anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received total daily doses between 20 to 40 mg/kg/day given twice daily with standard meals.
Eligibility criteria:
Inclusion Criteria:

Completed activities up to and including Visit 10 (Study Completion) of INS011-16- 085.
Participant and/or parent(s)/caregiver(s) fully comprehend the informed consent form and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
If female, is either not of childbearing potential or practicing medically acceptable methods of birth control.
Psychotropic treatment will be permitted if the participant has been on a stable dose during the INS011-16-085 and does not anticipate a dose change during the course of the study.
Growth hormone treatment will be permitted if the participant has been on a stable dose during INS01-16-085.
Any other treatment including thyroid hormones should be stable prior to entering the INS011-17-115 study.
In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules, including venipuncture, and the visit schedules.

Exclusion Criteria:

Participant or parent(s)/caregiver(s) have commitments during the study duration that would interfere with attending all study visits.
Experienced an anoxic episode related to study drug requiring resuscitation during the previous study.
Uncontrolled Type I and Type II Diabetes.
Developed an adverse event thought to be related to CBD in the previous study and the investigator determines that continuing treatment with CBD would not be in the best interest of the partient.
History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or other condition which would jeopardize safety or impact validity of results (per investigator).
Currently taking felbamate.
Compromised respiratory function or severe respiratory insufficiency.
Pregnant or lactating female.
In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.
Intervention: Atenolol
Trial phase: Phase 2
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: AAT was administered intravenously at a loading dose of 90 mg/kg (study day 0), followed by twice weekly doses of 45 mg/kg for 15 more doses (totaling 16 doses over 8 weeks).
Eligibility criteria:
Inclusion Criteria:

High risk prediction score as determined by the Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm at either day 7 or day 14 post Hematopoietic cell transplant (HCT).
Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood).
Donor and recipient match each other for at least 7/8 HLA-loci (HLA-A, B, C, and DR)
Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
GVHD prophylaxis must include a calcineurin inhibitor combined with methotrexate or mycophenolate.
The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days prior to enrollment.
Signed and dated written informed consent obtained from patient or legal representative.

Exclusion Criteria:

Patients who develop acute GVHD prior to start of study drug
Patients at very high risk for relapse post HCT as defined by very high disease risk index
Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
Patients who are pregnant
Patients on dialysis within 7 days of enrollment
Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.
Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of alpha-1-antitrypsin.
History of allergic reaction to alpha-1-antitrypsin
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: 200 mg Lasmiditan administered PO in one of four study periods.
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy males or females, as determined through medical history and physical examination.
Possess a valid driver's license and is an active driver at screening. Driven a minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.
Have a score of <10 on the Epworth Sleepiness Scale.

Exclusion Criteria:

Have a history within 3 months of admission, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
Have a history of difficulty either falling asleep or staying asleep in the previous 3 months of admission that is considered clinically significant by the investigator.
Are expected to use any other medication or dietary supplement to promote sleep including over the-counter sleep medications, during their participation in the study.
Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks prior to randomization.
Have worked in a night shift in the past 2 weeks prior to randomization.
Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraine, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
Show evidence of significant active neuropsychiatric disease (e.g., manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator.
Intervention: Vadadustat
Trial phase: Phase 3
ATC code: B03XA08
SMILES: O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CKD
Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis.
Not being treated with ESAs or if being treated with ESAs, leave defined interval between last ESAs administration and the first day of the screening period
Mean of the two screening Hb levels closest in time to the baseline visit is ≥8.0 g/dL and <10.0 g/dL
Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL
Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period
Folate and vitamin B12 ≥ lower limit of normal during the screening period

Exclusion Criteria:

Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia
Active bleeding or recent blood loss within 8 weeks prior to the screening period
RBC transfusion within 8 weeks prior to the screening period
Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period
AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period
Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) at the first day of the screening period and Day 1

Ophthalmic examinations during the screening period correspond to either of the following criteria;

No available fundal findings
Findings indicating the presence of active fundal disease
Severe heart failure (New York Heart Association Class IV)
Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period
Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion
New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period
Current or history of hemosiderosis or hemochromatosis
History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow
Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, females: during study and 30 days after the last dose)
Females who are pregnant or breast feeding, or are predicted to be pregnant
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 2
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.

Gallium Ga 68-labeled PSMA-11: Given IV

Magnetic Resonance Imaging: Undergo MRI in combination with PET

Positron Emission Tomography (PET): Undergo PET in combination with MRI
Eligibility criteria:
Inclusion Criteria:

History of thyroid cancer
Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past 90 days of the scheduled 68Ga-PSMA PET demonstrating uptake
Creatinine =< 3.0 mg/dL
Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

Patients who have had active infection within 15 days of study enrollment that may be considered to interfere with 68Ga-PSMA PET imaging by the study investigators
Patients who are unable to have placement of intravenous line access
Pregnant or breastfeeding women
Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or inability to lie still for the duration of the exam
Intervention: OXYTOCIN
Trial phase: Phase 3
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 227
Group description: Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby

Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Eligibility criteria:
Inclusion Criteria:

Pregnant woman with signed informed consent***
Understand English and/or Shona
Estimated gestational age of 38 weeks or older
Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour

Live intrauterine fetus

The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.

