anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Patients in this group received gabapentin which looked just like the sugar pill.
Eligibility criteria:
Inclusion Criteria:

All admitted patients with LOS expected to be > 48 hours (usually burn injury > 5%)
> 18 years of age
Thermal injury to skin

Exclusion Criteria:

Prisoners
Pregnant or nursing women
Children <18 years of age
Frostbite or non thermal injury to skin
Renal insuffiency (creatinine clearance < 60mL/min) or failure (on renal replacement)
Expected length of stay < 48 hours (this usually includes burn <5%
Intervention: Flutemetamol
Trial phase: Phase 3
ATC code: V09AX04
SMILES: CNc1ccc(-c2nc3ccc(O)cc3s2)cc1F
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 181
Group description: [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Eligibility criteria:
Inclusion Criteria:

The subject age is 18 to 40 years.
The subject has no evidence of thinking or memory problems by medical history.
The subject has a normal MRI scan.
The subject's general health is adequate to comply with study procedures.
The subject is willing and able to participate in all study procedures.

Exclusion Criteria:

The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
The subject has a contraindication for (cannot undergo) MRI.
The subject has a history of head injury with loss of consciousness.
The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.
Intervention: Tacrolimus
Trial phase: Not Applicable
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: 14
Group description: This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
Eligibility criteria:
Inclusion Criteria:

Male or female patients over 18 years of age who receive a deceased, living unrelated or living related donor renal transplant
No history of pre-existing diabetes mellitus
Not using diabetic medications (insulin, hypoglycemic agents) at the time of transplantation
Random plasma glucose level <11.1 at the time of transplantation
Peak PRA (panel reactive antibody) <30%
Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
The patient has given written informed consent to participate in the study

Exclusion Criteria:

Patients with primary non-function
Peak PRA>=30%
Multiple organ transplants
HLA (human leukocyte antigen) identical living donor transplant recipients
Cold ischemia time over 36 hours
Nonheart beating donor kidney recipients
Pediatric donor kidney recipients
Donor age>=65 years
Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C will be excluded.
Patients who are Epstein-Barr virus (EBV) negative and are receiving a transplant from an EBV-positive donor (mismatch).
Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to those used in the study
Patients with systemic infections
Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, preclude enrollment in this trial
Inability to cooperate or communicate with the investigator
Intervention: Tacrolimus
Trial phase: Not Applicable
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: 14
Group description: This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
Eligibility criteria:
Inclusion Criteria:

Male or female patients over 18 years of age who receive a deceased, living unrelated or living related donor renal transplant
No history of pre-existing diabetes mellitus
Not using diabetic medications (insulin, hypoglycemic agents) at the time of transplantation
Random plasma glucose level <11.1 at the time of transplantation
Peak PRA (panel reactive antibody) <30%
Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
The patient has given written informed consent to participate in the study

Exclusion Criteria:

Patients with primary non-function
Peak PRA>=30%
Multiple organ transplants
HLA (human leukocyte antigen) identical living donor transplant recipients
Cold ischemia time over 36 hours
Nonheart beating donor kidney recipients
Pediatric donor kidney recipients
Donor age>=65 years
Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C will be excluded.
Patients who are Epstein-Barr virus (EBV) negative and are receiving a transplant from an EBV-positive donor (mismatch).
Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to those used in the study
Patients with systemic infections
Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, preclude enrollment in this trial
Inability to cooperate or communicate with the investigator
Intervention: Paricalcitol
Trial phase: Phase 4
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 6-8 μg daily per os without special diet
Eligibility criteria:
Inclusion Criteria:

Age 40-75
Male
History of chronic kidney disease and cardiorenal syndrome
Written informed consent

Exclusion Criteria:

Female
Acute illness
Life-threat competitive illness
Mental disorders
Endocrinologic diseases (including diabetes mellitus, hyperparathyroidism, and other thyroid disorders)
Need for dialyses
Hypercalcemia
Concomitant use of hormone or cytokine medication
Participation to any drug-investigation during the previous 60 days as checked with VIP check
Intervention: Piclidenoson
Trial phase: Phase 2 | Phase 3
SMILES: CNC(=O)[C@H]1O[C@@H](n2cnc3c(NCc4ccc(I)cc4)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: CF101: orally q12h
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 to 80 years of age, inclusive
Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
Duration of psoriasis of at least 6 months
Physician global assessment (PGA) ≥3
Candidate for systemic treatment or phototherapy for psoriasis
Electrocardiogram (ECG) is normal
Females of child-bearing potential must have a negative serum pregnancy test
Females of child-bearing potential must be willing to use 2 methods of contraception
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent.

