anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Omaveloxolone
Trial phase: Phase 2
SMILES: CC1(C)CC[C@]2(NC(=O)C(C)(F)F)CC[C@]3(C)[C@H](C(=O)C=C4[C@@]5(C)C=C(C#N)C(=O)C(C)(C)[C@@H]5CC[C@]43C)[C@@H]2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
Eligibility criteria:
Inclusion Criteria:

Be male or female and ≥18 years of age and ≤80 years of age
Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
Have an intraocular pressure (IOP) ≤5 mmHg in either eye
Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments
Intervention: Omaveloxolone
Trial phase: Phase 2
SMILES: CC1(C)CC[C@]2(NC(=O)C(C)(F)F)CC[C@]3(C)[C@H](C(=O)C=C4[C@@]5(C)C=C(C#N)C(=O)C(C)(C)[C@@H]5CC[C@]43C)[C@@H]2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
Eligibility criteria:
Inclusion Criteria:

Be male or female and ≥18 years of age and ≤80 years of age
Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
Have an intraocular pressure (IOP) ≤5 mmHg in either eye
Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments
Intervention: Lipoic acid
Trial phase: Phase 1 | Phase 2
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: lipoic acid and omega-3 fatty acids

Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid
Eligibility criteria:
Inclusion Criteria:

• A definite diagnosis of multiple sclerosis (MS) with relapsing remitting or secondary progressive course

Age 18 to 65 years, inclusive
A score two or more standard deviations below the mean in one or more of the following cognitive tests: PASAT, COWAT, CVLT -II, Stroop
Expanded Disability Status Scale (EDSS) 0-7.5, inclusive
Suboptimal omega-3 levels (plasma docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA] < 5.0% of total plasma fatty acids)
If taking MS disease modifying medications, on stable dose for > 6 months preceding enrollment
Able to read and write English

Exclusion Criteria:

• Moderate to severe depression (Beck Depression Inventory score > 19)

Any significant uncontrolled medical problem including diabetes requiring insulin.
MS relapse within the 30 days before screening
Abnormalities of coagulation or current use of prescription anticoagulants or antiplatelet agents. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are not excluded.
Fish intake of one 6 ounce serving > once a week less than 2 months prior to enrollment
Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 2 months prior to enrollment
Lipoic Acid supplementation less than 1 month prior to enrollment
Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
Epilepsy or history of seizures.
Pregnancy or women not using a reliable form of contraception
Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color plates or sustained nystagmus or diplopia on primary gaze
Inability to complete the neuropsychological test battery at the screening visit
Participation in another intervention study
Intervention: Boron
Trial phase: Phase 4
SMILES: [B]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: epidural anesthesia with 2% lidocaine 5ml before propofol TCI
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) I-II physical status,
aged 40-60 yr,
BMI 19-25 kg/m2,
undergoing elective gastrointestinal surgery

Exclusion Criteria:

patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.
Intervention: Ivacaftor
Trial phase: Early Phase 1
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: twice a day administration of Ivacaftor: 150mg

Ivacaftor
Eligibility criteria:
Inclusion Criteria:

Male or Female age 40-65
A clinical diagnosis of COPD as defined by GOLD
At Least a 10 pack year smoking history
Exhibit symptoms of chronic bronchitis defined by MRC
FEV1% predicted ≥ 35% and ≤70% Post Bronchodilator
Clinically stable in the last 4 weeks with no evidence of COPD exacerbation
Weight of 40 kg-120 kg
Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives
Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy

Exclusion Criteria:

Current Diagnosis of Asthma
Daytime use of Oxygen Therapy
Documented history of drug abuse within the last year
Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
Cirrhosis or elevated liver transaminases > 3X ULN
GFR < 50 estimated by Cockcroft-Gault
Any illness of abnormal lab finding that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant or Breastfeeding
Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit/grapefruit juice.
Uncontrolled Diabetes
Excluded medications and foods include the drugs and foods provided in the appendix document.
Clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator affect patient safety have been added as exclusion criteria and criteria for withdrawal.