Exclusion Criteria:

Placental Abruption
Emergency caesarean section
Current or previous history of significant disease including heart disease, liver, renal disorders
Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
History of epilepsy or seizures
Autoimmune disease
Sickle cell disease
Severe haemorrhagic disease
Intrauterine fetal demise
Eclampsia/HELLP syndrome
Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: 400 mg lasmiditan administered PO in 1 of 4 treatment periods.
Eligibility criteria:
Inclusion Criteria:

Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)

In good physical and mental health as determined by the following:

Complete medical history
Complete physical examination
Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
Clinical laboratory tests

Exclusion Criteria:

Any of the following cardiac abnormalities on safety screening ECG:

QTcF interval >430 milliseconds (ms) for males, >450 ms for females
Unusual T wave morphology or flattened low voltage T waves
PR interval >240 ms or <110 ms
Second-degree or third-degree atrioventricular block
ECG evidence of complete left or right bundle branch block
Intraventricular conduction delay or QRS duration >110 ms
Supine resting heart rate <45 beats per minute (bpm) or >90 bpm
Pathological Q-waves
Evidence of ventricular pre-excitation
Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
Participants with a family history of Long QT syndrome
History of allergic hypersensitivity to lasmiditan or any component of the formulations
History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
Participants with a history of postural hypotension or fainting
Participant is not able to understand and comply with study requirements, instructions and study restrictions
Intervention: Moxifloxacin
Trial phase: Phase 1
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 52
Group description: Moxifloxacin administered PO in 1 of 4 treatment periods.
Eligibility criteria:
Inclusion Criteria:

Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)

In good physical and mental health as determined by the following:

Complete medical history
Complete physical examination
Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
Clinical laboratory tests

Exclusion Criteria:

Any of the following cardiac abnormalities on safety screening ECG:

QTcF interval >430 milliseconds (ms) for males, >450 ms for females
Unusual T wave morphology or flattened low voltage T waves
PR interval >240 ms or <110 ms
Second-degree or third-degree atrioventricular block
ECG evidence of complete left or right bundle branch block
Intraventricular conduction delay or QRS duration >110 ms
Supine resting heart rate <45 beats per minute (bpm) or >90 bpm
Pathological Q-waves
Evidence of ventricular pre-excitation
Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
Participants with a family history of Long QT syndrome
History of allergic hypersensitivity to lasmiditan or any component of the formulations
History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
Participants with a history of postural hypotension or fainting
Participant is not able to understand and comply with study requirements, instructions and study restrictions
Intervention: Rivaroxaban
Trial phase: Not Applicable
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.

Standard of Care: Anticoagulant therapy will be decided by physician and patient.
Eligibility criteria:
Inclusion Criteria:

Able to tolerate wearing a vascular boot, if randomized to this group.
Diagnosis of acute DVT±PE (within 24 - 48 hours) and received approximately 24 hours of anticoagulation prior to starting the study.

Exclusion Criteria:

Unable to tolerate wearing a vascular boot
Unable to comply with keeping log of activity/ of wearing a vascular boot.
Weight > 300 pounds. (weight limit for the venous plethysmography chair)
Previous history of DVT or PE.
On anticoagulation for another purpose (example stroke prevention with atrial fibrillation).
Patients who do not accept to participate in research studies.
Pregnant women will not be allowed to participate
Patients less than 18 yrs
Intervention: Humalog
Trial phase: Phase 1
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)NC(CCCCN)C(=O)N3CCCC3C(=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
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
Eligibility criteria:
Inclusion Criteria:

Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion Criteria:

Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
More than one episode of severe hypoglycaemia in the last 6 months
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
Have obvious clinical signs or symptoms of liver disease
Have a history of renal impairment
Intervention: Humalog
Trial phase: Phase 1
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)NC(CCCCN)C(=O)N3CCCC3C(=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
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
Eligibility criteria:
Inclusion Criteria:

Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion Criteria:

Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
More than one episode of severe hypoglycaemia in the last 6 months
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
Have obvious clinical signs or symptoms of liver disease
Have a history of renal impairment
Intervention: Insulin
Trial phase: Early Phase 1
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(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)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)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
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Subjects with type 2 diabetes on insulin.

Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.

exercise: Exercise in accordance to the guidelines established by the American Diabetes Association.

Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Eligibility criteria:
Inclusion Criteria:

15 Type 2 DM subjects with HbA1C > 7.5%
15 Type 1 DM subjects with HbA1C > 7.5%
Age 18-60
BMI ≥18 kg/m2
Weight ≤ 285 pounds

Exclusion Criteria:

Creatinine > 1.5 mg/dL, Hgb < 10 mg/dL, ALT > 2.5 X ULN,
untreated thyroid disease,
uncontrolled hypertension,
known neurological disorders,
untreated psychiatric disorders,
malignancy,
bleeding disorders,
current or recent steroid use in last 3 months,
illicit drug use;
for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter
MRI/MRS