anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ritonavir
Trial phase: Phase 3
ATC code: J05AE03 | J05AE30 | J05AP52 | J05AP53 | J05AR10 | J05AR23 | J05AR26
SMILES: CC(C)c1nc(CN(C)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C[C@H](O)[C@H](Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Females were postmenopausal for at least 2 years; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Screening and agreed to practice 1 effective method of birth control from Screening through 30 days after stopping study drug. Sexually active males were surgically sterile or, if sexually active with a female partner of childbearing potential, agreed to practice 1 effective form of birth control from Screening through 30 days after stopping study drug.
Screening central laboratory result indicated HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.

Chronic HCV infection is defined as one of the following:

Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.
A liver biopsy consistent with chronic HCV infection.
Agreed to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.
Participants who were able to understand and adhere to the study visit schedule and all other protocol requirements.
Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

Females who were pregnant or planned to become pregnant, or breastfeeding or males whose partner was pregnant or planning to become pregnant during the study.
Participants co-infected with hepatitis B virus or human immunodeficiency virus.
Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if known), whichever was longer, prior to the first dose of any study drug.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Any cause of liver disease other than chronic HCV infection.
Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of decompensated liver disease.
Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive ABT-493/ABT-530.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Females were postmenopausal for at least 2 years; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Screening and agreed to practice 1 effective method of birth control from Screening through 30 days after stopping study drug. Sexually active males were surgically sterile or, if sexually active with a female partner of childbearing potential, agreed to practice 1 effective form of birth control from Screening through 30 days after stopping study drug.
Screening central laboratory result indicated HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.

Chronic HCV infection is defined as one of the following:

Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.
A liver biopsy consistent with chronic HCV infection.
Agreed to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.
Participants who were able to understand and adhere to the study visit schedule and all other protocol requirements.
Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

Females who were pregnant or planned to become pregnant, or breastfeeding or males whose partner was pregnant or planning to become pregnant during the study.
Participants co-infected with hepatitis B virus or human immunodeficiency virus.
Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if known), whichever was longer, prior to the first dose of any study drug.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Any cause of liver disease other than chronic HCV infection.
Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of decompensated liver disease.
Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive ABT-493/ABT-530.
Intervention: Baricitinib
Trial phase: Phase 2
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

Exclusion Criteria:

Have active severe lupus nephritis.
Have active severe central nervous system (CNS) lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Intervention: Baricitinib
Trial phase: Phase 2
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

Exclusion Criteria:

Have active severe lupus nephritis.
Have active severe central nervous system (CNS) lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Intervention: Simethicone
Trial phase: Phase 4
SMILES: CO[Si](C)(C)O[Si](C)(C)C.O=[Si]=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 180
Group description: All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution

Simethicone
Eligibility criteria:
Inclusion Criteria:

diagnosis of IC according to Rome III criteria (2);
age ≥2 weeks to 4 months;
breast-fed or fomula-fed infants;
term delivery (≥37 weeks gestation at birth);
5-minute Apgar score ≥7; and 6) birth weight ≥2500 g

Exclusion Criteria:

a major medical problem or acute illness;
family history of atopy;
history of antibiotic treatment before or during the study;
history of probiotic supplementation.
Intervention: Nexium
Trial phase: Phase 4
SMILES: COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.O.O.O.[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
Eligibility criteria:
Inclusion Criteria:

Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.

Exclusion Criteria:

A history (past or present) of erosive esophagitis verified by endoscopy.
The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).

For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.
Eligibility criteria:
Inclusion Criteria:

Age 18-30 years, ASA I

Exclusion Criteria:

Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa
Intervention: Propafenone
Trial phase: Phase 1 | Phase 2
ATC code: C01BC03
SMILES: CCCNCC(O)COc1ccccc1C(=O)CCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 193
Group description: Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes

(R)-propafenone
Eligibility criteria:
Inclusion:

History of atrial fibrillation
Greater than or equal to 18 years of age
Scheduled to undergo an atrial fibrillation ablation procedure
Able to provide written informed consent

Exclusion:

Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)
Is in atrial fibrillation or atrial flutter the morning of the ablation procedure

