anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Felcisetrag
Trial phase: Phase 1
SMILES: COC(=O)N1CCC(CN2CCC(CNC(=O)c3cccc4[nH]c(C(C)C)nc34)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TD-8954: Intravenous infusion
Eligibility criteria:
Inclusion Criteria:

For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2 and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult males and females 18 to 45 or 65 to 85 years of age, inclusive.
Body mass index (BMI)between 18 to 36 kg/m2, inclusive.
Average frequency of ≥ 3 bowel movements per week.

Exclusion Criteria:

Persistent symptoms of functional GI disorder (such as irritable bowel syndrome, functional constipation, functional dyspepsia, or other symptom-based GI disorders unexplained by a pathologically based disorder) during the 6 months prior to screening, including a history of major surgery of the GI tract, excluding cholecystectomy and appendectomy.
History or presence of clinically significant respiratory, GI, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if the condition is well controlled and not anticipated to interfere with the objectives of the study.
Intervention: Tolvaptan
Trial phase: Phase 3
ATC code: C03XA01
SMILES: Cc1ccccc1C(=O)Nc1ccc(C(=O)N2CCCC(O)c3cc(Cl)ccc32)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)

Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)
Eligibility criteria:
Inclusion Criteria:

≥ 18 years of age
Daily oral dose of furosemide between ≥ 40 mg(or equivalent)
Identified within 24 hours of presentation, defined for purposes of this study as the time of initial dose of intravenous loop diuretic
Prior clinical HF diagnosis that was treated with oral loop diuretics for at least 1 month

Admission for acute decompensated Heart Failure (HF) as determined by

dyspnea at rest or with minimal exertion
Brain Natriuretic Peptide (BNP) > 400 or NTproBNP > 2000 pg/mL

AND at least one of the following additional signs and symptoms:

Orthopnea
Peripheral edema
Elevated JVP (Jugular Venous Pressure)
Pulmonary rales
Congestion on Chest X-ray
No plan for revascularization, cardiac transplant, of ventricular assist device implantation, or other cardiac surgery within 60 days of randomization
Signed informed consent

Exclusion Criteria:

Serum Na > 140 meq/L
Received IV vasoactive treatment or ultra-filtration therapy for HF since initial presentation
Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for HF
Systolic Blood Pressure (SBP)<90mmHg

Serum-Cr>3.5mg/dl or currently undergoing renal replacement therapy

. Known underlying liver disease

Hemodynamically significant arrhythmias
ACS(Acute coronary syndrome) within 4 weeks prior to study entry
Active myocarditis
Hypertrophic obstructive, restrictive, constrictive cardiomyopathy
Severe stenotic valvular disease
Complex congenital heart disease
Constrictive pericarditis
Clinical evidence of digoxin toxicity
Need for mechanical hemodynamic support
Terminal illness (other than heart failure) with expected survival time of less than 1 year
History of adverse reaction to Tolvaptan
Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
Pregnant or breast-feeding
Inability to comply with planned study procedures
Intervention: Tiotropium bromide
Trial phase: Phase 4
ATC code: R03BB04
SMILES: C[N+]1(C)C2CC(OC(=O)C(O)(c3cccs3)c3cccs3)CC1C1OC12.[Br-]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1328
Group description: Inhalator is administered once daily in the dosage of 18µg.
Eligibility criteria:
Inclusion criteria:

Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),
Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,
Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.

Exclusion criteria:

Uncooperative patients as judged by the physician,
Patients with any conditions excluded as per Country specific package insert,
Patients currently enrolled in any clinical trial,
Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.
Intervention: Clevidipine
Trial phase: Phase 2 | Phase 3
ATC code: C08CA16
SMILES: CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1cccc(Cl)c1Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Clevidipine
Eligibility criteria:
Inclusion Criteria:

Spinal fusion for neuromuscular scoliosis.

Exclusion Criteria:

Allergy to dihydropyridine calcium channel antagonists
Allergy to soy or eggs
Non-neuromuscular causes of scoliosis
Disorders of lipid metabolism (clevidipine is in a lipid base)
Intervention: CEFTAROLINE FOSAMIL
Trial phase: Phase 4
ATC code: J01DI02
SMILES: [H][C@]12SCC(Sc3nc(-c4cc[n+](C)cc4)cs3)=C(C(=O)[O-])N1C(=O)[C@H]2NC(=O)/C(=N\OCC)c1nsc(NP(=O)(O)O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Ceftaroline fosamil 600 mg IV over 60 minutes q8h
Eligibility criteria:
Inclusion Criteria:

Subjects are required to meet All of the following inclusion criteria:

