anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cephalexin
Trial phase: Not Applicable
ATC code: J01DB01
SMILES: [H][C@]12SCC(C)=C(C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
Eligibility criteria:
Inclusion Criteria:

All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).

Exclusion Criteria:

Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
Current or recent (within two weeks) use of any antibiotics
Allergy to clindamycin or cephalexin
Bites (e.g. dog, cat, or human)
Lacerations resulted from crush injury
Lacerations involving bone, tendon, blood vessel, or nerve
Lacerations inflicted more than 12 hours prior to ED visit
Pregnant or breast-feeding women
Intervention: Linolenic Acid
Trial phase: Phase 1 | Phase 2
SMILES: CCC=CCC=CCC=CCCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.

Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement.
Eligibility criteria:
Inclusion Criteria:

Acute myocardial infarction documented by at least 2 of the following:

Typical symptoms
Abnormal levels of cardiac biomarkers (troponin I or T or CK-MB mass) with at least one determination > 99th percentile or ULN for the laboratory
ECG findings diagnostic of myocardial infarction based on the American College of Cardiology criteria.
Status-post urgent or emergent PCI
Have a Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3 (complete perfusion) post PCI.
Have the capacity for informed consent (e.g. without significant dementia or sedation from medication)
Ingested 325 mg of chewed aspirin as part of the acute coronary syndrome treatment protocol.

Exclusion Criteria:

No informed consent
Daily aspirin use prior to index hospitalization
Known prior myocardial infarction
Known pregnancy
Known allergy to fish, fish oil, or aspirin
Known active internal or non-superficial bleeding, known bleeding disorder, coagulation defect, or thrombocytopenia
Thrombolysis in the past 12 hours
Treatment with a IIbIIIa inhibitor during index hospitalization
Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
Severe uncontrolled hypertension (≥180/110) or hypertensive retinopathy
A history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal (not hemorrhoidal) or genitourinary bleeding in the past 6 weeks
A history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
A known arteriovenous malformation or aneurysm
Severe liver insufficiency (ALT ≥ 3 times normal)
Renal insufficiency requiring dialysis
A known diagnosis of vasculitis
Participation in another clinical study
History of malignancy, except subjects who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
Oral contraceptive use
Daily use of NSAIDs
History of drug or alcohol abuse, or current weekly alcohol consumption >14 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 shot of alcohol)
Intervention: Ferumoxides
Trial phase: Phase 3
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Participants received 1 of the following 2 ferumoxytol dose regimens:

Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.
Eligibility criteria:
Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

Males or females 6 months to <18 years of age
CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level <100 nanograms/milliliter (ng/mL)
Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study

Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

History of allergy to either oral or IV iron
Hemoglobin level ≤7.0 g/dL
Serum ferritin level >600 ng/mL
Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test
Intervention: Ferrous Fumarate
Trial phase: Phase 3
ATC code: B03AA02 | B03AD02
SMILES: [Fe+2].[H]/C(C(=O)[O-])=C(/[H])C(=O)[O-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Eligibility criteria:
Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

Males or females 6 months to <18 years of age
CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level <100 nanograms/milliliter (ng/mL)
Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study

Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

History of allergy to either oral or IV iron
Hemoglobin level ≤7.0 g/dL
Serum ferritin level >600 ng/mL
Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test
Intervention: Ferumoxides
Trial phase: Phase 3
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Participants received 1 of the following 2 ferumoxytol dose regimens:

Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.
Eligibility criteria:
Key Inclusion Criteria for this study include:

Males or females 6 months to <18 years of age
Nondialysis dependent CKD, including kidney transplant recipients
Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter (dL) and b) transferrin saturation level <20%
Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria for this study include:

History of allergy to either oral or IV iron
Allergy to two or more classes of drugs
Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
Hemoglobin level ≤7.0 g/dL
Serum ferritin level >600 nanograms/milliliter
Intervention: Ferrous Fumarate
Trial phase: Phase 3
ATC code: B03AA02 | B03AD02
SMILES: [Fe+2].[H]/C(C(=O)[O-])=C(/[H])C(=O)[O-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Eligibility criteria:
Key Inclusion Criteria for this study include:

Males or females 6 months to <18 years of age
Nondialysis dependent CKD, including kidney transplant recipients
Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter (dL) and b) transferrin saturation level <20%
Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria for this study include:

History of allergy to either oral or IV iron
Allergy to two or more classes of drugs
Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
Hemoglobin level ≤7.0 g/dL
Serum ferritin level >600 nanograms/milliliter
Intervention: Testosterone
Trial phase: Phase 2
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: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: intramuscular injections every 2 weeks

testosterone: intramuscular every 2 weeks
Eligibility criteria:
Inclusion Criteria:

T2D Males with age 18-40 years

Exclusion Criteria:

planning to have children in the next one year
Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
Hemoglobin A1c > 8%
Hematocrit > 50%
History of obstructive sleep apnea
Congestive heart failure
Use of thiazolidinediones or exenatide
currently suffering from depression, with or without treatment
history of severe depression in the past which needed hospitalization
currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Coronary event or procedure in the previous 6 months
Hepatic disease (transaminase > 3 times normal) or cirrhosis
Renal impairment (serum creatinine > 1.5)
HIV or Hepatitis C positive status
Participation in any other concurrent clinical trial
Intervention: Enclomiphene
Trial phase: Phase 2
ATC code: G03GB02
SMILES: CCN(CC)CCOc1ccc(C(=C(Cl)c2ccccc2)c2ccccc2)cc1
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: oral drug thrice a week

clomiphene: thrice a week
Eligibility criteria:
Inclusion Criteria:

T2D Males with age 18-40 years

Exclusion Criteria:

planning to have children in the next one year
Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
Hemoglobin A1c > 8%
Hematocrit > 50%
History of obstructive sleep apnea
Congestive heart failure
Use of thiazolidinediones or exenatide
currently suffering from depression, with or without treatment
history of severe depression in the past which needed hospitalization
currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Coronary event or procedure in the previous 6 months
Hepatic disease (transaminase > 3 times normal) or cirrhosis
Renal impairment (serum creatinine > 1.5)
HIV or Hepatitis C positive status
Participation in any other concurrent clinical trial
Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Depot naltrexone (Vivitrol) 380 mg. IM monthly
Eligibility criteria:
Inclusion Criteria:

Homeless per the federal definition (HEARTH Act, 2009), which includes individuals who lack a fixed, regular, and adequate nighttime residence; and those who have a primary nighttime residence that is a supervised publicly or privately operated shelter designed to provide temporary accommodations (including welfare hotels, congregate shelters, and transitional housing); an institution that provides a temporary residence for individuals intended to be institutionalized; and/or a public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings (including doubled up with a friend or family member).
Meet criteria for a DSM-IV diagnosis of alcohol abuse or dependence in the past year.
Last reported drink between 12 hours and 12 months prior, and BAC by breathalyzer of .08 or less.
Age between 18 and 64 years.
Eligible to receive VA services.
Willing to provide informed consent that will include all study procedures.
Those who report any opiate use in the past month must pass a naloxone challenge test (no sign of opiate withdrawal after IM injection of 0.8 mg naloxone).
If female of childbearing potential -- must be using adequate contraception.
Cognitively intact and showing no signs of delusional thought processes on the Short Blessed test (Callahan, 2002) and SCID checklist. Those with an untreated SMI and/or not capable of understanding the study due to an active cognitive impairment or delusional thought process will be excluded.
Speak English sufficiently to understand instructions and assessments.

Exclusion Criteria:

Untreated disorder that might make participation hazardous (e.g. untreated psychosis or bipolar disorder with mania on SCID checklist or significant suicide risk on Modified Scale of Suicidal Ideation (MSSI).
Use of contraindicated medications such as an opioid for a documented diagnosis or opiate maintenance.
Chronic pain condition or expected procedure during the study that is likely to require opioid analgesia.
Contraindicated medical conditions including pregnancy/lactation; liver failure or liver function test levels greater than three times normal; glaucoma; prior adverse reaction to naltrexone; life expectancy of less than 6 months or medical condition that will likely require skilled nursing facility care) within 6 months.
Stated plan to leave the area within 6 months of enrollment.
Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Naltrexone 50 mg tablet PO daily
Eligibility criteria:
Inclusion Criteria:

Homeless per the federal definition (HEARTH Act, 2009), which includes individuals who lack a fixed, regular, and adequate nighttime residence; and those who have a primary nighttime residence that is a supervised publicly or privately operated shelter designed to provide temporary accommodations (including welfare hotels, congregate shelters, and transitional housing); an institution that provides a temporary residence for individuals intended to be institutionalized; and/or a public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings (including doubled up with a friend or family member).
Meet criteria for a DSM-IV diagnosis of alcohol abuse or dependence in the past year.
Last reported drink between 12 hours and 12 months prior, and BAC by breathalyzer of .08 or less.
Age between 18 and 64 years.
Eligible to receive VA services.
Willing to provide informed consent that will include all study procedures.
Those who report any opiate use in the past month must pass a naloxone challenge test (no sign of opiate withdrawal after IM injection of 0.8 mg naloxone).
If female of childbearing potential -- must be using adequate contraception.
Cognitively intact and showing no signs of delusional thought processes on the Short Blessed test (Callahan, 2002) and SCID checklist. Those with an untreated SMI and/or not capable of understanding the study due to an active cognitive impairment or delusional thought process will be excluded.
Speak English sufficiently to understand instructions and assessments.

Exclusion Criteria:

Untreated disorder that might make participation hazardous (e.g. untreated psychosis or bipolar disorder with mania on SCID checklist or significant suicide risk on Modified Scale of Suicidal Ideation (MSSI).
Use of contraindicated medications such as an opioid for a documented diagnosis or opiate maintenance.
Chronic pain condition or expected procedure during the study that is likely to require opioid analgesia.
Contraindicated medical conditions including pregnancy/lactation; liver failure or liver function test levels greater than three times normal; glaucoma; prior adverse reaction to naltrexone; life expectancy of less than 6 months or medical condition that will likely require skilled nursing facility care) within 6 months.
Stated plan to leave the area within 6 months of enrollment.
Intervention: Ethyl o-tolylacetate
Trial phase: Phase 3
SMILES: CCOC(=O)Cc1ccccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 286
Group description: T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
Eligibility criteria:
Inclusion Criteria:

Age ≥ one day of life and ≤ 18 years
Purulent bacterial conjunctivitis
Intervention: Prostaglandin
Trial phase: Phase 3
SMILES: CCCCCC(C=CC1C=CC(=O)C1CC=CCCCC(=O)OC)OC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 189
Group description: One drop of prostaglandin

Prostaglandin: One drop of prostaglandin at 9.00pm
Eligibility criteria:
Inclusion Criteria:

Adult patients diagnosed with glaucoma

Exclusion Criteria:

Under 18.
Intervention: Doxepin Hydrochloride
Trial phase: Phase 3
SMILES: CN(C)CCC=C1c2ccccc2COc2ccccc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
Eligibility criteria:
Inclusion Criteria:

≥ 18 years of age
Histologic proof of malignancy currently undergoing a course of RT (with or without chemotherapy) to a dose of ≥ 5000 cGy using 1.60 to 2.20 Gy per fraction. Note: At least one third of the oral cavity mucosa must be included in the radiation therapy fields.
≥ 4 oral pain felt to be related to mucositis for which the patient wants relief as measured by the Numeric Measure of Oral Pain. Note: An oral exam confirming the presence of mucositis should be performed by the enrolling clinician in addition to patient feedback.
Ability to complete questionnaire(s) independently or with assistance
ECOG Performance Status 0, 1 or 2.
Provide informed written consent.
Willingness to return to enrolling institution for follow-up.

Exclusion Criteria:

Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation
Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration
Current untreated or unresolved oral candidiasis or oral HSV infection
Current untreated narrow angle glaucoma
Current untreated urinary retention ≤ 6 weeks prior to registration
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Any of the following because this study involves a study agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Intervention: Pioglitazone
Trial phase: Phase 3
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: No
Participants at risk: 30
Group description: This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level

pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes, men and women, WHO criteria, aged 35-70 years
HbA1c 7.5-10.0%
BMI 26-39 Kg/m2
Either receiving dietary therapy only or monotherapy with either sulfonylurea or metformin
Already on statin therapy

Exclusion Criteria:

Cardiovascular disease
Renal disease
Other systemic disease
Abnormal liver function tests (ALT or AST>1.5 X ULN)
Uncontrolled hypertension (BP >160/110)
Triglyceride levels >400 mg/dl
Lipid modifying drugs; fibrates, ezetimibe, niacin, bile sequestrants, but not statins (see below),
Estrogen treatment or thyroid disease
Psychiatric condition or substance abuse