anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Brensocatib
Trial phase: Phase 2
SMILES: Cn1c(=O)oc2ccc(-c3ccc(C[C@@H](C#N)NC(=O)[C@@H]4CNCCCO4)cc3)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion Criteria:

Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
Are current smokers
Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
Have any acute infections, (including respiratory infections)
Intervention: Vecuronium
Trial phase: Phase 4
ATC code: M03AC03
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(C)CCCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCCCC1)[C@@H](OC(C)=O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex.

Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) Physical status 1-3
age 50-75
English speaking
able to provide informed consent
BMI equal to less than 30
non-emergent THR by anterolateral minimally invasive non-cemented total hip arthroplasty

Exclusion Criteria:

Revision surgery
Bilateral THR
ASA 4+
age less than 50 or greater than 75
BMI greater than 30
unable to provide informed consent
women taking oral contraceptives (Sugammadex used for reversal interferes with their efficacy
contraindications to general inhalation anesthesia (such as malignant hyperthermia)
contraindications to NMB (known allergy to NMB)
chronic kidney disease
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: 79
Group description: Normal saline, administered as an intravenous drip

Normal saline: 100ml normal saline
Eligibility criteria:
Inclusion Criteria:

Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:

Traumatic injury to the head has occurred
Headache has developed within 7 days of injury to the head
Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)

The headache must be rated as moderate or severe in intensity at the time of initial evaluation.

Exclusion Criteria:

Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
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: 362
Group description: Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.

Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Must be of Asian descent
Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) viral load ≥ 1000 IU/ mL at Screening Visit.

Chronic HCV infection defined as one of the following:

Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
A liver biopsy consistent with chronic HCV infection
HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon[pegIFN] with or without ribavirin, OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed ≥ 8 weeks prior to screening.
Participant must be documented as non-cirrhotic.

Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:

Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening
Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ percent ≥ 29%)
On a stable, qualifying HIV-1 ART regimen with CD4+ count ≥ 200 cells/mm³ (or CD4+ % ≥ 14%) at Screening and plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.
Any cause of liver disease other than chronic HCV-infection.
HCV genotype performed during screening indicating co-infection with more than one HCV genotype
Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
Chronic human immunodeficiency virus, type 2 (HIV-2) infection

Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:

For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening
Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.
Intervention: Reserpine
Trial phase: Phase 2
ATC code: C02AA02 | C02AA52 | C02LA01 | C02LA51 | C02LA71
SMILES: [H][C@]12C[C@@H](OC(=O)c3cc(OC)c(OC)c(OC)c3)[C@H](OC)[C@@H](C(=O)OC)[C@@]1([H])C[C@]1([H])c3[nH]c4cc(OC)ccc4c3CCN1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.

Reserpine: Open label reserpine 0.1 mg pill orally
Eligibility criteria:
Inclusion Criteria:

- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

Exclusion Criteria:

congestive heart failure (EF 40%)
chronic kidney disease (GFR <40 ml/min/1.73 mm)
stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months
ongoing depression
active peptic ulcer disease
bradycardia <50 beats per minute
2nd or 3rd degree heart block
known intolerance of reserpine
use of digoxin or tricycle antidepressants
Intervention: Idoxuridine
Trial phase: Phase 3
ATC code: D06BB01 | J05AB02 | S01AD01
SMILES: O=c1[nH]c(=O)n([C@H]2C[C@H](O)[C@@H](CO)O2)cc1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.

Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
Eligibility criteria:
Inclusion Criteria:

18-65 years of age
Ability to give informed consent
Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria
Baseline pain measured by the subject ≥3.5/10 on visual analog scale

Exclusion Criteria:

Baseline pain measured by the subject <3.5/10 on visual analog scale
Central/Neuropathic pain disorder affecting the masticatory muscles
Temporomandibular Joint Arthralgia that is more severe than the myofascial pain disorder affecting the masticatory muscles
Previous Temporomandibular Joint Surgery
Systemic arthropathies
Fibromyalgia
Allergy to study medications
Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
Mandibular fracture within last 12 months
Pregnancy or breast feeding
Cervical radiculopathy or surgery
Prior botox injection in the masticatory muscles
Initiation of additional treatment of MPD within the past 3 months
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: 37
Group description: The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.

0.9% Sodium Chloride Injection: 1cc syringe
Eligibility criteria:
Inclusion Criteria:

18-65 years of age
Ability to give informed consent
Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria
Baseline pain measured by the subject ≥3.5/10 on visual analog scale

Exclusion Criteria:

Baseline pain measured by the subject <3.5/10 on visual analog scale
Central/Neuropathic pain disorder affecting the masticatory muscles
Temporomandibular Joint Arthralgia that is more severe than the myofascial pain disorder affecting the masticatory muscles
Previous Temporomandibular Joint Surgery
Systemic arthropathies
Fibromyalgia
Allergy to study medications
Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
Mandibular fracture within last 12 months
Pregnancy or breast feeding
Cervical radiculopathy or surgery
Prior botox injection in the masticatory muscles
Initiation of additional treatment of MPD within the past 3 months
Intervention: Capsaicin
Trial phase: Phase 2
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 0.1% capsaicin cream, one application

Capsaicin 0.1% Cream: Topical application
Eligibility criteria:
Inclusion Criteria:

suspected cyclical vomiting syndrome / cannabinoid hyperemesis
active severe nausea or vomiting in the emergency department

Exclusion Criteria:

pregnant women, children < 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)
Intervention: Chondroitin 4-sulfate
Trial phase: Phase 4
ATC code: M01AX25
SMILES: CC(=O)NC1C(O)OC(OS(=O)(=O)O)C(O)C1OC1OC(C(=O)O)C(O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.

