anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 35
Group description: Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
Body Mass Index (BMI) between 27.5-40 kg/m^2

Exclusion Criteria:

Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Receipt of any investigational drug within 1 month prior to this trial
Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
Intervention: Allantoin
Trial phase: Phase 2 | Phase 3
SMILES: NC(=O)NC1NC(=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 500 mg #2 capsules three times daily
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes
No diabetes medication adjustments for at least 2 months
Stable hemoglobin A1C [Between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; If no A1C exists prior to the current visit and no medication adjustments are made, the current A1C may used as the baseline]

Exclusion Criteria:

On insulin
History of overt cardiovascular disease
History of missed appointments or non-compliance with medications
History of hepatic or renal insufficiency
History of hemoglobinopathies
Women of reproductive potential not on oral contraceptives
Pregnant/nursing women.
Intervention: Lovaza
Trial phase: Phase 4
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Lovaza, dietary counseling
Eligibility criteria:
Inclusion Criteria:

HIV-infected men and women at least 18 years of age
On stable HAART for previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke
Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use 2 methods of barrier contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for > 1 year
Ability to provide consent

Exclusion Criteria:

Plasma HIV-1 RNA > 10,000
Previous history of atherosclerotic disease or diabetes mellitus
Change in HAART regimen over three months prior to study entry
Change in lipid lowering therapy within 2 months
On chronic anticoagulants such as heparin or coumadin
On fish oil, omega 3 supplements, or Omacor currently or during the past month
Intervention: Ondansetron
Trial phase: Phase 2
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.

ondansetron: Given IV

survey administration: Correlative studies

management of therapy complications: Ondansetron IV
Eligibility criteria:
Inclusion

Autologous PBSC transplant patient
English-speaking
Planned cryopreserved PBSC infusion at the SCCA outpatient clinic

Exclusion

History of prior autologous transplant
Non-English-speaking
Planned cryopreserved PBSC infusion at the UWMC inpatient unit
Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion
Allergy or adverse reaction to ondansetron
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 153
Group description: VI-0521 7.5 mg PHEN/46 mg TPM
Eligibility criteria:
Inclusion Criteria:

To be eligible for enrollment into this study, subjects must meet all of the following criteria:

Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements
Written informed consent
Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects will not be included in the study if they meet any of the following:

Body mass index ≤22 kg/m2 at the completion of study OB-303
Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart
Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results
Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).
Intervention: Aclerastide
Trial phase: Phase 2
SMILES: [H]N(C(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CCCC)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@@H](N)CC(=O)O)[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N1CCC[C@H]1C(=O)O)[C@@H](C)CC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: control placebo vehicle
Eligibility criteria:
Inclusion Criteria:

Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel.
ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU
TcPO2 greater than 40 mm Hg or great toe systolic pressure greater than 50 mmHg
Type I or Type II diabetes under metabolic control
Female subjects must have a negative pregnancy test and be willing to use acceptable method of birth control for the duration of the study

Exclusion Criteria:

Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components
Chronic renal insufficiency and/or chronic liver dysfunction
Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart
Malignancy of any kind
Receiving hemodialysis or CAPD
Current history of drug abuse, and/or known to be HIV positive
Prior radiation therapy of the foot under study
Current use of corticosteroids (within past 8 weeks), immunosuppressants (within past 8 weeks), or use of a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the past 90 days
Ulcer is deemed clinically infected and requires topical antimicrobials or agents known to affect wound healing, or the subject has been taking systemic antibiotics for more than 7 days for any reason
Sickle-cell anemia, Raynaud's or other peripheral vascular disease
Wagner Grade 3 or higher DU, deep abscess or infection of the joint or tendon, or gangrene or osteomyelitis
An EKG with a marked baseline prolongation of QT/QTc interval
Intervention: Aclerastide
Trial phase: Phase 2
SMILES: [H]N(C(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CCCC)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@@H](N)CC(=O)O)[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N1CCC[C@H]1C(=O)O)[C@@H](C)CC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 0.01% DSC127 in Vehicle Control
Eligibility criteria:
Inclusion Criteria:

Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel.
ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU
TcPO2 greater than 40 mm Hg or great toe systolic pressure greater than 50 mmHg
Type I or Type II diabetes under metabolic control
Female subjects must have a negative pregnancy test and be willing to use acceptable method of birth control for the duration of the study

Exclusion Criteria:

Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components
Chronic renal insufficiency and/or chronic liver dysfunction
Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart
Malignancy of any kind
Receiving hemodialysis or CAPD
Current history of drug abuse, and/or known to be HIV positive
Prior radiation therapy of the foot under study
Current use of corticosteroids (within past 8 weeks), immunosuppressants (within past 8 weeks), or use of a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the past 90 days
Ulcer is deemed clinically infected and requires topical antimicrobials or agents known to affect wound healing, or the subject has been taking systemic antibiotics for more than 7 days for any reason
Sickle-cell anemia, Raynaud's or other peripheral vascular disease
Wagner Grade 3 or higher DU, deep abscess or infection of the joint or tendon, or gangrene or osteomyelitis
An EKG with a marked baseline prolongation of QT/QTc interval
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Patients of this arm received 10 mg IM olanzapine after randomization
Eligibility criteria:
Inclusion Criteria:

Men and non-pregnant, non-lactating women aged 18 to 65 years with a primary diagnosis of schizophrenia (DSM-IV)
were hospitalized due to an acute relapse
were clinically agitated with a minimum total score of ≧ 14 on the five items of the PANSS-EC and at least one individual item score of ≧ 4 using the 1-7 scoring system prior to first IM injection of study drug.

Exclusion Criteria:

female subjects who were either pregnant or breast-feeding;
patients with acute, serious or unstable medical conditions;
treatment with benzodiazepines within 4 hours prior to the first IM study drug administration;
treatment with an injection depot neuroleptic within 1 injection interval prior to study drug administration;
history of allergic reaction or intolerance to study medication(s);
had a known diagnosis of dementia of any type, as defined in the DSM-IV.
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 265
Group description: Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Eligibility criteria:
Inclusion Criteria:

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Male or female outpatients ≥ 18 years old.
Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).

Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:

Abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
Current HDL- Cholesterol <40 mg/dL in men and <50 mg/dL in women or medical treatment for this condition.
Fasting glucose >100 mg/dL and <126 mg/dL

Exclusion Criteria:

Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
History or evidence of secondary form of hypertension.
Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
Patients on 4 or more antihypertensive medications.
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 2% lidiocaine was used to inflate the cuff
Eligibility criteria:
Inclusion Criteria:

patients of the age group 18-60 years
patients belonging to ASA grade I and II undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using Poly Vinyl Chloride ETT (same type and make in all patients)

Exclusion Criteria:

anticipated difficult intubation
more than one attempt for intubation
need for naso gastric tube
episode of coughing and straining
history of respiratory tract infection and smoking
Intervention: Tetracaine
Trial phase: Not Applicable
ATC code: C05AD02 | D04AB06 | N01BA03 | N01BA53 | S01HA03
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 1% tetracaine was used to inflate the cuff
Eligibility criteria:
Inclusion Criteria:

patients of the age group 18-60 years
patients belonging to ASA grade I and II undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using Poly Vinyl Chloride ETT (same type and make in all patients)

Exclusion Criteria:

anticipated difficult intubation
more than one attempt for intubation
need for naso gastric tube
episode of coughing and straining
history of respiratory tract infection and smoking
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
Eligibility criteria:
Inclusion Criteria:

History of at least 1 gout flare prior to the Screening Visit
Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
Presence of acute gout flare for no longer than 5 days.
Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.
Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.

Exclusion Criteria:

Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
Presence of severe renal function impairment
Contraindication to intramuscular injection
Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
Evidence of active pulmonary disease
Live vaccinations within 3 months prior to the start of the study
Use of forbidden therapy

Other protocol-defined inclusion/exclusion criteria applied
Intervention: Moxifloxacin Hydrochloride
Trial phase: Phase 4
SMILES: COc1c(N2CC3CCCNC3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Diagnosis in one or both eyes of bacterial conjunctivitis based on:

symptoms less than or equal to 24 hours prior to first visit
rating > or equal to 1 for bulbar conjunctival injection
must have a rating > 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and
Must experience some matting in the affected eye(s).
1 year of age or older, of any race and either sex
Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.

Exclusion Criteria:

Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
Any current lid disease on clinical examination.
Known or suspected allergy or hypersensitivity to fluoroquinolones.
Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
Use of topical ocular medications during the study period.
Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Enrollment of more than one person per household at the same time.
Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Participation in any investigational drug or device study within 30 days of entering this study.
Intervention: Glucagon-like peptide 1
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(=O)O)NC(=O)C(CCCCN)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCCN)C(=O)NCC(=O)NC(CCCNC(=N)N)C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Eligibility criteria:
Inclusion Criteria:

Men and women age > 21 to 75 years of age.
All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
Able to obtain patient or proxy consent.

Exclusion Criteria:

Current diagnosis of malignancy.
Type 1 diabetes.
Inability to obtain informed consent.
On any Phase 1 trial.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Eligibility criteria:
Inclusion Criteria:

Men and women age > 21 to 75 years of age.
All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
Able to obtain patient or proxy consent.

Exclusion Criteria:

Current diagnosis of malignancy.
Type 1 diabetes.
Inability to obtain informed consent.
On any Phase 1 trial.