Male or female, ≥ 18 years old
Presence of CABP requiring hospitalization
Presence of CABP meeting the following criteria:

I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection

MRSA Risk Factors

• MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

Exclusion Criteria:

Subjects must Not meet any of the following exclusion criteria at baseline:

History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
Evidence of significant hepatic, hematological, or immunocompromising condition
Intervention: Abarelix
Trial phase: Not Applicable
ATC code: L02BX01
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N(C)[C@@H](Cc1ccc(O)cc1)C(=O)N[C@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Eligibility criteria:
Inclusion Criteria:

Age 18-80 years;
GERD for > 1 year;
History of daily PPIs for > 6 months;
At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs;
Hill grade I and II at gastroesophageal junction;
Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing;
Willingness to undergo pH testing;
Willingness to cooperate with the postoperative diet;
Availability for follow-up visits at 6, 12, 24, and 36 months;
Willingly and cognitively signed inform consent

Exclusion Criteria:

BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse dimension;
Esophagitis grade C and D;
Barrett's esophagus > 2 cm;
Esophageal ulcer;
Fixed esophageal stricture or narrowing;
Portal hypertension and/or varices;
Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
Gastroparesis;
Coagulation disorders;
History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;
Pregnancy or plans of pregnancy in the next 12 months;
Enrollment in another device or drug study that may confound the results
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: 25
Group description: During 5 months on ranolazine following adverse events were reported:

Ventricular fibrillation successfully treated with shock from implantable cardioverter-defibrillator (n=1) Ventricular fibrillation unsuccessfully treated with shock from implantable cardioverter-defibrillator with subsequent death (n=1) Bundle branch block (n=1) Dizziness/unsteadiness (n=3) Headache (n=1) Constipation (n=1) Hematuria (n=1) Hemorrhoids (n=1)
Eligibility criteria:
Inclusion Criteria:

Genotyped positive for LQT3 (SCN5A) mutation
Age 21 years or older
Not currently taking an antiarrhythmic drug (beta blockers are allowed)
Enrolled in LQTS Registry

Exclusion Criteria:

Age less than 21 years
Not confirmed to have an LQT3 mutation
Significant co-morbidity that would preclude subject's safe participation in this study
Females who are pregnant or nursing
Females of childbearing age who are not using acceptable method of birth control
Evidence of prior sensitivity to ranolazine
Hepatic or renal disease that might adversely affect ranolazine excretion
Currently taking strong CYP3A inhibitors
Currently taking P-gp inhibitors
Currently taking CYP3A inducers
In vitro studies of specific mutation show no effect of ranolazine on late sodium current kinetics or show repolarization prolongation
Intervention: Lesinurad
Trial phase: Phase 3
ATC code: M04AB05
SMILES: O=C(O)CSc1nnc(Br)n1-c1ccc(C2CC2)c2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 143
Group description: lesinurad 400 mg once daily (qd)
Eligibility criteria:
Inclusion Criteria:

Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
Subject completed the double-blind treatment period in Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
Subject is willing to adhere to the visit/protocol schedules.
Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

Exclusion Criteria:

Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
Subject developed kidney stones during Study RDEA594-303
Intervention: Naltrexone
Trial phase: Phase 2
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 | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: LDN, 5 mg/day-(1 cycle = 28 days).

Naltrexone
Eligibility criteria:
Conditions for Patient Eligibility

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Histologically or pathologically confirmed melanoma, renal cancer or prostate cancer.
Patients with melanoma or renal cancer must have metastatic disease.
Patients with melanoma or renal cancer must have radiographically measurable advanced disease. Patients with measurable cutaneous lesions are also evaluable patients with prostate cancer must be castrate refractory and must have radiographically assessable metastatic disease or must have rising PSA on two sequential measurements.
No prior chemotherapy, or have not received cytotoxic chemotherapy within the 6 months prior to entry..
No radiation for 3 weeks prior to beginning Naltrexone
No requirement for opioid analgesics orNo use of opioid analgesics for at least 10 days.
Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 75,000/uL.
Total bilirubin ≤ 1.5x upper institutional limit (ULN) and AST or ALT ≤ 3x ULN;
No prior history of hepatic failure, cirrhosis or hepatic encephalopathy
ECOG performance status 0 to 2.
Creatinine < 1.5 x ULN
Life expectancy of at least 8 weeks.
Age ≥ 18 years
Women of childbearing potential must have a negative pregnancy test.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.
Voluntary written informed consent.
Conditions for Patient Ineligibility Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
Must not have uncontrolled severe, intercurrent illness.
Women who are breast-feeding.
Patients who have undergone major surgery or radiotherapy within the last 3 weeks.
Patients on concurrent anticancer therapy.
Patients with known, untreated brain metastasis
Co-medication that may interfere with study results; e.g opioids
Known hypersensitivity to any component of naltrexone
Current or prior alcohol dependence
Patients who could benefit from conventional therapy are not eligible.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for knee arthroscopy

