anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Serelaxin
Trial phase: Phase 2
ATC code: C01DX21
SMILES: CCC(C)C1NC(=O)C(C)NC(=O)C(C(C)CC)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(NC(=O)C(CC(C)C)NC(=O)C(CCCCN)NC(=O)C(NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCSC)NC(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(CO)NC(=O)C(N)CC(=O)O)C(C)C)C(C)CC)CSSCC2NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(N)=O)NC(=O)C(C)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CO)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C3CCC(=O)N3)CSSCC(NC(=O)CNC(=O)C(C(C)C)NC(=O)C(Cc3cnc[nH]3)NC2=O)C(=O)NC(C(C)O)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CO)C(=O)NC(CC(C)C)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2ccccc2)C(=O)NC(C(=O)O)CSSCC(C(=O)NCC(=O)NC(CCSC)C(=O)NC(CO)C(=O)NC(C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CO)C(=O)O)C(C)O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
Eligibility criteria:
Key Inclusion Criteria:

Written informed consent must be obtained before any study-specific assessment is performed.
Male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg
Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
Dyspnea at rest or with minimal exertion
Pulmonary congestion on chest radiograph
BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL
SBP ≥125 mmHg at the start and at the end of screening
Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
Received intravenous (IV) furosemide of at least 40 mg (or equivalent) at any time between presentation (this include outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute heart failure (HF) episode.
Impaired renal function defined as an estimated glomerular filtration rate (eGFR) between presentation and randomization of ≥ 25 and≤ 75 mL/min/1.73 m2, calculated using the Japanese formula

Key Exclusion Criteria:

Dyspnea primarily due to non-cardiac causes
Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute.
Intervention: Lurasidone Hydrochloride
Trial phase: Phase 3
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 194
Group description: Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent and aged between 18 and 65 years of age.
Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
Any chronic organic disease of the CNS(other than schizophrenia)
Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
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: 10
Group description: Single 3 mL IA injection
Eligibility criteria:
Key Inclusion Criteria:

Written consent to participate in the study
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health

Key Exclusion Criteria:

History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History of infection in the index joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening
IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Prior arthroscopic or open surgery of the index knee within 12 months of Screening
Planned/anticipated surgery of the index knee during the study period
Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
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: 30
Group description: Single 3 mL IA injection
Eligibility criteria:
Key Inclusion Criteria:

Written consent to participate in the study
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health

Key Exclusion Criteria:

History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History of infection in the index joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening
IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Prior arthroscopic or open surgery of the index knee within 12 months of Screening
Planned/anticipated surgery of the index knee during the study period
Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Intervention: Duotrav
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CC(C)OC(=O)CCCC=CCC1C(O)CC(O)C1C=CC(O)COc1cccc(C(F)(F)F)c1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Travoprost/timolol for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
Must be able to understand and sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Use of medication excluded by the protocol.
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
Ocular surgeries or procedures excluded by the protocol.
Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Other protocol-specified exclusion criteria may apply.
Intervention: Brimonidine Tartrate
Trial phase: Phase 4
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 372
Group description: 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria:

Used Alphagan® in previous 3 months
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: 5
Group description: Niacin titrated up to 6 grams taken orally every day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease.
Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period

Exclusion Criteria:

Anxiety or claustrophobia prohibiting imaging
History of allergy to intravenous contrast, iodine, or shellfish
Renal insufficiency
History of allergy or severe intolerance to niacin
History of diabetes mellitus or elevated fasting glucose
Moderate to severe gout
Peptic ulcer disease
Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months
Heart failure or unstable angina pectoris
Use of daily non-statin lipid-altering therapy prior to the initiation of study medication
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 80
Group description: Azithromycin suspension at 10mg/kg/dose (max 500mg)

Once daily for 3 days

Azithromycin: Azithromycin suspension (200mg/5mL)
Eligibility criteria:
Inclusion Criteria:

4-12 years of age
Admission diagnosis of asthma at the Children's Hospital at Montefiore
History of persistent asthma (as defined by National Heart, Lung, and Blood Institute)

Exclusion Criteria:

Concurrent bacterial infection requiring antibiotics
Antibiotics received within previous 2 weeks
Contraindication to azithromycin (including allergy to macrolides)
Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis) or home oxygen requirement
Immunodeficiency (primary or acquired)
Chronic systemic steroid use
Invasive or non-invasive mechanical ventilation required acutely as result of current asthma admission
Significant cardiac co-morbidity (including hemodynamically significant cardiac disease or arrhythmia)
Liver disease (hepatitis)
Pregnancy
Seizure disorder, currently on anti-epileptic medication)
Receiving albuterol every 4 hours (q4h) at the time of enrollment
Previous enrollment in study
Intervention: Linagliptin
Trial phase: Phase 4
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: Linagliptin once daily + correction doses of aspart or lispro if needed.

Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
Eligibility criteria:
Inclusion Criteria:

Males or female surgical non-ICU patients ages between18 and 80 years
A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
Subjects with a BG >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones)

Exclusion Criteria:

Age < 18 or > 80 years.
Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Patients with clinically relevant pancreatic or gallbladder disease.
Patients with previous history of pancreatitis
Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Pregnancy or breast feeding at time of enrollment into the study.
Patients who received supplemental sliding scale insulin >72 hours prior to randomization
Patients who received basal insulin > 48 hours prior to randomization
Intervention: Linagliptin
Trial phase: Phase 4
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.

Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
Eligibility criteria:
Inclusion Criteria:

Males or female surgical non-ICU patients ages between18 and 80 years
A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
Subjects with a BG >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones)

Exclusion Criteria:

Age < 18 or > 80 years.
Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Patients with clinically relevant pancreatic or gallbladder disease.
Patients with previous history of pancreatitis
Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Pregnancy or breast feeding at time of enrollment into the study.
Patients who received supplemental sliding scale insulin >72 hours prior to randomization
Patients who received basal insulin > 48 hours prior to randomization
Intervention: Erythromycin
Trial phase: Not Applicable
ATC code: D10AF02 | D10AF52 | J01FA01 | S01AA17
SMILES: CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants who received a one time dose of IV erythromycin
Eligibility criteria:
Inclusion Criteria:

Subjects must have a definitive diagnosis of Parkinson's Disease (per United Kingdom brain bank criteria), Hoehn and Yahr stage 1-3,
must exhibit unequivocal levodopa responsiveness
must be able to distinguish between the "off" versus "on" state
Subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment and should be anticipated to maintain a stable dose throughout both study periods
Subjects may be on concomitant therapy with Monoamine oxidase B inhibitors, entacapone, and amantadine, though the doses of these medications must have remained stable for at least 28 days prior to enrollment and must be expected to remain stable throughout both study periods.

Exclusion Criteria:

History of deep brain stimulation for Parkinson Disease
History of ablative (tissue removal) surgery for Parkinson Disease
Presence of dementia (MMSE<25)
Presence of active psychosis
History of any chronic gastrointestinal diseases
History of any prior gastrointestinal surgeries except for appendectomy, cholecystectomy, and hysterectomy
Any gastrointestinal surgeries in the past 3 months
Severe dysphagia (difficulty swallowing) to pills or food
History of physiological or mechanical gastrointestinal obstruction
History of strictures or fistulae (abnormal or narrow connections) along the gastrointestinal tract
History of gastric bezoars (undigested mass)
Allergy to wheat, soy, milk, or nuts
Presence of portable electromechanical devices such as pacemaker, defibrillator, or infusion pump
Female subjects who are pregnant or lactating
Symptomatic orthostatic hypotension (low blood pressure)
Diabetes
Presence of symptomatic anemia
Abnormal liver or kidney function
Cardiac arrhythmia (past or present) or abnormal QT interval on entrance EKG
Known hypersensitivity to any of the study drugs
Subjects receiving certain medications during specified time frames
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.

Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
Eligibility criteria:
Inclusion Criteria:

Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
Age 25 to 75 years
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
Hepatic insufficiency
Renal insufficiency
Patients younger than 25 years old and older than 75
Patients intending to receive general anesthesia
Allergy or intolerance to one of the study medications
Patients with an ASA of IV
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months)
Patients with major prior ipsilateral open knee surgery
Intervention: Ferumoxides
Trial phase: Not Applicable
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Intravenous injection of Feraheme, 5 mg Fe/kg

Interventions:

Drug: Feraheme Procedure: MR Scan

Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging

MRI-GE Healthcare 3 Tesla magnet: All patients will undergo
Eligibility criteria:
Inclusion Criteria:

Completed solid organ transplant with referral for transplant follow-up

Exclusion Criteria:

Exclusion criteria comprise MR-incompatible metal implants, need of sedation (since an anesthesia is not supported by this), claustrophobia or hemosiderosis/hemochromatosis.