anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fenofibrate
Trial phase: Phase 4
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Single arm. Participants will take study medication

Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes of at least one year's duration; stable glycemic control (no more than 1.0% change in HbA1c in the previous six months, but no limit on HbA1c)
Triglycerides >150 mg/dL (in the previous six months)

Exclusion Criteria:

Previous use of Fenofibrate or other fibrates
Pregnancy
Active malignancy
Recent cardiac event or congestive heart failure
Active liver disease
Significant renal impairment (serum creatinine > 2mg/dl)
Intervention: Adapalene
Trial phase: Phase 3
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.

Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots
Eligibility criteria:
Inclusion Criteria:

Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
Diagnosis of pulmonary disease requiring flexible bronchoscopy
Greater than 18 years of age.

Exclusion Criteria:

Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
Inability to tolerate bronchoscopy.
Patients that receive paralytics.
Patients with neuromuscular diseases.
Inability to consent for procedures.
Allergies to lidocaine or any other drugs used in protocol.
Existing renal insufficiency or liver disease
Intervention: Cromolyn Sodium
Trial phase: Phase 3
SMILES: O=C([O-])c1cc(=O)c2c(OCC(O)COc3cccc4oc(C(=O)[O-])cc(=O)c34)cccc2o1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.

Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
Eligibility criteria:
Inclusion Criteria:

Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
Diagnosis of pulmonary disease requiring flexible bronchoscopy
Greater than 18 years of age.

Exclusion Criteria:

Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
Inability to tolerate bronchoscopy.
Patients that receive paralytics.
Patients with neuromuscular diseases.
Inability to consent for procedures.
Allergies to lidocaine or any other drugs used in protocol.
Existing renal insufficiency or liver disease
Intervention: Ethanol
Trial phase: Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.

Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
Eligibility criteria:
Inclusion Criteria:

Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
Diagnosis of pulmonary disease requiring flexible bronchoscopy
Greater than 18 years of age.

Exclusion Criteria:

Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
Inability to tolerate bronchoscopy.
Patients that receive paralytics.
Patients with neuromuscular diseases.
Inability to consent for procedures.
Allergies to lidocaine or any other drugs used in protocol.
Existing renal insufficiency or liver disease
Intervention: Insulin lispro (5.97 MG)
Trial phase: Phase 3
SMILES: CC(C)CC(NC(=O)C(C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1cnc[nH]1)NC(=O)C(CO)NC(=O)CNC(=O)C(CS)NC(=O)C(CC(C)C)NC(=O)C(Cc1cnc[nH]1)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc1ccccc1)C(C)C)C(C)C)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CS)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc1ccccc1)C(=O)NC(Cc1ccccc1)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(C(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)O)C(C)O)C(C)O)C(C)C.CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC(CS)C(=O)NC(CS)C(=O)NC(C(=O)NC(CO)C(=O)NC(C(=O)NC(CS)C(=O)NC(CO)C(=O)NC(CC(C)C)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(N)=O)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CS)C(=O)NC(CC(N)=O)C(=O)O)C(C)CC)C(C)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 471
Group description: Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with T1D and continuously using insulin for at least 1 year
Have been using CSII therapy for a minimum of 6 months
Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days

Exclusion Criteria:

Have hypoglycemia unawareness
Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Saline will be used as the matching placebo

Saline: This will be the matching placebo used in the study.
Eligibility criteria:
Inclusion Criteria:

Age 18 or greater
Able to obtain informed consent from patient or appropriate designee

Possible autoimmune encephalitis as defined by Table 1:

Reasonable exclusion of alternative causes
Subacute onset (< 3 months) of memory deficits, altered consciousness, and/or psychiatric symptoms

One or more of the following:

CSF (cerebrospinal fluid) pleocytosis (>5 cells/µl corrected, if necessary, for traumatic lumbar puncture)
EEG (electroencephalogram) with epileptiform or focal slow wave abnormalities involving temporal lobes
Brain abnormalities on T2/FLAIR MRI restricted to the mesial temporal (limbic) lobes
Associated dyskinesias (faciobrachial dystonic movements or orofacial dyskinesias)
Completed initial treatment with iv steroids (at least 3000mg solumedrol) and plasma exchange (at least 3 exchanges) within the past 8 weeks

