anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ARIPIPRAZOLE LAUROXIL
Trial phase: Phase 4
SMILES: CCCCCCCCCCCC(=O)OCN1C(=O)CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection
Eligibility criteria:
Inclusion Criteria:

Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
Has a diagnosis of schizophrenia
Is clinically stable
Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
Agreed to abide by the contraceptive requirements o the protocol
Resides in a stable living situation
Additional criteria may apply

Exclusion Criteria:

Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
Additional criteria may apply
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 133
Group description: Administered as a coated bilayer tablet

Olanzapine: Daily dosing
Eligibility criteria:
Inclusion Criteria:

Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
Meets criteria for the diagnosis of schizophrenia
Resides in a stable living situation when not hospitalized
Is willing and able to provide government-issued identification
Additional criteria may apply

Exclusion Criteria:

Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
Subject poses a current suicide risk
Subject has a history of treatment resistance
Subject has a history of poor or inadequate response to treatment with olanzapine
Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
Subject has a diagnosis of moderate or severe alcohol or drug use disorder
Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
Additional criteria may apply
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: 81
Group description: Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
Eligibility criteria:
Inclusion Criteria:

Meets protocol-specified criteria for qualification and contraception
Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff;
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
the analysis of results
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: 80
Group description: Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
Eligibility criteria:
Inclusion Criteria:

Meets protocol-specified criteria for qualification and contraception
Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff;
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
the analysis of results
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: 82
Group description: Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
Eligibility criteria:
Inclusion Criteria:

Meets protocol-specified criteria for qualification and contraception
Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff;
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
the analysis of results
Intervention: Utibron Neohaler
Trial phase: Phase 4
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: 31
Group description: Single daily dose of 110/50 μg QVA149 for 8-10 days.
Eligibility criteria:
Key Inclusion Criteria:

Males and females with COPD aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed with moderate to severe COPD according to GOLD 2015 criteria were included in the study. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC < 0.70 and by a post-bronchodilator FEV1 ≥ 30 % and <80 % were included in the study. Post-bronchodilator refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose).

Key Exclusion Criteria:

Patients with conditions which could compromise patient safety and compliance (as judged by the investigator), as well as conditions that required oxygen therapy for chronic hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with lower respiratory infections within 6 weeks of screening, and patients with concomitant pulmonary disease were excluded from the study. Patients with asthma were also excluded from the study.

Pregnant or nursing (lactating) women, patients with poorly controlled Type I or Type II diabetes, patients with poor renal function, and those who were unable to use a dry powder inhaler or perform spirometry, and had contraindications to MRI were also excluded.
Intervention: Cisatracurium
Trial phase: Phase 4
ATC code: M03AC04 | M03AC11
SMILES: COc1ccc(CC2c3cc(OC)c(OC)cc3CC[N+]2(C)CCC(=O)OCCCCCOC(=O)CC[N+]2(C)CCc3cc(OC)c(OC)cc3C2Cc2ccc(OC)c(OC)c2)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).

Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Eligibility criteria:
Inclusion Criteria:

Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring cardiopulmonary bypass

Exclusion Criteria:

Emergency surgery
Extremes of age
Previous cardiac surgery
Clinical contraindications to succinylcholine or cisatracurium
Anticipated difficult tracheal intubation
Preoperative mechanical ventilation
Preoperative pharmacologic/mechanical hemodynamic support
Intervention: Succinylcholine
Trial phase: Phase 4
ATC code: M03AB01
SMILES: C[N+](C)(C)CCOC(=O)CCC(=O)OCC[N+](C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.

Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
Eligibility criteria:
Inclusion Criteria:

Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring cardiopulmonary bypass

Exclusion Criteria:

Emergency surgery
Extremes of age
Previous cardiac surgery
Clinical contraindications to succinylcholine or cisatracurium
Anticipated difficult tracheal intubation
Preoperative mechanical ventilation
Preoperative pharmacologic/mechanical hemodynamic support
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Eligibility criteria:
Inclusion Criteria:

Inpatient or outpatient hematology patient receiving one of the following regimens:
Chemotherapy for hematologic malignancy:
ABVD
ICE ± R
7+3
Conditioning therapy for stem cell transplantation:
BEAM
Bu/Cy ± ATG
Bu/Flu ± ATG
FluCy ± ATG
FluCy + TBI
BuMel
FluBuCy
Melphalan
Etoposide + TBI
Cyclophosphamide + TBI

Exclusion Criteria:

Allergy to olanzapine
Documented nausea or vomiting ≤24 hours prior to enrollment
Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol therapy
Chronic alcoholism
Pregnant
Declined or unable to provide an informed consent
Intervention: Humalog
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Reference formulation: Single dose of lispro administered SC in one of five periods
Eligibility criteria:
Inclusion Criteria:

Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
Show signs of having an infection or infectious disease at the time of study entry
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: 121
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
Chronic HCV infection.
HCV treatment-naïve or treatment experienced (interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV]; sofosbuvir [SOF] plus RBV with or without pegIFN).
Non-cirrhotic participants.

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
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.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Co-infection with more than one HCV genotype.
Intervention: OXYBATE
Trial phase: Phase 4
SMILES: O=C(O)CCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: patients given single dose of Xyrem

Xyrem: single 3.0 gram dose
Eligibility criteria:
Inclusion Criteria:

current diagnosis of narcolepsy with cataplexy OR healthy control

Exclusion Criteria:

use of any sedative hypnotics, tranquilizers, anticonvulsants, antihistamines (except non-sedating), benzodiazepines, clonidine or any medication known to affect dopamine at start of baseline period
significant unstable or uncontrolled medical/psychiatric disease
significant history of head trauma/surgery or seizure disorder
radiation exposure exceeding 20mSv in last 12 months
pregnancy
substance abuse/dependence (including alcohol)
have sleep apnea, or are shift workers
on a sodium-restricted diet
has ever taken Xyrem / sodium oxybate / GHB at any time
claustrophobia
metal implants / objects in the body that may interfere with MRI
succinic semialdehyde dehydrogenase deficiency
Intervention: OXYBATE
Trial phase: Phase 4
SMILES: O=C(O)CCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: healthy controls given a single dose of Xyrem

Xyrem: single 3.0 gram dose
Eligibility criteria:
Inclusion Criteria:

current diagnosis of narcolepsy with cataplexy OR healthy control

Exclusion Criteria:

use of any sedative hypnotics, tranquilizers, anticonvulsants, antihistamines (except non-sedating), benzodiazepines, clonidine or any medication known to affect dopamine at start of baseline period
significant unstable or uncontrolled medical/psychiatric disease
significant history of head trauma/surgery or seizure disorder
radiation exposure exceeding 20mSv in last 12 months
pregnancy
substance abuse/dependence (including alcohol)
have sleep apnea, or are shift workers
on a sodium-restricted diet
has ever taken Xyrem / sodium oxybate / GHB at any time
claustrophobia
metal implants / objects in the body that may interfere with MRI
succinic semialdehyde dehydrogenase deficiency
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Single 5 mL intra-articular injection

FX006: Sustained Release Steroid
Eligibility criteria:
Inclusion Criteria:

Written consent to participate in the study
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month (as reported by the patient)
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health

Exclusion Criteria:

Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in the index knee joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
Presence of surgical hardware or other foreign body in the index knee
Unstable joint within 12 months of Screening
IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
Prior use of FX006
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Commercially available triamcinolone acetonide, single 1 mL intra-articular injection

TCA IR: Immediate Release Steroid
Eligibility criteria:
Inclusion Criteria:

Written consent to participate in the study
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month (as reported by the patient)
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health

Exclusion Criteria:

Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in the index knee joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
Presence of surgical hardware or other foreign body in the index knee
Unstable joint within 12 months of Screening
IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
Prior use of FX006
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: Ospemifene
Trial phase: Phase 3
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 317
Group description: Participants received one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject is postmenopausal.
Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion Criteria:

Subject has clinically significant abnormal findings in the physical examination.
Subject has a body mass index (BMI) equal to or greater than 38 kg/m^2
Subject has uncontrolled hypertension.
Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
Subject has uterine/vaginal bleeding of unknown origin.
Subject has a vaginal infection requiring medication (may be treated and be eligible for study).