anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Unii-T3B2aiz4BF
Trial phase: Phase 2
SMILES: CCC(C)C(NC(C)=O)C(=O)NC1CSSCC(C(=O)NC(C(N)=O)C(C)O)NC(=O)C(CCCNC(=N)N)NC(=O)C(Cc2c[nH]cn2)NC(=O)C(C)NC(=O)CNC(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(Cc2cn(C)c3ccccc23)NC(=O)C(C(C)C)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Eligibility criteria:
Inclusion Criteria:

Willing to give informed consent, make the required study visits and follow instructions;
Newly diagnosed with exudative age-related macular degeneration (AMD);
Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

History or current evidence of macular or retinal disease other than exudative AMD (study eye);
Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
Any evidence of vitreous hemorrhage (study eye);
History or evidence of surgery (study eye), as specified in protocol;
Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol;
History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study
History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator;
Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study;
Participation in any ocular or non-ocular investigational study within 30 days of screening;
Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins;
Other protocol-defined exclusion criteria may apply.
Intervention: Vancomycin
Trial phase: Not Applicable
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
Eligibility criteria:
Inclusion Criteria:

Admission to MD Anderson Cancer Center Surgical Intensive Care Unit (SICU) under the Thoracic Surgery physician group
Intravenous vancomycin therapy deemed necessary

Exclusion Criteria:

Age less than 18 years
History of hypersensitivity to vancomycin
Patient weight greater than 150 kg
Receival of 1 or more doses of the following agents within 72 hours prior to screening: amphotericin B (lipid, liposomal, or conventional formulation), aminoglycosides, foscarnet and/or intravenous contrast dye.
Prior exposure (within 7 days) to intravenous vancomycin
Current renal insufficiency defined as baseline Scr >/= 1.5 mg/dL, or increase in baseline serum creatinine (SCr) by >/= 0.5 mg/dL within the last 2 days, or estimated creatinine clearance (CrCl) </= 30 mL/min by Cockcroft-Gault equation.
Current need for hemodialysis or continuous renal replacement therapy
Intervention: Tolcapone
Trial phase: Not Applicable
ATC code: N04BX01
SMILES: Cc1ccc(C(=O)c2cc(O)c(O)c([N+](=O)[O-])c2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Tolcapone 200mg (single dose)
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 50 years.
Subject is right-handed.
If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device (IUD), hormonal birth control or barrier method).
Subject is able to read and speak English.
Subject is a high school graduate.
Subject is able and willing to provide written and informed consent.
Subject is able to understand and follow the instructions of the investigator, and understand all ratings scales.
Subject is in good health.

Exclusion Criteria:

Using cocaine, stimulants (other than THC, nicotine, & caffeine)amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain pills, sleeping pills or other psychoactive drugs within two weeks of the start of the study OR more than 10 times in the last year.
Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol.
Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
Subject has a history of major alcohol related complications within the proceeding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.)
Liver function test ≥ 3 times normal upper limit.
BAC level > 0.05% at the beginning of screening visit (within margin of error of detection).
Has a neurological dysfunction or psychiatric disorder.
Has severe low blood pressure.
Has uncontrolled high blood pressure.
Regular use of any of the drugs on the tolcapone or entacapone contraindications list OR within 2 weeks of drug administration.
Regular use of SSRIs.
Has an allergy or intolerance to tolcapone or entacapone.
Subject has received an investigational drug within 30 days of screening visit.
Subject is considered unsuitable for the study in the opinion of the investigator or study physician for any other reason.