Presence of one (or more) of the following autoantibodies in serum or CSF

NMDA receptor
LGI1
CASPR2
DPPX

Exclusion Criteria:

Prior immunosuppression treatment in past year (other than steroids, intravenous immunoglobulin and plasma exchange)
Active malignancy requiring chemotherapy
Pregnancy
Evidence of active hepatitis or tuberculosis infection
Medical condition that (in investigators opinion) precludes the use of ocrelizumab
Intervention: Arimoclomol
Trial phase: Phase 3
ATC code: N07XX17
SMILES: [O-][n+]1cccc(C(Cl)=NOCC(O)CN2CCCCC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: 248 mg arimoclomol base 3 times daily
Eligibility criteria:
Inclusion Criteria:

Subject is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures, or in the circumstance that the subject is incompetent, informed consent/assent is provided in accordance with local regulation and/or procedures
Subject has completed the ORARIALS-01 trial (i.e., met one of the surrogate survival endpoints of tracheostomy or PAV or has completed the 76 weeks randomized treatment period)
Subject completed ORARIALS-01 while on treatment, where on treatment is defined as having taken the last dose of IMP within 2 weeks of the End of Trial visit (whether at week 76 or prior)

Exclusion Criteria:

Known or suspected allergy or intolerance to the IMP (Arimoclomol or constituents)
Exposure to any other investigational treatment, advanced therapy medicinal product or use of any other prohibited concomitant medications
Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants until 3 months after last dose. Pre-menopausal women must have a negative pregnancy test prior to dosing with trial medication.

Any of the following medically significant conditions:

Clinically significant renal or hepatic disease OR clinical laboratory assessment (results ≥ 3 times the upper limit of normal [ULN] for aspartate aminotransferase and/or alanine aminotransferase, bilirubin ≥ 2 times the ULN, or creatinine ≥ 1.5 times the ULN).
Any new condition or worsening of existing condition which, in the opinion of the investigator, would put the subject at undue risk.
Any serious adverse event or moderate/severe adverse event from the ORARIALS-01 trial which is ongoing at the time of transitioning to ORARIALS-02 and assessed as probably related to IMP
Intervention: Mepivacaine
Trial phase: Phase 2 | Phase 3
ATC code: N01BB03 | N01BB53
SMILES: Cc1cccc(C)c1NC(=O)C1CCCCN1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.

Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physiological status I-III (patient must meet criteria of a status I-III in the ASA Physical Status Classification System: I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease)
Unilateral primary TKA or THA
18+ years of age
Able to provide informed consent

Exclusion Criteria:

Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
Chronic opioid use (>1 mos) with OME >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
Body mass index (BMI) > 45 kg/m2
Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever)

Major systemic medical comorbidities such as:

Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
Contraindication to spinal anesthesia technique (e.g., known spinal stenosis, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame*). *Per ASRA guidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) held for at least 5 days, Rivaroxaban (Xarelto)held for at least 3 days, Warfarin (Coumadin)held for at least 5 days or recent INR of less than 1.4, Enoxaparin (Lovenox) with doses > 1 mg/kg held for close to 24 hours.
Known to be currently pregnant or actively breastfeeding. Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test. Female patients that do not meet this criterion will be asked to submit a urine sample, and will require a negative urine sample in order to proceed with study protocol. Urine sample be collected pre-procedurally.
Impaired cognition
Intervention: Apixaban
Trial phase: Phase 3
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Apixaban: Dosage either 5mg or 2.5mg for 2 years
Eligibility criteria:
Inclusion Criteria:

Non-valvular Atrial Fibrillation
CHA2DS2-VASc Score > or = to 2
Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month
Candidate for oral anticoagulation as assessed by a treating physician

Exclusion Criteria:

Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
Active Bleeding
Prior treatment with Apixaban >1 month
Recent stroke within 7 days
Dementia
Implanted devices not compatible with MRI/any cardiac implanted device
Claustrophobia
Active alcohol/drug abuse
Life expectancy < 1 year
Taking asprin with >100mg doses
Known hypersensitivity to warfarin or Apixaban
Severe renal insufficiency
Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring transfusion)
Psychosocial reasons that make study participation impractical
Currently enrolled in another IND or IDE trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the study.
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole, itraconazole, ritonavir, clarithromycin)
Need for dual anti-platelet therapy with aspirin and another agent such as thienopyridine
Intervention: Warfarin
Trial phase: Phase 3
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Warfarin: Dosage assessed by your treating physician for 2 years
Eligibility criteria:
Inclusion Criteria:

Non-valvular Atrial Fibrillation
CHA2DS2-VASc Score > or = to 2
Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month
Candidate for oral anticoagulation as assessed by a treating physician

Exclusion Criteria:

Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
Active Bleeding
Prior treatment with Apixaban >1 month
Recent stroke within 7 days
Dementia
Implanted devices not compatible with MRI/any cardiac implanted device
Claustrophobia
Active alcohol/drug abuse
Life expectancy < 1 year
Taking asprin with >100mg doses
Known hypersensitivity to warfarin or Apixaban
Severe renal insufficiency
Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring transfusion)
Psychosocial reasons that make study participation impractical
Currently enrolled in another IND or IDE trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the study.
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole, itraconazole, ritonavir, clarithromycin)
Need for dual anti-platelet therapy with aspirin and another agent such as thienopyridine
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Digital Pills containing Truvada ingested once daily as PrEP

Digital pill: Digital pills over encapsulating Truvada

Truvada: Truvada prescribed with digital pills for PrEP
Eligibility criteria:
Inclusion Criteria:

MSM (cisgender male)
Self-reported use of non-alcohol substances of abuse in past 6 months
Currently taking PrEP
Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
Age 18 or older

Exclusion Criteria:

Does not speak English
HIV positive
Identifies as transgender
Estimated creatinine clearance <60ml/min
Active hepatitis B treatment
Does not own a smartphone
Taking proton pump inhibitors
History of Crohn's disease or ulcerative colitis
History of bowel surgery, gastric bypass, bowel stricture
History of GI malignancy or radiation to abdomen
Unable/unwilling to ingest digital pill
Intervention: Netarsudil
Trial phase: Phase 2
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: 55
Group description: 1 drop daily into each eye in the evening for 28 days

Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Must be 20 years of age or older
Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
Able and willing to give signed informed consent and following study instructions

Exclusion Criteria:

Clinically significant ocular diseases
Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
Previous glaucoma intraocular surgery
Refractive surgery in either eye
Ocular trauma
Ocular infection or inflammation
Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
Cannot demonstrate proper delivery of the eye drop
Clinically significant abnormalities in screen lab tests
Clinically significant systemic disease
Participation in any investigational study within 30 days of screening
Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Intervention: Netarsudil
Trial phase: Phase 2
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: 54
Group description: 1 drop daily into each eye in the evening for 28 days

Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Must be 20 years of age or older
Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
Able and willing to give signed informed consent and following study instructions

Exclusion Criteria:

Clinically significant ocular diseases
Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
Previous glaucoma intraocular surgery
Refractive surgery in either eye
Ocular trauma
Ocular infection or inflammation
Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
Cannot demonstrate proper delivery of the eye drop
Clinically significant abnormalities in screen lab tests
Clinically significant systemic disease
Participation in any investigational study within 30 days of screening
Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Intervention: Netarsudil
Trial phase: Phase 2
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: 51
Group description: 1 drop daily into each eye in the evening for 28 days

Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Must be 20 years of age or older
Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
Able and willing to give signed informed consent and following study instructions

Exclusion Criteria:

Clinically significant ocular diseases
Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
Previous glaucoma intraocular surgery
Refractive surgery in either eye
Ocular trauma
Ocular infection or inflammation
Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
Cannot demonstrate proper delivery of the eye drop
Clinically significant abnormalities in screen lab tests
Clinically significant systemic disease
Participation in any investigational study within 30 days of screening
Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control