Exclusion Criteria:

Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
Liver aminotransferase levels greater than the laboratory's upper limit of normal
Significant acute or chronic medical or psychiatric illness
Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
Intervention: Chirhostim
Trial phase: Phase 1 | Phase 2
SMILES: CC(C)CC(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(C)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(=O)NC(C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Human Secretin : Dose Escalation within participant
Eligibility criteria:
Inclusion Criteria:

Male or female, between the ages of 18-70 years old.
Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests.
If female, and not more than 1 year post-menopausal or surgically sterile, must use medically acceptable form of contraception or abstain from sexual activity during the study. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Screening Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
If a female of reproductive potential, receive counseling on pregnancy protection and effective contraception within 30 days prior to dosing with secretin.
Negative serum pregnancy within 72 hours of secretin administration.
Use of opioid analgesics for chronic pain from CP.
Willing and able to sign written informed consent.

Exclusion Criteria:

Male or female <18 or >70 years of age.
Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment.
Exhibiting signs and/or symptoms of an episode of acute pancreatitis.
Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
Severe renal disease (history of acute or chronic renal failure, dialysis dependent, baseline creatinine >2.0 mg/dL).
Previous adverse drug event to intravenous secretin.
Ongoing illicit drug use or abuse.
Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine and/or 1 oz liquor /day.
Acute pancreatitis as defined by the Atlanta Classification definition (refer to Table 1) within the previous two months or symptoms consistent with ongoing acute pancreatitis.
Prior pancreatic surgery.
Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception.
Use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides within 30 days prior to Visit 1.
Any medical condition which, in the judgment of the investigator, renders participation in this study medically inadvisable.
Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.
Unwilling or unable to give written, informed consent.
Intervention: Vigabatrin
Trial phase: Phase 4
ATC code: N03AG04
SMILES: C=CC(N)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
Eligibility criteria:
Inclusion Criteria:

The patient or patient's legally authorized representative must sign and date the Institutional Review Board approved Informed Consent and HIPPA Authorization Form.
Male and female patients 18+ years of age with a clinical diagnosis of Tuberous Sclerosis who experience an average of at least three partial seizures every two months, of which one must be a complex partial seizure
Patient must be on at least one and a maximum of four AEDs. Patient must be on a stable AED dose regimen for at least 30 days prior to screening. Neither a Vagal Nerve Stimulator (VNS) nor the ketogenic diet will count as an AED
In the investigator's opinion, the patient or caregiver must be able to keep a seizure diary
An MRI in the last 5 years, or willingness to undergo an MRI as part of the screening process

Exclusion Criteria:

Cause of patient's seizures is a neurologic disease that is not Tuberous Sclerosis
Current, clinical diagnosis of a major depressive episode or suicidal ideation
Patient is taking more than four concurrent AEDs. Note: VNS or ketogenic diet is allowed and will not be counted in the four allowed AEDs
Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Patient is currently abusing drugs or alcohol
Intervention: Proparacaine Hydrochloride
Trial phase: Not Applicable
SMILES: CCCOc1ccc(C(=O)OCCN(CC)CC)cc1N.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops

Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops
Eligibility criteria:
Inclusion Criteria:

Infants admitted to the Pennsylvania Hospital NICU who require an ophthalmologic examination.

Exclusion Criteria:

Infants with congenital anomalies, seizures, or other neurologic conditions or malformations that may alter the pain response
Infants with corneal abrasions, corneal ulcers or other relative or absolute contraindications to proparacaine administration
Intervention: Pterostilbene
Trial phase: Phase 2 | Phase 3
SMILES: COc1cc(/C=C/c2ccc(O)cc2)cc(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Pterostilbene 125 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory

Exclusion Criteria:

Patients with significant hepatic, renal or gastrointestinal tract disease
Receiving thiazolidinediones or fibric acid derivatives
Current overt cardiovascular disease
Women of reproductive potential not receiving birth control
Pregnant/nursing women
Intervention: Pterostilbene
Trial phase: Phase 2 | Phase 3
SMILES: COc1cc(/C=C/c2ccc(O)cc2)cc(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Pterostilbene 50 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory

Exclusion Criteria:

Patients with significant hepatic, renal or gastrointestinal tract disease
Receiving thiazolidinediones or fibric acid derivatives
Current overt cardiovascular disease
Women of reproductive potential not receiving birth control
Pregnant/nursing women
Intervention: Metoclopramide
Trial phase: Phase 4
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 109
Group description: Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS
Eligibility criteria:
Inclusion Criteria:

