anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Etoricoxib
Trial phase: Phase 4
ATC code: M01AH05
SMILES: Cc1ccc(-c2ncc(Cl)cc2-c2ccc(S(C)(=O)=O)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 500
Group description: Etoricoxib 60 mg once a day (q.d.)
Eligibility criteria:
Inclusion Criteria:

Must Be Over 20 Years Of Age, Regardless Of Sex
Must Have A Diagnosis Of OA That Requiring Treatment
Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From 0-100 mm)
Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
Must Agree To Participate Voluntarily In The Study
Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
Patient Is Willing To Sign Informed Consent Form

Exclusion Criteria:

Under 20 Years Of Age
Severe Hepatic Insufficiency (Child-Pugh Score > 9)
Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)
Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
Gi Ulcer With Active Bleeding Present At Study Enrollment
Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)
Intervention: Paliperidone
Trial phase: Phase 4
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.
Eligibility criteria:
Inclusion Criteria:

Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
Participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening
Male or female, aged greater than or equal to 18 years

Exclusion Criteria:

Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria
Intervention: Alvelestat
Trial phase: Phase 2
SMILES: Cc1c(-c2ccnn2C)cc(C(=O)NCc2ccc(S(C)(=O)=O)cn2)c(=O)n1-c1cccc(C(F)(F)F)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: AZD9668, 2 x 30 mg twice daily (bid)
Eligibility criteria:
Inclusion Criteria:

Male or post-menopausal or surgically sterile female patients
Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
Have normal renal function

Exclusion Criteria:

Lung transplant patients
Significant liver disease
Any other non-CF-related lung disease that may interfere with study assessments
Intervention: (S)-5-(((4-((5-Chloropyridin-2-yl)oxy)piperidin-1-yl)sulfonyl)methyl)-5-methylimidazolidine-2,4-dione
Trial phase: Phase 2
SMILES: CC1(CS(=O)(=O)N2CCC(Oc3ccc(Cl)cn3)CC2)NC(=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: AZD1236
Eligibility criteria:
Inclusion Criteria:

Diagnosis of COPD for 1 month
Men or postmenopausal women
Spirometry values indicating reduced lung function
Smoking history equivalent to using 20 cigarettes a day for 10 years

Exclusion Criteria:

Any current respiratory tract disorders other than COPD
Requirement for regular oxygen therapy
Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Eligibility criteria:
Inclusion Criteria:

Male or female participants
American Society of Anesthesiologists (ASA) class 1, 2 or 3
Age >=18 years
Scheduled to undergo a surgery requiring profound NMB such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of NMB in a position allowing neuromuscular monitoring
Given written informed consent

Exclusion Criteria:

Participants known or suspected to have neuromuscular disorders affecting NMB
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Eligibility criteria:
Inclusion Criteria:

Male or female participants
American Society of Anesthesiologists (ASA) class 1, 2 or 3
Age >=18 years
Scheduled to undergo a surgery requiring profound NMB such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of NMB in a position allowing neuromuscular monitoring
Given written informed consent

Exclusion Criteria:

Participants known or suspected to have neuromuscular disorders affecting NMB
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males and non-fertile females.
18-75 years inclusive.
Participants with mild-to-moderate uncomplicated essential hypertension.

Exclusion Criteria:

All women of child bearing potential.
Female participants on hormone replacement therapy.
Severe hypertension.
History or evidence of a secondary form of hypertension.
Known moderate or malignant retinopathy.
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (New York Heart Association [NYHA] class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study.
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment.
Treatment with potassium supplement or potassium sparing diuretics.
Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period.
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m^2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol).
Participants with night-shift employment.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males and non-fertile females.
18-75 years inclusive.
Participants with mild-to-moderate uncomplicated essential hypertension.

Exclusion Criteria:

All women of child bearing potential.
Female participants on hormone replacement therapy.
Severe hypertension.
History or evidence of a secondary form of hypertension.
Known moderate or malignant retinopathy.
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (New York Heart Association [NYHA] class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study.
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment.
Treatment with potassium supplement or potassium sparing diuretics.
Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period.
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m^2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol).
Participants with night-shift employment.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males and non-fertile females.
18-75 years inclusive.
Participants with mild-to-moderate uncomplicated essential hypertension.

Exclusion Criteria:

All women of child bearing potential.
Female participants on hormone replacement therapy.
Severe hypertension.
History or evidence of a secondary form of hypertension.
Known moderate or malignant retinopathy.
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (New York Heart Association [NYHA] class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study.
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment.
Treatment with potassium supplement or potassium sparing diuretics.
Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period.
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m^2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol).
Participants with night-shift employment.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males and non-fertile females.
18-75 years inclusive.
Participants with mild-to-moderate uncomplicated essential hypertension.

Exclusion Criteria:

All women of child bearing potential.
Female participants on hormone replacement therapy.
Severe hypertension.
History or evidence of a secondary form of hypertension.
Known moderate or malignant retinopathy.
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (New York Heart Association [NYHA] class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study.
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment.
Treatment with potassium supplement or potassium sparing diuretics.
Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period.
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m^2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol).
Participants with night-shift employment.
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: AZD1981 oral tablet 50 mg, twice daily
Eligibility criteria:
Inclusion Criteria:

Six months history of asthma
Daily use of inhaled glucocorticosteroids
FEV1 40-85% of predicted normal
Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

Other clinically relevant disease or disorders
History of smoking of more than 10 pack years
Respiratory infection within 30 days
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: AZD1981 oral tablet 400 mg, twice daily
Eligibility criteria:
Inclusion Criteria:

Six months history of asthma
Daily use of inhaled glucocorticosteroids
FEV1 40-85% of predicted normal
Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

Other clinically relevant disease or disorders
History of smoking of more than 10 pack years
Respiratory infection within 30 days
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: AZD1981 oral tablet 1000 mg, twice daily
Eligibility criteria:
Inclusion Criteria:

Six months history of asthma
Daily use of inhaled glucocorticosteroids
FEV1 40-85% of predicted normal
Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

Other clinically relevant disease or disorders
History of smoking of more than 10 pack years
Respiratory infection within 30 days
Intervention: Bromfenac
Trial phase: Phase 2
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: bromfenac ophthalmic solution 0.06% bilaterally twice a day
Eligibility criteria:
Inclusion Criteria:

Subjects 18 years of age or older

Exclusion Criteria:

No active ocular conditions of disease
Intervention: Telcagepant
Trial phase: Phase 2
SMILES: O=C(N[C@@H]1CC[C@@H](c2cccc(F)c2F)CN(CC(F)(F)F)C1=O)N1CCC(n2c(=O)[nH]c3ncccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Eligibility criteria:
Inclusion Criteria:

Must be 18 years of age or older
History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
Willing to stay awake for at least 2 hours after taking study drug
Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

Breast-feeding, pregnant, or plan to become pregnant during the study
Not able to tell migraine attack from other headaches
Older than 50 years of age at migraine onset
Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
History of gastric or small intestinal surgery
History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
Currently participating or have participated in a study with in investigational compound or device in the last 30 days