The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator

sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia
sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration
right bundle branch block, left bundle branch block, or bifascicular block
PR-interval > 280ms, or history of 2nd or 3rd degree atrioventricular block
Concomitant use of CYP3A4 and CYP2D6 inhibitors
Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure
Amiodarone use within 3 months prior to enrollment
Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation
Expected life span < 1 year
Creatinine clearance <30 mL/min
Reversible cause of atrial fibrillation (ie. thyrotoxicosis)
Unrevascularized coronary artery disease
Canadian class IV angina
Left ventricular ejection fraction <40%
New York Heart Association Class III or IV symptoms
Previous heart transplantation
Planned heart transplantation or ventricular assist device
Cardiac/thoracic surgery <6 months prior to enrollment
Severe asthma or chronic obstructive pulmonary disease
Breastfeeding
Intervention: Propafenone
Trial phase: Phase 1 | Phase 2
ATC code: C01BC03
SMILES: CCCNCC(O)COc1ccccc1C(=O)CCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 193
Group description: Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes

(S)-Propafenone
Eligibility criteria:
Inclusion:

History of atrial fibrillation
Greater than or equal to 18 years of age
Scheduled to undergo an atrial fibrillation ablation procedure
Able to provide written informed consent

Exclusion:

Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)
Is in atrial fibrillation or atrial flutter the morning of the ablation procedure

The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator

sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia
sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration
right bundle branch block, left bundle branch block, or bifascicular block
PR-interval > 280ms, or history of 2nd or 3rd degree atrioventricular block
Concomitant use of CYP3A4 and CYP2D6 inhibitors
Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure
Amiodarone use within 3 months prior to enrollment
Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation
Expected life span < 1 year
Creatinine clearance <30 mL/min
Reversible cause of atrial fibrillation (ie. thyrotoxicosis)
Unrevascularized coronary artery disease
Canadian class IV angina
Left ventricular ejection fraction <40%
New York Heart Association Class III or IV symptoms
Previous heart transplantation
Planned heart transplantation or ventricular assist device
Cardiac/thoracic surgery <6 months prior to enrollment
Severe asthma or chronic obstructive pulmonary disease
Breastfeeding
Intervention: INCB-057643
Trial phase: Phase 1 | Phase 2
SMILES: CN1C(=O)C(C)(C)Oc2c(-c3cn(C)c(=O)c4[nH]ccc34)cc(S(C)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Part1/Treatment Group A : 8mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.

Treatment Group A included solid tumors and lymphoma
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies:

Part 1: solid tumors or lymphomas, or hematologic malignancies
Part 2: histologically confirmed disease in specific tumor types
Part 3: advanced solid tumor or hematologic malignancy
Part 4: select advanced solid tumor or hematologic malignancy
For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)
For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort.
Life expectancy > 12 weeks, for MF subjects in Parts 3 and 4, life expectancy > 24 weeks

Eastern Cooperative Oncology Group (ECOG) performance status

Parts 1 and 3: 0 or 1
Parts 2 and 4: 0, 1, or 2
Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase.
Receipt of anticancer medications or investigational drugs within protocol-specified intervals
Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant
Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment
Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
Type 1 diabetes or uncontrolled Type 2 diabetes
HbA1c of ≥ 8% (all subjects will have HbA1c test at screening)
Any sign of clinically significant bleeding
Coagulation panel within protocol-specified parameters
Intervention: INCB-057643
Trial phase: Phase 1 | Phase 2
SMILES: CN1C(=O)C(C)(C)Oc2c(-c3cn(C)c(=O)c4[nH]ccc34)cc(S(C)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies:

Part 1: solid tumors or lymphomas, or hematologic malignancies
Part 2: histologically confirmed disease in specific tumor types
Part 3: advanced solid tumor or hematologic malignancy
Part 4: select advanced solid tumor or hematologic malignancy
For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)
For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort.
Life expectancy > 12 weeks, for MF subjects in Parts 3 and 4, life expectancy > 24 weeks

Eastern Cooperative Oncology Group (ECOG) performance status

Parts 1 and 3: 0 or 1
Parts 2 and 4: 0, 1, or 2
Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase.
Receipt of anticancer medications or investigational drugs within protocol-specified intervals
Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant
Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment
Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
Type 1 diabetes or uncontrolled Type 2 diabetes
HbA1c of ≥ 8% (all subjects will have HbA1c test at screening)
Any sign of clinically significant bleeding
Coagulation panel within protocol-specified parameters