal (ULN)
History of suspected or proven virologic failure since ART initiation (HIV-1 RNA "blips" less than 500 copies per milliliter with subsequent suppression are allowed)
Known genotypic resistance to any current ART component
Prior use of single or dual NRTI-only regimens, or history of any ART not considered highly active by current standards.
In females, pregnancy or breast feeding
Intervention: Sotagliflozin
Trial phase: Phase 2
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant had given written informed consent.
Young adult participants >=18 to <=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
At Screening, must had A1C >= 9.0%.
Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.

Exclusion Criteria:

Any prior use of LX4211/sotagliflozin.
Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
Chronic systemic corticosteroid use.
Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
History of severe hypoglycemic event within 1 month prior to the Screening Visit.
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 262
Group description: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
Eligibility criteria:
Inclusion Criteria:

Participants had given written informed consent to participate in the study in accordance with local regulations.
Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol.
At the Screening Visit, A1C must be between 7.0% to 11.0%.
Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test .

Exclusion Criteria:

Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to randomization.
Chronic systemic corticosteroid use.
Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.
Intervention: CID 12303048
Trial phase: Not Applicable
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery

2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily
Eligibility criteria:
Inclusion Criteria:

1. Patients > 18 years old scheduled for a colorectal surgical procedure ASA>2 OR pre-operatively hospitalized

Exclusion Criteria:

Unable to consent
Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
Current infection or history of abdominal infections.
Patients on chronic steroids or immunosuppressive medications.
Intervention: Sertraline
Trial phase: Phase 2
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid sertraline once per day for a period of six months.

Sertraline: Active medication
Eligibility criteria:
Inclusion Criteria:

Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
Subject between the ages of 24-72 months of age.
A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
Stable medications during the two months prior to enrollment.
Currently receiving interventions in the community or school for Autism Spectrum Disorder

Exclusion Criteria:

Current or past Selective Serotonin Reuptake Inhibitor treatment.
Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
Intervention: Melatonin
Trial phase: Phase 3
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.

Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.

Melatonin: Gelatin capsules
Eligibility criteria:
Inclusion Criteria part one:

Patients who are candidates for breast surgery.
BMI between 18 and 30
Visible veins in the elbow region
Fertile women use anti-contraception and have performed a negative pregnancy test

Exclusion Criteria part one:

Patients, who use daily opioids, benzodiazepines or melatonin
Patients diagnosed with a psychiatric disorder (defined as in medical treatment)
Patients with severe physical disease (ASA 3-4)
Patients with previous or ongoing alcohol or drug abuse
Patients with liver disease (defined as in medical treatment)
Patients diagnosed sleep disturbances
Patients who are unable to cooperate according to the protocol
Patients with allergy to melatonin

Inclusion Criteria part two:

- Male patients who are candidates for inguinal or umbilical hernia reapir

Exclusion Criteria part two:

Patients, who use daily opioids, benzodiazepines or melatonin
Patients diagnosed with a psychiatric disorder (defined as in medical treatment)
Patients with severe physical disease (ASA 3-4)
Patients with previous or ongoing alcohol or drug abuse
Patients with liver disease (defined as in medical treatment)
Patients diagnosed sleep disturbances
Patients who are unable to cooperate according to the protocol
Patients with allergy to melatonin

Withdrawal- and drop-out criteria part 2:

Patients can withdraw at any time during trial

Complications during surgery occur that lead to:

Immediate reoperation
Hospitalization to intensive care unit
If it is considered in the best interest of the patients physical- and psychological health to withdraw from the trial
Intervention: Plecanatide
Trial phase: Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 351
Group description: Plecanatide 3.0 mg tablets dosed once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

•Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

Refusal or inability to sign informed consent for the trial
Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
BMI > 35 or < 18
Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
Women who are pregnant or lactating
Diagnosis of IBS-D or IBS-M
Organic or obstructive disease of the small or large intestine
Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
Unstable medical illness
Bilirubin > 3X ULN in the absence of a conjugation defect
Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Intervention: Plecanatide
Trial phase: Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 347
Group description: Plecanatide 6.0 mg tablets dosed once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

•Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

Refusal or inability to sign informed consent for the trial
Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
BMI > 35 or < 18
Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
Women who are pregnant or lactating
Diagnosis of IBS-D or IBS-M
Organic or obstructive disease of the small or large intestine
Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
Unstable medical illness
Bilirubin > 3X ULN in the absence of a conjugation defect
Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Intervention: Amlodipine
Trial phase: Phase 1
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: amlodipine

HGP0904
Eligibility criteria:
Inclusion Criteria:

19~45 years old
Healthy men

Exclusion Criteria:

Gastroentestinal disease affecting drug absorption
Intervention: Losartan
Trial phase: Phase 1
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: losartan

HGP0608
Eligibility criteria:
Inclusion Criteria:

19~45 years old
Healthy men

Exclusion Criteria:

Gastroentestinal disease affecting drug absorption
Intervention: Chlorthalidone
Trial phase: Phase 1
ATC code: C03BA04 | C03BB04 | C03EA06 | G01AE10
SMILES: NS(=O)(=O)c1cc(C2(O)NC(=O)c3ccccc32)ccc1Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: chlorthalidone

HGP1405
Eligibility criteria:
Inclusion Criteria:

19~45 years old
Healthy men

Exclusion Criteria:

Gastroentestinal disease affecting drug absorption
Intervention: Tiagabine
Trial phase: Phase 2
ATC code: N03AG06
SMILES: Cc1ccsc1C(=CCCN1CCC[C@@H](C(=O)O)C1)c1sccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Tiagabine 12 mg administered at sleep time on the first or second study night
Eligibility criteria:
Inclusion Criteria:

Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)

Exclusion Criteria:

History of seizures
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Eligibility criteria:
Inclusion Criteria:

Children aged 3-17,
weighing less than 50kg
present to the pediatric ED with moderate-severe acute pain (defined as pain greater than or equal to 6/10).
Treating physician determines the patient to require opioid analgesia.

