anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lovenox
Trial phase: Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3716
Group description: Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Eligibility criteria:
Inclusion Criteria:

men and non-pregnant, non-breastfeeding women
anticipated to be severely immobilized for at least 24 hours after randomization

hospitalized with one of the following

congestive heart failure
acute respiratory failure,
acute infection without septic shock,
acute rheumatic disorders
acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

a condition requiring prolonged anticoagulation or anti-platelets
active bleeding or at high risk of bleeding
contraindication to anticoagulant therapy
general conditions in which subjects are not suitable to participate in the study
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Diuresis based on CHF-P

Furosemide: Based on clinical standard per clinician
Eligibility criteria:
Inclusion Criteria:

General Surgery patients with history of coronary artery disease, congestive heart failure, pulmonary hypertension
Cardiac surgery patients undergoing CABG (coronary artery bypass grafting) and valve replacements

Exclusion Criteria:

Recent myocardial infarction (within 3 months).
ASA class 4 and more.
Emergency surgeries.
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Diuresis based on clinical judgement without data for CHF-P
Eligibility criteria:
Inclusion Criteria:

General Surgery patients with history of coronary artery disease, congestive heart failure, pulmonary hypertension
Cardiac surgery patients undergoing CABG (coronary artery bypass grafting) and valve replacements

Exclusion Criteria:

Recent myocardial infarction (within 3 months).
ASA class 4 and more.
Emergency surgeries.
Intervention: Bivalirudin
Trial phase: Phase 1 | Phase 2
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose.
Eligibility criteria:
Inclusion Criteria:

Age 21 years or older
Adenocarcinoma of the prostate
Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml
Combined Gleason Score ≤ 8
Karnofsky level of performance of > 70%
Consented to undergo definitive Radiation Therapy

Exclusion Criteria:

Stage T4 or M1
Patient using own supply of Saw Palmetto or any other supplement containing the following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant sterols) or Cernilton (rye grass pollen).
Prior pelvic radiation therapy
Abnormality in liver and kidney function as evidenced by greater than twice the normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and alkaline phosphatase.
Uncontrolled hypertension despite use of antihypertensive medication
Presence of major psychiatric or medical illness (e.g., major cardiovascular events within the previous 12 months)
Intervention: Bivalirudin
Trial phase: Phase 1 | Phase 2
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960 mg.
Eligibility criteria:
Inclusion Criteria:

Age 21 years or older
Adenocarcinoma of the prostate
Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml
Combined Gleason Score ≤ 8
Karnofsky level of performance of > 70%
Consented to undergo definitive Radiation Therapy

Exclusion Criteria:

Stage T4 or M1
Patient using own supply of Saw Palmetto or any other supplement containing the following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant sterols) or Cernilton (rye grass pollen).
Prior pelvic radiation therapy
Abnormality in liver and kidney function as evidenced by greater than twice the normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and alkaline phosphatase.
Uncontrolled hypertension despite use of antihypertensive medication
Presence of major psychiatric or medical illness (e.g., major cardiovascular events within the previous 12 months)
Intervention: Testosterone
Trial phase: Not Applicable
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.

Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
Eligibility criteria:
Inclusion Criteria:

Males with 47,XXY
Participants must be in early puberty (Tanner stage II-III)
Age 8 - 18 will be considered, but eligibility will be determined by review of laboratory results, bone age X-ray, and physical examination to determine stage of puberty
All racial and ethnic groups

Exclusion Criteria:

Other genetic variations of Klinefelter syndrome (48,XXXY, 48,XXYY, 49,XXXXY). The investigator has other studies for these groups and we encourage interested individuals with these disorders to contact us about other available studies.
47,XXY plus another genetic disorder
Non-English speaking individuals (because the psychological tests are administered in English)
Participants with a medical history of blood clotting problems, blindness, deafness, or cancer
Intervention: Fexofenadine
Trial phase: Phase 4
ATC code: R06AX26
SMILES: CC(C)(C(=O)O)c1ccc(C(O)CCCN2CCC(C(O)(c3ccccc3)c3ccccc3)CC2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: 60 mg twice daily, oral
Eligibility criteria:
Inclusion Criteria:

Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study

Exclusion Criteria:

None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
Intervention: Hyaluronic acid
Trial phase: Phase 1 | Phase 2
ATC code: D03AX05 | M09AX01 | R01AX09 | S01KA01 | S01KA51
SMILES: CC(=O)N[C@@H]1C(O[C@@H]2O[C@H](C(=O)O)[C@@H](O)[C@H](O)[C@H]2O)[C@H](O)[C@@H](CO)O[C@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](OC2[C@@H](NC(C)=O)[C@H](O)O[C@H](CO)[C@H]2O)O[C@@H]1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Intraarticular injection of hyaluronic acid (60 mg)

Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
Eligibility criteria:
Inclusion Criteria:

Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
Chronic knee pain with mechanical characteristics.
No local or systemic septic process.
Haematological and biochemical analysis without significant alterations that contraindicate treatment.
Informed written consent of the patient.
The patient is able to understand the nature of the study

Exclusion Criteria:

Age over 75 or under 18 years or legally dependent
Present Infection (to be included in the study no signs of infection must be evidenced)
Congenital or acquired malformation resulting in significant deformity of the knee (varus<10º; valgus<20º) and leading to problems in application or evaluation of results.
Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
Women who are pregnant or intend to become pregnant or breast-feeding
Neoplasia
Immunosuppressive states
Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion
Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 195
Group description: Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
Eligibility criteria:
Inclusion Criteria:

Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.
ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]
BMI < 35
Smokers included
Ages 16-65

Exclusion Criteria:

Patients on steroids or requiring stress dose steroids
BMI > 35
Patient refusal
Allergy to study medications,
NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks
Lower extremity neurological dysfunction
Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)
Not in included age range (under 16 or over 65 years of age)
Contraindications to the use of dexamethasone
Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).
Intervention: Clopidogrel
Trial phase: Phase 2 | Phase 3
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Clopidogrel 75 mg QD
Eligibility criteria:
Inclusion Criteria:

Patient must be taking Aspirin or Plavix
Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria:

-None
Intervention: ASPIRIN
Trial phase: Phase 2 | Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Aspirin 81 mg QD
Eligibility criteria:
Inclusion Criteria:

Patient must be taking Aspirin or Plavix
Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria:

-None
Intervention: Naproxen
Trial phase: Phase 4
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Naproxen + placebo

Naproxen: Naproxen 500mg twice/ day x 10 days
Eligibility criteria:
Inclusion Criteria:

Non-radicular, non-traumatic low back pain of no more than 2 weeks duration

Exclusion Criteria:

Back pain longer than 2 weeks
Prior to the acute attack of low back pain, back pain once per month or more frequently
Prior to the acute attack of low back pain, daily or near daily use of pain medication
Intervention: ASCORBIC ACID
Trial phase: Phase 2
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Ascorbic Acid

Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
Eligibility criteria:
Inclusion Criteria:

Activation of the Mass Transfusion Protocol following surgery or trauma.
Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension (i.e. systolic blood pressure <90mmHg or drop of systolic blood pressure >40mmHg in the presence of infection) that does not respond to a 2 liter fluid bolus.

Exclusion Criteria:

Age less than 18 years.
Pregnant women.
Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney or end stage renal disease, rise in creatinine > 1 g/dl within 24 hours prior to enrollment.
Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive care unit
Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate dehydrogenase deficiency, Sickle Cell Disease and Thalassemia.
Patients in isolated cardiogenic shock.
History of liver cirrhosis
Transplant patients (liver, kidney, heart)
Intervention: Divalproex Sodium
Trial phase: Phase 4
SMILES: CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: After a washout period of up to 1 week, subjects will be openly randomized to treatment Divalproex for 2 weeks. Subjects who become intolerant to or divalproex at any point will be crossed over to the other mood stabilizer (Lithium) and continued in the study. Adverse events were not collected for Randomization 2.
Eligibility criteria:
Inclusion Criteria:

DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)
Male or female ≥ 18 years old
Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania &/or depression for ≥ 2 weeks
One of the following indicators of recent active illness: a depressive or manic or hypomanic or mixed episode in the past 12 months
If female of child bearing age must use effective birth control.

Exclusion Criteria:

Unwilling or unable to comply with study requirements
Renal impairment (serum creatinine > 1.5 mg/dL)
If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1
Patients who have had intolerable side effects to QTP, Li, Div, or LTG
Patients whose clinical status requires inpatient care
Drug/alcohol dependence within the past 30 days
Pregnancy as determined by serum pregnancy test or breastfeeding
History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.
Intervention: Pioglitazone
Trial phase: Phase 4
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 130
Group description: Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone

pioglitazone: 45 mg per day for 6 months
Eligibility criteria:
Inclusion Criteria:

Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Patients may be of either sex. Female patients must be non-lactating and must either be at least one year post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period
Patients must range in age from 18 to 75 years, inclusive.
Patients with type 2 diabetes must be drug naïve, receiving monotherapy with metformin or with a sulfonylurea, or combination therapy with both: metformin & sulfonylurea.

Patients must have the following laboratory values:

Hematocrit ≥ 34 vol%
Serum creatinine ≤ 1.8 mg/dl
AST (SGOT) ≤ 2.5 times upper limit of normal
ALT (SGPT) ≤ 2.5 times upper limit of normal
Alkaline phosphatase ≤ 2 times upper limit of normal
Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
Only subjects whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

Exclusion Criteria:

Patients must not have type 1 diabetes.
Patients must not be receiving any medications with known adverse effects on glucose tolerance (except metformin or a sulfonylurea) unless the patient has been on stable doses of such agents for the past three months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy, if the patient has been on these agents for the prior three months. Patients taking systemic glucocorticoids are excluded.
Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
Patients with hematocrit < 34% will be excluded.
Patient who were exposed to any procedure involves radiation exposure and his total radiation dose equivalent exceeds 5 rem during the past year will be excluded from the study.
Intervention: Cyclosporine
Trial phase: Phase 2 | Phase 3
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: LSC present, randomized to allogeneic transplant

Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years
Able to give informed consent
New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
Pregnancy: Women of childbearing potential who are β- HCG+
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 127
Group description: Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Females age 18-70
BMI 28-48 kg/m^2
Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
Ability to give informed consent and follow verbal and written instructions in English.

Exclusion Criteria:

Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
Unstable heart disease as evidenced by ongoing angina
Congestive heart failure
Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
Tobacco, marijuana, cocaine, or intravenous drug use
Shift workers (night shift or alternating day/night shifts)
Gastroparesis
Inflammatory bowel disease or irritable bowel syndrome
Malignancy treated with chemotherapy within the past 3 years
History of pancreatitis
Depression requiring hospitalization or diagnosis of psychosis
Renal insufficiency (eGFR less than 50)
Transaminases greater than 2 times above the normal range
Pregnancy within 6 months of the screening visit
Lactation
Failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
History of an eating disorder (anorexia, bulimia or laxative abuse)
Treatment with FDA-approved or over-the-counter weight loss medication within 6 months, with the exception of Xenical if there was no weight loss
History of gastric bypass surgery or gastric stapling
Biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit
Previous treatment with exenatide
Discretion of the PI