anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Upadacitinib
Trial phase: Phase 2
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: ABT-494 6 mg twice daily (BID) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Exclusion Criteria:

Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
Pregnant or breastfeeding female
Ongoing or active infection.
Intervention: Upadacitinib
Trial phase: Phase 2
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: ABT-494 12 mg twice daily (BID) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Exclusion Criteria:

Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
Pregnant or breastfeeding female
Ongoing or active infection.
Intervention: Upadacitinib
Trial phase: Phase 2
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: ABT-494 18 mg twice daily (BID) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Exclusion Criteria:

Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
Pregnant or breastfeeding female
Ongoing or active infection.
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months

Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
Eligibility criteria:
Inclusion Criteria:

History of mild (140-160 / 90-100) to moderate (160-200 / 100-120) hypertension
LV diastolic dysfunction (>/= Grade1)
LV ejection fraction >50%
Indexed left atrial volume >/= 28 mL/m^2
In sinus rhythm at the time of enrollment
Willingness to return for the 6-month follow up investigations

Exclusion Criteria:

Presence or history of any of the following at baseline:

History of mitral valve disease of greater than mild severity or prosthetic mitral valve, congenital heart disease or permanent pacemaker
Calculated creatinine clearance <50 mL/min
Terminal Illness with expected Survival of <1 year
Previous Heart Transplant
Individuals who are institutionalized
Systolic BP>180 mm Hg or diastolic BP > 120 mm Hg

Medical treatment for elevated BP with:

Calcium channel blocker (e.g. verapamil, nifedipine);
Alpha blocker (e.g. prazosin);
Alpha agonist (e.g. α-methyldopa, hydralazine, clonidine)
Patient unwilling or unable to provide informed consent for study participation
Pregnancy (current, or anticipated within the study period)
Secondary Hypertension
Previous echo contrast allergy
Poor echocardiography window
Previous stroke, known carotid stenosis
Contraindication for beta-blocker therapy (sinus bradycardia <50 beats/min);
2nd or 3rd degree AV conduction block
Overt congestive cardiac failure (NYHA Class III-IV)
Known bronchospastic disease
Known hepatic dysfunction (SGOT/PT > twice above normal levels)
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Male or non-pregnant female; aged from 18 to 80 years old.
Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria:

Any contraindication against the use of ticagrelor.
On treatment with a P2Y12 receptor antagonist in past 30 days.
Known allergies to aspirin or ticagrelor.
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Known blood dyscrasia or bleeding diathesis.
ST-segment elevation acute myocardial infarction.
Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Male or non-pregnant female; aged from 18 to 80 years old.
Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria:

Any contraindication against the use of ticagrelor.
On treatment with a P2Y12 receptor antagonist in past 30 days.
Known allergies to aspirin or ticagrelor.
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Known blood dyscrasia or bleeding diathesis.
ST-segment elevation acute myocardial infarction.
Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
Intervention: Tacrolimus
Trial phase: Phase 3
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Tacrolimus extended release
Eligibility criteria:
Inclusion criteria:

Age ≥18-80 old, male or female
African Americans
Willing to give written informed consent and to comply with study visits and restrictions, including being able to speak, write and understand English
Pt who have received a primary or secondary transplant
Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus
BMI ≥19
Pt who are sero-positive for Hepatitis B or C positive may also be enrolled
Pt maintained on concurrent immunosuppression with stable doses during screening
Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion of the study.
During PK phase Only: Pt taking any medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit, and pomegranate products), or medications must continue the same dose and are willing to continue the same dose/routine
During PK phase Only: the patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food

Exclusion Criteria:

Evidence of acute rejection episode within the past three months
Pt not Africa-American
Recipients of organ transplants other than kidney
Known to be HIV positive at transplant
Pt with recurrent focal segmental glomerulosclerosis (FSGS)
Pt with any severe medical condition (including infection) requiring acute or chronic treatment
Pt with a positive DSA
Pt with a positive BK virus results
GFR < 25 ml/min measured by MDRD4 as SOC within last 30 days
Patients with AST, ALT, total bilirubin > 2.5 x ULN or evidence of severe liver disease
Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl
Pt with mental or physical conditions or known non-adherence
Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus
Exposed to investigational therapy within 30 days prior to enrollment
No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol
Pt with severe diabetic gastroparesis or other severe GI disturbances
Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant
Pregnant or nursing (lactating) women, or planning to become pregnant
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method
Intervention: Tacrolimus
Trial phase: Phase 3
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: brand IR tacrolimus
Eligibility criteria:
Inclusion criteria:

Age ≥18-80 old, male or female
African Americans
Willing to give written informed consent and to comply with study visits and restrictions, including being able to speak, write and understand English
Pt who have received a primary or secondary transplant
Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus
BMI ≥19
Pt who are sero-positive for Hepatitis B or C positive may also be enrolled
Pt maintained on concurrent immunosuppression with stable doses during screening
Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion of the study.
During PK phase Only: Pt taking any medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit, and pomegranate products), or medications must continue the same dose and are willing to continue the same dose/routine
During PK phase Only: the patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food

Exclusion Criteria:

Evidence of acute rejection episode within the past three months
Pt not Africa-American
Recipients of organ transplants other than kidney
Known to be HIV positive at transplant
Pt with recurrent focal segmental glomerulosclerosis (FSGS)
Pt with any severe medical condition (including infection) requiring acute or chronic treatment
Pt with a positive DSA
Pt with a positive BK virus results
GFR < 25 ml/min measured by MDRD4 as SOC within last 30 days
Patients with AST, ALT, total bilirubin > 2.5 x ULN or evidence of severe liver disease
Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl
Pt with mental or physical conditions or known non-adherence
Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus
Exposed to investigational therapy within 30 days prior to enrollment
No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol
Pt with severe diabetic gastroparesis or other severe GI disturbances
Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant
Pregnant or nursing (lactating) women, or planning to become pregnant
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method
Intervention: Ovral
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)

EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)
Eligibility criteria:
Inclusion Criteria:

Women who have an ETG implant in place
Women who subjectively experience the side effect of an undesirable bleeding profile such as bleeding irregularity or heavy flow after ETG implant was placed and who desire intervention for this side effect by either treatment of bleeding or removal of the implant
Age 14 years an older, inclusive

Exclusion Criteria:

Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids, cervical polyp, or other organic cause of bleeding)
Has attempted prescription treatment for menstrual side effects while using ETG implant

Has one or more of the conditions considered Category 3 (risks outweigh benefits) or Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use:

Current or history of heart or vascular diseases, including deep venous thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum cardiomyopathy, and complicated valvular heart disease
Hypertension, even if adequately controlled
Diabetes with vascular involvement
Headaches with focal aura, or migraines in women age 35 and older even without focal aura
Major surgery with prolonged immobilization
Breast cancer (current or past)
Severe (decompensated) cirrhosis
Acute or flare viral hepatitis
Breastfeeding less than 1 month postpartum
Post-partum less than 3 weeks
35 years of age and older and smoking
Multiple risk factors for arterial cardiovascular disease
Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies
Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use
On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine)
On Ritonavir-boosted protease inhibitors for antiretroviral therapy
Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study
Intervention: Lente
Trial phase: Phase 4
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(CC3C=NC=N3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC3C=NC=N3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C.[Zn]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: daily dose will be titrated based on fasting morning glucose values

Insulin, Isophane: daily dosing based on fasting morning glucose levels
Eligibility criteria:
Inclusion Criteria:

Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
Ability to read consent form and give consent in English.

Exclusion Criteria:

Use of insulin or non-insulin hypoglycemic medication before transplantation
Cystic fibrosis patients
Age < 18 years of age
Pregnancy
Non-English speaking subjects
Intervention: Basaglar
Trial phase: Phase 4
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: daily dose will be titrated based on fasting morning glucose values

insulin glargine: daily dose based on fasting morning glucose levels
Eligibility criteria:
Inclusion Criteria:

Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
Ability to read consent form and give consent in English.

Exclusion Criteria:

Use of insulin or non-insulin hypoglycemic medication before transplantation
Cystic fibrosis patients
Age < 18 years of age
Pregnancy
Non-English speaking subjects