Exclusion Criteria:

Inadequate intravenous (IV) access.
History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.
Less than 18 years of age.
Use of analgesics less than 8 hours prior to surgery.
Patients with active, clinically significant anemia.
History or evidence of asthma or heart failure.
Pregnant.
Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.
Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
Refusal to provide written authorization for use and disclosure of protected health information.
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for knee arthroscopy

Exclusion Criteria:

Inadequate intravenous (IV) access.
History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.
Less than 18 years of age.
Use of analgesics less than 8 hours prior to surgery.
Patients with active, clinically significant anemia.
History or evidence of asthma or heart failure.
Pregnant.
Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.
Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
Refusal to provide written authorization for use and disclosure of protected health information.
Intervention: PROPYLENE GLYCOL
Trial phase: Not Applicable
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Sterile ophthalmic solution

Systane: Sterile ophthalmic solution used in the left eye
Eligibility criteria:
Inclusion Criteria:

OSDI >12

Exclusion Criteria:

Presence of any active ocular disease other than dry eye
Intervention: MALIC ACID
Trial phase: Phase 2 | Phase 3
SMILES: O=C(O)CC(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Patients treated with Malic Acid 1%
Eligibility criteria:
Inclusion Criteria:

Xerostomia
Drug consumption
Antidepressant and antihypertensive agents

Exclusion Criteria:

Systemic diseases
Head and neck radiotherapy
Intake of drugs with high xerostomizing capacity
Intervention: Erlotinib
Trial phase: Phase 3
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.

Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed locally advanced stage IIIB, not amenable to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of predominant squamous subtype, according to the 7th edition of the TNM classification, including M1a (separate tumor nodule in a contralateral lobe, tumor with pleural nodules or malignant pleural or pericardial effusion) and/or M1b (distant metastasis).
Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy.
Measurable or evaluable disease according to RECIST v1.1 (Appendix 2).
ECOG PS 0-2.
Age ≥ 18 years.
Adequate organ function, including:
Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
Hepatic: bilirubin <1.5 x ULN; AP, ALT < 3.0 x ULN; AP, ALT <5 x ULN is acceptable in case of liver metastasis.
Renal: calculated creatinine clearance > 40 ml/min based on the Cockroft and Gault formula.
Signed and dated informed consent form.
Male and female patients with reproductive potential must use an approved contraceptive method, during the trial and 12 months thereafter. Female patients with reproductive potential must have a negative pregnancy test within 7 days prior to study registration.
Estimated life expectancy >12 weeks.
Patient compliance and geographical proximity that allow adequate follow-up.

Exclusion Criteria:

Evidence of other medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus).
Previous treatment with any EGFR-TKI or docetaxel.
Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least 14 days prior to study registration.
Documented presence of activating EGFR mutations, if the patient was tested for EGFR mutations.
Previous malignancy within the past 5 years with the exception of adequately treated cervical carcinoma in situ, breast cancer in situ or localized non-melanoma skin cancer.
Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake.
Concurrent treatment with experimental drugs or other anti-cancer therapy treatment in a clinical trial within 21 days prior to study registration.
Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs or any concomitant drugs contraindicated.
Intervention: METHYLPREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Single intrabursal injection of methylprednisolone acetate

methylprednisolone acetate: Single intrabursal ultrasound guided injection
Eligibility criteria:
Inclusion Criteria:

painful rotator cuff calcific tendonitis demonstrated by ultrasounds

Exclusion Criteria:

pregnancy
use of corticosteroids in the previous 2 months
systemic chronic inflammatory or allergic diseases
allergy to methylprednisolone or triamcinolone
diabetes
glaucoma
coagulopathies or current treatment with antiaggregants or anticoagulants
septic arthritis or infections
calcific enthesopathy
Intervention: Kenalog
Trial phase: Phase 4
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: 44
Group description: Single intrabursal injection of Triamcinolone acetonide

Triamcinolone Acetonide: Single intrabursal ultrasound guided injection
Eligibility criteria:
Inclusion Criteria:

painful rotator cuff calcific tendonitis demonstrated by ultrasounds

Exclusion Criteria:

pregnancy
use of corticosteroids in the previous 2 months
systemic chronic inflammatory or allergic diseases
allergy to methylprednisolone or triamcinolone
diabetes
glaucoma
coagulopathies or current treatment with antiaggregants or anticoagulants
septic arthritis or infections
calcific enthesopathy