Exclusion Criteria:

Children with facial trauma or any abnormal nasal anatomy;
developmentally delayed children;
children with head trauma/increased intracranial pressure (ICP);
children with known allergy to fentanyl or ketamine;
children who are unable to provide pain scale assessment;
children with chronic pain of greater than 4 weeks;
Pregnant females;
and children with a Glasgow Coma Scale (GCS)<15.
Intervention: Letrozole
Trial phase: Not Applicable
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.

After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).

Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days
Eligibility criteria:
Inclusion Criteria:

Subjects will be determined to have PCOS based on clinical criteria such as history of irregular menses and clinical or laboratory evidence of hyperandrogenism.
Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start.

Exclusion Criteria:

Women with hemoglobin less than 11gm/dl at screening evaluation.
Women with untreated thyroid abnormalities
Pregnant women
Women with BMI>37
Women with known sensitivity to the agent being used.
Intervention: Tramadol hydrochloride and acetaminophen
Trial phase: Phase 4
SMILES: CC(=O)Nc1ccc(O)cc1.COc1cccc(C2(O)CCCCC2CN(C)C)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Postoperative Analgesia with Zaldiar

Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
Eligibility criteria:
Inclusion Criteria:

All patients incoming for inguinal hernia repair

Exclusion Criteria:

Preoperative abuse of analgesics
Intervention: Dalfampridine
Trial phase: Phase 2
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants received dalfampridine 10 mg tablet twice a day for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of MS of any course and duration
Evidence of mild to moderate internuclear ophthalmoparesis (INO), that is slowing of the adducting eye on physical examination of saccadic speed, whether INO is unilateral or bilateral, symmetrical or asymmetrical
Medically stable conditions, ability to give informed consent and understand and cooperate with the testing
Dalfampridine-naive as well as history of taking dalfampridine in the past, whether there was benefit in gait impairment or not, after a washout period of at least 2 weeks

Exclusion Criteria:

Lack of evidence of INO (slowing of the adducting eye) on physical examination of saccadic speed
Severe INO (i.e., exotropia in primary gaze) on physical examination
Medically unstable conditions, inability to give informed consent and understand and cooperate with the testing
History of side effects from dalfampridine
History of seizures
Moderate or severe renal failure, assessed by clearance of creatinine
Intervention: Warfarin
Trial phase: Not Applicable
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: All patients in the study will be in the intervention arm.

Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
requirement for indefinite warfarin therapy
target INR of 2-3
stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)
a patient of the Madison VA anticoagulation clinic for the previous 12 months

Exclusion Criteria:

consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months
diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months
life expectancy of < 1 year
enrolled in other investigational drug protocols
only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)
receiving visiting nurse services for INR monitoring
thrombocytopenia (<100K) within past 12 months
history of bleeding or thromboembolism requiring medical intervention within past 6 months
treatment for active liver disease (e.g. hepatitis)
diagnosis or documentation in EMR suggesting cognitive impairment
activated power of attorney
inability to provide informed consent
non-English speaking
unstable mental health disorder that impairs judgment
history of non-adherence to anticoagulation clinic policies and procedures (i.e. missed appointments, self-adjustment of warfarin dose, nonadherence, etc.).
Intervention: Prednisone
Trial phase: Phase 4
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.

Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18
Established diagnosis of Crohn's disease
Diagnosis of Crohn's flare
Decision by treating gastroenterologist to start corticosteroid therapy

Exclusion Criteria:

Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active cancer on chemotherapy or radiation treatment), severe liver disease (decompensated cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart failure
Patients on systemic corticosteroid therapy currently or within the past 8 weeks
Patients not on stable doses of immunomodulators or biologics for at least 8 weeks
Infectious colitis (e.g., C. difficile, CMV, HSV)
Systemic infections (bacteremia, fungal infections)
Fulminant Crohn's disease
Patients who require imminent surgery
Abscess
Pregnancy
Weight <35 kg
Intervention: Prednisone
Trial phase: Phase 4
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Corticosteroid dose fixed at equivalent to 40mg prednisone daily.

Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18
Established diagnosis of Crohn's disease
Diagnosis of Crohn's flare
Decision by treating gastroenterologist to start corticosteroid therapy

Exclusion Criteria:

Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active cancer on chemotherapy or radiation treatment), severe liver disease (decompensated cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart failure
Patients on systemic corticosteroid therapy currently or within the past 8 weeks
Patients not on stable doses of immunomodulators or biologics for at least 8 weeks
Infectious colitis (e.g., C. difficile, CMV, HSV)
Systemic infections (bacteremia, fungal infections)
Fulminant Crohn's disease
Patients who require imminent surgery
Abscess
Pregnancy
Weight <35 kg