anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sivelestat
Trial phase: Phase 3
SMILES: CC(C)(C)C(=O)Oc1ccc(S(=O)(=O)Nc2ccccc2C(=O)NCC(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 424
Group description: Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Eligibility criteria:
Inclusion Criteria:

Participant must have successfully enrolled in either study M10-877 or M10-880 and either met the endpoint of "Treatment Failure" or completed the study

Exclusion Criteria:

A participant will be excluded from this study if the participant discontinued from study M10-877 or M10-880 for any reasons other than having a Treatment Failure event
Participant with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
Participants with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications or evidence of glaucomatous optic nerve injury
Participant with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
Participant with neovascular/wet age-related macular degeneration
Participant with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
Participant with a systemic inflammatory disease that requires therapy with a prohibited immunosuppressive agent at the time of study entry
Intervention: Moxifloxacin
Trial phase: Phase 1
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
Eligibility criteria:
Inclusion Criteria:

Males and females 18 to 55 years of age, inclusive.
Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≤ 30 kg/m2.
Healthy as determined by unremarkable medical history, physical examination, vital signs, laboratory evaluations, electrocardiogram (ECG), and a 24-hour screening ECG telemetry.
Willing to refrain from strenuous exercise or contact sports during the study.
Female subjects must be surgically sterile or at least 2 years postmenopausal, or using an effective contraceptive method (intrauterine device, hormonal contraceptive, or double-barrier method).

Exclusion Criteria:

Any clinically significant illness during the 30 days prior to randomization.
Any history of allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class of drugs.
A clinically significant history of allergic reaction to wound dressings or bandages.
Any medical or surgical conditions which might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism, or excretion.
Abnormalities on physical examination, vital signs, ECG, or clinical laboratory values, unless those abnormalities are judged to be clinically insignificant by the Investigator.
Any cardiovascular disorders, including hypertension.
Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.
Any personal or family history of prolonged QT interval or disorders of cardiac rhythm.
Abnormal cardiac condition denoted by any of the following:
QT interval ≥ 450 milliseconds (msec).
PR interval > 240 msec or ≤ 110 msec.
Evidence of second- or third-degree atrioventricular (AV) block.
Pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.5 mV).
Evidence of ventricular preexcitation, complete left bundle branch block, right bundle branch block (RBBB), or incomplete RBBB.
A resting heart rate outside the range of 50 to 85 beats per minute (bpm).

Other protocol-specific exclusion/inclusion criteria may apply.
Intervention: Gentamicin
Trial phase: Not Applicable
ATC code: D06AX07 | J01GB03 | S01AA11 | S02AA14 | S03AA06
SMILES: CNC(C)C1CCC(N)C(OC2C(N)CC(N)C(OC3OCC(C)(O)C(NC)C3O)C2O)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
Eligibility criteria:
Inclusion Criteria:

Patients with non-calculus biliary obstruction who need palliative treatment

Exclusion Criteria:

Fever (> 37.8 Celsius)
Leukocytosis (WBC > 10,000 /mm3)
Not candidate for surgical cure of obstruction
Intervention: Ferumoxides
Trial phase: Phase 4
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 2 doses of 510 mg IV over 17 seconds separated by 3 days
Eligibility criteria:
Inclusion Criteria:

Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days
TSAT less than or equal to 25 percent
Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)
(Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)
Subjects who are able to read and write in English
Subjects who have signed consent

Exclusion Criteria:

Subjects who have been enrolled in a clinical trial within the past 30 days
Subjects who have received IV iron within 4 weeks of the start of the study
Serum ferritin greater than or equal to 1200 ng/dL
Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL
Evidence of iron overload
Known hypersensitivity to ferumoxytol or any of its components
Anemia caused by conditions other than iron deficiency
Subjects with elective surgeries scheduled within the next 3 months
Subjects with elective magnetic resonance procedure scheduled during the study period
Subjects who have been hospitalized within the past 30 days (excluding vascular access care)
Subjects who have received a blood transfusion in the past 30 days
Subjects who are transfusion dependent
(Female) Subjects who are pregnant or nursing
Subjects with known inflammatory conditions which may affect serum ferritin
Subjects who are considered to be clinically unstable at the discretion of Principal Investigator (P.I.)
Subjects who have a clinically unstable blood pressure (BP) of systolic greater than 180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting, pre-dialysis)
Subjects with life expectancy less than 6 months
Subjects who refuse to sign consent
Intervention: Aprepitant
Trial phase: Phase 2
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Aprepitant 125 mg per day

Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older at registration
Gastric emptying scintigraphy within 2 years of registration
Normal upper endoscopy or upper GI series within 2 years of registration
Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21
Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale

Exclusion Criteria:

Another active disorder which could explain symptoms in the opinion of the investigator
Use of narcotics more than 3 days per week
Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
Contraindications to aprepitant such as hypersensitivity or allergy
Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride
Pregnancy or nursing
Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
Failure to give informed consent
Intervention: Tamsulosin
Trial phase: Phase 1
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: 0.4 mg Capsule
Eligibility criteria:
Inclusion Criteria:

Healthy, non-smoking male subjects, 18 years of age or older.
BMI greater than or equal to 19 and less than or equal to 30.

