anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years, with chronic genotype 1 HCV infection
HCV RNA equal to or greater than 10,000 IU/mL at screening
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years, with chronic genotype 1 HCV infection
HCV RNA equal to or greater than 10,000 IU/mL at screening
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Intervention: Indacaterol
Trial phase: Phase 4
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
Eligibility criteria:
Key Inclusion Criteria:

Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.

Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including:

Smoking history of at least 10 pack years
FEV1/FVC < 70%

Key Exclusion criteria:

Previous diagnosis of asthma
Pregnant or nursing women
Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
Intervention: Tiotropium
Trial phase: Phase 4
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Eligibility criteria:
Key Inclusion Criteria:

Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.

Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including:

Smoking history of at least 10 pack years
FEV1/FVC < 70%

Key Exclusion criteria:

Previous diagnosis of asthma
Pregnant or nursing women
Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
Intervention: Utibron Neohaler
Trial phase: Phase 3
SMILES: CCc1cc2c(cc1CC)CC(NCC(O)c1ccc(O)c3[nH]c(=O)ccc13)C2.C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 258
Group description: 27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
Eligibility criteria:
Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Indacaterol
Trial phase: Phase 3
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 260
Group description: 27.5 ug b.i.d.
Eligibility criteria:
Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 262
Group description: 12.5 ug b.i.d.
Eligibility criteria:
Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 110
Group description: All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Eligibility criteria:
Inclusion Criteria:

Completed participation in Trial 31-12-293
Written ICF obtained from a legally acceptable representative & informed assent at Baseline as applicable by trial center's IRB/IEC
The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator

Exclusion Criteria:

Experienced AEs during the double-blind trial (31-12-293) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial
A positive drug screen
Sexually active patients not using 2 approved methods of contraception
Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
Risk of committing suicide
Body weight lower than 16 kg
Abnormal laboratory test results, vital signs and ECG results
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 197
Group description: Brexpiprazole, flexible dose and assigned ADT

Brexpiprazole: tablet/capsule
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
Subjects currently treated with insulin for diabetes.
Subjects with uncontrolled hypertension
Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
Inability to swallow tablets or tolerate oral medication
Abnormal laboratory test results, vital signs and ECG results
Subjects who previously participated in any prior brexpiprazole clinical trial.
Intervention: Daptomycin
Trial phase: Phase 4
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 22
Group description: Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
Eligibility criteria:
Inclusion Criteria:

To be included in this study, participants must:

Sign a parental consent form; if appropriate, sign an assent form
Be between 1 and 17 years of age
Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain
If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
If male, must take appropriate measures to not get partner pregnant
Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
Anticipate to require other antibiotics that may be potentially effective against S. aureus;
Have shock or hypotension unresponsive to standard therapy;
Have received an investigational product or have participated in an experimental procedure within 30 days;
Have an intolerance or hypersensitivity to daptomycin;
Have renal insufficiency;
Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);
Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
Have S. aureus pneumonia, empyema, meningitis, or endocarditis
Intervention: Daptomycin
Trial phase: Phase 4
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
Eligibility criteria:
Inclusion Criteria:

To be included in this study, participants must:

Sign a parental consent form; if appropriate, sign an assent form
Be between 1 and 17 years of age
Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain
If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
If male, must take appropriate measures to not get partner pregnant
Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
Anticipate to require other antibiotics that may be potentially effective against S. aureus;
Have shock or hypotension unresponsive to standard therapy;
Have received an investigational product or have participated in an experimental procedure within 30 days;
Have an intolerance or hypersensitivity to daptomycin;
Have renal insufficiency;
Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);
Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
Have S. aureus pneumonia, empyema, meningitis, or endocarditis
Intervention: VALPROIC ACID
Trial phase: Early Phase 1
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Valproic acid 250 mg or 500mg by mouth twice daily.

Valproic Acid: generic valproic acid tablets packaged in placebo-matched capsules.
Eligibility criteria:
Inclusion Criteria:

Men or women aged 65-90, inclusive.
English-speaking, to ensure compliance with cognitive testing and study visit procedures.
Female participants must not be pregnant or of childbearing potential, i.e. either surgically sterile or postmenopausal for > 1 year.

Stable medical condition for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined as follows:

Platelets > 100,000
Serum creatinine ≤ 1.6 mg/dL
Liver function tests ≤ 1.5 upper limit of normal
No clinically significant abnormalities of other laboratory studies (blood counts, chemistry panel, urinalysis) as determined by the study physician
Stable medications for 4 weeks prior to screening visit.
Able to ingest oral medications.
No history of adverse drug reactions to VPA or similar agents.
Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests in the opinion of the study physician.
Not demented by Hachinski Ischemic Index (< 4).

Exclusion Criteria:

Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse by history.
History of invasive cancer within the past two years (excluding non-melanoma skin cancer).
Contra-indications to lumbar puncture (bleeding disorder, platelet count < 100,000, anticoagulant treatment, major structural abnormality or sepsis in the area of the lumbosacral spine that would make spinal fluid collection technically difficult).
Clinically significant MRI abnormalities that contraindicate lumber or suggest central nervous system disease processes that could influence study outcomes in the opinion of the PI.
Use of any investigational agents within 30 days prior to screening.
Major surgery within eight weeks prior to the Baseline Visit.
Severe unstable medical illnesses, including uncontrolled cardiac conditions or heart failure (New York Heart Association Class III or IV) .
Antiretroviral therapy for human immunodeficiency virus (HIV).
Residence in a skilled nursing facility.
Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.

Excluded Medications

Experimental drugs
Lamictal
Tricyclic antidepressants (amitriptyline/nortryptiline)
Carbamazepine/ oxcarbazepine
Benzodiazepines
Phenobarbital
Phenytoin
Tolbutamide
Topiramate
Warfarin
Zidovudine
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
Eligibility criteria:
Inclusion Criteria:

Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation (NVAF);
Have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (>=1 year) NVAF;
Be suitable for anticoagulant therapy and catheter ablation as per the judgment of the investigator;
Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active;
Women of childbearing potential must have a negative serum pregnancy test at screening;
Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol;
Have a life expectancy of at least 6 months

Exclusion Criteria:

Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive status epilepticus within 6 months of the screening visit;
Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure;
Has had major surgery (requiring general anesthesia), within 6 months before screening or planned surgery during the time the subject is expected to participate in the study;
Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or noncardiac cause of NVAF;
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments