anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Trifluoperazine
Trial phase: Phase 1 | Phase 2
ATC code: N05AB06
SMILES: CN1CCN(CCCN2c3ccccc3Sc3ccc(C(F)(F)F)cc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Cohort A: Three subjects will receive Trifluoperazine (TFP) 1 mg PO daily.

If there is no non-neurologic toxicity Grade 3 at the end of the 21 days, Cohort B will start.
If 1/3 subjects in Cohort A demonstrates toxicity Grade 3, an additional 3 subjects will be enrolled in Cohort A.
If 2 or more of the 6 subjects in Cohort A demonstrate toxicity Grade 3, the trial will be stopped; no MTD will be declared.
If less than 2 of the 6 subjects in Cohort A demonstrate toxicity Grade 3 within 21 days of starting therapy, Cohort B will start.

Trifluoperazine: Trifluoperazine (TFP)1mg, 2mg, 5mg, or 10mg will be given once daily by mouth for 21 days
Eligibility criteria:
Inclusion Criteria:

Men and women age: 18 years and <65 years of age.
Weight: ≥45 kilograms.
DBA diagnosed according to the DBA criteria (Vlachos, 2008)
RBC transfusion-dependence (defined as 2 units packed RBCs per 28 days averaged over 84 days [12 weeks] prior to study entry)
Calculated creatinine clearance > 30 mL/min
Karnofsky performance status scale score ≥ 70
Female subjects of childbearing potential must have a negative serum pregnancy test and use highly effective methods of birth control during the study
Male subjects must agree to use a latex condom during any sexual contact with females of childbearing potential while participating in the study
Agreement to adhere to the study visit schedule, understand and comply with all protocol requirements.

Exclusion Criteria:

Liver: aspartate aminotransferase (AST) > 5 x the upper limit of normal (ULN), alanine aminotransferase (ALT) >5 x ULN, or bilirubin > 5 x ULN
Heart disease (New York Heart Association classification of ≥ 3)
History of angina
Uncontrolled hypertension
Subjects currently responsive to corticosteroids for treatment of DBA.
Treatment with another investigational drug or device <56 days pre-study entry.
Pregnant or lactating females
Any history of severe allergic reaction requiring the use of epinephrine
Known hypersensitivity to the study drug or other phenothiazines
History or presence of extrapyramidal signs
History of cancer
Intervention: Ketorolac
Trial phase: Phase 3
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Ketorolac: Oral Ketorolac
Eligibility criteria:
Inclusion Criteria

Patients between the ages of 18 and 89 years old, male or female
Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

Patients below the age of 18 or above the age of 89
Illiterate or non-English speaking patients
Patients with contraindications to Ketorolac
History of alcohol of drug abuse
Chronic use of analgesic or psychotropic drugs
Known peptic ulcer disease or bleeding diathesis
Renal dysfunction
Intervention: Tofacitinib
Trial phase: Phase 3
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 286
Group description: Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
Eligibility criteria:
Key inclusion criteria

>=18 years of age
Has had RA for >=6 months and was not diagnosed before 16 years of age

Has active disease, as defined by having both*

>=6/68 tender/painful joint count (TJC), and
>=6/66 swollen joint count (SJC)
Has at least 1 bone erosion present on hand/wrist or foot radiographs

Has had an inadequate response to one or two of the csDMARDs:

methotrexate (MTX) 15-25 mg/week** oral or injected
hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
sulfasalazine up to 3000 mg/day
leflunomide up to 20 mg/day***
bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)

iguratimod up to 50 mg/day

If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons.

Key exclusion criteria

History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).
Intervention: Netarsudil
Trial phase: Phase 2 | 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: 10
Group description: Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner

Netarsudil: netarsudil opthalmic solution 0.02%
Eligibility criteria:
Inclusion Criteria:

Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
Is able and willing to administer eye drops
Is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

Active intraocular inflammation
Corneal ulceration, keratitis, or conjunctivitis
Known sensitivity to any of the ingredients in the study medications
Abnormal eyelid function
History of herpetic keratitis
History of non-compliance with using prescribed medication
Current or planned pregnancy within the study duration
Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Intervention: Hydrogen
Trial phase: Phase 2 | Phase 3
SMILES: [HH]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: The ingredient in the tablet producing H2 is magnesium. Each tablet contains 80 mg magnesium, a safe level well below the recommended daily dietary allowance of 420 mg for men/ 320 mg for women. Dissolving one tablet in 250 mL of water will achieve a saturating H2 concentration of approximately 1.6 ppm. Twice a day subjects will dissolve a tablet into water and drink the effervescent water.

Hydrogen: each hydrogen tablet contains 80mg magnesium
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Parkinson's Disease
Modified Hoehn & Yahr Stage < III
Diagnosis of Parkinson's Disease made within past 3 years•
Ability to complete questionnaires
Willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments

Exclusion Criteria:

Other major diseases of the central nervous system
History of stroke
Use of antipsychotic neuroleptic medication within the last 6 months
Symptomatic (secondary) parkinsonism
Atypical parkinsonian variants
Unstable medical or psychiatric illness
Known kidney disease
History of stereotactic brain surgery
Significant cognitive impairment
Inability to safely tolerate 8 ounces of water twice daily associated with the study medication
Unable to avoid regular use of medications containing magnesium
Treatment with another investigational drug within the last 30 days that may interfere with the study medication
Pregnancy or nursing
Intervention: [(1R,3R)-4-[(15Z,17E)-16-formyl-18-(4-hydroxy-2,2,6,6-tetramethylcyclohexyl)-3,7,12-trimethyl-14-oxooctadeca-2,4,6,8,10,12,15,17-octaenylidene]-3-hydroxy-3,5,5-trimethylcyclohexyl] acetate
Trial phase: Phase 2
SMILES: CC(=O)OC1CC(C)(C)C(=CC=C(C)C=CC=C(C)C=CC=CC(C)=CC(=O)C=C(C=O)C=CC2C(C)(C)CC(O)CC2(C)C)C(C)(O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator

In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:

History of

Pathergy (ulcer occurring at the sites of trauma)
Personal history of inflammatory bowel disease or inflammatory arthritis
History of papule, pustule or vesicle that rapidly ulcerated

Clinical examination (or photographic evidence) of

Peripheral erythema, undermining border, and tenderness at site of ulceration
Multiple ulcerations (at least 1 occurring on the lower leg)
Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers

Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening

Exclusion Criteria:

Pyoderma gangrenosum target ulcer for more than 3 years before screening
Surgical wound debridement within the previous 2 weeks before screening
Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
Intervention: [(1R,3R)-4-[(15Z,17E)-16-formyl-18-(4-hydroxy-2,2,6,6-tetramethylcyclohexyl)-3,7,12-trimethyl-14-oxooctadeca-2,4,6,8,10,12,15,17-octaenylidene]-3-hydroxy-3,5,5-trimethylcyclohexyl] acetate
Trial phase: Phase 2
SMILES: CC(=O)OC1CC(C)(C)C(=CC=C(C)C=CC=C(C)C=CC=CC(C)=CC(=O)C=C(C=O)C=CC2C(C)(C)CC(O)CC2(C)C)C(C)(O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator

In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:

History of

Pathergy (ulcer occurring at the sites of trauma)
Personal history of inflammatory bowel disease or inflammatory arthritis
History of papule, pustule or vesicle that rapidly ulcerated

Clinical examination (or photographic evidence) of

Peripheral erythema, undermining border, and tenderness at site of ulceration
Multiple ulcerations (at least 1 occurring on the lower leg)
Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers

Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening

Exclusion Criteria:

Pyoderma gangrenosum target ulcer for more than 3 years before screening
Surgical wound debridement within the previous 2 weeks before screening
Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
Intervention: Tofacitinib
Trial phase: Phase 3
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 273
Group description: Participants received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with MTX plus placebo injection weekly to maintain the blind for 52 weeks.
Eligibility criteria:
Key inclusion criteria

>=18 years of age
Has had RA for >=6 months and was not diagnosed before 16 years of age

Has active disease, as defined by having both:*

>=6/68 tender/painful joint count (TJC), and
>=6/66 swollen joint count (SJC)
Has at least 1 bone erosion present on hand/wrist or foot radiographs

Has had an inadequate response to MTX, despite currently taking MTX 15-25 mg/week** oral or injected

If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

Key exclusion criteria

Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved)
Has received prior treatment with a biologic Disease-modifying antirheumatic drug (DMARD) which has been discontinued due to an inadequate response.
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.

Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
Eligibility criteria:
Inclusion Criteria:

Patients less than 21 years of age
American Society of Anesthesiologists physical status I and II
Undergoing elective anterior cruciate ligament reconstruction

Exclusion Criteria:

They are unable or unwilling to take part in the study
History of allergy to any of the medications administered for the nerve block
Contraindication to peripheral nerve block
Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)

Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
Eligibility criteria:
Inclusion Criteria:

Patients less than 21 years of age
American Society of Anesthesiologists physical status I and II
Undergoing elective anterior cruciate ligament reconstruction

Exclusion Criteria:

They are unable or unwilling to take part in the study
History of allergy to any of the medications administered for the nerve block
Contraindication to peripheral nerve block
Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Intervention: Ibrexafungerp
Trial phase: Phase 3
ATC code: J02AX07
SMILES: [H][C@@]12CC[C@@]3([H])C(=CC[C@@]4(C)[C@H](C(=O)O)[C@@](C)([C@H](C)C(C)C)CC[C@]34C)[C@]13COC[C@@]2(C)[C@@H](OC[C@](C)(N)C(C)(C)C)[C@H](n1ncnc1-c1ccncc1)C3
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 298
Group description: 300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day
Eligibility criteria:
Inclusion Criteria:

Subject is a postmenarchal female subject 12 years and older
Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Exclusion Criteria:

Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
Need for systemic and/or topical (vaginal) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
Subject has uncontrolled diabetes mellitus.
Subject has a vaginal sample with pH >4.5.
Subject has a history of or an active cervical/vaginal cancer.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 470
Group description: 5 mg tirzepatide administered subcutaneously (SC) once a week.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin >1500 mg/day for at least 3 months prior to screening
Be of stable weight (±5%) for at least 3 months before screening
Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate <45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 469
Group description: 10 mg tirzepatide administered SC once a week.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin >1500 mg/day for at least 3 months prior to screening
Be of stable weight (±5%) for at least 3 months before screening
Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate <45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months