Negative for:

HIV.
Hepatitis B surface antigen and Hepatitis C antibody.
Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
Urine cotinine test
No significant diseases or clinically significant findings in a physical examination.
No clinically significant abnormal laboratory values.
No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 60-90 mmgHg.
Be informed of the nature of the study and given written consent prior to receiving any study procedure.

Exclusion Criteria:

Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration.
Known or suspected carcinoma.

Known history or presence of:

Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity.
Alcoholism within the last 12 months.
Drug dependence and/or substance abuse.
Use of tobacco or nicotine-containing products within the last 6 months.
Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing.
Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing.
On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
Difficulty fasting or consuming the standard meals.
Do not tolerate venipuncture.
Unable to read or sign the ICF.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 106
Group description: Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
Eligibility criteria:
Inclusion Criteria:

Informed consent / assent
Ages 1-11 years (12 - 132 months)
American Society of Anesthesiology (ASA) physical status 1 or 2, which implies that the patient has no comorbidity that limits daily function.
Scheduled for non-emergent surgery/ procedure under general anesthesia in which the anesthesia team intends to place an endotracheal tube
Expected routine intubation according to physical exam and history
Weight under 50 kg

Exclusion Criteria:

Requires neuromuscular blocking agents
Emergent surgery / procedure
Expected difficult intubation
ASA physical status 3 or 4
Weight over 50 kg
Age under 12 months or over 132 months
Allergy to study drugs to be used
Intervention: Rosiglitazone
Trial phase: Phase 2
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: One 8mg capsule daily for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Overweight but otherwise in good general health.
Age 18 - 55 years.
Normal glucose tolerance.
Stable weight with BMI (27-44).
Stable medication use for the preceding month.
BP < 150/90.
Negative pregnancy test (*HCG), if female and of childbearing potential.
Practicing, and willing to continue to practice appropriate contraception throughout the study if a female of childbearing potential.

Exclusion Criteria:

Serious medical illness.
Pregnancy.
Tobacco use within the past 6 months.
Prior or current treatment with a thiazolidinedione.
Patients who have received an investigational drug in the past 30 days.
Use of systemic corticosteroids.
Known or suspected allergy to Rosiglitazone or any component of the preparation
Intervention: Buprenorphine
Trial phase: Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 189
Group description: Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
Eligibility criteria:
Inclusion Criteria:

Include:

Subjects of either sex aged 18 years or older.
Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.

Exclusion Criteria:

Include:

Subjects currently receiving daily morphine or oxycodone (mono-therapy).
Subjects who are discontinued from BUP3201 due to adverse events.
Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.

Refer to core study for additional inclusion/exclusion information.
Intervention: Dronedarone
Trial phase: Phase 3
ATC code: C01BD07
SMILES: CCCCc1oc2ccc(NS(C)(=O)=O)cc2c1C(=O)c1ccc(OCCCN(CCCC)CCCC)cc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 1614
Group description: Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
Eligibility criteria:
Inclusion criteria:

Permanent AF defined by the presence of all of the following criteria:

Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter;
Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization;
No evidence of sinus rhythm in the period between these two documentations of AF;
Decision of the patient and physician to allow AF to continue without further efforts to restore sinus rhythm.

At least one of the following risk criteria:

Coronary artery disease;
Prior stroke or Transient Ischemic Attack [TIA];
Symptomatic heart failure;
Left ventricular ejection fraction [LVEF] less or equal to 0.40;
Peripheral arterial occlusive disease;
Aged 75 years or older with both hypertension and diabetes mellitus.

Exclusion criteria:

Paroxysmal AF;
Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm;
Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA class III.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 105
Group description: Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
Eligibility criteria:
Inclusion Criteria:

msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
Must be able to swallow minitablets (2mm in diameter) administered in soft food
Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Exclusion Criteria:

Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
msSBP ≥ 25% above the 95th percentile
Second or third degree heart block without a pacemaker
AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
Total bilirubin > 2 times the upper limit of the reference range
Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
WBC count < 3000/mm³
Platelet count < 100,000/mm³
Serum potassium > 5.2 mEq/L
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Enalapril
Trial phase: Phase 3
ATC code: C09AA02 | C09BA02 | C09BB02 | C09BB06
SMILES: CCOC(=O)[C@H](CCc1ccccc1)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 103
Group description: Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
Eligibility criteria:
Inclusion Criteria:

msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
Must be able to swallow minitablets (2mm in diameter) administered in soft food
Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Exclusion Criteria:

Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
msSBP ≥ 25% above the 95th percentile
Second or third degree heart block without a pacemaker
AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
Total bilirubin > 2 times the upper limit of the reference range
Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
WBC count < 3000/mm³
Platelet count < 100,000/mm³
Serum potassium > 5.2 mEq/L
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Rufinamide
Trial phase: Phase 3
ATC code: N03AF03
SMILES: NC(=O)c1cn(Cc2c(F)cccc2F)nn1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
Eligibility criteria:
Inclusion criteria:

Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.
Male participants with reproductive ability and female participants with child-bearing potential, or their partners, had to be able to take medically appropriate contraceptive measures.
Participants who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the E2080-J081-304 study.
Participants who had a family member or a caregiver capable of recording the reporting diary, providing participant information necessary for the study, assisting treatment compliance, and accompanying the participant on scheduled visit days during the study period.

Exclusion criteria:

Participants who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the E2080-J081-304 Study.
Participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
Participants who were judged by the investigator that they were unfit to participate in this clinical trial.