PRO-087: 0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate
Eligibility criteria:
Inclusion Criteria:

>18 to < 90 years old
Both sexes
Mild to moderate tear film dysfunction clinical diagnose

Mild to moderate clinical stage of the disease

TBUT > 5 sec. and < 10 sec.
Schirmer: > 4 mm and < 14 mm
OSDI < 30 points
Corneal staining < grade III on the Oxford scale
Availability to go to each revision when indicated.

Exclusion Criteria:

General Criteria

Subjects with topical and/or systemic medication or mechanical devices that interfere determinedly on the results of the study (such as topical immunomodulators, punctal plugs, corticosteroids, preservative artificial tears, contact lenses).
Subjects (females) with active sexual life that do not use a contraceptive method.
Female subjects who are pregnant or lactating
Female subjects with a positive urine pregnancy test
Positive drug addictions* (verbal interrogatory)
Subjects who have participated on any other research clinical trials on the last 40 days
Subjects legal or mentally disabled to give an informed consent for participating on this study
Subjects who can't comply with the appointments or with every protocol requirement.

Criteria related with ophthalmic ailments

Serious tear film dysfunction syndrome TBUT < 5 s Schirmer: < 4 mm OSDI > 30 pints Corneal staining > grade III on the Oxford scale
Non perforated corneal ulcer
Perforated corneal ulcer
Autoimmune corneal ulcer
Ocular surface scarring diseases
Ocular surface or annexes metaplastic lesions
Fibro vascular proliferation lesions on the conjunctival and/or corneal surface (i.e.: pterygium)
Concomitant chronic inflammatory diseases on any ocular structure
Acute or infectious inflammatory disease
Corneal disease potentially requiring a treatment during the following 3 months
Use of topical or systemic drug products classified as forbidden
Ocular surgical procedures 3 months before the protocol inclusion
Treatments or procedures indicated on the tear film dysfunction treatment, as punctal silicone plugs.
Posterior segment diseases requiring a treatment or threatening the visual prognosis
Retinal diseases potentially requiring treatment during the following 3 months
History of penetrating keratoplasty.
Soft or hard contact lenses use during the last month from inclusion day
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 352
Group description: QAW039 150 mg
Eligibility criteria:
Inclusion Criteria:

A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
Demonstrated reversible airway obstruction.
Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.

A resting QTcF (Fridericia) ≥450 msec (male) or

≥460 msec (female).

Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Bupropion
Trial phase: Phase 2 | Phase 3
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Bupropion tablets taken twice daily for 5 weeks.

Bupropion: Bupropion
Eligibility criteria:
Key Inclusion Criteria:

Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

Exclusion Criteria:

Patient has dementia predominantly of non-Alzheimer's type.
Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the investigator.
Intervention: Elexacaftor
Trial phase: Phase 1 | Phase 2
ATC code: R07AX32
SMILES: Cc1nn(C)cc1S(=O)(=O)NC(=O)c1ccc(-n2ccc(OCC(C)(C)C(F)(F)F)n2)nc1N1C[C@@H](C)CC1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.
Eligibility criteria:
Key Inclusion Criteria:

Parts A, B, and C:

Female subjects must be of non-childbearing potential.
Between the ages of 18 and 55 years, inclusive.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Parts D, E, and F:

Body weight ≥35 kg.

Subjects must have an eligible CFTR genotype:

Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)
Part E: Homozygous for F508del (F/F)
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

Parts A, B, and C:

Any condition possibly affecting drug absorption.
History of febrile illness within 14 days before the first study drug dose.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Parts D, E, and F:

History of clinically significant cirrhosis with or without portal hypertension.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Lung infection with organisms associated with a more rapid decline in pulmonary status.
History of solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Elexacaftor
Trial phase: Phase 1 | Phase 2
ATC code: R07AX32
SMILES: Cc1nn(C)cc1S(=O)(=O)NC(=O)c1ccc(-n2ccc(OCC(C)(C)C(F)(F)F)n2)nc1N1C[C@@H](C)CC1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
Eligibility criteria:
Key Inclusion Criteria:

Parts A, B, and C:

Female subjects must be of non-childbearing potential.
Between the ages of 18 and 55 years, inclusive.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Parts D, E, and F:

Body weight ≥35 kg.

Subjects must have an eligible CFTR genotype:

Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)
Part E: Homozygous for F508del (F/F)
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

Parts A, B, and C:

Any condition possibly affecting drug absorption.
History of febrile illness within 14 days before the first study drug dose.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Parts D, E, and F:

History of clinically significant cirrhosis with or without portal hypertension.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Lung infection with organisms associated with a more rapid decline in pulmonary status.
History of solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Lvm0PK6ihg
Trial phase: Phase 1
SMILES: Cl.O=C(NC1CCOCC1)c1csc(C2CC2NCC2CC2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-418 5 mg, capsule, orally, once on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.
Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.

Female subjects with no childbearing potential, defined by at least 1 of the following criteria:

Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
Had a tubal ligation with appropriate documentation of surgical procedure.
Has a congenital condition resulting in no uterus.

Exclusion Criteria:

Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.