Patients who have not been stable or have been hospitalized in the past 3 months with any clinically significant cardiac conditions.

Subjects with history of cancer (current or past, unless remote (>5years))except for localized non-melanomatous skin cancers History of Stroke/CVA History of myocardial infarction/acute coronary syndrome Cardiac Failure NYHC grade III-IV Diabetes Type I Uncontrolled Hypertension Primary or secondary pulmonary hypertension

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Intervention: Canagliflozin
Trial phase: Phase 2
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have type 1 diabetes mellitus (T1DM) for at least 1 year
Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of >= 7.0% to <= 9.0%) on basal plus bolus insulin at screening
Must have body mass index 21 to 35 kg/m2 inclusive
Must be on a total daily dose of insulin >= 0.6 IU/kg at screening
Must be on a stable insulin regimen for at least 8 weeks prior to screening

Exclusion Criteria:

History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
Diabetic ketoacidosis within 6 months prior to study start
History of hereditary glucose-galactose malabsorption or primary renal glycosuria
An ongoing, inadequately controlled thyroid disorder
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.

Metformin
Eligibility criteria:
Inclusion Criteria:

male or female patients with clinical diagnoses of schizophrenia or schizo-affective disorder
between 18 and 60 years of age
patients whose treating clinicians have recommended treatment with clozapine (and the patients have agreed and provided signed informed consent for treatment with clozapine)

Exclusion Criteria:

patients who have contraindications to metformin use, such as:

a diagnosis of congestive heart failure
renal impairment (serum creatinine > 1.5 in males; > 1.4 in females)
hepatic disease (AST or ALT > 2.0 times upper limit of normal (ULN)
positive hepatitis B surface antigen or hepatitis C antibody
total bilirubin>1.2x ULN; majority conjugated
metabolic acidosis (serum CO2 < lower limit of normal),
known hypersensitivity to metformin,
recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
alcohol abuse/dependence within the past month
concurrent treatment with drugs that are known to increase metformin blood levels including furosemide, nifedipine, and cationic drugs including cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, and vancomycin
patients with blood dyscrasias that could be worsened by added fish oil
women who are pregnant or breastfeeding
Intervention: Morphine sulfate pentahydrate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours

duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Eligibility criteria:
Inclusion Criteria:

anticipated pain level estimated to be in the lowest 20th percentile (calculated <34.3 utilizing our standard preoperative questionnaire)
age >/= 18
not allergic to any study medications to be utilized in this study
singleton pregnancy

Exclusion Criteria:

allergies to morphine or acetaminophen
diagnosis of a chronic pain disorder
weight >300 lbs
hepatic disease
Intervention: Sirolimus
Trial phase: Phase 1
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.

1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)
Eligibility criteria:
Inclusion Criteria:

Subjects must:

Be capable of understanding the purpose and risks of the study and sign a written Informed Consent Form (ICF)
Be male or female ≥ 16 years of age at the time of the screening visit
Have a confirmed diagnosis of PC by genotyping (e.g., familial) and clinically correlated painful keratoderma.
Have roughly symmetrical calluses of similar severity on the plantar surface of both feet
Women of childbearing potential must have a negative serum pregnancy test
Subjects, whether male or female, with reproductive potential and who are sexually active must agree to use double-barrier contraception methods

Exclusion Criteria:

A Subject with any of the following criteria is not eligible for inclusion in this study:

Use of other investigational drugs within 30 days of the screening visit and/or has not recovered from any side effects of prior investigational drugs or procedure in the affected area (e.g., a biopsy)
Significant condition in the dermatologic treatment area such as trauma, or nonhealing chronic wound
Pregnant or nursing (lactating) female, or a positive serum pregnancy test
Active infection either systemic or local near the site of treatment requiring chronic or prolonged use of antimicrobial agents
Known immunodeficiency including: Hepatitis A; Hepatitis B; Hepatitis C; Human Immunodeficiency Virus (HIV)

Prior and Current Treatment

Unable to be discontinued from drugs known to either be inducers or inhibitors of CYP3A4/5 enzymes
Unable to be discontinued from drugs known to be P-glycoprotein inhibitors
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 580
Group description: Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.