IHS migraine without aura
IHS probable migraine (all migraine without arua criteria must be met except duration may be >72 hours or <4 hours)

Exclusion Criteria:

Allergy or contra-indication to investigational medication
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Ketorolac 30mg IV

Ketorolac: 30g IVSS
Eligibility criteria:
Inclusion Criteria:

IHS migraine without aura
IHS probable migraine (all migraine without arua criteria must be met except duration may be >72 hours or <4 hours)

Exclusion Criteria:

Allergy or contra-indication to investigational medication
Intervention: VALPROIC ACID
Trial phase: Phase 4
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 110
Group description: 1gm IV

Valproate: 1gm IVSS
Eligibility criteria:
Inclusion Criteria:

IHS migraine without aura
IHS probable migraine (all migraine without arua criteria must be met except duration may be >72 hours or <4 hours)

Exclusion Criteria:

Allergy or contra-indication to investigational medication
Intervention: Glyburide
Trial phase: Phase 1 | Phase 2
ATC code: A10BB01
SMILES: COc1ccc(Cl)cc1C(=O)NCCc1ccc(S(=O)(=O)NC(=O)NC2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Eligibility criteria:
Key Inclusion Criteria:

A clinical diagnosis of acute ischemic stroke in the MCA or MCA/ACA territory.
Pre-morbid mRS 0 - 1.
A baseline DWI lesion between 82 cm3 and 210 cm3 on MRI.
Patients treated with IV rtPA should meet established criteria for IV rtPA administration in the 0-3 and 3-4.5 hr time periods, respectively.
The time to the start of infusion of study compound must be ≤ 10 hr after time of symptom onset
Age ≥18 years and ≤70 years.
Provision of written informed consent by the patient or from a legally authorized representative according to institutional guidelines and national regulations.

Key Exclusion Criteria:

Evidence from imaging or pre-enrollment investigation of any diagnosis other than acute ischemic stroke likely to cause the presenting symptoms and signs.
Commitment to decompressive craniectomy (DC) prior to enrollment, or follow-ing enrollment and prior to start of study compound.
Treatment with IA rtPA or by mechanical means for clot disruption or with hypo-thermia.
Patients unable to tolerate MRI scanning, e.g. those with pacemakers or automatic defibrillators.
Pre-morbid mRS ≥ 2.
Clinical signs of herniation, e.g. one or two dilated, fixed pupils; unconsciousness (i.e., ≥ 2 on item 1a on the NIHSS); loss of other brain stem reflexes attributable to herniation according to the investigator's judgment.
CT or MRI evidence of hemorrhage or anteroseptal/pineal shift greater ≥2 mm prior to enrollment.
Rapidly improving symptoms.
Severe renal disorder from the patient's history (e.g. dialysis) or eGFR of < 30 mL/min/1.73 m2.
Severe liver disease or ALT, AST, or bilirubin >2 times normal.
Blood glucose <55 mg/dL at enrollment or immediately prior to administration of RP-1127, or a clinically significant history of hypoglycemia.
Diagnosis of decompensated heart failure (e.g. clinical diagnosis of pulmonary edema, chest x-ray consistent with heart failure, tachypnea > 20, etc.)
Sulfonylurea treatment within 30 days.
Known allergy to sulfa or specific allergy to sulfonylurea drugs.
Known G6PD enzyme deficiency.
Pregnancy or breast-feeding. Women must be either post-menopausal (judged by the investigator), permanently sterilized or, if of childbearing age, must have a negative test for pregnancy obtained before enrollment.
Patients already enrolled in a non-observation-only stroke study, or with life-expectancy <3 months not related to current stroke, or those unlikely to be com-pliant with follow up.
Patients who, in the opinion of the investigator, are not suitable for the study (reason to be documented).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: EXENATIDE
Trial phase: Phase 4
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Exenatide and long acting insulin before the boost.

Exenatide: 1.25 mcg before the boost sub-cutaneously.
Eligibility criteria:
Inclusion Criteria:

Age between 12-18 years of age at the time of enrollment.
Diagnosed with antibody positive T1DM in the past 3 months.
Otherwise healthy except for their TIDM and treated hypothyroidism.
Females must have a negative pregnancy test.
Hemoglobin equal to or greater than 12 g/dl before each study.
Weight greater than 44 kg.

Exclusion Criteria:

Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
Any medications that may affect glucose metabolism.
Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
Lack of a supportive family environment as detected by the clinicians and/or social workers.
History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
Positive pregnancy test in females.
Lactating and nursing mothers.