anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Trans sodium crocetinate
Trial phase: Phase 1 | Phase 2
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days

Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
Eligibility criteria:
Inclusion Criteria:

Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as SpO2 < 94% on room air or requiring supplemental oxygen
Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to enrollment.
WHO ordinal scale score of 3, 4 or 5 at baseline
Male or non-pregnant female adult ≥18 years of age at time of enrolment.
Subject (or legally authorized representative (LAR)) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Illness of any duration
Women of childbearing potential must have a negative blood pregnancy test at the screening/baseline visit (Day 1) and agree to use a double method of birth control through 30 days after the last dose of study drug.

Exclusion Criteria:

Intubated and mechanically ventilated at baseline
Receiving extracorporeal membrane oxygenation (ECMO) at baseline
Severe organ dysfunction (SOFA score > 10)
Patient or LAR unable to provide written informed consent
ALT/AST > 3 times the upper limit of normal or serum bilirubin > 1.5 times the upper limit of normal
Estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m^2 or on dialysis
Pregnancy or breast feeding.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Allergy to any study medication
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Subjects with statin related muscle complaints were enrolled in this arm and will have 3 visits. First visit is screening visit which will last for about 2 hrs and the next 2 visits will last for about 3.5 hrs. The screening visit will occur 2 weeks prior to visit 1.

Subjects will have height, weight and vitals measured. They will be asked pain and and demographic questionnaire. They will have their blood draw and will undergo MRS.

Some volunteers who do/do not regularly exercise or are/are not active in sports may be asked to exercise prior to the MRS. This exercise may be in the form of hand grasps, toe-raises, bicycling on a stationary bike or walking on a treadmill. Exercise will be limited to up to one hour, during which time the subject's vital signs and blood oxygenation will be monitored. During the scan, the subject's heart rate and respiratory rate may be monitored
Eligibility criteria:
Inclusion Criteria:

Adults age >18 yrs or <80 yrs Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness of legs.

Exclusion Criteria:

Patients who drink large quantities of grapefruit juice (>1 quart daily)
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Subjects with no statin related muscle complaints were enrolled in this arm and will have 3 visits. First visit is screening visit which will last for about 2 hrs and the next 2 visits will last for about 3.5 hrs. The screening visit will occur 2 weeks prior to visit 1.

Subjects will have height, weight and vitals measured. They will be asked pain and and demographic questionnaire. They will have their blood draw and will undergo MRS.

Some volunteers who do/do not regularly exercise or are/are not active in sports may be asked to exercise prior to the MRS. This exercise may be in the form of hand grasps, toe-raises, bicycling on a stationary bike or walking on a treadmill. Exercise will be limited to up to one hour, during which time the subject's vital signs and blood oxygenation will be monitored. During the scan, the subject's heart rate and respiratory rate may be monitored
Eligibility criteria:
Inclusion Criteria:

Adults age >18 yrs or <80 yrs Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness of legs.

Exclusion Criteria:

Patients who drink large quantities of grapefruit juice (>1 quart daily)
Intervention: Metronidazole
Trial phase: Phase 4
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days

Metronidazole: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Eligibility criteria:
Inclusion Criteria:

Pregnant women 18 to ≤50 years with the ability to give informed consent.
Patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening.
Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.
Gestational age ≥ 35 weeks

Exclusion Criteria:

Plan for elective cesarean delivery
Allergy or contraindications to metronidazole
Receipt of metronidazole or clindamycin on admission for delivery for other indications.
Hemodialysis
Severe liver dysfunction
Patient reports BV to nurse or clinician provider at current clinic visit or has been treated for BV within the past 3 months.
Intervention: Fostamatinib
Trial phase: Phase 2
ATC code: B02BX09
SMILES: COc1cc(Nc2ncc(F)c(Nc3ccc4c(n3)N(COP(=O)(O)O)C(=O)C(C)(C)O4)n2)cc(OC)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
Eligibility criteria:
INCLUSION CRITERIA:

Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.
Age >=18 years
Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug
Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment
Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale)

EXCLUSION CRITERIA:

ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST >= 3 x ULN and total bilirubin > 2 x ULN.
Estimated glomerular filtration rate (eGFR) <30ml/min
Pregnancy or breast feeding
Anticipated discharge in the next 72 hours
Allergy to study medication
Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
Shock or hypotension at the time of enrollment
Neutrophil count <1000/microliter
Concern for bacterial or fungal sepsis
Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6)
Received a live vaccine the last 4 weeks
Those who were cognitively impaired or mentally disabled prior to COVID diagnosis
Participation in another clinical trial for the treatment of COVID-19.
Intervention: Camostat mesylate
Trial phase: Phase 2
SMILES: CN(C)C(=O)COC(=O)Cc1ccc(OC(=O)c2ccc(N=C(N)N)cc2)cc1.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 195
Group description: Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.

Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
Eligibility criteria:
Inclusion Criteria:

Adults willing and able to provide informed consent before performing study procedures
Adults ≥18 years of age at time of informed consent
Participants must have written notification of laboratory confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed COVID-19
Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening

Participants must have at least 1 of the following risk factors for severe illness

Aged 65 years or older
Hypertension
Diabetes mellitus
Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)
Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy
Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)
Chronic liver disease, including cirrhosis
Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28
If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug

Exclusion Criteria:

Physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely
Known severe liver disease (eg, Child Pugh score > 12, AST >5 times upper limit)
SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg
Known allergic reaction to camostat mesilate or one of its excipients
Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m^2) or receiving dialysis
Pregnant or breastfeeding, or positive pregnancy test in a predose examination
Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off label use of a drug for COVID 19 is allowed.
History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)
Intervention: Mifepristone
Trial phase: Phase 2
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients will be provided a single dose of 600 milligram (mg) mifepristone to be administered orally, and subjects will be instructed to take the drug between 10PM and 11PM on Day 1.

Mifepristone: Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
Eligibility criteria:
Inclusion Criteria (1 of the following):

Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to present.
Are scheduled to complete ITT.
Are clinically suspected to have adrenal insufficiency but have not undergone ITT.

Exclusion Criteria:

Female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception.
Female patients not willing to use non-hormonal contraception for one month following treatment.
Women who are pregnant or breast feeding.
Patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone.
Patients on medications that are strong CYP3A
Patients taking other medications metabolized by CYP3A
Patients who have a history of QT prolongation and patients with any recent abnormal electrocardiogram (ECG).
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 122
Group description: Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection.

Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.

Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing primary total hip arthroplasty
Patients >=18 years of age
Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III
Primary THA (first THA operation in the patient's lifetime)

Exclusion Criteria:

Patients with ASA physical status classification 4 or above
Patients with allergies/intolerances to local anesthetic
Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
Patients on chronic opioid use or opioid tolerant (The FDA defines a patient as opioid tolerant if for at least 1 week he or she has been receiving oral morphine 60 mg/day; transdermal fentanyl 25 mcg/hour; oral oxycodone 30 mg/day; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day; or an equianalgesic dose of any other opioid)
Poor understanding of English language.
Patients with coexisting coagulopathy
Patients that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block would be contraindicated according to ASRA (American Society for Regional Anesthesia) guidelines
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants will receive varenicline 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation

Varenicline: varenicline: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks
Eligibility criteria:
Inclusion Criteria:

Ages 18-25 inclusive;
Self report of daily or near daily nicotine vaping for the prior ≥ 3 months, screening semi-quantitative urine cotinine positive for recent nicotine use, exhaled CO <10 ppm and score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI);
Self-report of no combusted tobacco use in the past 2 months at enrollment;
Total body weight at screening ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;
Report motivation to quit vaping in the next 30 days;
Able to understand study procedures and read and write in English;
Competent and willing to consent to participate in study procedures.

Exclusion Criteria:

Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
Unwillingness to abstain during the study from using smoking cessation aids other than those provided by the study;
Unstable medical condition, epilepsy, severe renal impairment;
Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate;
Prior adverse drug reaction to varenicline;
Unwilling to provide urine samples;
Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.

sugammadex: neuromuscular blockade reversal agent
Eligibility criteria:
Inclusion Criteria:

has diagnosis of COPD or ILD
ASA 3 or 4
procedure requires general anesthesia in the outpatient bronchoscopy suite
glomerular filtration rate > 30 ml/min

Exclusion Criteria:

pregnant women
prisoners
those unable to consent for themselves
procedures not requiring general anesthesia
ASA 1 or 2
Intervention: Netarsudil
Trial phase: Phase 3
ATC code: S01EE51 | S01EX05
SMILES: Cc1ccc(C(=O)OCc2ccc([C@@H](CN)C(=O)Nc3ccc4cnccc4c3)cc2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: 1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.

Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
Eligibility criteria:
Inclusion Criteria:

20 years of age or older
Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg in both eyes at screening visit
For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye).
For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye)
Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
Willingness and ability to give signed informed consent and follow study instructions

Exclusion Criteria:

Clinically significant ocular disease
Retinal diseases that may progress during the study period
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Previous glaucoma intraocular surgery
Refractive surgery in either eye
Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
Ocular trauma
Ocular infection or inflammation
Any corneal disease that may confound assessment
Evidence of corneal deposits or cornea verticillata
Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
Mean central corneal thickness >620 um
Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus)
Cannot demonstrate proper delivery of the eye drop
Clinically significant systemic disease
Participation in any investigational study within 30 days prior to screening
Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Intervention: Ripasudil hydrochloride dihydrate
Trial phase: Phase 3
ATC code: S01EX07
SMILES: CC1CNCCCN1S(=O)(=O)c1cccc2cncc(F)c12.Cl.O.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: 1 drop ripasudil twice daily in the morning and evening in each eye.

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
Eligibility criteria:
Inclusion Criteria:

20 years of age or older
Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg in both eyes at screening visit
For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye).
For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye)
Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
Willingness and ability to give signed informed consent and follow study instructions

Exclusion Criteria:

Clinically significant ocular disease
Retinal diseases that may progress during the study period
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Previous glaucoma intraocular surgery
Refractive surgery in either eye
Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
Ocular trauma
Ocular infection or inflammation
Any corneal disease that may confound assessment
Evidence of corneal deposits or cornea verticillata
Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
Mean central corneal thickness >620 um
Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus)
Cannot demonstrate proper delivery of the eye drop
Clinically significant systemic disease
Participation in any investigational study within 30 days prior to screening
Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.