anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Etrasimod
Trial phase: Phase 2
ATC code: L04AE05
SMILES: O=C(O)C[C@H]1CCc2c1[nH]c1ccc(OCc3ccc(C4CCCC4)c(C(F)(F)F)c3)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
Eligibility criteria:
Key Inclusion Criteria:

Males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3 criteria:

Anti-mitochondrial antibodies (AMA) titer >1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies (anti-GP210 and/or anti-SP100)
Alkaline phosphatase (ALP) >1.5 x upper limit of normal (ULN) for at least 6 months
Liver biopsy findings consistent with PBC
Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening)
Participants must have ALP >1.5 x ULN but <10 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 x ULN, and total bilirubin <ULN, at all screening visits
AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other

Key Exclusion Criteria:

Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied with primary Sjögren's syndrome (pSS) are eligible to be enrolled.
History or evidence of clinically significant hepatic decompensation
Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
Clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis C virus anytime in the past
Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start
Treatment with obeticholic acid (OCA) within 30 days prior to Day 1

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Ciprofloxacin
Trial phase: Phase 4
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 4
Group description: Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Eligibility criteria:
Inclusion criteria

At least 1 of the following CT or MRI findings:

Peri-appendicular abscess
Extruded appendicolith
Visible hole in appendiceal wall
Free peritoneal air

OR

CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3 of the following (with CT) or 2 of 3 of the following (with MRI) *:

White blood cell count (WBC) >15
Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign, percussion tenderness, and/or rebound tenderness)
Temperature > 38.0 C *>90% specificity for complicated appendicitis based on unpublished institutional data

Exclusion Criteria

Immunocompromized state
History of major abdominal operation
Previous appendicitis
Major comorbidities that preclude safe operation
Inability to follow-up or appropriately consent
Pregnant women

Allergy to penicillin plus any one of the following:

Hypersensitivity to ciprofloxacin and/or metronidazole
Pregnant/lactating women
Patients taking theophylline
Patient taking tizanidine
Intervention: Reldesemtiv
Trial phase: Phase 2
SMILES: NC(=O)c1ccn(-c2cnc(NC[C@]3(c4ncccc4F)C[C@H](F)C3)nc2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of familial or sporadic ALS ≤ 24 months prior to screening
Upright Slow Vital Capacity (SVC) ≥ 60% of predicted for age, height and sex at screening
Able to swallow tablets
A caregiver (if one is needed)
Able to perform reproducible pulmonary function tests
Pre-study clinical laboratory findings within the normal range or, if outside the normal range, deemed not clinically significant by the Investigator
Male patients who have not had a vasectomy and confirmed zero sperm count must agree after receiving the first dose of study drug until 10 weeks after the last dose to either use acceptable methods of contraception or abstain from sex
Female patients must be post-menopausal or sterilized or must not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the study and use acceptable methods of contraception or abstain from heterosexual intercourse from Screening until 10 weeks after last dose of study drug
Patients must be either on riluzole for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and not planning to start riluzole during the course of the study.
Patients on edaravone must have completed at least 2 cycles of dosing with edaravone at the time of screening or have not taken edaravone for at least 30 days prior to screening and not planning to start edaravone during the course of the study.

Exclusion Criteria:

At the time of screening, any use of non-invasive ventilation (NIV), e.g. continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV] for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
Neurological impairment due to a condition other than ALS
Presence at screening of any medically significant cardiac, pulmonary, GI, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data
Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
Known to have received CK-2127107 or tirasemtiv in any previous clinical trial
Has received or is considering receiving during the course of the study any form of stem cell therapy for the treatment of ALS
Has received or is considering receiving during the course of the study any form of gene therapy for the treatment of ALS
Has received or is considering obtaining during the course of the study a diaphragmatic pacing system
History of substance abuse within the past 2 years
Use of certain medications
Intervention: Reldesemtiv
Trial phase: Phase 2
SMILES: NC(=O)c1ccn(-c2cnc(NC[C@]3(c4ncccc4F)C[C@H](F)C3)nc2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of familial or sporadic ALS ≤ 24 months prior to screening
Upright Slow Vital Capacity (SVC) ≥ 60% of predicted for age, height and sex at screening
Able to swallow tablets
A caregiver (if one is needed)
Able to perform reproducible pulmonary function tests
Pre-study clinical laboratory findings within the normal range or, if outside the normal range, deemed not clinically significant by the Investigator
Male patients who have not had a vasectomy and confirmed zero sperm count must agree after receiving the first dose of study drug until 10 weeks after the last dose to either use acceptable methods of contraception or abstain from sex
Female patients must be post-menopausal or sterilized or must not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the study and use acceptable methods of contraception or abstain from heterosexual intercourse from Screening until 10 weeks after last dose of study drug
Patients must be either on riluzole for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and not planning to start riluzole during the course of the study.
Patients on edaravone must have completed at least 2 cycles of dosing with edaravone at the time of screening or have not taken edaravone for at least 30 days prior to screening and not planning to start edaravone during the course of the study.

Exclusion Criteria:

At the time of screening, any use of non-invasive ventilation (NIV), e.g. continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV] for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
Neurological impairment due to a condition other than ALS
Presence at screening of any medically significant cardiac, pulmonary, GI, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data
Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
Known to have received CK-2127107 or tirasemtiv in any previous clinical trial
Has received or is considering receiving during the course of the study any form of stem cell therapy for the treatment of ALS
Has received or is considering receiving during the course of the study any form of gene therapy for the treatment of ALS
Has received or is considering obtaining during the course of the study a diaphragmatic pacing system
History of substance abuse within the past 2 years
Use of certain medications
Intervention: Reldesemtiv
Trial phase: Phase 2
SMILES: NC(=O)c1ccn(-c2cnc(NC[C@]3(c4ncccc4F)C[C@H](F)C3)nc2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of familial or sporadic ALS ≤ 24 months prior to screening
Upright Slow Vital Capacity (SVC) ≥ 60% of predicted for age, height and sex at screening
Able to swallow tablets
A caregiver (if one is needed)
Able to perform reproducible pulmonary function tests
Pre-study clinical laboratory findings within the normal range or, if outside the normal range, deemed not clinically significant by the Investigator
Male patients who have not had a vasectomy and confirmed zero sperm count must agree after receiving the first dose of study drug until 10 weeks after the last dose to either use acceptable methods of contraception or abstain from sex
Female patients must be post-menopausal or sterilized or must not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the study and use acceptable methods of contraception or abstain from heterosexual intercourse from Screening until 10 weeks after last dose of study drug
Patients must be either on riluzole for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and not planning to start riluzole during the course of the study.
Patients on edaravone must have completed at least 2 cycles of dosing with edaravone at the time of screening or have not taken edaravone for at least 30 days prior to screening and not planning to start edaravone during the course of the study.

Exclusion Criteria:

At the time of screening, any use of non-invasive ventilation (NIV), e.g. continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV] for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
Neurological impairment due to a condition other than ALS
Presence at screening of any medically significant cardiac, pulmonary, GI, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data
Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
Known to have received CK-2127107 or tirasemtiv in any previous clinical trial
Has received or is considering receiving during the course of the study any form of stem cell therapy for the treatment of ALS
Has received or is considering receiving during the course of the study any form of gene therapy for the treatment of ALS
Has received or is considering obtaining during the course of the study a diaphragmatic pacing system
History of substance abuse within the past 2 years
Use of certain medications
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Dexamethasone 48 mg pre-operative, single shot injection

Dexamethasone: intravenous
Eligibility criteria:
Inclusion Criteria:

planned unilateral periacetabular osteotomy
informed signed consent

Exclusion Criteria:

Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)
ongoing (<30 days) use of immunosuppressive therapy
insulin dependent diabetes
pregnancy/breastfeeding
allergies toward study medication, or medication in the standard treatment
surgery cannot be performed
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Dexamethasone 8 mg pre-operative, single shot injection