Intravenous Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Written informed consent
18-85 years old
above 50 kg
American Society of Anaesthesiologists Physical Status 1-3
Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
Patients with anticipated hospitalization of two nights
Expected to require parenteral opioids for at least 48 hours for postoperative pain
Able to use IV Patient-Controlled Analgesia systems

Exclusion Criteria:

Hepatic disease, e.g. twice the normal levels of liver enzymes
Kidney disease, e.g. twice the normal level of serum creatinine
Epidural analgesia or regional blocks (including Transverse abdominis plane block)
Acetaminophen sensitivity or known allergy
Female patients who are pregnant or breastfeeding
Patients taking warfarin
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 580
Group description: 0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.

Intravenous Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Written informed consent
18-85 years old
above 50 kg
American Society of Anaesthesiologists Physical Status 1-3
Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
Patients with anticipated hospitalization of two nights
Expected to require parenteral opioids for at least 48 hours for postoperative pain
Able to use IV Patient-Controlled Analgesia systems

Exclusion Criteria:

Hepatic disease, e.g. twice the normal levels of liver enzymes
Kidney disease, e.g. twice the normal level of serum creatinine
Epidural analgesia or regional blocks (including Transverse abdominis plane block)
Acetaminophen sensitivity or known allergy
Female patients who are pregnant or breastfeeding
Patients taking warfarin
Intervention: Spironolactone
Trial phase: Phase 4
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Spironolactone

Spironolactone: Patients will be given Spironolactone 12.5 mg on week 0 (visit 2). Patients will be escalated to 25 mg daily Spironolactone or maximal tolerated dose over a 4-week period. Patients will continue treatment for an additional 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female patients >45 or >40 years with known atherosclerotic events (examples include MI, Stroke) and able to provide informed consent (females must be either post-menopausal for one year, surgically sterile, or using effective contraception. Oral contraceptives are disallowed.
Patients with Type II Diabetes with HbA1c ≤ 9.0 on stable anti-glycemic regimen that may include oral and/or injectable therapy (GLP-1/Insulin etc.). Changes in dose of glycemic regimen is allowed during the course of the trial if felt to be clinically appropriate.
GFR <90 and evidence of proteinuria (Urine albumin/creatinine ratio of >30 mg/g or equivalent) in a urine specimen within 12 months OR GFR <60 mg/g regardless of proteinuria.
Patients must be on ACE and/or ARB therapy with no planned dose adjustments.

Exclusion Criteria:

Uncontrolled hypertension (SBP>160 and/or DBP>95 mmHg at visit 0 (screening) and SBP >145 mm Hg at visit 2).
GFR (MDRD) of <15 at Visit 0 (screening).
Hyperkalemia defined as serum K+≥ 5.1 meq/L at visit 0 (screening).
LDL cholesterol >150 mg/dl.
Plasma triglycerides >400 mg/dl.
Contraindications to MRI (metallic implants, severe claustrophobia).
Acute coronary syndrome, Transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months.
Evidence of a secondary form of hypertension.
Initiation of new therapy with statins, ACEI/ARB, anti-oxidants, CCBs, diuretics, β blockers.
Type I diabetes mellitus
Known contraindication, including history of allergy to Spironolactone.
. Any surgical or medical condition which might alter pharmacokinetics of drug (e.g. renal transplant, liver failure, liver transplant).
Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
Significant hyponatremia defined as Na <130 meq/L.
History of prior malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and localized Prostate cancer).
History of any severe, life-threatening disease.
Any surgical or medical conditions which places the patient at higher risk derived from his/her participation into the study, or likely to prevent patient from complying with requirements.
History of drug abuse within the last 2 years, noncompliance and unwillingness/inability to consent.
Pregnant women and nursing mothers.
Class III or IV Congestive Heart Failure.
Primary Hyperaldosteronism.