MRI Exclusion Criteria:

The subject has metal (metal plates, pins, wires or screws, artificial limb, joint replacement or anything that might have been inserted during an operation) in his/her body.
Subject has a pacemaker, defibrillator, stent, or any metal implants related to heart/blood flow problems.
Subject has worked with metals (ie. metallurgy, metal shaving, welding, soldering, etc).
Subject has been wounded with anything metal (bullet, shrapnel or metal filling).
Has ever gotten a piece of metal in the eye.
Has tattoos done with ink containing metal or permanent eyeliner.
Wears color contact lenses.
Has a hearing problem or hearing aid, cochlear implant or past ear surgery.
Has any irremovable dental bridges, dental plates, metal caps or any other non-removable metal in the mouth.
The subject is claustrophobic.
The subject is pregnant. (women only)
Has a IUD. (women only)
Significantly overweight.
Intervention: NIACIN
Trial phase: Not Applicable
ATC code: C04AC01 | C10AD02 | C10AD52 | C10BA01
SMILES: O=C(O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Blood sample and scan results to be compared before and after intervention in each subject.

Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A signed consent form;
Male or Female, 18 years or older;
Diagnosed with ESRD, on maintenance hemodialysis for at least six (6) months;
Subject must be able to understand and provide informed consent;
No known contraindications to therapy with nicotinic acid;
Female subjects of childbearing potential must be willing to be on an acceptable form of birth control for the duration of the study and for two month after they have stopped taking the study drug.

Exclusion Criteria:

Any patient with a medical condition or taking any medications that would be contraindicated with the use of extended release niacin, such as active peptic ulcer disease;
History of severe allergic reactions to the study medication;
History of active infection or acute gouty attack within 2 weeks prior to enrollment;
Known serological positivity for HIV, HBsAg, or HCV Ab;
HbA1C > 9;
Total CK of more than three times of the upper limit of normal;
Elevation of liver function tests at time of entry (AST and/or ALT > 2 times the upper limit of normal);
History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;
History of malignancy except adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
History of an inflammatory disease such as SLE, rheumatoid arthritis or ulcerative colitis;
Patients currently on pharmacological doses of nicotinic acid;
Patients receiving chronic anti-inflammatory therapy;
Patients with average baseline hs-CRP levels of > 20 mg/L or < 1 mg/L;
Patients in whom FDG-PET/CT dual scans are contraindicated (e.g., pregnant patients or those with severe allergy to IV contrast; a pregnancy test will be performed in each female subject between 18 and 45 years of age prior to each scan)
Intervention: Olopatadine Hydrochloride
Trial phase: Phase 4
SMILES: CN(C)CCC=C1c2ccccc2COc2ccc(CC(=O)O)cc21.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 215
Group description: 1 drop self-administered in each eye once daily in the morning for 7 days
Eligibility criteria:
Inclusion Criteria:

12 years of age or older.
History (within the past 24 months) of allergic conjunctivitis.
Active signs and symptoms of ocular allergies.
Ocular health within normal limits, as determined by the investigator or subinvestigator.
Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Contraindications or hypersensitivity to study medication or its components.
One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
Known history of recurrent corneal erosion syndrome.
Ocular trauma or surgical intervention within 6 months prior to Visit 1.
Participation in any other investigational study within 30 days before Visit 1.
Pregnant or nursing.
Other protocol-defined exclusion criteria may apply.
Intervention: Vancomycin
Trial phase: Not Applicable
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Vancomycin 15mg/kg

Vancomycin : 15mg/kg
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Treated in Christiana Emergency Department
Receiving Vancomycin for an infection or presumed infection
Being admitted to Christiana Hospital
Planned continued use of Vancomycin after admission.

Exclusion Criteria:

Less than 18 years of age
Weight greater than 120 kg.
Concurrent use of aminoglycosides or acyclovir
Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia
Patients currently undergoing dialysis
Pregnant or breast feeding
No plan to continue Vancomycin after admission.
Creatinine clearance less than 50ml/min.
Intervention: Vancomycin
Trial phase: Not Applicable
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Vancomycin 30mg/kg

Vancomycin : 30mg/kg
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Treated in Christiana Emergency Department
Receiving Vancomycin for an infection or presumed infection
Being admitted to Christiana Hospital
Planned continued use of Vancomycin after admission.

Exclusion Criteria:

Less than 18 years of age
Weight greater than 120 kg.
Concurrent use of aminoglycosides or acyclovir
Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia
Patients currently undergoing dialysis
Pregnant or breast feeding
No plan to continue Vancomycin after admission.
Creatinine clearance less than 50ml/min.
Intervention: Epinephrine
Trial phase: Phase 4
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Injection combination prior to skin closure.

Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Eligibility criteria:
Inclusion Criteria:

Unilateral primary total knee replacement.
Weight 50-125 kg.
Age 18-79 years.
Intact neurological exam to the surgical lower extremity.
Cognitively intact with ability to sign informed consent.

Exclusion Criteria:

Renal insufficiency with creatinine >1.5 mg/dL.
Allergy to medication used in the study.
Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.)
Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Intervention: Argatroban
Trial phase: Phase 4
ATC code: B01AE03
SMILES: CC1CNc2c(cccc2S(=O)(=O)N[C@@H](CCCNC(=N)N)C(=O)N2CC[C@@H](C)C[C@@H]2C(=O)O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.

Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment
Eligibility criteria:
Inclusion Criteria:

For extracranial artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%; according to intracranial artery lesion, stenting was considered for symptomatic stenosis≥70% in invalid patients after intensive medical therapy.
Successfully had intracranial or extracranial artery stenting

Exclusion Criteria:

Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months
Hypersensitivity to contrast agent
Malignant hypertension
Difficult to perform the intracranial and extracranial artery stenting
Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
Serum creatinine >1.5 mg/dL
Hypersensitivity to test drugs
Difficult to hand follow-up visit
Intervention: Mapracorat
Trial phase: Phase 2
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: 2% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects who have a diagnosis of dry eye disease.
Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

Subjects with known hypersensitivity or contraindication to any component of the study medication.
Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
Subjects who are expected to require treatment with corticosteroids during the study.
Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
Subjects who have undergone any type of ocular surgery within three months prior to screening.
Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Intervention: Mapracorat
Trial phase: Phase 2
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)

2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects who have a diagnosis of dry eye disease.
Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

Subjects with known hypersensitivity or contraindication to any component of the study medication.
Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
Subjects who are expected to require treatment with corticosteroids during the study.
Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
Subjects who have undergone any type of ocular surgery within three months prior to screening.
Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Intervention: Mapracorat
Trial phase: Phase 2
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: 1% BOL-303242-X ophthalmic suspension

1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects who have a diagnosis of dry eye disease.
Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

Subjects with known hypersensitivity or contraindication to any component of the study medication.
Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
Subjects who are expected to require treatment with corticosteroids during the study.
Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
Subjects who have undergone any type of ocular surgery within three months prior to screening.
Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Intervention: Mapracorat
Trial phase: Phase 2
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: 0.3% BOL-303242-X ophthalmic suspension

0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects who have a diagnosis of dry eye disease.
Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

Subjects with known hypersensitivity or contraindication to any component of the study medication.
Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
Subjects who are expected to require treatment with corticosteroids during the study.
Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
Subjects who have undergone any type of ocular surgery within three months prior to screening.
Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Participants were randomized to receive ranolazine for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant with T2DM on stable non-insulin antidiabetic therapy in addition to diet and exercise
Body mass index (BMI) ≥ 25 kg/m^2 and ≤ 40 kg/m^2
HbA1c 7 - 11%
Ability and willingness to maintain a complete and accurate Subject Activity Log during the course of the trial
Female of child-bearing potential must have agreed to use effective methods of contraception
Ability to understand and willing to sign written informed consent

Exclusion Criteria:

Type 1 Diabetes Mellitus (T1DM)
T2DM with history of or current insulin therapy. Prior use during pregnancy or gestational diabetes was acceptable.
History of ketoacidosis or ketosis-prone diabetes
Clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial
History of a severe episode of hypoglycemia
Change in non-insulin antidiabetic therapy in addition to diet and exercise < 2 months prior to screening
Any clinically significant cardiovascular event < 2 months prior to screening
Clinically significant, inadequately controlled or unstable hypertension
Hospitalization < 2 months prior to screening
Major surgery < 3 months prior to screening
Weight loss medication (prescription or non-prescription) < 2 months prior to screening