Dexamethasone: intravenous
Eligibility criteria:
Inclusion Criteria:

planned unilateral periacetabular osteotomy
informed signed consent

Exclusion Criteria:

Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)
ongoing (<30 days) use of immunosuppressive therapy
insulin dependent diabetes
pregnancy/breastfeeding
allergies toward study medication, or medication in the standard treatment
surgery cannot be performed
Intervention: SALICYLIC ACID
Trial phase: Phase 1
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: All subjects who were administered TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer).
Eligibility criteria:
Inclusion Criteria:

Healthy male or female between 18 and 65 years of age, non-smoker.
Body mass index >18.5 and <30.0 kg/m2
Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study.
Capable of consent.

Exclusion Criteria:

Any clinically significant abnormality or abnormal laboratory test results found during medical screening
Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening.
History of hypersensitivity to cyclobenzaprine, any of the formulation component, or other related drugs.
Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
Positive pregnancy test at screening.
Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening.
History of significant alcohol or drug abuse within one year prior to screening
Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
Breast-feeding subject.
Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue.
Intervention: SALICYLIC ACID
Trial phase: Phase 1
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: All subjects who were administered TNX-102 SL 2.8 mg white yellow tablet (original manufacturer).
Eligibility criteria:
Inclusion Criteria:

Healthy male or female between 18 and 65 years of age, non-smoker.
Body mass index >18.5 and <30.0 kg/m2
Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study.
Capable of consent.

Exclusion Criteria:

Any clinically significant abnormality or abnormal laboratory test results found during medical screening
Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening.
History of hypersensitivity to cyclobenzaprine, any of the formulation component, or other related drugs.
Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
Positive pregnancy test at screening.
Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening.
History of significant alcohol or drug abuse within one year prior to screening
Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
Breast-feeding subject.
Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue.
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: 44
Group description: Patients randomized to receive Sugammadex

Sugammadex: Sugammadex 2 mg/kg
Eligibility criteria:
Inclusion Criteria:

18-80 years old
Undergoing non-emergent thoracic surgery
ASA physical status classification 2 to 4
Willing and able to consent in English or Spanish
No personal history of neuromuscular disease

Exclusion Criteria:

Age less than 18 or older than 80
Patient does not speak English or Spanish
Planned postoperative intubation or ICU admission
Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
Family or personal history of malignant hyperthermia
Patient refusal
Monitored anesthesia care (MAC) or regional anesthesia planned
Pregnant or nursing women
"Stat" (emergent) cases
Estimated creatinine clearance <30 mL/min
Pre-existing muscle weakness of any etiology
Patients on toremifene (a selective estrogen receptor modulator)
Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery
Intervention: Tazarotene
Trial phase: Phase 3
ATC code: D05AX05 | D05AX55
SMILES: CCOC(=O)c1ccc(C#Cc2ccc3c(c2)C(C)(C)CCS3)nc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 392
Group description: IDP-123 (Tazarotene 0.045%) Lotion
Eligibility criteria:
Inclusion Criteria:

Male or female at least 9 years of age and older;
Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
Subjects with two or fewer nodules

Exclusion Criteria:

Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema;
Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
Subjects with a facial beard or mustache that could interfere with the study assessments;
Subjects with more than two (2) facial nodules;
Evidence or history of cosmetic-related acne
Intervention: Efinaconazole
Trial phase: Phase 3
ATC code: D01AC19
SMILES: C=C1CCN([C@H](C)[C@](O)(Cn2cncn2)c2ccc(F)cc2F)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings.
Involvement of at minimum 20% of the target great toenail.

Exclusion Criteria:

Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis
Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail
Inability to follow through with all requisite office visits
Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years.
Active interdigital tinea pedis refractory to topical antifungal treatments
Known hypersensitivity to efinaconazole
Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes
Any history of oral systemic antifungal with known activity against dermatophytes